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1 revision
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Food safety management systems-

Vocabulary
 Food safety management systems- Vocabulary

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) are 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.
For example:

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.

For example:

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

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
st
In this 1 revision, terms not related to food safety were removed (ex. quality manual, quality
objectives, etc.). However, terms with universal application, although defined in ISO 9000:2005 QMS-
Fundamentals and Vocabulary (ex. customer requirements ISO 9000, 2.1; document ISO 9000, 3.7.2;
st
non-conformity ISO 9000, 3.1.2; etc.) were still retained. The 1 edition was also modified due to the
release of PAS 221:2012 (Draft).

Mark B. Kwan
Food Safety Management System Auditor
01 Sep 2012, Abu Dhabi, UAE

MK 21999 Page 1
 Food safety management systems- Vocabulary

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 22004, 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)

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 fresh 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 affecting 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]

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 Food safety management systems- Vocabulary

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 221, 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 223, 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)

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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)

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)

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

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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]

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]

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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 effect (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

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good agricultural practices [GAP] (GlobalGAP, Definition 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, 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
distribution process

good hygiene practice [GHP] (APO- FSMS manual, Definition 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

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

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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)

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

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

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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)

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 / ISO 19011, 3.20)
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)

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nonconformity (ISO 9000, 3.6.2 / ISO 19011, 3.19)

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

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

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

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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

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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)

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 include 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

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 Food safety management systems- Vocabulary

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

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

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 Food safety management systems- Vocabulary

Threat Assessment Critical Control Point (TACCP) (PAS 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

updating (ISO 22000, 3.17)

immediate and/or planned activity to ensure application of the most recent information

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

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 Food safety management systems- Vocabulary

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

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

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.

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 Food safety management systems- Vocabulary

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 critical
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 product 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 retail 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 PRPs [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

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 Food safety management systems- Vocabulary

Bibliography
[1] APO – Food safety management system manual, Jun 2009
rd
[2] CAC- Basic text on food hygiene, 3 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 22002-1:2009 Prerequisite programmes [PRPs] on food safety- Part 1: Food
manufacturing (formerly known as PAS 220:2008 Prerequisite programmes [PRPs] on food
safety for food manufacturing)

[14] ISO/TS 22002-2:2013 Prerequisite programmes [PRPs] on food safety- Part 2: Catering

[15] ISO/TS 22002-3:2011 Prerequisite programmes [PRPs] on food safety- Part 3: Farming

[16] ISO/TS 22002-4 (Draft) Prerequisite programmes [PRPs] on food safety- Part 4: Food packaging
manufacturing

[17] ISO/TS 22002-5 (Draft) Prerequisite programmes [PRPs] on food safety- Part 5: Transport and
Storage

[18] ISO/TS 22003:2007 Food safety management systems- Requirements for bodies providing audit
and certification of food safety management systems

[19] ISO/TS 22004:2005 Food safety management systems- Guidance on the application of ISO
22000:2005

[20] ISO 19011:2011 Guidelines for auditing management systems

[21] ISO 22005:2007 Traceability in the feed and food chain- General principles and basic
requirements for system design and implementation

[22] ISO 22006:2009 Guidelines on the application of ISO 9001:2008 in crop production

MK 21999 Page 17
 Food safety management systems- Vocabulary

[23] 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

[24] PAS 99:2006 Specification of common management system requirements as a framework for
integration

[25] PAS 221:2012 (Draft) Prerequisite programmes [PRPs] for food safety in food retail

[26] PAS 222:2011 Prerequisite programmes [PRPs] for food safety in the manufacture of food and
feed for animals

[27] PAS 223:2011 Prerequisite programmes [PRPs] and design requirements for food safety in the
manufacturing and provision of food packaging

[28] WHO- Good distribution practices [GDP], 2005

MK 21999 Page 18