H A C C PH A C C P

WHO & ICD

ILSI Europe

Inneke Hantoro

Introduction: Traditional QC vs Preventive System

• Traditional QC programs spot-checked manufacturing conditions, and randomly sampled and tested final products to ensure safe food.

• If the finished product met the specifications, it was approved; otherwise, the product was held, reprocessed, or destroyed.

Reactive & inefficient

Introduction: Traditional QC vs Preventive System

• An HACCP program is about preventive systems — to eliminate a problem before it happens.

• The actions that these systems provoke are essentially preclusive — they are designed to prevent problems rather than solve them after they have occurred.

• QC checks occur during the process so that a finished product is deemed consistently safe.

Hazard Analysis Critical Control Point (HACCP)

• The HACCP system has grown to become the universally accepted method for food safety assurance.

• A major focus of the HACCP program is “from farm to table.” HACCP is a concept as well as a method of operation, applied to all phases of food production, including agricultural production, food handling, food processing, food services, food distribution, and consumer use.

Everyone is responsible for safe food products

Hazard Analysis Critical Control Point (HACCP)

• The Hazard Analysis and Critical Control Point (HACCP) system is a science-based system created to identify specific hazards and actions to control them in order to ensure food safety and quality.

• A ‘hazard’ is ‘a biological, chemical or physical agent in, or condition of, food with the potential to cause an adverse health effect’ (Codex Alimentarius, 1997).

The need for an effective food safety assurance method

• Foodborne disease are a widespread public health problem.

• Emergence of foodborne disease.• Increased knowledge and awareness of the serious

and chronic health effects.• New food technologies and processing methods.• Increased awareness of the economic consequences

of foodborne disease.

• Increase in the number of vulnerable people.• Industrialization and mass production.• Urbanization and changing lifestyle.• Increase tourism and international trade in

foodstuffs.• Increase consumer awareness of food safety.

The need for an effective food safety assurance method

Food Safety Assurance

Good Manufacturing practices (GM)and

Good Hygiene Practices (GHP)

necessary But not always sufficient

The History of HACCP

• The HACCP concept was developed in the early 1970s as a system to assure food safety

• 1983: WHO Europe recommends HACCP• 1991: Codex HACCP draft• 1998: FAO/WHO provide guidance for regulatory

assessment of HACCP• 2006+: Increased worldwide use of HACCP in food

safety legislation

Stake holders involved in HACCP

The objectives HACCP application

• Focuses on identifying and preventing hazards from contaminating food, based on sound science.

• Permits more efficient and effective government oversight, primarily because record keeping allows investigators to see how well a firm is complying with food safety laws over a period, rather than how well it is doing on any given day.

• Places responsibility for ensuring food safety on the food manufacturer or distributor.

• Helps food companies to compete more effectively in the world market.

• Reduces barriers to international trade.

HACCP Concept

• Identifying potential food safety problems• Determining how and where these hazards can be

controlled or prevented• Describing what to do and training the personnel• Implementation and recording

HACCP Program Prerequisites

• Facilities• Supplier control• Specifications for all

ingredients, products and packaging materials

• Production equipment• Cleaning and sanitation• Personal hygiene• Training• Chemical control• Receiving, storage,

shipping

• Traceability and recall• Pest control• QA procedures• SOP and SSOP• Glass control• Procedures for receiving,

storage and shipping• Labeling• Employee food and

ingredient handling

GMPGMP

Preliminary Tasks of HACCP Program

• Choosing the HACCP team• Description of the food product and its distribution• Description of the intended use and consumer of the

product• Development of a flow diagram describing a food

product manufacturing process• Verification of the flow diagram

The principles of HACCP

1. Conduct a hazard analysis2. Determine the CCPs3. Establish critical limit(s)4. Establish a monitoring system5. Establish corrective actions6. Establish verification procedures7. Establish documentation

Source: CODEX

1. 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 should be addressed in the HACCP plan.

Information needed for hazard analysis:

• the agents that could be present in the food under study

• the severity of the effects and the likelihood of their occurrence

• the levels that could cause adverse health effects• the conditions that could lead to unacceptable levels

Areas to consider in Hazard Analysis

• Raw materials and ingredients• Product formulation• Processing conditions• Packaging• Storage and distribution• Preparation and use• Target groups

Probability - Severity

Probabilitas

Severity/ Keparahan/KeakutanKritikal Serius Mayor MinorSignifikan Signifikan Signifikan Tidak

Signifikan

Signifikan Signifikan TidakSignifikan

TidakSignifikan

Signifikan TidakSignifikan

TidakSignifikan

TidakSignifikan

NACMCF

Tinggi

Medium

Rendah

Probability - Severity

• Probabilitas: Tinggi – mungkin terjadi Medium – dapat tejadi Rendah tidak mungkin terjadi

• Keparahan/Keakutan: Kritikal – akan otomatis mengakibatkan makanan tidak

aman Serius – kemungkinan mengakibatkan makanan tidak aman Mayor – dapat mengakibatkan makanan tidak aman Minor – kemungkinan tidak mengakibatkan makanan tidak

aman

Hazard Determination

YES

YES

YES

No Hazard

No Hazard

NO

NO

NO

YES

YES

NO

NO

Is the presence of agent in raw material probable?

Is the presence of agent in line or environment probable?

Is an unacceptable survival, persistence or increase at this step probable?

Is an unacceptable contamination at this step probable?

Is reduction, if any at a further step adequate? HAZARD

YES

2. Determination of CCPs

Critical control point decision tree• Questions to be asked for each raw material used

Q1. Is it likely that the raw material contains the hazard under study at unacceptable levels?

Q2. Will processing, including expected consumer use, eliminate the hazard or reduce it to an acceptable level?

YES

NO

NO

YES

Not CCP

Not CCPCCP for the raw materials for this hazard

• Questions to be asked for each process step

Q3. Is the formulation/composition or structure of the intermediateproduct/final product essential for preventing the hazard under study from increasing to unacceptable levels?

Not CCPFormulation is a CCP for this hazard

YES NO

Q4. Is it likely that, at this step, a hazard will be introduced or an existing hazard will increase to unacceptable levels?

Q5. Will subsequent processing steps including expected consumer use, guarantee removal of the hazard orreduction to an acceptable level?

Q6. Is the process step intended toeliminate or reduce thehazard to an acceptable level?

YES NO

Not CCP

CCP

YESNO

3. The establishment of critical limits

• A criterion which separates acceptability from unacceptability

• Critical limits can be:– Values of pH, aw, temperature, time– Absorbed radiation dose– Levels of disinfectant or antimicrobial agents– Level of cleanliness– Limits of residues– Limits of contaminants– Limits of microbiological criteria

When is deviation from normality unacceptable?( i.e. establishment of Critical Limits )

Monitoring Corrective

Actions Point control

(raw material /

process step

Hazards Control Measure

Critical Limits

Proce-dure

Frequency Respon- sibilities

Proce- dure

Respon- sibility

• The key document

• Holding all the essential details about the steps or stages

in the process where there are CCP’s

The HACCP Control Chart

4 & 5. Monitoring and Corrective Action

• Control measure– Any factor or activity which can be used to

prevent, eliminate, or reduce food safety hazards to an acceptable level

• Critical limit– The safety boundaries (criteria that separate safe

from unsafe)– Sources of information: literature, regulation,

experiment, etc– Contain safety buffer zone

• Monitoring– Observation or measurement to ensure that the

process is operating within the critical limit– Based on some form of inspection and testing– The frequency depends on the nature of the CCP

and the type of monitoring procedure– Clarify to all personnel involve (what to do and

how to do it)

• Corrective action– The action should be taken when the result shows

a deviation from the critical limit– Adjust the process to bring it back under control– Deal with the material produced under the

deviation period• Hold on the product• Rework • Release product after sampling and testing• Direct into less sensitive products, e.g. animal

feed– Clarify to all personnel involve (what to do and

how to do it)

6. Verification

• The application of methods, procedures, tests, and other evaluations, in addition to monitoring, to determine conformity with the HACCP plan.

• This is primarily the responsibility of the industry, however some verification activities can be undertaken during regulatory assessments

Conformity:– Activities are carried out according to the

established procedures e.g. the HACCP plan and prerequisites

7. Establishment of the record - keeping procedures

• An HACCP program should be thoroughly documented and implemented establishing procedures for the identification, storage, retrieval maintenance, protection, and disposition of documents.

• The documentation generated must be formal written records providing factual evidence that an activity has been performed in a timely manner in accordance with established procedures.

• Information contained in corrective action records provides a description of the deviation and an evaluation of the corrective action taken, as well as a notation as to final disposition of the affected product.

• The name of the individual responsible for taking the corrective action should be included.

Example of documentation about HACCP system deviation report

Example of documentation about corrective action report

References

• Arvanitoyannis, I.S. 2009. HACCP and ISO 22000: Application to Foods of Animal Origin. Blackwell Publishing Ltd.

• Vasconcellos, J. A. 2004. Quality Assurance for the Food Industry: A Practical Approach. CRC Press, Boca Raton.

• van Schothorst, M. 2004. A simple guide to understanding and applying the hazard analysis critical control point concept 3rd Ed. Belgium. ILSI Europe.