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1 1 ISO 22000 ISO 22000 :Food safety management systems — :Food safety management systems — Requirements for organizations throughout the Requirements for organizations throughout the food chain: Contents Page food chain: Contents Page Foreword Foreword Introduction Introduction 1 1 Scope Scope 2 2 Normative reference Normative reference 3 3 Terms and definitions Terms and definitions 4 4 Food safety management system Food safety management system 4.1 4.1 General requirements General requirements 4.2 4.2 Documentation requirements Documentation requirements 5 5 Management responsibility Management responsibility 5.1 5.1 Management commitment Management commitment 5.2 5.2 Food safety policy Food safety policy

Foreword Introduction 1 Scope 2 Normative reference 3 Terms and definitions

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ISO 22000ISO 22000:Food safety management systems — Requirements for :Food safety management systems — Requirements for organizations throughout the food chain: Contents Pageorganizations throughout the food chain: Contents Page

ForewordForeword IntroductionIntroduction 1 1 Scope Scope 2 2 Normative referenceNormative reference 3 3 Terms and definitionsTerms and definitions 4 4 Food safety management systemFood safety management system 4.1 4.1 General requirementsGeneral requirements 4.2 4.2 Documentation requirementsDocumentation requirements 5 5 Management responsibilityManagement responsibility 5.1 5.1 Management commitmentManagement commitment 5.2 5.2 Food safety policyFood safety policy

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5.3 5.3 Food safety management system planningFood safety management system planning 5.4 5.4 Responsibility and authorityResponsibility and authority 5.5 5.5 Food safety team leaderFood safety team leader 5.6 5.6 CommunicationCommunication 5.7 5.7 Contingency preparedness and responseContingency preparedness and response 5.8 5.8 Management reviewManagement review 6 6 Resource managementResource management 6.1 6.1 Provision of resourcesProvision of resources 6.2 6.2 Human resourcesHuman resources 6.3 6.3 InfrastructureInfrastructure 6.4 6.4 Work environmentWork environment

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7 7 Planning and realization of safe products Planning and realization of safe products 7.1 7.1 GeneralGeneral 7.2 7.2 Prerequisite programe(s)Prerequisite programe(s) 7.3 7.3 Preliminary steps to enable hazard analysisPreliminary steps to enable hazard analysis 7.4 7.4 Hazard analysisHazard analysis 7.5 7.5 Design and redesign of the operational PRPsDesign and redesign of the operational PRPs 7.6 7.6 Design and redesign of the HACCP planDesign and redesign of the HACCP plan 7.7 7.7 Updating of preliminary information andUpdating of preliminary information and documentsdocuments specifying the PRP(s) and the HACC Planspecifying the PRP(s) and the HACC Plan 7.8 7.8 Verification planningVerification planning 7.9 7.9 Operation of the food safety management system Operation of the food safety management system

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8 8 Verification, validation and improvement of the food Verification, validation and improvement of the food safety management system safety management system

8.1 General8.1 General 8.2 8.2 Monitoring and measuringMonitoring and measuring 8.3 8.3 Food safety management system verificationFood safety management system verification 8.4 8.4 Validation of control measure combinationsValidation of control measure combinations 8.5 8.5 ImprovementImprovement Annex A Annex A (informative) Guidance on the use of the (informative) Guidance on the use of the

standardstandard Annex B Annex B (informative) (informative) Correspondence between ISO 22000:200X and ISO Correspondence between ISO 22000:200X and ISO

9001:2000 9001:2000 Annex C Annex C (informative) Codex References providing (informative) Codex References providing

Examples of Control Measures, includingExamples of Control Measures, including Prerequisite Programs and guidance for Their Selection Prerequisite Programs and guidance for Their Selection

and Use Bibliographyand Use Bibliography

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IntroductionIntroduction

The requirement for food safety for all organizations, The requirement for food safety for all organizations, which produce, manufacture, handle or supply food, is which produce, manufacture, handle or supply food, is paramount. paramount.

Furthermore, all these organizations recognize the Furthermore, all these organizations recognize the increasing need to demonstrate and provide adequate increasing need to demonstrate and provide adequate evidence of their ability to identify and control food safety evidence of their ability to identify and control food safety hazards and the many conditions impacting food safety.hazards and the many conditions impacting food safety.

This requirement may apply to all types of organizations This requirement may apply to all types of organizations within the food chain ranging from feed producers, within the food chain ranging from feed producers, primary producers through food manufacturers, transport primary producers through food manufacturers, transport and storage operators and subcontractors to retail and and storage operators and subcontractors to retail and food service outlets - together with inter-related food service outlets - together with inter-related organizations such as producers of equipment, organizations such as producers of equipment, packaging material, cleaning agents, additives and packaging material, cleaning agents, additives and ingredients.ingredients.

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Food safety is related to the presence of and Food safety is related to the presence of and levels of food borne hazards in food at the point levels of food borne hazards in food at the point of consumption (intake by the consumer).of consumption (intake by the consumer).

As food safety hazards may be introduced at As food safety hazards may be introduced at any stage of the food chain, adequate control any stage of the food chain, adequate control throughout the food chain is essential. throughout the food chain is essential.

Thus, food safety is a joint responsibility that is Thus, food safety is a joint responsibility that is principally assured through the combined efforts principally assured through the combined efforts of all the parties participating in the food chain.of all the parties participating in the food chain.

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This International Standard specifies the This International Standard specifies the requirements for a food safety management requirements for a food safety management system that combines the following generally system that combines the following generally recognized key elements to ensure food safety recognized key elements to ensure food safety along the food chain, up to the point of final along the food chain, up to the point of final consumption; these elements are:consumption; these elements are:

interactive communication;interactive communication; system management;system management; process control (ISO 9001);process control (ISO 9001); HACCP principles;HACCP principles; prerequisite programsprerequisite programs..

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Communication along the food chain is essential Communication along the food chain is essential to ensure that all relevant food safety hazards to ensure that all relevant food safety hazards are identified and adequately controlled at each are identified and adequately controlled at each step within the food chain. step within the food chain.

This implies communication of the needs of the This implies communication of the needs of the organization to both organizations upstream in organization to both organizations upstream in the food chain and organizations downstream in the food chain and organizations downstream in the food chain.the food chain.

This implies communication of the needs This implies communication of the needs of the organization to both organizations of the organization to both organizations upstream in the food chain and upstream in the food chain and organizations downstream in the food organizations downstream in the food chain.chain.

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Communication with customers and suppliers, Communication with customers and suppliers, based on the information generated through based on the information generated through systematic hazard analysis, will also assist in systematic hazard analysis, will also assist in substantiating customer and supplier substantiating customer and supplier requirements with regard to their feasibility, needrequirements with regard to their feasibility, need

and impact on the end product.and impact on the end product. Recognition of the organization's role and position within Recognition of the organization's role and position within

the food chain is essential to ensure effective interactive the food chain is essential to ensure effective interactive communication throughout the chain in order to deliver communication throughout the chain in order to deliver safe food products to the final consumer. safe food products to the final consumer.

The possible scope of the communication channels The possible scope of the communication channels among typical interested parties of the food chain is among typical interested parties of the food chain is schematically exemplified in Figure 1.schematically exemplified in Figure 1.

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Figure 1 – Example for communication Figure 1 – Example for communication along the food chainalong the food chain

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This International Standard integrates the principles of This International Standard integrates the principles of the Hazard Analysis and Critical Control Point (HACCP)the Hazard Analysis and Critical Control Point (HACCP)

system and application steps developed by the Codex system and application steps developed by the Codex Alimentarius Commission and dynamically combines it Alimentarius Commission and dynamically combines it with prerequisite programs (PRP(s)) necessary to control with prerequisite programs (PRP(s)) necessary to control and reduce any food safety hazards identified for the end and reduce any food safety hazards identified for the end products delivered to the next step in the food chain to products delivered to the next step in the food chain to acceptable levels. acceptable levels.

Hazard analysis is the key to an effective food safety Hazard analysis is the key to an effective food safety management system, as it organizes the knowledge management system, as it organizes the knowledge required to design an effective combination of control required to design an effective combination of control measures. measures.

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This International Standard requires that all This International Standard requires that all hazards that may be reasonably expected to hazards that may be reasonably expected to occur in the food chain, including hazards that occur in the food chain, including hazards that may be associated with the type of process and may be associated with the type of process and facilities used, are identified and assessed, facilities used, are identified and assessed, resulting in a clear determination of those to be resulting in a clear determination of those to be controlled within the organization and those that controlled within the organization and those that are to be controlled (or are already controlled) are to be controlled (or are already controlled) by other organizations within the food chain by other organizations within the food chain and/or by the final consumer. and/or by the final consumer.

Thus, this standard provides the means to Thus, this standard provides the means to document and justify both inclusions and document and justify both inclusions and omissions in setting control measures.omissions in setting control measures.

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This International Standard further clarifies the This International Standard further clarifies the concept of prerequisite programs. The prerequisite concept of prerequisite programs. The prerequisite programs (PRP(s)) are separated into two programs (PRP(s)) are separated into two subcategories: infrastructure and maintenance subcategories: infrastructure and maintenance programs and operational prerequisite programs.programs and operational prerequisite programs.

This separation takes into account differences in This separation takes into account differences in the nature of control measures that may be the nature of control measures that may be applied and their feasibility for monitoring, applied and their feasibility for monitoring, verification, or validation.verification, or validation.

The effective production of safe products requires The effective production of safe products requires the balanced integration of both types of the balanced integration of both types of prerequisite programs and a detailed HACCP prerequisite programs and a detailed HACCP plan.plan.

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Infrastructure and maintenance programs are Infrastructure and maintenance programs are used to address basic requirements of food used to address basic requirements of food hygiene and accepted good (manufacturing, hygiene and accepted good (manufacturing, agricultural, hygienic, etc.) practices of a more agricultural, hygienic, etc.) practices of a more permanent nature; whereas operational PRP(s) permanent nature; whereas operational PRP(s) are used to control or reduce the impact of are used to control or reduce the impact of identified food safety hazards in the product or the identified food safety hazards in the product or the processing environment. processing environment.

The HACCP plan is used to manage the CCP(s) The HACCP plan is used to manage the CCP(s) identified to eliminate, prevent or reduce specified identified to eliminate, prevent or reduce specified food safety hazards from the product, as food safety hazards from the product, as determined during hazard analysis. determined during hazard analysis.

During hazard analysis the organization During hazard analysis the organization determines the strategy to be used to ensure determines the strategy to be used to ensure hazard control by combining the PRP(s) and the hazard control by combining the PRP(s) and the HACCP plan. HACCP plan.

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This International Standard requires that This International Standard requires that organizations identify, monitor, control and organizations identify, monitor, control and routinely update both the PRP(s) and the HACCP routinely update both the PRP(s) and the HACCP plan.plan.

To facilitate the application of this International To facilitate the application of this International Standard, it has been developed as an auditable Standard, it has been developed as an auditable standard.standard.

However, individual organizations are free to However, individual organizations are free to choose the necessary methods and approaches to choose the necessary methods and approaches to fulfill the requirements of this International fulfill the requirements of this International Standard. Standard.

To assist individual organizations with To assist individual organizations with development and implementation of this development and implementation of this International Standard an informative explanation International Standard an informative explanation and guide for its use are provided in Annex A.and guide for its use are provided in Annex A.

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This International Standard recognizes that there This International Standard recognizes that there are differences amongst organizations within the are differences amongst organizations within the food chain. It specifies a mechanism that will food chain. It specifies a mechanism that will allow a small and/or less developed organization, allow a small and/or less developed organization, such as a small farm, a small packer-distributor, a such as a small farm, a small packer-distributor, a small retail or food service outlet, to implement an small retail or food service outlet, to implement an externally developed and designed combination of externally developed and designed combination of PRP(s) and HACCP plans, if PRP(s) and HACCP plans, if

a) it is demonstrated that it has been developed in a) it is demonstrated that it has been developed in compliance with the requirements of this compliance with the requirements of this International Standard specified for the hazard International Standard specified for the hazard analysis, PRP(s) and HACCP plan,analysis, PRP(s) and HACCP plan,

b) specific measures have been undertaken to b) specific measures have been undertaken to adapt the externally developed system to the adapt the externally developed system to the organization, and organization, and

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c) it has been implemented and is operated in c) it has been implemented and is operated in accordance with the other requirements of this accordance with the other requirements of this International Standard.International Standard.

The most effective food safety systems are The most effective food safety systems are designed, operated and updated within the designed, operated and updated within the framework of a structured management system framework of a structured management system and incorporated into the overall management and incorporated into the overall management activities of the organization. This providesactivities of the organization. This provides

maximum benefit for the organization and maximum benefit for the organization and interested parties. interested parties.

This International Standard has taken due This International Standard has taken due consideration of the provisions of ISO consideration of the provisions of ISO 9001:2000 in order to enhance compatibility of 9001:2000 in order to enhance compatibility of the two standards. the two standards.

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The correspondence between ISO 9001:2000 The correspondence between ISO 9001:2000 and this International Standard is provided in and this International Standard is provided in Annex B.Annex B.

This International Standard may be applied This International Standard may be applied independently from other management system independently from other management system standards. standards.

Its implementation can be aligned or integrated Its implementation can be aligned or integrated with existing related management system with existing related management system requirements while organizations may utilize requirements while organizations may utilize existing management system(s) to establish a existing management system(s) to establish a food safety management system that complies food safety management system that complies with the requirements of this International with the requirements of this International Standard. Standard.

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As with other management system standards, the use of As with other management system standards, the use of this International Standard must have the commitment of this International Standard must have the commitment of the organization's top management.the organization's top management.

The aim of this International Standard is to harmonize The aim of this International Standard is to harmonize the requirements for food safety management for the requirements for food safety management for businesses within the food chain on a global level. businesses within the food chain on a global level.

It is particularly intended for application by organizations It is particularly intended for application by organizations that seek a more focused, coherent and integrated food that seek a more focused, coherent and integrated food safety management system than is normally required by safety management system than is normally required by law.law.

This International Standard is not intended for This International Standard is not intended for application as minimum requirements for regulatory application as minimum requirements for regulatory purposes. purposes.

However, it requires an organization to incorporate any However, it requires an organization to incorporate any applicable food safety related statutory and regulatory applicable food safety related statutory and regulatory requirements into its food safety management system.requirements into its food safety management system.

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1 Scope1 Scope This International Standard specifies This International Standard specifies

requirements for a food safety management requirements for a food safety management system in the food chain where an organization system in the food chain where an organization needs to demonstrate its ability to control food needs to demonstrate its ability to control food safety hazards in order to consistently provide safety hazards in order to consistently provide safe end products that both meet agreed safe end products that both meet agreed customer and applicable regulatory food safety customer and applicable regulatory food safety requirements, and aims to enhance customer requirements, and aims to enhance customer satisfaction through the effective control of food satisfaction through the effective control of food safety hazards, including processes for updating safety hazards, including processes for updating the system.the system.

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This International Standard specifies This International Standard specifies requirements to enable an organization torequirements to enable an organization to

plan, design, implement, operate, maintain and plan, design, implement, operate, maintain and update a food safety management system aimed update a food safety management system aimed at providing end products that according to its at providing end products that according to its intended use will ensure that the food, when intended use will ensure that the food, when eaten, are safe for the consumer,eaten, are safe for the consumer,

evaluate and assess customer requirements and evaluate and assess customer requirements and demonstrate conformity with those mutually demonstrate conformity with those mutually agreed customer requirements that relate to agreed customer requirements that relate to food safety,food safety,

demonstrate effective communication with demonstrate effective communication with customers and other interested parties along the customers and other interested parties along the food chainfood chain

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demonstrate conformity with applicable regulatory demonstrate conformity with applicable regulatory requirements as regard to food safety,requirements as regard to food safety,

assure that it complies with its stated food safety policy,assure that it complies with its stated food safety policy, demonstrate such compliance to other interested parties, demonstrate such compliance to other interested parties,

andand seek certification or registration of its food safety seek certification or registration of its food safety

management system by an external organization.management system by an external organization. All requirements of this International Standard are All requirements of this International Standard are

generic and intended to be applicable to all generic and intended to be applicable to all organizations wishing to design and implement an organizations wishing to design and implement an effective food safety management system, effective food safety management system, regardless of type, size and product provided, that regardless of type, size and product provided, that they operate in the food chain. they operate in the food chain.

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This includes organizations directly involved in one This includes organizations directly involved in one or more steps of the food chain (for example, but or more steps of the food chain (for example, but not limited to feed producers, farmers, producers not limited to feed producers, farmers, producers of ingredients, food producers, retailers, food of ingredients, food producers, retailers, food services, catering services, organizations services, catering services, organizations providing cleaning, transportation, storage and providing cleaning, transportation, storage and distribution services) and other organizations distribution services) and other organizations indirectly involved with the food chain (such as indirectly involved with the food chain (such as suppliers of equipment, cleaning agents and suppliers of equipment, cleaning agents and packaging material and other food contact packaging material and other food contact material).material).

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2 Normative reference2 Normative reference 3 Terms and definitions3 Terms and definitions 3.8 food chain3.8 food chain sequence of the stages and operations involved in the sequence of the stages and operations involved in the

production, processing, distribution, and handling of a foodproduction, processing, distribution, and handling of a food and its ingredients, from primary production to consumptionand its ingredients, from primary production to consumption NOTE Primary production includes the production of feed NOTE Primary production includes the production of feed

for food producing animals and for animals intended for for food producing animals and for animals intended for food production.food production.

3.9 food safety3.9 food safety assurance that food will not cause harm to the consumer assurance that food will not cause harm to the consumer

when it is prepared and/or eaten according to its intended when it is prepared and/or eaten according to its intended useuse

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8 Verification, validation and improvement of the 8 Verification, validation and improvement of the food safety management systemfood safety management system

8.1 General8.1 General The food safety team shall plan and implement the The food safety team shall plan and implement the

processes needed to verify, validate and update the food processes needed to verify, validate and update the food safety management system. safety management system.

The outcome of these activities shallThe outcome of these activities shall a) demonstrate the compliance with the requirements of a) demonstrate the compliance with the requirements of

this International Standard and the food safety related this International Standard and the food safety related objectives of the organization (see 5.2), andobjectives of the organization (see 5.2), and

b) ensure updating of the food safety management b) ensure updating of the food safety management system when needed.system when needed.

This shall include determination of applicable methods, This shall include determination of applicable methods, including statistical techniques, and the extent of their including statistical techniques, and the extent of their use.use.

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8.2 Monitoring and measuring8.2 Monitoring and measuring As a prerequisite for valid monitoring and As a prerequisite for valid monitoring and

verification, the organization shall verification, the organization shall determine suitable methods for the determine suitable methods for the monitoring and measurement. monitoring and measurement.

When it has been determined that When it has been determined that monitoring and measurement devices are monitoring and measurement devices are needed, the organization shall provide needed, the organization shall provide evidence that the devices are adequate to evidence that the devices are adequate to ensure the performance of the food safety ensure the performance of the food safety management system.management system.

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The organization shall establish the processes The organization shall establish the processes needed to ensure that monitoring and needed to ensure that monitoring and measurement are carried out in a manner that is measurement are carried out in a manner that is consistent with the specified requirements.consistent with the specified requirements.

Where necessary to ensure valid results, the Where necessary to ensure valid results, the measuring equipment and methods used shallmeasuring equipment and methods used shall

a) be calibrated or verified at specified intervals, a) be calibrated or verified at specified intervals, or prior to use, against measurement standards or prior to use, against measurement standards traceable to international or national traceable to international or national measurement standards; where no such measurement standards; where no such standards exist, the basis used for calibrationstandards exist, the basis used for calibration

or verification shall be recorded,or verification shall be recorded,

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b) be adjusted or re-adjusted as necessary,b) be adjusted or re-adjusted as necessary, c) be identified to enable the calibration status to c) be identified to enable the calibration status to

be determined,be determined, d) be safeguarded from adjustments that would d) be safeguarded from adjustments that would

invalidate the measurement results, andinvalidate the measurement results, and e) be protected from damage and deterioration.e) be protected from damage and deterioration. Records of the results of calibration and Records of the results of calibration and

verification shall be maintained.verification shall be maintained. In addition, the organization shall assess the In addition, the organization shall assess the

validity of the previous measuring results when validity of the previous measuring results when the equipment is found not to conform to the equipment is found not to conform to requirements. requirements.

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If the measurement equipment is non-If the measurement equipment is non-conforming, the organization shall takeconforming, the organization shall take

appropriate action on the equipment and any appropriate action on the equipment and any product affected. product affected.

Records of such assessment and resulting Records of such assessment and resulting actions shall be maintained.actions shall be maintained.

When used in the monitoring and measurement When used in the monitoring and measurement of specified requirements, the ability of computer of specified requirements, the ability of computer software to satisfy the intended application shall software to satisfy the intended application shall be confirmed. This shall be undertaken prior to be confirmed. This shall be undertaken prior to initial use and reconfirmed as necessary.initial use and reconfirmed as necessary.

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8.3 Food safety management system verification8.3 Food safety management system verification 8.3.1 Internal audit8.3.1 Internal audit The organization shall conduct internal audits at planned The organization shall conduct internal audits at planned

intervals to determine whether the food safety intervals to determine whether the food safety management systemmanagement system

a) conforms to the planned arrangements, to the a) conforms to the planned arrangements, to the requirements of this International Standard and to the requirements of this International Standard and to the food safety management system requirements food safety management system requirements established by the organization, andestablished by the organization, and

b) is effectively implemented and updated.b) is effectively implemented and updated. An audit program shall be planned taking into An audit program shall be planned taking into

consideration the status and importance of the processes consideration the status and importance of the processes and areas to be audited, as well as any updating actions and areas to be audited, as well as any updating actions resulting from previous audits (see 8.5.2 and 5.8.2). resulting from previous audits (see 8.5.2 and 5.8.2).

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The audit criteria, scope, frequency and methods The audit criteria, scope, frequency and methods shall be defined. shall be defined.

Selection of auditors and conduct of audits shall Selection of auditors and conduct of audits shall ensure objectivity and impartiality of the audit ensure objectivity and impartiality of the audit process. process.

Auditors shall not audit their own workAuditors shall not audit their own work The responsibilities and requirements for The responsibilities and requirements for

planning and conducting audits, and for reporting planning and conducting audits, and for reporting results and maintaining records shall be defined results and maintaining records shall be defined in a documented procedure.in a documented procedure.

The management responsible for the area being The management responsible for the area being audited shall ensure that actions are taken audited shall ensure that actions are taken without undue delay to eliminate detected without undue delay to eliminate detected nonconformities and their causes. nonconformities and their causes.

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Follow-up activities shall include the verification Follow-up activities shall include the verification of the actions taken and the reporting of the of the actions taken and the reporting of the verification results.verification results.

Results of audits shall in relevant form be Results of audits shall in relevant form be reported to top management as part of the reported to top management as part of the analysis of results of verification activities (see analysis of results of verification activities (see 8.3.3 and 5.7.2) and shall be used as an input to 8.3.3 and 5.7.2) and shall be used as an input to the food safety management system updating the food safety management system updating (see 8.5.2).(see 8.5.2).

8.3.2 Evaluation of individual verification 8.3.2 Evaluation of individual verification resultsresults

The individual results of planned verification (7.8) The individual results of planned verification (7.8) shall be systematically evaluated, including shall be systematically evaluated, including internal audits (8.3.1).internal audits (8.3.1).

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If verification does not demonstrate conformity If verification does not demonstrate conformity with the planned arrangements, the organization with the planned arrangements, the organization shall take action to achieve the required shall take action to achieve the required conformity. Such action shall include but is not conformity. Such action shall include but is not limited tolimited to

a) review of existing updating procedures and a) review of existing updating procedures and communication channels (see 5.5 and 7.7),communication channels (see 5.5 and 7.7),

b) review of the conclusions of the hazard b) review of the conclusions of the hazard analysis (see 7.4), the design of operational analysis (see 7.4), the design of operational PRP’s (see 7.5) and the HACCP plan (see PRP’s (see 7.5) and the HACCP plan (see 7.6.1),7.6.1),

c) evaluation of the infrastructure and c) evaluation of the infrastructure and maintenance programs (see 7.2.2), andmaintenance programs (see 7.2.2), and

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d) evaluation of the effectiveness of human resource d) evaluation of the effectiveness of human resource management and of training activities (see 6.2).management and of training activities (see 6.2).

Verification results shall be recorded and shall be Verification results shall be recorded and shall be communicated to the food safety team. communicated to the food safety team.

Verification results shall be provided to enable the Verification results shall be provided to enable the analysis of the results of the verification activities (see analysis of the results of the verification activities (see 8.3.3).8.3.3).

If system verification is based on testing of end product If system verification is based on testing of end product samples and where such testing samples show lack of samples and where such testing samples show lack of compliance with the acceptable level of the food safety compliance with the acceptable level of the food safety hazard (see 7.4.2), the affected lot(s) shall be handled hazard (see 7.4.2), the affected lot(s) shall be handled asas

potentially unsafe products in accordance with 7.9.4.potentially unsafe products in accordance with 7.9.4.

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8.3.3 Analysis of results of verification 8.3.3 Analysis of results of verification activitiesactivities

The food safety team shall analyze the results of The food safety team shall analyze the results of verification activities, including the results of the verification activities, including the results of the internal audits.internal audits.

The analysis shall be carried out in order toThe analysis shall be carried out in order to a) confirm that the overall performance of the a) confirm that the overall performance of the

system meets the planned arrangements, meets system meets the planned arrangements, meets the requirements of this International Standard the requirements of this International Standard and the food safety management system and the food safety management system requirements established by therequirements established by the

organization,organization,

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b) identify the need for updating or improvement b) identify the need for updating or improvement of the food safety management system,of the food safety management system,

c) identify trends which indicate the risk of a c) identify trends which indicate the risk of a higher incidence of potentially unsafe products,higher incidence of potentially unsafe products,

d) establish information for the planning of the d) establish information for the planning of the internal audit program concerning the status and internal audit program concerning the status and importance of areas to be audited, andimportance of areas to be audited, and

e) provide evidence that corrective actions and e) provide evidence that corrective actions and corrections that have been taken are effective.corrections that have been taken are effective.

The result of the analysis and resulting activities The result of the analysis and resulting activities shall be recorded and shall in relevant form be shall be recorded and shall in relevant form be reported to top management as input to the reported to top management as input to the management review (see 5.8.2). It shall also be management review (see 5.8.2). It shall also be used as an input to food safety management used as an input to food safety management system updating (see 8.5.2).system updating (see 8.5.2).

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** 8.4 Validation of control measure 8.4 Validation of control measure

combinationscombinations For the initial design of the combination of For the initial design of the combination of

control measures to be included in operational control measures to be included in operational PRPs and the HACCP plan and after any PRPs and the HACCP plan and after any change therein (7.4.4), the organization shall change therein (7.4.4), the organization shall confirm that the control measure combinations confirm that the control measure combinations are capable of achieving the intended level of are capable of achieving the intended level of control of the identified food safety hazards.control of the identified food safety hazards.

Validation activities shall include actions to Validation activities shall include actions to confirm that a) the established critical limits for confirm that a) the established critical limits for CCPs are capable of achieving the intended CCPs are capable of achieving the intended control of the food safety hazard(s) for which control of the food safety hazard(s) for which they are designated (7.6.3), andthey are designated (7.6.3), and

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b) the control measures are effective and capable of, in b) the control measures are effective and capable of, in combination, ensuring control of the identified food combination, ensuring control of the identified food safety hazards to obtain end products that meet the safety hazards to obtain end products that meet the defined acceptable levels (7.4.4).defined acceptable levels (7.4.4).

If validation results show that one or more of the above If validation results show that one or more of the above elements cannot be confirmed, the control measure elements cannot be confirmed, the control measure systemsystem

shall be modified and reassessed (see 7.4.1). shall be modified and reassessed (see 7.4.1). Modifications may include changes in control measures Modifications may include changes in control measures

(i.e. process parameters, stringencies, intensities and/or (i.e. process parameters, stringencies, intensities and/or their combination) and/or change(s) in the raw materials, their combination) and/or change(s) in the raw materials, manufacturing technologies, end product characteristics, manufacturing technologies, end product characteristics, methods of distribution, and/or intended use of the end methods of distribution, and/or intended use of the end product.product.

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8.5 Improvement8.5 Improvement 8.5.1 Continual improvement8.5.1 Continual improvement The organization shall continually improve its food safety The organization shall continually improve its food safety

management by meeting the requirements concerning management by meeting the requirements concerning planning and realization of safe product, as presented in 7.planning and realization of safe product, as presented in 7.

Top management shall ensure that the organization Top management shall ensure that the organization continually improves the effectiveness of the food safety continually improves the effectiveness of the food safety management system through the use of communication management system through the use of communication (see 5.5), management review (see 5.8), internal audit (see 5.5), management review (see 5.8), internal audit (see 8.3.1), evaluation of individual verification results (see (see 8.3.1), evaluation of individual verification results (see 8.3.2), analysis of results of verification activities (see 8.3.2), analysis of results of verification activities (see 8.3.3), validation of control measure combinations (see 8.3.3), validation of control measure combinations (see 8.4) and food safety management system updating (see 8.4) and food safety management system updating (see 8.5.2).8.5.2).

NOTE See ISO 9001 for guidance on continual NOTE See ISO 9001 for guidance on continual improvement of quality management system effectiveness.improvement of quality management system effectiveness.

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8.5.2 Food safety management system 8.5.2 Food safety management system updatingupdating

Top management shall ensure that the food Top management shall ensure that the food safety management system is updated in a safety management system is updated in a timely manner to ensure food safety.timely manner to ensure food safety.

The food safety team shall at defined intervals The food safety team shall at defined intervals evaluate and assess customer feed back evaluate and assess customer feed back including complaints related to food safety, audit including complaints related to food safety, audit reports, and results of verification activity reports, and results of verification activity analyses (see 8.3.3). analyses (see 8.3.3).

The necessity of reviewing the hazard analysis The necessity of reviewing the hazard analysis (7.4) and the design of the operational PRP(s) (7.4) and the design of the operational PRP(s) (7.5) and the HACCP plan (7.6) shall then be (7.5) and the HACCP plan (7.6) shall then be considered.considered.

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The input for the updating evaluation and The input for the updating evaluation and assessment activities shall beassessment activities shall be

a) communication, external as well as internal, a) communication, external as well as internal, as stated in 5.5,as stated in 5.5,

b) other information concerning the suitability, b) other information concerning the suitability, adequacy and effectiveness of the food safety adequacy and effectiveness of the food safety management system,management system,

c) output from the analysis of results of c) output from the analysis of results of verification activities (8.3.3), andverification activities (8.3.3), and

d) output from management review.d) output from management review. System updating activities shall be recorded and System updating activities shall be recorded and

in relevant form be reported as input to the in relevant form be reported as input to the management review (see 5.7.2).management review (see 5.7.2).