APPENDIX I: IDEFINITION OF SOME TERMS USED IN THIS GUIDE – Food and Drink – Good Manufacturing Practice, 7th Edition

APPENDIX I
IDEFINITION OF SOME TERMS USED IN THIS GUIDE

Adulteration Intentionally adding extraneous, improper or inferior ingredients to a food product.
Analytical Method A detailed description of the procedures to be followed in performing tests for assessing conformity with the specification.
Aseptic Processing A production process where a commercially sterile product (see Commercial Sterility), otherwise known as aseptic product, is packed into a container that has been independently and previously sterilised in a way that prevents contamination and maintains full sterility. Examples include Tetra Pak technology and Bag‐in‐Box technology.
Authentic Products that demonstrate a given connection to a recipe, location or social characteristic.
Authenticity The innate quality of being authentic, genuine and of undisputed origin.
Batch The quantity of material that has been produced during a defined period of manufacture. A ‘batch’ may actually have been produced by a batch‐wise process, or may correspond to a particular time duration during the run of a continuous process.
Or an identifiable amount of product or material that has undergone a given treatment or process at a given time in a given location.
Batch Manufacturing Record A document stating the materials used and operations carried out during the manufacture of a given batch, including details of in‐process controls and the results of any corrective action taken. It should be based on the master manufacturing instructions, and be compiled as the manufacturing operation proceeds.
Batch Number A unique combination of numbers or letters, or both, used to identify a batch and permit its history to be traced.
Botulinum Cook The heat treatment given to a low‐acid canned food (having a pH higher than 4.5) sufficient to inactivate 1012 spores of Clostridium botulinum. This heat treatment is called the Fo value, and it is equivalent to a process of 3 minutes at 121°C.
Bulk Product Any product that has completed all processing stages up to, but not including, packaging (not applicable to those products where processing takes place inside the container and the latter is itself therefore part of the processing).
Chill Chain An organised system governing the conditions under which chilled foods are stored and handled by the producer, distributor and retailer. The conditions, as set out in Chapter 44, are those which ensure that temperatures maintained during storage, distribution and sale are those consistent with maintenance of quality and safety.
Chilled Foods Perishable foods that, to extend the time during which they remain wholesome, are kept within controlled and specified ranges of temperature above their freezing points and normally below 8°C.
Cold Chain An organised system governing the conditions under which frozen foods are stored and handled by the producer, distributor and retailer. The conditions, as set out in Chapter 45, are those which ensure that temperatures maintained during storage, distribution and sale are those consistent with maintenance of quality and safety.
Commercial Sterility A term common in the canning industry meaning the condition achieved by the application of heat that renders the processed product free from viable micro‐organisms, including those of known public health significance, capable of growing in the food at the temperatures at which the food is likely to be held during distribution and storage.
Contract Manufacture Manufacture or partial manufacture ordered by one person or organisation (the contract giver) and carried out by a separate person or organisation (the contract acceptor).
Corrective action The action taken on the identification of non‐conformance in terms of ingredients, products, behaviours or activities with specified documented requirements.
Countermeasure The action taken by an individual, organisation or other body to counteract or offset a given danger or threat.
Critical Control Point CCP; a material, or a location, or a practice, or a procedure, or a process stage where loss of control would result in an unacceptable food safety risk.
Cybersecurity The measures taken to protect a computer system or individual appliance against an intentional malicious target attack and/or unauthorised access and unintentional or accidental access.
Dehydrated Food Food or food products from which all but a small percentage of the water has been removed under controlled conditions.
Detergent A chemical or mixture of chemicals that is used to remove soiling or grease from a surface, leaving it accessible to the action of disinfectants.
Disinfection Defined by British Standard 5283:1986 as ‘the destruction of microorganisms, but not usually bacterial spores; it may not kill all microorganisms but reduces them to a level which is neither harmful to health, nor the quality of perishable foods’.
Documentation All the written production procedures, instructions and records, quality control procedures and recorded test results involved in the manufacture of a product.
Economically Motivated Adulteration The process of adulteration with the specific intent of reducing the cost of production or misrepresenting a food to increase profits.
Extrinsic A property derived from outside of the food product or ingredient; for example an extrinsic hazard could arise from contamination from the environment, equipment, people or pests or extrinsic quality attribute could describe the way the product or ingredients have been grown or produced, for example, free range, organic (see Intrinsic).
Finished Product A product that has undergone all stages of manufacture and packaging.
Food Allergen A food substance that, in some sensitive individuals, causes an immune response causing bodily reactions resulting in the release of histamine and other substances into the tissues from the body’s mast cells in the eyes, skin, respiratory system and intestinal system. Allergic reactions may range from relatively short‐lived discomfort to anaphylactic shock and death.
Food Control The Institute of Food Science & Technology uses the term ‘food control’ to describe a comprehensive quality and safety system involving hazard analysis critical control point or HACCP‐linked food safety, integrity and quality assurance and food safety, integrity and quality control.
Food Crime Dishonesty relating to the production or supply of food that is either complex or likely to be seriously detrimental to consumers, businesses or the overall public interest (see 5.1).
Defence The activities required to protect a food product or indeed a food supply chain from intentional or deliberate acts of contamination and includes ideological or malicious threat (see 5.4).
Food Fraud A dishonest act or omission, relating to the production or supply of food, which is intended for personal gain or to cause loss to another party (see 5.1).
Food Hygiene All environmental factors, practices, processes and precautions involved in protecting food from contamination by any agency, and preventing any organism present from multiplying to an extent that would expose consumers to risk or result in premature spoilage or decomposition of food.
Food Integrity Concerned with the nature, substance and quality and safety of food, as well as other aspects of food production such as the way food has been ‘sourced, procured, and distributed and being honest about those areas to consumers’ (see 5.1).
Food Integrity Management System FIMS; a documented set of policies, procedures and associated documentation that combines to form a comprehensive system that effectively manages food integrity in terms of product, process, data and people.
Food Poisoning Illness associated with consumption of food that has been contaminated, particularly with harmful microorganisms or their toxins.
Food Safety Management System FSMS; a documented set of policies, procedures and associated documentation that combines to form a comprehensive system that effectively manages food safety.
Food Spoilage The deterioration of food, including that caused by the growth of undesirable micro‐organisms to high levels, which may result in fermentation, mould growth and development of undesirable odours and flavours.
Frozen Foods Foods preserved by freezing and storing at temperatures low enough to inhibit the growth of micro‐organisms and to retard chemical and physical reactions to a negligible rate.
Functional Fulfilling a specific physical, chemical or biological function.
Functional Foods The term is one of the marketing‐coined names (others are ‘nutraceuticals’ and ‘designer foods’) to categorise foods that are considered or claimed to offer specific health benefits over and above those provided by recognised nutrients, while avoiding the requirement to be licensed medicines.
Genetic Modification GM; the process of making changes to the genes of an organism (whether an animal or plant organism or a microorganism). Genetic changes occur spontaneously in nature over a long period of time, but they may be produced intentionally either by traditional methods of selective breeding of animals and plants or by modern methods of removal or insertion of genes.
Genetically Modified Organism GMO; descriptive of an organism undergoing genetic modification or of an organism resulting from genetic modification (see above).
Good Manufacturing Practice GMP; that combination of manufacturing and quality control procedures aimed at ensuring that products are consistently manufactured to their designated specifications.
HACCP Plan A document that is prepared using the seven principles of hazard analysis critical control point, as defined in Codex Alimentarius, in order to identify realistic food safety hazards, the points at which they could arise in the manufacturing process (including materials intake and transport to the consumer) and the means for their effective control.
Hazard A property of a system, operation, material or situation that could, if uncontrolled, lead to an adverse consequence.
Hazard Analysis Preparation of a list of the steps in a manufacturing process (best done by preparing and verifying a process flow chart), identification of points at which hazards could arise and then an assessment of the nature and potential seriousness of each hazard so as to establish critical control point(s) and the means for their effective control.
Hazard Analysis and Operability Study HAZOP; a systematic structured approach to questioning the sequential stages of a proposed operation in order to optimise the efficiency and the management of risk. Thus, the application of HAZOP to the design of a proposed food‐related operation should result in a system in which as many critical control points as possible have been eliminated, making hazard analysis critical control point during subsequent operations much easier to carry out.
Hazard Analysis Critical Control Point HACCP; a systematic preventive food safety tool designed to assist manufacturing organisations to develop an appropriate and effective food safety management system.
High‐care Area HCA; an area designed to a high standard of facility specification and hygienic design where practices relating to personnel, ingredients, equipment and environment are managed to minimise microbial contamination of a ready‐to‐eat or ready‐to‐reheat product containing uncooked ingredients
High‐risk Area HRA; an area designed to a high standard of facility specification and hygiene design where practices relating to personnel, ingredients, equipment and environment are managed to minimise microbial contamination of a ready‐to‐eat or ready‐to‐reheat product comprising only cooked ingredients.
Identity Preserved Material A material or food product that is traceable to a known source or specific method of growing or food production (see Provenance), for example kosher, halal, organic or farm assured.
Ingredients All materials, including starting materials, processing aids, additives and compounded foods, that are included in the formulation of the product.
In‐process Control A system of checks made and actions taken during the course of manufacture to ensure that materials at any stage comply with the specification for that stage, and that the processing and processing environment comply with the conditions stated in the master manufacturing instructions.
Intermediate Material A partly processed material that must undergo further processing before it becomes a bulk product or a finished product.
Intrinsic An inherent component of a food. Intrinsic food safety hazards are derived from the product, for example bones in fish and stones in fruit. Control measures are therefore product specific and can include declarations on the packaging of the finished product. Intrinsic quality relates to characteristics of the food itself for example shape, colour or physio‐chemical characteristics.
Irradiated Having been subjected to ionising radiation.
Lot ISO 20005:2007 defines a lot as ‘a set of units of a product which has been produced and/or processed or packaged under similar circumstances’. Alternatively, vocabulary is used in the manufacturing sector such as lot (group of items defined by the manufacturer; see also 14.9), trade unit (quantity defined at its lowest repeatable unique unit, e.g. jar, box, pack, bag) and logistic unit (quantity defined at its lowest repeatable unique unit for storage or transportation, e.g. tray, box, pallet or container).
Low‐risk Area LRA; an area where good manufacturing practice standards are in place as described within this publication but the area and the practices have not been specifically designed to minimise microbial contamination, for example raw material intake, storage areas of ready‐to‐cook foods and packaged product where the product is fully enclosed.
Manufacture The complete cycle of production of a food or drink product from the acquisition of all materials through all stages of subsequent processing, packaging and storage to the despatch of the finished product.
Master Manufacturing Instructions A document or documents identifying the raw materials, with their quantities, to be used in the manufacture of a product, together with a description of the manufacturing operations and procedures, including identification of the plant and facilities to be used, processing conditions, in‐process controls, packaging materials to be used and instructions for the removal of the finished product to storage.
Monitoring The process of undertaking a prescheduled sequence of observations or measurements to assess whether a product, ingredient, process, procedure, prerequisite programme or critical control point is adequately controlled in order to consistently manufacture safe and legal food of the required quality.
Non‐conformance/Non‐compliance A failure to comply with an element of the food safety management system, food integrity management system, quality management system or hazard analysis critical control point plan. The failure can be classed as major or minor. The term ‘critical’ is sometimes used to highlight a major non‐conformance that has been identified that could lead to a food safety or legality issue.
Novel (Food, Process) A food or food ingredient produced from raw material that has not hitherto been used (or has been used only to a small extent) for human consumption in the area of the world in question, or that is produced by a new or extensively modified process not previously used in the production of food.
Nutraceutical See Functional Foods.
Packaging Any container or material used in the packaging of a product. This may include materials in direct contact with the product, printed packs, including labels, carrying statutory and other information, and other packaging materials, including outer cartons or delivery cases. These categories are, of course, not necessarily mutually exclusive.
Prerequisite Programme PRP; an element of the food safety management system (FSMS) food integrity management system and/or quality management system that has been adopted by the manufacturer in order to effectively manage food safety, legality and compliance with quality specifications. The existence and effectiveness of prerequisite programmes should be considered during the development of the FSMS and hazard analysis critical control point plan and in the determining of critical control points.
Preservation Index A term deriving from the pickles and sauces industry to designate the percentage of acetic acid contained in the total volatile constituents of a product or ingredient, thus indicating probable microbial stability.
Preventive Action An action that is adopted in order to address a weakness in a food safety management system, food integrity management system and/or quality management system that has not to date been responsible for non‐conformance, but if not addressed could be in the future.
Processed Having been subjected to treatment designed to change one or more of the properties (physical, chemical, microbiological, sensory) of food.
Processing Aid The UK Food Labelling Regulations 1996 define processing aid as ‘any substance not consumed as a food by itself, intentionally used in the processing of raw materials, foods or their ingredients, to fulfil a certain technological purpose during treatment or processing, and which may result in the unintentional but technically unavoidable presence of residues of the substance or its derivatives in the final product, provided that these residues do not present any health risk and do not have any technological effect on the finished product’. It follows that a processing aid is an additive that facilitates processing without significantly influencing the character or properties of the finished product.
Provenance Relates to not only the geographic elements of where the ingredients and the final food are grown, processed and finally manufactured, but also how that food is produced and whether the methods of production and processes employed comply with certain standards and protocols.
Quality Assurance See Chapter 2.
Quality Control See Chapter 2.
Quality Management System QMS; the organisational framework of policies, procedures, associated documentation and resources needed to implement the strategy required to consistently deliver product that is within predetermined specifications.
Quarantine The status of any materials or product set aside while awaiting a decision on its suitability for its intended use or sale.
Radiation Dose Doses of radiation are defined in terms of the energy absorbed by the substance irradiated. The unit for radiation dose is the gray (Gy), which is defined as the dose corresponding to the absorption of 1 joule per kilogram of the matter through which the radiation passes [1 kilogray (kGy) = 1000 Gy].
Raw Material Any material, ingredient, starting material, semi‐prepared or intermediate material, packaging material and so on used by the manufacturer for the production of a product.
Ready to Cook RTC; food designed to be given a heat process by the consumer that will deliver a 6‐log kill with respect to vegetative pathogens (a minimum process equivalent to 70°C for 2 minutes) throughout all components.
Ready to Eat RTE; food intended by the producer or the manufacturer for direct human consumption without the need for cooking or other processing effective to reduce to an acceptable level or eliminate microorganisms of concern (i.e. cold eating).
Ready to Reheat RTRH; food manufactured in a high‐care area or high‐risk area that has been designed to be reheated by the final consumer.
Revalidation The process by which an element of the food safety management system, food integrity management system, quality management system or hazard analysis critical control point plan is reassessed to ensure its continuing ability to deliver food safety, integrity, quality or legal compliance objectives.
Reworking The process of taking food that does not meet specification and reprocessing, resorting or otherwise handling it in order to address the non‐conformance so that it will then meet specification.
Risk The probability that a particular adverse consequence results from a hazard within a stated time under stated conditions.
Risk Assessment The management process of identification, evaluation and estimation of the levels of risk associated with a food safety hazard, situation or process or procedural failure. Further categorisation of the risk identified is by determining the likelihood and the severity of occurrence and determining the acceptable level of risk to the consumer. This can include the acceptable level of a component in a food product, for example a pesticide residue, or absence versus presence of a foreign body.
Root Cause Analysis The structured management approach that identifies the factors that resulted in non‐conformance in order to determine the most appropriate corrective or preventive action. The factors that could be considered include the actual nature of the non‐conformance, the magnitude (major or minor) and the consequences of the problem in order to identify the actions, conditions or behaviours that need to be changed to prevent reoccurrence and/or other similar problems from occurring.
Specification A document giving a description of material, machinery, equipment, process or product in terms of its required properties or performance. Where quantitative requirements are stated, they are in terms of either limits or standards with permitted tolerances.
Starting Material See Raw Material.
Threat A threat is defined by PAS 96:2017 as ‘something that can cause loss or harm which arises from the ill‐intent of people’.
Threat Analysis Critical Control Point TACCP; PAS 96:2017 describes threat analysis critical control point as a ‘systematic management of risk through the evaluation of threats, identification of vulnerabilities, and implementation of controls to materials and products, purchasing, processes, premises, distribution networks and business systems by a knowledgeable and trusted team with the authority to implement changes to procedures’.
Traceability Regulation EC/178/2002 defines traceability as the ability to trace and follow a food, feed, food‐producing animal or substance intended to be, or expected to be, incorporated into a food or feed through all stages of production, processing and distribution.
Traceable Resource Unit TRU; a unique batch of material or product that, using a specific set of traceability characteristics, is readily distinguishable from other batches of material.
Validation The process of obtaining of evidence that the elements of the food safety management system, food integrity management system, quality management system or hazard analysis critical control point plan are effective at delivering food safety, integrity, quality or legal compliance objectives.
Verification The process of developing procedures, assessments and other evaluations, including auditing, that is in addition to monitoring to determine compliance with the food safety management system, the food integrity management system, the quality management system and hazard analysis critical control point plans.