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Quality Assurance

Juhász, Csaba Peles, Ferenc

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Quality Assurance írta Juhász, Csaba és Peles, Ferenc

TÁMOP-4.1.2.A/1-11/1-2011-0009

University of Debrecen, Service Sciences Methodology Centre

Debrecen, 2013.

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Tartalom

Tárgymutató ....................................................................................................................................... 1 1. 1. Concept and importance of quality. Historical background ........................................................ 2

1. 1.1. Concept of quality .......................................................................................................... 2 2. 1.2. History of quality development ...................................................................................... 4 3. 1.3. Quality assurance professionals ..................................................................................... 6

2. 2. Concepts and basics of quality assurance ................................................................................. 10 1. 2.1. Terms relating to Quality Management ........................................................................ 10 2. 2.2. Evolution of Quality Management ............................................................................... 10

2.1. 2.2.1. Quality Inspection/Check (QCh) .................................................................. 10 2.2. 2.2.2. Quality Control (QC) .................................................................................... 11 2.3. 2.2.3. Total Quality Control (TQC) ........................................................................ 13 2.4. 2.2.4. Quality Assurance (QA) ............................................................................... 13 2.5. 2.2.5. Quality Management (QM) .......................................................................... 14 2.6. 2.2.6. Total Quality Management (TQM) ............................................................... 14

3. 3. Demand satisfaction .................................................................................................................. 16 1. 3.1. Concepts ....................................................................................................................... 16

1.1. Types of consumer demand satisfaction: ................................................................ 19 1.2. Stages of the demand satisfaction process: ............................................................ 20

2. 3.2. Characteristics of demand satisfaction process‘ quality ............................................... 20 2.1. Components of quality ............................................................................................ 20 2.2. Temporality of quality – reliability ......................................................................... 20 2.3. Acceptable risk of quality – safety: ........................................................................ 22 2.4. Product conformance; fitness for use ...................................................................... 23 2.5. CE marking ............................................................................................................. 24

4. 4. National quality control system ................................................................................................ 25 1. 4.1. National quality control ................................................................................................ 25 2. 4.2. Three main parts of national quality control system .................................................... 25

2.1. 4.2.1. Technical legal regulatory system ................................................................ 26 2.1.1. 4.2.1.1. Standardization, metrology ........................................................... 26 2.1.2. 4.2.1.2. General technical regulation system .............................................. 26 2.1.3. 4.2.1.3. Official technical regulation system .............................................. 26

2.2. 4.2.2. Judicial regulatory system ............................................................................ 27 2.2.1. 4.2.2.1. Protection of consumer .................................................................. 27 2.2.2. 4.2.2.2. Protection of producers ................................................................. 28 2.2.3. 4.2.2.3. Protection of market ...................................................................... 28 2.2.4. 4.2.3. Support - promoting system ............................................................. 28

3. Safety in the agri-food chain ............................................................................................... 28 4. Most commonly used systems in some sectors ................................................................... 31 5. Quality management systems in agriculture sector practice ............................................... 32

5. 5. Good practices .......................................................................................................................... 34 1. 5.1. Good Manufacturing Practice (GMP) .......................................................................... 34 2. 5.2. Good Hygiene Practice (GHP) ..................................................................................... 36

2.1. 5.2.1. Pre-requisite programs .................................................................................. 36 2.1.1. 5.2.1.1. Premises and facilities ................................................................... 36 2.1.2. 5.2.1.2. Personnel training, hygiene and practices ..................................... 38 2.1.3. 5.2.1.3. Sanitation and cleaning ................................................................. 39 2.1.4. 5.2.1.4. Pest control .................................................................................... 40 2.1.5. 5.2.1.5. Equipment ..................................................................................... 40 2.1.6. 5.2.1.6. Transportation, receiving, storage, and shipping ........................... 41 2.1.7. 5.2.1.7. Traceability and recall ................................................................... 41 2.1.8. 5.2.1.8. Chemical control ........................................................................... 41

3. 5.3. Good Agricultural and Environmental Condition and Good Farming Practice ........... 42 3.1. 5.3.1. ―Cross-compliance‖ ...................................................................................... 42 3.2. 5.3.2. Statutory Management Requirements (SMRs) ............................................. 42 3.3. 5.3.3. Good Agricultural and Environmental Condition (GAEC) .......................... 42

4. 5.4. Good Agricultural Practice (GAP) ............................................................................... 43

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5. 5.5. European System Related to Good Agricultural Practice (EUREPGAP) .................... 44 6. 6. HACCP ..................................................................................................................................... 50

1. 6.1. Food Safety .................................................................................................................. 50 2. 6.2. Food safety hazards ...................................................................................................... 50

2.1. 6.2.1. Biological hazards ........................................................................................ 50 2.2. 6.2.2. Chemical hazards .......................................................................................... 51 2.3. 6.2.3. Physical hazards ........................................................................................... 52 2.4. 6.2.4. Definitions .................................................................................................... 52

3. 6.3. Hazard Analysis and Critical Control Point (HACCP) ................................................ 52 3.1. 6.3.1. History of the HACCP system ...................................................................... 53 3.2. 6.3.2. Seven principles of HACCP ......................................................................... 53 3.3. 6.3.3. Components of HACCP ............................................................................... 54 3.4. 6.3.4. The Codex Alimentarius Logic Sequence for the Application of HACCP ... 55

7. 7. ISO 9000 family of standards ................................................................................................... 58 1. 7.1. The evolution of the ISO 9000 quality system standards ............................................. 58 2. 7.2. Principles and fundamentals of quality management systems ..................................... 59

2.1. 7.2.1. Quality management principles .................................................................... 59 2.2. 7.2.2. Fundamentals of quality management systems ............................................. 60

3. 7.3. ISO 9000 and ISO 9001 ............................................................................................... 62 3.1. 7.3.1. Contents of ISO 9001:2008 .......................................................................... 62 3.2. 7.3.2. Process approach and PDCA ........................................................................ 62 3.3. 7.3.3. Documentation requirements ........................................................................ 64 3.4. 7.3.4. Management responsibility ........................................................................... 65

3.4.1. 7.3.4.1. Management commitment ............................................................. 65 3.4.2. 7.3.4.2. Customer focus .............................................................................. 66 3.4.3. 7.3.4.3. Quality policy ............................................................................... 66 3.4.4. 7.3.4.4. Planning ....................................................................................... 66 3.4.5. 7.3.4.5. Responsibility, authority and communication ............................... 66 3.4.6. 7.3.4.6. Management review (input and output) ........................................ 66

3.5. 7.3.5. Resource management .................................................................................. 66 3.5.1. 7.3.5.1. Provision of resources ................................................................... 66 3.5.2. 7.3.5.2. Human resources ........................................................................... 66 3.5.3. 7.3.5.3. Infrastructure ................................................................................. 66 3.5.4. 7.3.5.4. Work environment ........................................................................ 66

3.6. 7.3.6. Product realization ........................................................................................ 67 3.6.1. 7.3.6.1. Planning of product realization ..................................................... 67 3.6.2. 7.3.6.2. Customer-related processes ........................................................... 67 3.6.3. 7.3.6.3. Design and development ............................................................... 67 3.6.4. 7.3.6.4. Purchasing ..................................................................................... 67 3.6.5. 7.3.6.5. Production and service provision .................................................. 67 3.6.6. 7.3.6.6. Control of monitoring and measuring equipment .......................... 67

3.7. 7.3.7. Measurement, analysis and improvement ..................................................... 67 3.7.1. 7.3.7.1. Monitoring and measurement ........................................................ 67 3.7.2. 7.3.7.2. Control of nonconforming product ................................................ 68 3.7.3. 7.3.7.3. Analysis of data ............................................................................. 68 3.7.4. 7.3.7.4. Improvement ................................................................................. 68

3.8. 7.3.8. Benefits of ISO 9001 .................................................................................... 68 8. 8. ISO 14000 family of standards ................................................................................................. 69

1. 8.1. Environmental policy ................................................................................................... 69 2. 8.2. Environmental Management System (EMS) ................................................................ 69

2.1. 8.2.1. Benefits of Environmental Management System .......................................... 69 2.2. 8.2.2. Risks of Environmental Management System .............................................. 70 2.3. 8.2.3. ISO 14000 family of standards ..................................................................... 70 2.4. 8.2.4. Economic benefits of ISO 14000 family of standards .................................. 72 2.5. 8.2.5. The 17 requirements of the ISO 14001:2004 standard ................................ 72 2.6. 8.2.6. Principles of ISO 14001:2004 ....................................................................... 73

9. 9. ISO 22000 family of standards ................................................................................................. 74 1. 9.1. Food safety management systems (FSMS) .................................................................. 74

1.1. 9.1.1. Introduction .................................................................................................. 75 1.2. 9.1.2. Interactive communication ........................................................................... 75

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1.3. 9.1.3. Requirements of standard (Fig. 21): ............................................................ 76 1.4. 9.1.4. Alignment and integration ............................................................................ 77 1.5. 9.1.5. ISO 22000 and HACCP ................................................................................ 78 1.6. 9.1.6. Hazard analysis ............................................................................................. 78 1.7. 9.1.7. The aim of this International Standard .......................................................... 78 1.8. 9.1.8. Terms and definitions ................................................................................... 79 1.9. 9.1.9. Food safety management system .................................................................. 79 1.10. 9.1.10. Management responsibility ....................................................................... 80 1.11. 9.1.11. Resource management .............................................................................. 80 1.12. 9.1.12. Planning and realization of safe products ................................................. 81 1.13. 9.1.13. Validation, verification and improvement of the food safety management system

........................................................................................................................................ 82 10. 10. Integrated systems ................................................................................................................ 83

1. 10.1. Integrated Management Systems (IMS) ..................................................................... 83 2. 10.2. Characteristics of Integrated Management Systems ................................................... 83 3. 10.3. When should we build a system? ............................................................................... 85 4. 10.4. Structure of system documentation ............................................................................ 86 5. 10.5. The advantages of Integrated Management Systems ................................................. 86 6. 10.6. Integrating Systems for business success ................................................................... 87

11. 11. TQM ..................................................................................................................................... 88 1. 11.1. General characteristics of Total Quality Management ............................................... 88 2. 11.2. History of TQM .......................................................................................................... 89 3. 11.3. Definition of TQM ..................................................................................................... 90 4. 11.4. Principles of TQM ...................................................................................................... 91 5. 11.5. Eight key elements of TQM ....................................................................................... 93 6. 11.6. Benefits of TQM include ............................................................................................ 94

12. 12. EFSIS, BRC, IFS .................................................................................................................. 95 1. 12.1. EFSIS ......................................................................................................................... 95 2. 12.2. BRC ............................................................................................................................ 95

2.1. 12.2.1. Contents of BRC Global Standard for Food Safety - Issue 6 ..................... 96 2.2. 12.2.2. Key changes ................................................................................................ 97 2.3. 12.2.3. BRC Food Safety Management System Implementation ........................... 97

3. 12.3. International Food Standard (IFS) .............................................................................. 98 3.1. 12.3.1. IFS Food version 6 ..................................................................................... 99 3.2. 12.3.2. Structure/recognition of IFS ....................................................................... 99

13. 13. Quality awards .................................................................................................................... 101 1. 13.1. Deming prize ............................................................................................................ 101 2. 13.2. Malcolm Baldrige National Quality Award ............................................................. 102 3. 13.3. EFQM Excellence Award (European Quality Award) ............................................. 104

14. 14. Quality tools and techniques ............................................................................................... 107 1. 14.1. Check sheet .............................................................................................................. 107 2. 14.2. Pareto analysis (80-20 rule) ...................................................................................... 108 3. 14.3. Histogram ................................................................................................................. 109 4. 14.4. Scatter diagram ......................................................................................................... 110 5. 14.5. Cause and effect diagram ......................................................................................... 111 6. 14.6. Control chart ............................................................................................................ 112 7. 14.7. Flowchart ................................................................................................................. 113 8. 14.8. Seven steps to problem solving ................................................................................ 114

8.1. 14.8.1. Define and identify the problem ............................................................... 114 8.2. 14.8.2. Analyze the problem ................................................................................. 114 8.3. 14.8.3. Identifying possible solutions ................................................................... 114 8.4. 14.8.4. Selecting the best solutions ....................................................................... 115 8.5. 14.8.5. Evaluating solutions .................................................................................. 115 8.6. 14.8.6. Develop an action plan ............................................................................. 115 8.7. 14.8.7. Implement the solution ............................................................................. 115

15. 15. Accreditation and certification ............................................................................................ 116 1. 15.1. Concepts of conformity assessment and standards of conformity assessment ......... 116 2. 15.2. ISO/IEC 17011:2004 ............................................................................................... 117

2.1. 15.2.1. Contents of ISO/IEC 17011:2004 ............................................................. 118 2.2. 15.2.2. Terms and definitions ............................................................................... 118

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2.3. 15.2.3. Accreditation body .................................................................................... 119 2.4. 15.2.4. Accreditation process ................................................................................ 120

3. 15.3. Organizations of international accreditation ............................................................ 120 4. 15.4. ISO/IEC 17021:2011 ................................................................................................ 122

4.1. 15.4.1. Contents of ISO/IEC 17021:2011 ............................................................. 122 4.2. 15.4.2. Terms and definitions ............................................................................... 123

5. 15.5. ISO 19011:2011 ....................................................................................................... 123 5.1. 15.5.1. Contents of ISO 19011:2011 .................................................................... 123 5.2. 15.5.2. Terms and definitions ............................................................................... 123 5.3. 15.5.3. Principles of auditing ................................................................................ 124 5.4. 15.5.4. Managing an audit programme ................................................................. 124 5.5. 15.5.5. Performing an audit .................................................................................. 125 5.6. 15.5.6. Competence and evaluation of auditors .................................................... 128

16. References ................................................................................................................................ 130 17. Questions .................................................................................................................................. 133

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Az ábrák listája

1.1. Fig. 1: Quality loop (Juhász – Szőllősi, 2008) ............................................................................. 3 1.2. Fig. 2: Levels of quality (Juhász – Szőllősi, 2008) ...................................................................... 4 2.1. Table 1: Characteristics of Quality Check (Topár, 2005; Nagy, 2007) ..................................... 11 2.2. Table 2: Characteristics of Quality Control (Topár, 2005; Nagy, 2007) ................................... 12 2.3. Table 3: Characteristics of Quality Assurance (Topár, 2005; Nagy, 2007) ............................... 14 2.4. Table 4: Characteristics of Total Quality Management (Topár, 2005; Nagy, 2007) ................. 15 3.1. Fig. 3: Concepts relating to quality (ISO 9000:2005) ................................................................ 16 3.2. Fig. 4: Concepts relating to organization (ISO 9000:2005) ....................................................... 17 3.3. Fig. 5: Concepts relating to process and product (ISO 9000:2005) ........................................... 17 3.4. Fig. 6: Consumer demand satisfaction process .......................................................................... 18 3.5. Fig. 7: Types of consumer demand satisfaction (Veress et al., 2005) ........................................ 19 3.6. ig. 8: Concepts relating to conformity (ISO 9000:2005) ........................................................... 22 3.7. Fig. 9: Flow diagram of decisions on conformance and fitness for use (Juran - Godfrey, 1999) 23 4.1. Fig. 10: Legally binding guidelines and concepts as well as standards under private law to assure food

safety (Jouve et al., 1998; Luning et al., 2006) ................................................................................. 28 4.2. Fig. 11: Food safety tools – An integrated approach for microbiological hazards in food (Crossley -

Motarjemi, 2011) .............................................................................................................................. 30 4.3. Fig. 12: Quality management systems in agriculture sector practice (Juhász – Szőllősi, 2008) 32 5.1. Fig. 13: GLOBALG.A.P. standards ........................................................................................... 46 6.1. Fig. 14: HACCP decision tree ................................................................................................... 56 7.1. Fig. 15: Model of a process-based QMS (ISO 9000:2005) ....................................................... 63 7.2. Fig. 16: PDCA cycle (Juhász – Szőllősi, 2008) ......................................................................... 64 7.3. Fig. 17: Concepts relating to documentation (ISO 9000: 2005) ................................................ 64 8.1. Fig. 18: PDCA cycle (Juhász – Szőllősi, 2008) ......................................................................... 72 9.1. Fig. 19: Principle of ISO 22000 ................................................................................................. 74 9.2. Fig. 20: Example of communication within the food chain (ISO 22000) .................................. 75 9.3. Fig. 21: ISO 22000 pyramid ...................................................................................................... 76 9.4. Fig. 22: ISO 9001 and ISO 22000 ............................................................................................. 77 9.5. Fig. 23: Advantages of ISO 22000 certification ........................................................................ 78 10.1. Fig. 24: Integrated Management Systems (Juhász – Szőllősi, 2008) ....................................... 83 10.2. Fig. 25: Integrated Management Systems (Juhász – Szőllősi, 2008) ....................................... 84 10.3. Fig. 26: Requirements of Integrated Management System (Juhász – Szőllősi, 2008) ............. 84 10.4. Fig. 27: Integrated System documentations (Juhász – Szőllősi, 2008) .................................... 86 11.1. Fig. 28: The five pillars of TQM ............................................................................................. 88 11.2. Fig. 29: Structure of TQM ....................................................................................................... 90 11.3. Fig. 30: Model of TQM ........................................................................................................... 91 11.4. Fig. 31: TQM pyramid (Dahlgaard et al., 2007) ...................................................................... 92 11.5. Fig. 32: Continuous improvements and their consequences (Dahlgaard et al., 2007) ............. 93 13.1. Fig. 33: Deming prize model ................................................................................................. 101 13.2. Fig. 34: Schematic diagram of Baldrige award model ........................................................... 103 13.3. Fig. 35: Model for the European Quality Award ................................................................... 105 14.1. Table 5: Check sheet (self-made) .......................................................................................... 107 14.2. Fig. 36: Check-list check sheet (Dahlgaard et al., 2007) ....................................................... 107 14.3. Table 6: Data collected from production process (self-made) ............................................... 108 14.4. Fig. 37: Pareto chart (self-made) ........................................................................................... 109 14.5. Fig. 38: Histogram ................................................................................................................. 109 14.6. Fig. 39: Scatter diagram ......................................................................................................... 110 14.7. Fig. 40: Cause and effect diagram ......................................................................................... 111 14.8. Fig. 41: Control chart ............................................................................................................. 112 14.9. Fig. 42: Flowchart .................................................................................................................. 113 15.1. Fig. 43: Conformity assessment system ................................................................................. 116 15.2. Fig. 44: Flowchart (ISO/IEC 17011:2004) ............................................................................ 118 15.3. Fig. 45: Accreditation bodies ................................................................................................. 120 15.4. Fig. 46: Organizations of international accreditation (self-made) ......................................... 121 15.5. Fig. 47: Typical audit activities (ISO 19011:2011) ............................................................... 125 15.6. Fig. 48: Overview of the process of collecting and verifying information (ISO 19011:2011) 127

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15.7. Table 7: Possible evaluation methods (ISO 19011:2011) ...................................................... 128

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Tárgymutató


1. fejezet - 1. Concept and importance of quality. Historical background

1. 1.1. Concept of quality

Quality is interpreted and used in many ways in everyday life. If we ask a few people about their definition of

quality, we will get as many different answers as the number of people we have asked, with definitions

including the appropriate specifications, reliability and compliance with standards, legislation, good service

network, durability, comfort and useful knowledge, expertise, kindness, courtesy, fast service, aesthetic

appearance, packaging, fashion, competitiveness and reputation, status symbols, energy-saving,

environmentally-friendly product, price, economy, timeliness, timely delivery, etc.

Today, there is no single universal definition of quality. Some people view quality as ―performance to

standards‖. Others view it as ―meeting the customer‘s needs‖ or ―satisfying the customer‖. Let‘s look at some of

the more common definitions of quality.

Conformance to specifications measures how well the product or service meets the targets and tolerances

determined by its designers.

Fitness for use focuses on how well the product performs its intended function or use.

Value for price paid is a definition of quality that consumers often use for product or service usefulness. This is

the only definition that combines economics with consumer criteria; it assumes that the definition of quality is

price sensitive.

Support services provided are often how the quality of a product or service is judged. Quality does not apply

only to the product or service itself; it also applies to the people, processes, and organizational environment

associated with it.

“Psychological criteria” is a subjective definition that focuses on the judgmental evaluation of what constitutes

product or service quality. Different factors contribute to the evaluation, such as the atmosphere of the

environment or the perceived prestige of the product.

The "quality" is extremely complex and diverse concept, in addition to relative and subjective category, too. The

quality concept of complexity takes a diversity of interpretations.

In principle, allocated to three qualities of interpretation, which are the following:

1. Standards-based, mostly manufacturers of quality interpretation;

2. Market, consumer, commercial quality interpretation;

3. Multiple simultaneous use of the term.

Philip Crosby defines quality as being ―conformance to requirements‖ and recommends using statistical analysis

to measure and control the quality of a process.

Edwards Deming concentrated on the ―efficient production of the quality that the market expects‖.

Joseph M. Juran: „Fitness for use. Fitness is defined by the customer‖.

A few examples of the interpretation of quality in the case of markets, consumers and commercial interests:

• The common element of business definitions is that the quality of a product or service refers to the perception

of the degree to which the product or service meets the customer's expectations. Quality has no specific

meaning unless related to a specific function and/or object. Quality is a perceptual, conditional and somewhat

subjective attribute.

• ―Quality is defined as meeting the direct needs of each user/ consumer‖ (Juran).

1. Concept and importance of

quality. Historical background


• ―The quality of the product or service is of all the characteristics which make it possible to match direct or

indirect needs. Quality: usability, safety, feasibility, accessibility, sustainability, etc.‖ (Freund).

• Groocock defines quality as the degree to which the relevant features and characteristics of a product/service

satisfy all aspects of customer‗s needs, limited by the price and delivery the customer will accept.

The most common definition: the quality of a product or service is all the characteristics which make it suitable

to meet the expected demands. This formulation combines the standards-based and market-based quality of

thinking.

Quality is the degree to which a set of inherent characteristics fulfils requirements. Requirement is need or

expectation expressed which is usually self-evident or required (ISO 9000).

Customer expectations are the anticipated characteristics and performance of the goods or service. There are

three levels of customer expectation related to product attributes. The ―expected‖ level of quality represents the

minimum or ―must be‖ attributes. We cannot drive satisfaction up with these attributes because they are taken

for granted, but if performance of the basic attributes is poor then strong dissatisfaction will result. At the

―unitary‖ (or desired) level, better performance leads to greater satisfaction but (in a limited time period) usually

in small increments. For the ―attractive‖ (or surprising) level, better performance results in delighted customers

because the attributes or the level of performance are a pleasant surprise to the customers. Of course, these

attributes must be translated into the product design.

From viewpoint of modern approach of quality is not just a product, but quality of complete production process.

To achieve adequate quality contain quality spiral (quality loop) (Fig. 1).

1.1. ábra - Fig. 1: Quality loop (Juhász – Szőllősi, 2008)

Factors affecting the quality are market, money, management, men (manpower), motivation, materials,

machines (and mechanization), modern information methods and mounting product requirement.




Levels of quality

Aspect of Japanese thinking, quality has 4 different levels (Fig. 2). Ranking and grouping of different quality

levels known by the literature. Most of them agree with that the lowest level of quality is compliance with

standard and the highest level is compliance with customer‘s latent, not known needs. Because of the market

competition, the first three level of conformity must be met in any event, and the fourth one is competitive edge.

1.2. ábra - Fig. 2: Levels of quality (Juhász – Szőllősi, 2008)

2. 1.2. History of quality development

Quality has been part of human life, culture, and history from its earliest beginnings and it has always had two

aspects. One aspect, represented by the 11,000-year-old Sphinx at Giza, is beauty. Indefinable and alluring,

beauty draws us, adding richness to our lives. Another aspect is represented at Giza as well; the 5000-year-old

Great Pyramid – still standing – represents the functional quality of great engineering.

The concepts of inspection and inspectors are of ancient origin. Wall paintings and reliefs in Egyptian tombs

show the inspections used during stone construction projects. The measuring instruments included the square,

level, and plumb bob for alignment control. Surface flatness of stones was checked by ―boning rods‖ and by

threads stretched across the faces of the stone blocks.

The ―Book of the Dead‖ is an ancient Egyptian funerary text, used from the beginning of the New Kingdom.

The text consists of a number of magic spells intended to assist a dead person's journey through the Duat, or

underworld, and into the afterlife.

The ―Book of the Dead‖ is made up of a number of individual texts and their accompanying illustrations. At

present, some 192 spells are known, though no single manuscript contains them all. They served a range of

purposes. Some are intended to give the deceased mystical knowledge in the afterlife, or perhaps to identify

them with the gods. Others are incantations to ensure the different elements of the dead person's being were

preserved and reunited, and to give the deceased control over the world around him. Still others protect the

deceased from various hostile forces, or guide him through the underworld past various obstacles.




Governments have long involved themselves in managing for quality. Their purposes have included protecting

the safety and health of citizens, defending and improving the economics of the state, and protecting consumers

against fraud. Each of these purposes includes some aspect of managing for quality. Early forms of protection of

safety and health were after-the fact measures. The Code of Hammurabi (c. 2000 B.C.) prescribed the death

penalty for any builder of a house that later collapsed and killed the owner. In medieval times, the same fate

awaited the baker who inadvertently had mixed rat poison with the flour.

Qin Shi Huangdi was the king of the Chinese State of Qin from 246 BC to 221 BC, during the Warring States

Period. He became the first emperor of a unified China in 221 BC. He ruled until his death in 210 BC at the age

of 49.

He undertook gigantic projects, including building and unifying various sections of the Great Wall of China, the

now famous city-sized mausoleum guarded by the life-sized Terracotta Army, and a massive national road

system, all at the expense of numerous lives.

In the imperial court all material to be marked. It was the ancestor of trademark.

Roman roads were a vital part of the development of the Roman state, from about 500 BC through the

expansion during the Roman Republic and the Roman Empire. Roman roads enabled the Romans to move

armies and trade goods and to communicate.

The Roman road system spanned more than 400,000 km of roads, including over 80,500 km of paved roads. The

Romans became adept at constructing roads, which they called viae. To make the roads the Romans used stones,

broken stones mixed with cement and sand, cement mixed with broken tiles, curving stones - so the water could

drain, and on the top they used tightly packed paving stones.

The laws of the Twelve Tables, dated to approximately 450 BC, specified that a road shall be 2.45 m wide

where straight and 4.90 m where curved. Actual practices varied from this standard.

The Romans had a preference for standardization whenever they could.

The quality movement can trace its roots back to medieval Europe, where craftsmen began organizing into

unions called guilds in the late 13th century.

From the end of the 13th century to the early 19th century, craftsmen across medieval Europe were organized

into unions called guilds. These guilds were responsible for developing strict rules for product and service

quality. Inspection committees enforced the rules by marking flawless goods with a special mark or symbol.

Craftsmen themselves often placed a second mark on the goods they produced. At first this mark was used to

track the origin of faulty items. But over time the mark came to represent a craftsman‘s good reputation. For

example, stonemasons‘ marks symbolized each guild member‘s obligation to satisfy his customers and enhance

the trade‘s reputation.

Inspection marks and master-craftsmen marks served as proof of quality for customers throughout medieval

Europe. This approach to manufacturing quality was dominant until the Industrial Revolution in the early 19th

century.

Until the early 19th century, manufacturing in the industrialized world tended to follow this craftsmanship

model. The factory system, with its emphasis on product inspection, started in Great Britain in the mid-1750s

and grew into the Industrial Revolution in the early 1800s.

American quality practices evolved in the 1800s as they were shaped by changes in predominant production

methods: craftsmanship, the factory system, the Taylor system.

Craftsmanship: In the early 19th century, manufacturing in the United States tended to follow the

craftsmanship model used in the European countries. In this model, young boys learned a skilled trade while

serving as an apprentice to a master, often for many years.

Since most craftsmen sold their goods locally, each had a tremendous personal stake in meeting customers‘

needs for quality. If quality needs weren‘t met, the craftsman ran the risk of losing customers not easily

replaced. Therefore, masters maintained a form of quality control by inspecting goods before sale.




The Factory System: The factory system, a product of the Industrial Revolution in Europe, began to divide the

craftsmen‘s trades into specialized tasks. This forced craftsmen to become factory workers and forced shop

owners to become production supervisors, and marked an initial decline in employees‘ sense of empowerment

and autonomy in the workplace.

Quality in the factory system was ensured through the skill of laborers supplemented by audits and/or

inspections. Defective products were either reworked or scrapped.

The Taylor System: Late in the 19th century the United States broke further from European tradition and

adopted a new management approach developed by Frederick W. Taylor. Taylor‘s goal was to increase

productivity without increasing the number of skilled craftsmen. He achieved this by assigning factory planning

to specialized engineers and by using craftsmen and supervisors, who had been displaced by the growth of

factories, as inspectors and managers who executed the engineers‘ plans.

Taylor‘s approach led to remarkable rises in productivity, but it had significant drawbacks: Workers were once

again stripped of their dwindling power, and the new emphasis on productivity had a negative effect on quality.

To remedy the quality decline, factory managers created inspection departments to keep defective products from

reaching customers. If defective product did reach the customer, it was more common for upper managers to ask

the inspector, ―Why did we let this get out?‖ than to ask the production manager, ―Why did we make it this way

to begin with?‖

In the early 20th century, manufacturers began to include ―quality processes‖ in quality practices. A ―process‖ is

defined as a group of activities that takes an input, adds value to it and provides an output, such as when a chef

transforms a pile of ingredients into a meal.

The concept of quality as we think of it now first emerged out of the Industrial Revolution. Previously goods

had been made from start to finish by the same person or team of people, with handcrafting and tweaking the

product to meet „quality criteria‖. Mass production brought huge teams of people together to work on specific

stages of production where one person would not necessarily complete a product from start to finish.

In the late 1800s pioneers such as Frederick Winslow Taylor and Henry Ford recognized the limitations of

the methods being used in mass production at the time and the subsequent varying quality of output.

Taylor established Quality Departments to oversee the quality of production and rectifying of errors, and Ford

emphasized standardization of design and component standards to ensure a standard product was produced.

Management of quality was the responsibility of the Quality Department and was implemented by Inspection of

product output to „catch‖ defects. Application of statistical control came later as a result of World War

production methods.

Quality management systems are the outgrowth of work done by W. Edwards Deming, a statistician, after

whom the Deming Prize for quality is named.

Quality, as a profession and the managerial process associated with the quality function, was introduced during

the second-half of the 20th century, and has evolved since then.

Over this period, few other disciplines have seen as many changes as the quality profession. The quality

profession grew from simple control, to engineering, to systems engineering.

Quality control activities were predominant in the 1940s, 1950s, and 1960s.

The 1970s were an era of quality engineering and the 1990s saw quality systems as an emerging field. Like

medicine, accounting, and engineering, quality has achieved status as a recognized profession.

3. 1.3. Quality assurance professionals

Frederick Winslow Taylor (1856-1915)

He was an American mechanical engineer, who sought to improve industrial efficiency. He is sometimes called

―the father of scientific management‖, and he was one of the first management consultants. He was one of the




intellectual leaders of the Efficiency Movement and part of his approach laid further foundations for quality

management regarding aspects like standardization and adopting improved practices.

Walter Andrew Shewhart (1891-1967)

He was an American physicist, engineer and statistician. He was a statistician at Bell Labs during the 1920s and

1930s. Shewhart studied randomness and recognized that variability existed in all manufacturing processes.

He is recognized for his pioneering work in bringing together the disciplines of statistics, engineering, and

economics. This work is the subject of his book “Economic Control of Quality of Manufactured Product”. He

has authored books on Statistical Quality Control (SQC) and is best known for creating the control chart.

He sometimes had known as the ―father of Statistical Quality Control‖. He made a major step in the evolution of

quality management by creating a method for quality control for production, using statistical methods (first

proposed in 1924). This became the foundation for his ongoing work on SQC.

The concept of the PDCA cycle was originally developed by Shewhart (further developed by W. Edwards

Deming).

He developed quality control charts that are used to identify whether the variability in the process is random or

due to an assignable cause, such as poor workers or miscalibrated machinery. He stressed that eliminating

variability improves quality.

William Edwards Deming (1900-1993)

He was an American statistician, professor, author, lecturer and consultant. Deming often referred to as the

―father of quality control.‖ He was a statistics professor at New York University in the 1940s. After World War

II (1950s) he assisted many Japanese companies in improving quality.

He applied statistical process control methods in the United States during World War II, thereby successfully

improving quality in the manufacture of munitions and other strategically important products. The Japanese

regarded him so highly that in 1951 they established the Deming Prize, an annual award given to firms that

demonstrate outstanding quality. It was almost 30 years later that American businesses began adopting

Deming‘s philosophy.

Deming outlined his philosophy on quality in his famous ―14 points‖. These points are principles that help guide

companies in achieving quality improvement. The principles are founded on the idea that upper management

must develop a commitment to quality and provide a system to support this commitment that involves all

employees and suppliers. Deming stressed that quality improvements cannot happen without organizational

change that comes from upper management.

Deming has authored several books in the field of quality management and is also recognized for his expertise

in Statistical Quality Control (SQC). He began to introduce SQC into industrial operations.

PDCA was made popular by Deming; however, he always referred to it as the "Shewhart cycle". Later in

Deming's career, he modified PDCA to "Plan, Do, Study, Act" (PDSA) because he felt that "check" emphasized

inspection over analysis.

Joseph Moses Juran (1904-2008)

After Deming, Juran is considered to have had the greatest impact on quality management. Juran originally

worked in the quality program at Western Electric. He became better known in 1951, after the publication of his

book “Quality Control Handbook”.

In 1954 he went to Japan to work with manufacturers and teach classes on quality. Though his philosophy is

similar to Deming‘s, there are some differences. Whereas Deming stressed the need for an organizational

―transformation,‖ Juran believes that implementing quality initiatives should not require such a dramatic change

and that quality management should be embedded in the organization.

One of Juran‘s significant contributions is his focus on the definition of quality and the cost of quality. Juran is

credited with defining quality as fitness for use rather than simply conformance to specifications.




Juran is also credited with developing the concept of cost of quality, which allows us to measure quality in

dollar terms rather than on the basis of subjective evaluations.

Juran is well known for originating the idea of the quality trilogy: quality planning, quality control, and quality

improvement. The first part of the trilogy, quality planning, is necessary so that companies identify their

customers, product requirements, and overriding business goals. Processes should be set up to ensure that the

quality standards can be met. The second part of the trilogy, quality control, stresses the regular use of statistical

control methods to ensure that quality standards are met and to identify variations from the standards. The third

part of the quality trilogy is quality improvement. According to Juran, quality improvements should be

continuous as well as breakthrough. Together with Deming, Juran stressed that to implement continuous

improvement workers need to have training in proper methods on a regular basis.

Juran began to apply the Pareto principle (also known as the 80–20 rule) to quality issues (80% of a problem is

caused by 20% of the causes).

Philip Bayard Crosby (1926-2001)

He was a businessman and author who contributed to management theory and quality management practices.

He developed the phrase ―Do it right the first time‖ (DIRFT) and the notion of zero defects, arguing that no

amount of defects should be considered acceptable. DRIFT was Crosby's response to the quality crisis. He

initiated the Zero Defects program at the Martin Company Orlando (Florida) plant.

He scorned the idea that a small number of defects are a normal part of the operating process because systems

and workers are imperfect. Instead, he stressed the idea of prevention.

To promote his concepts, Crosby wrote a book titled “Quality is free”, which was published in 1979. He

became famous for coining the phrase ―quality is free‖ and for pointing out the many costs of quality, which

include not only the costs of wasted labour, equipment time, scrap, rework, and lost sales, but also

organizational costs that are hard to quantify. Crosby stressed those efforts to improve quality more than pay for

them because these costs are prevented. Therefore, quality is free.

Like Deming and Juran, Crosby stressed the role of management in the quality improvement effort and the use

of statistical control tools in measuring and monitoring quality.

He was one of the recognized guru in the area of TQM. He would also include four major principles.

Crosby‘s ―four absolutes of quality‖ form the cornerstone of his process:

1. Quality is conformance to the requirements: Management must communicate in no uncertain terms to

employees all the actions that are necessary to run an organization, produce a product or service and deal

with customers and help them comply through leadership, training and cultivating a culture of cooperation in

the organization.

2. Prevention is the system of quality: The only system that produces quality is prevention since eliminating

errors after they occur is costly. Crosby‘s approach to prevention is training, leadership, discipline and

example. Thus, management must commit itself to a culture that is prevention-oriented.

3. ―Zero defect‖ is the performance standard: This is in line with Crosby‘s fundamental view about quality and

its generation. Management has the duty to provide employees with the tools, skills and other resources to

facilitate the production of zero-defect products and services.

4. Price of non-conformance is the measure of quality.

Crosby believes that if management adheres to these ―four absolutes of quality,‖ they will succeed in decreasing

the costs as quality improved, leading him to state that ―quality is free but not a gift‖.

Armand Vallin Feigenbaum (1922-)

He is an American quality control expert and businessman. He was director of Manufacturing Operations at

General Electric.




Feigenbaum introduced the concept of Total Quality Control (TQC). In his 1961 book „Total Quality Control”,

he outlined his quality principles in 40 steps. Feigenbaum took a total system approach to quality. He promoted

the idea of a work environment where quality developments are integrated throughout the entire organization,

where management and employees have a total commitment to improve quality, and people learn from each

other‘s successes. This philosophy was adapted by the Japanese and termed ―company-wide quality control‖.

Kaoru Ishikawa (1915-1989)

Kaoru Ishikawa was a Japanese university professor and influential quality management innovator. He is best

known for the development of quality tools called cause-and-effect diagrams, also called fishbone or Ishikawa

diagrams. These diagrams are used for quality problem solving, and we will look at them in detail later in the

chapter. He was the first quality guru to emphasize the importance of the ―internal customer,‖ the next person in

the production process. He was also one of the first to stress the importance of total company quality control,

rather than just focusing on products and services.

Dr. Ishikawa believed that everyone in the company needed to be united with a shared vision and a common

goal. He stressed that quality initiatives should be pursued at every level of the organization and that all

employees should be involved.

Dr. Ishikawa was a proponent of implementation of quality circles, which are small teams of employees that

volunteer to solve quality problems.

Shoji Shiba (1933- )

Prof. Shoji Shiba is an international expert in Total Quality Management (TQM) and Breakthrough

Management. Globally he is best known for developing the "Five step discovery process" for Breakthrough

Management.

He is a Deming Prize winner in an individual capacity for propagating TQM amongst corporates and

governments. He has authored books like ―A New American TQM”, “Integrated Management Systems”, “Four

Practical Revolutions in Management” and “Breakthrough Management”.

Shiba has also diffused TQM concepts to industry and governments of various countries, including Chile,

China, France, Hungary, Ireland, Italy, Malaysia, Norway, Portugal, Spain, Sweden, Switzerland, Thailand,

USA, the United Kingdom, and the former USSR.

The IIASA-Shiba Quality Award was created by the International Institute for Applied System Analysis

(IIASA) based in Austria and by Professor Shoji Shiba (in 1989), who introduced TQM to industry in Hungary.


2. fejezet - 2. Concepts and basics of quality assurance

1. 2.1. Terms relating to Quality Management

Quality Management System: management system to direct and control an organization with regard to quality.

Quality policy: overall intentions and direction of an organization related to quality as formally expressed by

top management.

Quality objective: something sought, or aimed for, related to quality.

Quality Management: coordinated activities to direct and control an organization with regard to quality

(quality planning, -control, -assurance, -improvement).

Quality planning: focused on setting quality objectives and specifying necessary operational processes and

related resources to fulfil the quality objectives.

Quality control: focused on fulfilling quality requirements.

Quality assurance: focused on providing confidence that quality requirements will be fulfilled.

Quality improvement: focused on increasing the ability to fulfil quality requirements.

2. 2.2. Evolution of Quality Management

2.1. 2.2.1. Quality Inspection/Check (QCh)

The Industrial Revolution began in Europe during the mid-eighteenth century. Its origin was the simultaneous

development of power-driven machinery and sources of mechanical power. It gave birth to factories that soon

outperformed the artisans and small shops and made them largely obsolete.

By the late 1800s, many things were being made in factories, using powerful furnaces and engines, powered

tools, assembly lines, and inspection. At the end of each assembly line, every single component or product was

inspected to make sure that it either met specifications or that it worked. Items that didn‘t work were either

discarded or reworked.

The Factory System: Destruction of Crafts. The goals of the factories were to raise productivity and reduce

costs. Under the craft system, productivity had been low due to primitive technology, whereas costs had been

high due to the high wages of skilled artisans. To reach their goals, the factories reengineered the manufacturing

processes. Under the craft system, an artisan performed every one of the numerous tasks needed to produce the

final product. Under the factory system, the tasks within a craft were divided up among several or many factory

workers. Special tools were designed to simplify each task down to a short time cycle. A worker then could, in a

few hours, carry out enough cycles of his or her task to reach high productivity. The broad economic result of

the factory system was mass production at low costs. This made the resulting products more affordable and

contributed to economic growth in industrialized countries, as well as to the associated rise of a large ―middle

class‖.

Quality Control under the Factory System. The factory system required associated changes in the system of

quality control. When craft tasks were divided among many workers, those workers were no longer their own

customers, over and over again. The responsibility of workers was no longer to provide satisfaction to the buyer

(also customer, user).

Mass production also brought new technological problems. Products involving assemblies of bits and pieces

demanded interchangeability of those bits and pieces. Then, with the growth of technology and of interstate

commerce, there emerged the need for standardization as well. All this required greater precision throughout

machinery, tools, measurement.

2. Concepts and basics of quality

assurance


Given the limitations of quality planning, what emerged was an expansion of inspection by departmental

supervisors supplemented by full-time inspectors. Where inspectors were used, they were made responsible to

the respective departmental production supervisors. The concept of a special department to coordinate quality

activities broadly also had to await the coming of the twentieth century.

The Taylor System of Scientific Management. A further blow to the craft system came from F. W. Taylor‘s

system of ―scientific management.‖ This originated in the late nineteenth century when Taylor, an American

manager, wanted to increase production and productivity by improving manufacturing planning. His solution

was to separate planning from execution. He brought in engineers to do the planning, leaving the shop

supervisors and the work force with the narrow responsibility of carrying out the plans.

Taylor‘s system was stunningly successful in raising productivity. It was widely adopted in the United States

but not so widely adopted elsewhere. It had negative side effects in human relations, which most American

managers chose to ignore. It also had negative effects on quality. The American managers responded by taking

the inspectors out of the production departments and placing them in newly created inspection departments. In

due course, these departments took on added functions to become the broad-based quality departments of today.

Frederick Winslow Taylor, mechanical engineer, who sought to improve industrial efficiency. He is sometimes

called "the father of scientific management". He was one of the intellectual leaders of the Efficiency Movement

and part of his approach laid a further foundation for quality management, including aspects like standardization

and adopting improved practices.

Check all end products. The production and the final product inspection were separated. Taylor established

Quality Departments to oversee the quality of production and rectifying of errors.

Management of quality was the responsibility of the Quality Department and was implemented by inspection of

product output to „catch‖ defects (Table 1).

2.1. ábra - Table 1: Characteristics of Quality Check (Topár, 2005; Nagy, 2007)

Disadvantages of Quality Check:

• Does not provide the further development,

• There are ongoing conflicts between the production and quality departments,

• Its methods are mainly concerns the determination of the error at the end of the process,

• Senior managers are completely broken away from the quality function.

2.2. 2.2.2. Quality Control (QC)

Quality Control (QC) has two meanings. The narrow meaning refers to statistical quality control, where we test

a small sample of the entire product batch and extrapolate to define qualities of the entire batch. In the broader


assurance


use, quality control is synonymous with checking. It refers to all activities of review, inspection, and testing of

the product or its technical process, with or without sampling and statistics (Table 2).

Walter Shewhart was the next great figure in the history of quality management. After working as a professor of

physics, he joined Western Electric in 1918, and then moved to Bell Labs at its founding in 1924 and remained

there until 1956. The central focus of his work was statistical quality control (called at the time statistical

process control). Now, it is generally referred to as Quality Control, though it is important to remember that

quality control is simply inspection plus statistics. Shewhart also developed an approach called Plan, Do, Check,

Act (PDCA) which is essential to quality management, both in statistical quality control and also more generally

in continuous improvement.

Quality Control is a process by which entities review the quality of all factors involved in production. This

approach places an emphasis on three aspects:

• Elements such as controls, job management, defined and well managed processes, performance and integrity

criteria, and identification of records.

• Competence, such as knowledge, skills, experience, and qualifications.

• Soft elements, such as personnel integrity, confidence, organizational culture, motivation, team spirit, and

quality relationships.

Quality Control emphasizes testing of products to uncover defects, and reporting to management who make the

decision to allow or deny the release.

Walter A. Shewhart made a major step in the evolution towards quality management by creating a method for

quality control for production, using statistical methods, first proposed in 1924. This became the foundation for

his ongoing work on statistical quality control.

While PDCA can apply to both general efforts to improve quality and more technical engineering

improvements, statistical quality control is the core of the more advanced engineering side of quality

management. Shewhart developed the methods at Bell Labs, and they were included in best practices from the

U.S. military for providing war materiel during World War II. Once again, the demand for large quantities of

high-quality weapons drove the improvement in quality methods. In this case, the issue was the high cost and

delays created by the requirement that every single item had to be inspected after manufacture and before

delivery. Shewhart found a way to apply statistical sampling to the process of inspection.

He developed control charts and other tools for this work. Proper application of statistical theories about how to

choose the sample, and then measurement of the sample to control limits that were tighter tolerances than

customer requirements, could allow confidence that if, say, 10% of an entire batch was within the tighter

tolerances, and the sample met certain other requirements, then the entire batch would meet customer

requirements.

2.2. ábra - Table 2: Characteristics of Quality Control (Topár, 2005; Nagy, 2007)


assurance


2.3. 2.2.3. Total Quality Control (TQC)

TQC is a Japanese model, associated to Armand Vallin Feigenbaum.

Total Quality Control is application of quality management principles to all areas of business from design to

delivery instead of confining them only to production activities. Popularized by the US quality pioneer Armand

Vallin Feigenbaum in his 1951 book „'Total Quality Control‖.

This is a system for optimizing production based on ideas developed by Japanese industries from the 1950s on.

This system blends Western and Eastern ideas, began with the concept of quality circles. It gradually evolved

into various techniques involving both workers and managers to maximize productivity and quality, including

close monitoring of staff and excellent customer service.

A quality circle (QC) is a small group of employees who meet periodically to solve quality problems related to

their job. Participation is usually voluntary, although there may be considerable organizational and peer pressure

to become involved. Often, members are trained in problem solving, data gathering, and statistical methods that

help them with their innovative quality improvements efforts.

Main characteristics of TQC are job commitment, diligence, high degree of cooperation and bottom-up

organization.

Core of TQC are quality circles which is a work unit organized on a voluntary basis by 5-8 people.

Basic philosophy of TQC are: cause of production errors can be noticed by workers and they can change and

improve the situation.

2.4. 2.2.4. Quality Assurance (QA)

Quality Assurance (QA) developed in North America. QA focused on solving quality problems, rather than

living with rework and scrapping. It includes quality activities outside the realm of checking and quality control.

QA includes cross-departmental communication about quality, communication with vendors, redesign of the

product or process to prevent error, and a variety of audit processes to make sure that work and management are

being done to standards or in accordance with best practices (Table 3).

QA refers to a program for the systematic monitoring and evaluation of the various aspects of a project, service,

or facility to ensure that standards of quality are being met. It is important to realize also that quality is

determined by the program sponsor.

QA cannot absolutely guarantee the production of quality products, unfortunately, but makes this more likely.

Two key principles characterise QA:

• – "fit for purpose" (the product should be suitable for the intended purpose) and

• – "right first time" (mistakes should be eliminated).

QA includes:

• – regulation of the quality of raw materials, assemblies, products and components;

• – services related to production;

• – and management, production and inspection processes.

QA attempts to improve and stabilize production, and associated processes, to avoid, or at least minimize, issues

that led to the defects in the first place. On applying Quality Assurance in Education the gross purpose of

applying quality assurance is served.

During the Second World War, the allied forces didn‘t want to rely on test results alone and wanted guarantees

that the bombs, ammunition etc. were produced under controlled circumstances. These demands resulted in the

emphasis on control of the production processes.


assurance


Quality assurance systems in the food industry are much more extensive in scope than quality control programs.

They include the inspection, testing, and monitoring activities of quality control programs, along with additional

activities that are devoted to prevention of food safety hazards and quality defects. The activities are integrated

and interrelated to form a system. Quality assurance systems are intended to provide confidence to a food

company‘s management, its customers and to government regulatory agencies that the company is capable of

meeting the food quality and food safety requirements. These quality systems include documents that describe

operations and activities that directly relate to food quality and safety. An example of a quality assurance system

is the ISO 9001:1994 quality assurance system standard, which was replaced by the ISO 9001:2000 quality

management system standard. In companies that operate with quality management systems, the quality

assurance activities are integrated into the quality management systems.

2.3. ábra - Table 3: Characteristics of Quality Assurance (Topár, 2005; Nagy, 2007)

2.5. 2.2.5. Quality Management (QM)

All of the following are necessary to the implementation of the organization's quality objectives:

• process design and operation

• insurance of the necessary resources.

The primary objective:

• continuous improvement of the quality standard

• achieve customer satisfaction.

Quality management systems are elaborate management systems that can be used by any organization to

develop and achieve its quality objectives. Quality management systems include quality planning and

improvement activities, in addition to quality control and assurance activities. These systems are intended to

provide a company with the capability to meet all quality requirements. The best example of a quality

management system is the ISO 9001:2000 Quality management system – requirements standard.

2.6. 2.2.6. Total Quality Management (TQM)

W. Edwards Deming, a colleague of Shewhart, deserves a chapter of his own. He popularized and advanced

Shewhart‘s work, and added significantly to it. In cooperation with Japanese scientists, engineers, and industrial

leaders, he pioneered the development of Total Quality Management (TQM).

TQM was the first total solution to the quality problem that actually worked on a large scale. It includes PDCA,

QC, and other quality methods which, used together, allow companies to sustain continuous improvement.


assurance


During the mid-1980s, the term Total Quality Management (TQM) was introduced in North America. The term

was associated with the management approach to quality improvement used in Japan for achieving long-term

success. The TQM approach embodies both management principles and quality concepts, including customer

focus, empowerment of people, leadership, strategic planning, improvement, and process management. These

principles and concepts evolved during the second half of the twentieth century with substantial contributions

from several recognized experts in the field of quality management. Of these contributions, the most widely

recognized are the 14 points for quality management proposed by W. Edwards Deming. During the 1980s and

1990s many North American businesses adopted the TQM approach and developed the framework for its use in

their quality management systems, with the objective of achieving competitive advantage in the global

marketplace.

Management concept coined by W. Edwards Deming. The basis of TQM is to reduce the errors produced during

the manufacturing or service process, increase customer satisfaction, streamline supply chain management, aim

for modernization of equipment and ensure workers have the highest level of training.

One of the principal aims of TQM is to limit errors to 1 per 1 million units produced. Total Quality Management

is often associated with the development, deployment, and maintenance of organizational systems that are

required for various business processes (Table 4).

2.4. ábra - Table 4: Characteristics of Total Quality Management (Topár, 2005; Nagy,

2007)


3. fejezet - 3. Demand satisfaction

1. 3.1. Concepts

Requirement: need or expectation that is stated, generally implied or obligatory.

Grade: category or rank given to different quality requirements for products, processes or systems having the

same functional use.

Quality: degree to which a set of inherent characteristics fulfils requirements.

Competence: demonstrated ability to apply knowledge and skills.

Capability: ability of an organization, system or process to realize a product that will fulfil the requirements for

that product.

Customer satisfaction: customer's perception of the degree to which the customer's requirements have been

fulfilled (Fig. 3).

3.1. ábra - Fig. 3: Concepts relating to quality (ISO 9000:2005)

Organization: group of people and facilities with an arrangement of responsibilities, authorities and

relationships.

3. Demand satisfaction


Interested party: person or group having an interest in the performance or success of an organization.

Supplier: organization or person that provides a product.

Customer: organization or person that receives a product.

Contract: binding agreement.

Organizational structure: arrangement of responsibilities, authorities and relationships between people.

Infrastructure: organization system of facilities, equipment and services needed for the operation of an

organization.

Work environment: set of conditions under which work is performed (Fig. 4).

3.2. ábra - Fig. 4: Concepts relating to organization (ISO 9000:2005)

Process: set of interrelated or interacting activities which transform inputs into outputs.

Product: result of a process.

Procedure: specified way to carry out an activity or a process.

Project: unique process, consisting of a set of coordinated and controlled activities with start and finish dates,

undertaken to achieve an objective conforming to specific requirements, including the constraints of time, cost

and resources.

Design and development: set of processes that transform requirements into specified characteristics or into the

specification of a product, process or system (Fig. 5).

3.3. ábra - Fig. 5: Concepts relating to process and product (ISO 9000:2005)



The consumer demand satisfaction is basic concepts of quality.

Main message of quality assurance is control of quality of customer-oriented production.

Essentials of quality assurance are production process of producer, consumption process of consumer;

furthermore producer and consumer meet at the market.

Customer satisfaction is a state of mind in which the customer‘s needs, wants, and expectations throughout the

product of service life haven been met or exceeded, resulting in future repurchase and loyalty (Fig. 6).

Satisfaction can be measured from a perspective of performance evaluations, making the inclusion of the

disconfirmation process needless. Furthermore, satisfaction is not only consists of cognitive element but have to

include emotional element in determining customer satisfaction.

Creating customer satisfaction is a defensive strategy and the behavioural objective for defence is customer

loyalty.

The consumer satisfaction category has the main position in marketing theory and is based on the premise that

the profit is made through the process of satisfaction of consumers' demands, i.e. achievement of their

satisfaction. Researches continually confirm a significant correlation between satisfaction and repeated buying,

greater brand loyalty and spreading a positive opinion of the product.

3.4. ábra - Fig. 6: Consumer demand satisfaction process



(http://www.emeraldinsight.com/journals.htm?articleid=843004&show=html )

1.1. Types of consumer demand satisfaction:

Production is the act of creating output, a good or service which has value and contributes to the utility of

individuals. The act may or may not include factors of production other than labor. Any effort directed toward

the realization of a desired product or service is a "productive" effort and the performance of such act is

production. The relation between the amount of inputs used in production and the resulting amount of output is

called the production function.

Production the processes and methods used to transform tangible inputs (raw materials, semi-finished goods,

subassemblies) and intangible inputs (ideas, information, knowledge) into goods or services. Resources are used

in this process to create an output that is suitable for use or has exchange value.

Product is defined as a "thing produced by labor or effort" or the "result of an act or a process".

Service is the non-material equivalent of a good in economics and marketing, within the service-product

continuum (Fig. 7).

In economics, a service is an intangible commodity. More specifically, services are an intangible equivalent of

economic goods.

A service system (or customer service system, CSS) is a configuration of technology and organizational

networks designed to deliver services that satisfy the needs, wants, or aspirations of customers.

3.5. ábra - Fig. 7: Types of consumer demand satisfaction (Veress et al., 2005)

http://www.emeraldinsight.com/journals.htm?articleid=843004&show=html



1.2. Stages of the demand satisfaction process:

1. Market research of consumer demands.

2. Precise definition of consumer needs.

3. Planning product, technology, production systems, and production supply system.

4. Production process (production).

5. Consumer relations (may include recycling of the product).

Stakeholders of the demand satisfaction process:

Stakeholders in consumer process are customer, consumer, consumer protection organization, suppliers and

unions.

Stakeholders in production process are producer (owner, shareholders, executive officers, managers and

employees), pool (interest association) of producers and competitors.

Quality players in the market are metrology organizations, standardization organization, laboratory

investigators, certifiers, accrediting agency and person, furthermore instructors and advisors in quality field.

Other players in the market are infrastructure providers, other service providers and traders.

Stakeholders in state administration side are state administration / polity (taxes), public administration (taxes)

and supervisory authorities.

Stakeholders in social side are labour market, local community and society (civil) organizations.

2. 3.2. Characteristics of demand satisfaction process’ quality

2.1. Components of quality

Existence of beneficial features: useful components (e.g. economical, success) and fun / enjoyment components

(e.g. aesthetic enjoyment, good working atmosphere).

Absence of adverse features: harmful ingredients (e.g. noise, dust, etc.) and hazardous ingredients (possibility of

harm).

2.2. Temporality of quality – reliability

Reliability is the ability of a person or system to perform and maintain its functions in routine circumstances, as

well as hostile or unexpected circumstances for a specified period of time.



Reliability has to do with the quality of measurement. In its everyday sense, reliability is the "consistency" or

"repeatability" of measures.

Dependability is a measure of a system's availability, reliability, and its maintenance support. This may also

encompass mechanisms designed to increase and maintain the dependability of a system.

Qualification process is process to demonstrate the ability to fulfill specified requirements.

Review is activity undertaken to determine the suitability, adequacy and effectiveness of the subject matter to

achieve established objectives.

Preventive action is action to eliminate the cause of a potential nonconformity (3.6.2) or other undesirable

potential situation.

Maintenance, repair, and operations (MRO) or maintenance, repair, and overhaul involve fixing any sort of

mechanical, plumbing or electrical device should it become out of order or broken (known as repair,

unscheduled or casualty maintenance). It also includes performing routine actions which keep the device in

working order (known as scheduled maintenance) or prevents trouble from arising (preventive maintenance).

Correction is action to eliminate a detected nonconformity.

Corrective action is action to eliminate the cause of a detected nonconformity or other undesirable situation.

Corrective action requires the journeys of diagnosis and remedy. These journeys are simpler than for quality

improvement. Sporadic problems are the result of adverse change, so the diagnostic journey aims to discover

what has changed. The remedial journey aims to remove the adverse change and restore conformance.

Availability is the quality of being available. It is the degree to which a system, subsystem, or equipment is in a

specified operable and committable state at the start of a mission, when the mission is called for at an unknown,

i.e., a random, time. Simply put, availability is the proportion of time a system is in a functioning condition.

Conformity is fulfilment of a requirement.

Nonconformity is non-fulfilment of a requirement.

Defect is non-fulfilment of a requirement related to an intended or specified use.

Rework is action on a nonconforming product to make it conform to the requirements.

Regrade is alteration of the grade of a nonconforming product in order to make it conform to requirements

differing from the initial ones.

Repair is action on a nonconforming product to make it acceptable for the intended use.

Scrap is action on a nonconforming product to preclude its originally intended use.

Concession is permission to use or release a product that does not conform to specified requirements.

Deviation permit is permission to depart from the originally specified requirements of a product prior to

realization.

Release is permission to proceed to the next stage of a process (Fig. 8).

Conformity assessment, also known as compliance assessment is any activity to determine, directly or

indirectly, that a process, product, or service meets relevant technical standards and fulfils relevant

requirements. Conformity assessment activities may include testing, surveillance, inspection, auditing,

certification, registration and accreditation.

Test is determination of one or more characteristics according to a procedure.

Verification is confirmation, through the provision of objective evidence, that specified requirements have been

fulfilled.



Validation is confirmation, through the provision of objective evidence, that the requirements for a specific

intended use or application have been fulfilled.

Certificate of conformity is a document certified by a competent authority that the supplied good or service

meets the required specifications. It is also called ―certificate of conformance‖ or ―certificate of compliance‖.

3.6. ábra - ig. 8: Concepts relating to conformity (ISO 9000:2005)

2.3. Acceptable risk of quality – safety:

Safety is the state of being "safe", the condition of being protected against physical, social, spiritual, financial,

political, emotional, occupational, psychological, educational or other types or consequences of failure, damage,

error, accidents, harm or any other event which could be considered non-desirable. Safety can also be defined to

be the control of recognized hazards to achieve an acceptable level of risk. This can take the form of being

protected from the event or from exposure to something that causes health or economical losses. It can include

protection of people or of possessions.

Critical processes which are key to the functioning, products, or services of the work unit. It is

It is business process that must be restored immediately after a disruption to ensure the affected firm's ability to

protect its assets, meet its critical needs, and satisfy mandatory regulations and requirements.



Risk is the potential that a chosen action or activity (including the choice of inaction) will lead to a loss (an

undesirable outcome). The notion implies that a choice having an influence on the outcome sometimes exists (or

existed). Potential losses themselves may also be called "risks".

Risk management is the identification, assessment, and prioritization of risks followed by coordinated and

economical application of resources to minimize, monitor, and control the probability and/or impact of

unfortunate events or to maximize the realization of opportunities.

Risk assessment is the determination of quantitative or qualitative value of risk related to a concrete situation

and a recognized threat (also called hazard). Quantitative risk assessment requires calculations of two

components of risk (R): the magnitude of the potential loss (L), and the probability (p) that the loss will occur.

In the context of public health, risk assessment is the process of quantifying the probability of a harmful effect

to individuals or populations from certain human activities. In most countries the use of specific chemicals or

the operations of specific facilities (e.g. power plants, manufacturing plants) is not allowed unless it can be

shown that they do not increase the risk of death or illness above a specific threshold.

Risk analysis is the science of risks and their probability and evaluation. Risk analysis should be performed as

part of the risk management process for each project.

A food safety risk analysis is essential not only to produce or manufacture the highest quality goods and

products to ensure safety and protect public health, but also to comply with international and national standards

and market regulations. With risk analyses food safety systems can be strengthened and food-borne illnesses can

be reduced. During a food safety risk analysis, all time and attention is directed to the major safety concerns in

manufacturing premises.

Risk control is a technique that utilizes findings from risk assessments, and implementing changes to reduce

risk in these areas.

Risk control takes that information gained during risk assessments and develops and applies changes to control

the risks. Risk control can involve the implementation of new polices and standards, physical changes and

procedural changes that can reduce or eliminate certain risks within the business. Risk control is an important

action taken by firms that is intended to proactively identify, manage and reduce or eliminate risks.

2.4. Product conformance; fitness for use

There are two levels of product features, and they serve different purposes. One of these levels serves such

purposes as meeting customer needs, protecting human safety and protecting the environment (Fig. 9).

Product features are said to possess ―fitness for use‖ if they are able to serve the above purposes.

The second level of product features serves purposes such as providing working criteria to those who lack

knowledge of fitness for use, creating an atmosphere of law and order; and protecting innocents from

unwarranted blame.

Such product features are typically contained in internal specifications, procedures, standards, etc. Product

features which are able to serve the second list of purposes are said to possess conformance to specifications,

etc. We will use the shorter label ―conformance‖.

The presence of two levels of product features results in two levels of decision making: Is the product in

conformance? Is the product fit for use?

3.7. ábra - Fig. 9: Flow diagram of decisions on conformance and fitness for use (Juran -

Godfrey, 1999)



The Product Conformance Decision. Under prevailing policies, products which conform to specification are

sent on to the next destination or customer. The assumption is that products which conform to specification are

also fit for use. This assumption is valid in the great majority of cases.

The combination of large numbers of product features when multiplied by large volumes of product creates

huge numbers of product conformance decisions to be made. Ideally these decisions should be delegated to the

lowest levels of organization—to the automated devices and the operating work force. Delegation of this

decision to the work force creates what is called ―self-inspection‖.

Self-Inspection. We define ―self-inspection‖ as a state in which decisions on the product are delegated to the

work force. The delegated decisions consist mainly of: Does product quality conform to the quality goals? What

disposition is to be made of the product?

Note that self-inspection is very different from self-control, which involves decisions on the process.

2.5. CE marking

The CE marking as it has been legally called since 1993 (per directive 93/68/EEC), or formerly EC mark, is a

mandatory conformity marking for products placed on the market in the European Economic Area (EEA).

By placing the CE mark on a product, a manufacturer guarantees that the product conforms to the essential

requirements of the applicable EC directives.

―CE‖ is often taken to be an abbreviation of ―Conformité Européenne‖, meaning "European Conformity".

Legally, the CE marking is not a quality mark. But, depending on the applicable directive, the CE marking can

actually be considered to be a quality mark.

Existing in its present form since 1993, the CE marking is a key indicator of a product's compliance with EU

legislation and enables the free movement of products within the European market.


4. fejezet - 4. National quality control system

State level consists of quality programs, quality legislation, institutional quality assurance systems and

supporting education. Company level consists of quality system.

1. 4.1. National quality control

The ability of an industrial company to secure income is strongly influenced by the economic climate and by the

cultural habits which the various economies have evolved. These overriding influences affect product quality as

well as other elements of commerce.

The form of a nation‘s economy and its degree of affluence strongly influence the approach to its quality

problems.

Role of state in quality are market regulation (e.g. taxes, regulations, etc.); regulation of public services (e.g.

public education, public administration, law enforcement, etc.); and protection (protection of citizens,

businesses, property, environment etc.).

Basic pillars of state quality control are legal metrology and national standardization.

Target of National quality control system (NQCS) is state / government quality policy. Controlled processes are

market consumer demand satisfaction processes. Measurement, observation of NQCS is market surveillance.

Analysis, decision-making of NQCS is quality assessment of the situation. Interventions of NQCS are

legislation and institutional system operation.

Aims of national quality control system are definition of quality policy which meets the objectives of the

national economic goals, quality control of nation economy, quality assessment of the situation and quality

rulemaking.

Tasks of national quality control system are creation and development of national quality policy, quality

rulemaking, quality monitoring of the situation and quality assessment of the situation.

Main organization of national quality control system:

• Metrology organization (National Office of Measures),

• Standardization organization (Hungarian Standards Institution),

• Accreditation organization (National Accreditation Board),

• Defense industries organizations (Hungarian Intellectual Property Office, associations of various

industrialists),

• Testing organizations (HUNGAROLAB),

• Certification organizations,

• Official quality control engineering organizations (major sectoral inspectorates),

• Quality supervision of market (Hungarian Competition Authority),

• Consumer protection organizations (Hungarian Authority for Consumer Protection, National Association for

Consumer Protection in Hungary).

2. 4.2. Three main parts of national quality control system

4. National quality control system


I. Technical legal regulatory system

II. Judicial regulatory system

III. Support - promoting system

2.1. 4.2.1. Technical legal regulatory system

2.1.1. 4.2.1.1. Standardization, metrology

Standardization is the process of developing and implementing technical standards. The goals of standardization

can be to help with independence of single suppliers (commoditization), compatibility, interoperability, safety,

repeatability, or quality.

Standardization is the process of establishing a technical standard which could be a standard specification,

standard test method, standard definition, or standard procedure.

Standardization means that there is a standard specification, unit, instruction or something that is understood

globally.

In the science of measurement, a standard is an object, system, or experiment that bears a defined relationship to

a unit of measurement of a physical quantity. A technical standard is an established norm or requirement about

technical systems. It is usually a formal document that establishes uniform engineering or technical criteria,

methods, processes and practices.

Metrology is the science of measurement. Metrology includes all theoretical and practical aspects of

measurement.

International standardization organizations:

• ISO (International Organization for Standardization) Founded: 1946, Geneva

• IEC (International Electrotechnical Commission).

European standardization organizations:

• CEN (European Committee for Standardization, Comité Européen de Normalisation)

• CENELEC (European Committee for Electrotechnical Standardization, Comité Européen de Normalisation

Electronique)

• ETSI (European Telecommunications Standards Institute).

2.1.2. 4.2.1.2. General technical regulation system

• Conformance testing, -evaluation, and -certification (inspection, verification, testing and evaluation),

• Accreditation of testing and certification bodies (recognition),

• General market surveillance (supervision).

2.1.3. 4.2.1.3. Official technical regulation system

Main aims of official technical regulation system are:

1. estimation the magnitude, likelihood and consequences of hazards, which occur during various activities,

2. determination the appropriate level of protection on the basis of risk assessment,

3. establishment, operation and supervision of the requirements and system of technical regulation.

Steps of risk assessment:



1. risk identification,

2. risk quantification,

3. risk analysis,

4. risk minimization.

Tasks of official technical regulation system:

1. Official (technical) inspection, verification, evaluation of conformity, conformity certification, conformity

marking,

2. Government authorization, registration,

3. Official supervision,

4. Official information, disaster recovery.

2.2. 4.2.2. Judicial regulatory system

It is the second implementation level of the national quality control system. It summarizes legal institutions of

quality. Primary objective is protecting the interest of society, producers and consumers.

Main parts of judicial regulatory system:

1. Protection of consumer

2. Protection of producers

3. Protection of market

2.2.1. 4.2.2.1. Protection of consumer

There are three groups of criminal assets of consumer protection:

1. Protection of quality

• Abuse with harmful consumer goods (e.g. preparation and storage of consumer goods which are harmful to

public health),

• Marketing low-quality products,

• False certification of quality (compliance) or false data.

2. Protection of copyright and industrial property

• Usurpation (a wrongful seizure or exercise of authority or privilege belonging to another),

• Infringement copyright (is the unauthorized use of works under copyright, infringing the copyright holder's

"exclusive rights", such as the right to reproduce, distribute, display or perform the copyrighted work,

spread the information contained within copyrighted works, or to make derivative works),

• False marking goods (it protects against unauthorized use of trademark, brand name).

3. Protection of consumers

• Warranty (is an assurance by one party to the other party that specific facts or conditions are true or will

happen; the other party is permitted to rely on that assurance and seek some type of remedy if it is not true

or followed),

• Guarantee (a promise or an assurance, especially one given in writing that attests to the quality or

durability of a product or service),



• Liquidated damages (are damages whose amount the parties designate during the formation of a contract

for the injured party to collect as compensation upon a specific breach - e.g., late performance),

• Product liability (is the area of law in which manufacturers, distributors, suppliers, retailers, and others

who make products available to the public are held responsible for the injuries those products cause).

2.2.2. 4.2.2.2. Protection of producers

- Patent (is a form of intellectual property. It consists of a set of exclusive rights granted by a sovereign state to

an inventor or their assignee for a limited period of time, in exchange for the public disclosure of the invention),

- Trademark (is a recognizable sign, design or expression which identifies products or services of a particular

source from those of others).

2.2.3. 4.2.2.3. Protection of market

• Prohibition of unfair market practices and competition restriction (e.g. denigration, trade secrets violations,

call for boycott),

• Contract law (e.g. legislation of public procurement),

• Market surveillance (for products ensures that products on the market are in conformity with the applicable

law).

2.2.4. 4.2.3. Support - promoting system

• Launch quality programs and movements,

• Quality awards and recognition (National Quality Award),

• Quality marks, trademarks (primarily in the food industry – e.g. Excellent Hungarian Food),

• Information and education systems,

• Tender support systems,

• Indirect support systems.

3. Safety in the agri-food chain

In addressing food quality and food safety, it is important to keep in mind that the term ―food‖ covers any

unprocessed, semi-processed, or processed item that is intended to be used as food or drink. This includes any

ingredient incorporated into a food or drink, and any substance that comes into direct contact with a food during

processing, preparation, or treatment. Therefore, food quality and food safety principles and practices are

applied to foods from farm produce and livestock production; manufactured and processed food products for

consumers; and all raw materials, ingredients, processing aids, food-contact packaging materials, and food-

contact surfaces that are used in the preparation of food and beverage products.

Quality together with safety in the food chain is one of the most important issues facing the agricultural and

food industries. While quality of food is important to consumers, the safety of food is essential.

Food safety concepts and programs are designed to limit exposure to foodborne risks. They will educate

processors as well as consumers about the importance of safe food handling and how to reduce the risks

associated with foodborne illness. Figure 10 shows legally binding guidelines and concepts as well as standards

under private law that assure food safety.

4.1. ábra - Fig. 10: Legally binding guidelines and concepts as well as standards under

private law to assure food safety (Jouve et al., 1998; Luning et al., 2006)



The basic requirement of safe food production is the consideration of generally accepted principles and

procedures. Without these, the production of defect-free products with consistent quality is nearly impossible.

On the level of processing, these requirements are described as ―Good Manufacturing Practice‖ (GMP). Less

well established are ―Good Agricultural Practice‖ (GAP) and ―Good Distribution Practice‖ (GDP) that are

similar to GHP (Good Hygiene Practice) in processing.

Good Manufacturing Practice (GMP) describes the basic requirements in food processing. It includes

regulations concerning cleaning, personal hygiene, infrastructure and traceability. GMP is that part of quality

assurance which ensures that products are consistently required by the marketing authorization or product

specification. GMP is concerned with both production and quality control.

Good Agricultural Practices (GAPs) are a collection of principles applied to on-farm production and post-

production processes, resulting in safe and healthy food and non-food agricultural products, while taking into

account economic, social and environmental sustainability.

Good Distribution Practice (GDP) is that part of quality assurance which ensures that products are

consistently stored, transported and handled under suitable conditions as required by the marketing authorization

or product specification.

Hazard Analysis and Critical Control Point (HACCP) system is an effective and rational means of assuring

food safety from harvest to consumption.

Self-control. Each company can use a system of self-control (e.g. audits and random end-product control) to

verify the function of its quality assurance systems (GMO and HACCP) on a regular basis. GMP, HACCP as

well as self-control are legally binding.

Certification systems. Food Safety Standards are certification systems under private law. Concerning

traceability, they go further than the law: the processor has to include the whole preliminary processing chain.

Furthermore, these standards also include other quality aspects (elements of ISO 9000), e.g. safety of supply.

The most important food safety standards: EUREP-GAP, BRC, EFSIS, IFS

EUro-REtailer Produce Working Group (EUREP-GAP) started in 1997 as an initiative of retailers

belonging to the Euro-Retailer Produce Working Group (EUREP). It has subsequently evolved into an equal

partnership of agricultural producers and their retail customers. Its mission is to develop widely accepted

standards and procedures for the global certification of Good Agricultural Practice (GAP).



British Retail Consortium (BRC). In 1998 the BRC developed and introduced the BRC Technical Standard

and Protocol for Companies Supplying Retailer Branded Food Products (the BRC Food Technical Standard).

Although originally developed primarily for the supply of retailer branded products, in recent years the BRC

Food Technical Standard has been widely used across a number of other sectors of the food industry such as

food service and ingredients manufacturing.

European Food Safety Inspection Service (EFSIS) is the premier third party independent inspection service,

providing retailers, manufacturers and caterers, throughout the world, with expert inspection of their operations

and suppliers to ensure only the highest standards are maintained. These range from accredited inspection of

food premises to ISO 9000 system audits to HACCP certification and beyond.

International Food Standard (IFS). Food retailers (and wholesalers) regularly make audits to check the food

safety aspects of their suppliers of own branded food products. These audits are made by independent auditors

from qualified bodies. In 2002, German food retailers developed a common audit standard called International

Food Standard, in order to create a common food safety standard. The IFS officially launched by the Global

Food Safety Initiative (GFSI) in 2003.

Global Food Safety Initiative (GFSI) is an initiative of more than 200 retailers from more than 50 countries.

Their aim is a uniform international standard of food safety.

The practical success of the food safety programme will depend on the proper use of appropriate methods and

tools. These will include Good Hygiene Practice (GHP), Good Manufacturing Practice (GMP) and HACCP

(Hazard Analysis Critical Control Points). Other tools of more general application are standardised models for

management systems and the Total Quality Management (TQM) approach. Increasingly risk assessment,

developed in the framework of risk analysis, emerges as a means to ulink operational performance and

regulatory or business requirements to the health and safety of consumers.

Food safety objectives as defined by governmental authorities represent the minimum target on which food

operators base their own approach. The government's food safety objectives may be adopted as such in the form

of a company's food safety requirements. Alternatively, depending on commercial factors, a company may wish

to establish more demanding food safety requirements. Food safety requirements provide input to the food

safety programme. They direct product and process planning, design and implementation of GMP, GHP,

HACCP and quality assurance systems with the aim of fulfilling the food safety requirements.

Figure 11 illustrates the interrelationship among the commonly used food safety tools.

4.2. ábra - Fig. 11: Food safety tools – An integrated approach for microbiological

hazards in food (Crossley - Motarjemi, 2011)



An essential foundation of any activity involving food manufacture, handling and catering is a thorough

understanding of the appropriate requirements of GHP and GMP associated with the particular product or

commodity. Adherence to these good practices is the absolute minimum requirement in any food business.

HACCP is now widely adopted as an essential approach to the systematic identification, evaluation and control

of hazards associated with the production, manufacture, distribution and use of food products.

It provides a mechanism to define preventive measures for hazard control. Although GMP and GHP address the

generic requirements for manufacturing safe food, the benefit of HACCP is that it addresses specific hazards

unique to particular products and processes.

Food businesses are increasingly concerned to achieve and demonstrate sound food safety performance.

Consequently, they develop management systems, which address key aspects of food safety control and

assurance. Where such a system exists, GMP/GHP and HACCP are integral parts of the overall system. Models

for the development of food safety management systems include International Standards (ISO 22000) and other

standards such as the BRC standard-food or the IFS model. Food safety management systems can be integrated

with other management systems, quality management and environmental management in particular. There are

many forms for such systems; perhaps the most widely used are based on the ISO 9001 standard for quality

management and on the ISO 14000 series for environmental management. They are components of a longer-

term strategy to manage industrial risks.

Risk analysis, as carried out by governments, encompasses three components which are risk assessment, risk

management and risk communication. The approach is key to understanding the factors that determine the

impact of food chain activities on human health, as well as determining and communicating the most

appropriate measures for mitigating risk. Risk mitigation strategies used by governments include public

information campaigns, mandatory standards and codes of practice. The application of risk analysis is now

central to public decision making on food safety. This includes determination of objectives intended to guide the

performance of food operators along the food chain.

4. Most commonly used systems in some sectors

Quick freezing industry is leader in the implementation of food safety and quality system. They receive only

high quality raw materials and primary commodities (due to the detailed acceptance standards). Extend the use

of metal detectors, sorting machine (on the basis of color), X-ray foreign material detection and removal



systems. There is greater emphasis on the hygienic design of equipment and improve the efficiency of cleaning

and disinfection.

Quick freezing industry manages comprehensive quality assurance and food safety programs that far exceed

industry mandates. These programs include good manufacturing procedures, sanitation programs,

microbiological testing, and a recall preparedness program. Together, they address all aspects of our products'

life cycles, from seed selection all the way through harvesting, freezing, and distribution.

At the center of the quality assurance efforts is the Hazard Analysis and Critical Control Points (HACCP)

program. This rigorous program identifies food safety risks, establishes controls, and outlines monitoring

procedures to prevent food safety problems.

Most of them use the most important food safety standards: ISO 22000, BRC or IFS.

In meat industry most of the large companies (especially the export-oriented companies) are in compliance

with the international quality (ISO 9001) and food safety (ISO 22000, BRC, IFS) standards, and most of them

have internal testing laboratory.

In case of dairy industry significant portion of dairy farms has made serious efforts to introduce quality

assurance systems. Many companies use international quality (ISO 9001) and food safety (ISO 22000, BRC,

IFS) standards.

5. Quality management systems in agriculture sector practice

The agricultural sector must assure that the use of agricultural chemicals is strictly within the allowances

specified, so that risks of toxic exposure to these by consumption of the treated plants is within the scientifically

safe limits established by government regulation and chemical company specifications. Agricultural workers

also should be trained in the use of these chemicals both for their own protection as well as for the production of

safe food.

Animal-slaughtering operations also require employee training in the use of safe processing and handling

methods and the identification of contaminated or suspect meats. In the distribution and sales sector, operators

must assure that proper storage temperature and sanitary conditions are observed. Clearly, knowledge of the

functions being carried out and supervision to ensure that correct procedures and materials are being used are

basic elements to all sectors of the food industry.

Quality management systems in agriculture sector practice:

GAEC: Good Agricultural and Environmental Condition,

GFP: Good Farming Practice,

GMP: Good Manufacturing Practice,

GLP: Good Laboratory Practice,

GHP: Good Hygiene Practice,

HACCP: Hazard Analysis and Critical Control Points,

EUREPGAP/GLOBALGAP: European System Related to Good Agricultural Practice,

ISO: International Organization for Standardization,

TQM: Total Quality Management (Fig. 12).

4.3. ábra - Fig. 12: Quality management systems in agriculture sector practice (Juhász –

Szőllősi, 2008)


5. fejezet - 5. Good practices

1. 5.1. Good Manufacturing Practice (GMP)

Many food safety practices are good manufacturing practices (GMPs) that have been mandated by government

agencies on the basis of scientific knowledge relating to known health hazards in foods, and the need to prevent

unacceptable levels of these hazards or to eliminate them from foods. In addition, some mandatory GMPs

address food quality and fitness of food for human use. Some other GMPs are not mandatory but recommended

practices, advisory practices, or common food industry practices; these serve as guidance for achieving food

safety and food quality.

Traditionally, the food industry, and particularly the food processing sector, has relied on the use of GMPs in its

efforts to ensure the safety of processed foods. Most of these GMPs are used by many national governments

worldwide for monitoring the safety of consumer foods and for inspection of establishments that process,

package, handle, and store foods.

In addition to their use for purposes of government regulations and international trade, GMPs are commonly

used as part of business practices in the food industry. GMPs have been used very widely as the basis for

developing and establishing food safety programs within food processing establishments. In many cases, and

particularly in large- and medium-sized establishments, food manufacturers have developed food safety

programs that substantially exceed the GMP requirements of governments. The objective of these programs is to

meet government requirements as well as customer requirements, and to achieve competitive advantage in

securing business with potential customers. Many food companies use GMP criteria as an important

consideration in the selection of their suppliers of raw materials, ingredients, packaging materials, and services.

GMP is a system to ensure that products meet food safety, quality and legal requirements. Required actions or

conditions to prevent harm to human beings. Avoid production of unsanitary, contaminated, adulterated or

dangerous product. Many countries have adopted these as laws or federal regulations.

It is used in the pharmaceutical industry and it is the most widespread in the food industry. This is a collection

of product safety and uniform product quality which involves general application methods. The two main

elements are efficient manufacturing operations and effective control, which complement each other and affect

each other.

While GMP gives comprehensive information about food production, or specify the general requirements of an

industry. GMP is essentially quality, so it must be considered and should be implemented to achieve compliance

by person concerned:

• very precise control of processes - in the manner established by the activity;

• the necessary measurements, monitoring, quality control;

• all factors that affect quality: staff, facilities, equipment, tools.

GMPs have become part of the very basic requirements that must be in place before an effective HACCP system

can be implemented. Consequently, the traditional GMPs, along with some additional requirements, are now

universally regarded as Prerequisite Programs for the implementation of an HACCP system.

Principles of GMP

The GMP criteria are addressed in the following subparts: General Provisions, Buildings and Facilities,

Equipment, Production and Process Controls, and Defect Action Levels.

In addition to GMPs that have been developed by national governments, food safety practices have been

developed for use at the international level for the purposes of facilitating fairness in global food trade, and for

the protection of health of consumers around the world. The recognized practices relating to food safety are

described in the ―Recommended International Code of Practice, General Principles of Food Hygiene‖ of the

Codex Alimentarius Commission, Food and Agricultural Organization/World Health Organization (FAO/WHO)

Food Standards Programme.

5. Good practices


These practices are covered in the following sections of this standard: Primary Production; Establishment:

Design and Facilities; Control of Operation; Establishment: Maintenance and Sanitation; Establishment:

Personal Hygiene; Transportation; Product Information and Consumer Awareness; and Training.

The GMP requirements of many national governments are compatible with the food safety practices described

in this Codex Alimentarius standard.

When GMP programs or HACCP prerequisite programs are developed and implemented at a food plant, they

should cover the basic controls required for raw materials, ingredients, packaging materials and products, and

for the plant‘s facilities, employees, equipment, operations, and environment that influence the safety of a food.

Many of the GMPs and prerequisite program activities are directed at ensuring that the necessary conditions

exist for the prevention of potential contamination and cross-contamination of food.

Ten Principles of GMP:

1. Design and construct the facilities and equipments properly

2. Follow written procedures and Instructions

3. Document work

4. Validate work

5. Monitor facilities and equipment

6. Write step by step operating procedures and work on instructions

7. Design, develop and demonstrate job competence

8. Cleanliness, protect against contamination

9. Control components and product related processes

10. Conduct planned and periodic audits

5 core elements of GMP:

1. Working conditions (factory, facilities, means)

2. Labour (healthy, trained, disciplined)

3. Raw material, commodity (good quality)

4. Manufacturing operations (expertly developed, monitored)

5. Transport (ensure the preservation of the quality of transport and storage conditions)

GMP covers all parts of the business:

Standard Operating Procedures (SOP‘s)

1. Sanitation and hygiene

2. Good house keeping

3. Facility design and plant layout

4. Process controls

5. Documentation and record keeping

6. Personnel – behaviour and dress

The GMP is closely related to the:

5. Good practices


• GHP (Good Hygiene Practice), which ensures the purity requirements for compliance with the

microbiological, chemical, physical and other points of view;

• GLP (Good Laboratory Practice), which ensures the production of independent, globally-designed and

properly executed verification procedures.

GMP benefits are:

Good business practices, improved product consistency, helps to lower costs, builds future business, and legal

requirements.

2. 5.2. Good Hygiene Practice (GHP)

All practices regarding the conditions and measures necessary to ensure the safety and suitability of food at all

stages of the food chain (Codex definition of Food Hygiene, General Principles of Food Hygiene). GHP must be

applied from „farm to fork‖ to be effective.

This prerequisite program addresses the requirements for the location, design, construction, and maintenance of

buildings that are used for food processing. It covers the grounds, all exterior and interior structures of

buildings, and all facilities and essential services required in food processing establishments. Many sections of

this prerequisite program need to be considered during the design and construction stages of a food plant.

Engineering, design, and construction requirements and guidelines for food plants have been developed by some

government agencies.

The general conditions in a food plant, including the state of repairs, maintenance, and cleanliness of all

structures and facilities, are critical in order to achieve the sanitary requirements for food processing. The

primary considerations are that the building, its grounds, structures, and facilities are not a source of

contamination or cross-contamination of food, there is protection from entry of pests into the building, and clean

and sanitary conditions can be maintained.

2.1. 5.2.1. Pre-requisite programs

1. Premises and facilities

2. Personnel training, hygiene and practices

3. Sanitation and cleaning

4. Pest control

5. Equipment

6. Transportation, receiving, storage, and shipping

7. Traceability and recall

8. Chemical control

2.1.1. 5.2.1.1. Premises and facilities

Location

The buildings in which food is processed or stored should not be located in close proximity to sites that are

sources of environmental pollutants, pest infestations, smoke or dust, to areas that accumulate wastes or stagnant

water, or have industrial, agricultural or other activities which are potential sources of food contamination. If

any of these undesirable conditions exist, there should be adequate safeguard to protect against any potential

contamination or pest infestation.

Grounds

The grounds of buildings in which food is processed or stored should be adequately sloped and drained to

prevent stagnant water, be free of waste and debris, be controlled for dust, and be adequately maintained to

5. Good practices


protect against becoming a source of contamination or pest infestation. In order to protect from pests,

maintenance of the grounds should address grass and lawns, hedges, shrubs, trees, receptacles for storage of

garbage, and any structures located on the grounds. In particular, the perimeter of the building exterior should be

well maintained to prevent breeding or attraction of pests.

Building exterior

The design, construction and maintenance of exterior walls and roofs of buildings, should prevent the entry of

sources of contamination and pests, and leakage of water into the building. Exterior walls should be free of

cracks that could be breeding sites for pests. Openings for exhaust fans and air intake ducts, and exterior

drainpipes should be adequately screened and protected to prevent entry of pests. The loading and unloading

areas of the building, and all exterior doors and windows should be adequately protected to prevent entry of

pests. The location of exterior lighting should not attract insects into the building.

The design and layout of the building interior and the location of all structures, equipment, services, and

facilities should permit movement of personnel and equipment, flow of air, materials and products, movement

of waste and garbage, and storage of materials and products, in a manner that prevents contamination and cross-

contamination of materials and products.

The design and construction of all building structures such as floors, walls, ceilings, overhead structures,

windows, doors, and stairs, and all utilities and service structures such as ducts, pipes and drains should meet all

requirements for construction of food plants. The materials used for construction and finishing of these

structures should not be sources of contamination and should be durable, impervious, smooth and easily cleaned

and maintained. The materials used for construction of walls and floors should withstand the routine plant

operating conditions and the routine cleaning and sanitizing conditions.

Glass or glass-like materials such as breakable plastic in food plants can be sources of physical hazards and

should not be used in processing areas where there is a likelihood of breakage that will result in contamination

of product. If these materials must be used, they must be adequately protected from breakage.

Corners and joints in all structures should be designed to prevent accumulation of contaminants and to facilitate

cleaning; they should be free of cracks and openings.

The surface of floors should be even, but with the appropriate slope for waste-water and other liquids to be

drained at the designated outlets. Floor surfaces should be impervious, durable and free of cracks to facilitate

cleaning.

Windows on exterior walls should be sealed or fitted with screens to prevent entry of pests. Exterior doors

should be self-closing, should always be kept closed, and should be without gaps or openings when closed, to

prevent entry of pests. Exterior doors should be kept closed to prevent unauthorized access into the building.

The building interior should be equipped with adequate light and lighting facilities to permit employees to carry

out their designated tasks in areas where processing, handling, storage, testing, inspection and cleaning activities

take place.

There should be adequate ventilation and air exchange throughout the building to prevent airborne

contamination, condensation on any structure or equipment, and accumulation of dust. High humidity should be

avoided to prevent mould growth and some types of insects. The direction of air-flow should not result in

contamination or cross-contamination of foods.

The drainage and sewage systems should be designed to prevent cross-connection of sewage with other wastes

from the plant in order to avoid any potential for contamination.

Water pipes should be free of condensation. Insulated pipes should be well maintained and should be free of

condensation drips and mould growth.

Access to premises

The entrances and exits of a food plant should be controlled to prevent access by unauthorized personnel.

Exterior doors should not open from the outside of the building. Food plant employees should use only the

designated entrances and exits. Receiving and shipping locations should not be used by employees as entrances

or exits. Access of visitors into food plants should be controlled.

5. Good practices


Employee facilities

There should be accessible hand-washing stations at the appropriate locations, with potable running water at a

suitable temperature, soap or other hand-cleaning and sanitizing materials, sanitary hand-drying equipment or

supplies for employees to wash and dry hands as required.

Washrooms and toilet rooms in particular, should be separated from and should not open directly into food

storage, handling and processing areas.

Change-rooms should be available for employees to change from their personal external clothing into

designated work uniform and footwear.

There should be designated lunchrooms and break-rooms for employees.

Cleaning and sanitizing facilities

Potable running water at the required temperatures and pressures should be available for all cleaning and

sanitizing activities. The required equipment and tools for cleaning and sanitizing should be available.

Equipment and tools used for cleaning of food-contact surfaces, food processing equipment and utensils should

be appropriately identified and stored so that they are separate from those used for cleaning of building

structures such as floors and walls.

Storage facilities

There should be adequate and appropriate facilities such as warehouse, storage rooms, silos, tanks, vats, bins, or

other containers, for the storage of raw materials, ingredients, packaging materials, products to be reworked or

recycled, semi-finished products, finished products, cleaning materials and non-food chemicals. These storage

facilities should be designed to ensure that there is no contamination, cross-contamination, or pest infestation of

raw materials, ingredients, packaging materials, and semi-finished and finished products during storage. There

should be separate storage facilities to segregate food materials from non-food chemicals.

Waste collection and storage facilities

There should be designated containers with covers, if necessary, for collection of waste and garbage and for

their temporary storage until disposal. These containers should be properly identified, and be made of durable,

impervious material and maintained in a sanitary condition.

Water

There should be an adequate supply of potable water, at the desired temperatures and pressures, for use in

processing operations and for cleaning. There should be facilities to ensure that temperature and pressure

requirements for water can be achieved.

Only potable water should be used in all food plant processing and cleaning operations. The water quality

should conform to the guidelines for potable water based on microbiological, chemical, and physical

specifications of applicable government agencies. Water should be tested periodically to determine if it complies

with these specifications; the records of water quality test results should be maintained.

Ice and steam

Ice for use in food plants should be made from potable water and should be handled and stored to protect from

contamination. Steam that comes into contact with food or food contact surfaces should be generated from

potable water.

2.1.2. 5.2.1.2. Personnel training, hygiene and practices

This prerequisite program addresses the requirements for employees of food plants; some of the requirements

are also applicable to visitors to food plants as well as any other personnel who are not employees at a food

plant, but carry out some type of work on the premises or facilities. The requirements for personnel at food

plants can be conveniently classified under the sections, Personnel training, Personal hygiene, and Personnel

practices.

5. Good practices


Employees in a food plant play a critical role in ensuring the safety of foods produced at the plant. In addition,

employees should not contribute to or be a source of contamination or cross-contamination of foods. In this

prerequisite program, the primary considerations are to ensure that both temporary and permanent employees

have the required education and training, are adequately supervised, and follow their required work-related

tasks, personal hygiene requirements and acceptable personnel practices during their work.

Personnel training

Food safety training: All food plant employees, including temporary employees, should be trained in the basic

food safety principles and practices that are required to prevent contamination and cross-contamination of foods.

Technical training: Employees whose tasks involve operation, maintenance, and cleaning of food processing

equipment, furthermore sanitation and cleaning activities should be provided with the relevant technical training

that is required to carry out their specific tasks so that all food safety requirements are met.

Personnel practices

Personal hygiene: In order to protect against contamination of products, food plant employees are required to

maintain satisfactory personal grooming and cleanliness and to practice good personal hygiene habits during all

food handling operations. This includes general cleanliness of clothing and body, including hair and fingernails.

Hand-washing: In order to protect hands from being a source of contamination of products, food plant

employees should wash, sanitize if necessary, and dry their hands at the designated hand-washing stations when

their hands become dirty. Employees should wash hands before start of work, when re-entering their work area,

after a visit to the toilet, after coughing or sneezing into their hands, or after handling raw materials, equipment,

waste or waste containers, or after any other situation that will cause the hands to become dirty and be a source

of contamination or cross-contamination.

Eating, drinking and smoking: Employees should eat, drink, and if permitted, smoke only in the designated

lunchrooms and break-rooms or other authorized areas. Employees‘ food or drink should be kept in the

designated areas and should not be taken into their work areas.

Garments and work-wear: Employees should wear the uniforms or outer garments provided for their work.

Uniforms and garments should be clean at the start of work and should be changed when they become dirty or

according to the required change frequency.

Personal items: Employees should not wear jewellery, hairpins, wristwatches or other personal items such as

false eyelashes, false fingernails and nail polish during food handling operations.

Illness and injuries

Food plant employees with certain illnesses or injuries should be excluded from food handling activities; these

illnesses include jaundice, diarrhoea, vomiting, fever, sore throat with fever, open or infected skin lesions (e.g.,

boils, cuts, burns), discharges from the eyes, ears or nose, or any disease that can be transmitted through food.

Employees should inform their supervisors if they suffer from any of these health conditions. In addition,

supervisory personnel in food plants should constantly monitor food-handling employees for these injuries and

illnesses.

2.1.3. 5.2.1.3. Sanitation and cleaning

This prerequisite program covers all ongoing and periodic activities and operations that are directed at

maintaining the environment, facilities, structures, and equipment in a food plant under sanitary conditions at all

times. The design, construction, and layout considerations that relate to sanitation and cleaning are covered in

the prerequisite program Premises and Facilities. It is quite common for the term sanitation alone to include

house-keeping, cleaning and sanitizing; however, the distinction should be made between cleaning and

sanitizing. In general, cleaning activities cover the removal of dust, dirt, debris, accumulated raw materials,

ingredients or product, and any chemical residues, from utensils, food processing equipment, and structures.

Sanitizing activities cover the use of a chemical agent or a specific technique to kill microorganisms present on

equipment, utensils and structures.

The maintenance of sanitary conditions in a food plant, including clean and sanitary environment, structures,

facilities, and equipment is essential to ensure that food is produced under sanitary conditions, to prevent

5. Good practices


contamination from these sources and to prevent breeding of pests. Food processing operations in a food plant

should only commence after all the required cleaning and sanitizing activities have been completed. In this

prerequisite program, the primary considerations are the activities for maintaining sanitary conditions by means

of a sanitation program, and ongoing monitoring of the sanitary conditions during all operations at a food plant.

There should be a written program for cleaning and sanitizing of the structures, facilities, and equipment in a

food plant. This written program should identify each structure, facility, and equipment to be cleaned and

sanitized.

All chemical compounds used for cleaning and sanitizing should be approved as safe for use in food

establishments, and on food-contact surfaces in particular, by an appropriate government regulatory agency. The

manufacturer‘s guidelines and directions for use of these chemicals must be followed to ensure the effectiveness

of the cleaning and sanitizing, and to remove or prevent potential contamination. The chemicals themselves

must not be a source of contamination.

All tools and equipment (e.g., brushes, dustpans, brooms, mops, trays, carts) used for cleaning should also be

subjected to appropriate cleaning and storage. Broken or damaged tools should not be used.

There should be designated location and facility for cleaning of cleaning tools and equipment. This area or

facility, as well as all sinks and washbasins and surrounding areas, should be kept clean and sanitary.

2.1.4. 5.2.1.4. Pest control

This prerequisite program covers the specific activities that are directed at controlling, preventing and excluding

the occurrence of pests, particularly rodents, insects and birds, from a food plant. Pet animals such as cats and

dogs should not be allowed to enter food plants. The prerequisite program Premises and facilities includes

certain preventive measures for pest control; these relate to the building structures, as well as the internal

environment and the external surroundings. Pest control measures are also part of the prerequisite programs

Sanitation and cleaning and Transportation, receiving, storage, and shipping.

The pest control program includes the specific activities directed at detecting pests and pest activity, both within

a food plant and its immediate exterior, preventing pests from entering the building, eliminating pests from the

building and the immediate surroundings, and monitoring of the pest control program for its effectiveness. In

addition, the program includes control of the use and storage of chemicals or other materials used for pest

control to prevent contamination of product.

There should be a formal, documented pest control program that is maintained for the establishment. This

program should cover all of the preventive measures that are taken to exclude and eliminate pests, the various

pest-control devices and pest-control chemicals that are used, the monitoring of pest activity, and compliance

with government regulations on use of pesticides and pest control devices. It is common for food companies to

engage the services of external pest control contractors to undertake some of the required pest-control activities.

Only chemicals approved as pesticides by the appropriate regulatory agency should be used for pest control in a

food plant.

2.1.5. 5.2.1.5. Equipment

This prerequisite program covers activities directed at design, construction, installation, performance,

maintenance, and use of equipment in a food plant. It also includes the calibration of equipment used for

monitoring and measuring parameters at any point in a process of detection, elimination, control, or prevention

of food safety hazards, and for measuring product characteristics that are indicators of the safety of a product.

The cleaning and sanitation of equipment is covered under the prerequisite program Sanitation and cleaning.

Equipment used for storage of materials and products is covered under the prerequisite program Transportation,

receiving, storage, and shipping.

The particular types of equipment that are used in a food plant depend on the specific type of products that are

processed. The performance of equipment should ensure that the safety or quality specifications of a food can be

achieved. In this prerequisite program, the primary considerations are to ensure that the equipment are capable

of processing products that meet the safety and quality requirements, while at the same time the equipment must

not be a source of contamination of the product.

5. Good practices


2.1.6. 5.2.1.6. Transportation, receiving, storage, and shipping

This prerequisite program covers the activities directed at transportation and receiving of all materials to be used

in the processing and packaging operations, storage and warehousing of all materials and products at the food

establishment, and shipping and transportation of all foods to the point of delivery.

In this prerequisite program, the primary consideration is the prevention of contamination, cross-contamination

and deterioration of products by control of incoming raw materials, ingredients, packaging materials, and

processing aids from the time they arrive at a food plant, their subsequent inspection, acceptance and storage

until they are utilized; and control of the storage of semi-finished and finished products from the time they are

produced, their subsequent move to designated storage areas or containers, their shipment, delivery, and

distribution to their point of use or sale.

2.1.7. 5.2.1.7. Traceability and recall

This prerequisite program addresses the requirements for identifying and tracing all raw materials, ingredients,

and products, including all semi-finished, finished, reworked, or recycled products, and the procedures to be

followed for conducting a recall of a food that has reached the marketplace, should this become necessary. In

the food industry, it is quite common for foods to be recalled from the marketplace. This occurs in spite of the

enforcement of and compliance with regulatory requirements of GMPs in food establishments and the use of

government mandated HACCP system requirements in some food industry sectors.

A recall of a food can take place whenever it has been determined that there is an unacceptable health hazard

associated with the food that has reached the consumer marketplace, or some aspect of the food violates the laws

or regulations that govern the product. A recall can be initiated without any evidence that the health of a

consumer of the food has been affected. A food can contain an unacceptable health hazard as a result of

deficiencies during the manufacture of the product. For some types of foods, contamination can take place

during storage, distribution, handling, and retailing.

The accurate recorded identification of the usage and movement of raw materials, ingredients, and products,

including recycled or reworked products, at all stages of processing, handling, storage, and distribution of a

food, are essential for the traceability of a food.

All raw materials, ingredients, and products, including intermediate, semi-finished, pre-finished, finished,

recycled, reworked, pre-packaged, and packaged products should be identified and the identification recorded.

The identification of a food to be shipped from a food plant should cover the identity of the food (e.g., product

name, recipe, product code) and the time or period of production (e.g., production date, day code, lot number,

batch number).

There should be a program for traceability for every food that is manufactured and shipped from a food plant.

This program should cover forward traceability (for use of raw materials and ingredients) and backward

traceability (for finished products). The traceability program should be based on the use of the relevant

identification records and should cover all foods that are in inventory in all warehouses, foods that have been

shipped from a food plant and its warehouses, foods delivered to customers, and foods that have been sold to

consumers.

A written recall procedure should be developed to ensure that if a food which is known to present an actual or

potential unacceptable health risk to the consumer has entered the food distribution and retail chain, the food can

be retrieved quickly and completely.

2.1.8. 5.2.1.8. Chemical control

This prerequisite program addresses the control of the various chemical hazards that are used in food plants and

in the processing of foods that are not covered by CCPs of HACCP plans. These chemical hazards include some

permitted food additives, foods that are known allergens, cleaning and sanitizing chemicals, pest control

chemicals, and chemicals used for equipment maintenance. The control of many of these chemicals can be

achieved by the other prerequisite programs described earlier. For allergens, an allergen control program should

be developed to control allergens that are not controlled as chemical hazards by CCPs of HACCP plans. This

program should be devoted to preventing allergen contamination or cross-contamination of foods which do not

contain allergenic ingredients.

5. Good practices


3. 5.3. Good Agricultural and Environmental Condition and Good Farming Practice

The 156/2004. (X. 27.) MARD Regulation sets out the environmental requirements in the form of the Good

Agricultural and Environmental Condition (GAEC) and Good Farming Practice (GFP).

This regulation is provided for both quality assurance systems.

Quality system demonstrates that the enterprise is committed to:

• The consumer confidence in food quality and safety of maintenance;

• The environment imposed to minimize adverse impacts, the environment and wildlife protection.

3.1. 5.3.1. “Cross-compliance”

The concept “Cross-compliance”:

• The 2003 CAP reform made direct support for farmers dependent on compliance with requirements of public

interest.

• Cross-compliance concerns regulations/directives in the field of environment, public and animal health,

animal welfare, plant protection products and the maintenance of all agricultural land in good agricultural and

environmental condition.

Main elements of cross-compliance:

• A farmer receiving direct payments must respect the statutory management requirements (SMRs) and the

good agricultural and environmental condition (GAEC).

• The competent national authority must provide the farmer with the complete list of statutory management

requirements and the GAEC.

• In case of non-respect: reduction or cancellation of the direct payments.

It penalizes farmers who infringe EU law on environmental, public and animal health, animal welfare or land

management – by reducing the EU support they receive. The size of the reduction depends on the severity of the

infringement.

3.2. 5.3.2. Statutory Management Requirements (SMRs)

There are 19 Community legislative acts in the areas of environment, public, animal and plant health, and

animal welfare (Annex III of R. 1782/2003). Directives apply as implemented by the Member States. SMRs

from 2006: Public health, animal health, plant protection products, notification of diseases (Foodlaw

Regulation).

3.3. 5.3.3. Good Agricultural and Environmental Condition (GAEC)

Requirements for Good Agricultural and Environmental Condition (GAEC) are to be defined by Member States

(MS), taking into account soil and climatic condition, existing farm systems, land use, crop rotations, farming

practices and farm structures.

On the basis of the common framework set up in Annex IV of Council Regulation (EC) No 1782/2003 covering:

1. Protecting soil from erosion,

2. Maintaining soil organic matter,

3. Maintaining soil structure,

5. Good practices


4. Ensuring a minimum level of maintenance and avoiding deterioration of habitats,

In addition it is required that the ratio of permanent pastures at national level is maintained within certain limits.

4. 5.4. Good Agricultural Practice (GAP)

Good Agricultural Practices (GAP) are specific methods which, when applied to agriculture, produce results that

are in harmony with the values of the proponents of those practices. There are numerous competing definitions

of what methods constitute "Good Agricultural Practices".

They are Application Practices that improve safety and efficacy.

The Food and Agricultural Organization (FAO) of the United Nations uses Good Agricultural Practices as a

collection of principles to apply for on-farm production and post-production processes, resulting in safe and

healthy food and non-food agricultural products, while taking into account economical, social and

environmental sustainability.

GAPs may be applied to a wide range of farming systems and at different scales. They are applied through

sustainable agricultural methods.

It must be document in Fumigant Management Plan and/or Post-Application Summary to show compliance.

GAP includes practices that have to be followed at the primary production, in order to ensure a safe and

wholesome product. Whilst also minimizing the negative impact of those practices on the environment and on

workers' health.

GAP guidelines:

• Crop production,

• Grassland management,

• Nutrient management,

• Plant protection,

• Nature and landscape protection,

• Animal husbandry,

• Soil erosion,

• Nutrient content of organic matter,

• Soil structure,

• The minimum level of cultivation,

• Keeping order in the economic territory,

• Required records (nutrient supply and spray diary).

Chapters of GAP:

• Production area selection

• Species and material selection

• Tillage

• Manuring

• Irrigation

5. Good practices


• Plant protection

• Harvesting and post-harvest operations

• Treatment of waste and pollutants

• Nature conservation

• Documentation system.

5. 5.5. European System Related to Good Agricultural Practice (EUREPGAP)

EUREPGAP is a common standard for farm management practice created in the late 1990s by several European

supermarket chains and their major suppliers. GAP is an acronym for Good Agricultural Practices.

The aim was to bring conformity to different retailers' supplier standards, which had been creating problems for

farmers. It is now the world's most widely implemented farm certification scheme. Most European customers

for agricultural products now demand evidence of EUREPGAP certification as a prerequisite for doing business.

The standard was developed using the Hazard Analysis and Critical Control Points (HACCP) guidelines

published by the United Nations Food and Agriculture Organization, and is governed according to the ISO

Guide 65 for certifications schemes.

Unlike other farm certification schemes, it has definitive rules for growers to follow, and each production unit is

assessed by independent third party auditors.

These auditors work for commercial certification companies who are licensed by the EUREPGAP secretariat to

conduct audits and award certificates where merited.

Requirements of the EUREPGAP Euro-Retailer Produce Working Group (EUREP), a body created at the

initiative of retailers in 1997. The aim has been to the Good Agricultural Practice (Good Agricultural Practice,

GAP), a framework for the record, that the agricultural production throughout the production processes

developed best management include the essential elements.

In EUREPGAP standards, which allow an individual farmer, farm productive or farmer group internationally

recognized certification. The certificate holders to the normal conditions of use EUREPGAP logo.

Good Agricultural Practices (GAP) can be applied both to crop farms and wherever animals are reared. They are

applied to vegetable and fruit production, flower and houseplant production (Ornamentals), agricultural plant

production, livestock and combinable crops, fish breeding, coffee shrub production (Green Cof.).

The EUREPGAP agriculture by the given set of requirements given by the following criteria:

• – Food security;

• – Worker health, safety and welfare,

• – Environmental and

• – Animal welfare issues.

The Good Agricultural Practices Standards Items:

• Following up,

• Documentation and internal review,

• Varieties and stocks for plantation,

• Website update and management,

5. Good practices


• Soil management,

• Fertilizer application,

• Irrigation,

• Crop protection,

• Harvesting,

• Post-harvest treatment,

• Lose and pollution management and reuse,

• Workers health and safety,

• Environmental issues.

The most important requirements making the companies eligible for the EUREPGAP certification are laid down

in three scheme documents:

• The EUREGAP General Regulations provides instructions on how the certificate can be applied, in addition

to duties and rights of the EUREPGAP Secretariat, Certifiers and farmers applying for certification. Also,

describes the requirements of the farmer Group Quality Management System.

• EUREGAP Control Points and Compliance Criteria (CPCC) is the standard which the farmer must comply

with, and gives specific details on how the farmer comply with each of the scheme requirements.

• The EUREGAP Checklist which forms the basis the farmer must use to fulfil the annual internal audit

requirements. It contains the control points, used for the self-inspection by the farmer and for inspecting and

evaluating compliance.

The control points that the applicant is required to undertake in order to obtain recognition are divided into three

types: Major Must, Minor Must and Recommendation activities. To obtain a EUREPGAP certificate the

company has to meet 100% of the Major Must and 95% of the Minor Must requirements. Also, the companies

need to undertake a residue analysis of their registered crops (immediately after the crop is harvested) and

possible analysis of the irrigation and/ or washing water. For the first inspection visit, it is necessary to keep

record since three months before the date of inspection.

If the farmers want to get what degree of their current farming system meets the EUREPGAP requirement, they

can make a self-assessment with the official EUREPGAP Checklist. In addition, the Control Union Certification

(formerly Skal International) can offer pre-scoping visit to farmers as an additional service to make sure that

everything is settled before the first inspection (audit). This visit will give the farmers an opportunity to realize

all insufficiencies before the inspection.

Why does one need a EUREPGAP system?

• To maintain consumer confidence in food quality and safety and to increase consumer‘s satisfaction,

• To achieve minimum consumer requirements,

• To minimize detrimental impact on the environment, whilst conserving nature and wildlife,

• To assure long-term maintenance of agriculture,

• To ensure a responsible attitude towards worker health and safety,

• To obtain loyal customers,

• To improve the efficiency of natural resource use; and

• To reduce the use of chemical products in agriculture.

5. Good practices


GLOBALG.A.P.

In September 2007, EUREPGAP changed its name to GLOBALG.A.P. The decision was taken to reflect its

expanding international role in establishing Good Agricultural Practices between multiple retailers and their

suppliers.

GLOBALG.A.P. Standards:

• GLOBALG.A.P. Integrated Farm Assurance Standard (IFA),

• GLOBALG.A.P. Compound Feed Manufacturer Standard (CFM),

• GLOBALG.A.P. Plant Propagation Material Standard (PPM),

• GLOBALG.A.P. Risk Assessment on Social Practice (GRASP).

The GLOBALG.A.P. Integrated Farm Assurance (IFA) Standard is a pre-farm gate or on-farm standard that

covers the certification of the whole agricultural production process of the product from before the plant is in the

ground (origin and propagation material control points) or from when the animal enters the production process

to non-processed product (no processing, manufacturing or slaughtering is covered, except for the first level in

Aquaculture).

GLOBALG.A.P. provides the standard and framework for independent, recognized third party certification of

farm production processes based on ISO/IEC 17065:2012. Certification of the production process (cropping,

growing, rearing, or producing) of products ensures that only those that reach a certain level of compliance with

established Good Agricultural Practice (GAP) set out in the GLOBALG.A.P. normative documents are certified.

The IFA Standard offers several benefits to producers:

i. Reducing food safety risks in primary production by encouraging the development and adoption of national

and regional farm assurance schemes and with a clear risk assessed HACCP based reference standard serving

the consumer and food chain. It also serves as technical communication platform for continuous

improvement and transparency through consultation across the entire food chain.

ii. Reducing the cost of compliance by avoiding multiple product audits on mixed farming enterprises by a

single ―one-stop-shop‖, avoiding excess regulators burden by pro-active adoption by industry and by

achieving global harmonization leading to a more level playing field.

iii. Increase in the integrity of farm assurance schemes worldwide by defining and enforcing a common level of

auditor competence, verification status reporting and harmonizing interpretation of compliance criteria.

The IFA Control Points and Compliance Criteria document is separated into different modules, each one

covering different areas or levels of activity on a production site. These sections are grouped into:

i. ―Scopes‖ – covering more generic production issues, classified more broadly. These are:

All Farm Base (AF), Crops Base (CB), Livestock Base (LB) and Aquaculture Module (AB).

ii. ―Modules‖ (or ―sub-scopes‖) – covering more specific production details, classified per product type.

Legislation overrides GLOBALG.A.P. where relevant legislation is more demanding. Where there is no

legislation (or legislation is not so strict), GLOBALG.A.P. provides a minimum acceptable level of compliance.

Legal compliance of all applicable legislation per se is not a condition for certification. The audit carried out by

the GLOBALG.A.P. Certification Body is not replacing the responsibilities of public compliance agencies to

enforce legislation.

Figure 13 explains the structure of the IFA Standard and the interaction with other GLOBALG.A.P. Standards.

5.1. ábra - Fig. 13: GLOBALG.A.P. standards

5. Good practices


GLOBALG.A.P. Integrated Farm Assurance Standard (IFA) – Crops base

• Traceability (documented identification and traceability system),

• Propagation material (record/certificate of the seed quality; document that propagation material complies with

sector organization guidelines and fit for purpose; quality control system that contains a monitoring system;

recorded chemical treatments; genetically modified organisms),

• Site history and site management (records of sowing/planting, rate, and date; crop rotation),

• Soil management (the types of soil are identified for each site; avoid soil compaction; minimize soil erosion),

• Fertilizer application (nutritional needs of the crop and soil fertility; advice on quantity and type of fertilizer;

records of application; fertiliser storage; organic fertilizer; documentary evidence detailing N, P, K content),

• Irrigation/fertigation (predicting irrigation requirements; irrigation/fertigation method; quality of irrigation

water; supply of irrigation/fertigation water),

• Integrated pest management (assistance; prevention; observation and monitoring; intervention),

• Plant protection products (choice of plant protection products; advice on quantity and type of plant protection

production; records of application; pre-harvest interval; disposal of surplus application mix; plant protection

product residue analysis; plant protection product storage; plant protection product handling; empty plant

protection product containers; obsolete plant protection products; application of substances other than

fertilizer and plant protection products),

• Equipment (sensitive to food safety and the environment; equipment is kept in a good state of repair with

documented evidence).

GLOBALG.A.P. Integrated Farm Assurance Standard (IFA) – Fruit and vegetables

• Soil management (soil fumigation; pre-planting interval must be recorded),

5. Good practices


• Substrates (the producer keeps records documenting quantities recycled and dates; there are records which

prove the source of the substrates of natural origin being use),

• Pre-harvest (quality of water used for plant protect ion product application; application of organic fertilizer;

pre-harvest check),

• Harvesting (there is a documented and up to date risk assessment covering physical, chemical and

microbiological contaminants and human transmissible diseases, customized to the products; based on the

risk assessment, there is a documented hygiene procedure for the harvesting process; all field packed produce

must be protected from contamination; if packed produce is stored on farm, storage areas must be cleaned and

must protect it against contamination),

• Produce handling (principles of hygiene; personal hygiene, sanitary facilities; packing and storage areas,

quality control; pest control; post-harvest washing; post-harvest treatments).

GLOBALG.A.P. Integrated Farm Assurance Standard (IFA) – Livestock base

• Site (facilities are suitable for the intended purpose, maintained and in good repair; soil maps for the farm

drawn up; all electrical installations at mains voltage inaccessible to stock, protected and earthed properly; all

paints, preservatives, disinfectants and other chemical compounds stored away from livestock and feed to

prevent contamination; pest control; machinery and equipment hygiene),

• Worker health, safety and welfare (workers must demonstrate awareness at interview on how to act in case of

emergency with regard to human health, food safety, livestock health and welfare, including procedures to

cover the event of failure of the feed or water supply),

• Livestock sourcing, identification and traceability (all farms with livestock enterprises maintain a movement

record; there must be a written procedure for the production of certified and non-certified animals of the same

species available and implemented; all livestock must have individual or batch identification; there must be

procedures in place to demonstrate full traceability of livestock back to farm of birth/hatching; unique

identification of individual livestock with movement history to farm of birth/hatching registered on a

centralized database),

• Livestock feed and water (Sufficient clean water must be available, fouled drinking facilities must be cleaned;

there must be a mechanism in place to ensure supplies in extreme weather/climates; feedstuffs labels that

cover the contents of the feed must be kept; all feed materials stocked on farm are traceable to the supplier;

feed records demonstrate that only permitted sources are used; detailed records show the percentage of the

components; feed records; storage and provision of animal feeds),

• Livestock housing and facilities (sufficient size floor space to allow appropriate stocking densities; effective

and appropriate ventilation; clean and hygienic condition; floors maintained so as to avoid slippage and to

prevent stress to animals; need troughs on a firm foundation with free drainage),

• Livestock health (veterinary visits must take place on at least an annual basis or more frequently if required; a

written veterinary health plan formulated, implemented, reviewed and updated at least annually; each farm is

equipped with suitable facilities to isolate sick or injured livestock; all veterinary equipment are clean and

properly maintained; farm must take part in a screening and improvement program for appropriate zoonotic

pathogens),

• Medicines (do not past the expiry date; only use medicines that are approved for use; follow strictly the

medicine label instructions; growth promoters; residue testing; maintain up to date purchase medicine

records; medicines store in accordance with the label instructions),

• Fallen stock disposal (method of disposal must meet the legal requirements),

• Livestock dispatch (identification and traceability; livestock loaded/unloaded quietly from suitable facilities

using minimum force while ensuring stress is kept to a minimum; fitness of livestock).

GLOBALG.A.P. Compound Feed Manufacturer Standard (CFM)

• Official approval,

5. Good practices


• Workers health, safety and welfare (risk assessments; training; hazards and first aid; protective

clothing/equipment; worker welfare),

• Quality management system – HACCP,

• Internal audits,

• Feed ingredients management (selection and verification of suppliers; feed ingredients specifications and risk

assessment; procedures for control of incoming feed ingredients; registration of incoming feed ingredients;

inspection and sampling; analyses of incoming feed ingredients; rejection of deliveries; transport of incoming

feed ingredients; off site feed material stores),

• Storage facilities on site (feed ingredients and finished feed; bulk storage; bag storage; veterinary medicines,

medicated premixtures, premixtures and feed additives),

• Processing (documentation, formulations and specifications; production scheduling; cross contamination

matrix and flushing; rework material; production; intakes; routing, blending and weighing; mixing; veterinary

medicines, medicated premixtures, feed additives and premix addition; routing and bulk finished feed;

packaged feed for delivery to farm),

• Finished feed transport and loading (transport by the feed mill or subcontracted; bulk loading; packaged

feed),

• Site hygiene and management (external environment of the site; internal environment of the site, pest control;

personnel),

• Quality control of finished feed (Responsibility; Analytical Schedule; Finished Feed Sampling and Analysis;

Recall Procedure; ),

• Ingredients declaration (all feed must be clearly and correctly labelled according to the legislation of the

country of origin and destination),

• Complaints (there must be a clearly identifiable document for complaints relating to issues of compliance

with all feed),

• Documentation on traceability (records must be maintained for the entire production process from feed

ingredient selection to delivery to customers for a minimum of 2 years and capable of providing traceability

one step back and one step forward.),

• Animal protein (The Compound Feed Manufacturer must follow the national legislation of the country of

production and the purchase requirements of the country of destination regarding the specifications of the

content of animal protein in the compound feed),

• Responsible use of natural resources (there shall be a written sustainability sourcing policy in place covering

the purchases of raw materials or there shall be a plan in place to create such a policy with specific timelines).


6. fejezet - 6. HACCP

1. 6.1. Food Safety

Food safety is the assurance that food will not cause harm to the consumer when it is prepared and eaten

according to its intended use. All requirements relating to the safety characteristics of a food must be met; there

must be no unacceptable health risk associated with a food. The assurance that a food will not cause harm,

injury, or illness is determined by: (1) whether all harmful substances present in the food have been eliminated,

reduced to an established acceptable level, or prevented from exceeding the acceptable level; and (2) the food

has been prepared, handled, and stored under controlled and sanitary conditions in conformance with practices

prescribed by government regulations. The harmful substances in foods are food safety hazards. The prescribed

conditions and practices for preparing, handling, and storing food are considered GMPs.

For decades, the food industry has depended on the use of quality programs based on inspection and testing of

food products for hazards, and on GMPs for addressing food safety. Since the late 1980s, there has been

widespread use of the HACCP system specifically to achieve food safety; the system addresses food safety

primarily on the basis of prevention or elimination of unacceptable hazard levels. The GMPs, which were used

to address food safety requirements prior to the use of the HACCP system, have been incorporated into

prerequisite programs for the HACCP system.

Customers/consumers expect that product is free from microbial contamination, free from insect/rodent

contamination, free from pesticides / chemicals and free from physical hazards.

Hazard: A biological, chemical or physical agent in, or condition of, food with the potential to cause an adverse

health effect.

2. 6.2. Food safety hazards

For a known food safety hazard, the extent of the harmful effects of the hazard on the health of the consumer is

established by risk analysis and by hazard analysis. Risk analysis is usually conducted by a national food or

health regulatory agency and addresses a public health concern regarding a particular food safety hazard

associated with a sector of the food industry.

A risk analysis is comprised of risk assessment, risk management, and risk communication. A primary objective

of risk analysis is to establish a national food safety objective for a hazard in a food. The food safety objective

for a hazard is the maximum frequency and concentration of a hazard in a food at the time of consumption that

provides the appropriate level of protection from the hazard. The food safety objective can be considered as the

maximum acceptable level for the hazard in a food.

At the level of production, processing, handling, or storage, a food company performs hazard analysis as part of

the development of an HACCP plan for the food. Hazard analysis is the first of the seven HACCP principles,

and is performed to determine the health risk associated with a hazard present in a food when it is produced,

processed, handled, or stored, according to an established sequence of steps at a particular location. Once a food

safety objective for a hazard has been established by risk analysis, it must be considered during the hazard

analysis step of HACCP plan development.

2.1. 6.2.1. Biological hazards

Food-borne pathogenic bacteria are responsible for a large proportion of food poisoning incidents. Therefore,

the importance of this group of hazards must be emphasized. More than forty different pathogenic bacteria are

known; however, a large proportion of the reported cases of food poisoning can be attributed to the following

pathogenic bacteria: Salmonella spp., Eschericha coli 0157:H7, Listeria monocytogenes, Clostridium

perfringens, Clostridium botulinum, Staphylococcus aureus, and Campylobacter jejuni. Food poisoning from

these organisms occur frequently, with symptoms that include headache, muscle pain, nausea, fatigue, chills or

fever, stomach or abdominal pain, vomiting, and diarrhea. Numerous severe and fatal illnesses occur as a result

of food poisoning from pathogenic bacteria; infants and the elderly are particularly vulnerable. The foods that

are commonly involved in these food poisoning incidents include meat and poultry and their products, seafood

6. HACCP


and seafood products, egg and egg products, milk and dairy products, fruits and vegetables and their products,

low-acid canned foods, and water.

Foods can be the medium for transmission of certain viruses. Examples of viruses that are known to be food

safety hazards are the hepatitis A and E viruses, the Norwalk group of viruses, and rotavirus.

Several human parasites can be transmitted by foods. The most common human parasites include parasitic

protozoan species (e.g., Entamoeba histolytica, Giardia lambia, Cryptosporidium parvum), and parasitic worms

(Ascaris lumbricoides, Taenia solium, Trichinella spiralis).

2.2. 6.2.2. Chemical hazards

Permitted food additives

Although food additives are permitted by government regulations, many can be harmful if they are present in

the food at levels above the maximum established, and are therefore, potential chemical hazards. In some

instances, a permitted food additive present below the maximum allowable level in a food can be a health hazard

for specific segments of the population. For example, sodium bisulfite is a permitted food additive in some

foods; however, individuals who are asthmatic could be at risk from foods containing sodium bisulfite. The

labels on the containers containing the foods must clearly indicate the presence of the additives for the benefit of

individuals who may be at risk from these additives.

Naturally occurring harmful compounds

It is well known that many foods contain as their normal or inherent components naturally occurring substances

that can be harmful if they are present in excess of certain levels; examples are oxalate in rhubarb, alkaloids in

potatoes, toxins in mushrooms and in shellfish.

Unavoidable contaminants

Some foods can contain naturally occurring harmful substances that are not normal or inherent components of

the foods. These substances are considered unavoidable contaminants in the food and cannot be removed

through processing or manufacturing practices; examples are aflatoxins from molds in peanuts and in some

cereals.

Agricultural residues

Agricultural residues are a group of residual chemical or biochemical substances found in foods and are directly

attributable to certain substances that have been approved for use in the production of crops and livestock for

food. They include residues of permitted pesticides, herbicides, fungicides, drugs, hormones, and antibiotics.

Industrial contaminants

Several harmful chemicals that enter the environment as a result of industrial activity have been shown to be

present in foods. These substances include heavy metals (lead, mercury, arsenic), organo-chlorinated

compounds such as polychlorinated biphenyls (PCBs), and are considered as industrial or environmental

contaminants.

Chemical residues

In food processing operations, some chemical compounds that are not permitted substances in food are used

during certain operations and care must be taken to prevent unintentional contamination. These substances

include chemical compounds used for cleaning and sanitizing food contact surfaces of processing, handling, and

storage equipment, and for lubricating certain parts of food processing equipment.

Food allergens

Certain foods are known to contain inherent components that cause serious immunological, allergic responses in

a relatively small proportion of food consumers. These foods are entirely safe for most consumers who are not

sensitive to the allergens. The following foods and some of their products are generally considered to be the

most common food allergens: peanuts, soybeans, milk, eggs, fish, crustaceans, tree nuts, and wheat. Some other

foods (e.g., sesame seeds) are also known to cause allergenicity occasionally. In addition, sulfites (including

6. HACCP


bisulfites and metabisulfites) used as ingredients in certain foods can produce non-immunological allergic

reactions in certain sensitive individuals.

2.3. 6.2.3. Physical hazards

Physical hazards include organic or inorganic substances, commonly referred to as foreign objects, foreign

matter, or extraneous materials. Hard and sharp physical hazards are of particular concern. Depending on their

size and dimensions, hard and sharp physical hazards can cause injury to the mouth or teeth, or can cause

serious injuries if swallowed. In addition, some physical hazards, depending on their size, shape, and texture,

have the potential to cause choking if swallowed. Physical hazards in foods can be particularly harmful to

infants.

The common hazards considered as avoidable physical hazards in foods include broken glass, pieces of hard or

soft plastic materials, stones, pieces of metal, pieces of wood, and personal articles.

Producer/grower, manufacturer, distributor, transporter, retailer and consumer are all responsible for food safety.

Food safety management systems help the process and the people to produce a safe product by controlling

hazards. A food safety management system needs effective procedures, delegated responsibilities, and trained

people.

2.4. 6.2.4. Definitions

Control measure: Any action and activity that can be used to prevent or eliminate a food safety hazard or

reduce it to an acceptable level.

Corrective action: Any action to be taken when the results of monitoring at the CCP indicate a loss of control.

Critical limit: A criterion which separates acceptability from unacceptability.

Control Point: A step in the process where the product can be stopped and a measurement taken.

Critical Control Point (CCP): A step at which control can be applied and is essential to prevent or eliminate a

food safety hazard or reduce it to an acceptable level.

Measurement is taken to determine if product is acceptable or not. CCP has corrective actions that bring the

process back to acceptability and takes care of product that is unacceptable.

Flow diagram: A systematic representation of the sequence of steps or operations used in the production or

manufacture of a particular food item.

HACCP plan: A document prepared in accordance with the principles of HACCP to ensure control of hazards

which are significant for food safety in the segment of the food chain under consideration.

Hazard: A biological, chemical or physical agent in, or condition of, food with the potential to cause an adverse

health effect.

Hazard analysis: The process of collecting and evaluating information on hazards and conditions leading to

their presence to decide which are significant for food safety and therefore should be addressed in the HACCP

plan.

3. 6.3. Hazard Analysis and Critical Control Point (HACCP)

HACCP system is a system which identifies, evaluates, and controls hazards which are significant for food

safety. It is a systematic preventive approach to food safety and pharmaceutical safety that addresses physical,

chemical, and biological hazards as a means of prevention rather than finished product inspection.

HACCP is used in the food industry to identify potential food safety hazards, so that key actions, known as

Critical Control Points (CCPs) can be taken to reduce or eliminate the risk of the hazards being realized.

6. HACCP


The system is used at all stages of food production and preparation processes including packaging, distribution,

etc.

3.1. 6.3.1. History of the HACCP system

The evolution of the HACCP system during the second half of the twentieth century, from its roots in the U.S.

space program to its present use for consumer foods worldwide, can be traced through several milestones. In

addition, the evolution of the HACCP system can be traced through a series of formal recognition and adoption

activities by the food industry, government regulatory agencies, and national and international scientific and

professional organizations.

HACCP itself was conceived in the 1960s when the US National Aeronautics and Space Administration

(NASA) asked Pillsbury Company to design and manufacture the first foods for space flights.

After the initial success with foods for the space program, the Pillsbury Company pioneered the development of

the HACCP system for food safety in the manufacture of consumer foods in its food processing plants. The

Pillsbury Company announced the use of the HACCP system for consumer foods in the early 1970s

Since then, HACCP has been recognized internationally as a logical tool for adapting traditional inspection

methods to a modern, science-based, food safety system.

Based on risk-assessment, HACCP plans allow both industry and government to allocate their resources

efficiently in establishing and auditing safe food production practices.

In 1987, the International Commission on Microbiological Specifications for Foods (ICMSF) of the World

Health Organization (WHO) endorsed the use of the HACCP approach. More extensive international

recognition of HACCP emerged in 1991 when the Codex Committee on Food Hygiene prepared a draft report

on HACCP for Codex Alimentarius member countries. Essentially, the Codex Committee recommended that the

HACCP system be accepted as the basis for an internationally recognized approach for addressing food safety.

The final version of the Codex Alimentarius HACCP system was later incorporated into the Codex Alimentarius

Basic Texts on Food Hygiene.

In 1994, the organization of International HACCP Alliance was established initially for the US meat and poultry

industries to assist them with implementing HACCP and now its membership has been spread over other

professional/industrial areas. Hence, HACCP has been increasingly applied to industries other than food, such as

cosmetics and pharmaceuticals.

This method, which in effect seeks to plan out unsafe practices, differs from traditional "produce and test"

quality control methods which are less successful and inappropriate for highly perishable foods.

3.2. 6.3.2. Seven principles of HACCP

The HACCP plan for a food is developed on the basis of the seven principles of HACCP.

Principle 1: Conduct a hazard analysis

Plans determine the food safety hazards and identify the preventive measures the plan can apply to control these

hazards. A food safety hazard is any biological, chemical, or physical property that may cause a food to be

unsafe for human consumption.

Principle 2: Determine critical control points

A Critical Control Point (CCP) is a point, step, or procedure in a food manufacturing process at which control

can be applied and, as a result, a food safety hazard can be prevented, eliminated, or reduced to an acceptable

level.

Principle 3: Establish critical limits for each critical control point

A critical limit is the maximum or minimum value to which a physical, biological, or chemical hazard must be

controlled at a critical control point to prevent, eliminate, or reduce to an acceptable level.

Principle 4: Establish monitoring procedures

6. HACCP


Monitoring activities are necessary to ensure that the process is under control at each critical control point. In

the United States, the FSIS is requiring that each monitoring procedure and its frequency be listed in the

HACCP plan.

Principle 5: Establish corrective action procedures

These are actions to be taken when monitoring indicates a deviation from an established critical limit. The final

rule requires a plant's HACCP plan to identify the corrective actions to be taken if a critical limit is not met.

Corrective actions are intended to ensure that no product injurious to health or otherwise adulterated as a result

of the deviation enters commerce.

Principle 6: Establish verification procedures

Validation ensures that the plants do what they were designed to do; that is, they are successful in ensuring the

production of safe product.

Review and correct the system periodically and whenever you make changes to your operation.

Principle 7: Establish record-keeping and documentation procedures

The HACCP regulation requires that all plants maintain certain documents, including its hazard analysis and

written HACCP plan, and records documenting the monitoring of critical control points, critical limits,

verification activities, and the handling of processing deviations.

3.3. 6.3.3. Components of HACCP

• Pre-requisite program

• Foundation to a HACCP program

• Includes Good Manufacturing Practices

• Addresses food safety at all stages from receiving to shipping (including indirect hazards)

• Hazard analysis

Pre-requisite programs

At a food plant that operates with the HACCP system, the system is comprised of the HACCP prerequisite

programs, which apply to the entire establishment, and the HACCP plans, which apply to the foods produced at

the establishment.

1. Premises (Outside property and building; Design, construction and maintenance; Lighting; Ventilation;

Waste disposal; Inedible areas; Employee and sanitary facilities; Water/steam/ice)

2. Transportation and storage (Food carriers; Temperature controls; Receiving and storage; Finished product

storage)

3. Equipment (Design and installation; Maintenance and calibration)

4. Personnel/training (Trained for their job; Understand food safety)

5. Sanitation and pest control (Sanitation; Pest control)

6. Recall (Product identification; Locating product; Returning product)

7. Allergen control (Identification of Allergens; Control of allergens)

8. Supplier quality assurance (Vendor approval process; Product specifications; Inspect incoming materials)

6. HACCP


3.4. 6.3.4. The Codex Alimentarius Logic Sequence for the Application of HACCP

The twelve steps in the Codex Alimentarius Logic Sequence for the Application of HACCP are as follows:

Step 1: Assemble an HACCP team

An HACCP team is a group of a food company‘s employees who should be assembled and given the

responsibility by management to develop and implement an HACCP system for the company‘s establishment at

which the food product is produced.

The team, which commonly consists of four to eight people, should be composed of personnel who can

contribute knowledge in quality assurance, quality control, food microbiology, food processing, GMPs, and

equipment maintenance. Personnel who are responsible for ongoing activities in inspection, testing, production,

cleaning, and sanitation can also be included in the HACCP team.

People chosen that have expertise in different areas e.g. production, shipping, Quality Assurance, sanitation,

maintenance and sales.

Step 2: Describe the food product that the HACCP plan will address

The important characteristics relating to the safety of the product must be clearly described by the HACCP

team. This information will be used by the team in the identification and analysis of all hazards (Step 6, HACCP

Principle 1) associated with all aspects of preparation of the product.

Step 3: Identify the intended use of the food product

The normal or common use of the product must be known in order for the hazard analysis to be done (Step 6;

HACCP Principle 1). Therefore, this step should establish where and by whom the product will be used (e.g.,

food service or institutional use, industrial use, or household use by the general consumer).

Step 4: Construct a flow diagram of the process that is used to produce the food product

The HACCP team, with assistance from personnel who are familiar with the process, should construct a process

flow diagram that shows a simple but logical step-by-step outline of the process from which the product will be

obtained. The process flow diagram should identify all key steps from receiving of raw materials and ingredients

for preparing of the product.

Step 5: Conduct an on-site verification of the process flow diagram

The HACCP team, with assistance from personnel who actually operate the process, should verify the process

flow diagram prepared in Step 4, to establish that the diagram accurately represents the actual activities and

operations used to prepare the product. This is done by observing each step of the process, from receiving of raw

materials to shipping of finished product, as each activity and operation identified on the process flow diagram

actually takes place. Based on the results of this observation, the process flow diagram should be modified as

required.

Step 6: Conduct a hazard analysis of (a) all raw materials and ingredients and (b) each step (in the

process flow diagram) used for preparation of the food product (principle 1)

After Steps 1 to 5 have been completed, the HACCP team can then proceed to develop the HACCP plan for the

product. HACCP Principle 1 hazard analysis must be performed at this stage. The hazard analysis can be an

extensive exercise for the HACCP team, since it addresses the three categories of hazards (biological, chemical,

and physical). The hazard analysis should be carried out in two stages; the first stage is hazard identification,

which is followed by hazard evaluation. In addition, the control measures for the hazards that need to be

addressed in the HACCP plan should be identified at the completion of the hazard analysis.

Step 7: Apply HACCP decision tree to determine critical control points (CCP’s) (Principle 2)

With the information obtained from the hazard analysis step, the HACCP team must then determine the points at

which there will be control of the hazards that present unacceptable risks; this will establish the CCPs of the

6. HACCP


HACCP plan. A useful tool for the determination of whether a raw material or process step is a CCP, is the CCP

decision tree (Fig. 14).

The CCP decision trees consist of a set of either three or four questions, which are asked in a particular sequence

for each identified hazard so that the points of control of that hazard within the HACCP plan can be determined.

At the completion of Step 7, the HACCP team should be in a position to determine at which points in the

process, the identified biological, chemical and physical hazards associated with the product will be controlled

so that the hazard will be eliminated, prevented, or reduced to an acceptable level. It is possible that more than

one step could be a critical control point (CCP) for the same hazard (e.g., pasteurization and refrigerated storage

can be CCPs for the same microbiological hazard); on the other hand, a single CCP could control more than one

hazard (e.g., a screening step in a process can be a CCP for various physical hazards).

6.1. ábra - Fig. 14: HACCP decision tree

Step 8: Establish critical limits or tolerances for each of the critical control points identified in Step 7

(Principle 3)

For each of the CCPs that have been determined in Step 7, the HACCP team must establish critical limits which

will serve as the criteria for accepting or rejecting a raw material or ingredient that is a CCP, or a semi-finished

or finished product that is obtained at a process step that is a CCP. A critical limit is commonly a maximum

value of a parameter that must not be exceeded or a minimum value of a parameter that must be reached at a

CCP. At a CCP, the critical limits must be respected for the hazard to be prevented, eliminated or reduced to an

acceptable level, and therefore for the product obtained at the CCP to be acceptable. If the critical limits at a

CCP are not respected, the product obtained at the CCP will not be acceptable.

Step 9: Establish monitoring procedures for each of the critical control points identified in Step 7

(Principle 4)

For each of the CCPs that have been determined, the HACCP team must establish the monitoring procedures

which will be used to monitor or measure the parameters at the CCP to determine whether the critical limits are

being respected. Monitoring can also reveal whether a trend toward loss of control at the CCP is developing so

that appropriate action can be taken to prevent loss of control before it actually occurs.

It is essential that the monitoring procedures be reliable; if the monitoring procedure involves a measurement,

the reliability of the method used should be known.

The monitoring procedures should be adequately documented to ensure that these points are addressed.

6. HACCP


Step 10: Establish corrective action procedures to be followed when monitoring of the critical control

points reveals that the established critical limits have been exceeded or have not been met (Principle 5)

During the development of the HACCP plan, the HACCP team must establish procedures to be followed if and

when the monitoring of a CCP reveals that the critical limits are not respected (i.e., a deviation occurs), and

therefore there is a loss of control of the hazard at the CCP. A product that is obtained at a process step where

the CCPs are not respected is a nonconforming product and is likely to be unsafe if consumed. The procedures

that are established to prevent unsafe product from reaching the consumer are the corrective action procedures

or deviation procedures.

Step 11: Establish verification procedures to confirm and provide confidence that (a) the critical control

points are being monitored effectively and are under control, and (b) the HACCP plan for the product is

operating effectively (Principle 6)

This HACCP principle requires that the HACCP team develop measures that will evaluate (a) the effectiveness

of the HACCP plan that has been developed and (b) the effectiveness of the HACCP system on an ongoing basis

after its implementation.

Review and correct the system periodically and whenever you make changes to your operation.

Step 12: Establish record-keeping and documentation procedures for records and documents that are

required by the HACCP plan (Principle 7)

For the successful implementation of HACCP, appropriate documentation and records must be kept and be

readily available. It is unrealistic to operate HACCP or to demonstrate compliance with the current legislation

without providing evidence such as written records.

This HACCP principle covers all records and documents that are required for all HACCP plans and for the

entire HACCP system. In the development of the HACCP plan, the HACCP team must identify which

documents will be required and which records will be kept as part of the monitoring procedures, corrective

action procedures, and verification procedures (HACCP Principles 4–6; Steps 9–11).


7. fejezet - 7. ISO 9000 family of standards

The ISO 9000 quality system standards were developed by the International Organization for Standardization

(ISO) for use by any organization that needs to develop, implement and operate with a quality management

system. The ISO 9000 quality system standards have had considerable impact on the evolution of quality

activities on a global scale since the first set of standards were issued in 1987.

1. 7.1. The evolution of the ISO 9000 quality system standards

ISO 9000 was first published in 1987. It was based on the BS 5750 series of standards from British Standards

Institution (BSI) that were proposed to ISO in 1979. However, its history can be traced back some twenty years

before that, to the publication of the United States Department of Defense MIL-Q-9858 standard in 1959. MIL-

Q-9858 was revised into the NATO AQAP series of standards in 1969, which in turn were revised into the BS

5179 series of guidance standards published in 1974, and finally revised into the BS 5750 series of requirements

standards in 1979 before being submitted to ISO.

The ISO 9000 standard is continually being revised by standing technical committees and advisory groups, who

receive feedback from those professionals who are implementing the standard.

The ISO 9000 quality system standards, which were introduced in 1987, were revised in 1994, 2000 and 2005

again in. The objective of these periodic revisions is to satisfy the needs of the standards‘ users.

ISO 9000:1987 had the same structure as the UK Standard BS 5750, with three 'models' for quality management

systems, the selection of which was based on the scope of activities of the organization:

1. ISO 9000:1987 „Quality management and quality assurance standards - Guidelines for selection and use”.

2. ISO 9001:1987 “Quality systems - Model for quality assurance in design, development, production,

installation, and servicing” was for companies and organizations whose activities included the creation of

new products.

3. ISO 9002:1987 “Quality systems - Model for quality assurance in production and installation” had basically

the same material as ISO 9001 but without covering the creation of new products.

4. ISO 9003:1987 “Quality systems - Model for quality assurance in final inspection and test” covered only the

final inspection of finished product, with no concern for how the product was produced.

5. ISO 9004:1987 “Quality management and quality system elements - Guidelines”

ISO 9000:1987 was also influenced by existing U.S. and other Defense Standards ("MIL SPECS"), and so was

well-suited to manufacturing. The emphasis tended to be placed on conformance with procedures rather than the

overall process of management, which was likely the actual intent.

ISO 9000:1994 emphasized quality assurance via preventive actions, instead of just checking final product, and

continued to require evidence of compliance with documented procedures. As with the first edition, the down-

side was that companies tended to implement its requirements by creating shelf-loads of procedure manuals, and

becoming burdened with an ISO bureaucracy. In some companies, adapting and improving processes could

actually be impeded by the quality system.

1. ISO 8402:1994 “Quality management and quality assurance – Vocabulary”.

2. ISO 9000-1:1994 “Quality management and quality assurance standards - Part 1: Guidelines for selection

and use”.

3. ISO 9001:1994 “Quality systems - Model for quality assurance in design, development, production,

installation and servicing”.

7. ISO 9000 family of standards


4. ISO 9002:1994 “Quality systems - Model for quality assurance in production, installation and servicing”.

5. ISO 9003:1994 “Quality systems - Model for quality assurance in final inspection and test”.

6. ISO 9004-1:1994 “Quality management and quality system elements - Part 1: Guidelines”.

The 1994 revisions were considered minor revisions with little change in the structure of the initial 1987 version

of the three standards ISO 9001, ISO 9002, and ISO 9003, which were models for quality assurance. However,

in the 2000 revisions the structure of the standards was considerably modified. This led to cancellation of the

ISO 9001, ISO 9002, and ISO 9003 quality assurance system standards and their replacement by the single ISO

9001:2000 quality management system standard. The ISO 9001:2000 standard, the requirements of which are

described in five clauses, was substantially restructured when compared with the ISO 9001:1994 standard in

which the requirements were described in 20 elements.

In the 2000 revisions, several documents in the ISO 9000 family of documents were retired, while some others

were revised.

The 2000 edition of the ISO 9000 family of standards cancelled and replaced the 1994 edition of several of the

standards. ISO 9001:2000 combines the three standards 9001, 9002, and 9003 into one.

In the 2000 revision, quality management principles and fundamentals of quality management systems were

formally recognized and incorporated into the ISO 9000 family of standards. The 2000 revision, which was the

first major revision of the standards, resulted in the following three standards:

1. ISO 9000:2000 “Quality management systems - Fundamentals and vocabulary”.

2. ISO 9001:2000 “Quality management systems - Requirements”.

3. ISO 9004:2000 “Quality management systems - Guidelines for performance improvements”.

The two standards ISO 9001:2000 and ISO 9004:2000 have been referred to as a consistent pair, indicating that

they are compatible with each other.

ISO 9001:2000 defines minimum requirements for an organization that seeks to have its quality management

system recognized by a formal registration process.

ISO 9004:2000 is not used for registration but provides guidance for performance improvement of a quality

management system. The scope of this guidance extends much beyond the minimum requirements of ISO

9001:2000.

ISO 9001:2008 basically renarrates ISO 9001:2000. The 2008 version only introduced clarifications to the

existing requirements of ISO 9001:2000 and some changes intended to improve consistency with ISO

14001:2004. There were no new requirements. For example, in ISO 9001:2008, a quality management system

being upgraded just needs to be checked to see if it is following the clarifications introduced in the amended

version.

Latest version of ISO 9000 family of standards:

1. ISO 9000:2005 (MSZ EN ISO 9000:2005) “Quality management systems - Fundamentals and vocabulary”

2. ISO 9001:2008 (MSZ EN ISO 9001:2009) “Quality Management System - Requirements”

3. ISO 9004:2009 (MSZ EN ISO 9004:2010) “Managing for the sustained success of an organization - A

quality management approach”

2. 7.2. Principles and fundamentals of quality management systems

2.1. 7.2.1. Quality management principles

Quality management is becoming increasingly important to the leadership and management of all organizations.



It is necessary to identify Quality Management as a distinct discipline of management and lay down universally

understood and accepted rules for this discipline.

The ISO technical committee working on the ISO 9000 standards had published a document detailing the

quality management principles and application guidelines.

The latest revision (version 2008) of ISO 9000 standards are based on these principles.

Principle 1 – Customer focus:

"Organizations depend on their customers and therefore should understand current and future customer needs,

should meet customer requirements and strive to exceed customer expectations".

Principle 2 - Leadership:

"Leaders establish unity of purpose and direction of the organization. They should create and maintain the

internal environment in which people can become fully involved in achieving the organization's objectives".

Principle 3 - Involvement of people:

"People at all levels are the essence of an organization and their full involvement enables their abilities to be

used for the organization's benefit".

Principle 4 - Process approach:

"A desired result is achieved more efficiently when related resources and activities are managed as a process".

Principle 5 - System approach to management:

"Identifying, understanding and managing interrelated processes as a system contributes to the organization‘s

effectiveness and efficiency in achieving its objectives ".

Principle 6 - Continual improvement:

"Continual improvement of the organization‘s overall performance should be a permanent objective of the

organization ".

Principle 7 - Factual approach to decision making:

"Effective decisions are based on the analysis of data and information".

Principle 8 - Mutually beneficial supplier relationships:

"An organization and its suppliers are interdependent, and a mutually beneficial relationship enhances the ability

of both to create value".

2.2. 7.2.2. Fundamentals of quality management systems

The ISO 9000 standard recognizes the following 12 fundamentals, which are the basis for the contents of the

ISO 9001 and ISO 9004 quality management system standards.

These fundamentals, which incorporate the eight quality management principles, are:

• Rationale for quality management systems:

A quality management system can provide benefits to an organization. In general, these benefits include:

• Assist in enhancing the satisfaction of the organization‘s customers

• Provide a framework for continual improvement in the organization

• Provide confidence to the organization and its customers that the organization has the capability to provide

products that meet the requirements of customers, regulatory agencies and the organization.



• Requirements for quality management systems and requirements for products:

The ISO 9000 standards distinguish between the requirements of quality management systems and

requirements of products. The ISO 9001 standard provides generic quality management system requirements

that are applicable to any organization but does not provide requirements for an organization‘s products. An

organization, its customers, and government regulatory agencies establish requirements for products; these

requirements are also part of the quality management system.

• Quality management systems approach:

In the development, implementation, maintenance, and improvement of its quality management system, an

organization needs to adopt an approach in which certain specified activities should be undertaken; the

standard identifies these activities.

• The process approach:

The process approach is described as systematic identification and management of an organization‘s

processes and the interactions between these processes. This approach should be used to manage an

organization.

• Quality policy and quality objectives:

An organization‘s quality policy and quality objectives can provide a focus for the direction of the

organization. The quality policy should provide a framework for establishing the quality objectives, which

should be consistent with the quality policy.

• Role of top management within the quality management system:

An organization‘s top management, through the use of quality management principles, and its leadership and

actions can create an environment for the involvement of its people and for effective operation of the

organization‘s quality management system.

• Documentation:

Documentation is an essential feature of an organization‘s quality management system. Various types of

documents are needed in a quality management system; each should serve a particular function.

• Evaluating quality management systems:

An organization‘s quality management system should be assessed by evaluating the various processes within

the system, by auditing the system, and by top management‘s review of the system. An organization should

also carry out self-assessment of its activities and performance.

• Continual improvement:

An organization‘s quality management system should include activities that are devoted to continually

improving the system with the objective of enhancing the satisfaction of its customers and other interested

parties.

• Role of statistical techniques:

An organization should use statistical techniques to understand and solve problems such as variability, for

continual improvement of its effectiveness and efficiency, and in making decisions.

• Quality management systems and other management system focuses:

An organization‘s quality management system can be integrated with other management systems (e.g.,

financial management system, environmental management system, employee health and safety management

system). The quality objectives of the quality management system can complement the objectives of the other

management systems.

• Relationship between quality management systems and excellence models:



The approach of ISO 9000:2000 family of standards has many similarities to those of excellence models.

However, the ISO 9000 standards provide quality management system requirements (ISO 9001) and guidance

for performance improvement (ISO 9004), while the excellence models provide assessment criteria for

comparing an organization‘s performance against the performance of other organizations.

3. 7.3. ISO 9000 and ISO 9001

The Quality Management System standards created by ISO are meant to certify the processes and the system of

an organization, not the product or service itself.

ISO 9000 standards do not certify the quality of the product or service.

A quality system standard is a document that describes the requirements of a quality system. The ISO 9001

quality management system standard is the recognized international quality system standard. Many countries

have formally adopted this international standard as their national quality system standard. Prior to the adoption

of the international quality system standard, some countries had developed their own national quality system

standards. In addition, some industry sectors have developed sector-specific quality system standards. In some

instances, these sector-specific quality system standards are based on the ISO 9000 quality standard; an example

is the QS 9000 standard of the North American automotive industry.

ISO 9001 is for quality management. Quality refers to all those features of a product (or service) which are

required by the customer. Quality management means what the organization does to ensure that its products or

services satisfy the customer's quality requirements and comply with any regulations applicable to those

products or services, enhance customer satisfaction, and achieve continual improvement of its performance.

ISO 9001 helps organizations to implement quality management. ISO 9001 is the standard that gives the

requirements for a quality management system. ISO 9001:2008 is the latest, improved version. It is the only

standard in the ISO 9000 family that can be used for certification.

ISO 9001 is generic standards. Generic means that the same standards can be applied to any organization, large

or small, whatever its product or service, in any sector of activity, and whether it is a business enterprise, a

public administration, or a government department.

Generic also signifies that no matter what the organization's scope of activity if it wants to establish a quality

management system, ISO 9001 gives the essential features.

3.1. 7.3.1. Contents of ISO 9001:2008

Outline contents are as follows:

• Introduction

• Section 1: Scope

• Section 2: Normative references

• Section 3: Terms and definitions (specific to ISO 9001, not specified in ISO 9000)

• Section 4: Quality Management System

• Section 5: Management responsibility

• Section 6: Resource management

• Section 7: Product realization

• Section 8: Measurement, analysis and improvement

3.2. 7.3.2. Process approach and PDCA



This International Standard promotes the adoption of a process approach when developing, implementing and

improving the effectiveness of a quality management system, to enhance customer satisfaction by meeting

customer requirements.

The model of a process-based quality management system shown in Figure 11 illustrates the process ulinkages

presented in Clauses 4 to 8. This illustration shows that customers play a significant role in defining

requirements as inputs. Monitoring of customer satisfaction requires the evaluation of information relating to

customer perception as to whether the organization has met the customer requirements. The model shown in

Figure 15 covers all the requirements of this International Standard, but does not show processes at a detailed

level.

7.1. ábra - Fig. 15: Model of a process-based QMS (ISO 9000:2005)

PDCA

PDCA was made popular by Dr. W. Edwards Deming, who is considered by many to be the father of modern

quality control; however he always referred to it as the "Shewhart cycle".

Later in Deming's career, he modified PDCA to "Plan, Do, Study, Act" (PDSA) so as to better describe his

recommendations.

The concept of PDCA is based on the scientific method, as developed from the work of Francis Bacon (Novum

Organum, 1620).

In addition, the methodology known as Plan-Do-Check-Act (PDCA) can be applied to all processes.

PDCA can be briefly described as follows (Fig. 16):

• Plan: establish the objectives and processes necessary to deliver results in accordance with customer

requirements and the organization‘s policies.

• Do: implement the processes.

• Check: monitor and measure processes and product against policies, objectives and requirements for the

product and report the results.

• Act: take actions to continually improve process performance.



7.2. ábra - Fig. 16: PDCA cycle (Juhász – Szőllősi, 2008)

3.3. 7.3.3. Documentation requirements

The quality management system documentation shall include:

a. documented statements of a quality policy and quality objectives,

b. a quality manual,

c. documented procedures and records required by this International Standard, and

d. documents, including records, determined by the organization to be necessary to ensure the effective

planning, operation and control of its processes (Fig. 17).

7.3. ábra - Fig. 17: Concepts relating to documentation (ISO 9000: 2005)



Documents:

Quality manual: document specifying the quality management system of an organization (including quality

policy and objectives).

Processes and procedures: describe processes and how they are to be managed (e.g. to train personnel).

Work Instructions (step by step operating procedures): describe tasks and how they are to be carried out (e.g.

sample testing, equipment calibration).

Forms, checklists, records (e.g. maintenance, test and training records).

Standard specifies six compulsory documents:

1. Control of Documents (Clause 4.2.3)

2. Control of Records (Clause 4.2.4)

3. Internal Audits (Clause 8.2.2)

4. Control of Nonconforming Product / Service (Clause 8.3)

5. Corrective Action (Clause 8.5.2)

6. Preventive Action (Clause 8.5.3)

In addition to these, ISO 9001:2008 requires a Quality Policy and Quality Manual (which may or may not

include the above documents).

3.4. 7.3.4. Management responsibility

3.4.1. 7.3.4.1. Management commitment

Top management shall provide evidence of its commitment to the development and implementation of the

quality management system and continually improving its effectiveness by

a. communicating to the organization the importance of meeting customer as well as statutory and regulatory

requirements,

b. establishing the quality policy,



c. ensuring that quality objectives are established,

d. conducting management reviews, and

e. ensuring the availability of resources.

3.4.2. 7.3.4.2. Customer focus

This clause focuses attention on the application of the quality management principle of ―customer focus‖. It

emphasizes that top management must ensure that customer requirements are determined and met, so as to

enhance customer satisfaction.

3.4.3. 7.3.4.3. Quality policy

The quality policy and quality objectives, as established by top management, provide the focus to direct the

organization. Together they determine the desired results and guide the organization in allocating its resources

to achieve these results. The quality policy provides the framework for establishing and reviewing the quality

objectives.

3.4.4. 7.3.4.4. Planning

Quality planning should be focused on setting quality objectives, specifying necessary processes and related

resources to fulfil these objectives.

3.4.5. 7.3.4.5. Responsibility, authority and communication

Top management needs to ensure that responsibilities and authority are properly defined, usually in the quality

manual by means of organizational charts and job descriptions, and widely communicated within the

organization.

3.4.6. 7.3.4.6. Management review (input and output)

Management review is the process conducted by top management at planned intervals on a regular basis, for

example annually, to evaluate the effectiveness and efficiency of the quality management system. It also

assesses the need for changes and opportunities for improvement to the system, including the quality policy and

quality objectives.

3.5. 7.3.5. Resource management

3.5.1. 7.3.5.1. Provision of resources

The organization has to determine and make available the resources, in particular human resources,

infrastructure and the work environment, needed to meet customer requirements and to implement and

continually improve the quality management system.

3.5.2. 7.3.5.2. Human resources

The staff whose work affects product quality must be competent, appropriately educated and trained, skilled and

experienced.

3.5.3. 7.3.5.3. Infrastructure

Infrastructure, which includes the workspace, process equipment (both hardware and software, for example

computers and meteorological sensors) and supporting services such as communications facilities, has to be

determined and maintained to achieve conformity to product requirements.

3.5.4. 7.3.5.4. Work environment

The work environment needed to achieve conformity with product requirements has to be determined and

maintained.



3.6. 7.3.6. Product realization

3.6.1. 7.3.6.1. Planning of product realization

The organization has to plan and develop the processes needed for product realization. Planning of product

realization must be consistent with the requirements of the other processes of the quality management system

specified in Clause 4.1.

3.6.2. 7.3.6.2. Customer-related processes

The organization must determine requirements specified by the customer. The organization has to review the

requirements related to the product. The organization has to implement effective channels of communication

with the customer in relation to product information, enquiries, contracts or order handling, amendments and

customer feedback including complaints.

3.6.3. 7.3.6.3. Design and development

Design is required in the production of a new product or of a variation to an existing product. The organization

must plan and control the design and development of the products and services it provides. Product

requirements, those are complete, unambiguous and not in conflict with each other are necessary for any design.

The organization has to determine and review these requirements as design and development inputs and must

maintain records. The outputs must go through an approval process before they are released.

3.6.4. 7.3.6.4. Purchasing

This clause establishes control on the purchasing phase during the product realization process to ensure good

quality of purchased products.

3.6.5. 7.3.6.5. Production and service provision

The organization has to control the process of planning and carrying out product and service provision. The

organization must identify the product by suitable means throughout the product realization. The organization

must preserve the conformity of product and constituent parts of the product during internal processing and

delivery to the destination. The preservation includes identification, handling, packaging, storage and protection.

3.6.6. 7.3.6.6. Control of monitoring and measuring equipment

This clause requires that the organization determine the monitoring and measurement, and the associated

equipment, needed to provide evidence of conformity of product.

The organization has to establish processes to ensure that monitoring and measurement can be carried out as

planned and in a manner that is consistent with the monitoring and measurement requirements.

3.7. 7.3.7. Measurement, analysis and improvement

This clause requires the organization to plan and implement the monitoring, measurement, analysis and

improvement processes to demonstrate conformity of its quality management system and products, and to

continually improve the effectiveness of the system.

3.7.1. 7.3.7.1. Monitoring and measurement

It is a specific requirement that the organization monitor customer satisfaction. The organization is also required

to conduct internal audits at planned intervals, typically at 6- or 12-month intervals between visits by registered

auditors, to determine whether the quality management system conforms to various requirements stipulated in

ISO 9001:2008 and whether the system has been effectively implemented.

The quality management system processes must be monitored, and where applicable, measured to demonstrate

the ability of the processes to achieve the planned results, in particular, the assurance that no nonconforming

product will be produced. Internal audit is one way to monitor and measure the processes. There are many other



methods that can be applied, such as the use of suitable statistical techniques, or regular verification against the

prescribed objectives of the processes.

3.7.2. 7.3.7.2. Control of nonconforming product

Nonconforming products have to be identified and controlled to prevent them from being inadvertently released.

The organization must establish a documented procedure detailing the control, associated responsibilities and

authority for dealing with those nonconforming products.

3.7.3. 7.3.7.3. Analysis of data

The organization must determine, collect and analyse appropriate data to demonstrate the suitability and

effectiveness of the quality management system, and to evaluate the opportunities for continual improvement of

system effectiveness. The data can be generated by the monitoring and measurement processes conducted by the

organization

3.7.4. 7.3.7.4. Improvement

This requires the organization to seek continual improvement to the effectiveness of the quality management

system through the use of the following: quality policy; quality objectives; audit results, including those from

both internal and external audits; analysis of data; corrective and preventive action; and management review.

The organization has to take corrective action to prevent recurrence of detected nonconformities.

The organization has to determine the preventive action needed to prevent the actual occurrence of potential

nonconformities.

3.8. 7.3.8. Benefits of ISO 9001

• International, expert consensus on state-of-the-art practices for quality management

• Increase efficiency and effectiveness

• Model for continual improvement

• Model for satisfying customers and other stakeholders

• Build quality into products and services from design onwards

• Integrate with global economy

• Sustainable business

• Unifying base for industry sectors

• Qualify suppliers for global supply chains

• Technical support for regulations



1. 8.1. Environmental policy

It is useful to consider that environmental policy comprises two major terms: environment and policy.

Environment primarily refers to the ecological dimension (ecosystems), but can also take account of social

dimension (quality of life) and an economic dimension (resource management).

Policy can be defined as a „course of action or principle adopted or proposed by a government, party, business

or individual‖. Thus, environmental policy focuses on problems arising from human impact on the environment,

which retroacts onto human society by having a (negative) impact on human values such as good health or the

„clean and green‖ environment.

Environmental issues generally addressed by environmental policy include (but are not limited to):

• air and water pollution,

• waste management,

• ecosystem management,

• biodiversity protection,

• and the protection of natural resources, wildlife and endangered species

Relatively recently, environmental policy has also attended to the communication of environmental issues.

2. 8.2. Environmental Management System (EMS)

The environmental management bases on double-orientation. On one case, handling the environmental problems

affected by the company and on the other hand, ensures development of success factors and the elimination of

the risks related to environmental management. Planning and validation of these tasks need relatively longer

period.

An effective EMS can help a firm manage, measure, and improve the environmental aspects of its operations.

EMS has the potential to lead to more efficient compliance with mandatory and voluntary environmental

requirements. EMS may help companies effect a culture change as environmental management practices are

incorporated into its overall business operations.

An EMS creates processes and procedures that allow an organization to analyze, control, and reduce the

environmental impact of its activities, products and services The EMS also allows an organization to continually

improve its environmental performance and to adapt to changes which occur often inside and outside the

organization.

2.1. 8.2.1. Benefits of Environmental Management System

1. Better acknowledgement by society;

2. Convince new and stable costumer groups;

3. Purchase of new markets (market-orientated environment, increasing eco-shopping habits);

4. Ensuring competitive advantages;

5. Better relationship with market partners (banks, insurance companies etc);



6. Higher public orders (for example public procurement);

7. Reduce costs;

8. Prioritize environmental issues;

9. Identify potential problems;

10. Improve environmental compliance;

11. Use materials and energy more efficiently;

12. Streamline operations;

13. Improve internal communication;

14. Enhance employee morale.

2.2. 8.2.2. Risks of Environmental Management System

1. The implementation of the tasks affects environmental costs;

2. Environmental regulations level of consistency varies by country and in the short term reduce the

international competitiveness;

3. Uncertainty demand of environmental friendly products;

4. Missing the cooperation between partners;

5. Intra-corporate resistance against the new tasks;

6. Bureaucracy of authorities.

2.3. 8.2.3. ISO 14000 family of standards

Some members of the family of standards:

ISO 14001:2004 Environmental management systems – Requirements with guidance for use.

ISO 14004:2004 Environmental management systems – General guidelines on principles, systems and support

techniques.

ISO 14005:2010 Environmental management systems – Guidelines for the phased implementation of an

environmental management system, including the use of environmental performance evaluation.

ISO 14006:2011 Environmental management systems – Guidelines for incorporating ecodesign.

ISO Technical Committee 207 is responsible for the ISO 14000 series of standards. The ISO 14000 series are

based on the British standard BS 7750 which was instituted in 1992. This standard also served as the basis for

the European Union's Eco-Management and Audit Scheme (EMAS), a more stringent set of standards strongly

influenced by the high environmental standards of German companies. EMAS differs from ISO 14000 in that it

emphasizes public environmental reporting.

The actual environmental standards of ISO 14000 deal with how a company manages the environment inside it's

facilities and the immediate outside environment. However, the standards also call for analysis of the entire life

cycle of a product, from raw material to eventual disposal.

These standards do not mandate a particular level of pollution or performance, but focus on awareness of the

processes and procedures that can effect the environment. It should be noted that adherence to the ISO 14000

standards does not in anyway release a company from any national or local regulations regarding specific

performance issues regarding the environment.



Organizations of all kinds are increasingly concerned with achieving and demonstrating sound environmental

performance by controlling the impacts of their activities, products and services on the environment, consistent

with their environmental policy and objectives.

They do so in the context of increasingly stringent legislation, the development of economic policies and other

measures that foster environmental protection, and increased concern expressed by interested parties about

environmental matters and sustainable development.

Many organizations have undertaken environmental reviews or audits to assess their environmental

performance.

On their own, however, these reviews and audits may not be sufficient to provide an organization with the

assurance that its performance not only meets, but will continue to meet, its legal and policy requirements. To be

effective, they need to be conducted within a structured management system that is integrated within the

organization.

ISO 14001:2004 standard specifies requirements for an environmental management system to enable an

organization to develop and implement a policy and objectives which take into account legal requirements and

information about significant environmental aspects. It is intended to apply to all types and sizes of organization

and to accommodate diverse geographical, cultural and social conditions.

The success of the system depends on commitment from all levels and functions of the organization, and

especially from top management. A system of this kind enables an organization to develop an environmental

policy, establish objectives and processes to achieve the policy commitments, take action as needed to improve

its performance and demonstrate the conformity of the system to the requirements of this International Standard.

The overall aim of this International Standard is to support environmental protection and prevention of pollution

in balance with socio-economic needs. It should be noted that many of the requirements can be addressed

concurrently or revisited at any time.

This International Standard is based on the methodology known as Plan-Do-Check-Act (PDCA).

PDCA can be briefly described as follows:

• Plan: establish the objectives and processes necessary to deliver results in accordance with the organization‘s

environmental policy.

• Do: implement the processes.

• Check: monitor and measure processes against environmental policy, objectives, targets, legal and other

requirements, and report the results.

• Act: take actions to continually improve performance of the environmental management system.

PDCA was made popular by Dr. W. Edwards Deming, who is considered by many to be the father of modern

quality control; however he always referred to it as the "Shewhart cycle".

Later in Deming's career, he modified PDCA to "Plan, Do, Study, Act" (PDSA) so as to better describe his

recommendations.

The concept of PDCA is based on the scientific method, as developed from the work of Francis Bacon (Novum

Organum, 1620).

The scientific method can be written as "hypothesis"–"experiment"–"evaluation" or plan, do and check (Fig. 18

and 19).

• PLAN: Design or revise business process components to improve results

• DO: Implement the plan and measure its performance

• CHECK: Assess the measurements and report the results to decision makers

• ACT: Decide on changes needed to improve the process.



8.1. ábra - Fig. 18: PDCA cycle (Juhász – Szőllősi, 2008)

2.4. 8.2.4. Economic benefits of ISO 14000 family of standards

The ISO 14000 standards not only provide environmental benefits, but also significant tangible economic

benefits, including the following:

• Reduced raw material/resource use,

• Reduced energy consumption,

• Improved process efficiency,

• Reduced waste generation and disposal costs,

• Utilization of recoverable resources.

2.5. 8.2.5. The 17 requirements of the ISO 14001:2004 standard

1. Environmental policy - develop a statement of the organization‘s commitment to the environment.

2. Environmental aspects and impacts - identify environmental attributes of products, activities and services and

their effects on the environment.

3. Legal and other requirements - identify and ensure access to relevant laws and regulations

4. Objectives and targets and Environmental Management Program - set environmental goals for the

organization and plan actions to achieve objectives and targets.

5. Structure and responsibility - establish roles and responsibilities within the organization.

6. Training, awareness and competence - ensure that employees are aware and capable of their environmental

responsibilities.



7. Communication - develop processes for internal and external communication on environmental management

issues.

8. EMS Documentation - maintain information about the EMS and related documents.

9. Document control - ensure effective management of procedures and other documents.

10. Operational control - identify, plan and manage the organization‘s operations and activities in line with

the policy, objectives and targets, and significant aspects.

11. Emergency preparedness and response - develop procedures for preventing and responding to potential

emergencies.

12. Monitoring and measuring - monitor key activities and track performance including periodic

compliance evaluation.

13. Evaluation of compliance - develop procedure to periodically evaluate compliance with legal and other

requirements.

14. Non-conformance and corrective and preventive action - identify and correct problems and prevent

recurrences.

15. Records - keep adequate records of EMS performance.

16. EMS Audit - periodically verify that the EMS is effective and achieving objectives and targets.

17. Management review - review the EMS.

2.6. 8.2.6. Principles of ISO 14001:2004

The standard covers all service areas and commit us to comply with environmental legislation, have procedures

to prevent pollution and continual improvement through setting targets. These are also the benefits of having the

standard. Whilst we carry out internal assessments to measure progress, there is also a yearly external

assessment to maintain accreditation to the standard.

ISO14001 follows five universal principles proven to be the core of effective management.

1. Commit to a policy. A documented policy commits us to pollution prevention, compliance with

environmental legislation and continuous improvement.

2. Plan. It is essential to establish what environmental issues the environmental management system will

manage. The priorities are to ensure compliance with legislation and for service areas to set objectives and

targets to address the council‘s risks for the environment.

3. Implement. Having decided what to manage through objectives and targets the next step is to allocate people

and set procedures to make the EMS effective. Documented procedures are needed to describe key aspects of

the operation.

4. Measure and evaluate. Measurement, monitoring, internal audit and record keeping is needed to check

progress against the council‘s objectives and targets and also, check the management system itself and its

procedures are working properly.

5. Review and improvement. Senior managers revisit the EMS to ensure that it is working properly and is

meeting the aims of the council‘s needs and aims.



Prerequisite programmes on food safety:

1. ISO/TS 22002-1:2009 Part 1: Food manufacturing

2. ISO/TS 22002-2:2013 Part 2: Catering

3. ISO/TS 22002-3:2011 Part 3: Farming

4. ISO/DTS 22002-4 Part 4: Food packaging manufacturing

5. ISO/WD TS 22002-5 Part 5: Transport and storage

ISO/TS 22003:2007 Food safety management systems - Requirements for bodies providing audit and

certification of food safety management systems.

ISO/TS 22004:2005 Food safety management systems - Guidance on the application of ISO 22000:2005.

ISO 22005:2007 Traceability in the feed and food chain - General principles and basic requirements for system

design and implementation.

ISO 22006:2009 Quality management systems - Guidelines for the application of ISO 9001:2008 to crop

production.

1. 9.1. Food safety management systems (FSMS)

ISO 22000:2005 Food safety management systems. Requirements for any organization in the food chain.

Outline contents of ISO 22000:2005:

Introduction

Section 1: Scope

Section 2: Normative references

Section 3: Terms and definitions

Section 4: Food safety management system

Section 5: Management responsibility

Section 6: Resource management

Section 7: Planning and realization of safe products

Section 8: Validation, verification and improvement of the food safety management system (Fig. 19).

9.1. ábra - Fig. 19: Principle of ISO 22000



(http://www.asiafoodjournal.com/article/iso-22000-market-decides-top-or-flop/2765)

1.1. 9.1.1. Introduction

Food safety is related to the presence of food-borne hazards in food at the point of consumption. Food safety

hazards can occur at any stage of the food chain. Adequate control throughout the food chain is essential. Food

safety is ensured through the combined efforts of all the parties participating in the food chain.

It is a generic standard. All requirements of this International Standard are generic and are intended to be

applicable to all organizations in the food chain regardless of size and complexity. This includes organizations

directly or indirectly involved in one or more steps of the food chain.

Organizations that are directly involved include feed producers, harvesters, farmers, producers of ingredients,

food manufacturers, retailers, food services, catering services, organizations providing cleaning and sanitation

services, transportation, storage and distribution services.

Other organizations that are indirectly involved include suppliers of equipment, cleaning and sanitizing agents,

packaging material, and other food contact materials.

1.2. 9.1.2. Interactive communication

Communication along the food chain is essential to ensure that all relevant food safety hazards are identified and

adequately controlled at each step within the food chain. This implies communication between organizations

both upstream and downstream in the food chain.

Recognition of the organization‘s role and position within the food chain is essential to ensure effective

interactive communication throughout the chain in order to deliver safe food products to the final consumer. An

example of the communication channels among interested parties of the food chain is shown in Figure 20.

9.2. ábra - Fig. 20: Example of communication within the food chain (ISO 22000)

http://www.asiafoodjournal.com/article/iso-22000-market-decides-top-or-flop/2765



1.3. 9.1.3. Requirements of standard (Fig. 21):

• Interactive communication;

• Prerequisite programmes;

• HACCP principles;

• System management.

9.3. ábra - Fig. 21: ISO 22000 pyramid



(http://www.axcentus.com/22000)

1.4. 9.1.4. Alignment and integration

This International Standard has been aligned with ISO 9001 in order to enhance the compatibility of the two

standards. This International Standard can be applied independently of other management system standards. Its

implementation can be aligned or integrated with existing related management system requirements (Fig. 22).

9.4. ábra - Fig. 22: ISO 9001 and ISO 22000

http://www.axcentus.com/22000



(http://www.fantus.co.za/change06.htm)

1.5. 9.1.5. ISO 22000 and HACCP

This International Standard integrates the principles of the Hazard Analysis and Critical Control Point (HACCP)

system and application steps developed by the Codex Alimentarius Commission. By means of auditable

requirements, it combines the HACCP plan with prerequisite programmes (PRPs).

1.6. 9.1.6. Hazard analysis

It is the key to an effective food safety management system. This International Standard requires that all hazards

that may be reasonably expected to occur in the food chain. Thus it provides the means to determine and

document why certain identified hazards need to be controlled by a particular organization and why others need

not.

During hazard analysis, the organization determines the strategy to be used to ensure hazard control by

combining the PRP(s), operational PRP(s) and the HACCP plan.

It is an auditable standard. To facilitate the application of this International Standard, it has been developed as

an auditable standard. To assist individual organizations with the implementation of this International Standard,

guidance on its use is provided in ISO/TS 22004.

1.7. 9.1.7. The aim of this International Standard

To harmonize on a global level the requirements for food safety management for businesses within the food

chain. It is particularly intended for application by organizations that seek a more focused, coherent and

integrated food safety management system than is normally required by law. It requires an organization to meet

any applicable food safety related statutory and regulatory requirements through its food safety management

system (Fig. 23).

9.5. ábra - Fig. 23: Advantages of ISO 22000 certification

http://www.fantus.co.za/change06.htm



(http://www.vts.net.my/ISO22000.html)

1.8. 9.1.8. Terms and definitions

Food safety: concept that food will not cause harm to the consumer when it is prepared and/or eaten according

to its intended use.

Food safety hazard: biological, chemical or physical agent in food, or condition of food, with the potential to

cause an adverse health effect.

Food safety policy: overall intentions and direction of an organization related to food safety as formally

expressed by top management.

PRP (prerequisite programme): basic conditions and activities that are necessary to maintain a hygienic

environment throughout the food chain suitable for the production, handling and provision of safe end products

and safe food for human consumption.

Operational PRP (operational prerequisite programme): PRP identified by the hazard analysis as essential

in order to control the likelihood of introducing food safety hazards to and/or the contamination or proliferation

of food safety hazards in the product(s) or in the processing environment.

1.9. 9.1.9. Food safety management system

General requirements

The organization shall establish, document, implement and maintain an effective food safety management

system and update it when necessary in accordance with the requirements of this International Standard.

Documentation requirements

The food safety management system documentation shall include:

• documented statements of a food safety policy and related objectives,

http://www.vts.net.my/ISO22000.html



• documented procedures and records required by this International Standard, and

• documents needed by the organization to ensure the effective development, implementation and updating of

the food safety management system.

1.10. 9.1.10. Management responsibility

Management commitment

Top management shall provide evidence of its commitment to the development and implementation of the food

safety management system and to continually improving its effectiveness.

Food safety policy

Top management shall define, document and communicate its food safety policy.

Food safety management system planning

Top management shall ensure that planning of the food safety management system is carried out as well as the

objectives of the organization that support food safety; and the integrity of the food safety management system

is maintained when changes to the food safety management system are planned and implemented.

Responsibility and authority

Top management shall ensure that responsibilities and authorities are defined and communicated within the

organization to ensure the effective operation and maintenance of the food safety management system.

Food safety team leader

Top management shall appoint a food safety team leader who, irrespective of other responsibilities.

Communication

To ensure that sufficient information on issues concerning food safety is available throughout the food chain, the

organization shall establish, implement and maintain effective arrangements for communicating with suppliers

and contractors, customers or consumers, statutory and regulatory authorities, and other organizations.

Emergency preparedness and response

Top management shall establish, implement and maintain procedures to manage potential emergency situations

and accidents that can impact food safety and which are relevant to the role of the organization in the food

chain.

Management review

Top management shall review the organization‘s food safety management system at planned intervals to ensure

its continuing suitability, adequacy and effectiveness.

1.11. 9.1.11. Resource management

Provision of resources

The organization shall provide adequate resources for the establishment, implementation, maintenance and

updating of the food safety management system.

Human resources

The food safety team and the other personnel carrying out activities having an impact on food safety shall be

competent and shall have appropriate education, training, skills and experience.

Infrastructure



The organization shall provide the resources for the establishment and maintenance of the infrastructure needed

to implement the requirements of this International Standard.

Work environment

The organization shall provide the resources for the establishment, management and maintenance of the work

environment needed to implement the requirements of this International Standard.

1.12. 9.1.12. Planning and realization of safe products

General

The organization shall plan and develop the processes needed for the realization of safe products. The

organization shall implement, operate and ensure the effectiveness of the planned activities and any changes to

those activities. This includes PRP(s) as well as operational PRP(s) and/or the HACCP plan.

Prerequisite programmes (PRPs)

The organization shall establish, implement and maintain PRP(s).

Preliminary steps to enable hazard analysis

All relevant information needed to conduct the hazard analysis shall be collected, maintained, updated and

documented. Records shall be maintained.

Hazard analysis

The food safety team shall conduct a hazard analysis to determine which hazards need to be controlled, the

degree of control required to ensure food safety, and which combination of control measures is required.

Establishing the operational prerequisite programmes (PRPs)

The operational PRPs shall be documented and shall include the following information for each programme:

• food safety hazard(s) to be controlled by the programme;

• control measure(s);

• monitoring procedures that demonstrate that the operational PRPs are implemented;

• corrections and corrective actions to be taken if monitoring shows that the operational PRPs are not in

control;

• responsibilities and authorities;

• record(s) of monitoring.

Establishing the HACCP plan

The HACCP plan shall be documented and shall include the following information for each identified critical

control point (CCP):

• food safety hazard(s) to be controlled at the CCP;

• control measure(s);

• critical limit(s);

• monitoring procedure(s);

• corrections and corrective action(s) to be taken if critical limits are exceeded;

• responsibilities and authorities;



• record(s) of monitoring.

Updating of preliminary information and documents specifying the PRPs and the HACCP plan

Following the establishment of operational PRP(s) and/or the HACCP plan, the organization shall update the

following information (product characteristics; intended use; flow diagrams; process steps; control measures), if

necessary.

Verification planning

Verification planning shall define the purpose, methods, frequencies and responsibilities for the verification

activities.

Traceability system

The organization shall establish and apply a traceability system that enables the identification of product lots

and their relation to batches of raw materials, processing and delivery records.

The traceability system shall be able to identify incoming material from the immediate suppliers and the initial

distribution route of the end product.

Control of nonconformity

The organization shall ensure that when critical limits for CCP(s) are exceeded, or there is a loss of control of

operational PRP(s), the products affected are identified and controlled with regard to their use and release.

1.13. 9.1.13. Validation, verification and improvement of the food safety management system

The food safety team shall plan and implement the processes needed to validate control measures and/or control

measure combinations, and to verify and improve the food safety management system.

Validation of control measure combinations

Prior to implementation of control measures to be included in operational PRP(s) and the HACCP plan and after

any change therein, the organization shall validate that the selected control measures are capable of achieving

the intended control of the food safety hazard(s) for which they are designated.

Control of monitoring and measuring

The organization shall provide evidence that the specified monitoring and measuring methods and equipment

are adequate to ensure the performance of the monitoring and measuring procedures.

Food safety management system verification

The organization shall conduct internal audits at planned intervals to determine whether the food safety

management system conforms to the planned arrangements, to the food safety management system requirements

established by the organization, and to the requirements of this International Standard, and is effectively

implemented and updated.

Improvement

Top management shall ensure that the organization continually improves the effectiveness of the food safety

management system.


10. fejezet - 10. Integrated systems

1. 10.1. Integrated Management Systems (IMS)

The intent of integration of standards was obvious in case of both environmental and quality management

systems as indicated in the following citations.

„During the development of this International Standard, due consideration was given to the provisions of ISO

14001: 2004 to enhance the compatibility of the two standards for the benefit of the user community‖ (ISO

9001:2008, Chapter 0.4.).

„The second edition of this International Standard has taken due consideration of the provisions of ISO 9001 to

enhance the compatibility of the two standards for the benefit of the user community‖ (ISO 14 001:2004,

Introduction).

2. 10.2. Characteristics of Integrated Management Systems

Integrated: i.e. it includes system installation approaches from different aspects of management.

Differentiated: since it allows unified but differentiated attention of different organizations (institution types).

Modular: that is it contains elements depending on the type and size of the organization that allows for gradual

installation.

Dynamic: i.e. it is not a strictly defined model; however it provides tools to continual development as well as

structural and parametric renewal.

Organic: that is it is in connection with the organization, forms an organic part of the operation and

management, as well as completes and helps in provision of functional tasks.

Profile neutral: i.e. it can be applied uniformly and independently from the profiles of the certain organizations

(Fig. 24 and 25).

10.1. ábra - Fig. 24: Integrated Management Systems (Juhász – Szőllősi, 2008)

10. Integrated systems


10.2. ábra - Fig. 25: Integrated Management Systems (Juhász – Szőllősi, 2008)

New standards enable the integration of systems. Systems must meet measures and consumer‘s requirements;

they must be created, documented, introduced, maintained, checked, measured and analyzed, developed and

approved (Fig. 26).

10.3. ábra - Fig. 26: Requirements of Integrated Management System (Juhász – Szőllősi,

2008)



3. 10.3. When should we build a system?

Ownership: Ownership is clear, owners agree with the introduction of the system.

Leadership: Leaders recognize market needs.

Experts: Only well-trained, highly educated experts can assist for building system formation.

Product structure: Only a stable product structure can be the base for a good quality system.

Financial situation: Firm and stable financial situation is required for starting a system.

Summary: We can only build a system if the venture is stable and firm at all fields.

Advantages of building the integrated system from own sources:

• Leaders know their own field very well, so they aware of all the possible effects (effects on quality and

environment);

• System creation can be started immediately, there is no need to explain all the processes to an outer

consultant;

• The communication channels are already set between the ones who build the system, so good cooperation is

assured;

• No need to pay for consultants, costs are relatively low;

• The one responsible for system building is one of the top leaders, so he has the power to decide on every

question.

Disadvantages of building the integrated system from own sources:

• Leaders of special fields may skip important details, which can highly affect the system (wrong company

procedures);

• Experts building the system will have more pressure on them, as they usually perform tasks out of their usual

job;

• Experts may judge questions differently, so they draw different conclusions (what‘s good for production

development, may not be good for production);

• Sometimes experts not focus on vital questions, so documents must be revised several times, requiring more

work;

• There can be no cooperation between the different fields, datelines may not be kept (wrong communication,

due to some „old abuse‖);

• System can be too complicated and bureaucratic, as each field wants to regulate their own the most, which

may negatively affect the whole system (Overregulation, different solutions for the same problem);

• May result in increasing costs (failed audit);

• Field leaders may not aware of all requirements of standards, or they misinterpret them.

Advantages of building with outer consultant(s):

• Professional knowledge of standards and systems;

• They can provide the best and most suitable solution for a problem;

• System building will not be delayed, the consultant keep the datelines of the schedule;



• They are not affected by the inner „power structure‖ of the company, they are not interested in favouring any

field;

• They know the requirements of the auditing companies, so they can prepare the company for „special‖ needs;

• With an outer consultant, failed audit is almost impossible.

Disadvantages of building with outer consultant(s):

1. Mapping the local specialities takes much time;

2. Much more expensive, than building from own sources.

4. 10.4. Structure of system documentation

The documentation of the integrated management system can be provided with a five-level system

documentation. The levels are the following (Fig. 27):

Level I. Company policies;

Level II. Manual(s);

Level III. Procedures;

Level IV. Instructions;

Level V. Other documents (rules, records, specifications, etc).

10.4. ábra - Fig. 27: Integrated System documentations (Juhász – Szőllősi, 2008)

5. 10.5. The advantages of Integrated Management Systems

• United and more clear documentation system;

• Economic advantages, due to the united audit system;

• Common audit procedures;



• United monitoring;

• Definite liability and authority;

• System-centeredness;

• Number of parallel, repeated task are reduced, as well as overlays;

• Measurable cost reduction, due to the all-round and conformed actions;

• Less administration;

• More efficient usage of resources;

• Quick reaction time;

• Increase in company efficiency.

6. 10.6. Integrating Systems for business success

The answer is to develop and maintain a comprehensive business management system, which addresses quality

and environmental requirements (as well as others).

This single integrated management system must be based firmly in the needs and values of the business itself.

Then each new requirement that emerges can be carefully considered and integrated into the existing systems

framework. Rather than implementing separate systems for managing quality and environmental, a company has

a single business management system which encompasses these areas and more. The overall goals and processes

of the business don't change with each new initiative.

Companies that are registered to ISO 9001 already have a head start. ISO 9001 requires many of the core system

elements which are common to any management system. The key is to make sure that these systems satisfy

internal business needs as well as the external requirements which are audited. Systems which are non-value

adding should be closely examined and improved so that they are beneficial to the business.


11. fejezet - 11. TQM

1. 11.1. General characteristics of Total Quality Management

Management concept coined by W. Edwards Deming.

The bases of TQM are:

• to reduce the errors produced during the manufacturing or service process,

• increase customer satisfaction,

• streamline supply chain management,

• aim for modernization of equipment and

• ensure workers have the highest level of training.

One of the principal aims of TQM is to limit errors to 1 per 1 million units produced.

Total Quality Management is often associated with the development, deployment and maintenance of

organizational systems that are required for various business processes.

• T stands for Total. It is the integration of the staff, suppliers, customers and other stakeholders.

• Q stands for Quality. It is the quality of the work and the process of the enterprise leading to quality of

products.

• M for Management. It stresses the leadership task "Quality" and the quality of leadership. From a scientific

point of view TQM can count as school of Leadership. From the enterprises point of view TQM can be seen

as a Leadership Model.

5 pillars of TQM:

1. Organization

2. Leadership

3. Commitment

4. Product

5. Process (Fig. 28)

11.1. ábra - Fig. 28: The five pillars of TQM

11. TQM


(http://www.emeraldinsight.com/journals.htm/journals.htm?articleid=1806101&show=html&WT.mc_id=alsore

ad)

2. 11.2. History of TQM

TQM is the West‘s answer to Japan‘s total quality control (TQC). In the 1980 the U.S. Navy Naval Air Systems

coined the TQM phrase. The Navy based most of the principles on the Japanese Total Quality Control

philosophy. Many companies adopted TQM during the 80s. Many companies started the program and failed

miserably because they weren't willing to change.

In the 1990s' TQM evolved. Experts introduce new methods that supported TQM. These include Lean

Manufacturing and Six Sigma. Organizations could now become certified to ISO 9001.

14 management points of Deming:

1. Create constancy of purpose for continual improvement of product and service,

2. Adopt the new philosophy,

3. Eliminate the need for mass inspection as a way to achieve quality,

4. End the practice of awarding business solely on the basis of price tag,

5. Improve every process,

6. Institute training on the job,

7. Adopt and institute leadership aimed at helping people and machines to do a better job,

8. Encourage effective two-way communication,

http://www.emeraldinsight.com/journals.htm/journals.htm?articleid=1806101&show=html&WT.mc_id=alsoread

http://www.emeraldinsight.com/journals.htm/journals.htm?articleid=1806101&show=html&WT.mc_id=alsoread

11. TQM


9. Break down barriers between department and staff areas,

10. Eliminate the use of slogans, posters and exhortations,

11. Eliminate work standards that prescribe numerical quotas for the workforce and numerical goals for

people in management,

12. Permit pride of workmanship,

13. Encourage education,

14. Clearly define top management‘s permanent commitment to ever-improving quality and productivity.

10 steps for quality improvements by Juran:

1. Build awareness of the need and opportunity for improvement,

2. Set goals for improvement,

3. Organize to reach the goals (establish a quality council, identify problems, select projects, appoint teams,

designate facilitators),

4. Provide training,

5. Carry out projects to solve problems,

6. Report progress,

7. Give recognition,

8. Communicate results,

9. Keep score,

10. Maintain momentum by making annual improvement part of the regular systems and processes of the

company.

3. 11.3. Definition of TQM

A corporate culture characterized by increased customer satisfaction through continuous improvements, in

which all employees in the firm actively participate.

TQM is a Management method relying on the cooperation of all members of an organization.

It is a Management method that centres on quality and on the long-term success of the organization through the

satisfaction of the customers, as well as the benefit of all its members and society (Fig. 29 and 30).

11.2. ábra - Fig. 29: Structure of TQM

11. TQM


(http://www.kwaliteg.co.za/tqm/Total%20Quality%20Management.htm)

11.3. ábra - Fig. 30: Model of TQM

(http://82.109.207.14/journals.htm?issn=0309-0590&volume=26&issue=6&articleid=837101&show=html)

4. 11.4. Principles of TQM

5 principles of TQM:

1. Management‘s commitment (leadership);

http://www.kwaliteg.co.za/tqm/Total%20Quality%20Management.htm

http://82.109.207.14/journals.htm?issn=0309-0590&volume=26&issue=6&articleid=837101&show=html

11. TQM


2. Focus on the customer and the employee;

3. Focus on facts;

4. Continuous improvements (KAIZEN);

5. Everybody‘s participation (Fig. 31).

11.4. ábra - Fig. 31: TQM pyramid (Dahlgaard et al., 2007)

1. Management’s commitment (leadership)

A vital task for any management is to outline quality goals, quality policies and quality plans in accordance

with the four sides of the TQM pyramid. This is so important in fact that, in many firms, top management

(the board of directors) ought to review the firm‘s quality goals and policies and if necessary reformulate

them so that they conform to the four sides of the TQM pyramid.

2. Focus on the customer and the employee

The new message in TQM is in addition to focusing on external customers and their expectations and

demands, it is necessary to focus on so-called internal customer and supplier relations to create customer

satisfaction, it is not enough just to live up to the customer‘s expectations.

In order to produce and deliver quality, employees need to know what both internal and external customers

want/expect of them. Only when employees have this information will they be able to start improving the

processes which is a first step towards becoming a „TQM firm‖.

11. TQM


Live up expectations of customers („expected quality‖). For many customers it is not enough. Creating

satisfaction demands more. Customers need „value-added‖ quality. Extra qualities will surprise the customer

and make him/her happy, satisfied, or excited with the product.

3. Focus on facts

Firms first need to set up a system for the continuous measurement, collection and reporting of quality facts.

Traditionally, managers have mainly measured the firm‘s business result. The problem with this, however, is

that it is retrospective, since the business result only gives a picture of past events.

What is needed is a number of forward-looking measurements connected with the business result.

4. Continuous improvements (KAIZEN)

Masaaki Imai‘s world-famous book Kaizen, written in 1986, focused precisely on this aspect of TQM. Imai

simply defined quality as „everything which can be improved‖. Important message in TQM: „A way can

always be found to achieve higher quality at lower cost‖.

Higher quality both should and can be achieved through internal and external quality improvements (Fig. 32).

11.5. ábra - Fig. 32: Continuous improvements and their consequences (Dahlgaard et

al., 2007)

5. Everybody’s participation

TQM is process-oriented. Customers, including internal customers (i.e. the firm‘s employees), are part of the

firm‘s processes. These customers, together with their requirements and expectations, must be identified in

all the processes.

To get everybody to participate demands the education and motivation of both management and employees.

Management must ensure that every employee in the company participates actively in a team (work team,

quality circle). Make sure that work teams start making improvements as quickly as possible. It may be

necessary to establish a parallel quality organization.

5. 11.5. Eight key elements of TQM

11. TQM


1. Ethics,

2. Integrity,

3. Trust,

4. Training,

5. Teamwork,

6. Leadership,

7. Recognition,

8. Communication.

6. 11.6. Benefits of TQM include

• Improves competitive position,

• increase adaptability to global markets,

• elevated productivity,

• superior global image,

• eliminates defects,

• significantly reduces waste,

• reduces quality costs,

• improves management communication,

• raises profits,

• drives customer focus,

• customer loyalty,

• reduces design time.


12. fejezet - 12. EFSIS, BRC, IFS

1. 12.1. EFSIS

European Food Safety Inspection Service (EFSIS). EFSIS provide a worldwide independent inspection service

designed for food, drink and allied industries, including packaging and raw materials.

The inspection covers all areas critical to food safety, food hygiene and quality management, to ascertain the

company‘s ability to demonstrate due diligence and ensure it meets the requirements of the particular standard

that it is being inspected against.

EFSIS is the premier third party independent inspection and certification service, providing retailers,

manufacturers, farmers and caterers, throughout the world, with expert inspection and certification of their

operations to ensure that only the highest standards are maintained.

EFSIS also inspect against various industries quality assurance schemes, covering an extensive range of food

products.

EFSIS provides a wide range of inspection and certification services, including Certificated Supplier

Evaluations, IFS, Organic Inspections, Packaging Inspection and Certification, Storage and Distribution, Farm

Inspection and Certification, ISO 9000, ISO 22000, HACCP Verification, Foodservice Inspections, Store

Inspections, Health & Safety Audits.

The EFSIS Safe & Legal Standard is designed specifically for small food manufacturers to provide an all-

encompassing food safety audit, providing small volume manufacturers and producers with an all-encompassing

food safety audit, acting as a stepping stone to achieving the requirements of the full BRC Standard.

Benefit of the scheme is that, audit considers good manufacturing practice and ensures that those involved in the

food industry have ensured the safety and legality of their quality and hygiene systems and procedures.

2. 12.2. BRC

British Retail Consortium (BRC). In 1992 the British Retailers' Association and the Retail Consortium merged.

It is one of the leading trade associations in the United Kingdom. They represent all forms of retailers from

small, independently owned stores, to big chain stores and department stores. It represents 80% of retail trade in

the UK by turnover.

BRC standard is a global standard for food safety. In 1998 BRC produced the first edition of the BRC Food

Technical Standard and Protocol for food suppliers.

Main aim is eliminating multiple audits by retailer and third party auditors on food manufacturers supplying UK

retailers with their own brand products.

This standard is used as the benchmark for food safety management and has been extensively revised to reflect

EU legislation and continuous best practice requirements. It possesses a comprehensive scope covering all areas

of product safety and legality issues. The BRC standard has now become the internationally recognised mark of

excellence.

The retailers, food producers, importers, caterers, ingredient suppliers and the food service industry can all

benefit greatly from this essential standard.

It is currently used by suppliers in Europe, Africa, North and South America, Asia Pacific, and the Middle East.

Now it has almost 14.000 certificated sites in over 10 countries across the world.

Over the past thirteen years, BRC has developed the BRC global standards, a suite of four industry-leading

Technical Standards that specify production, packaging, storage and distribution requirements to guarantee safe

food and consumer products:

1. Global standards for Food Safety,

12. EFSIS, BRC, IFS


2. Global standard for Consumer Products,

3. Global standard for Packaging and Packaging Materials,

4. Global standard for Storage and Distribution.

2.1. 12.2.1. Contents of BRC Global Standard for Food Safety - Issue 6

Section I: Introduction

1. Background

2. What‘s new for Issue 6?

3. The scope of the Global Standard for Food Safety

4. Food safety legislation

5. Benefits of the Global Standard for Food Safety

6. The certification process

Section II: Requirements

1. Senior management commitment

2. The Food Safety Plan – HACCP (prerequisite programmes)

3. Food safety and quality management system

4. Site standards

5. Product control

6. Process control

7. Personnel (training, hygiene)

Section III: Audit protocol

1. Introduction

2. Self-assessment of compliance with the standard

3. Selection of an audit option

4. Selection of a certification body

5. Company/certification body contractual arrangements

6. Scope of audit

7. Audit planning

8. The on-site audit

9. Non-conformities and corrective action

10. Grading of the audit

11. Audit reporting

12. EFSIS, BRC, IFS


12. Certification

13. BRC logos and plaques

14. The BRC Global Standards directory

15. Surveillance of certificated companies

16. Ongoing audit frequency and certification

17. Communication with certification bodies

Section IV: Operation and governance of the scheme

1. Requirements for Certification Bodies

2. Technical Governance of the Global Standard for Food Safety

3. Achieving Consistency – Compliance

2.2. 12.2.2. Key changes

Key changes for issue 5 include:

• More guidance on implementing HACCP.

• Greater emphasis on senior management.

• Expanded sections on issues of major importance, such as allergens and identity preserved materials,

laboratory management, furthermore physical and chemical contamination control.

1. A more rigorous grading system for grades B, C and D has been introduced.

2. A new section has been introduced on site security requiring controlled access and training of staff, secure

storage of materials, registration and approval of premises.

Key changes for issue 6 include:

• Places increased emphasis on GMP.

• Expanded sections on foreign body control, hygiene, housekeeping and allergens.

• Introduction of a new voluntary 2 stage unannounced audit scheme.

• A reduced number of clauses to ensure each express a significant idea.

2.3. 12.2.3. BRC Food Safety Management System Implementation

1. Introduction to the BRC Standard for Food Safety.

2. Assessment of Prerequisites.

3. Senior Management Implementation.

4. Food Safety Plan/HACCP Implementation.

5. Food Safety Quality Management System.

6. Training & Implementation.

7. Internal Auditing Training and Checklists.

12. EFSIS, BRC, IFS


8. Final Steps to BRC Certification.

3. 12.3. International Food Standard (IFS)

The members of the German Retail Federation (Germany, France) have collaborated on a quality and food

safety standard for retailer (and wholesaler) branded food products, which is intended to assess suppliers‘ food

safety and quality systems, with a uniform approach that harmonizes the elements of each. The first version

implemented (version 3) of the IFS Standard was launched in 2003. This Standard is now managed by IFS

Management GmbH, and applies to all the post-farm gate stages of food processing. IFS Food Standard has

been benchmarked with GFSI Guidance Document and is recognised by GFSI (Global Food Safety Initiative).

Food retailers (and wholesalers) regularly carry out audits to assess the food safety features of retailer branded

food product suppliers. These audits are made by certification body independent auditors. Every producer of

retail branded food products, who is working with German and French retailers (and wholesalers) is affected by

IFS audits.

The IFS Food Standard is important for all food manufacturers, especially those producing private labels

because it contains many requirements related to specifications‘ compliance. It supports production and

marketing efforts for brand safety and quality.

IFS Food standard version 6 has been developed with full and active involvement of certification bodies,

retailers, industry and food service companies from all over the world.

The objectives of the IFS Food are to establish a common standard with a uniform evaluation system, to work

with accredited certification bodies and qualified IFS approved auditors, to ensure comparability and

transparency throughout the entire supply chain and to reduce costs and time for both manufacturers and

retailers.

IFS Food is a standard for auditing quality and food safety of processes / products of food manufacturers and

includes requirements about the following topics:

• Senior management responsibility,

• Quality and food safety management systems,

• Resource management,

• Production process,

• Measurements, analysis, improvements,

• Food defence.

IFS certification can offer a number of key benefits to companies:

• striving for excellence in quality, food safety and customer satisfaction,

• seeking a competitive advantage in their market place.

Production benefits of IFS:

• Improved understanding between management and staff relating to good practices, standards and procedures,

• Monitoring of compliance with food regulations,

• More effective use of resources,

• Reduction in the need for customer audits,

• Independent third party audits,

• Ability to reduce total audit time by combining multiple audits,

12. EFSIS, BRC, IFS


• Higher flexibility through individual implementation due to a risk based approach.

3.1. 12.3.1. IFS Food version 6

The International Technical Committee and the French, German and Italian working groups have been actively

involved, in addition to retailers, stakeholders and representatives of industry, food services and certification

bodies. During the development of IFS Food version 6, IFS gained input from a recently formed IFS North

America working group and retailers from Spain, Asia and South America.

Main changes in the version 6

A slightly revised scoring system implemented to better identify companies implementing best practices.

Clear rules for determining audit duration have been created, based on a pragmatic calculation tool, which

provide the minimum mandatory audit duration to be applied by all certification bodies.

IFS Integrity Program, which was created in 2010 to monitor performance of certification bodies and of

auditors, it has been described in the new audit protocol.

It includes more quality requirements (e.g. nutritional analyses, more requirements on weight control, more

requirements on the quality/quantity of information provided on labelling, etc.).

Food defence requirements it has been introduced in IFS Food audit check-list. Exhaustive guidelines has been

developed in order to help companies implement those requirements, based on risk assessment and – most of all

– on legislation of destination country.

IFS auditors approved for products and technology scopes. Technology scopes are newly introduced to improve

auditors‘ expertise even more on products and processes.

3.2. 12.3.2. Structure/recognition of IFS

The IFS is divided into four main sections:

Part 1: Audit protocol

1. The history of IFS standard

2. Introduction

3. Types of audit

4. Scope of the audit

5. The certification process (evaluation of requirements, KO)

6. Awarding the certificate.

Part 2: List of audit requirements

1. Senior management responsibility

2. Quality and food safety management system

3. Resource management

4. Planning and production process

5. Measurements, analysis, improvements

6. Food defense and external inspections.

Part 3: Requirements for accreditation bodies, certification bodies and IFS auditors

12. EFSIS, BRC, IFS


Part 4: Reporting, auditXpress software, IFS audit portal and IFS database

The IFS program is recognized by the Global Food Safe Initiative (GFSI), and is also specified worldwide by

many retail chains.


13. fejezet - 13. Quality awards

Governments in some developed countries have instituted programs aimed at recognizing organizations that use

the TQM approach in their quality management systems. The objective of these recognition programs is to

promote and foster the use of quality management principles, concepts, and practices within organizations, and

particularly for achieving competitive advantage in the global marketplace. These recognition programs are

based on an established framework for TQM and are essentially excellence models for organizations that use

TQM to achieve world-class quality.

1. 13.1. Deming prize

The Deming prize, established in December 1950 in honor of W. Edwards Deming, was originally designed to

reward Japanese companies for major advances in quality improvement.

Over the years it has grown, under the guidance of Japanese Union of Scientists and Engineers (JUSE) to where

it is now also available to non-Japanese companies.

William Edwards Deming (1900-1993), one of the foremost experts of quality control in the United States, was

invited to Japan by the Union of Japanese Scientists and Engineers (JUSE) in July 1950. Upon his visit, Deming

lectured day after day his "Eight-Day Course on Statistical Quality Control". Deming donated his royalties to

JUSE. The managing director of JUSE proposed using it to fund a prize. The awards ceremony is broadcast

every year in Japan on national television.

The award has been given by the Union of Japanese Scientists and Engineers (JUSE) since 1951. Competition

for the Deming Prize was opened to foreign companies in 1984.

Categories of the Deming Prize:

1. The Deming Prize for Individuals (given to individuals who have made outstanding contributions to the study

of TQM or statistical methods used for TQM, or individuals who have made outstanding contributions in the

dissemination of TQM),

2. The Deming Application Prize (given to companies or divisions of companies that have achieved distinctive

performance improvement through the application of TQM in a designated year),

3. The Quality Control Award for Operations. Business Units (given to operations business units of a company

that have achieved distinctive performance improvement through the application of quality

control/management in the pursuit of TQM in a designated year).

Deming prize criteria (Fig. 33):

1. Management policies and their deployment regarding quality management (20 point),

2. New product development, work process innovation (20 point),

3. Maintenance and improvement of product and operational qualities (20 point),

4. Establishment of systems for managing quality (10 point),

5. Collection and analysis of quality information and utilization of information technology (15 point),

6. Human resources development (15 point).

13.1. ábra - Fig. 33: Deming prize model

13. Quality awards


(http://emeraldinsight.com)

2. 13.2. Malcolm Baldrige National Quality Award

In North America, the U.S. Malcolm Baldrige National Quality Award (MBNQA) administered by the National

Institute for Standards and Technology (NIST), is the best known example of a government recognition program

for organizations that use TQM.

It is the most popular award model in the world. It is the Quality Award Model of USA. Award was signed into

law on August 20, 1987. Principal support for the program comes from the Foundation for the Malcolm

Baldrige National Quality Award, established in 1988.

It recognizes U.S. organizations in the business, health care, education, and non-profit sectors for performance

excellence.

The Baldrige Award is the only formal recognition of the performance excellence of both public and private

U.S. organizations given by the President of the United States.

The award is jointly administered by the National Institute of Standards and Technology (NIST) and the

American Society for Quality Control (ASQC).

The Baldrige performance excellence criteria are a framework that any organization can use to improve overall

performance.

Up to 18 awards may be given annually across six eligibility categories (manufacturing, service, small

business, education, health care, and non-profit). As of 2011, 90 organizations had received the award.

The Award is named for Malcolm Baldrige, who served as Secretary of Commerce from 1981 until his tragic

death in a rodeo accident in 1987. His managerial excellence contributed to long-term improvement inefficiency

and effectiveness of government.

In 2010, the program's name was changed to the Baldrige Performance Excellence Program to reflect the

evolution of the field of quality from a focus on product, service, and customer quality to a broader, strategic

focus on overall organizational quality - called performance excellence.

http://emeraldinsight.com/

13. Quality awards


It is a competition to identify and recognize top-quality U.S. companies. This model addresses a broadly based

range of quality criteria, including commercial success and corporate leadership.

Once an organization has won the award it has to wait several years before being eligible to apply again.

The Baldrige Criteria for Performance Excellence serve two main purposes:

1. To identify Baldrige Award recipients that will serve as role models for other organizations,

2. and to help organizations assess their improvement efforts, diagnose their overall performance management

system, and identify their strengths and opportunities for improvement.

Seven categories make up the award criteria (Leadership; strategic planning; customer and market focus;

measurement, analysis, and knowledge management; workforce focus; process management; results):

Leadership examines how senior executives guide the organization and how the organization addresses its

responsibilities to the public and practices good citizenship.

Strategic planning examines how the organization sets strategic directions and how it determines key action

plans.

Customer and market focus examines how the organization determines requirements and expectations of

customers and markets; builds relationships with customers; and acquires, satisfies, and retains customers.

Measurement, analysis, and knowledge management examines the management, effective use analysis, and

improvement of data and information to support key organization processes and the organization‘s performance

management system.

Workforce focus examines how the organization enables its workforce to develop its full potential and how the

workforce is aligned with the organization‘s objectives.

Process management examines aspects of how key production/delivery and support processes are designed,

managed, and improved.

Results examine the organization‘s performance and improvement in its key business areas (customer

satisfaction, financial and marketplace performance, human resources, supplier and partner performance,

operational performance, and governance and social responsibility). The category also examines how the

organization performs relative to competitors (Fig. 34).

13.2. ábra - Fig. 34: Schematic diagram of Baldrige award model

13. Quality awards


(http://www.qualityintegration.biz/MalcolmBaldrige.html)

Baldrige Award has three important aspects:

1. Stakeholder orientation: the purpose of the organization is to achieve sustainability by addressing the

expectations of all stakeholders.

2. Results indicate the value delivered: the results should be viewed as outcomes as they indicate the value

delivered to each of the stakeholders.

3. Diagnosing and balancing the value to stakeholders: organization should learn from the results and

improve the processes to ensure that each stakeholder is getting the expected value from the organization.

3. 13.3. EFQM Excellence Award (European Quality Award)

The European Foundation for Quality Management's EFQM Excellence Model supports an award scheme

similar to the Malcolm Baldrige Award for European companies. The prize recognises companies with excellent

and sustainable results across all areas of the EFQM Excellence Model.

European Foundation for Quality Management (EFQM) was created in 1988 on the initiative of 14 leading

European companies (Bosch, Philips, Ericson, British Telecom, VW, Renault, Fiat, Volkswagen, Nestlé etc.).

EFQM today has around 600 members.

The initiator of this Award was EFQM which is an organization whose purpose is to promote quality as the

fundamental process for continuous improvements within a Company.

Awarded organizations are the best proponent in Europe of Total Quality Management (private and public

sector).

In 1991, the European Quality Award, now known as the EFQM Excellence Award, was instituted by the

European Foundation for Quality Management (EFQM) and the European Organization for Quality (EOQ). This

yearly award is recognized as the most successful exponent of TQM in Europe for that particular year. The first

award was made in 1992 to Rank Xerox (2000: Nokia).

The EFQM Excellence Model is the most popular quality tool in Europe, used by more than 30 000

organizations to improve performance. It supports self-assess and reflect. The last update was published in 2010

(revise in every 3 years).

http://www.qualityintegration.biz/MalcolmBaldrige.html

13. Quality awards


Self-assessment has wide applicability to organizations large and small, in the public as well as the private

sectors. Self-assessment using the EFQM Excellence Model can give the management team a holistic overview

of the whole organization.

It is a framework to assess your performance, to identify key strengths and improvement areas; integrate

existing tools, procedures and processes, to align all and remove duplicates; introduce a way of thinking that

encourages reflection and stimulates continuous improvement; and identify what actions are really driving your

results, which areas need more attention, and which approaches should be made redundant.

Benefits of the EFQM Excellence Model are guarantee to address the needs of all stakeholders; ensure that

initiatives don‘t run on a stand-alone basis but rather interulinked towards the same goal; show your

stakeholders that you are a credible, trustworthy partner achieving sustainable results; achieve your results

faster, more effectively and efficiently; define solutions tailored to your specific organization and situation; and

it is easy to use and understand, as it is developed by organizations for organizations.

The EFQM Excellence Model is used as a basis for (self) assessment, an exercise in which an organization is

graded against a detailed set of 9 criteria. These criteria are based on the 8 Fundamental Concepts of Excellence.

Finally, the RADAR logic is used to score organizations. The model is updated every three years to ensure it

reflects the current and future environment.

The fundamental concepts of excellence are adding value for customers, creating a sustainable future,

developing organizational capability, harnessing creativity and innovation, leading with vision, inspiration and

integrity, managing with agility, succeeding through the talent of people, sustaining outstanding results.

It appears that the model consists of nine elements grouped in two halves, one of which comprises the enablers

of the company and the other the results. The assessment reflects the general perception of what characterizes

leading TQM companies (Fig. 35).

13.3. ábra - Fig. 35: Model for the European Quality Award

(http://www.vniis.org/russianqualityaward/modelRQA)

The assessment process is one of the most robust of any award, with a team of independent assessors spending

an average of 500 hours per applicant reviewing documentation and conducting interviews on-site. The resulting

assessment against the EFQM Excellence Model provides a holistic overview of how effectively the

organization develops and deploys their strategy, in line with the needs and expectations of their stakeholders.

The RADAR Logic is a dynamic assessment framework and powerful management tool that provides a

structured approach to questioning the performance of an organization. RADAR logic helps to measure the

performance of an organization.

http://www.vniis.org/russianqualityaward/modelRQA

13. Quality awards


RADAR logic states that an organization needs to determine the results it is aiming to achieve as part of its

strategy, plan and develop an integrated set of sound approaches to deliver the required results both now and in

the future, deploy the approaches in a systematic way to ensure implementation, furthermore assess and refine

the deployed approaches based on monitoring and analysis of the results achieved and ongoing learning

activities.

In case of EFQM Excellence Award, a prize winner is an organization which demonstrates role model behaviour

in one of the following 8 criteria‘s (leading with vision, inspiration and integrity, managing processes,

succeeding through people, adding value for customers, nurturing creativity and innovation, building

partnerships, taking responsibility for a sustainable future, achieving balanced results.

Key Dates of EFQM Excellence Award 2012:

• Applicant workshop – 16th November 2011,

• Call for Assessors – November 2011,

• Applicant intent to apply – 30th November 2011,

• Final submission document due – 31st January 2012,

• Assessor briefing events – March 2012,

• Site visit – 21-25 May 2012,

• EFQM Forum 9-10th October 2012, Brussels, Belgium.


14. fejezet - 14. Quality tools and techniques

Seven classical tools of quality and process improvement:

1. Check sheet

2. Pareto chart

3. Histogram

4. Scatter diagram

5. Cause and effect diagram

6. Control chart

7. Flowchart

1. 14.1. Check sheet

In order to carry out the data collection and analysis effectively it is a good idea to design a check sheet which

simplifies the whole process. It is structured forms that make it easy to record and analyze data. Tabulate the

frequency of occurrence. Visually display the data to reveal underlying patterns (Table 5).

14.1. ábra - Table 5: Check sheet (self-made)

To ensure adherence it is advisable to design a „check-list check sheet‖ with the constraints (‗must-be

operations‘) listed (Fig. 36).

During the process the operator has to document that all the must-be operations have been followed.

The documentation may be the signature of the operator or an ‗OK mark‘ for each operation listed and a

signature at the end of the check-list.

In the „check phase‖ of the PDCA cycle the results are compared with the plan and the causes behind any

significant gaps are identified and studied. As a rule of thumb check sheets need both ‗result data‘ (defect,

failures) and ‗cause data‘ (men, machines, materials, methods, management).

14.2. ábra - Fig. 36: Check-list check sheet (Dahlgaard et al., 2007)

14. Quality tools and techniques


2. 14.2. Pareto analysis (80-20 rule)

Pareto analysis is a technique used to identify quality problems based on their degree of importance. The logic

behind Pareto analysis is that only a few quality problems are important, whereas many others are not critical.

Business-management consultant Joseph M. Juran suggested the principle and named it after Italian economist

Vilfredo Pareto. Pareto Analysis was first used by Wilfredo Pareto, an Italian economist. He observed in 1906

that 80% of the land in Italy was owned by 20% of the population.

80% of the effects come from 20% of the causes. It is generally known that in most cases a few types of errors

(problems or causes) account for 80–90% of the total number of errors in the products and it is therefore

important to identify these few major types of errors.

Pareto chart is a graphical diagram that illustrates the relationship of two variables. Visually portrays problems

and causes in order of severity or frequency. It helps determine which problem or cause to tackle first. Purposes

of the chart are to separate the most important causes of a problem from the many trivial and to identify the most

important problems for a team to work on.

One way to use Pareto analysis is to develop a chart that ranks the causes of poor quality in decreasing order

based on the percentage of defects each has caused (Table 6 and Fig. 37).

14.3. ábra - Table 6: Data collected from production process (self-made)



14.4. ábra - Fig. 37: Pareto chart (self-made)

3. 14.3. Histogram

A histogram is a chart that shows the frequency distribution of observed values of a variable. We can see from

the plot what type of distribution a particular variable displays, such as whether it has a normal distribution and

whether the distribution is symmetrical.

Histogram portrays the frequency of occurrence. A histogram is a bar graph of a frequency distribution in which

the widths of the bars are proportional to the classes into which the variable has been divided and the heights of

the bars are proportional to the class frequencies (Fig. 38).

14.5. ábra - Fig. 38: Histogram



(http://www.brighthub.com/computing/windows-platform/articles/14809.aspx)

4. 14.4. Scatter diagram

Scatter diagram is a graph that show how two variables are related to one another. It is particularly useful in

detecting the amount of correlation, or the degree of linear relationship, between two variables.

It helps determine if two variables are related. It illustrates the degree of correlation (not causation) between two

variables. If a parameter exists that is systematically incremented and/or decremented by the other.

The greater the degrees of correlation, the more linear are the observations in the scatter diagram. On the other

hand, the more scattered the observations in the diagram, the less correlation exists between the variables (Fig.

39).

14.6. ábra - Fig. 39: Scatter diagram

http://www.brighthub.com/computing/windows-platform/articles/14809.aspx



(http://en.wikipedia.org/wiki/File:Scatter_diagram_for_quality_characteristic_XXX.svg)

5. 14.5. Cause and effect diagram

It is also called Ishikawa-, or fishbone diagram. It is a causal diagram created by Kaoru Ishikawa (1968). Cause

and effect diagram is chart that identifies potential causes for particular quality problems. It portrays possible

causes of a problem. It helps determine root cause and to identify potential factors causing an overall effect (Fig.

40).

The ―head‖ of the fish is the quality problem, such as damaged zippers on a garment or broken valves on a tire.

The diagram is drawn so that the ―spine‖ of the fish connects the ―head‖ to the possible cause of the problem.

These causes could be related to the machines, workers, measurement, suppliers, materials, and many other

aspects of the production process. Each of these possible causes can then have smaller ―bones‖ that address

specific issues that relate to each cause.

Cause-and-effect diagram is a problem-solving tool commonly used by quality control teams. Specific causes of

problems can be explored through brainstorming. The development of a cause-and-effect diagram requires the

team to think through all the possible causes of poor quality.

14.7. ábra - Fig. 40: Cause and effect diagram

http://en.wikipedia.org/wiki/File:Scatter_diagram_for_quality_characteristic_XXX.svg



(http://en.wikipedia.org/wiki/File:Ishikawa_Fishbone_Diagram.svg)

6. 14.6. Control chart

It is also called Shewhart-, or process-behavior chart. This chart is used to evaluate whether a process is

operating within expectations relative to some measured value such as weight, width, or volume (Fig. 41).

It is used to monitor a process to see whether it is in statistical control. If the chart indicates that the monitored

process is not in control, analysis of the chart can help determine the sources of variation, as this will result in

degraded process performance.

To evaluate whether or not a process is in control, we regularly measure the variable of interest and plot it on a

control chart. The chart has a line down the center representing the average value of the variable we are

measuring. Above and below the center line are two lines, called the upper control limit (UCL) and the lower

control limit (LCL). As long as the observed values fall within the upper and lower control limits, the process is

in control and there is no problem with quality. When a measured observation falls outside of these limits, there

is a problem.

14.8. ábra - Fig. 41: Control chart

http://en.wikipedia.org/wiki/File:Ishikawa_Fishbone_Diagram.svg



(http://en.wikipedia.org/wiki/File:ControlChart.svg)

7. 14.7. Flowchart

It is a schematic diagram of the sequence of steps involved in an operation or process. It provides a visual tool

that is easy to use and understand. By seeing the steps involved in an operation or process, everyone develops a

clear picture of how the operation works and where problems could arise (Fig. 42).

Flowchart portrays all the steps in a process. It helps understand the process. It represents a process, showing the

steps as boxes of various kinds, and their order by connecting them with arrows. This diagrammatic

representation can give a step-by-step solution to a given problem.

Symbols of flowchart:

• Start and end symbols: represented as circles, ovals or rounded (fillet) rectangles,

• Flow of control: represented as arrows,

• Generic processing steps: represented as rectangles,

• Decision: represented as a rhombus.

14.9. ábra - Fig. 42: Flowchart

http://en.wikipedia.org/wiki/File:ControlChart.svg



(http://en.wikipedia.org/wiki/File:LampFlowchart.svg)

8. 14.8. Seven steps to problem solving

8.1. 14.8.1. Define and identify the problem

Sometimes information needs to be gathered via various techniques to define the problem. These techniques

may include interviews, statistics, questionnaires, technical experiments, check sheets, brainstorming, Pareto

chart.

8.2. 14.8.2. Analyze the problem

In this stage of problem solving, questions should be asked (e.g. How serious is the problem? What are the

causes of the problem? What are the effects of the problem? What are the symptoms of the problem?) and

information gathered and sifted.

Techniques used to analyse the problem: Pareto chart, histogram, scatter diagram, cause and effect diagram.

8.3. 14.8.3. Identifying possible solutions

The goal is to complete a list of all conceivable alternatives to the problem. Using a variety of creative

techniques, group participants create an extensive list of possible solutions. Asking each group member for input

ensures that all viewpoints will be considered.

It is a problem solving approach and it is designed to help a group generate several creative solutions to a

problem. It was first developed by Alex Osborn. He is an advertising executive who felt the need for a problem

http://en.wikipedia.org/wiki/File:LampFlowchart.svg



solving technique that, instead of evaluating and criticizing ideas, would focus on developing imaginative and

innovative solutions.

Steps of Brainstorming: A group's members are presented with a problem and all its details. Members are

encouraged to come up with as many solutions as possible, putting aside all personal judgments and evaluations.

All ideas are recorded so the whole group can see them. Ideas are evaluated at another session.

8.4. 14.8.4. Selecting the best solutions

At this stage in the process the group is working towards an agreement on the final solution. This is done by

testing all previously made solutions using the decision making criteria. The group goal in this step is to make

sure they have found the solution that will best solve the problem and address any other issues that may have

been a consequence of that problem.

8.5. 14.8.5. Evaluating solutions

During evaluating solutions need to make a T-Chart to weigh the pros and cons of each idea. It is often helpful

to make a T-chart and ask members of the group to name the pros and cons of each solution. This method will

visually illustrate the strengths and weaknesses of each solution.

Techniques used to evaluating solutions: check sheet, Pareto chart, histogram, cause and effect diagram, control

chart.

8.6. 14.8.6. Develop an action plan

An action plan is a chart that lists the tasks that need to be done and identifies who will be responsible for each,

when and what action is necessary, where to start, and how.

8.7. 14.8.7. Implement the solution

Sometimes the groups who choose the solution are not the ones who will implement it. If this is the case,

members who select the solution should clearly explain why they selected it to the ones who will implement it.

Showing that the problem solving process was an organized and orderly process will convince others that the

solution is valid.


15. fejezet - 15. Accreditation and certification

1. 15.1. Concepts of conformity assessment and standards of conformity assessment

Conformity assessment: demonstration that specified requirements relating to product, process, system, person

or body are fulfilled.

First-party conformity assessment activity: performed by the person or organization that provides the object.

Second-party conformity assessment activity: performed by the person or organization that has a user interest

in the object.

―Accreditation bodies recognize the competence of conformity assessment bodies (testing labs, inspection

bodies, certification bodies, etc.), ensuring that these bodies are legal entities, independent and free of conflicts

of interest, employ qualified people, and have proper oversight. Accreditation programs generally rely on the

requirements defined in the ISO 17000 series of international standards. Accreditation programs do not verify

scientific or technical accuracy of conformity assessment results, but instead examine the process of

certification, testing, or inspection bodies.

Certification, testing, and inspection bodies provide a level of consumer confidence in a product. Product

certification involves two basic components: evaluation, which may include testing, comparing requirements,

and determining compliance; and surveillance, which may include among other things, product inspections and

witnessing of production. Certification bodies may also certify (or register) management systems (e.g. quality

management systems such as ISO 9000 and environmental management systems such as ISO 14000). This type

of certification applies to the management system of an organization only, and does not replace other applicable

product certification for quality or safety.

Testing laboratories conduct product tests to specified standards. Testing can be performed by laboratories

differing widely in size, legal status, purpose, range of testing services offered, and technical competence. They

may be government laboratories, college/university laboratories, independent private sector laboratories,

laboratories affiliated with or owned by industrial firms or industry associations, or manufacturers' in-house

laboratories.

Inspection bodies typically inspect buildings, facilities, mines, or procedures for quality or safety. Inspection is

usually described as "conformity evaluation by observation and judgment accompanied as appropriate by

measurement, testing or gauging‖ (Fig. 43).

15.1. ábra - Fig. 43: Conformity assessment system

15. Accreditation and certification


(http://www.standardsportal.org/usa_en/conformity_assessment/key_organizations.aspx)

Standards of conformity assessment:

ISO/IEC 17000:2004 – Vocabulary and general principles

ISO/IEC 17011:2004 – General requirements for accreditation bodies

ISO/IEC 17021:2011 – Requirements for bodies providing audit and certification of management systems

ISO/IEC 17024:2003 – General requirements for bodies operating certification of persons

ISO/IEC 17025:2005 – General requirements for the competence of testing and calibration laboratories

ISO/IEC 17050-1:2004 and 17050-2:2004 – Supplier's declaration of conformity

ISO/IEC 17065:2012 – Requirements for certification bodies certifying products, processes and services

2. 15.2. ISO/IEC 17011:2004

Title of standard is conformity assessment, general requirements for accreditation bodies accrediting conformity

assessment bodies

ISO/IEC 17011 was prepared by the ISO, Committee on conformity assessment (CASCO). The first edition of

ISO/IEC 17011 cancels and replaces ISO/IEC Guide 58, ISO/IEC Guide 61, and ISO/IEC/TR 17010.

In today‘s society it is often required to state objectively conformity of products (including services) to specified

requirements. Conformity assessment bodies (CABs) can objectively state such conformity. These CABs

perform conformity assessment activities that include certification, inspection, testing and, in the context of this

International Standard, calibration.

It is important for the purchaser, regulator and the public to know that these CABs are competent to perform

their tasks. For that reason there is an increasing demand for impartial verification of their competence. Such

verification is done by authoritative accreditation bodies that are impartial in relation to both the CABs and their

clients, and which normally operate in a non-profit distributing manner (Fig. 44).

http://www.standardsportal.org/usa_en/conformity_assessment/key_organizations.aspx



A system to accredit CAB conformity assessment services should provide confidence to the purchaser and

regulator. Such a system should facilitate cross-border trade, as pursued by trade authorities and organizations.

The ultimate goal is to achieve one-stop accreditation and one-stop conformity assessment.

A ―cross border‖ trade facilitating system can work well if accreditation bodies and CABs all operate to globally

accepted requirements in an equivalent manner and take into account the interests of all parties concerned.

Accreditation bodies assess the competence of CABs. They can facilitate trade by promoting global acceptance

of conformity assessment results issued by accredited CABs. CABs assess conformity of products, services and

suppliers to specifications and/or requirements (Fig. 44).

15.2. ábra - Fig. 44: Flowchart (ISO/IEC 17011:2004)

2.1. 15.2.1. Contents of ISO/IEC 17011:2004

1. Introduction

2. Scope

3. Normative references

4. Terms and definitions

5. Accreditation body

6. Management

7. Human resources

8. Accreditation process

9. Responsibilities of the accreditation body and the CAB




Accreditation: third-party attestation related to a conformity assessment body conveying formal demonstration

of its competence to carry out specific conformity assessment tasks.

Accreditation body: authoritative body that performs accreditation.

Accreditation certificate: formal document or a set of documents, stating that accreditation has been granted

for the defined scope.

Conformity assessment body (CAB): body that performs conformity assessment services and that can be the

object of accreditation.

Assessment: process undertaken by an accreditation body to assess the competence of a CAB, based on

particular standard(s) and/or other normative documents and for a defined scope of accreditation.

Assessor: person assigned by an accreditation body to perform, alone or as part of an assessment team, an

assessment of a CAB.

2.3. 15.2.3. Accreditation body

Legal responsibility

The accreditation body shall be a registered legal entity.

Structure

The structure and operation of an accreditation body shall be such as to give confidence in its accreditations.

The accreditation body shall have authority and shall be responsible for its decisions relating to accreditation,

including the granting, maintaining, extending, reducing, suspending and withdrawing of accreditation.

The accreditation body shall have a description of its legal status, including the names of its owners if

applicable, and, if different, the names of the persons who control it.

The accreditation body shall document the duties, responsibilities and authorities of top management and other

personnel associated with the accreditation body who could affect the quality of the accreditation.

Impartiality

The accreditation body shall be organized and operated so as to safeguard the objectivity and impartiality of its

activities.

For safeguarding impartiality and for developing and maintaining the principles and major policies of operation

of its accreditation system, the accreditation body shall have documented and implemented a structure to

provide opportunity for effective involvement by interested parties. The accreditation body shall ensure a

balanced representation of interested parties with no single party predominating.

Confidentiality

The accreditation body shall have adequate arrangements to safeguard the confidentiality of the information

obtained in the process of its accreditation activities at all levels of the accreditation body, including committees

and external bodies or individuals acting on its behalf. The accreditation body shall not disclose confidential

information about a particular CAB outside the accreditation body without written consent of the CAB, except

where the law requires such information to be disclosed without such consent.

Liability and financing

The accreditation body shall have arrangements to cover liabilities arising from its activities.

The accreditation body shall have the financial resources, demonstrated by records and/or documents, required

for the operation of its activities. The accreditation body shall have a description of its source(s) of income.

Accreditation activity



The accreditation body shall clearly describe its accreditation activities, referring to the relevant International

Standards, Guides or other normative documents.

2.4. 15.2.4. Accreditation process

1. Accreditation criteria and information

2. Application for accreditation

3. Resource review

4. Subcontracting the assessment

5. Preparation for assessment

6. Document and record review

7. On-site assessment

8. Analysis of findings and assessment report

9. Decision-making and granting accreditation

3. 15.3. Organizations of international accreditation

Accreditation bodies:

ISO: International Organization for Standardization

ILAC: International Laboratory Accreditation Cooperation

IAF: International Accreditation Forum

ANSI: American National Standards Institute

ASQ: American Society for Quality

A2LA: American Association for Laboratory Accreditation

UKAS: United Kingdom Accreditation Service

RVA: Dutch Accreditation Council (Raad Voor Accreditatie)

BSI: British Standards Institution

NQA: National Quality Assurance

SGS: Société Générale de Surveillance (Fig. 45).

15.3. ábra - Fig. 45: Accreditation bodies



(http://www.aclasscorp.com/media/17169/kg%20fda%20presentation%20june%202011.pdf)

Organizations of international accreditation:

ILAC: International Laboratory Accreditation Cooperation

IAF: International Accreditation Forum

APEC: Asia-Pacific Economic Cooperation

APLAC: Asia Pacific Laboratory Accreditation Cooperation

EFTA: European Free Trade Association

EA: European co-operation for Accreditation

NAFTA: North American Free Trade Agreement

MERCOSUR: Mercado Comum do Sul = Common Southern Market

IAAC: Inter-American Accreditation Cooperation

PAC: Pacific Accreditation Cooperation (Fig. 46).

15.4. ábra - Fig. 46: Organizations of international accreditation (self-made)

http://www.aclasscorp.com/media/17169/kg%20fda%20presentation%20june%202011.pdf



4. 15.4. ISO/IEC 17021:2011

Title of standard is conformity assessment, requirements for bodies providing audit and certification of

management systems.

ISO/IEC 17021 was prepared by the ISO, Committee on conformity assessment (CASCO).

The second edition cancels and replaces the first edition (ISO/IEC 17021:2006), which has been revised to

expand the scope.

4.1. 15.4.1. Contents of ISO/IEC 17021:2011

1. Introduction

2. Scope



5. Principles

6. General requirements

7. Structural requirements

8. Resource requirements

9. Information requirements

10. Process requirements

11. Management system requirements for certification bodies

Certification of a management system, such as a quality or environmental management system of an

organization is one means of providing assurance that the organization has implemented a system for the

management of the relevant aspects of its activities, in line with its policy.

Certification of a management system provides independent demonstration that the management system of the

organization conforms to specified requirements, is capable of consistently achieving its stated policy and

objectives, and is effectively implemented.

It gives generic requirements for such certification bodies performing audit and certification in the field of

quality, environmental and other forms of management systems.




Certified client: organization whose management system has been certified.

Management system: consultancy: participation in designing, implementing or maintaining a management

system.

Third-party certification audit: audit carried out by an auditing organization independent of the client and the

user, for the purpose of certifying the client's management system.

Client: organization whose management system is being audited for certification purposes.

Guide: person appointed by the client to assist the audit team.

Technical area: area characterized by commonalities of processes relevant to a specific type of management

system.

5. 15.5. ISO 19011:2011

Title of standard is guidelines for auditing management systems. ISO 19011 was prepared by Technical

Committee ISO/TC 176, Quality management and quality assurance, Subcommittee SC 3, Supporting

technologies. The second edition cancels and replaces the first edition (ISO 19011:2002), which has been

technically revised.

Types of audit:

• Internal auditing (first party audit)

• External auditing

• Supplier auditing (second party audit)

• Third party auditing for legal, regulatory and similar purposes, and for certification.

5.1. 15.5.1. Contents of ISO 19011:2011

1. Introduction

2. Scope



5. Principles of auditing

6. Managing an audit programme

7. Performing an audit

8. Competence and evaluation of auditors


Audit: systematic, independent and documented process for obtaining audit evidence and evaluating it

objectively to determine the extent to which the audit criteria are fulfilled.

Audit criteria: set of policies, procedures or requirements used as a reference against which audit evidence is

compared.

Audit client: organization or person requesting an audit.



Auditee: organization being audited.

Auditor: person who conducts an audit.

Audit team: one or more auditors conducting an audit.

Audit programme: arrangements for a set of one or more audits planned for a specific time frame and directed

towards a specific purpose.

Audit plan: description of the activities and arrangements for an audit.

5.3. 15.5.3. Principles of auditing

Integrity: the foundation of professionalism.

Fair presentation: the obligation to report truthfully and accurately.

Due professional care: the application of diligence and judgement in auditing.

Confidentiality: security of information.

Independence: the basis for the impartiality of the audit and objectivity of the audit conclusions.

Evidence-based approach: the rational method for reaching reliable and reproducible audit conclusions in a

systematic audit process.

5.4. 15.5.4. Managing an audit programme

An organization needing to conduct audits should establish an audit programme that contributes to the

determination of the effectiveness of the auditee‘s management system. The audit programme can include audits

considering one or more management system standards, conducted either separately or in combination.

Establishing the audit programme objectives

The top management should ensure that the audit programme objectives are established to direct the planning

and conduct of audits and should ensure the audit programme is implemented effectively. Audit programme

objectives should be consistent with and support management system policy and objectives.

Establishing the audit programme

The person managing an audit programme should inform the top management of the contents of the audit

programme and, where necessary, request its approval.

Implementing the audit programme

The person managing the audit programme should implement the audit programme by means of the following

communicating the pertinent parts of the audit programme to relevant parties and informing them periodically of

its progress; defining objectives, scope and criteria for each individual audit; coordinating and scheduling audits

and other activities relevant to the audit programme; ensuring the selection of audit teams with the necessary

competence; providing necessary resources to the audit teams; ensuring the conduct of audits in accordance with

the audit programme and within the agreed time frame; ensuring that audit activities are recorded and records

are properly managed and maintained.

Monitoring the audit programme

The person managing the audit programme should monitor its implementation considering the need to evaluate

conformity with audit programmes, schedules and audit objectives; evaluate the performance of the audit team

members; evaluate the ability of the audit teams to implement the audit plan; evaluate feedback from top

management, auditees, auditors and other interested parties.

Reviewing and improving the audit programme



The person managing the audit programme should review the audit programme to assess whether its objectives

have been achieved. Lessons learned from the audit programme review should be used as inputs for the

continual improvement process for the programme.

5.5. 15.5.5. Performing an audit

Initiating the audit

When an audit is initiated, the responsibility for conducting the audit remains with the assigned audit team

leader until the audit is completed.

The initial contact with the auditee for the performance of the audit can be informal or formal and should be

made by the audit team leader.

The feasibility of the audit should be determined to provide reasonable confidence that the audit objectives can

be achieved (Fig. 47).

Preparing audit activities

The relevant management system documentation of the auditee should be reviewed in order to gather

information to prepare audit activities and applicable work documents (e.g. on processes, functions); and

establish an overview of the extent of the system documentation to detect possible gaps.

The audit team leader should prepare an audit plan based on the information contained in the audit programme

and in the documentation provided by the auditee.

The audit team leader, in consultation with the audit team, should assign to each team member responsibility for

auditing specific processes, activities, functions or locations.

The audit team members should collect and review the information relevant to their audit assignments and

prepare work documents, as necessary, for reference and for recording audit evidence.

15.5. ábra - Fig. 47: Typical audit activities (ISO 19011:2011)



Conducting the audit activities

• Conducting the opening meeting

• Performing document review while conducting the audit

• Communicating during the audit

• Assigning roles and responsibilities of guides and observers

• Collecting and verifying information (Fig. 48)

• Generating audit findings

• Preparing audit conclusions

• Conducting the closing meeting



15.6. ábra - Fig. 48: Overview of the process of collecting and verifying information

(ISO 19011:2011)

Preparing and distributing the audit report

The audit team leader should report the audit results in accordance with the audit programme procedures.

The audit report should be issued within an agreed period of time. If it is delayed, the reasons should be

communicated to the auditee and the person managing the audit programme.

Completing the audit

The audit is completed when all planned audit activities have been carried out, or as otherwise agreed with the

audit client.

Documents pertaining to the audit should be retained or destroyed by agreement between the participating

parties and in accordance with audit programme procedures and applicable requirements.

Conducting audit follow-up

The conclusions of the audit can, depending on the audit objectives, indicate the need for corrections, or for

corrective, preventive or improvement actions. Such actions are usually decided and undertaken by the auditee

within an agreed timeframe. As appropriate, the auditee should keep the person managing the audit programme

and the audit team informed of the status of these actions.

The completion and effectiveness of these actions should be verified. This verification may be part of a

subsequent audit.



5.6. 15.5.6. Competence and evaluation of auditors

Determining auditor competence to fulfil the needs of the audit programme

Personal behaviour

• ethical, i.e. fair, truthful, sincere, honest and discreet;

• open-minded, i.e. willing to consider alternative ideas or points of view;

• diplomatic, i.e. tactful in dealing with people;

• observant, i.e. actively observing physical surroundings and activities;

• perceptive, i.e. aware of and able to understand situations;

• versatile, i.e. able to readily adapt to different situations;

• tenacious, i.e. persistent and focused on achieving objectives;

• decisive, i.e. able to reach timely conclusions based on logical reasoning and analysis;

• self-reliant, i.e. able to act and function independently whilst interacting effectively with others;

• acting with fortitude, i.e. able to act responsibly and ethically, even though these actions may not always

• be popular and may sometimes result in disagreement or confrontation;

• open to improvement, i.e. willing to learn from situations, and striving for better audit results;

• culturally sensitive, i.e. observant and respectful to the culture of the auditee;

• collaborative, i.e. effectively interacting with others, including audit team members and the auditee‘s

personnel.

Establishing the auditor evaluation criteria

The criteria should be qualitative (such as having demonstrated personal behaviour, knowledge or the

performance of the skills, in training or in the workplace) and quantitative (such as the years of work experience

and education, number of audits conducted, hours of audit training).

Selecting the appropriate auditor evaluation method

The evaluation should be conducted using two or more of the methods selected from those in Table 7.

15.7. ábra - Table 7: Possible evaluation methods (ISO 19011:2011)



Conducting auditor evaluation

When a person expected to participate in the audit programme does not fulfil the criteria, then additional

training, work or audit experience should be undertaken and a subsequent re-evaluation should be performed.

Maintaining and improving auditor competence

Auditors and audit team leaders should continually improve their competence. Auditors should maintain their

auditing competence through regular participation in management system audits and continual professional

development. Continual professional development involves the maintenance and improvement of competence.

This may be achieved through means such as additional work experience, training, private study, coaching,

attendance at meetings, seminars and conferences or other relevant activities.


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http://www.fao.org/docrep/005/Y1579E/y1579e03.htm

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ISO/IEC 17021:2011 Conformity assessment – Requirements for bodies providing audit and certification of

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17. fejezet - Questions

1. Describe some quality concept.

2. What are the main factors affecting the quality?

3. What is quality loop?

4. What are the main levels of quality?

5. What were the main steps of quality development?

6. What are the main characteristics of quality assurance professionals?

7. What are the main terms which are relating to Quality Management?

8. What was the evolution of Quality Management?

9. What are the main characteristics of Quality Check?

10. What are the main characteristics of Quality Control?

11. What are the main characteristics of Quality Assurance?

12. What are the main characteristics of Total Quality Control?

13. What are the main characteristics of Quality Management?

14. What are the main types of consumer demand satisfaction?

15. What are the stages of the demand satisfaction process?

16. What are the main stakeholders of the demand satisfaction process?

17. What are the main characteristics of demand satisfaction process‘ quality?

18. What are the main roles of state in quality?

19. What are the main aims, tasks and organizations of national quality control system?

20. What are the main parts of national quality control system?

21. What are the main features of GMP?

22. What are the main features of GHP?

23. What are the main features of GAEC and GFP?

24. What are the main features of GAP?

25. What are the main features of EUREPGAP and GLOBALGAP?

26. What are the main food safety hazards?

27. What are the main characteristics of HACCP?

28. What is the definition of Critical control point?

29. What is the history of HACCP?

30. What are the seven principles of HACCP?

31. What are the prerequisite programs?

Questions


32. What are the steps of the HACCP plans?

33. What is HACCP decision tree?

34. What are the latest versions of ISO 9000 standards?

35. What are the quality management principles?

36. What are the main characteristics of ISO 9001 standard?

37. What are the main contents of ISO 9001: 2008 standard?

38. What are the main requirements of ISO 9001 standard?

39. What are the main benefits of ISO 9001 standard?

40. What are the benefits of EMS?

41. What are the risks of EMS?

42. What are the economic benefits of ISO 14000?

43. What are the 17 requirements of the ISO 14001:2004 standard?

44. Which organizations are involved?

45. What are the main characteristics of standard?

46. What is interactive communication?

47. What are the main requirements of standard?

48. What is the aim of standard?

49. What are the main contents of ISO 22000?

50. What are the main characteristics of Integrated Management Systems?

51. What are the requirements of IMS?

52. When and how to build a system?

53. What are the main types of Integrated System documentation?

54. What are the advantages of IMS?

55. What are the pillars of TQM?

56. What is the definition of TQM?

57. What are the man principles of TQM?

58. What are the benefits of TQM?

59. What are the main characteristics of EFSIS and EFSIS standard?

60. What are the main characteristics BRC and BRC global standard?

61. What are the main characteristics of International Food Standard?

62. What are the main characteristics of the Deming prize?

63. What are the main characteristics of the Malcolm Baldrige National Quality Award?

Questions


64. What are the main characteristics of the EFQM Excellence Award?

65. What are the main characteristics of the EFQM Excellence Model?

66. Which are the classical tools of quality and process improvement?

67. Which are the main steps to problem solving?

68. What are the main characteristics of classical tools?

69. What are the definitions of conformity assessment, accreditation, audit?

70. What are the main standards of conformity assessment?

71. What are the main steps of audit programme managing and audit performing?

72. What are the main competences of auditor?

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