ISO 22000-2018 Transition Guidance PDF

TNV Certification Pvt. Ltd. Food Safety Management System ISO 22000:2018 www.isoindia.org Food safety management system principles Food safety is related to the presence of food safety hazards at the time of consumption (intake by the consumer). As the introduction of food safety hazards can occur at any stage of the food chain, adequate control throughout the food chain is essential. Thus, food safety is ensured through the combined efforts of all the parties in the food chain. This document specifies the requirements for a food safety management system that combines the following generally recognized key elements Interactive communication; System management; Prerequisite programmes; Hazard analysis and critical control points (HACCP) principles. Plan‐Do‐Check‐Act cycle The PDCA cycle can be described briefly as follows: Plan: establish the objectives of the system and its processes and provide the resources needed to deliver the results and identify and address risks and opportunities; Do: implement what was planned; Check: monitor and (where relevant) measure processes and the resulting products and services against policies, objectives, requirements and planned activities, and report the results; Act: take actions to improve performance, as necessary. Plan‐Do‐Check‐Act cycle The process approach embraces two PDCA cycles. One cycle covers the overall frame of the food safety management system (Clause 4 to Clause 7 and Clause 9 to Clause 10). The other cycle covers the operational processes within the food safety system as described in Clause 8. This means that communication between the two cycles is essential. Food Safety Management Systems Cultural and social differences in the global market demand flexibility Different hazards are associated with different products and different technologies Companies both the standard structure to effectively manage food safety and the latitude to implement the specific controls that work in their system Risk Management Framework: Risk Communication Risk Management Framework Risk Management Framework: Risk Communication Much of the work performed by the Joint FAO/WHO Committees is performing food risk management/risk assessments in order to define safe exposure levels or allowable limits where no adverse health affects are noted. Risk communication begins with the gathering of information on the risk issue of concern and continues throughout the assessment process, so the output can be communicated among all stakeholders : World-wide to assist FAO and WHO member countries in order to protect consumers from microbiological and chemical hazards Internationally to assist Codex Alimentarius Commission, in the development of standards, guidelines and recommendations for food safety Open communication among all stakeholders during all stages in food safety management is crucial to obtain the most reliable current information Risk Management Framework Risk analysis : Defined by CAC as a process consisting of three components: risk assessment, risk management, and risk communication Risk Management: Weighing policy alternatives with all stakeholders considering risk assessment and other factors relevant for the health protection of consumers and for the promotion of fair trade practices, and if needed, selecting appropriate prevention and control options Risk communication: interactive exchange of information and opinions throughout the risk analysis process concerning risks and hazards, risk-related factors and perceptions, among all parties in the food chain including explanation of risk assessment findings and the basis of risk management decisions. Risk Management Framework Risk Assessment “A scientifically based process consisting of the following steps…” Hazard Identification: Identification of the chemical, physical, and/or microbiological agents which can be potentially present in a food that is capable of causing adverse health effects Hazard Characterization: Qualitative or quantitative evaluation of the nature of the adverse health effects associated with the hazard that may be present in the food. A dose-response assessment should be performed for chemical agents and if the data is obtainable for microbiological and physical agents. Exposure Assessment: Qualitative or quantitative evaluation of the likely intake of the hazard via food as well as from other relevant sources Risk Characterization: Qualitative or quantitative estimation of the probability of occurrence and severity of known or potential adverse health effects in a given population based on hazard identification, characterization, and exposure assessment. Risk Management Risk Evaluation Identify food safety problem Establish risk profile (description, product or commodity involved, values at risk, example: health, potential consequences, consumer perception of risk, and distribution of risks and benefits Ranking of the hazard for risk assessment and risk management priority Establishing of risk assessment policy for conduct of risk assessment (guidelines for value judgment and policy choices applied at specific decision points, example: establishing the population(s) at risk, establishing criteria for ranking of hazard, and guidelines for application of safety factors) Commissioning of risk assessment Consideration of risk assessment result Risk Management Option Assessment Identification of available management options. Risk Management Selection of preferred management option including consideration of an appropriate safety standard do Safety standard defined as level of acceptable risk example: “balancing” standard used in cost-benefit, cost-effectiveness ALARA as low as reasonable achievable, “procedural” standards (acceptable level of risk is determined by an agreed process, such as a negotiation or referendum, “threshold” standards ( a nonzero level of risk is stipulated as acceptable), “zero-risk” standards such as ADI levels, allowable daily intake levels Final management decision Implementation of management decision Monitoring and review Assessment of effectiveness of measures taken Review risk management and/or assessment as necessary Outcome of the risk evaluation process should be combined with evaluation of available risk management options in order to reach a decision on management of risk Human health should be primary concern Risk Management Other factors: economic costs, benefits, technical feasibility, risk perceptions considered appropriately Implementation should be followed by monitoring both effectiveness of control measure and impact on risk to the exposed consumer population to ensure that the food safety objective is met All interested parties, stakeholders, should have opportunity for input into the risk management process if likely to be affected by the decision examples: consumer organizations, industry representatives, regulatory bodies Risk Management HACCP Hazard Analysis Critical Control Points HACCP provides a proactive systematic approach for identifying food safety hazards categorized as biological, chemical, and physical hazards. Applied through seven principles which facilitate prevention, elimination, or reduction of food safety hazards to an acceptable level and is effective and economical Biological Hazards Most food borne illnesses are caused by microbiological safety hazards Include: pathogenic bacteria, fungal organisms and toxins, viruses, prions (BSE) and parasites A pathogen or toxin must be present to cause a food borne illness Generally infants, elderly, and immuno-compromised persons aremost susceptible Top 5 food borne pathogens: Escherichia coli 0157, E. coli, Campylobacter, Listeria monocytogenes, and Salmonella Most pathogens must grow to high enough numbers to cause an infection or produce a toxin- E. coli 0157:H7 has a low infectious dose Viruses account for 10 % Examples: Norovirus, Hepatitis A Cannot multiply in food Results from fecal contamination Parasites In US most common: Cryptosporidium parvum (unpasteurized apple cider and poor personnel hygiene by an infected person) , Cyclospora cayetanensis (berries such as raspberries and blackberries, and mesclun lettuce, basil) Trichinella spiralis (undercooked bear meat and pork), Giardia lambia (waterborne parasites, so contamination occurs during washing of fruits and vegetables) Biological Hazards Factors Causing Biological Contamination Should be assumed that the raw material potentially contains a biological hazard Improper Storage/Holding Temperatures Bacteria growth in food at temps 31ºF - 122ºF and rapid growth 77ºF - 104ºF Inadequate Cooking or Reheating examples: poultry must reach an internal temp of at least 160ºF Poor Personal Hygiene Major contributing factor (fecal-oral route) Cross-Contamination and Poor Storage Practices Raw vs. finished handling and storage Prevention/Controls Three distinct methods 1. Prevent contamination of foods Following Good Agricultural Practices Following Good Husbandry Practices in animal production Harvesting of shellfish (filter feeders) Following good personal hygiene and avoiding cross contamination Biological Hazards 2. Destroy food borne disease agents Following the appropriate time and temperature kill step (dependent on food material and biological hazard) Irradiation Pasteurization or high pressure processing in avocados Ultraviolet Light used to pasteurize apple cider New technologies: pulsed light, pulsed electronic fields, etc. Chemical rinses ex. Propylene oxide to kill salmonella in almonds and spices 3. Prevent growth of food borne disease agents Using a preservative or high salt concentrations Decreasing pH and/or water activity Holding food at low or high temps and rapid cooling Chemical Hazards Food can become contaminated with a chemical hazard during any stage in the food chain. Chemical hazards vary widely. They can be naturally occurring, or chemical hazards can be introduced into a plant or animal tissue by the use of agrichemicals. Foods may also become chemically contaminated from leaching of chemicals or metals introduced through the environment, processing equipment and/or packaging The presence and allowable limits of a chemical in a food is typically established by regulatory agencies Naturally Occurring Chemicals Usually allowed at certain levels or food can be toxic and must be avoided Naturally occurring toxins found in certain types of plants (mushrooms), shellfish, or can be created by microorganisms (molds and bacteria) Histamine, produces an allergenic response, is associated with certain species of fish (caused by inadequate time/temp control causing growth of microorganisms, which produce the enzyme histidine) Mycotoxins are by products from the growth of mold Occur during pre-harvesting or storage Cause acute and chronic toxicity in humans & animals Associated with fruits and their juices, grains and nuts Chemical Hazards Acrylamides produced as a by-product of food processing and cooking (undefined doses are thought to be toxic to nervous system and to cause cancer) Allergens Proteins that cause an immunological response ranging from a sensitivity such as asthma or a rash to anaphylaxis shock, death US focuses on the “Big 8”: peanuts, tree nuts, milk, soy, wheat, shellfish, egg, and fish Considered a chemical hazard, because if not properly controlled can be introduced into a food product not labeled as containing the allergen Labeling requirements are established by The Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA) Intentionally Added Chemicals Chemicals added during growing, harvesting, storing, processing, packaging, or distribution If chemicals are not used in accordance with regulatory guidelines, chemicals become potential hazards Examples include: pesticides, herbicides, Dioxin/PCB, antibiotics/veterinary drug residues, fertilizers, preservatives, coloring agents, sanitation chemicals, indirect food additives such as lubricants, and materials used in food contact packaging Controls Harvesting fish and shellfish from waters that have been approved by health authorities or water quality meets standards Use chemicals in accordance to regulatory requirements Following Good Agricultural Practices and Animal husbandry practices Prevent cross-contamination by following Current Good Manufacturing Practices and establishing programs that control approval, storage, and usage of chemicals Knowledgeable about the food product and potential sources of chemical contamination, source of product (imported), acceptable limits, and any new information on regulations and toxicity of chemicals Physical Hazards Can enter into the food supply chain at any stage Mortimore and Wallace classify physical hazards as extraneous sharp, hard items that could potentially: Penetrate skin or gastrointestinal tract Damage teeth Block respiratory tract and cause chocking Typical examples: glass, metal, plastic, bone, insect fragments, sand, etc. FDA has established allowable defect limits, ADL, for unavoidable contaminants that pose no health risk Potential sources Raw material Poorly maintained equipment Personnel practices Storage conditions Facility environment Controls/Prevention Following current Good Manufacturing Practices and employee training Use of detection equipment such as magnets, filters, screens, metal detectors, x-ray equipment Inspection practices and maintenance of equipment and facility Programs to control glass, brittle plastic and ceramics ISO 22000:2018 Scope This document specifies requirements for a food safety management system (FSMS) to enable an organization that is directly or indirectly involved in the food chain: a) to plan, implement, operate, maintain and update a FSMS providing products and services that are safe, in accordance with their intended use; b) to demonstrate compliance with applicable statutory and regulatory food safety requirements; c) to evaluate and assess mutually agreed customer food safety requirements and to demonstrate conformity with them; d) to effectively communicate food safety issues to interested parties within the food chain; e) to ensure that the organization conforms to its stated food safety policy; f) to demonstrate conformity to relevant interested parties; g) to seek certification or registration of its FSMS by an external organization, or make a self assessment or self-declaration of conformity to this document. All requirements of this document are generic and are intended to be applicable to all organizations in the food chain, regardless of size and complexity Organizations that are directly or indirectly involved include, but are not limited to, feed producers, animal food producers, harvesters of wild plants and animals, farmers, producers of ingredients, food manufacturers, retailers, and organizations providing food services, catering services, cleaning and sanitation services, transportation, storage and distribution services, suppliers of equipment, cleaning and disinfectants, packaging materials and other food contact materials. This document allows any organization, including small and/or less developed organizations (e.g. a small farm, a small packer- distributor, a small retail or food service outlet) to implement externally developed elements in their FSMS. Internal and/or external resources can be used to meet the requirements of this document. Normative references There are no normative references in this document. Terms and definitions 3.1 acceptable level of a food safety hazard (3.22) not to be exceeded in the end product (3.15) provided by the organization (3.31) 3.2 Action criterion measurable or observable specification for the monitoring (3.27) of an OPRP (3.30) Note 1 to entry: An action criterion is established to determine whether an OPRP remains in control, and distinguishes between what is acceptable (criterion met or achieved means the OPRP is operating as intended) and unacceptable (criterion not met nor achieved means the OPRP is not operating as intended) 3.3 audit systematic, independent and documented process (3.36) for obtaining audit evidence and evaluating it objectively to determine the extent to which the audit criteria are fulfilled Note 1 to entry: An audit can be an internal audit (first party) or an external audit (second party or third party) , and it can be a combined audit (combining two or more disciplines). Note 2 to entry: An internal audit is conducted by the organization itself, or by an external party on its behalf. Note 3 to entry: Audit evidence and audit criteria are defined in ISO 19011. Note 4 to entry: Relevant disciplines are, for example, food safety management, quality management or environmental management. 3.4 competence ability to apply knowledge and skills to achieve intended results 3.5 conformity fulfilment of a requirement (3.38) 3.6 contamination introduction or occurrence of a contaminant including a food safety hazard (3.22) in a product (3.37) or processing environment 3.7 continual improvement recurring activity to enhance performance (3.33) 3.8 control measure action or activity that is essential to prevent a significant food safety hazard (3.22) or reduce it to an acceptable level (3.1) Note 1 to entry: See also significant food safety hazard (3.40). Note 2 to entry: Control measure(s) is (are) identified by hazard analysis. Terms and definitions 3.9 correction action to eliminate a detected nonconformity (3.28) Note 1 to entry: A correction includes the handling of potentially unsafe products and can therefore be made in conjunction with a corrective action (3.10). Note 2 to entry: 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). 3.10 corrective action action to eliminate the cause of a nonconformity (3.28) and to prevent recurrence Note 1 to entry: There can be more than one cause for a nonconformity. Note 2 to entry: Corrective action includes cause analysis. 3.11 critical control point CCP step in the process (3.36) at which control measure(s) (3.8) is (are) applied to prevent or reduce a significant food safety hazard (3.40) to an acceptable level, and defined critical limit(s) (3.12) and measurement (3.26) enable the application of corrections (3.9) 3.12 critical limit measurable value which separates acceptability from unacceptability Note 1 to entry: Critical limits are established to determine whether a CCP (3.11) remains in control. If a critical limit is exceeded or not met, the products affected are to be handled as potentially unsafe products. [SOURCE: CAC/RCP 1-1969, modified — The definition has been modified and Note 1 to entry has been added.] 3.13 documented information information required to be controlled and maintained by an organization (3.31) and the medium on which it is contained Note 1 to entry: Documented information can be in any format and media, and from any source. Note 2 to entry: Documented information can refer to: — the management system (3.25), including related processes (3.36); — information created in order for the organization to operate (documentation); — evidence of results achieved (records). Terms and definitions 3.14 effectiveness extent to which planned activities are realized and planned results achieved 3.15 end product (3.37) that will undergo no further processing or transformation by the organization (3.31) Note 1 to entry: A product 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. 3.16 feed single or multiple product(s), whether processed, semi-processed or raw, which is (are) intended to be fed to food-producing animals Note 1 to entry: Distinctions are made in this document between the terms food (3.18), feed (3.16) and animal food (3.19): — food is intended for consumption by humans and animals, and includes feed and animal food; — feed is intended to be fed to food-producing animals; — animal food is intended to be fed to non-food-producing animals, such as pets. [SOURCE: CAC/GL 81-2013, modified — The word “materials” has been changed to “products” and “directly” has been deleted.] 3.17 flow diagram schematic and systematic presentation of the sequence and interactions of steps in the process Terms and definitions 3.18 Food substance (ingredient), whether processed, semi-processed or raw, which is intended for consumption, and includes drink, chewing gum and any substance which has been used in the manufacture, preparation or treatment of “food” but does not include cosmetics or tobacco or substances (ingredients) used only as drugs Note 1 to entry: Distinctions are made in this document between the terms food (3.18), feed (3.16) and animal food (3.19): — food is intended for consumption by humans and animals, and includes feed and animal food; — feed is intended to be fed to food-producing animals; — animal food is intended to be fed to non-food-producing animals, such as pets. [SOURCE: CAC/GL 81-2013, modified — The word “human” has been deleted.] 3.19 animal food single or multiple product(s), whether processed, semi-processed or raw, which is (are) intended to be fed to non-food-producing animals Note 1 to entry: Distinctions are made in this document between the terms food (3.18), feed (3.16) and animal food (3.19): — food is intended for consumption by humans and animals, and includes feed and animal food; — feed is intended to be fed to food-producing animals; — animal food is intended to be fed to non-food-producing animals, such as pets. [SOURCE: CAC/GL 81-2013, modified — The word “materials” has been changed to “products”, “non” has been added and “directly” has been deleted.] 3.20 food chain sequence of the stages in the production, processing, distribution, storage and handling of a food (3.18) and its ingredients, from primary production to consumption Terms and definitions Note 1 to entry: This includes the production of feed (3.16) and animal food (3.19). Note 2 to entry: The food chain also includes the production of materials intended to come into contact with food or raw materials. Note 3 to entry: The food chain also includes service providers. 3.21 food safety assurance that food will not cause an adverse health effect for the consumer when it is prepared and/or consumed in accordance with its intended use Note 1 to entry: Food safety is related to the occurrence of food safety hazards (3.22) in end products (3.15) and does not include other health aspects related to, for example, malnutrition. Note 2 to entry: It is not to be confused with the availability of, and access to, food (“food security”). Note 3 to entry: This includes feed and animal food. [SOURCE: CAC/RCP 1-1969, modified — The word “harm” has been changed to “adverse health effect” and notes to entry have been added.] 3.22 food safety hazard biological, chemical or physical agent in food (3.18) with the potential to cause an adverse health effect Note 1 to entry: The term “hazard” is not to be confused with the term “risk” (3.39) 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 (e.g. death, hospitalization) when exposed to a specified hazard. Note 2 to entry: Food safety hazards include allergens and radiological substances. Terms and definitions Note 3 to entry: In the context of feed and feed ingredients, relevant food safety hazards are those that can be present in and/or on feed and feed ingredients and that can through animal consumption of feed be transferred to food and can thus have the potential to cause an adverse health effect for the animal or the human consumer. In the context of operations other than those directly handling feed and food (e.g. producers of packaging materials, disinfectants), relevant food safety hazards are those hazards that can be directly or indirectly transferred to food when used as intended (see 8.5.1.4). Note 4 to entry: In the context of animal food, relevant food safety hazards are those that are hazardous to the animal species for which the food is intended. [SOURCE: CAC/RCP 1-1969, modified — The phrase “or condition of” has been deleted from the definition and notes to entry have been added.] 3.23 interested party (preferred term) stakeholder (admitted term) person or organization (3.31) that can affect, be affected by, or perceive itself to be affected by a decision or activity 3.24 lot defined quantity of a product (3.37) produced and/or processed and/or packaged essentially under the same conditions Note 1 to entry: The lot is determined by parameters established beforehand by the organization and may be described by other terms, e.g. batch. Note 2 to entry: The lot may be reduced to a single unit of product. [SOURCE: CODEX STAN 1, modified — Reference to “and/or processed and/or packaged” has been included in the definition and notes to entry have been added.] Terms and definitions 3.25 management system set of interrelated or interacting elements of an organization (3.31) to establish policies (3.34) and objectives (3.29) and processes (3.36) to achieve those objectives Note 1 to entry: A management system can address a single discipline or several disciplines. Note 2 to entry: The system elements include the organization's structure, roles and responsibilities, planning and operation. Note 3 to entry: The scope of a management system may include the whole of the organization, specific and identified functions of the organization, specific and identified sections of the organization, or one or more functions across a group of organizations. Note 4 to entry: Relevant disciplines are, for example, a quality management system or an environmental management system. 3.26 Measurement process (3.36) to determine a value 3.27 monitoring determining the status of a system, a process (3.36) or an activity Note 1 to entry: To determine the status, there may be a need to check, supervise or critically observe. Note 2 to entry: In the context of food safety, monitoring is conducting a planned sequence of observations or measurements to assess whether a process is operating as intended. Note 3 to entry: Distinctions are made in this document between the terms validation (3.44), monitoring (3.27) and verification (3.45): — validation is applied prior to an activity and provides information about the capability to deliver intended results; — monitoring is applied during an activity and provides information for action within a specified time frame; — verification is applied after an activity and provides information for confirmation of conformity. Terms and definitions 3.28 nonconformity non-fulfilment of a requirement (3.38) 3.29 objective result to be achieved Note 1 to entry: An objective can be strategic, tactical, or operational. Note 2 to entry: Objectives can relate to different disciplines (such as financial, health and safety, and environmental goals) and can apply at different levels (such as strategic, organization-wide, project, product and process (3.36)). Note 3 to entry: An objective can be expressed in other ways, e.g. as an intended outcome, a purpose, an operational criterion, as a FSMS objective, or by the use of other words with similar meaning (e.g. aim, goal, or target). Note 4 to entry: In the context of FSMS, objectives are set by the organization, consistent with the food safety policy, to achieve specific results. 3.30 operational prerequisite programme OPRP control measure (3.8) or combination of control measures applied to prevent or reduce a significant food safety hazard (3.40) to an acceptable level (3.1), and where action criterion (3.2) and measurement (3.26) or observation enable effective control of the process (3.36) and/or product (3.37) 3.31 organization person or group of people that has its own functions with responsibilities, authorities and relationships to achieve its objectives (3.29) Note 1 to entry: The concept of organization includes, but is not limited to sole-trader, company, corporation, firm, enterprise, authority, partnership, charity or institution, or part or combination thereof, whether incorporated or not, public or private. Terms and definitions 3.32 outsource, verb make an arrangement where an external organization (3.31) performs part of an organization’s function or process (3.36) Note 1 to entry: An external organization is outside the scope of the management system (3.25), although the outsourced function or process is within the scope. 3.33 performance measurable result Note 1 to entry: Performance can relate either to quantitative or qualitative findings. Note 2 to entry: Performance can relate to the management of activities, processes (3.36), products (3.37) (including services), systems or organizations (3.31). 3.34 policy intentions and direction of an organization (3.31) as formally expressed by its top management (3.41) 3.35 prerequisite programme PRP basic conditions and activities that are necessary within the organization (3.31) and throughout the food chain (3.20) to maintain food safety Note 1 to entry: The PRPs needed depend on the segment of the food chain in which the organization operates and the type of organization. Examples of equivalent terms are: good agricultural practice (GAP), good veterinary practice (GVP), good manufacturing practice (GMP), good hygiene practice (GHP), good production practice (GPP), good distribution practice (GDP) and good trading practice (GTP). 3.36 process set of interrelated or interacting activities which transforms inputs to outputs 3.37 product output that is a result of a process (3.36) Note 1 to entry: A product can be a service. Terms and definitions 3.38 requirement need or expectation that is stated, generally implied or obligatory Note 1 to entry: “Generally implied” means that it is custom or common practice for the organization and interested parties that the need or expectation under consideration is implied. Note 2 to entry: A specified requirement is one that is stated, for example in documented information. 3.39 Risk effect of uncertainty Note 1 to entry: An effect is a deviation from the expected – positive or negative. Note 2 to entry: Uncertainty is the state, even partial, of deficiency of information related to, understanding or knowledge of, an event, its consequence, or likelihood. Note 3 to entry: Risk is often characterized by reference to potential “events” (as defined in ISO Guide 73:2009, 3.5.1.3) and “consequences” (as defined in ISO Guide 73:2009, 3.6.1.3), or a combination of these. Note 4 to entry: Risk is often expressed in terms of a combination of the consequences of an event (including changes in circumstances) and the associated “likelihood” (as defined in ISO Guide 73:2009, 3.6.1.1) of occurrence. Note 5 to entry: Food safety risk is a function of the probability of an adverse health effect and the severity of that effect, consequential to (a) hazard(s) in food (3.18), as specified in the Codex Procedural Manual. 3.40 significant food safety hazard food safety hazard (3.22), identified through the hazard assessment, which needs to be controlled by control measures (3.8) Terms and definitions 3.41 top management person or group of people who directs and controls an organization (3.31) at the highest level Note 1 to entry: Top management has the power to delegate authority and provide resources within the organization. Note 2 to entry: If the scope of the management system (3.25) covers only part of an organization, then top management refers to those who direct and control that part of the organization. 3.42 traceability ability to follow the history, application, movement and location of an object through specified stage(s) of production, processing and distribution Note 1 to entry: Movement can relate to the origin of the materials, processing history or distribution of the food (3.18). Note 2 to entry: An object can be a product (3.37), a material, a unit, equipment, a service, etc. [SOURCE: CAC/GL 60-2006, modified — Notes to entry have been added.] 3.43 update immediate and/or planned activity to ensure application of the most recent information Note 1 to entry: Update is different from the terms “maintain” and “retain”: — “maintain” is to keep something on-going/to keep in good condition; — “retain” is to keep something that is retrievable. 3.44 validation obtaining evidence that a control measure (3.8) (or combination of control measures) will be capable of effectively controlling the significant food safety hazard (3.40) Terms and definitions Note 1 to entry: Validation is performed at the time a control measure combination is designed, or whenever changes are made to the implemented control measures. Note 2 to entry: Distinctions are made in this document between the terms validation (3.44), monitoring (3.27) and verification (3.45): — validation is applied prior to an activity and provides information about the capability to deliver intended results; — monitoring is applied during an activity and provides information for action within a specified time frame; — verification is applied after an activity and provides information for confirmation of conformity. 3.45 verification confirmation, through the provision of objective evidence, that specified requirements (3.38) have been fulfilled Note 1 to entry: Distinctions are made in this document between the terms validation (3.44), monitoring (3.27) and verification (3.45): — validation is applied prior to an activity and provides information about the capability to deliver intended results; — monitoring is applied during an activity and provides information for action within a specified time frame; — verification is applied after an activity and provides information for confirmation of conformity. 4 Context of the organization ISO Key Content Comment 4.1 Understanding determine external and internal Issues can include positive the organization and issues and negative factors or its context Include intended result(s) of its conditions for consideration FSMS Understanding the context can be facilitated by considering external and internal issues, including, but not limited to, legal, technological, competitive, market, cultural, social and economic environments, cyber security and food fraud, food defence and intentional contamination, knowledge and performance of the organization, whether international, national, regional or local parties Determine the needs and parties. expectations of interested It is the requirements that parties help us understand what Determiner the compliance compliance obligations to take obligations into account. 4.3 Determining the scope of Determine the scope of the Understand the products and the food safety management FSMS services, processes and system Take into account the production site(s) that external and internal issues included in the FSMS Take into account the Understand influence on the compliance obligations food safety of its end products Take into account the units, functions and physical boundaries Take into account the authority, control and influence of the organization Include in the FSMS the scope, the activities, products and services Maintain a documented information on the scope 4.4 Food safety management system ISO Key Content Comment 4.4 Food safety management establish, implement, Incorporate the system maintain, update and requirements of the FSMS in continually improve a FSMS business functions, processes including the processes and their interactions needed and their interactions, Maintain a documented information 5 Leadership ISO Key Content Comment 5.1 Leadership and Assume responsibility for the Top management commitment effectiveness of the FSMS demonstrates leadership Establish an Food Safety policy (assumes its responsibility and associated objectives and commitment) Integrate FSMS requirements in The policy and objectives the internal process requirements are consistent with the Provide the necessary resources strategic direction and for the FSMS business context Raise awareness on the And ensure that these importance of an effective and resources are really available. compliant FSMS Confirm in the Support the staff contribution to management review the effectiveness of the FSMS Thanks to the acquired Promote continual improvement skills Support the leadership of Essential commitment of managers top management 5 Leadership ISO Key Content Comment 5.2 Policy establish, implement and Fits with the role the 5.2.1 Establishing the food maintain a food safety policy organization plays in the safety policy setting and reviewing the food chain objectives of the FSMS Conforms with includes a commitment to requirements of statutory, satisfy applicable food safety regulatory, and the mutually requirements agreed food safety includes a commitment to requirements of customer continual improvement addresses the need to ensure competencies related to food safety FOOD SAFETY POLICY EXAMPLE XYZ TEA FACTORY ISO 22000 FOOD SAFETY MANAGEMENT SYSTEM ORTHODOX BLACK TEA MANUFACTURE FOOD SAFETY POLICY We will make sure to provide our customers hygienically safe black tea and added value in their teacup. We will ensure to provide pure orthodox black tea made at our factory is free from physical, chemical and microbiological hazards which are conforming to the relevant statutory and regulatory requirements. We will train and motivate our employees continuously to upgrade and maintain ISO 22000 FSMS effectively. Prepaid B :…..ABC Issue : ----- Rev : ------- Approved B : ….XYZ Date : ---------------- 5 Leadership ISO Key Content Comment 5.2.2 Communicating the food safety policy documented and food safety policy available and maintained as communicated by top documented information management communicated, understood inspire teams to make and applied at all levels effective use of their food within the organization safety management system available to relevant interested parties 5.3 Organizational roles, Assign responsibilities and Internally. Clarity of roles, responsibilities and authorities of roles responsibilities and authorities authorities and expected results In order to ensure that the FSMS meets the requirements of the ISO 22000 standard In order to report on the performance of the FSMS to top management 6 Planning ISO Key Content Comment 6.1 Actions to address risks determine the risks and the concept of risks and and opportunities opportunities that need to be opportunities is limited to addressed to: events and their assurance that the FSMS can consequences relating to the achieve its intended result(s) performance and enhance desirable effects effectiveness of the FSMS. prevent, or reduce, undesired Public authorities are effects responsible for addressing achieve continual public health risks. improvement. Organizations are required to Plan include actions to manage food safety hazards address these risks and Actions to address risks and opportunities. opportunities can include: integrate and implement the avoiding risk, taking risk in actions into its FSMS order to pursue an processes. opportunity, eliminating the evaluate the effectiveness of risk source, changing the these actions. likelihood or consequences, sharing the risk, or accepting the presence of risk by 6 Planning ISO Key Content Comment 6.2 Objectives of the food establish objectives for the be consistent with the food safety management system FSMS at relevant functions safety policy and planning to achieve them and levels be measurable (if how to achieve its objectives practicable); for the FSMS take into account applicable retain documented food safety requirements, information on the objectives including statutory, regulatory for the FSMS and customer requirements; be monitored and verified; be communicated; be maintained and updated as appropriate. Resource , responsible , evaluation 6 Planning ISO Key Content Comment 6.3 Planning of changes determines the need for the purpose of the changes changes to the FSMS, and their potential including personnel changes consequences communicated in a planned the allocation or re-allocation manner of responsibilities and authorities the availability of resources integrity of the FSMS 7 Support ISO Key Content Comment 7.1 Resources determine and provide the capability of internal 7.1.1 General resources needed for the resources; establishment, need for external resources implementation, maintenance, update and continual improvement of the FSMS 7.1.2 People ensure that persons Training and support necessary to operate and (external providers if maintain an effective FSMS necessary) on the Food are competent Safety and the FSMS evidence of agreement or Evaluate the effectiveness of contracts defining the the actions competency, responsibility and authority of external experts Retain documented information on the competence of persons 7 Support ISO Key Content Comment 7.1.3 Infrastructure provide the resources for the Infrastructure can include: determination, establishment and land, vessels, buildings and maintenance of the infrastructure associated utilities; necessary equipment, including hardware and software; transportation; information and communication technology 7.1.4 Work environment determine, provide and maintain the A suitable environment can be a resources for the establishment, combination of human and physical management and maintenance of the factors such as: work environment a) social (e.g. non-discriminatory, calm, non-confrontational); b) psychological (e.g. stress-reducing, burnout prevention, emotionally protective); c) physical (e.g. temperature, heat, humidity, light, air flow, hygiene, noise). These factors can differ substantially depending on the products and services provided. 7 Support ISO Key Content Comment 7.2 Competence determine the necessary work under its control that competence of person(s) affects its food safety ensure that these persons, performance and including the food safety effectiveness of the FSMS team and those responsible provision of training to, the for the operation of the mentoring of, or the re- hazard control plan assignment of currently Competency on the basis of employed persons; or the appropriate education, hiring or contracting of training and/or experience competent persons. ensure that the food safety team has a combination of multi-disciplinary knowledge Retain documented information on the competence of persons 7 Support ISO Key Content Comment 7.3 Awareness Ensure persons are aware of the Food Including external persons Safety policy performing work under the Ensure persons are aware of the organization's control. objectives of the FSMS relevant to And the impact on the workplace. their task In order to improve the performance Ensure persons are aware of their of the FSMS contribution Ensure persons are aware of the consequences of not conforming 7.4 Communication Plan and implement a communication Communication is transparent, in 7.4.1 General process - on what good faith, appropriate, factual and when understandable with whom Quick response to complaints and how claims but also to recommendations Take into account compliance and proposals for improvement obligations Internally and externally via those Ensure that communication is responsible for communication adequate In writing, orally, Intranet, Internet, Respond to communications on its video, presentation, report EMS Communication is clear, transparent, Retain documented information on appropriate, factual, in good faith communication 7 Support ISO Key Content Comment 7.4.2 External communication ensure that sufficient product information related to information is communicated food safety, to enable the externally handling, display, storage, available for interested parties preparation, distribution and use of the food chain. of the product within the food external providers and chain or by the consumer contractors identified foods safety hazards defined responsibility and that need to be controlled by authority for the external other organizations in the food communication of any chain and/or by consumers; information concerning food contractual arrangements, safety enquiries and orders, including their amendments; customer and/or consumer feedback, including complaints 7 Support ISO Key Content Comment 7.4.3 Internal communication establish, implement and maintain an products or new products; effective system for communicating raw materials, ingredients and services; issues having an impact on food safety. production systems and equipment; ensure that the food safety team is production premises, location of informed in a timely manner of changes equipment and surrounding ensure that this information is included environment; when updating the FSMS cleaning and sanitation programmes; ensure that relevant information is packaging, storage and distribution included as input to the management systems; review competencies and/or allocation of responsibilities and authorizations; applicable statutory and regulatory requirements; knowledge regarding food safety hazards and control measures; Customer, sector and other requirements that the organization observes; relevant enquiries and communications from external interested parties; complaints and alerts indicating food safety hazards associated with the end product; other conditions that have an impact on food safety 7 Support ISO Key Content Comment 7.5 Documented information documented information The extent of documented 7.5.1 General determined by the organization information for a FSMS can differ as being necessary for the from one organization to effectiveness of the FSMS another due to: documented information and the size of organization and its food safety requirements type of activities, processes, required by statutory, regulatory products and services; authorities and customers. the complexity of processes and their interactions; the competence of persons. 7.5.2 Creating and updating ensure creating and updating identification and description documented information (e.g. a title, date, author, or reference number); format (e.g. language, software version, graphics) and media (e.g. paper, electronic); review and approval for suitability and adequacy 7 Support ISO Key Content Comment 7.5.3 Control of documented Control the availability of the Where and when required in information documented information a form that is suitable for Control the protection of the use documented information Loss of confidentiality, loss Control the distribution, of integrity, misuse access and use of the Who is responsible, method documented information to use, rule to follow Control the storage of the Including protection documented information Use updated versions, Control the changes of the limited access to outdated documented information versions Control the retention and Retention period, disposal disposition of the method documented information Unique codification, access, Control the documented protection information of external origin 8 Operation ISO Key Content Comment 8.1 Operational planning plan, implement, control, control planned changes and and control maintain and update the review the consequences of processes needed to meet unintended changes, taking requirements for the action to mitigate any realization of safe products. adverse effects establishing criteria for the processes implementing control of the processes ensure that outsourced processes are controlled 8 Operation ISO Key Content Comment 8.2 Prerequisite programmes establish, implement, maintain prevention and/or reduction of (PRPs) and update PRP(s) contaminants (including food appropriate to the organization safety hazards) in the products, and its context with regard to product processing and work food safety environment appropriate to the size and type the applicable part of the ISO/TS of the operation and the nature 22002 series; of the products being manufactured and/or handled; implemented across the entire production system, either as programmes applicable in general or as programmes applicable to a particular product or process; approved by the food safety team. ensure that applicable statutory, regulatory and mutually agreed customer requirements ISO/TS 22002-1 Food Manufacturing 4 Construction and layout of buildings 4.1 General requirements Buildings shall be designed, constructed and maintained in a manner appropriate to the nature of the processing operations to be carried out, the food safety hazards associated with those operations and the potential sources of contamination from the plant environs. Buildings shall be of durable construction which presents no hazard to the product. NOTE An example of “durable construction”is self-draining roofs which do not leak. 4.2 Environment Consideration shall be given to potential sources of contamination from the local environment. Food production should not be carried out in areas where potentially harmful substances could enter the product. The effectiveness of measures taken to protect against potential contaminants shall be periodically reviewed. ISO/TS 22002-1 Food Manufacturing 4.3 Locations of establishments The site boundaries shall be clearly identified. Access to the site shall be controlled. The site shall be maintained in good order. Vegetation shall be tended or removed. Roads, yards and parking areas shall be drained to prevent standing water and shall be maintained. 5 Layout of premises and workspace 5.1 General requirements Internal layouts shall be designed, constructed and maintained to facilitate good hygiene and manufacturing practices. The movement patterns of materials, products and people, and the layout of equipment, shall be designed to protect against potential contamination sources. 5.2 Internal design, layout and traffic patterns The building shall provide adequate space, with a logical flow of materials, products and personnel, and physical separation of raw from processed areas. NOTE Examples of physical separation include walls, barriers or partitions, or sufficient distance to minimize risk. Openings intended for transfer of materials shall be designed to minimize entry of foreign matter and pests. ISO/TS 22002-1 Food Manufacturing 5.3 Internal structures and fittings Process area walls and floors shall be washable or cleanable, as appropriate for the process or product hazard. Materials of construction shall be resistant to the cleaning system applied. Wall floor junctions and corners shall be designed to facilitate cleaning. It is recommended that wall floor junctions be rounded in processing areas. Floors shall be designed to avoid standing water. In wet process areas, floors shall be sealed and drained. Drains shall be trapped and covered. Ceilings and overhead fixtures shall be designed to minimize build-up of dirt and condensation. External opening windows, roof vents or fan, where present, shall be insect screened. External opening doors shall be closed or screened when not in use. 5.4 Location of equipment Equipment shall be designed and located so as to facilitate good hygiene practices and monitoring. Equipment shall be located to permit access for operation, cleaning and maintenance. 5.5 Laboratory facilities In-line and on-line test facilities shall be controlled to minimize risk of product contamination. Microbiology laboratories shall be designed, located and operated so as to prevent contamination of people, plant and products. They shall not open directly on to a production area. ISO/TS 22002-1 Food Manufacturing 5.6 Temporary or mobile premises and vending machines Temporary structures shall be designed, located and constructed to avoid pest harbourage and potential contamination of products. Additional hazards associated with temporary structures and vending machines shall be assessed and controlled. 5.7 Storage of food, packaging materials, ingredients and non-food chemicals Facilities used to store ingredients, packaging and products shall provide protection from dust, condensation, drains, waste and other sources of contamination. Storage areas shall be dry and well ventilated. Monitoring and control of temperature and humidity shall be applied where specified. Storage areas shall be designed or arranged to allow segregation of raw materials, work in progress and finished products. All materials and products shall be stored off the floor and with sufficient space between the material and the walls to allow inspection and pest control activities to be carried out. The storage area shall be designed to allow maintenance and cleaning, prevent contamination and minimize deterioration. A separate, secure (locked or otherwise access controlled) storage area shall be provided for cleaning materials, chemicals and other hazardous substances. Exceptions for bulk or agricultural crop materials shall be documented in the food safety management system. ISO/TS 22002-1 Food Manufacturing 6 Utilities —air, water, energy 6.1 General requirements The provision and distribution routes for utilities to and around processing and storage areas shall be designed to minimize the risk of product contamination. Utilities’quality shall be monitored to minimize product contamination risk. 6.2 Water supply The supply of potable water shall be sufficient to meet the needs of the production process(es). Facilities for storage, distribution and, where needed, temperature control of the water shall be designed to meet specified water quality requirements. Water used as a product ingredient, including ice or steam (including culinary steam), or in contact with products or product surfaces, shall meet specified quality and microbiological requirements relevant to the product. Water for cleaning or applications where there is a risk of indirect product contact (e.g. jacketed vessels, heat exchangers) shall meet specified quality and microbiological requirements relevant to the application. Where water supplies are chlorinated, checks shall ensure that the residual chlorine level at the point of use remains within limits given in relevant specifications. Non-potable water shall have a separate supply system that is labelled and not connected to the potablewater system. Take measures to prevent non-potable water refluxing into the potable system. It is recommended that water that can come into contact with the product should flow through pipes that can be disinfected. ISO/TS 22002-1 Food Manufacturing 6.3 Boiler chemicals Boiler chemicals, if used, shall be either: a) approved food additives which meet relevant additive specifications; or b) additives which have been approved by the relevant regulatory authority as safe for use in water intended for human consumption. Boiler chemicals shall be stored in a separate, secure (locked or otherwise access-controlled) area when not in immediate use. 6.4 Air quality and ventilation The organization shall establish requirements for filtration, humidity (RH%) and microbiology of air used as an ingredient or for direct product contact. Where temperature and/or humidity are deemed critical by the organization, a control system shall be put in place and monitored. Ventilation (natural or mechanical) shall be provided to remove excess or unwanted steam, dust and odours, and to facilitate drying after wet cleaning. Room air supply quality shall be controlled to minimize risk from airborne microbiological contamination. Protocols for air quality monitoring and control shall be established in areas where products which support the growth or survival of microorganisms are exposed. Ventilation systems shall be designed and constructed such that air does not flow from contaminated or raw areas to clean areas. Specified air pressure differentials shall be maintained. Systems shall be accessible for cleaning, filter changing and maintenance. Exterior air intake ports shall be examined periodically for physical integrity. ISO/TS 22002-1 Food Manufacturing 6.5 Compressed air and other gases Compressed air, carbon dioxide, nitrogen and other gas systems used in manufacturing and/or filling shall be constructed and maintained so as to prevent contamination. Gases intended for direct or incidental product contact (including those used for transporting, blowing or drying materials, products or equipment) shall be from a source approved for food contact use, filtered to remove dust, oil and water. Where oil is used for compressors and there is potential for the air to come into contact with the product, the oil used shall be food grade. Use of oil free compressors is recommended. Requirements for filtration, humidity (RH%) and microbiology shall be specified. Filtration of the air should be as close to the point of use as is practicable. 6.6 Lighting The lighting provided (natural or artificial) shall allow personnel to operate in a hygienic manner. The intensity of the lighting should be appropriate to the nature of the operation. Light fixtures shall be protected to ensure that materials, product or equipment are not contaminated in the case of breakages. 7 Waste disposal 7.1 General requirements Systems shall be in place to ensure that waste materials are identified, collected, removed and disposed of in a manner which prevents contamination of products or production areas. ISO/TS 22002-1 Food Manufacturing 7.2 Containers for waste and inedible or hazardous substances Containers for waste and inedible or hazardous substances shall be: a) clearly identified for their intended purpose; b) located in a designated area; c) constructed of impervious material which can be readily cleaned and sanitized; d) closed when not in immediate use; e) locked where the waste may pose a risk to the product. 7.3 Waste management and removal Provision shall be made for the segregation, storage and removal of waste. Accumulation of waste shall not be allowed in food-handling or storage areas. Removal frequencies shall be managed to avoid accumulations, with a minimum daily removal. Labelled materials, products or printed packaging designated as waste shall be disfigured or destroyed to ensure that trademarks cannot be reused. Removal and destruction shall be carried out by approved disposal contractors. The organization shall retain records of destruction. 7.4 Drains and drainage Drains shall be designed, constructed and located so that the risk of contamination of materials or products is avoided. Drains shall have capacity sufficient to remove expected flow loads. Drains shall not pass over processing lines. Drainage direction shall not flow from a contaminated area to a clean area. ISO/TS 22002-1 Food Manufacturing 8 Equipment suitability, cleaning and maintenance 8.1 General requirements Food contact equipment shall be designed and constructed to facilitate cleaning, disinfection and maintenance. Contact surfaces shall not affect, or be affected by, the intended product or cleaning system. Food contact equipment shall be constructed of durable materials able to resist repeated cleaning. 8.2 Hygienic design Equipment shall be able to meet established principles of hygienic design, including: a) smooth, accessible, cleanable surfaces, self draining in wet process areas; b) use of materials compatible with intended products and cleaning or flushing agents; c) framework not penetrated by holes or nuts and bolts. Piping and ductwork shall be cleanable, drainable, and with no dead ends. Equipment shall be designed to minimize contact between the operator’s hands and the products. 8.3 Product contact surfaces Product contact surfaces shall be constructed from materials designed for food use. They shall be impermeable and rust or corrosion free. ISO/TS 22002-1 Food Manufacturing 8.4 Temperature control and monitoring equipment Equipment used for thermal processes shall be able to meet the temperature gradient and holding conditions given in relevant product specifications. Equipment shall provide for the monitoring and control of the temperature. 8.5 Cleaning plant, utensils and equipment Wet and dry cleaning programmes shall be documented to ensure that all plant, utensils and equipment are cleaned at defined frequencies. The programmes shall specify what is to be cleaned (including drains), the responsibility, the method of cleaning (e.g. CIP, COP), the use of dedicated cleaning tools, removal or disassembly requirements and methods for verifying the effectiveness of the cleaning. 8.6 Preventive and corrective maintenance A preventive maintenance programme shall be in place. The preventive maintenance programme shall include all devices used to monitor and/or control food safety hazards. NOTE: Examples of such devices include screens and filters (including air filters), magnets, metal detectors and X-ray detectors. Corrective maintenance shall be carried out in such a way that production on adjoining lines or equipment is not at risk of contamination. ISO/TS 22002-1 Food Manufacturing Maintenance requests which impact product safety shall be given priority. Temporary fixes shall not put product safety at risk. A request for replacement by a permanent repair shall be included in the maintenance schedule. Lubricants and heat transfer fluids shall be food grade where there is a risk of direct or indirect contact with the product. The procedure for releasing maintained equipment back to production shall include clean up, sanitizing, where specified in process sanitation procedures, and pre-use inspection. Local area PRP requirements shall apply to maintenance areas and maintenance activities in process areas. Maintenance personnel shall be trained in the product hazards associated with their activities. 9 Management of purchased materials 9.1 General requirements Purchasing of materials which impact food safety shall be controlled to ensure that the suppliers used have the capability to meet the specified requirements. The conformance of incoming materials to specified purchase requirements shall be verified. 9.2 Selection and management of suppliers There shall be a defined process for the selection, approval and monitoring of suppliers. The process used shall be justified by hazard assessment, including the potential risk to the final product, and shall include: ISO/TS 22002-1 Food Manufacturing a) assessment of the supplier’s ability to meet quality and food safety expectations, requirements and specifications; b) description of how suppliers are assessed; NOTE Examples of a description of how suppliers are assessed include: 1) audit of the supplying site prior to accepting materials for production; 2) appropriate third party certification. c) monitoring the performance of the supplier to assure continued approval status. NOTE: Monitoring includes conformity with material or product specifications, fulfilment of COA requirements, satisfactory audit outcomes. 9.3 Incoming material requirements (raw/ingredients/packaging) Delivery vehicles shall be checked prior to, and during, unloading to verify that the quality and safety of the material has been maintained during transit (e.g. integrity of seals, freedom from infestation, existence of temperature records). Materials shall be inspected, tested or covered by COA to verify conformity with specified requirements prior to acceptance or use. The method of verification shall be documented. NOTE: The inspection frequency and scope can be based on the hazard presented by the material and the risk assessment of the specific suppliers. Materials which do not conform to relevant specifications shall be handled under a documented procedure which ensures they are prevented from unintended use. ISO/TS 22002-1 Food Manufacturing Access points to bulk material receiving lines shall be identified, capped and locked. Discharge into such systems shall take place only after approval and verification of the material to be received. 10 Measures for prevention of cross-contamination 10.1 General requirements Programmes shall be in place to prevent, control and detect contamination. Measures to prevent physical, allergen and microbiological contamination shall be included. 10.2 Microbiological cross-contamination Areas where potential for microbiological cross-contamination exists (airborne or from traffic patterns) shall be identified and a segregation (zoning) plan implemented. A hazard assessment shall be carried out to determine potential contamination sources, susceptibility of the product and control measures suitable for these areas as follows: a) separation of raw from finished or ready to eat (RTE) products; b) structural segregation — physical barriers, walls or separate buildings; c) access controls with requirements to change into required workwear; d) traffic patterns or equipment segregation — people, materials, equipment and tools (includin use of dedicated tools); e) air pressure differentials. ISO/TS 22002-1 Food Manufacturing 10.3 Allergen management Allergens present in the product, either by design or by potential manufacturing cross- contact, shall be declared. The declaration shall be on the label for consumer products, and on the label or the accompanying documentation for products intended for further processing. Products shall be protected from unintended allergen cross-contact by cleaning and line change-over practices and/or product sequencing. NOTE: Manufacturing cross-contact can arise from either: 1) traces of product from the previous production run which cannot be adequately cleaned from the product line due to technical limitations; or 2) when contact is likely to occur, in the normal manufacturing process, with products or ingredients that are produced on separate lines, or in the same or adjacent processing areas. Rework containing allergen(s) shall be used only: a) in products which contain the same allergen(s) by design; or b) through a process which is demonstrated to remove or destroy the allergenic material. NOTE: For general rework requirements, see Clause 14. Employees handling food should receive specific training in allergen awareness and associated manufacturing practices. ISO/TS 22002-1 Food Manufacturing 10.4 Physical contamination Where brittle materials are used, periodic inspection requirements and defined procedures in case of breakage shall be put in place. Brittle materials, such as glass and hard plastic components in equipment, should be avoided where possible. Glass breakage records shall be maintained. Based on hazard assessment, measures shall be put in place to prevent, control or detect potential contamination. NOTE 1 Examples of such measures include: a) adequate covers over equipment or containers for exposed materials or products; b) use of screens, magnets, sieves or filters; c) use of detection or rejection devices such as metal detectors or X-ray. NOTE 2 Sources of potential contamination include wooden pallets and tools, rubber seals, and personal protective clothing and equipment. 11 Cleaning and sanitizing 11.1 General requirements Cleaning and sanitizing programmes shall be established to ensure that the food-processing equipment and environment are maintained in a hygienic condition. Programmes shall be monitored for continuing suitability and effectiveness. ISO/TS 22002-1 Food Manufacturing 11.2 Cleaning and sanitizing agents and tools Facilities and equipment shall be maintained in a condition which facilitates wet or dry cleaning and/or sanitation. Cleaning and sanitizing agents and chemicals shall be clearly identified, food grade, stored separately and used only in accordance with the manufacturer’s instructions. Tools and equipment shall be of hygienic design and maintained in a condition which does not present a potential source of extraneous matter. 11.3 Cleaning and sanitizing programmes Cleaning and sanitizing programmes shall be established and validated by the organization to ensure that all parts of the establishment and equipment are cleaned and/or sanitized to a defined schedule, including the cleaning of cleaning equipment. Cleaning and/or sanitizing programmes shall specify at a minimum: a) areas, items of equipment and utensils to be cleaned and/or sanitized; b) responsibility for the tasks specified; c) cleaning/sanitizing method and frequency; d) monitoring and verification arrangements; e) post-clean inspections; f) pre start-up inspections. ISO/TS 22002-1 Food Manufacturing 11.4 Cleaning in place (CIP) systems CIP systems shall be separated from active product lines. Parameters for CIP systems shall be defined and monitored (including type, concentration, contact time and temperature of any chemicals used). 11.5 Monitoring sanitation effectiveness Cleaning and sanitation programmes shall be monitored at frequencies specified by the organization to ensure their continuing suitability and effectiveness. 12 Pest control 12.1 General requirements Hygiene, cleaning, incoming materials inspection and monitoring procedures shall be implemented to avoid creating an environment conducive to pest activity. 12.2 Pest control programmes The establishment shall have a nominated person to manage pest control activities and/or deal with appointed expert contractors. Pest management programmes shall be documented and shall identify target pests, and address plans, methods, schedules, control procedures and, where necessary, training requirements. Programmes shall include a list of chemicals which are approved for use in specified areas of the establishment. ISO/TS 22002-1 Food Manufacturing 12.3 Preventing access Buildings shall be maintained in good repair. Holes, drains and other potential pest access points shall be sealed. External doors, windows or ventilation openings shall be designed to minimize the potential for entry of pests. 12.4 Harbourage and infestations Storage practices shall be designed to minimize the availability of food and water to pests. Material found to be infested shall be handled in such a way as to prevent contamination of other materials, products or the establishment. Potential pest harbourage (e.g. burrows, undergrowth, stored items) shall be removed. Where outside space is used for storage, stored items shall be protected from weather or pest damage (e.g. bird droppings). 12.5 Monitoring and detection Pest-monitoring programmes shall include the placing of detectors and traps in key locations to identify pest activity. A map of detectors and traps shall be maintained. Detectors and traps shall be designed and located so as to prevent potential contamination of materials, products or facilities. Detectors and traps shall be of robust, tamper-resistant construction. They shall be appropriate for the target pest. ISO/TS 22002-1 Food Manufacturing The detectors and traps shall be inspected at a frequency intended to identify new pest activity. The results of inspections shall be analysed to identify trends. 12.6 Eradication Eradication measures shall be put in place immediately after evidence of infestation is reported. Pesticide use and application shall be restricted to trained operatives and shall be controlled to avoid product safety hazards. Records of pesticide use shall be maintained to show the type, quantity and concentrations used; where, when and how applied, and the target pest. 13 Personnel hygiene and employee facilities 13.1 General requirements Requirements for personal hygiene and behaviours proportional to the hazard posed to the process area or product shall be established and documented. All personnel, visitors and contractors shall be required to comply with the documented requirements. 13.2 Personnel hygiene facilities and toilets Personnel hygiene facilities shall be available to ensure that the degree of personal hygiene required by the organization can be maintained. The facilities shall be located close to the points where hygiene requirements apply and shall be clearly designated. ISO/TS 22002-1 Food Manufacturing Establishments shall: a) provide adequate numbers, locations and means of hygienically washing, drying and, where required, sanitizing hands (including wash-basins, supply of hot and cold or temperature controlled water, and soap and/or sanitizer); b) have sinks designated for hand washing, whose taps should not be hand operated, separate from sinks for food use and equipment-cleaning stations; c) provide an adequate number of toilets of appropriate hygienic design, each with hand- washing, drying and, where required, sanitizing facilities; d) have employee hygiene facilities that do not open directly on to production, packing or storage areas; e) have adequate changing facilities for personnel; f) have changing facilities sited to enable personnel handling food to move to the production area in such a way that risk to the cleanliness of their workwear is minimized. 13.3 Staff canteens and designated eating areas Staff canteens and designated areas for food storage and consumption shall be situated so that the potential for cross-contamination of production areas is minimized. Staff canteens shall be managed to ensure hygienic storage of ingredients and preparation, storage and serving of prepared foods. Storage conditions and storage, cooking and holding temperatures, and time limitations, shall be specified. Employees’own food shall be stored and consumed in designated areas only. ISO/TS 22002-1 Food Manufacturing 13.4 Workwear and protective clothing Personnel who work in, or enter into, areas where exposed products and/or materials are handled shall wear work clothing that is fit for purpose, clean and in good condition (e.g. free from rips, tears or fraying material). Clothing mandated for food protection or hygiene purposes shall not be used for any other purpose. Workwear shall not have buttons. Workwear shall not have outside pockets above waist level. Zips or press stud fastenings are acceptable. Workwear shall be laundered to standards and at intervals suitable for the intended use of the garments. Workwear shall provide adequate coverage to ensure that hair, perspiration, etc. cannot contaminate the product. Hair, beards, and moustaches shall be protected (i.e. completely enclosed) by restraints unless hazard analysis indicates otherwise. Where gloves are used for product contact, they shall be clean and in good condition. Use of latex gloves should be avoided where possible. Shoes for use in processing areas shall be fully enclosed and made from non-absorbent materials. Personal protective equipment, where required, shall be designed to prevent product contamination and maintained in hygienic condition. ISO/TS 22002-1 Food Manufacturing 13.5 Health status Subject to legal restrictions in the country of operation, employees shall undergo a medical examination prior to employment in food contact operations (including site catering), unless documented hazard or medical assessment indicates otherwise. Additional medical examinations, where permitted, shall be carried out at intervals defined by the organization. 13.6 Illness and injuries Where permitted by law, employees shall be required to report the following conditions to management for possible exclusion from food-handling areas: jaundice, diarrhoea, vomiting, fever, sore throat with fever, visibly infected skin lesions (boils, cuts or sores) and discharges from the ear, eye or nose. People known or suspected to be infected with, or carrying, a disease or illness transmissible through food shall be prevented from handling food or materials which come into contact with food. In food-handling areas, personnel with wounds or burns shall be required to cover them with specified dressings. Any lost dressing shall be reported to supervision immediately. NOTE: Dressings should be brightly coloured and metal detectable where appropriate. ISO/TS 22002-1 Food Manufacturing 13.7 Personal cleanliness Personnel in food production areas shall be required to wash and, where required, sanitize hands: a) before starting any food-handling activities; b) immediately after using the toilet or blowing the nose; c) immediately after handling any potentially contaminated material. Personnel shall be required to refrain from sneezing or coughing over materials or products. Spitting (expectorating) shall be prohibited. Fingernails shall be kept clean and trimmed. 13.8 Personal behaviour A documented policy shall describe the behaviours required of personnel in processing, packing and storage areas. The policy shall at a minimum cover: a) permissibility of smoking, eating, chewing in designated areas only; b) control measures to minimize hazards presented by permitted jewellery, such as that worn by personnel in processing and storage areas, taking into account religious, ethnic, medical and cultural imperatives; c) permissibility of personal items, such as smoking materials and medicines, in designated areas only; d) prohibition of the use of nail polish, false nails and false eyelashes; ISO/TS 22002-1 Food Manufacturing e) prohibition of carrying of writing implements behind the ears; f) maintenance of personal lockers so that they are kept free from rubbish and soiled clothing; g) prohibition of storage of product contact tools and equipment in personal lockers. 14 Rework 14.1 General requirements Rework shall be stored, handled and used in such a way that product safety, quality, traceability and regulatory compliance are maintained. 14.2 Storage, identification and traceability Stored rework shall be protected from exposure to microbiological, chemical or extraneous matter contamination. Segregation requirements for rework (e.g. allergen) shall be documented and met. Rework shall be clearly identified and/or labelled to allow traceability. Traceability records for rework shall be maintained. The rework classification or the reason for rework designation shall be recorded (e.g. product name, production date, shift, line of origin, shelf-life). 14.3 Rework usage Where rework is incorporated into a product as an “in-process”step, the acceptable quantity, type and conditions of rework use shall be specified. The process step and method of addition, including any necessary pre-processing stages, shall be defined. ISO/TS 22002-1 Food Manufacturing Where rework activities involve removing a product from filled or wrapped packages, controls shall be put in place to ensure the removal and segregation of packaging materials and to avoid contamination of the product with extraneous matter. 15 Product recall procedures 15.1 General requirements Systems shall be in place to ensure that products failing to meet required food safety standards can be identified, located and removed from all necessary points of the supply chain. 15.2 Product recall requirements A list of key contacts in the event of a recall shall be maintained. Where products are withdrawn due to immediate health hazards, the safety of other products produced under the same conditions shall be evaluated. The need for public warnings shall be considered. 16 Warehousing 16.1 General requirements Materials and products shall be stored in clean, dry, well-ventilated spaces protected from dust, condensation, fumes, odours or other sources of contamination. 16.2 Warehousing requirements Effective control of warehousing temperature, humidity and other environmental conditions shall be provided where required by product or storage specifications. ISO/TS 22002-1 Food Manufacturing It is recommended that where products are stacked, consideration is given to measures necessary to protect the lower layers. Waste materials and chemicals (cleaning products, lubricants, and pesticides) shall be stored separately. A separate area or other means of segregating materials identified as non-conforming shall be provided. Specified stock rotation systems (FIFO/FEFO) shall be observ

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