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Food safety management systemsVocabulary

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 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, For example:

, served as alternative meaning to a previous definition.

validation (ISO 22000, 3.15) food safetyobtaining 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 This 2 revision encompassed the emerging trends of food fraud, expanding the definitions adopted by GlobalGAP, and have included materials of food safety importance such as lubricants, with incidental product (food) contact.
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Mark B. Kwan 31 May 2013 Abu Dhabi, UAE

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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, 2009) (in any plant protection product) is the substance that kills, or otherwise controls, target pests. Plant protection products are regulated primarily on the basis of active ingredients adulteration (NCFPD, 2011) <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 wit hin 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)

biocide (GlobalGAP, 2009) a biocide can be a pesticide, which includes fungicides, herbicides, insecticides, algicides, moluscicides, miticides and rodenticides; or it can be an antimicrobial, which includes germicides, antibiotics, antibacterials, antivirals, antifungals, antiprotozoas and antiparasites biosecurity (GlobalGAP, 2009) policies and measures taken to protect from biological harm
Biosecurity in aquaculture is the protection of fish and shellfish from infectious agents (viruses, bacteria, fungi or parasites). 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. In addition, as the density of fish and shellfish in intensive farming becomes more concentrated and actively managed, the probability of individuals coming into contact or becoming a source of potential pathogen is much greater. Thus, it is critical to implement appropriate safeguards in production facilities to protect the health of aquatic animals. These safeguards include diagnostics, disease prevention, disease control etc., which are imperative and should be enforced through Ecologically Sustainable Development (ESD) strategies.

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biosecurity plan (GlobalGAP, 2009) a plan that identifies potential pathways for the introduction and spread of disease in a zone or compartment, and describes the measures which are being or will be applied to mitigate the disease risks in accordance. The plan also describes how these measures are audited to ensure that the risks are regularly re-assessed and the measures adjusted accordingly C

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 suppliers 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)

chain of custody (GlobalGAP, 2009) an unbroken trail of acceptability that ensures the physical security of data, records and/or samples. Also, a process used to maintain and document the chronological history of the evidence 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 22002-2, 3.12). Sometimes used interchangeably with attribute

clean water (ISO/TS 22002-3, 3.1) <FSMS> 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) <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> 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> 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

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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 (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) <FSMS> 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

compound feed (GlobalGAP, 2009) (which can be complete or complementary) produced using any ingredients (except medicated feed/supplements) as raw materials. Compound feeds 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, 2013) <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 (PAS 220, 3.2 / PAS 221, 3.5 / PAS 222, 2.2 / PAS 223, 3.4) <PRPs> 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) <PRPs> 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) <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 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]

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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, 2011) <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 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

customer requirements (ISO 9000, 2.1) <QMS> needs and expectation expressed in product specifications (PAS 220, 3.7)

data (ISO 22005, 3.11) <FSMS> recorded information disinfection (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 microorganisms 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

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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)

Economically Motivated Adulteration [EMA] (NCFPD, 2011) <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

establishment (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]

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

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)
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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
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 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 (USFDA, 2013) <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, 2011) 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 protection (NCFPD, 2011) <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> 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> physical building under direct full or partial control of the retailer

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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 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) <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) 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)
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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, 2009) volatile liquid or gas to kill insects, nematodes, fungi, bacteria, seeds, roots, rhizomes, or entire plants

good agricultural practices [GAP] (GlobalGAP, 2009) 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 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) <QMS> 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) <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]

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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 text

hazard assessment (PAS 222, 2.11) <animal feed> 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, 2009) 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)

impact (PAS 99, 3.4) <IMS> effect on the organizations 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

incidental product contact (ISO 21469, 3.6) 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) 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> 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 semifinished material and article such as a film, sheet or laminate requiring further processing/reformulation steps to become a finished MK 21999 Page 10

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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) <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; 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) <FSMS> place of production, processing, distribution, storage and handling from primary production (ISO 15161, 3.9) to consumption lot (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) substance capable of reducing friction, adhesion, heat and wear when introduced as a film between solid surfaces

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) 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) <FSMS> feed and food, feed and food ingredients and packaging materials (PAS 223, 3.14)
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materials (PAS 220, 3.4 / PAS 221, 3.16) <PRPs> 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) <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 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

misbranded (NCFPD, 2011) <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 regula tions, 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)

nonconformity (ISO 9000, 3.6.2 / ISO 19011, 3.19) <IMS> 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) <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 in the product(s) (ISO 22005, 3.1) or in the processing environment
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organization (ISO 22005, 3.10 / ISO 9000, 3.3.1) <IMS> 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

over-run (NCFPD, 2011) <food fraud> legitimate product that is made in excess of production agreements Ex. Under-reporting of production

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) <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 individuals 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) <FSMS> 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

potable water (ISO 22002-3, 4.14) <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, 2013) <food defense> actions taken to avoid an incident or to intervene to stop an incident from occurring

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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

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

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) processing (ISO 21469, 3.4) 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) any substance intended to be applied or taken into humans or domestic animals, e.g. by ingestion, injection, topical application, insertion product contact (PAS 220, 3.6 / PAS 221, 3.17 / PAS 222, 2.15) <PRPs> 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) <food manufacturing> 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

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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, 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 retail> 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

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

recovery (USFDA, 2013) <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 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
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response (USFDA, 2013) <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) 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

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> process (ISO 22005, 3.2) of cleaning (PAS 220, 3.5), followed by disinfection (PAS 220, 3.9) sanitizing (PAS 221, 3.20) <food retail> 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) <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, 2011) <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> utensils and bulk food containers designed and constructed to be used once and discarded
NOTE includes disposable gloves and plastic/aluminium wrap/containers

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site (PAS 222, 2.20) <animal feed> 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)

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]

system (ISO 9000, 3.2.1) <QMS> set of interrelated or interacting elements

tampering (NCFPD, 2011) <food fraud> legitimate product and packaging used in a fraudulent way Ex. Changed expiry information, product up-labeling, etc. theft (NCFPD, 2011) <food fraud> legitimate product stolen and passed off as legitimately procured Ex. Stolen products are co-mingled with legitimate products threat (USFDA, 2013) <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 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) <QMS> 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, 2009) the ability to retrace the history, use or location of a product (that is the origin of materials and parts, the history of processes applied to the product, or the distribution and placement of the product after
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delivery) by the means of recorded identification 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

updating (ISO 22000, 3.17) <FSMS> immediate and/or planned activity to ensure application of the most recent information

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

verification (ISO 22000, 3.16 / ISO 9000, 3.8.4) <FSMS> 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 vulnerability (USFDA, 2013) <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

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
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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) <PRPs> 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 crosscontamination (PAS 221 addition) to ready-to-eat [RTE] (PAS 221, 3.18) products 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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Alphabetical Index
A acceptable level 2 active ingredient 2 adulteration 2 appropriate level of protection [ALOP] 2 aspect 2 B biocide 2 biosecurity 2 biosecurity plan 3 C certificate of analysis [COA] 3 certificate of conformance [COC] 3 chain of custody 3 characteristic 3 clean water 3 cleaning 3 cleaning in place [CIP] 3 cleaning out of place [COP] 4 competent person 4 compound feed 4 Consequence 4 contaminant 4 contamination 4 contingency planning 4 contract 4 control measure 4 correction 5 corrective action 5 counterfeiting 5 critical control point [CCP] 5 critical limit 5 customer requirement 5 D M data 5 disinfection 5 document 5 E Economically Motivated Adulteration [EMA] 6 electronic security 6 end product 6 establishment 6 F feed and food chain 6 first expired first out [FEFO] 6 first in first out [FIFO] 6 flow diagram 6 flow of materials 6 food chain 7 food defense 7 food fraud 7 food grade 7 food protection 7 food retail establishment 7 food retail premises 7 food safety 8 food safety control system 8 food safety hazard 8 food safety management systems [FSMS] 8 food safety objective [FSO] 8 food safety policy 8 food supply 8 food terrorism 8 management 11 management system 11 materials 11 material specification [product specification] 12 migration 12 misbranded 12 monitoring 12 N nonconformity 12 non-intentionally added substance [NIAS] 12 O Z operational PRPs [operational prerequisite programmes] 12 organization 13 over-run 13 P packaging materials 13 performance criterion [PC] 13 performance objective [PO] 13 personnel security 13 pest 13 potable water 13 prevention 13 primary production 14 procedure 14 zoning 19 HACCP plan 9 hazard analysis 9 hazard analysis and critical control point [HACCP] 10 hazard assessment 10 herbicide 10 hierarchy 10 I impact 10 Incidental product contact infrastructure 10 intended use 10 interested party 10 intermediate material 10 L label 11 location 11 lot 11 lot identification 11 lubricant 11 form 8 fumigant 9 G good agriculture practice [GAP] 9 good distribution practice [GDP] 9 good hygiene practice [GHP] 9 good manufacturing practice [GMP] 9 good trading practice [GTP] 9 good veterinary practice [GVP] 9 guidelines 9 H process 14 Process approach 14 processing 14 product 14 product contact 14 product recall 14 product security 14 protective security 14 PRP [prerequisite programme] 15 R ready-to-eat [RTE] 15 record 15 recovery 15 relevant food safety hazard 15 requirement 15 response 16 risk 16 S sanitation 16 sanitizing 16 shelf life 16 simulation 16 single-use articles 16 site 17 specification 17 step 17 system 17 T tampering 17 theft 17 threat 17 Threat Assessment Critical Control Point [TACCP] 17 top management 17 traceability 17 traceability system 18 U updating 18 V validation 18 verification 18 vulnerability 18 W work environment 18 work instructions 18

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