FSMS Vocabulary, Rev.03 Sep 2013

3

rd revision

2013-09-30

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) 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 defense> 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) <FSMS> 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) <FSMS> 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

This 3

rd revision encompassed emerging trends of food fraud, food defense, expanding the

definitions adopted by GlobalGAP, and included materials of food safety importance such as lubricants, with incidental product (food) contact.

Mark B. Kwan 30 Sep 2013

Abu Dhabi, UAE


MK 21999 Page 2

A acceptable level (ISO/TS 22004, 7.4.2) <FSMS> 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) active ingredient (GlobalGAP, 3) pesticide or pharmaceutical drug that is biologically active Some pesticides and medications may contain more than one active ingredient/substance

adulteration (NCFPD) <food fraud> a component of the finished (food) product is fraudulent ex. melamine added to milk

According to USDA, a (food) product is considered adulterated if:

“it bears or contains any poisonous or deleterious substance which may render it injurious to health”

“it bears or contains any added poisonous or deleterious substance”

“any filthy, putrid, or decomposed, or otherwise unfit food” [including if it achieved this during handling]

“the product of a diseased animal or of an animal which has died other than by slaughter”

“its container [package] is composed, in whole or in part, of any poisonous or deleterious substance”

“any valuable constituent has been in whole or in part omitted or abstracted therefrom”

“damage or inferiority has been concealed in any manner”

“any substance has been added thereto or mixed or packed therewith so as to increase its bulk or weight, or reduce its quality or strength, or make it appear better or of greater value than it is”

“it bears or contains a color additive which is unsafe within the meaning of this section”

appropriate level of protection [ALOP] (ISO/TS 22004, 7.4.2) <FSMS> 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) <IMS> 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)

B biocide (GlobalGAP, 16) a chemical substance or a microorganism used to manage, mitigate, or remove any harmful organisms via chemical or biological methods There are two primary categories of biocides: (1) pesticides (e.g. fungicides, herbicides, insecticides, algicides, moluscicides, miticides and rodenticides) and (2) antimicrobials (e.g. germicides, antibiotics, antibacterials, antivirals, antifungals, antiprotozoas and antiparasites)

biosecurity (GlobalGAP, 19) a set of preventative measures taken to protect from infectious diseases, quarantined pests, invasive alien species, and living modified organisms Mortality due to diseases and decreased production due to infections are major factors for economic loss but also a serious food safety concern for the consumers


MK 21999 Page 3

biosecurity plan (GlobalGAP, 18) a written document addressing potential pathways for the introduction and spread of disease in a zone or compartment, and describing the preventative measures which are being or will be applied to mitigate the chemical and biological risks The plan also describes procedures to ensure that the risks are regularly re-assessed and the measures adjusted accordingly

C catering (ISO/TS 22002-2, 3.1) ˂catering PRPs˃ preparation, storage and, where appropriate, delivery of food for consumption, at the place of preparation or at a satellite unit certificate of analysis [COA] (PAS 220, 3.14 / PAS 221, 3.1 / PAS 222, 2.1 / PAS 223, 3.1) <PRPs> 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 PRPs> 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) <FSMS> 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 22002-3, 3.12). Sometimes used interchangeably with attribute

clean water (ISO/TS 22002-3, 3.1) <farming PRPs> 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 ISO/TS 22002-3, 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 (ISO/TS 22002-2, 3.2 / PAS 220, 3.5 / PAS 221, 3.2) <PRPs> 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) <food manufacturing PRPs> 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]

cleaning in place [CIP] (PAS 221, 3.3) <food retail PRPs> 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) <PRPs> 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…


MK 21999 Page 4

… [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

competence (ISO/TS 22003, 3.3) ability to apply knowledge and skills to achieve intended results competent person (ISO/TS 22002-3, 3.2) <farming PRPs> 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

compliance criteria (CC) (GlobalGAP, 35) Information provided to further illustrate each control point and how to successfully address the requirement(s) identified in the control point (GlobalGAP, 42) compound feed (GlobalGAP, 38) (which can be complete or complementary), may be produced using any ingredients (except medicated feed/supplements) as raw materials Compound Feeds in the context of GlobalGAP exclude the production of ingredients such as forage or grains (Simple Feed Materials), pre-mixtures, additives or medicated feeds (Prepared Feed Supplements) etc.

consequence (USFDA) <food defense> the result of a terrorist attack or other incident that reflects the level, duration and nature of the loss resulting from the incident [NOTE] For purposes of US National Infrastructure Protection Plan (NIPP), there are four main categories: health, economic, psychological and governance

contaminant (ISO/TS 22002-2, 3.4 / ISO/TS 22002-3, 3.4 / PAS 220, 3.2 / PAS 221, 3.5 / PAS 222, 2.2 / PAS 223, 3.4 / EN 15593, 3.1) <PRPs> any biological ([for EN 15593] including microbiological) or chemical agent, foreign matter or other substances not intentionally added to (food or feed) 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 [For ISO/TS 22002-3] NOTE 2 In the context of ISO/TS22002-3, the term “foreign matter” refers to physical contaminants NOTE 3 This definition is similar to the definition of “food safety hazard (ISO 22000, 3.3)” given in ISO 22000:2005. In fact, in the context of ISO 22000:2005, food safety hazards are identified during the hazard analysis, after the establishment of PRPs. Consequently, the term “contaminant” is used in this Technical Specification (ISO/TS 22002-3)

contamination (ISO/TS 22002-3, 3.3 / PAS 220, 3.1 / PAS 221, 3.6 / PAS 222, 2.3 / PAS 223, 3.5 / EN 15593, 3.2) <PRPs> introduction or occurrence of a contaminant (PAS 220, 3.2) in food or food environment [addition for ISO/TS 22002-3] …in food, feed or in food and feed 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) <IMS> 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


MK 21999 Page 5

contract (ISO 15161, 3.1) <food quality> agreed requirements (ISO 9000, 3.1.2) between a supplier and a customer, transmitted by any means control measure (ISO 22000, 3.7) <FSMS> 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] Control Points (CP) (GlobalGAP, 42) those measurable issues associated with the implementation of good agricultural practices (GlobalGAP, 84) throughout the farming business Within the GlobalGAP standards, control points are classified as major musts (GlobalGAP, 111), minor musts (GlobalGAP, 117), or recommendations (GlobalGAP, 161)

Control Points and Compliance Criteria (CPCC) (GlobalGAP, 43) the comprehensive set of control points (GlobalGAP, 42) and compliance criteria (GlobalGAP, 35) that make up the checklist against which producer/farm performance is measured both internally and externally correction (ISO 22000, 3.13) <FSMS> 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)

corrective action (ISO 22000, 3.14) <FSMS> 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

counterfeiting (NCFPD) <food fraud> Intellectual Property Rights infringement, which could include all aspects of the fraudulent product and packaging being fully replicated ex. copies of popular foods not produced with same food safety assurances critical control point [CCP] (ISO 22000, 3.10) <FSMS> 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 defect (GlobalGAP, 49) a deviation at a critical control point (ISO 22000, 3.10) which results in a hazard occurring critical limit (ISO 22000, 3.11) <FSMS> 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

critical limits (GlobalGAP, 50) a maximum and/or minimum value to which a biological, chemical or physical parameter must be controlled at a critical control point (ISO 22000, 3.10) to prevent, eliminate or reduce to an acceptable level (ISO/TS 22004, 7.4.2) the occurrence of a food-safety hazard


MK 21999 Page 6

cross-contamination (ISO/TS 22002-2, 3.5) ˂catering PRPs˃ contamination of cooked and pre-cooked foods by direct or indirect contact with material at an earlier stage of the process customer (GlobalGAP, 52) a person or entity who purchases products or services from a supplier (GlobalGAP, 191) customer requirements (ISO 9000, 2.1) <QMS> needs and expectation expressed in product specifications (PAS 220, 3.7) D data (ISO 22005, 3.11) <FSMS> recorded information disinfection (ISO/TS 22002-2, 3.6 / PAS 220, 3.9 / PAS 221, 3.7 / PAS 222, 2.7) <PRPs> 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) <IMS> 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 Economically Motivated Adulteration [EMA] (NCFPD) <food fraud> the fraudulent, intentional substitution or addition of a substance in a product for the purpose of increasing the apparent value of the product or reducing the cost of its production. EMA includes dilution of products with increased quantities of an already-present substance to the extent that such dilution poses a known or possible health risk to consumers, as well as the addition or substitution of substances in order to mask dilution [NOTE] The corollary concept of economically motivated misbranding is when an act specifically meets the US Federal Food, Drug, and Cosmetic (FD&C) Act definition of “misbranding” and not “adulteration”

electronic security (PAS 96, 2.1) <food defense> 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 end product (ISO 22000, 3.5) <FSMS> 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


MK 21999 Page 7

equipment (PAS 221, 3.8) article that is used in the operation of food retail premises

NOTE 1 Equipment may include: freezer, grinder, hood, ice maker, meat block, mixer, oven, reach-in refrigerator, scale, sink, slicer, stove, table, thermometers, etc. NOTE 2 Equipment does not include apparatus used for handling or storing large quantities of packaged foods that are received from a supplier in a cased or over-wrapped lot/batch, such as hand trucks, forklifts, dollies, racks and skids

establishment (ISO/TS 22002-2, 3.7 / PAS 220, 3.3 / PAS 223, 2.6) <PRPs> 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 farm (GlobalGAP, 67) geographically owned or rented land with sufficient infrastructure and management to enable the production of the product

feed (ISO/TS 22002-3, 3.5) <farming PRPs> any single or multiple materials, whether processed, semi-processed or raw, which is intended to be fed directly to food-producing animals feed additives (ISO/TS 22002-3, 3.6) <farming PRPs> any intentionally added ingredient not normally consumed as feed by itself, whether or not it has nutritional value, which affects the characteristics of feed or animal products feed and food chain (ISO 22005, 3.7) <FSMS> 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

feed ingredient (ISO/TS 22002-3, 3.7) <farming PRPs> a component part or constituent of any combination or mixture making up a feed, whether or not it has a nutritional value in the animal’s diet, including feed additives

NOTE Ingredients are of plant or animal origin, whether terrestrial or aquatic, or other organic or inorganic substances

first expired first out [FEFO] (PAS 220, 3.18 / PAS 221, 3.9) <PRPs> 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) <PRPs> stock rotation based on the principle of dispatching earliest received products (ISO 22005,

3.1) first flow diagram (ISO 22000, 3.6) <FSMS> schematic and systematic presentation of the sequence and interactions of step(s) (ISO

15161, 3.10) flow of materials (ISO 22005, 3.8) <FSMS> 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) <FSMS> 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


MK 21999 Page 8

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-contact side (EC 223, e) <food packaging> the surface of a material or article that is directly in contact with the food

food defense (PAS 96, 2.2) <food defense> 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 defense (GlobalGAP, 71) activities associated with protecting food supply (ISO 22000, 3.3) from intentional contamination (food defense refers to intentional, sporadic, and plausible but unknown threat) food defense (USFDA) <food defense> the collective term used by the US Food and Drug Administration (FDA), US Department of Agriculture (USDA), US Department of Homeland Security (DHS), etc. to encompass activities associated with protecting the nation's food supply from deliberate or intentional acts of contamination or tampering. This term encompasses other similar verbiage (i.e., bioterrorism (BT), counter-terrorism (CT), etc.)

food fraud (NCFPD) the deliberate and intentional substitution, addition, tampering, or misrepresentation of food, food ingredients, or food packaging; or false or misleading statements made about a product, for economic gain [NOTE] Food fraud is a broader term than either the economically motivated adulteration (EMA) defined by the US Food and Drug Administration (USFDA) or the more specific general concept of food counterfeiting. Food fraud may not include “adulteration” or “misbranding,” as defined in the US Food, Drug, and Cosmetic Act (FD&C Act), when it involves acts such as tax-avoidance and smuggling. The economic motivation behind food fraud is distinctly different from those for food safety, food defense, and food quality. The cause of an event might be food fraud, but if a public health threat becomes involved, the effect is an adulterated product and a food safety incident. All of this is under the umbrella of food protection, which encompasses food fraud, food quality, food safety, and food defense Three types of public health risks can result from food fraud:

Direct food fraud risk occurs when there is an immediate or imminent risk to the consumer, such as the inclusion of an acutely toxic or lethal contaminant

Indirect food fraud risk occurs when the consumer is put at risk through long-term exposure, such as the build up in the body of a chronically toxic contaminant through the ingestion of low doses. Indirect risk also includes the omission of beneficial ingredients, such as preservatives or vitamins

Technical food fraud risk is non-material in nature. For example, food documentation fraud occurs when product content or country-of-origin information is deliberately misrepresented

food grade (PAS 220, 3.8 / PAS 221, 3.11) <PRPs> 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 handler (ISO/TS 22002-2, 3.8) ˂catering PRPs˃ any person who directly handles packaged or unpackaged food, food equipment and utensils, or food contact surfaces and is therefore expected to comply with food hygiene requirements food handling (ISO/TS 22002-2, 3.9) ˂catering PRPs˃ any operation in the preparation, processing, cooking, packaging (EN 15593, 3.7), storage, transport, distribution and service of food food ingredient (ISO/TS 22002-2, 3.11) ˂catering PRPs˃ any substance, including food additives, used in the manufacturing or preparation of food and which is present, whether maintaining its original aspect or modified, in the end product


MK 21999 Page 9

food protection (NCFPD) <food fraud> an overall concept that includes prevention, intervention, and response for incidents in food quality, food safety, food fraud, and food defense food retail establishment (PAS 221, 3.12) <food retail PRPs> 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]

food retail premises (PAS 221, 3.13) <food retail PRPs> physical building under direct full or partial control of the retailer food safety (ISO 22000, 3.1) <FSMS> 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) <FSMS> 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 1 to entry: See ISO 9000:2005, 3.2.1, 3.2.2 and 3.2.3. Note 2 to entry: In this Technical Specification (ISO/TS 22003), “food safety management system” replaces the term “management system” used in ISO/IEC 17021.

food safety objective [FSO] (ISO/TS 22004, 7.4.2) <FSMS> 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) <FSMS> 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)


MK 21999 Page 10

food supply (PAS 96, 2.3) <food defense> 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)

food terrorism (WHO, 2008) an act or threat of deliberate contamination of food for human consumption with chemical, biological, or radionuclear agents for the purpose of causing injury or death to civilian populations and/or disruption of social, economic or political stability form (ISO/TR 10013, 3.2) <QMS> 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

fumigant (GlobalGAP, 74) volatile liquid or gas used to kill insects, nematodes, fungi, bacteria, seeds, roots, rhizomes, or entire plants G GlobalGAP Risk Assessment on Social Practice [GRASP] (GlobalGAP, 79) a voluntary assessment on the implemented social practices on farm (GlobalGAP, 67). The outcome of the assessment does not affect the GlobalGAP certification but serves as additional information to supply chain partners who have been granted access to the results good agricultural practices [GAP] (GlobalGAP, 84) practices that address environmental, economic, and social sustainability for on-farm processes, and result in safe and quality food and non-food agricultural products 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) <food quality> 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 manufacturing practice [GMP] (EC 223, a) those aspects of quality assurance which ensure that materials and articles are consistently produced and controlled to ensure conformity with the rules applicable to them and with the quality standards appropriate to their intended use by not endangering human health or causing an unacceptable change in the composition of the food or causing a deterioration in the organoleptic characteristics thereof

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


MK 21999 Page 11

good veterinary practice [GVP] (FVE) 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) <QMS> 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 hand washing (ISO/TS 22002-2, 3.10) ˂catering PRPs˃ removal of dirt from skin with the help of a skin compatible soap hazard (EN 15593, 3.3) ˂food packaging˃ biological, chemical or physical contaminant in the product, or a condition of the product (EN 15593, 3.8) that may cause an adverse health effect or a nonconformity to the hygiene (EN 15593, 3.4) requirements for that product

hazard (GlobalGAP, 89) a biological, chemical, physical or any other property that may cause a situation unsafe for workers, consumers, and/or the environment

hazard analysis (ISO 15161, 3.8) <food quality> 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) <FSMS> 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 texts

hazard analysis critical control points [HACCP] (GlobalGAP, 88) a food safety management methodology used in the analysis and control of biological, chemical, and physical hazards from raw material production, procurement and handling, to manufacturing, distribution and consumption of the finished product

hazard assessment (PAS 222, 2.11) <animal feed PRPs> 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

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]

herbicide (GlobalGAP, 90) a chemical that controls or destroys undesirable plants

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)


MK 21999 Page 12

hygiene (EN 15593, 3.4) ˂food packaging˃ set of measures taken to ensure the safety and suitability of a product (EN 15593,

3.8) that might otherwise become hazardous or harmful

hygiene (ISO 14159, 3.11) <safety of machinery> taking of all measures during product handling, preparation and processing to ensure its suitability for use by humans or domestic animals

I impact (PAS 99, 3.4) <IMS> 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

incident (EN 15593, 3.5) ˂food packaging˃ event that may potentially compromise the safety and suitability of a material or product (EN 15593, 3.8)

incidental product contact (ISO 21469, 3.6) <safety of machinery> contact with product that is not intended but which is not preventable 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)

intended use (ISO 21469, 3.5) <safety of machinery> use of a lubricant in accordance with the instructions of the lubricant and machinery manufacturers in consideration of the expected operating conditions including service life, chemical, thermal and mechanical loads interested party (ISO 9000, 3.3.5 / PAS 99, 3.5) <IMS> 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 PRPs> physical output of part of the production process that still requires further processing to create finished food packaging (EN 15593, 3.7)

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) <PRPs> 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;


MK 21999 Page 13

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

[addition for PAS 221]

c) Point of sale display material/signage 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) <FSMS> place of production, processing, distribution, storage and handling from primary production (ISO 15161, 3.9) to consumption lot (ISO/TS 22002-3, 3.8 / ISO 22005, 3.3) <FSMS> 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) <FSMS> process (ISO 22005, 3.2) of assigning a unique code to a lot (ISO 22005, 3.3) lubricant (ISO 21469, 3.1) <safety of machinery> substance capable of reducing friction, adhesion, heat and wear when introduced as a film between solid surfaces M major must (GlobalGAP, 111) one of three types of control points (GlobalGAP, 42) that the producer is required to comply with in order to obtain GlobalGAP certification. Complying with 100% of the major musts is compulsory

management (ISO 9000, 3.2.6) <QMS> 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) <IMS> 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

mass balance (GlobalGAP, 114) or quantity check; may be undertaken in any traceability (GlobalGAP, 197) test or recall (GlobalGAP, 159) scenario to account for all materials. This is defined as a reconciliation of the amount of incoming raw material against the amount used in the resulting finished products, taking into account process waste and rework materials (ISO 22005, 3.9) <FSMS> feed and food, feed and food ingredients and packaging materials (PAS 223, 3.14)

materials (PAS 220, 3.4 / PAS 221, 3.13) <PRPs> general term used to indicate raw materials, packaging materials (PAS 223, 3.14), ingredients, process aids, cleaning materials and lubricants


MK 21999 Page 14

material specification [product specification] (PAS 220, 3.7 / PAS 221, 3.12) <PRPs> detailed documented description or enumeration of parameters, including permissible variations and tolerances, which are required to achieve a define level of acceptability or quality medicated feed (ISO/TS 22002-3, 3.9) <farming PRPs> any feed which contains veterinary drugs (ISO/TS 22002-3, 3.15)

migration (PAS 223, 3.12) <food packaging PRPs> 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

minor must (GlobalGAP, 117) One of three types of control points (GlobalGAP, 42) that the producer is required to comply with in order to obtain GlobalGAP certification. Producers shall comply with 95% of all of the applicable minor musts misbranded (NCFPD) <food fraud> to brand falsely or in a misleading way, specifically, to label in violation of statutory requirements According to USDA, a (food) product is considered misbranded if:

“it is offered for sale under the name of another food”

“it is an imitation of another food” (unless is bears the word “imitation” on the label)

“its container [package] is so made, formed, or filled as to be misleading”

“it purports to be, or is represented as, a food for which a definition and standard identity have been prescribed by regulations”

“it falls below such standards”

“a food for which a standard or standards of fill of a container have been prescribed by regulations, and it falls below the standard”

monitoring (ISO 22000, 3.12) <FSMS> 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)

N nonconformity (ISO 9000, 3.6.2 / ISO 19011, 3.19) <IMS> non-fulfilment of a requirement (ISO 9000, 3.1.2) non-food-contact side (EC 223, d) <food packaging> the surface of the material or article that is not directly in contact with food non-intentionally added substance [NIAS] (PAS 223, 3.13) <food packaging PRPs> 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) <FSMS> 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 (ISO 22000, 3.3) in the product(s) (ISO 22005, 3.1) or in the processing environment


MK 21999 Page 15

organization (ISO/TS 22002-3, 3.10 / ISO 22005, 3.10 / ISO 9000, 3.3.1) <IMS> group of people and facilities with an arrangement of responsibilities, authorities and relationships [ISO/TS 22002-3 addition] (e.g. company, corporation, firm, enterprise, institution, charity, sole trader, association, or parts or combination thereof)

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 NOTE [ISO/TS 22002-3 addition] In the context of ISO/TS 22002-3, the term refers to a farmer, a group of farmers, farming company and/or an association, an authority or a processing company establishing PRPs for farmers. An organization can be public or private

outsourced activity (EN 15593, 3.6) ˂food packaging˃ any activity subcontracted by an organization to an external organization over-run (NCFPD) <food fraud> legitimate product that is made in excess of production agreements ex. under-reporting of production P packaging (ISO/TS 22002-3, 3.11) <farming PRPs> any product to be used for containment, protection, handling, delivery, storage, transport and presentation of agricultural products or foods

packaging (EN 15593, 3.7) ˂food packaging˃ any kind of product or material used by the packaging industry to wrap, pack, protect, handle or transport its own product (EN 15593, 3.8)

packing materials (PAS 223, 3.14) <food packaging PRPs> materials used to hold and protect food packaging (EN 15593, 3.7) during shipping, transport and storage performance criterion [PC] (ISO/TS 22004, 7.4.4) <FSMS> 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) <FSMS> 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 defense> 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) <farming PRPs> 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 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


MK 21999 Page 16

plant protection product (ISO/TS 22002-3, 3.13) <farming PRPs> any substance or micro-organism, including a virus, or a mixture or solution composed of two or more of them, put up in the form in which it is supplied to the user, intended to protect plants or plant products against all harmful organisms or prevent the action of such organisms; or influence the life processes of plants other than as a nutrient; or preserve plant products; or destroy undesired plants or parts of plants or check or prevent the undesired growth of plants NOTE In the context of ISO/TS 22002-3, the term refers to herbicides, algaecides, rodenticides, talpicides, leporicides, molluscicides, nematocides, insecticides, acaricides, fungicides, bactericides, viricides, disinfectants, repellents, attractants, fumigants, plant activators, plant growth regulators, elicitators of self-defence mechanisms, etc. intended to be used in growing, harvesting and post-harvest activities

Plant Protection Product (PPP) (GlobalGAP, 139) any substance or mixture of substances intended for controlling insects, weeds, fungi, and other forms of plant or animal life considered to be pests to agricultural plants

portioning (ISO/TS 22002-2, 3.13) ˂catering PRPs˃ division of food into single or multiple portions post harvest chemicals (GlobalGAP, 142) includes plant protection products (GlobalGAP, 139) applied after harvest (e.g., including wax, detergents, and lubricants where applicable) potable water (ISO 22002-3, 3.14) <farming PRPs> 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

prevention (USFDA) <food defense> actions taken to avoid an incident or to intervene to stop an incident from occurring preventive measure (GlobalGAP, 145) physical, chemical, or biological factors that may be used to manage, mitigate, or eliminate an identified hazard primary production (ISO 15161, 3.9) <food quality> 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) <IMS> specified way to carry out an activity or a process (PAS 99, 3.8)

NOTE Procedures can be documented or not

procedure (GlobalGAP, 147) step-by-step instruction to achieve a desired result

process (ISO 22005, 3.2 / ISO 9000, 3.4.1 / PAS 99, 3.8) <IMS> 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


MK 21999 Page 17

process approach (ISO 9000, 2.4) <QMS> 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)

processed product (GlobalGAP, 148) when the structure of the product is altered in appearance or form processing (ISO 21469, 3.4) <safety of machinery> unit operations such as weighing, measuring, filling and refilling, stamping, printing, packing, container filling, container sealing/closure, cooling, storage and transportation of products product (ISO 22005, 3.1 / ISO 9000, 3.4.2) <IMS> result of a process (ISO 22005, 3.2)

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

product (ISO 21469, 3.2) <safety of machinery> any substance intended to be applied or taken into humans or domestic animals, e.g. by ingestion, injection, topical application, insertion product (EN 15593, 3.8) ˂food packaging˃ physical final output of any kind of production process that takes place in the packaging (EN 15593, 3.7) industry NOTE This includes products that undergo further production steps to fulfil the specification defined by the filler/packer

product contact (PAS 220, 3.6 / PAS 221, 3.14 / PAS 222, 2.15) <PRPs> all surfaces that are in contact with the (exposed) product (ISO 22005, 3.1) or the primary package during normal operation product recall (PAS 220, 3.17) <food manufacturing PRPs> 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 defense> 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 defense> 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 PRP [prerequisite programme] (ISO 22000, 3.8) <FSMS> 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, 84), 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)


MK 21999 Page 18

Q

quality assurance system (EC 223, b) the total sum of the organised and documented arrangements made with the purpose of ensuring that materials and articles are of the quality required to ensure conformity with the rules applicable to them and the quality standards necessary for their intended use quality control system (EC 223, c) the systematic application of measures established within the quality assurance system that ensure compliance of starting materials and intermediate and finished materials and articles with the specification determined in the quality assurance system (EC 223, b)

R

ready-to-eat food [RTE] (PAS 221, 3.15) <food retail PRPs> 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

recall (GlobalGAP, 159) the process by which a product is removed from the supply chain and returned to the grower/handler. In some cases, consumers are advised to take action, such as returning or destroying produce items recall procedure (EN 15592, 3.9) ˂food packaging˃ procedure to ensure the efficient return of products identified as potentially having a nonconformity that could present a hazard recommendation (GlobalGAP, 161) one of three types of control points (GlobalGAP, 42) within the GlobalGAP standards All recommendation control points must be inspected during the self-assessments and external announced inspections but there is no requirement for successfully meeting recommendations

record (ISO 9000, 3.7.6) <QMS> 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

record (GlobalGAP, 162) a document containing objective evidence illustrating activities being performed and/or results achieved

recovery (USFDA) <food defense>The return-to-service activities that industry and government must undertake to assure consumers the products will be safe and secure following an event. The development, coordination and execution of service- and site-restoration plans for impacted communities and the reconstitution of government operations and services through individual, private sector, non-governmental and public assistance programs relevant food safety hazards (ISO 22000, 3.3 NOTE 4) <FSMS> 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


MK 21999 Page 19

requirement (ISO 9000, 3.1.2) <QMS> 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

resolved (GlobalGAP, 167) positive closure of a non-compliance response (USFDA) <food defense> activities that address the short-term, direct effects of an incident (e.g., save and limit loss of life and property, meet basic human needs, execution of emergency plans, apply intelligence to lessen consequences, immunizations, law enforcement operations) retail premises (PAS 221, 3.16) <food retail PRPs> building under direct food full or partial control of the retailer, in which food is stored, prepared, packaged, served, vended, sold, or otherwise provided for consumption risk (ISO 22000, 3.3 NOTE 2) <FSMS> 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 (ISO/IEC Guide 51 Definition, see ISO 22000, 3.3 NOTE 2) <FSMS> the combination of the probability of occurrence of harm and the severity of that harm risk (PAS 99, 3.9) <IMS> 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

risk (GlobalGAP, 172) the likelihood of a hazard occurring in the future. For food safety, risks are categorized as biological, chemical, or physical

risk assessment (GlobalGAP, 171) an estimate of the probability, frequency and severity of the occurrence of a hazard or other non-conformity with regard to food safety, worker safety, and pesticide safety (also called a risk analysis) S safety (EN 15593, 3.11) ˂food packaging˃ condition of product (EN 15593, 3.8) being free from unacceptable risk of harm


MK 21999 Page 20

sanitation (PAS 220, 3.13 / PAS 221, 3.19) <PRPs> 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 manufacturing PRPs> process (ISO 22005, 3.2) of cleaning (PAS 220, 3.5), followed by disinfection (PAS 220, 3.9)

sanitizing (PAS 221, 3.18) <food retail PRPs> the process (ISO 22005, 3.2) of cleaning (PAS 220, 3.5), 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

satellite/satellite kitchen (ISO/TS 22002-2, 3.15) ˂catering PRPs˃ kitchen where food from a central kitchen is portioned, reheated if needed, and made ready for service shelf life (ISO/TS 22004, 7.3) <FSMS> 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 simulation (NCFPD) <food fraud> illegitimate product designed to look like but not exactly copy of the legitimate product ex. “Knock-offs” of popular foods not produced with same food safety assurances single-use articles (PAS 221, 3.21) <food retail PRPs> 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) <animal feed PRPs> 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) <QMS> 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)

specification (EN 15593, 3.12) ˂food packaging˃ explicit or detailed description of a material, product (EN 15593, 3.8) or service including hygiene (EN 15593, 3.4) aspects

standard operating procedures (SOP) (GlobalGAP, 184) a written document detailing an operation, analysis, or action whose mechanisms are prescribed thoroughly and which is commonly accepted as the method for performing certain routine or repetitive tasks step (ISO 15161, 3.10) <food quality> 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]

sterilization (ISO 14159, 3.33) <safety of machinery> process that inactivates all micro-organisms and relevant microbial spores


MK 21999 Page 21

supplier (GlobalGAP, 191) a person or an organization which provides products or services to customers (GlobalGAP, 52) system (ISO 9000, 3.2.1) <QMS> set of interrelated or interacting elements T tampering (NCFPD) <food fraud> legitimate product and packaging used in a fraudulent way ex. changed expiry information, product up-labeling, etc. theft (NCFPD) <food fraud> legitimate product stolen and passed off as legitimately procured ex. stolen products are co-mingled with legitimate products threat (USFDA) <food defense> an indicator of possible violence, harm or danger that includes both intent and capabilities Threat Assessment Critical Control Point (TACCP) (PAS 96, 2.7) <food defense> systematic management (ISO 9000, 3.2.6) of risks (PAS 99, 3.9) through the process of assessment of threats, identification of vulnerabilities, and implementation of controls to raw materials, packaging (EN 15593, 3.7), 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 / EN 15593, 3.13) <IMS> 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) <FSMS> 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 (GlobalGAP, 197) the ability to retrace the history, use or location of a product (e.g. the origin of materials and parts, the history of processes applied to the product, and/or the distribution and placement of the product after delivery) by the means of recorded identification markers

traceability system (ISO 22005, 3.12) <FSMS> 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) <FSMS> immediate and/or planned activity to ensure application of the most recent information


MK 21999 Page 22

V validation (ISO 22000, 3.15) <FSMS> 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) <FSMS> 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

vector (ISO/TS 22002-2, 3.16) <epidemiology> organism which does not cause disease itself but which transmits infection by conveying pathogens from one host to another verification (ISO 22000, 3.16 / ISO 9000, 3.8.4) <IMS> confirmation, through the provision of objective evidence, that specified requirements (ISO

9000, 3.1.2) have been fulfilled

verification (ISO/TS 22004, 7.8) <FSMS> 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 verification (GlobalGAP, 198) confirmation by examination of evidence that a product, process or service fulfills specified requirements

veterinary drug (ISO/TS 22002-3, 3.15) <farming PRPs> any substance applied or administered to any food-producing animal, such as meat or milk-producing animals, poultry, fish or bees, whether used for therapeutic, prophylactic or diagnostic purposes or for modification of physiological functions or behaviour NOTE This definition of veterinary drugs includes parasiticides intended to be applied or administered to food producing animals

visitor (ISO/TS 22002-2, 3.17) ˂catering PRPs˃ person who is not a permanent staff member of the establishment, including external visitors and service support staff Note 1 to entry: Examples of external visitors are auditors, enforcement officers, suppliers, and contractors. Service support staff includes any other person who is not working in that particular area, e.g. maintenance, management staff, and cleaners

vulnerability (USFDA) <food defense> A weakness in the design, implementation or operation of an asset or system that can be exploited by an adversary or disrupted by a natural hazard W withdrawal (GlobalGAP, 204) the process by which a product is removed from the supply chain prior to it reaching the end consumer


MK 21999 Page 23

withholding/withdrawal period (ISO/TS 22002-3, 3.16) <farming PRPs> time during which a crop, an animal or its products cannot be used for human consumption following the last application of a plant protection product (ISO/TS 22002-3, 3.13) to the crop (including pastures), or the last application or administration of a veterinary drug (ISO/TS 22002-3,

3.15) to the animal, that ensures that the foodstuff does not contain any residues in quantities in excess of established maximum residue limits work environment (ISO 9000, 3.3.4) <QMS> 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) <QMS> 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

wrapping (ISO/TS 22002-3, 3.17) <farming PRPs> the action of placing a foodstuff in a wrapper or container in direct contact with the foodstuff concerned; or the wrapper or container itself Z zoning (PAS 220, 3.15) <PRPs> demarcation of an area within an establishment (PAS 220, 3.3) where specific operating, hygiene (ISO 14159, 3.11) or other practices may be applied to minimize the potential for microbiological cross-contamination (ISO/TS 22002-2, 3.5)

Examples of practices include: clothing change on entry or exit, positive air pressure, modified traffic flow patterns


MK 21999 Page 24

Alphabetical Index

A form 10 process 16 fumigant 10 process approach 17 acceptable level 2 processed product 17 active ingredient 2 G processing 17 adulteration 2 product 17 appropriate level of protection [ALOP] 2 GlobalGAP Risk Assessment on Social product contact 17 aspect 2 Practice [GRASP] 10 product recall 17 good agriculture practice [GAP] 10 product security 17

B good distribution practice [GDP] 10 protective security 17 good hygiene practice [GHP] 10 PRP [prerequisite programme] 17 biocide 2 good manufacturing practice [GMP] 10 biosecurity 2 good trading practice [GTP] 10 Q biosecurity plan 3 good veterinary practice [GVP] 11 guidelines 11 quality assurance system 18

C quality control system 18 H catering 3 R certificate of analysis [COA] 3 HACCP plan 11 certificate of conformance [COC] 3 hand washing 11 ready-to-eat [RTE] 18 characteristic 3 hazard 11 recall 18 clean water 3 hazard analysis 11 recall procedure 18 cleaning 3 hazard analysis and critical control point recommendation 18 cleaning in place [CIP] 3 [HACCP] 11 record 18 cleaning out of place [COP] 3 hazard assessment 11 recovery 18 competence 4 herbicide 11 relevant food safety hazard 18 competent person 4 hierarchy 11 requirement 19 compliance criteria [CC] 4 hygiene 12 resolved 19 compound feed 4 response 19 consequence 4 I retail premises 19 contaminant 4 risk 19 contamination 4 impact 12 risk assessment 19 contingency planning 4 incident 12 contract 5 incidental product contact 12 S control measure 5 infrastructure 12 control points [CP] 5 intended use 12 safety 19 control point and compliance criteria interested party 12 sanitation 20 [CPCC] 5 intermediate material 12 sanitizing 20 correction 5 satellite/satellite kitchen 20 corrective action 5 L shelf life 20 counterfeiting 5 simulation 20 critical control point [CCP] 5 label 12 single-use articles 20 critical defect 5 location 13 site 20 critical limit 5 lot 13 specification 20 cross-contamination 6 lot identification 13 standard operating procedures [SOP] 20 customer 6 lubricant 13 step 20 customer requirement 6 sterilization 20

M supplier 21 D system 21 major must 13

data 6 management 13 T disinfection 6 management system 13 document 6 mass balance 13 tampering 21 materials 13 theft 21

E material specification [product threat 21 specification] 14 Threat Assessment Critical Control Point economically motivated adulteration [EMA] 6 medicated feed 14 [TACCP] 21 electronic security 6 migration 14 top management 21 end product 6 minor must 14 traceability 21 equipment 7 misbranded 14 traceability system 21 establishment 7 monitoring 14 U

F N updating 21

farm 7 nonconformity 14 feed 7 non-food contact side 14 V feed additives 7 non-intentionally added substance [NIAS] 14 feed and food chain 7 validation 22 feed ingredient 7 O vector 22 first expired first out [FEFO] 7 verification 22 first in first out [FIFO] 7 operational PRPs [operational prerequisite veterinary drug 22 flow diagram 7 programmes] 14 visitor 22 flow of materials 7 organization 15 vulnerability 22 food chain 7 outsourced activity 15 food-contact side 8 over-run 15 W food defense 8 food fraud 8 P withdrawal 22 food grade 8 withholding/withdrawal period 23 food handler 8 packaging 15 work environment 23 food handling 8 packaging materials 15 work instructions 23 food ingredient 8 performance criterion [PC] 15 wrapping 23 food protection 9 performance objective [PO] 15 food retail establishment 9 personnel security 15 Z food retail premises 9 pest 15 food safety 9 plant protection product 16 zoning 23 food safety control system 9 portioning 16 food safety hazard 9 post harvest chemicals 16 food safety management systems [FSMS] 9 potable water 16 food safety objective [FSO] 9 prevention 16 food safety policy 9 preventive measure 16 food supply 10 primary production 16 food terrorism 10 procedure 16


MK 21999 Page 25

Bibliography [1] APO- Food safety management system manual, Jun 2009 [2] CAC- Food Hygiene Basic texts, 4

th ed., 2009

[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] Commission Regulation (EC) No 2023/2006 of 22 Dec 2006 on good manufacturing

practice for materials and articles intended to come into contact with food [6] EN 15593:2008 Packaging- Management of hygiene in the production of packaging for

foodstuffs- Requirements [7] Federations of Veterinarians of Europe- Code of good veterinary practice, 2002 [8] GlobalGAP Glossary, English Version 1.0, valid from Apr 2013 [9] International Life Science Institute (ILSI)- Food safety objective [FSO]: An integral part

of food chain management, 2005 (as cited within the ISO FSMS series] [10] ISO/TC 176/SC 2/N 526 R2- Guidance on the terminology used in ISO 9001 and ISO 9004,

Oct 2008 [11] ISO 7218:2007 Microbiology of food and animal feeding stuffs- General requirements and

guidance for microbiological examination [12] ISO 9000:2005 Quality management systems- Fundamentals and vocabulary [13] ISO/TR 10013:2001 Guidelines for quality management system documentation [14] ISO 14159:2002 Safety of machinery- Hygiene requirements for the design of machinery [15] ISO 15161:2001 Guidelines on the application of ISO 9001:2000 for the food and drink

industry [16] ISO 19011:2011 Guidelines for auditing management systems [17] ISO 21469:2006 Safety of machinery- Lubricants with incidental product contact- Hygiene

requirements [18] ISO 22000:2005 Food safety management systems- Requirements for any organization in

the food chain [19] 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)

[20] ISO/TS 22002-2:2013 Prerequisite programmes [PRPs] on food safety- Part 2: Catering [21] ISO/TS 22002-3:2011 Prerequisite programmes [PRPs] on food safety- Part 3: Farming [22] ISO/TS 22002-4 (Draft) Prerequisite programmes [PRPs] on food safety- Part 4: Food

packaging manufacturing [23] ISO/TS 22002-5 (Draft) Prerequisite programmes [PRPs] on food safety- Part 5: Transport

and Storage


MK 21999 Page 26

[24] ISO/TS 22003:2013 Food safety management systems- Requirements for bodies providing audit and certification of food safety management systems

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

22000:2005 [26] ISO 22005:2007 Traceability in the feed and food chain- General principles and basic

requirements for system design and implementation [27] ISO 22006:2009 Guidelines on the application of ISO 9001:2008 in crop production [28] 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

[29] PAS 99:2006 Specification of common management system requirements as a framework

for integration [30] PAS 221:2013 Prerequisite programmes [PRPs] for food safety in food retail - specification [31] PAS 222:2011 Prerequisite programmes [PRPs] for food safety in the manufacture of food

and feed for animals [32] PAS 223:2011 Prerequisite programmes [PRPs] and design requirements for food safety in

the manufacturing and provision of food packaging [33] US Food and Drug Administration (FDA)- Food defense acronyms, abbreviations, and

definitions, 12 Apr 2013 [34] US National Center for Food Protection and Defense (NCFPD)- Defining the public health

threat of food fraud, John Spink & Douglas C Moyer, 30 Apr 2011 [35] WHO- Good distribution practices [GDP], 2005 [36] WHO- Terrorist Threats to Food: Guidelines for Establishing and Strengthening Prevention

and Response Systems, May 2008

FSMS Vocabulary, Rev.03 Sep 2013

Documents

Transcript of FSMS Vocabulary, Rev.03 Sep 2013