ISO 22000:2018 Transition Workshop (Auditors)

Transcription

1 ISO 22000:2018 Transition Workshop (Auditors)

2 What has changed? high level structure consistent with all MS standards risk approach different approach to understanding risk consistent with other MS standards PDCA cycle clarified to one for the FSMS and one for the principles of HACCP operations clearer differences between CCPs, OPRPs and PRPs Hazard Control Plan rather than OPRP and/or HACCP Plan more logical reorganisation of Standard s clauses.

3 What else? FSMS principles common to ISO Management system standards have been included elimination of redundant terms (eg suppliers & customers are now all included under interested parties) number of definitions increased from 17 to 45; significant food safety hazard ; elimination" of significant food safety hazards has been removed, leaving only reduction or prevention definitions of CCPs and OPRPs have been enhanced; clarification between validation, verification and monitoring included; food, feed and animal food terms have also been included.

4 And more. organisational context external and internal issues; needs and expectations of interested parties services added to scope definition requirements the word "document" has been removed giving an open decision how to manage the FSMS responsibilities of top management have been extended, including demonstrable leadership and supporting other relevant management roles responsibilities need to be understood new requirements for determining risks and opportunities (events and their consequences relating to performance & effectiveness of the FSMS).

5 And more. food safety, statutory, regulatory and customer requirements shall be taken into account when defining objectives consideration of capability & constraints of existing resources (incl external resources discussion of external experts) control of providers of products and services in addition to outsourced processes now requirement for evaluation, selection, monitoring of performance/re-evaluation competence rather than trained awareness of Policy, relevant objectives and affect of nonconforming.

6 And more.. external communication relevant to FSMS not only food safety documentation to include ID, description and format operational control now includes planned and unintended charges and outsourced processes PRPs for supplier approval and product information, consumer awareness traceability system must be verified and tested minimum info required to conduct hazard analysis, including distribution and delivery.

7 And more! hazard ID to include regulatory/customer requirements elimination of food safety hazards removed; must ID significant food safety hazards control measures to be managed as OPRPs or CCPs; Hazard Control Plan rather than HACCP Plan; feasibility of establishing control measures and timely corrections verification includes effectiveness of PRPs and impartiality of verifier action criteria (for OPRP) triggers correction/ca changes in FSMS and monitoring of PRPs may affect Audit Program more inputs to management review (performance/effectiveness) increased trend analysis for nonconformities.

8 Overarching Requirement Must comply with local legislative and regulatory requirements!

9 TQCSI Transition Arrangement clients will need to be certified to ISO 22000:2018 by 1 June 2021 applications only for ISO 22000:2018 after 30 June 2019 clients transferring to ISO 22000:2018 will need an audit with same duration as for a Triennial Audit (recertification audit); hence transition will normally coincide with next Triennial Audit certification expiry date will not normally change clients may opt to transition before the next scheduled Triennial Audit but only when their respective auditors have been trained and deemed competent from 1 January 2019, ISO 22000:2005 audits will include ISO 22000:2018 requirements as time allows but only Observations will be raised.

10 High Level Structure the new standard adopts the high-level structure and terminology of Annex SL (used for the development of all new ISO standards) High Level Structure - identical core text and common terms and core definitions for use in all Management System Standards: purpose - enhance the consistency and alignment of different management system standards organisations that integrate multiple standards (eg FSMS with QMS, EMS, OHS, etc) will see the most benefit uses simplified language and writing styles to aid understanding and consistent interpretations of requirements.

11 Common structure for MSS Introduction 1. Scope 2. Normative references 3. Terms and definitions 4. Context of the organisation 5. Leadership 6. Planning 7. Support 8. Operation 9. Performance evaluation 10. Improvement.

12 Clause structure (4-6) 4. Context of the organisation Understanding the organisation and its context Understanding the needs and expectations of interested parties Determining the scope of the food safety management system Food safety management system 5. Leadership Leadership and commitment Policy Organisational roles, responsibilities and authorities 6. Planning Actions to address risks and opportunities Objectives of the FSMS and planning to achieve them Planning of changes.

13 Clause structure (7-8) 7. Support Resources Competence Awareness Communication Documented information 8. Operation Operational planning and control Prerequisite programs (PRPs) Traceability system Emergency preparedness and response Hazard control Updating the information specifying the PRPs and the hazard control plan Control of monitoring and measuring Verification related to PRPs and the hazard control plan Control of product and process nonconformities.

14 Clause structure (9-10) 9. Performance evaluation Monitoring, measurement, analysis and evaluation Internal audit Management review 10. Improvement Nonconformity and corrective action Continual improvement Update of the food safety management system.

15 ISO 22000:2018 Food safety management systems Requirements for any organisations in the food chain.

16 Introduction 0.1 General 0.2 FSMS principles 0.3 Process approach Introduces the rationale for the Standard - more formally structured. 0.4 Relationship with other management system standards

17 0.1 General improving performance in food safety process approach risk based thinking.

18 0.2 FSMS principles adequate control throughout the food chain through interactive communication, system management, prerequisite programmes and HACCP principles principles common to ISO management standards: customer focus leadership engagement of people process approach improvement evidence-based thinking relationship management.

19 0.3 Process approach adoption of process approach managing inter-related processes as a System recognition of role and position within the food chain is essential to ensure effective communication PDCA cycle see over.

20 PDCA cycle at two levels

21 0.4 Relationship with other management system standards ISO 22000:2018 conforms to the high level structure (identical core text and common terms with core definitions) facilitates integrating multiple systems embraces risk based thinking role of prerequisite programmes;

22 0.4 Prerequisite programs ISO/TS :2009, Food manufacturing ISO/TS :2013, Catering ISO/TS :2011, Farming ISO/TS :2013, Food packaging manufacturing ISO/TS :2016, Feed and animal food production PAS 221:2013, Retail/supermarkets NEN/NTA 8059:2016, Transport and storage (ISO in Oct 19).

23 Section 1 - Scope minor change applicable to any organisation products and services.

24 Section 2 Normative references nil! maintains clause numbering consistency.

25 Section 3 Terms and Definitions action criteria measureable or observable specification for the monitoring of an OPRP animal food single or multiple products, whether processed, semi-processed or raw, which are intended to be fed to non-food producing animals contamination introduction or occurrence of a contaminant, including a food safety hazard in a product or processing environment control measure - action or activity that is essential to prevent a significant food safety hazard or reduce it to an acceptable level correction - action to eliminate a detected nonconformity corrective action - action to eliminate the causes of a nonconformity and to prevent recurrence.

26 Terms and Definitions cont. critical control point (CCP) - step in the process at which control measures are applied to prevent or reduce a significant food safety hazard to an acceptable level, and defined critical limits and measurement enable the application of corrections critical level measureable value which separates acceptability from unacceptability end product product that will undergo no further processing or transformation by the organisation.

27 Terms and Definitions cont. feed single or multiple products, whether processed, semiprocessed or raw, which are intended to be fed to food producing animals food substance (ingredient), whether processed, semiprocessed 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 flow diagram schematic and systematic presentation of the sequence and interactions of steps in the process food safety hazard - biological, chemical or physical agent in food with the potential to cause an adverse health effect.

28 Terms and Definitions cont. nonconformity non-fulfilment of a requirement prerequisite programme (PRP) - basic conditions and activities that are necessary within the organisation and throughout the food chain to maintain food safety operational prerequisite programme (OPRP) control measure or combination of control measures applied to prevent or reduce a significant food safety hazard to an acceptable level, and where action criteria and measurement or observation enable effective control of the process and/or product.

29 Terms and Definitions cont. significant food safety hazard food safety hazard, identified through the hazard assessment, which needs to be controlled by control measures. verification obtaining evidence that a control measure (or combination of control measures) will be capable of effectively controlling the significant food safety hazard validation confirmation, through the provision of objective evidence, that specified requirements have been fulfilled.

30 Section 4 Context of the Organisation 4.1 Understanding the organisation and its context 4.2 Understanding the needs and expectations of interested parties 4.3 Determining the scope of the food safety management system 4.4 Food safety management system this is a new clause and provides a key insight into the organisation What determines the organisation s food safety management system.

31 Section 4 Context of the organisation 4.1 Understanding the organisation and its context 4.2 Understanding the needs and expectations of interested parties 4.3 Determining the scope of the food safety management system 4.4 Food safety management system determine external and internal issues relevant to the FSMS identify, review and update relevant information No equivalent

32 Section 4 Context of the organisation 4.1 Understanding the organisation and its context 4.2 Understanding the needs and expectations of interested parties 4.3 Determining the scope of the food safety management system 4.4 Food safety management system determine interested parties relevant to the FMS determine their needs and requirements identify, review and update relevant information No equivalent

33 Section 4 Context of the organisation 4.1 Understanding the organisation and its context 4.2 Understanding the needs and expectations of interested parties 4.3 Determining the scope of the food safety management system 4.4 Food safety management system establish scope by determining boundaries and applicability of the FSMS consider external/internal issues, interested parties and their requirements scope must be documented and available clause 4.1

34 Section 4 Context of the organisation 4.1 Understanding the organisation and its context 4.2 Understanding the needs and expectations of interested parties 4.3 Determining the scope of the food safety management system 4.4 Food safety management system must establish, implement, maintain, update and continually improve the FSMS clause 4.1

35 Section 5 - Leadership 5.1 Leadership and commitment 5.2 Policy 5.3 Organisational roles, responsibilities and authorities top management s involvement in the FSMS What is required by top management.

36 Section 5 Leadership 5.1 Leadership and commitment 5.2 Policy 5.3 Organisational roles, responsibilities and authorities ensure food safety and objectives are established FSMS integrated into business processes resources communicating importance of effective FSMS and compliance evaluate and maintained supporting contributions to the FSMS promoting continual improvement supporting all managers to demonstrate leadership clauses 5.1 & 7.4.3

37 Section 5 - Leadership 5.2 Policy Establishing the food safety policy Communicating the food safety policy appropriate provides a framework for setting and reviewing FSMS objectives commitment to food safety requirements, including statutory/regulatory and customer requirements addresses internal and external communication commitment to continual improvement ensure food safety competencies clause 5.2

38 Section 5 Leadership 5.2 Policy Establishing the food safety policy Communicating the food safety policy documented and available communicated, understood and applied within the organisation available to interested parties clause 5.2

39 Section 5 Leadership 5.1 Leadership and commitment 5.2 Policy 5.3 Organisational roles, responsibilities and authorities responsibilities and authorities are assigned, communicated and understood, ensuring: FSMS conformance to ISO reporting on FSMS performance appointing FST and FST Leader initiate and document actions; 2005 clauses 5.4, 5.5 & 7.3.2

40 Section 5 Leadership 5.1 Leadership and commitment 5.2 Policy 5.3 Organisational roles, responsibilities and authorities FST Leader must be responsible for: ensuring FSMS is established, maintained and updated managing and organising work for FST ensuring relevant training and competencies of the FST reporting on effectiveness and of FSMS. everyone must have responsibility to report problems clauses 5.4, 5.5 & 7.3.2

41 Section 6 - Planning 6.1 Actions to address risks and opportunities 6.2 Objectives of the food safety management system and planning to achieve them 6.3 Planning of changes introduces risk based approach to planning addresses food safety objectives How food safety management is planned.

42 Section 6 Planning 6.1 Actions to address risks and opportunities 6.2 Objectives of the food safety management system and planning to achieve them 6.3 Planning of changes must consider external/internal issues and interested parties must determine and address risks and opportunities assurance that FSMS can work, enhance desirable effects, prevent undesired effects and achieve continual improvement action taken is to be proportionate to the impact on food safety, conformity and requirements of interested parties in food chain no equivalent

43 Section 6 Planning 6.1 Actions to address risks and opportunities 6.2 Objectives of the food safety management system and planning to achieve them 6.3 Planning of changes FSMS objectives must be established and documented must be consistent with Food Safety Policy, measureable, compliant, monitored and verified, communicated, maintained and updated objectives must include what, resources, who, when and evaluation clause 5.3

44 Section 6 Planning 6.1 Actions to address risks and opportunities 6.2 Objectives of the food safety management system and planning to achieve them 6.3 Planning of changes changes to FSMS, including personnel, must be planned and communicated consider: purpose of change and potential consequences continued integrity of FSMS availability of resources responsibilities and authorities clause 5.3

45 Section 7.1- Support 7.1 Resources 7.2 Competence 7.3 Awareness 7.4 Communication 7.5 Documented Information much of the previous Clause 6 has been written into this newly constructed clause The support required to meet the organisation s food safety goals.

46 Section 7 - Support 7.1 Resources General People Infrastructure Work environment Externally developed elements of the FSMS Control of externally provided processes, products and services must determine and provide resources required for FSMS consider capability and constraints of internal resources and need for external resources clause 6.1

47 Section Support 7.1 Resources General People Infrastructure Work Environment Externally developed elements of the FSMS Control of externally provided processes, products and services must ensure competence if using external experts, evidence of agreements or contracts defining the competence and responsibility must be documented clauses 6.2

48 Section Support 7.1 Resources General People Infrastructure Work Environment Externally developed elements of the FSMS Control of externally provided processes, products and services infrastructure must be maintained to ensure conformity with the FSMS clause 6.3

49 Section Support 7.1 Resources General People Infrastructure Work Environment Externally developed elements of the FSMS Control of externally provided processes, products and services must determine, provide and maintain resources for work environment clause 6.4

50 Section Support 7.1 Resources General People Infrastructure Work Environment Externally developed elements of the FSMS Control of externally provided processes, products and services when using externally developed elements of a FSMS (eg PRPs, hazard analysis and hazard control plan), must ensure the provided elements: developed in conformance with ISO applicable and specifically adapted documented no equivalent

51 Section Support 7.1 Resources General People Infrastructure Work Environment Externally developed elements of the FSMS Control of externally provided processes, products and services must establish and apply criteria for evaluation, selection, monitoring of performance and re-evaluation of external providers ensure adequate communication ensure externally provided process, products or services don t adversely affect FSMS records required clause 4.1

52 Section 7- Support 7.1 Resources 7.2 Competence 7.3 Awareness 7.4 Communication 7.5 Documented Information must determine competency, including external providers and FST ensure FST has multi-disciplinary knowledge and experience records required clauses 6.2 & 7.3.2

53 Section Support 7.1 Resources 7.2 Competence 7.3 Awareness 7.4 Communication 7.5 Documented Information must ensure awareness of: Food Safety Policy FSMS objectives individual contribution to FSMS implications of not conforming with FSMS clause 6.2.2

54 Section 7- Support 7.4 Communication General External communication Internal communication must determine what internal and external communication is relevant to FSMS, including who, what, when, who to and how must ensure the requirements for effective communication is understood clause 6.2.2

55 Section 7.1- Support 7.4 Communication General External communication Internal communication must ensure sufficient information is communicated and available to the food chain, including: external providers and contractors customers and consumers (product information, food safety hazards requiring control, contractual arrangements, feedback and complaints) statutory and regulatory authorities other organisations impacting the FSMS must define responsibilities and authorities for external commutation records of external communication must be retained clause 5.6.1

56 Section 7.1- Support 7.4 Communication General External communication Internal communication must establish, implement and maintain effective communication regarding food safety FST must be informed of various requirements listed in the clause FST must ensure information is included when updating the FSMS clause 5.6.2

57 Section 7 - Support 7.5 Documented Information General Creating and updating Control of documented information FSMS must include: documents and records required by ISO documents and records required by the organisation documents, records and food safety requirements required by regulatory authorities and customers clauses & 5.6.1

58 Section 7 - Support 7.5 Documented Information General Creating and updating Control of documented information documented information requires: identification and description format and media review and approval clause 4.2

59 Section 7 - Support 7.5 Documented Information General Creating and updating Control of documented information documented information (including external origin) is to be controlled to ensure: availability and suitability adequate protection must address: distribution, access, retrieval and use storage and preservation version control retention and disposition clauses & 4.2.3

60 Section 8 - Operation 8.1 Operational planning and control 8.2 Prerequisite programmes (PRPs) 8.3 Traceability system 8.4 Emergency preparedness and response 8.5 Hazard control 8.6 Updating the information specifying the PRPs and hazard control plan 8.7 Control monitoring and measuring 8.8 Verification related to PRPs and the hazard control plan specific section created for operational planning, controlling food safety and dealing with emergencies How to control operations. 8.9 Control of product and process nonconformities

61 Section 8 - Operation 8.1 Operational planning and control 8.2 Prerequisite Programmes (PRPs) 8.3 Traceability system 8.4 Emergency preparedness and response 8.5 Hazard control 8.6 Updating the information specifying the PRPs and hazard control plan 8.7 Control monitoring and measuring 8.8 Verification related to PRPs and the hazard control plan 8.9 Control of product and process nonconformities must control processes to ensure safe food by establishing criteria, implementing controls and retaining records to have confidence in the controls must control changes must control outsourced processes No equivalent

62 Section 8 - Operation 8.1 Operational planning and control 8.2 Prerequisite plans (PRPs) 8.3 Traceability system 8.4 Emergency preparedness and response 8.5 Hazard control 8.6 Updating the information specifying the PRPs and the hazard control plan 8.7 Control of monitoring and measuring 8.8 Verification related to PRPs and the hazard control plan 8.9 Control of product and process nonconformities must implement PRPs to prevent/reduce contaminants, including food safety hazards PRPs must be appropriate, implemented across entire production system and approve by FST must consider applicable ISO and other standards/codes/guidelines required considerations for establishing PRPs are listed in the clause procedures are required clause 7.2

63 Section 8 - Operation 8.1 Operational planning and control 8.2 Prerequisite plans (PRPs) 8.3 Traceability system 8.4 Emergency preparedness and response 8.5 Hazard control 8.6 Updating the information specifying the PRPs and the hazard control plan 8.7 Control of monitoring and measuring 8.8 Verification related to PRPs and the hazard control plan 8.9 Control of product and process nonconformities must be able to uniquely identify incoming material and first stage of distribution route for end product records required to prove traceability system for shelf life of product traceability system must be verified and tested clause 7.9

64 Section 8 - Operation 8.1 Operational planning and control 8.2 Prerequisite plans (PRPs) 8.3 Traceability system 8.4 Emergency preparedness and response 8.5 Hazard control 8.6 Updating the information specifying the PRPs and the hazard control plan 8.7 Control of monitoring and measuring 8.8 Verification related to PRPs and the hazard control plan 8.9 Control of product and process nonconformities see over clause 7.9

65 Section 8 - Operation 8.4 Emergency preparedness and response General Handling emergencies and incidents procedures are required to respond to emergency situations that can affect food safety clause 5.7

66 Section 8 - Operation 8.4 Emergency preparedness and response General Handling emergencies and incidents must respond to actual emergencies, including ensuring compliance and communicating internally and externally must mitigate potential food safety impact test procedures with practical review procedures after any emergency or test No equivalent

67 Section 8 - Operation 8.1 Operational planning and control 8.2 Prerequisite plans (PRPs) 8.3 Traceability system 8.4 Emergency preparedness and response 8.5 Hazard control 8.6 Updating the information specifying the PRPs and the hazard control plan 8.7 Control of monitoring and measuring 8.8 Verification related to PRPs and the hazard control plan 8.9 Control of product and process nonconformities see over clause 7.9

68 Section 8 - Operation 8.5 Hazard control Preliminary steps to enable hazard analysis General Characteristics of raw materials, ingredients and product contact materials Characteristics of end products Intended use Flow diagrams and descriptions of processes documented information must be collected, maintained and updated, including complying with conformance and/or customer requirements; organisation s products, process and equipment; and food safety hazards clause 7.3.1

69 Section 8 - Operation 8.5 Hazard control Preliminary steps to enable hazard analysis General Characteristics of raw materials, ingredients and product contact materials Characteristics of end products Intended use Flow diagrams and descriptions of processes must ensure statutory/regulatory food safety requirements are met for raw materials, ingredients and packaging records must be retained to facilitate hazard analysis, including criteria described in the clause clause

70 Section 8 - Operation 8.5 Hazard control Preliminary steps to enable hazard analysis General Characteristics of raw materials, ingredients and product contact materials Characteristics of end products Intended use Flow diagrams and descriptions of processes must ensure statutory/regulatory food safety requirements are met for end products records must be retained to facilitate hazard analysis, including information described in the clause clause

71 Section 8 - Operation 8.5 Hazard control Preliminary steps to enable hazard analysis General Characteristics of raw materials, ingredients and product contact materials Characteristics of end products Intended use Flow diagrams and descriptions of processes must document to facilitate hazard analysis of the end product s: intended use (including reasonably expected handling) unintended use (but reasonably expected mishandling and misuse) consumer groups may be identified, particularly if they are especially vulnerable clause 7.3.4

72 Section 8 - Operation 8.5 Hazard control Preliminary steps to enable hazard analysis General Characteristics of raw materials, ingredients and product contact materials Characteristics of end products Intended use Flow diagrams and description of processes see over clause

73 Section 8 - Operation 8.5 Hazard control Preliminary steps to enable hazard analysis Flow diagrams and description of processes Preparation of the flow diagrams On-site confirmations of flow diagrams Description of processes and process environment documented flow diagrams for products or product categories and processes flow diagrams must include: sequence and interaction of steps in operation any outsourced processes where raw materials, ingredients, processing aids, packaging, utilities, etc enter the flow where reworking or recycling occurs where end products, intermediate products, by-products and waste are removed clause

74 Section 8 - Operation 8.5 Hazard control Preliminary steps to enable hazard analysis Flow diagrams and description of processes Preparations of the flow diagrams On-site confirmation of flow diagrams Description of processes and process environment FST must confirm accuracy of flow diagrams clause

75 Section 8 - Operation 8.5 Hazard control Preliminary steps to enable hazard analysis Flow diagrams and description of processes Preparations of the flow diagrams On-site confirmation of flow diagrams Description of processes and process environment must document: layout of premises processing equipment and contact materials, processing aids existing PRPs and procedures, process parameters and control measure. any external requirements any variations resulting from seasonal changes or shift patterns clauses &

76 Section 8 - Operation 8.5 Hazard control Hazard analysis General Hazard identification and determination of acceptable levels Hazards assessment Selection and categorisation of control measures hazard analysis is to be conducted to determine the hazards that need to be controlled clause 7.4

77 Section 8 - Operation 8.5 Hazard control Hazard analysis General Hazard identification and determination of acceptable levels Hazards assessment Selection and categorisation of control measures must document all food safety hazards expected based on: preliminary information experience internal and external information information from the food chain statutory/regulatory and compliance requirements the steps at which food safety hazards occur must be identified the acceptable level in end product of each food safety hazard is to be determined and documented acceptable levels must be justified clause 7.4.2

78 Section 8 - Operation 8.5 Hazard control Hazard analysis General Hazard identification and determination of acceptable levels Hazards assessment Selection and categorisation of control measures hazard assessment is to be conducted to determine whether each food safety hazard s prevention or reduction to an acceptable level is essential assessment is to include: likelihood of occurrence in end product without controls severity of health effects assessment methodology is to be documented and records of the hazard assessment are to be retained clauses & 7.6.2

79 Section 8 - Operation 8.5 Hazard control Hazard analysis General Hazard identification and determination of acceptable levels Hazards assessment Selection and categorisation of control measures appropriate control measures or combination of control measures capable of preventing or reducing the food safety hazards to an acceptable level are to be selected using a systematic approach control measures are to be managed as OPRPs or CCPs for each control measure, there is to be an assessment for: likelihood of failure severity of consequence for each control measure there is to be an assessment of feasibility of: establishing measurable critical limits and/or measureable, observable action criteria monitoring timely corrections the selection and categorization of control measures is to be documented, including any external requirements clauses & 7.4.4

80 Section 8 - Operation 8.5 Hazard control Validation of control measures and combinations of control measures control measures are to be validated validation methodology and evidence of the control measures capability is to be documented clause 8.2

81 Section 8 - Operation 8.5 Hazard control Hazard control plan (HACCP/OPRP plan) General Determination of critical limits and action criteria Monitoring systems at CCPs and for OPRPs Actions when critical limits or actions criteria are not met Implementation of the hazard control plan hazard control plan is to be documented and include the following for each: food safety hazard critical limit for CCP or action criteria for OPRP monitoring procedure corrections to be made if critical limits or action criteria are not met responsibilities or authorities records of monitoring clause 7.5 & 7.6.1

82 Section 8 - Operation 8.5 Hazard control Hazard control plan (HACCP/OPRP plan) General Determination of critical limits and action criteria Monitoring systems at CCPs and for OPRPs Actions when critical limits or actions criteria are not met Implementation of the hazard control plan rationale for determining critical limits and action criteria is to be documented critical limits for CCPs are to be measurable action criteria for OPRPs is to be measurable or observable clause 7.6.3

83 Section 8 - Operation 8.5 Hazard control Hazard control plan (HACCP/OPRP plan) General Determination of critical limits and action criteria Monitoring systems at CCPs and for OPRPs Actions when critical limits or actions criteria are not met Implementation of the hazard control plan CCPs and OPRPs are to be monitored and documented, including: the measurements or observations the monitoring methods or devices used applicable calibration methods (for OPRPs, equivalent methods of verification) monitoring frequency monitoring results responsibilities or authorities responsibility and authority for evaluation results monitoring of CCPs must be timely monitoring of OPRPs are to be proportionate to the likelihood and severity clauses & 7.6.4

84 Section 8 - Operation 8.5 Hazard control Hazard control plan (HACCP/OPRP plan) General Determination of critical limits and action criteria Monitoring systems at CCPs and for OPRPs Actions when critical limits or actions criteria are not met Implementation of the hazard control plan corrections and corrective action is to be taken when critical limits or action criteria are not met clause 7.6.5

85 Section 8 - Operation 8.5 Hazard control Hazard control plan (HACCP/OPRP plan) General Determination of critical limits and action criteria Monitoring systems at CCPs and for OPRPs Actions when critical limits or actions criteria are not met Implementation of the hazard control plan the hazard control plan is to be implemented and records retained accordingly No equivalent

86 Section 8 - Operation 8.1 Operational planning and control 8.2 Prerequisite programmes (PRPs) 8.3 Traceability system 8.4 Emergency preparedness and response 8.5 Hazard control 8.6 Updating the information specifying the PRPs and the hazard control plan 8.7 Control monitoring and measuring 8.8 Verification related to PRPs and the hazard control plan 8.9 Control of product and process nonconformities when the hazard control plan is implemented, preliminary information is to be updated the hazard control plan and PRPs are to be up to date clause 7.7

87 Section 8 - Operation 8.1 Operational planning and control 8.2 Prerequisite programmes (PRPs) 8.3 Traceability system 8.4 Emergency preparedness and response 8.5 Hazard control 8.6 Updating the information specifying the PRPs and the hazard control plan 8.7 Control of monitoring and measuring 8.8 Verification related to PRPs and the hazard control plan 8.9 Control of product and process nonconformities monitoring and measuring equipment is to be calibrated or verified at specified intervals, adjusted if necessary, identified and safeguarded from adjustments and protected results of calibration and verification are to be retained calibration is to be traceable to international or national standards equipment found nonconforming is to be validated for previous measurements software used for monitoring and measuring is to be validated clause 8.3

88 Section 8 - Operation 8.1 Operational planning and control 8.2 Prerequisite programmes (PRPs) 8.3 Traceability system 8.4 Emergency preparedness and response 8.5 Hazard control 8.6 Updating the information specifying the PRPs and the hazard control plan 8.7 Control monitoring and measuring 8.8 Verification related to PRPs and the hazard control plan 8.9 Control of product and process nonconformities see over.

89 Section 8 - Operation 8.8 Verification related to PRPs and the hazard control plan Verification Analysis of results of verification activities verification of PRPs and hazard control plan is to be planned and implemented verification records are to be retained end product tested and identifying nonconformities is to be treated as potentially unsafe product and corrective action is to be implemented clauses 7.8 & 8.4.2

90 Section 8 - Operation 8.8 Verification related to PRPs and the hazard control plan Verification Analysis of results of verification activities FST is to analyse results of verification clause 8.4.3

91 Section 8 - Operation 8.1 Operational planning and control 8.2 Prerequisite programmes (PRPs) 8.3 Traceability system 8.4 Emergency preparedness and response 8.5 Hazard control 8.6 Updating the information specifying the PRPs and the hazard control plan 8.7 Control of monitoring and measuring 8.8 Verification related to PRPs and the hazard control plan 8.9 Control of product and process nonconformities see over clause 7.10

92 Section 8 - Operation 8.9 Control of product and process nonconformities General Corrections Corrective actions Handling of potentially unsafe products Withdrawal/recall CCP and OPRP monitoring data is to be evaluated by persons with the authority to initiate corrections and corrective action clauses &

93 Section 8 - Operation 8.9 Control of product and process nonconformities General Corrections Corrective actions Handling of potentially unsafe products Withdrawal/recall when critical limits or action criteria are exceeded, the product affected is to be identified and controlled (potentially unsafe product) procedures required to document: the method of identification, assessment and correction review of corrections records are to be retained on corrections of nonconforming product and processes, including nature of nonconforming cause of the failure consequences clause

94 Section 8 - Operation 8.9 Control of product and process nonconformities General Corrections Corrective actions Handling of potentially unsafe products Withdrawal/recall need for corrective action is to be evaluated when critical limits or action criteria are exceeded actions to identify and eliminate cause of nonconformities is to be documented, including trend analysis, root cause analysis, corrective action and verification of corrective action clauses

95 Section 8 - Operation 8.9 Control of product and process nonconformities General Corrections Corrective actions Handling of potentially unsafe products Withdrawal/recall see over clause

96 Section 8 - Operation 8.9 Control of product and process nonconformities Handling of potentially unsafe products General Evaluation for release Disposition of nonconforming products acceptable levels must be met before food can enter the food chain potentially unsafe products must be controlled if potentially unsafe products have entered the food chain, must notify relevant interested parties and initiate withdrawal/recall records must be retained of all relevant information and communication clauses

97 Section 8 - Operation 8.9 Control of product and process nonconformities Handling of potentially unsafe products General Evaluation for release Disposition of nonconforming products each lot/batch of products affected by the nonconformity is to be evaluated if product is outside critical limits (CCPs), they are not to be released if product is outside action criteria (OPRPs), they are not to be released unless other evidence proves it is safe records of evaluation for release of products is to be retained clause

98 Section 8 - Operation 8.9 Control of product and process nonconformities Handling of potentially unsafe products General Evaluation for release Disposition of nonconforming products product that cannot be released is to be: reprocessed to acceptable limits redirected for other use as long as safe to do so destroyed or disposed as waste records must be retained, including identification of the approver clause

99 Section 8 - Operation 8.9 Control of product and process nonconformities General Corrections Corrective actions Handling of potentially unsafe products Withdrawal/recall must be able to withdraw/recall competently records must be retained of: communicating with interested parties handling withdrawn/recalled products and product in stock the withdrawal/recall process the cause, extent and result of the withdrawal/recall withdrawn/recalled product and product in stock must be controlled mock recalls or similar must be conducted and recorded clause

100 Section 9 Performance evaluation 9.1 Monitoring, measurement, analysis and evaluation 9.2 Internal audit 9.3 Management review performance is to be monitored and analysed conducting internal audits and management review How food safety performance is evaluated.

101 Section 9 Performance Evaluation 9.1 Monitoring, measurement, analysis and evaluation General Analysis and evaluation must determine what, how, when needs to be measured and how results are analysed and evaluated records must be retained and reported must evaluate the performance and effectiveness of the FSMS No equivalent

102 Section 9 Performance Evaluation 9.1 Monitoring, measurement, analysis and evaluation General Analysis and evaluation must analyse and evaluate monitoring and measurement data, including verification activities and internal and external audits results of analysis must be recorded and reported clauses & 8.4.3

103 Section 9 Performance Evaluation 9.1 Monitoring, measurement, analysis and evaluation 9.2 Internal audit 9.3 Management review planned intervals must plan audit program, including frequency, methods, responsibilities, planning and reporting based on risk, changes to FSMS, results of monitoring and audits competent, objective and impartial report results to FST records retained take appropriate action determine if FSMS meets Food Safety Policy and objectives clause 8.4.1

104 Section 9 Performance Evaluation 9.1 Monitoring, measurement, analysis and evaluation 9.2 Internal audit 9.3 Management review planned intervals increased agenda items evidence of management review results, including decisions and actions, and changes to the FSMS, must be documented clause 5.8

105 Section 10 - Improvement 10.1 Nonconformity and corrective action 10.2 Continual improvement 10.3 Update of the food safety management system nonconformities must be identified and reacted to corrective action must be considered FSMS must continually improve Continual improvement remains a core focus of the FSMS.

106 Section 10 Improvement 10.1 Nonconformity and corrective action 10.2 Continual improvement 10.3 Update of the food safety management system When nonconformities occur, must: react to the nonconformity evaluate need for corrective action take appropriate action review effectiveness of any corrective action change FSMS, if necessary retain records of nonconformities and subsequent action, and results of corrective action No equivalent

107 Section 10 Improvement 10.1 Nonconformity and corrective action 10.2 Continual improvement 10.3 Update of the food safety management system must continually improve the FSMS! 2005 clauses 8.1 & 8.5.1

108 Section 10 Improvement 10.1 Nonconformity and corrective action 10.2 Continual improvement 10.3 Update of the food safety management system FSMS must be continually updated through the FST updates must be documented and retained clause 8.5.2

109 Annex A (informative) Cross references between the CODEX HACCP and ISO 22000:2018.

110 Annex B (informative) Cross reference between ISO 22000:2018 and ISO 22000:2005.

111 Auditing Requirements ISO 22003:2013, Food safety management systems Requirements for bodies providing audit and certification of food safety management systems currently being reviewed.

112 Food Defence & Food Fraud Food Defence Plan and Food Fraud Vulnerability Plan are not specifically required, unlike FSSC however, Clause 6.1 requires clients to determine and address risks, prevent undesired effects and action taken is to be proportionate to the impact on food safety and requirements of interested parties in food chain so its subjective and depends on the business risks must be considered and acted upon but not a full TACCP/VACCP unless circumstances require it.

113 Summary of Changes better format and ease of integration context of organisation risks and opportunities clearer differences between OPRP, CCP & PRP critical limits (CCPs) vs action criteria (OPRPs) Hazard Control Plan in lieu of OPRP/HACCP Plan external provider evaluation competence in lieu of training use of PRPs greater inputs to management review.

114 Any Questions?