FSMS Vocabulary Rev.01 Sep. 2012

1st revision

2012-09-01

Food safety management systems- Vocabulary


MK 21999 Page 1

Key to the FSMS Vocabulary A term in a definition or note which is defined elsewhere in this FSMS vocabulary is indicated by boldface and text highlighted in yellow followed by its entry number (ISO standard, PAS, CAC, reference documents, and their clause numbers source) in parentheses. Such a boldface term may be replaced in the definition by its complete definition. For example: correction (ISO 22000, 3.13) action to eliminate a detected nonconformity (ISO 9000, 3.6.2) nonconformity (ISO 9000, 3.6.2) non-fulfilment of a requirement (ISO 9000, 3.1.2) requirement (ISO 9000, 3.1.2) need or expectation that is stated, generally implied or obligatory If the term “nonconformity ” and “requirement” are replaced by its definition, as follows correction then becomes “action to eliminate a detected non-fulfilment of a need or expectation that is stated, generally implied or obligatory” A concept limited to a special meaning in a particular context is indicated by designating the subject field in angle brackets, ⟨⟨⟨⟨ ⟩⟩⟩⟩, before the definition. EXAMPLE In the context of an audit , the term entry for technical expert is: protective security (PAS 96, 2.6) <food defence> all the measures related to physical, electronic and personnel security (PAS 96, 2.4) which any organization (ISO 22005, 3.10) takes to minimize the threat of malicious attack

Terms defined within a box, �, served as alternative meaning to a previous definition. In this 1st revision, terms not related to food safety were removed (ex. quality manual, quality objectives, etc.). However, terms with universal application, although defined in ISO 9000 QMS- Fundamentals and Vocabulary, (ex. customer requirements ISO 9000, 2.1; document ISO 9000, 3.7.2; non-conformity ISO 9000, 3.1.2; etc.) were still retained. The 1st edition was also modified due to the release of PAS 221:2012 (Draft).

Mark B. Kwan Food Safety Management System Auditor

01 Sep 2012, UAE


MK 21999 Page 2

A acceptable level (ISO/TS 22004, 7.4.2) the level of a particular hazard in the end product (ISO 22000, 3.5) of the organization (ISO 22005, 3.10) that is needed at the next step (ISO 15161, 3.10) in the food chain (ISO 22000, 3.2) to ensure food safety (ISO 22000, 3.1) appropriate level of protection [ALOP] (ISO/TS 2200 4, 7.4.2) level of protection deemed appropriate by the member (country) establishing a sanitary or phyto-sanitary measures to protect human, animal, or plant life or health within its territory [Definition derived from ILSI-FSO] aspect (ISO PAS 99, 3.1) characteristic (ISO 20006, 3) of an activity, product (ISO 22005, 3.1) or service that has or can have an impact (PAS 99, 3.4)

NOTE 1 See PAS 99 A.4.3.2 (identification and evaluation of aspects, impacts, and risk ) for additional explanation of this concept NOTE 2 A significant aspect (PAS 99, 3.1) has or can have a significant impact (PAS 99, 3.4)

C certificate of analysis [COA] (PAS 220, 3.14 / PAS 221 3.1 / PAS 222, 2.1 / PAS 223, 3.1) <food safety> document (PAS 99, 3.3) provided by the supplier which indicates results of specific test or analysis, including test methodology, performed on a defined lot (ISO 22005, 3.3) of the supplier’s product (ISO 22005, 3.1) certificate of conformance [CoC] (PAS 223, 3.1) <food packaging> document (PAS 99, 3.3) that confirms conformance to relevant specifications (ISO 9000, 3.7.3) or regulations

NOTE This is sometimes referred to as a certificate of compliance or declaration of compliance (DoC) characteristic (ISO 22006, 3) distinctive trait that sets something apart

Guidance: An identifiable hereditary property, such as a specific component, a structural detail, a color or pattern, or resistance to pests (ISO/TS 22002-2, 3.12). Sometimes used interchangeably with attribute

clean water (ISO/TS 22002-3, 3.1) water that does not compromise food safety (ISO 22000, 3.1) in circumstances of its use

NOTE 1 Adapted from CAC/RCP 53-2003, Code of hygienic practices for fre sh fruits and vegetables NOTE 2 In the context of this Technical Specification, the term refers to natural, artificial or purified water that does not contain micro-organisms, harmful substances in quantities capable of directly or indirectly affect ing the safety of food

cleaning (PAS 220, 3.5 / PAS 221 3.2) <food safety> removal of soil, food residue, dirt, grease or other objectionable matter [NOTE Adapted from CAC/RCP 1, 2.3] cleaning in place [CIP] (PAS 220, 3.10) cleaning (PAS 220, 3.5) of equipment by impingement or circulation of flowing chemical solutions, cleaning liquids, and water rinses into, on to and over surfaces in equipment or systems (ISO 9000, 3.2.1) without dismantling and designed for the purpose [ISO 14159, 3.3]


MK 21999 Page 3

cleaning in place [CIP] (PAS 221, 3.3) system that cleans solely by circulating and/or flowing chemical detergent solutions and water rinses by mechanical means onto and over surfaces to be cleaned

NOTE an example of this would be the method used, in part, to clean and sanitize a frozen dessert machine, oven or dishwasher

cleaning out of place [COP] (PAS 220, 3.11 / PAS 22 1 3.4) system (ISO 9000, 3.2.1) where equipment is disassembled and cleaned in a tank or in an automatic washer by circulating a cleaning solution and maintaining a minimum temperature throughout the cleaning (PAS 220, 3.5) cycle… … (PAS 221 addition) or using combination of the above with hoses or pressure sprays

NOTE an example of this would be equipment such as band saws, meat slicers or mixers that are subjected to COP manual cleaning without the use of CIP

competent person (ISO/TS 22002-3, 3.2) a person, qualified by knowledge and practical experience, with the necessary skills and ability to perform an assigned task

NOTE Education, training or experience is how a person achieves competency contaminant (PAS 220, 3.2 / PAS 221 3.5 / PAS 222, 2.2 / PAS 22 3, 3.4) <food safety> any biological or chemical agent, foreign matter or other substances not intentionally added to which may compromise food safety (ISO 22000, 3.1) or suitability [CAC/RCP 1, 2.3]

NOTE Measures for prevention of malicious contamination are outside the scope of this PAS (PAS 220, PAS 221, PAS 222, & PAS 223). For further information and guidance on approaches to the protection of food businesses from all forms of malicious attack see PAS 96

contamination (PAS 220, 3.1 / PAS 221 3.6 / PAS 222 , 2.3 / PAS 223, 3.5) <food safety> introduction or occurrence of a contaminant (PAS 220, 3.2) in food or food environment [NOTE Adapted from CAC/RCP 1, 2.3]

NOTE (for PAS 223) in the content of this PAS “contamination” may also refer to the introduction of non intentionally added substances (NIAS) (see PAS 223, 3.13)

contingency planning (PAS 99, 3.2) consideration of the potentially serious incidents that could affect the operations of the organization (ISO 22005, 3.10) and the formulation of a plan(s) to prevent or mitigate the effects and to enable the organization to operate as normally as possible contract (ISO 15161, 3.1) agreed requirements (ISO 9000, 3.1.2) between a supplier and a customer, transmitted by any means control measure (ISO 22000, 3.7) <food safety> action or activity that can be used to prevent or eliminate a food safety hazard (ISO 22000, 3.3) or reduce it to an acceptable level (ISO/TS 22004, 7.4.2) [NOTE Adapted from CAC- Basic texts on food hygiene] correction (ISO 22000, 3.13) action to eliminate a detected nonconformity (ISO 9000, 3.6.2)

NOTE 1 For the purposes of this International Standard (ISO 22000), a correction relates to the handling of potentially unsafe products , and can therefore be made in conjunction with a corrective action (ISO 22000, 3.1.4) NOTE 2 A correction may be, for example, reprocessing, further processing, and/or elimination of the adverse consequences of the nonconformity (such as disposal for other use or specific labelling)


MK 21999 Page 4

corrective action (ISO 22000, 3.14) action to eliminate the cause of a detected nonconformity (ISO 9000, 3.6.2) or other undesirable situation

NOTE 1 There can be more than one cause for a nonconformity (ISO 9000, 3.6.5) NOTE 2 Corrective action includes cause analysis and is taken to prevent recurrence

critical control point [CCP] (ISO 22000, 3.10) <food safety> step (ISO 15161, 3.10) at which control can be applied and is essential to prevent or eliminate a food safety hazard (ISO 22000, 3.3) or reduce it to an acceptable level (ISO/TS 22004, 7.4.2) [NOTE Adapted from CAC- Basic texts on food hygiene] critical limit (ISO 22000, 3.11) criterion which separates acceptability from unacceptability

NOTE 1 Adapted from CAC- Basic texts on food hygiene NOTE 2 Critical limits are established to determine whether a CCP (ISO 22000, 3.10) remains in control. If a critical limit is exceeded or violated, the products (ISO 22005, 3.1) affected are deemed to be potentially unsafe

customer requirements (ISO 9000, 2.1) needs and expectation expressed in product specifications (PAS 220, 3.7) D data (ISO 22005, 3.11) recorded information disinfection (PAS 220, 3.9 / PAS 221 3.7 / PAS 222, 2.7) <food safety> reduction, by means of chemical agents and/or physical methods, of the number of micro-organisms in the environment, to a level that does not compromise food safety (ISO 22000, 3.1) or suitability [NOTE adapted from CAC/RCP 1, 2.3] document (ISO 9000, 3.7.2 / PAS 99, 3.3) information and its supporting medium

NOTE 1 The medium can be paper, magnetic, electronic or optical computer disc, photograph or master sample, or a combination thereof. NOTE 2 A set of documents , for example specifications (ISO/TR 10013, 4.9) or records (ISO 9000, 3.7.6), is frequently called “documentation” NOTE 3 Some requirements [(SO 9000, 3.1.2) (e.g. the requirement to be readable) relate to all types of documents , however there can be different requirements for specification (e.g. the requirement to be revision controlled) and records (ISO 9000, 3.7.6) (e.g. the requirement to be retrievable)

E electronic security (PAS 96, 2.1) <food defence> procedures (ISO 9000, 3.4.5) used to protect electronic systems from sources of threat, such as malware and hackers, intent on misusing them, corrupting them or putting them out of use


MK 21999 Page 5

end product (ISO 22000, 3.5) product (ISO 22005, 3.1) that will undergo no further processing or transformation by the organization (ISO 22005, 3.10)

NOTE A product (ISO 22005, 3.1) that undergoes further processing or transformation by another organization is an end product in the context of the first organization and a raw material or an ingredient in the context of the second organization

establishment (PAS 220, 3.3 / PAS 223, 2.6) <food safety> any building or area in which food is handled and the surroundings under the control of the same management (ISO 9000, 3.2.6) [adapted from CAC/RCP 1, 2.3] F feed and food chain (ISO 22005, 3.7) sequence of the stages and operations involved in the production, processing, distribution and handling of feed and food, from primary production (ISO 15161, 3.9) to consumption

NOTE Primary production includes the production of feed for food-producing animals and for animals intended for food production

first expired first out [FEFO] (PAS 220, 3.18 / PAS 221 3.9) stock rotation based on the principle of dispatching earliest expiration dates first first in first out [FIFO] (PAS 220, 3.19 / PAS 221 3.10) stock rotation based on the principle of dispatching earliest received products (ISO 22005, 3.1) first flow diagram (ISO 22000, 3.6) schematic and systematic presentation of the sequence and interactions of step(s) (ISO 15161, 3.10) flow of materials (ISO 22005, 3.8) movement of any materials (ISO 22005, 3.9) at any point in the feed and food chain (ISO 22005, 3.7) food chain (ISO 22000, 3.2) sequence of the stages and operations involved in the production, processing, distribution, storage and handling of a food and its ingredients, from primary production (ISO 15161, 3.9) to consumption

NOTE 1 This includes the production of feed for food-producing animals and for animals intended for food production NOTE 2 The food chain also includes the production of materials (ISO 22005, 3.9) intended to come into contact with food or raw materials

food defence (PAS 96, 2.2) <food defence> security of food and drink and their supply chains from all forms of malicious attack including ideologically motivated attack leading to contamination (PAS 220, 3.1) or supply failure food grade (PAS 220, 3.8 / PAS 221 3.11) lubricants and heat transfer fluids formulated to be suitable for use in food processes where there may be incidental contact between the lubricant and the food food retail establishment (PAS 221 3.12) any building or area under the control of the owner or designated person-in-charge, including the contents, and the contiguous land or property (surrounds), in which food is stored, prepared, packaged, served, vended, or otherwise provided as food for human consumption [Adapted from Codex Alimentarius, 2.3 and US FDA Code, 1.2]


MK 21999 Page 6

food retail premises (PAS 221 3.13) physical building under direct full or partial control of the retailer food safety (ISO 22000, 3.1) concept that food will not cause harm to the consumer when it is prepared and/or eaten according to its intended use

NOTE 1 Adapted from CAC- Basic texts on food hygiene NOTE 2 Food safety is related to the occurrence of food safety hazards (ISO 22000, 3.3) and does not include other human health aspects related to, for example, malnutrition

food safety control system (CAC/GL 69-2008, 3.2) The combination of control measures (ISO 22000, 3.7) that, when taken as a whole, ensure that food is safe for its intended use food safety hazard (ISO 22000, 3.3) biological, chemical or physical agent in food, or condition of food, with the potential to cause an adverse health effect

NOTE 1 Adapted from CAC- Basic texts on food hygiene NOTE 2 The term “hazard” is not to be confused with the term “risk” which, in the context of food safety , means a function of the probability of an adverse health ef fect (e.g. becoming diseased) and the severity of that effect (death, hospitalization, absence from work, etc.) when exposed to a specified hazard . Risk is defined in ISO/IEC Guide 51 as the combination of the probability of occurrence of harm and the severity of that harm NOTE 3 Food safety hazards include allergens NOTE 4 In the context of feed and feed ingredients, relevant food safety hazards are those that may be present in and/or on feed and feed ingredients and that may subsequently be transferred to food through animal consumption of feed and may thus have the potential to cause an adverse human health effect. In the context of operations other than those directly handling feed and food (e.g. producers of packaging materials (PAS 223, 3.14), cleaning agents, etc.), relevant food safety hazards are those hazards that can be directly or indirectly transferred to food because of the intended use of the provided products (ISO 22005, 3.1) and/or services and thus can have the potential to cause an adverse human health effect

food safety management system [FSMS] (ISO/TS 22003, 3.2) set of interrelated or interacting elements to establish policy and objectives and to achieve those objectives, used to direct and control an organization (ISO 22005, 3.10) with regard to food safety (ISO 22000, 3.1) [NOTE See 3.2.1 system , 3.2.2 management system , and 3.2.3 quality management system of ISO 9000] food safety objective [FSO] (ISO/TS 22004, 7.4.2) the maximum frequency and/or concentration of a hazard in a food at the time of consumption that provides or contributes to the appropriate level of protection [ALOP] (ISO/TS 22004, 7.4.2) food safety policy (ISO 22000, 3.4) overall intentions and direction of an organization (ISO 22005, 3.10) related to food safety (ISO 22000, 3.1) as formally expressed by top management (ISO 9000, 3.2.7) food supply (PAS 96, 2.3) <food defence> any and all elements of what is commonly called the food supply chain, net or web with the inclusion of drink and supporting and allied services (see PAS 96, 4.3 the food supply web ) form (ISO/TR 10013, 3.2) document (ISO 9000, 3.7.2) used to record (ISO 9000, 3.7.6) data (ISO 22005, 3.11) required by the quality management system (ISO 9000, 3.2.3) (and, or other) management system (ISO 9000, 3.2.2)

NOTE A form (ISO/TR 10013, 3.2) becomes a record (ISO 9000, 3.7.6) when data (ISO 22005, 3.11) are entered


MK 21999 Page 7

G good agricultural practices [GAP] (GlobalGAP, Defin ition 65) practices that address environmental, economic and social sustainability for on-farm processes, and result in safe and quality food and non-food agricultural products (FAO COAG 2003 GAP paper) good distribution practices [GDP] (WHO- GDP, Glossa ry) that part of quality assurance that ensure that the quality of food and pharmaceutical products is maintained through adequate control throughout the numerous activities which occur during the distribution process good hygiene practice [GHP] (APO- FSMS manual, Defi nition Box 9) refers to all practices regarding the conditions and measures necessary to ensure the safety and suitability of food at all stages of the food chain good manufacturing practice [GMP] (ISO 15161, 3.6) combination of manufacturing and quality procedures aimed at ensuring that products (ISO 22005, 3.1) are consistently manufactured to their specifications (ISO/TR 10013, 4.9), and to avoid contamination (PAS 220, 3.1) of the product by internal or external sources good trading practices [GTP] (WHO- GDP, Glossary) that part of quality assurance that ensure that the quality of food and pharmaceutical products is maintained through adequate control throughout the numerous activities which occur during the trading process good veterinary practice [GVP] (FVE- Code of GVP, 4 Definition) a standard which ensures that services provided by the veterinary profession are consistently produced and controlled to the quality standards guidelines (ISO 9000, 2.7.2.d) documents (ISO 9000, 3.7.2) stating recommendations or suggestions H HACCP plan (CAC/RCP-01, Annex 2.10) a document (ISO 9000, 3.7.2) prepared in accordance with the principles of HACCP (ISO/TS 22003, 3.1) to ensure control of hazards which are significant for food safety (ISO 22000, 3.1) in the segment of the food chain (ISO 22000, 3.2) under consideration hazard analysis (ISO 15161, 3.8) process (ISO 22005, 3.2) of collecting and evaluating information on hazards and conditions leading to their presence to decide which are significant for food safety (ISO 22000, 3.1) and therefore should be addressed in the HACCP plan (CAC/RCP-01, Annex 2.10) [NOTE Taken from CAC- Basic texts on food hygiene] hazard analysis and critical control point [HACCP] (ISO/TS 22003, 3.1) system (ISO 9000, 3.2.1) which identifies, evaluates and controls hazards which are significant for food safety (ISO 22000, 3.1)

NOTE Adapted from CAC Food hygiene basic text

hazard assessment (PAS 222, 2.11) evaluation to determine, for each food safety hazard (ISO 22000, 3.3) identified, whether its elimination or reduction to acceptable levels (ISO/TS 22004, 7.4.2) is essential to the production of a safe product (ISO 22005, 3.1), and whether its control is needed to enable the defined acceptable levels to be met


MK 21999 Page 8

NOTE In hazard assessment (see Annex A of PAS 222), possible severity of adverse health effects and the likelihood of occurrence of identified hazards are considered. [Derived from ISO 22000, 7.4.3]

hierarchy (ISO/TR 10013, 4.1) <document> the structure of the documentation used in the quality management system (ISO 9000, 3.2.3) (or any) management system (ISO 9000, 3.2.2) I impact (PAS 99, 3.4) effect on the organization’s policy commitments and objectives, its interested parties (ISO 9000, 3.3.7), the organization (ISO 22005, 3.10) itself and/or on the environment

NOTE An effect can be positive or negative

infrastructure (ISO 9000, 3.3.3) ⟨⟨⟨⟨organization ⟩⟩⟩⟩ system (ISO 9000, 3.2.1) of facilities, equipment and services needed for the operation of an organization (ISO 9000, 3.3.1) interested party (ISO 9000, 3.3.5 / PAS 99, 3.5) person or group concerned with or affected by the activities, products (ISO 22005, 3.1) and/or services of an organization (ISO 22005, 3.10)

NOTE 1 This could include customers, owners, regulators, non governmental organizations (NGO), people in an organization, suppliers, bankers, unions, partners or society NOTE 2 A group can comprise an organization (ISO 9000, 3.3.1), a part thereof or more than one organization

intermediate material (PAS 223, 3.10) <food packaging> physical output of part of the production process that still requires further processing to create finished food packaging

NOTE For example, a plastic powder, granules or flakes (including “masterbatch”), ink, coating, adhesive, pre-polymer, any semi-finished material and article such as a film, sheet or laminate requiring further processing/reformulation steps to become a finished material or article. In short, this is any product that is not a basic chemical and not yet a finished material or article, and includes part-processed, semi-converted and converted materials

L label (PAS 220, 3.16 / PAS 221 3.15 / PAS 223, 3.11 ) <food safety> printed matter that is part of the finished product package conveying specific information about the contents of the package, the food ingredients and any storage and preparation requirements (ISO 9000, 3.1.2)

(For PAS 220 and PAS 221) EXAMPLE The term covers, but is not limited to:

a) The package itself, printed matter attached to the package, or a sticker used for over-labelling;

b) Multi-packs which have an inner label on the individual product (ISO 22005, 3.1) and an outer combined label for the whole contents

NOTE (for PAS 223) This includes the package itself, printed matter that is, or is intended to be, attached to the package or a sticker used for over-labelling

location (ISO 22005, 3.5) place of production, processing, distribution, storage and handling from primary production (ISO 15161, 3.9) to consumption


MK 21999 Page 9

lot (ISO 22005, 3.3) set of units of a product (ISO 22005, 3.1) which have been produced and/or processed or packaged under similar circumstances

NOTE 1 The lot is determined by parameters established beforehand by the organization (ISO 22005, 3.10) NOTE 2 A set of units may be reduced to a single unit of product (ISO 22005, 3.1)

lot identification (ISO 22005, 3.4) process (ISO 22005, 3.2) of assigning a unique code to a lot (ISO 22005, 3.3) M management (ISO 9000, 3.2.6) coordinated activities to direct and control an organization (ISO 9000, 3.3.1)

NOTE In English, the term “management” sometimes refers to people, i.e. a person or group of people with authority and responsibility for the conduct and control of an organization . When “management” is used in this sense, it should always be used with some form of qualifier to avoid confusion with the concept “management” defined above. For example, “management shall…” is deprecated whereas “top management (ISO 9000, 3.2.7) shall…” is acceptable

management system (PAS 99, 3.6 / ISO 9000, 3.2.2) system(s) (ISO 9000, 3.2.1) to establish policy and objectives and to achieve those objectives

(PAS 99) NOTE A management system comprises the elements of policy, planning, implementation and operation, performance assessment, improvement and management review

materials (ISO 22005, 3.9) feed and food, feed and food ingredients and packaging materials (PAS 223, 3.14) materials (PAS 220, 3.4 / PAS 221 3.16) <food safety> general term used to indicate raw materials, packaging materials (PAS 223, 3.14), ingredients, process aids, cleaning materials and lubricants material specification [product specification] (PAS 220, 3.7 / PAS 221 3.14) <food safety> detailed documented description or enumeration of parameters, including permissible variations and tolerances, which are required to achieve a define level of acceptability or quality migration (PAS 223, 3.12) <food packaging> transfer of substances from an external source (e.g. packaging material [PAS 223, 3.14], environment) to food

NOTE Transfer of substances can take place by migration through the substrate, by set-off to the reverse side and subsequent migration into food, or by gas phase transfer

monitoring (ISO 22000, 3.12) conducting a planned sequence of observations or measurements to assess whether control measures (ISO 22000, 3.7) are operating as intended monitoring (ISO/TS 22004, 7.8) <verification planning> a procedure (ISO 9000, 3.4.5) to detect any failures in the control measure (ISO 22000, 3.7)


MK 21999 Page 10

N nonconformity (ISO 9000, 3.6.2) non-fulfilment of a requirement (ISO 9000, 3.1.2) non-intentionally added substance [NIAS] (PAS 223, 3.13) <food packaging> impurity in the materials (ISO 22005, 3.9) used in, or a decomposition or reaction product formed during, the production process O operational PRP [operational prerequisite programme ] (ISO 22000, 3.9) PRP (ISO 22000, 3.8) identified by the hazard analysis (ISO 15161, 3.8) as essential in order to control the likelihood of introducing food safety hazards (ISO 22000, 3.3) to and/or the contamination (PAS 220, 3.1) or proliferation of food safety hazards in the product(s) (ISO 22005, 3.1) or in the processing environment organization (ISO 22005, 3.10 / ISO 9000, 3.3.1) group of people and facilities with an arrangement of responsibilities, authorities and relationships

NOTE 1 An organization may consist of one person NOTE 2 An organization can be public or private NOTE 3 (for ISO 9000, 3.3.1) The definition is valid for the purposes of quality management system (ISO 9000, 3.2.3) (and, or other) management system standards. The term “organization” is defined directly in ISO/IEC Guide 2

P packing materials (PAS 223, 3.14) <food packaging> materials used to hold and protect food packaging during shipping, transport and storage performance criterion [PC] (ISO/TS 22004, 7.4.4) The effect in frequency and/or concentration of a hazard in a food that must be achieved by the application of one or more control measures (ISO 22000, 3.7) to provide or contribute to a performance objective [PO] (ISO/TS 22004, 7.4.2) or a food safety objectives [FSO] (ISO/TS 22004, 7.4.2) [Definition derived from ILSI-FSO] performance objective [PO] (ISO/TS 22004, 7.4.2) the maximum frequency and/or concentration of a hazard in a food at a specified step (ISO 15161, 3.10) in the food chain (ISO 22000, 3.2) before the time of consumption that provides or contributes to a food safety objective [FSO] (ISO/TS 22004, 7.4.2) or an appropriate level of protection [ALOP] (ISO/TS 22004, 7.4.2), as applicable personnel security (PAS 96, 2.4) <food defence> procedures (ISO 9000, 3.4.5) used to confirm an individual’s identity, qualifications, experience and right to work, and to monitor conduct as an employee or contractor

NOTE Not to be confused with ‘personal security’

pest (ISO/TS 22002-3, 3.12) unwanted species of plants or animals that may have a detrimental effect for humans, their activities or the products they use or produce, or for animals or for the environment


MK 21999 Page 11

NOTE In the context of ISO/TS 22002-3, the term refers to small animals, birds and insects that destroy crops , spoil food, or spread disease at fields/premises on farm

potable water (ISO 22002-3, 4.14) water of sufficiently high quality that can be consumed or used with low risk of immediate or long term harm

NOTE Quality standards of drinking water are described in the WHO Guidelines for Drinking Water Quality

primary production (ISO 15161, 3.9) those steps (ISO 15161, 3.10) in the food chain (ISO 22000, 3.2) up to and including, for example, harvesting, slaughter, milking, fishing [NOTE Taken from CAC- Basic texts on food hygiene] procedure (ISO 9000, 3.4.5 / PAS 99, 3.7) specified way to carry out an activity or a process (PAS 99, 3.8)

NOTE Procedures can be documented or not

process (ISO 22005, 3.2 / ISO 9000, 3.4.1 / PAS 99, 3.8) set of interrelated or interacting activities which transforms inputs into outputs

NOTE 1 Inputs to a process are generally outputs of other processes NOTE 2 Processes in an organization (ISO 22005, 3.10) are generally planned and carried out under controlled conditions to add value NOTE 3 A process where the conformity of other resulting product (ISO 22005, 3.1) cannot be readily or economically verified is frequently referred to as a “special process” [ISO 9000, 3.4.1] NOTE (for PAS 99, 3.8) Processes may be classified in a number of different ways. A distinction is sometimes made between operational processes which are directly concerned with the planned outputs of the organization (ISO 22005, 3.10), and management processes which provide the framework that enables the operational processes to take place

process approach (ISO 9000, 2.4) the systematic identification and management (ISO 9000, 3.2.6) of the processed employed within an organization (ISO 9000, 3.3.1) and particularly the interactions between such processes (ISO 9000, 3.4.1) product (ISO 22005, 3.1 / ISO 9000, 3.4.2) result of a process (ISO 22005, 3.2)

NOTE Product may include packaging material (PAS 223, 3.14)

product contact (PAS 220, 3.6 / PAS 221 3.17 / PAS 222, 2.15) All surfaces that are in contact with the product (ISO 22005, 3.1) or the primary package during normal operation product recall (PAS 220, 3.17) removal of a non-conforming product from the market, trade and warehouses, distribution centers and/or customer warehouses because it does not meet specified standards product security (PAS 96, 2.5) <food defence> techniques used to make food products resistant to contamination (PAS 220, 3.1) or misuse including tamper-evident closures and lot (ISO 22005, 3.3) marking protective security (PAS 96, 2.6) <food defence> all the measures related to physical, electronic and personnel security (PAS 96, 2.4) which any organization (ISO 22005, 3.10) takes to minimize the threat of malicious attack


MK 21999 Page 12

PRP [prerequisite programme] (ISO 22000, 3.8) <food safety> basic conditions and activities that are necessary to maintain a hygienic environment throughout the food chain (ISO 22000, 3.2) suitable for the production, handling and provision of safe end products (ISO 22000, 3.5) and safe food for human consumption

NOTE The PRPs needed depend on the segment of the food chain (ISO 22000, 3.2) in which the organization (ISO 22005, 3.10) operates and the type of organization (see Annex C). Examples of equivalent terms are: Good Agricultural Practice (GAP) (GLOBALGAP, Definition 65), Good Veterinarian Practice (GVP) (FVE code of GVP, 4 Definitions), Good Manufacturing Practice (GMP) (ISO 15161, 3.6), Good Hygienic Practice (GHP) (APO- FSMS manual, Definition Box 9), Good Production Practice (GPP), Good Distribution Practice (GDP) (WHO- GDP, Glossary) and Good Trading Practice (GTP) (WHO- GDP, Glossary)

R Ready-to-eat food [RTE] (PAS 221, 3.18) food that is in a form that is edible without additional preparation to achieve food safety based on law or recognized industry practices NOTE this can included raw or partially cooked animal food as allowed by law when the consumer is adviced of the hazards associated with that food as consuming raw, molluscan shellfish relevant food safety hazards (ISO 22000, 3.3 NOTE 4) hazards that can be directly or indirectly transferred to food because of the intended use of the provided products (ISO 22005, 3.1) and/or services and thus can have the potential to cause an adverse human health effect record (ISO 9000, 3.7.6) document (ISO 9000, 3.7.2) stating results achieved or providing evidence of activities performed

NOTE 1 Records can be used, for example, to document traceability (ISO 9000, 3.5.4) and to provide evidence of verification (ISO 9000, 3.8.4), preventive action (ISO 9000, 3.6.4) and corrective action (ISO 9000, 3.6.5) NOTE 2 Generally records need not be under revision control

requirement (ISO 9000, 3.1.2) need or expectation that is stated, generally implied or obligatory

NOTE 1 “Generally implied ” means that it is custom or common practice for the organization (ISO 9000, 3.3.1), its customers (ISO 9000, 3.3.5) and other interested parties (ISO 90000, 3.3.7), that the need or expectation under consideration is implied NOTE 2 A qualifier can be used to denote a specific type of requirement (ISO 9000, 3.1.2), e.g. product requirement, quality management requirement, customer requirement NOTE 3 A specified requirement is one that is stated, for example in a document (ISO 9000, 3.7.2) NOTE 4 Requirements can be generated by different interested parties (ISO 9000, 3.3.7) NOTE 5 This definition differs from that provided in 3.12.1 of ISO/IEC Directives, Part 2:2004

requirement (ISO/IEC Directive Part 2:2004, 3.12.1) expression in the content of a document conveying criteria to be fulfilled if compliance with the document is to be claimed and from which no deviation is permitted

risk (ISO 22000, 3.3 NOTE 2) <food safety> a function of the probability of an adverse health effect (e.g. becoming diseased) and the severity of that effect (death, hospitalization, absence from work, etc.) when exposed to a specified hazard


MK 21999 Page 13

risk (ISO/IEC Guide 51 Definition, see ISO 22000 3.3 NOTE 2) the combination of the probability of occurrence of harm and the severity of that harm risk (PAS 99, 3.9) likelihood of an event occurring that will have an impact (PAS 99, 3.4) on objectives

NOTE 1 Risk is normally determined in terms of combination of the likelihood of an event and its consequences NOTE 2 An event may be the occurrence of an aspect (PAS 99, 3.1) with the associated impact (PAS 99, 3.4) as its consequence NOTE 3 (PAS 99, A.3) Risks are possible occurrences that could impact (PAS 99, 3.4) upon objectives

S sanitation (PAS 220, 3.13 / PAS 221, 3.19) all actions dealing with cleaning (PAS 220, 3.5) or maintaining hygienic conditions in an establishment (PAS 220, 3.3), ranging from cleaning and/or sanitizing (PAS 220, 3.21) of specific equipment to periodic cleaning activities throughout the establishment ( PAS 220, 3.3) [including building, structural, and grounds cleaning activities] sanitizing (PAS 220, 3.12) <food safety> process (ISO 22005, 3.2) of cleaning (PAS 220, 3.5), followed by disinfection (PAS 220, 3.9) sanitizing (PAS 221, 3.20) the process of cleaning, followed by the application of cumulative heat or chemicals on cleaned food contact surfaces that, when evaluated for efficiency, is sufficient to yield a reduction of 5 logs, which is equal to a 99.999% reduction of representative disease micro-organisms of public health significance shelf life (ISO/TS 22004, 7.3) the period during which the product (ISO 22005, 3.1) maintains its microbiological safety and suitability at a specific storage temperature and under specific conditions, which may or may not be the same as the durability specifications (ISO 9000, 3.7.3) used in product labeling single-use articles (PAS 221, 3.21) utensils and bulk food containers designed and constructed to be used once and discarded NOTE includes disposable gloves and plastic/aluminium wrap/containers. site (PAS 222, 2.20) area in which animal food is handled, together with any immediate surrounding area under which prerequisite programmes [PRPs] (ISO 22000, 3.8) apply specifications (ISO 9000, 3.7.3 / ISO/TR 10013, 4.9 ) documents (ISO 9000, 3.7.2) stating requirements (ISO 9000, 3.1.2)

NOTE A specification can be related to activities (e.g. procedure document, process specification and test specification), or products (ISO 9000, 3.4.2) (e.g. product specification (PAS 220, 3.7), performance specification and drawing)

step (ISO 15161, 3.10) point, procedure (ISO 9000, 3.4.5), operation or stage in the food chain (ISO 22000, 3.2), including raw materials, from primary production (ISO 15161, 3.9) to final consumption [NOTE Taken from CAC- Basic texts on food hygiene] system (ISO 9000, 3.2.1) set of interrelated or interacting elements


MK 21999 Page 14

T Threat Assessment Critical Control Point (TACCP) (P AS 96, 2.7) <food defence> systematic management (ISO 9000, 3.2.6) of risks through the process (PAS 99, 3.8) of assessment of threats, identification of vulnerabilities, and implementation of controls to raw materials, packaging, finished products, processes, premises, distribution networks and business systems by a knowledgeable and trusted team with the authority to implement changes to procedures (ISO 9000, 3.4.5) top management (ISO 9000, 3.2.7) person or group of people who directs and controls an organization (ISO 9000, 3.3.1) at the highest level traceability (ISO 22005, 3.16) ability to follow the movement of a feed or food through specified stage(s) of production, processing and distribution

NOTE 1 Adapted from ISO 10012 Measurement management systems NOTE 2 Movement can relate to the origin of the materials , processing history or distribution of the feed or food NOTE 3 Terms such as “document traceability”, “computer traceability” or “commercial traceability” should be avoided

traceability system (ISO 22005, 3.12) totality of data (ISO 22005, 3.11) and operations that is capable of maintaining desired information about a product (ISO 22005, 3.1) and its components through all or part of its production and utilization chain U updating (ISO 22000, 3.17) immediate and/or planned activity to ensure application of the most recent information V validation (ISO 22000, 3.15) <<<<food safety > > > > obtaining evidence that the control measures (ISO 22000, 3.7) managed by the HACCP plan (CAC/RCP-01, Annex 2.10) and by the operational PRPs (ISO 22000, 3.9) are capable of being effective

NOTE This definition is based on CAC- Basic texts on food hygiene and is more suitable for the field of food safety (ISO 22000, 3.1) than the definition given in ISO 9000

validation (ISO/TS 22004, 7.8) an assessment prior to operation, the role of which is to demonstrate that individual (or a combination of) control measures (ISO 22000, 3.7) are capable of achieving the intended level of control verification (ISO 22000, 3.16 / ISO 9000, 3.8.4) confirmation, through the provision of objective evidence, that specified requirements (ISO 9000, 3.1.2) have been fulfilled


MK 21999 Page 15

verification (ISO/TS 22004, 7.8) an assessment carried out during and after the operation, the role of which is to demonstrate that the intended level of control has actually been achieved W work environment (ISO 9000, 3.3.4) set of conditions under which work is performed

NOTE Conditions include physical, social, psychological and environmental factors (such as temperature, recognition schemes, ergonomics and atmospheric composition)

work instructions (ISO/TR 10013, 3.1) detailed descriptions of how to perform and record (ISO 9000, 3.7.6) tasks

NOTE 1 Work instructions may be documented or not NOTE 2 Work Instructions may be, for example, detailed written descriptions, flowcharts, templates, models, technical notes incorporated into drawings, specifications (ISO 9000, 3.7.3), equipment instruction manuals, pictures, videos, checklists, or combinations thereof. Work instructions should describe any materials (ISO 22005, 3.9), equipment and documentation to be used. When relevant, work instructions include acceptance criteria

Z zoning (PAS 220, 3.15 / PAS 221, 3.22) <food safety> demarcation of an area within an establishment (PAS 220, 3.3) where specific operating, hygiene or other practices may be applied to minimize the potential for microbiological cross-contamination… (PAS 221 addition) …to ready-to-eat [RTE] products (PAS 221, 3.18) or food contact surfaces used for RTE products

NOTE (from PAS 220) Examples of practices include: clothing change on entry or exit, positive air pressure, modified traffic flow patterns NOTE (from PAS 221) Example include: restricting entry between meat market and bakery operations, modified traffic flow patterns between foodservice cook station and packaging locations.


MK 21999 Page 16

Alphabetical Index

A G performance criterion PC) 10

performance objective [PO] 10 acceptable level 2 good agriculture practice (GAP ] 7 personnel security 10 appropriate level of protection good distribution practice pest 10 [ALOP] 2 [GDP] 7 potable water 11 aspect 2 good manufacturing practice primary production 11 [GMP] 7 procedure 11

C good hygiene practice [GHP] 7 process 11 good trading practice [GTP] 7 process approach 11 certificate of analysis [COA] 2 good veterinary practice product 11 certificate of conformance [GVP] 7 product contact 11 [COC] 2 guidelines 7 product recall 11 characteristic 2 product security 11 clean water 2 H protective security 11 cleaning 2 PRP [prerequisite programme ] 12 cleaning in place [CIP] 2 HACCP plan 7 cleaning out of place [COP] 3 hazard analysis 7 R competent person 3 hazard analysis and cri tical contaminant 3 control point [HACCP] 7 ready -to-eat [RTE] 12 contamination 3 hazard assessment 7 relevant food safety hazard 12 contingency planning 3 hierarchy 8 record 12 contract 3 requirement 12 control measure 3 I risk 12 correction 3 corrective action 4 impact 8 S critical control point [CCP] 4 infrastructure 8 critical limit 4 interested party 8 sanitation 13 customer requirement 4 intermediate material 8 sanitizing 13 shelf life 13

D L single -use articles site 13 data 4 label 8 specification 13 disinfection 4 location 8 step 13 document 4 lot 9 system 13 lot identification 9

E T M electronic security 4 Threat Assessment Critical end pr oduct 5 management 9 Control Point [TACCP] 14 establishment 5 management system 9 top management 14 materials 9 traceability 14

F material specification [product traceability system 14 specification ] 9 feed and food chain 5 migration 9 U first expired first out [FEFO] 5 monitoring 9 first in first out [FIFO] 5 updating 14 flow diagram 5 N food chain 5 V food defence 5 nonconformity 10 food grade 5 non-intentionally added validation 14 food r etail establishment 5 substance [NIAS] 10 verification 14 food retail premises 6 food safety 6 O W food safety control measure 6 food safety hazard 6 operational PRP s [operational work environment 15 food safety management systems prerequisite programmes ] 10 work instructions 15 [FSMS] 6 organization 10 food safety objective [FSO] 6 Z food safety policy 6 P food supply 6 zoning 15 form 6 packaging materials 10


MK 21999 Page 17

Bibliography

[1] APO – Food safety management system manual, Jun 2009

[2] CAC- Basic text on food hygiene , 3rd ed., 2003 [3] CAC/RCP 1-1969, Rev.4-2003 Recommended international code of practice, General principles of food

hygiene with annex, Guidelines for the application of the HACCP system [4] CAC/GL 69-2008 Guidelines for the validation of food safety control measure [5] Federations of Veterinarians of Europe- Code of good veterinary practice, 2002 [6] GLOBALGAP Annex I.1 GLOBALGAP (EUREPGAP] Definitions IFA 3.1 GR I ver. V3.1, Nov 2009 [7] ILSI- Food safety objective (FSO]: An integral part of food chain management, 2005 (as cited within the

ISO FSMS series] [8] ISO/TC 176/SC 2/N 526 R2- Guidance on the terminology used in ISO 9001 and ISO 9004, Oct 2008 [9] ISO 9000:2005 Quality management systems- Fundamentals and vocabulary [10] ISO/TR 10013:2001 Guidelines for quality management system documentation [11] ISO 15161:2001 Guidelines on the application of ISO 9001:2000 for the food and drink industry [12] ISO 22000:2005 Food safety management systems- Requirements for any organization in the food chain [13] ISO/TS 22002-2 Prerequisite programmes (PRPs] on food safety- Part 2 Good manufacturing practices for

food services (Committee Draft stage as of 2011] [14] ISO/TS 22002-3:2011 Prerequisite programmes (PRPs] on food safety- Part 3 Farming [15] ISO/TS 22003:2007 Food safety management systems- Requirements for bodies providing audit and

certification of food safety management systems [16] ISO/TS 22004:2005 Food safety management systems- Guidance on the application of ISO 22000:2005 [17] ISO 22005:2007 Traceability in the feed and food chain- General principles and basic requirements for

system design and implementation [18] ISO 22006:2009 Guidelines on the application of ISO 9001:2008 in crop production [19] PAS 96:2010 Defending food and drink- Guidance for the deterrence, detection, and defeat of ideologically

motivated and other forms of malicious attack on food and drink and their supply arrangements [20] PAS 99:2006 Specification of common management system requirements as a framework for integration [21] PAS 220:2008 Prerequisite programmes (PRPs] on food safety for food manufacturing

(adapted and released by ISO as ISO/TS 22002-1:2009 PRPs on food safety- Part 1 Food manufacturing] [22] PAS 221:2012 (Draft] Prerequisite programmes (PRPs] for food safety in food retail [23] PAS 222:2011 Prerequisite programmes (PRPs] for food safety in the manufacture of food and feed for

animals [24] PAS 223:2011 Prerequisite programmes (PRPs] and design requirements for food safety in the

manufacturing and provision of food packaging [25] WHO- Good distribution practices (GDP], 2005

FSMS Vocabulary Rev.01 Sep. 2012

Documents

Transcript of FSMS Vocabulary Rev.01 Sep. 2012