ISO22000 Standard PDF

POLYTECHNIC UNIVERSITY FOOD SANITATION AND SAFETY MANAGEMENT ISO22000 STANDARD EVA TANG OCTOBER 2024 EMAIL: 1 COURSE OUTLINE Session Course Outline 1...

POLYTECHNIC UNIVERSITY FOOD SANITATION AND SAFETY MANAGEMENT ISO22000 STANDARD EVA TANG OCTOBER 2024 EMAIL: 1 COURSE OUTLINE Session Course Outline 1 Introduction to ISO22000 Standard (the "Standard") - Overview of ISO Standards and the PDCA cycle V - Benefits of implementing the Standard in food organizations - Introduction to the Standard, key terms and definitions in the Standard - Context of the organization 2 Requirements of the Standard I - Leadership - Planning - Support - Operation planning and control - Traceability system v - Emergency preparedness and response 3 Requirements of the Standard II - Prerequisite programs - HACCP - Control of monitoring and measuring * - Verification - Control of product and process nonconformities 4 Requirements of the Standard III - Performance evaluation - Internal audit and management review - Improvement and update Implementing ISO22000 in Food Organizations Auditing and Certification 2 INTRODUCTION TO ISO22000:2018 STANDARD (THE STANDARD) ISO STANDS FOR THE INTERNATIONAL ORGANIZATION FOR STANDARDIZATION ISO22000 IS AN INTERNATIONAL STANDARD THAT SPECIFIES THE REQUIREMENTS FOR A FOOD SAFETY MANAGEMENT SYSTEM (FSMS). IT PROVIDES A FRAMEWORK FOR ORGANIZATIONS TO IDENTIFY AND CONTROL FOOD SAFETY HAZARDS, ENSURING THAT FOOD IS SAFE FOR CONSUMPTION THROUGHOUT THE FOOD CHAIN THE 2018 EDITION IS THE SECOND EDITION THAT CANCELS AND REPLACES THE FIRST (2005) EDITION THE STANDARD WAS PREPARED BY TECHNICAL COMMITTEE ISO/TC 34, FOOD PRODUCTS, SUBCOMMITTEE SC 17, MANAGEMENT SYSTEMS FOR FOOD SAFETY 3  INTRODUCTION TO ISO22000:2018 STANDARD (THE STANDARD) every -review 5 years This publication was last reviewed and confirmed in 2023, this version remains current. - ↳ underdevelopment 4 Source: https://www.iso.org/standard/65464.html#amendment THE INTERNATIONAL ORGANIZATION FOR STANDARDIZATION 5 THE ISO/TC 34/SC 17 FAMILY... 6 THE ISO/TC 34/SC 17 FAMILY... 7 ISO/TS 22002-1:2009(EN) PREREQUISITE PROGRAMMES ON FOOD SAFETY — PART 1: FOOD MANUFACTURING 8 WHY ISO22000:2018?? WHAT ARE THE BENEFITS?? “IT MAPS OUT WHAT AN ORGANIZATION NEEDS TO DO TO DEMONSTRATE ITS ABILITY TO CONTROL FOOD SAFETY HAZARDS IN ORDER TO ENSURE THAT FOOD IS SAFE. IT CAN BE USED BY ANY ORGANIZATION REGARDLESS OF ITS SIZE OR POSITION IN THE FOOD CHAIN.” (BY ISO) THE ADOPTION OF A FSMS IS A STRATEGIC DECISION FOR AN ORGANIZATION THAT CAN HELP TO IMPROVE ITS OVERALL PERFORMANCE IN FOOD SAFETY. THE POTENTIAL BENEFITS TO AN ORGANIZATION OF IMPLEMENTING A FSMS: a. THE ABILITY TO CONSISTENTLY PROVIDE SAFE FOODS AND PRODUCTS AND SERVICES THAT MEET CUSTOMER AND APPLICABLE STATUTORY AND REGULATORY REQUIREMENTS; b. ADDRESSING RISKS ASSOCIATED WITH ITS OBJECTIVES; c. THE ABILITY TO DEMONSTRATE CONFORMITY TO SPECIFIED FSMS REQUIREMENTS. !! Please obtain the STANDARD for our class discussion and exam preparation!! 9  THE STANDARD The PDCA cycle enables an organization to ensure that its processes are adequately PDCA resourced and managed, and that opportunities for improvement are determined and acted on > systematic management process - approach Risk-based thinking enables an organization to risk- determine the factors that could cause its processes and its FSMS to deviate from the based planned results, and to put in place controls to thinking prevent or minimize adverse effects Risk-based thinking is addressed on two levels, organizational and operational 10 THE PDCA CYCLE Establish the objectives of the system and its processes, take actions to improve provide the resources needed performance, as necessary to deliver the results, and Act Plan identify and address risks and opportunities Monitor and (where relevant) measure processes and the resulting products and services, analyse and evaluate information and data from monitoring, Check Do Implement what was planned measuring and verification activities, and report the 11 results THE PDCA CYCLE Conduct hazard Implement the Verification Update the Plan (e.g.) Check (e.g.) Act (e.g.) Do (e.g.) analysis hazard control activities HACCP Establish hazard plan Internal audit documentation control plan Implement the Management Continually Understand the FSMS review improve the context of the Control the FSMS organization nonconformities Establish food safety objectives 12  THE STANDARD 1. Scope 2. Normative References 3. Terms and Definitions 4. Context 5. 8. 9. 10. of the 6. Planning 7. Support Performance Leadership Operation Improvement organization evaluation 13  The requirements of the STANDARD are generic and are intended to be applicable to all organizations in the food chain. THE STANDARD How is regulatory compliance addressed in the standard?? 14 THE STANDARD... 2-LEVEL PDCA CYCLE ILLUSTRATION OF THE PDCA CYCLE AT THE TWO LEVELS (FIGURE 1 FROM THE STANDARD) 15 KEY TERMS AND DEFINITIONS IN THE STANDARD Shall Food safety risk Is a function of the probability of an Indicates a requirement adverse health effect and the severity of that effect, consequential to (a) hazard(s) in food Should Food safety hazard Indicates a recommendation Biological, chemical or physical agent in food with the potential to cause an adverse health effect Documented information Food safety Information required to be controlled and maintained by assurance that food will not cause an an organization and the medium adverse health effect for the consumer when it is prepared and/or consumed in 16 on which it is contained accordance with its intended use  KEY TERMS AND DEFINITIONS IN THE STANDARD Prerequisite program (PRP) Validation basic conditions and activities that are necessary obtaining evidence that a control measure within the organization and throughout the food chain to maintain food safety (or combination of control measures) will be capable of effectively controlling the Operational prerequisite program significant food safety hazard (OPRP) shall be done prior to implementation of control measure or combination of control measures control measure(s) and combinations of applied to prevent or reduce a significant food control measures to be included in the safety hazard to an acceptable level, and where hazard control plan and after any action criterion and measurement or observation enable effective control of the process and/or change therein product Verification Critical limit measurable value which separates acceptability from confirmation, through the provision of unacceptability objective evidence, that specified requirements (3.38) have been fulfilled Action criterion is applied after an activity and provides 17 information for confirmation of conformity measurable or observable specification for the monitoring of an OPRP  4.1 Understanding the organization and its context 4. CONTEXT OF determine external and internal issues that are THE relevant to its purpose and that affect its ability ORGANIZATION to achieve the intended result(s) of its FSMS identify, review and update such information 18 4. CONTEXT OF THE ORGANIZATION Source: https://www.iso.org/obp/ui/en/#iso:std:iso:22000:ed-2:v1:amd:1:v1:en 19 4.1 UNDERSTANDING THE ORGANIZATION AND ITS CONTEXT SWOT Analysis PESTLE Analysis Update Identify Industry Analysis (10.3) (4.1) Stakeholder Analysis External issues +ve/-ve (international, national, Review Monitor regional or local) (9.3) (9.1) ▪ Legal Organization ▪ Technological Intended results of ▪ Competitive Internal issues +ve/-ve the FSMS ▪ Market (international, national, ▪ Conformity of ▪ Cultural regional or local) ▪ Social ▪Values products and ▪ Economic environments ▪Culture Now the person behave - when Xone is watching services ▪ Cybersecurity and food ▪Knowledge within the ▪ Enhanced fraud organization customer ▪ Food defence and ▪Performance of the organization satisfaction intentional contamination 20 ▪ Climate change  4.2 UNDERSTANDING THE NEEDS AND EXPECTATIONS OF INTERESTED PARTIES DETERMINE: A) THE INTERESTED PARTIES THAT ARE RELEVANT B) THE RELEVANT REQUIREMENTS OF THE INTERESTED PARTIES IDENTIFY, REVIEW AND UPDATE SUCH INFORMATION 21 4.2 UNDERSTANDING THE NEEDS AND EXPECTATIONS OF INTERESTED PARTIES Determine relevant interested parties Customers to FSMS Requirements related to climate change?? Owners Determine relevant requirements of interest parties Partners People in the organization Update Determine Providers (10.3) (4.2) Regulators Focus on food safety Unions Review Monitor Society (competitors or (9.3) (9.1) opposing pressure groups) 22 4.3 DETERMINING THE SCOPE OF THE FOOD SAFETY MANAGEMENT SYSTEM THE SCOPE SHALL SPECIFY THE External and internal issues Requirements PRODUCTS AND SERVICES, PROCESSES of interested parties AND PRODUCTION SITE(S) THAT ARE The activities, INCLUDED IN THE FSMS processes, products or services having an influence THE SCOPE SHALL BE AVAILABLE AND MAINTAINED AS DOCUMENTED INFORMATION. e.g. the Quality THE SCOPE 23 Manual, but not necessarily 4.4 FOOD SAFETY MANAGEMENT SYSTEM establish continually implement improve The FSMS update maintain 24. REQUIREMENTS OF THE STANDARD 2nd 5 LEADERSHIP 6 PLANNING 7 SUPPORT 8.1 OPERATION PLANNING AND CONTROL 8.3 TRACEABILITY SYSTEM 8.4 EMERGENCY PREPAREDNESS AND RESPONSE 25 5. LEADERSHIP 5.1 Leadership and commitment Top management shall demonstrate leadership and commitment with respect to the FSMS by: a) ensuring that the food safety policy (5.2) and the objectives (6.2) of the FSMS are established... b) ensuring the integration of the FSMS requirements into the organization’s business processes c) ensuring that the resources needed for the FSMS are available ↳ human resource ↳ hard/ software ↳ equipments. d) communicating the importance of effective food safety management and conforming to the requirements The Requirements ▪ FSMS req. ▪ applicable statutory and regulatory req. ▪ mutually agreed customer req. 26 related to food safety 5. LEADERSHIP 5.1 Leadership and commitment Top management shall demonstrate leadership and commitment with respect to the FSMS by: e) ensuring that the FSMS is evaluated and maintained to achieve its intended result(s) > - checking f) directing and supporting persons to contribute to the effectiveness of the FSMS & g) promoting continual improvement > - Act h) supporting other relevant management roles to demonstrate their leadership as it applies to their areas of responsibility. 27 5.2 POLICY FOOD SAFETY POLICY 5.2.1 ESTABLISHING ▪ is appropriate to the purpose and context THE FOOD SAFETY ▪ provides a framework for setting and POLICY reviewing the objectives of the FSMS ESTABLISH, IMPLEMENT ▪ includes a commitment to satisfy applicable food safety requirements The..Requirements AND MAINTAIN A.... FOOD SAFETY POLICY... -review previodly ▪ addresses internal and external communication ▪ includes a commitment to continual improvement ▪ addresses the need to ensure competencies related to food safety 28  AS DOCUMENTED INFORMATION BE COMMUNICATED, UNDERSTOOD AND APPLIED AT ALL LEVELS WITHIN THE 5.2.2 ORGANIZATION COMMUNICATING THE FOOD SAFETY BE AVAILABLE TO RELEVANT POLICY INTERESTED PARTIES, AS APPROPRIATE 29  5.3 ORGANIZATIONAL ROLES, RESPONSIBILITIES AND AUTHORITIES 5.3.1 TOP MANAGEMENT SHALL ENSURE THAT THE RESPONSIBILITIES AND AUTHORITIES FOR RELEVANT ROLES ARE ASSIGNED, COMMUNICATED AND UNDERSTOOD WITHIN THE ORGANIZATION. ASSIGN THE RESPONSIBILITY AND AUTHORITY FOR...... > - APPOINTING THE FOOD SAFETY TEAM AND THE FOOD SAFETY TEAM LEADER 30 5.3.2 THE FOOD SAFETY TEAM LEADER SHALL BE RESPONSIBLE FOR: ensuring the managing ensuring reporting to Top management The food safety team The food safety team FSMS FSMS is and relevant top established, organizing training and management implemented, the work of competencies on the maintained the food for the food effectiveness and updated safety team safety team and suitability of the FSMS 5.3.3 ALL PERSONS SHALL HAVE THE RESPONSIBILITY TO REPORT PROBLEM(S) WITH REGARDS TO THE FSMS TO IDENTIFIED PERSON(S) 31 6. PLANNING 6.1 ACTIONS TO ADDRESS RISKS AND OPPORTUNITIES Requirements of Risks and opportunities External & internal issues interested parties need to be addressed Planning for FSMS Give assurance Prevent, or that FSMS can Enhance Achieve achieve its reduce, desirable effects undesired improvement effects intended result(s) 32 6.1 ACTIONS TO ADDRESS RISKS AND OPPORTUNITIES Determine Plan actions to [brainstorming sessions, address them Plan how to risk register, etc.] Avoiding risk Integrate and implement actions into FSMS processes Risks e.g. Opportunities e.g. Taking risk Evaluate the effectiveness Change in regulatory Compliance and of these actions compliance/Non- Competitive compliance Advantage · Increased food costs · Local sourcing, Eliminate risk source · Adverse weather impact - alternative materials, & material material source on production new raw Changing likelihood / supply consequence · Procurement challenge · New practices/machines for materials technology New product development Sharing risk · Assets / Equipment aging of - terminated supply equipment spare parts Accepting risk · Increased competition > - Labor I skill shortage 33 Process failure Adoption of new practices, technology, etc. · outbreak · Foodborne illness 6.2 OBJECTIVES OF THE FOOD SAFETY MANAGEMENT SYSTEM AND PLANNING TO ACHIEVE THEM 6.2.1 The organization Objectives shall establish objectives ▪ Be consistent with the food safety policy for the FSMS at relevant ▪ Be measurable > Quanitative functions and levels. - ▪ Consider applicable food safety requirements The Requirements......... ▪ Be monitored and verified ▪ Be communicated ▪ Be maintained and updated as appropriated ▪ Be retained as documented information 34 6.2.2 PLANNING HOW TO ACHIEVE THE OBJECTIVES WHAT will be done What RESOURCES required WHO will be responsible WHEN it will be completed HOW the results will be EVALUATED 35 6.3 PLANNING OF CHANGES determines the need for changes to the FSMS, and the plan for the changes Considerations Purpose of the changes and their potential consequences The continued Integrity of the FSMS Availability of resources to effectively implement the changes Allocation or reallocation of responsibilities and authorities 36 6.3 PLANNING OF CHANGES Potential Changes that may Occur in a Food Business 1. Introduction of New Ingredient 2. Process Modification 3. Supplier change 4. relocation Factory 5. Introduction of new product 6. Regulation change 7. Product Packaging change 8. New production Team 9. New egipment Control 10. New Allergen 37 7 SUPPORT 7.1 RESOURCES of principle resource planning Update and Considerations continual improvement Establishment Capabilities of and constraints on, existing internal resources The needs for Maintenance Implementation external resources 38 7.1 RESOURCES Resources Requirements People (7.1.2) Ensure that person necessary to operate and maintain an effective FSMS are competent Evidence of agreement or contracts defining the competency, responsibility and authority of external experts shall be retained as documented information Infrastructure (7.1.3) Provide the resources necessary to achieve conformity with the requirements of the FSMS Work environment (7.1.4) determine, provide and maintain together resource necessary to achieve conformity with the requirements of the FSMS Externally developed elements of the food safety management system (7.1.5) Control of externally provided processes,... products or services (7.1.6) 39  establish and apply criteria for the evaluation, selection, monitoring of performance and re-evaluation of external 7.1.6 providers of processes, products and/or services; CONTROL OF ensure adequate communication of requirements to the EXTERNALLY external provider(s); PROVIDED PROCESSES, ensure that externally provided processes, products or services do not adversely affect the organization's ability to consistently meet the requirements of the FSMS; PRODUCTS OR SERVICES retain documented information of these activities and any necessary actions as a result of the evaluations and re- evaluations. 40 7.2 COMPETENCE Appropriate Appropriate training education Acquire Appropriate necessary experience competence Persons within the External org. providers Multi- disciplinary food safety team 41 Retained documented information > Auditor as evidence of Competence - safety > - food team  ALL RELEVANT PERSONS DOING WORK UNDER THE ORGANIZATION’S 7.3 AWARENESS CONTROL SHALL BE AWARE OF A) THE FOOD SAFETY POLICY; B) THE OBJECTIVES OF THE FSMS RELEVANT TO THEIR TASK(S); C) THEIR INDIVIDUAL CONTRIBUTION TO THE EFFECTIVENESS OF THE FSMS...; D) THE IMPLICATIONS OF NOT CONFORMING WITH THE FSMS REQUIREMENTS. 42 7.4 COMMUNICATION *WHAT to communicate Internal communication *WHEN to communicate *With WHOM FSMS to communicate *HOW to communicate External communication *Who communicates 43 7.4.2 EXTERNAL COMMUNICATION External providers and contractors Customers and/or consumers Nutrition Tables eg. Ingredient --- Statutory and regulatory authorities Other involved organizations 44 FOOD LABELLING REQUIREMENTS FOR PRE-PACKAGED FOOD IN HONG KONG 45 FOOD LABELLING REQUIREMENTS FOR PRE-PACKAGED FOOD IN HONG KONG 46 7.4.3 INTERNAL COMMUNICATION THE FOOD SAFETY TEAM IS INFORMED IN A TIMELY MANNER OF CHANGES Changes?? 47 7.4.3 INTERNAL COMMUNICATION THE FOOD SAFETY TEAM IS INFORMED IN A TIMELY MANNER OF CHANGES a) products or new products h) applicable statutory and regulatory requirements b) raw materials, ingredients and services i) knowledge regarding food safety hazards and control measures c) production systems and equipment j) customer, sector and other requirements that the organization observes d) production premises, location of equipment and k) relevant enquiries and communications from surrounding environment external interested parties e) cleaning and sanitation programmes l) complaints and alerts indicating food safety hazards associated with the end product f) packaging, storage and distribution systems m) other conditions that have an impact on food safety g) competencies and/or allocation of 48 responsibilities and authorizations  7.4.3 INTERNAL COMMUNICATION POTENTIAL ACTIONS THAT THE FOOD SAFETY TEAM SHOULD CONSIDER TAKING IN RESPONSE TO THE IDENTIFIED CHANGES Changes Potential actions c) Production Systems and Evaluate the impact of changes in production systems or equipment on food safety. Equipment Conduct risk assessments to identify potential hazards introduced by the changes. Update standard operating procedures (SOPs) and work instructions to incorporate any necessary changes. Ensure that personnel are trained on the proper use, maintenance, and cleaning of new or modified equipment. b) raw materials, ingredients and services e) cleaning and sanitation program f) packaging, storage and distribution systems h) applicable statutory and regulatory requirements l) complaints and alerts indicating 49 food safety hazards associated with the end product 7.5 DOCUMENTED INFORMATION Identification & description (e.g. title, date, author, reference number) 7.5.2 Creating Format (language, software version, graphics, media) & updating Review and approval Ensure available and suitable for use, where and when 7.5.3 Ensure adequate protection (e.g. from loss of confidentiality, improper use, or loss of integrity) Control Distribution, Storage and Control of Retention and access, retrieval preservation, change disposition and use legibility Include documented information Required by ISO 22000 The Requirements 50... Determined Ki necessary by organization...... The Requirements  PLAN, IMPLEMENT, CONTROL, MAINTAIN AND UPDATE THE PROCESSES NEEDED TO MEET 8.1 REQUIREMENTS FOR THE REALIZATION OF SAFE PRODUCTS... OPERATIONAL PLANNING CONTROL PLANNED CHANGES AND REVIEW THE AND CONSEQUENCES OF UNINTENDED CHANGES... CONTROL ENSURE THAT OUTSOURCED PROCESSES ARE CONTROLLED 51 8.3 TRACEABILITY SYSTEM Lots of received materials, ingredients, intermediate products to the end products SHALL BE ABLE TO Verify and test the effectiveness Reworking of UNIQUELY IDENTIFY of the materials or traceability products INCOMING MATERIAL system FROM THE SUPPLIERS AND Traceability System THE FIRST STAGE OF THE DISTRIBUTION ROUTE OF Documented info. retained for a THE END PRODUCT defined period Distribution of the (shelf life of the end product products as a minimum) The Requirements The Requirements... 52......  8.4 EMERGENCY PREPAREDNESS AND RESPONSE 8.4.1 GENERAL PROCEDURES ARE IN PLACE TO RESPOND TO POTENTIAL EMERGENCY SITUATIONS OR INCIDENTS THAT CAN HAVE AN IMPACT ON FOOD SAFETY... Documented information shall be established and maintained to manage these situations and incidents. 53  8.4.2 HANDLING OF EMERGENCIES AND INCIDENTS Examples of emergency situations that can affect food safety and/or production?? 54 8.4.2 HANDLING OF EMERGENCIES AND INCIDENTS RESPOND TO ACTUAL EMERGENCY SITUATIONS AND INCIDENTS ensuring applicable statutory and regulatory requirements communicating internally communicating externally are identified REDUCE THE CONSEQUENCES OF THE EMERGENCY SITUATION... PERIODICALLY TEST PROCEDURES WHERE PRACTICAL REVIEW AND, WHERE NECESSARY, UPDATE THE DOCUMENTED INFORMATION AFTER THE OCCURRENCE OF ANY INCIDENT, EMERGENCY SITUATION OR TESTS. 55 REQUIREMENTS OF THE STANDARD 3rd 8.2 PREREQUISITE PROGRAMS (PRPs) 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 56 8.2 PREREQUISITE PROGRAMS (PRPs) PRP BASIC CONDITIONS AND ACTIVITIES THAT ARE NECESSARY WITHIN THE ORGANIZATION AND THROUGHOUT THE FOOD CHAIN O 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). What might go wrong if the PRPs are not in place or not effectively - ↑ contamination implemented?? 57 8.2 PREREQUISITE PROGRAMS (PRPs) 8.2.1 THE ORGANIZATION SHALL ESTABLISH, IMPLEMENT, MAINTAIN AND UPDATE PRP(S)... Appropriate to 8.2.2 THE PRPs SHALL BE: the organization and its context 8.2.3 THE REQUIREMENTS Appropriate to the size and type of the operation and the nature of the products ARE IDENTIFIED The Requirements... being manufactured and/or handled...... Implemented across the entire production system Approved By the food safety team ISO/TS 22002 series 58 8.2.4 WHEN ESTABLISHING PRP(s) THE ORGANIZATION SHALL CONSIDER: a) construction, lay-out of buildings and associated utilities; b) lay-out of premises, including zoning, workspace and employee facilities; c) supplies of air, water, energy and other utilities; d) pest control, waste and sewage disposal and supporting services; e) the suitability of equipment and its accessibility for cleaning and maintenance; f) supplier approval and assurance processes (e.g. raw materials, ingredients, chemicals and packaging); g) reception of incoming materials, storage, dispatch, transportation and handling of products; h) measures for the prevention of cross contamination; i) cleaning and disinfecting; j) personal hygiene; k) product information/consumer awareness; l) others, as appropriate. 59 Documented information shall specify the selection, establishment, applicable monitoring and verification of the PRP(s). 8.5 HAZARD CONTROL 8.5.1 Preliminary steps to enable hazard analysis 8.5.2 Hazard analysis 8.5.3 Validation of control measure(s) and combinations of control measures 8.5.4 hazard control plan (haccp/oprp plan) operational Prerequisite 60 Programs 8.5.1 PRELIMINARY STEPS TO ENABLE HAZARD ANALYSIS 8.5.1.1 GENERAL TO CARRY OUT THE HAZARD ANALYSIS, PRELIMINARY DOCUMENTED INFORMATION SHALL BE COLLECTED, MAINTAINED AND UPDATED BY THE FOOD SAFETY TEAM. THIS SHALL INCLUDE, BUT NOT BE LIMITED TO: The Requirements... The products, Food safety The...... processes and hazards Requirements equipment relevant to the FSMS 8.5.1.2 CHARACTERISTICS OF RAW MATERIALS, INGREDIENTS AND Hazard Analysis PRODUCT CONTACT MATERIALS 8.5.1.3 CHARACTERISTICS OF END PRODUCTS 8.5.1.4 INTENDED USE 8.5.1.5 FLOW DIAGRAMS AND DESCRIPTION OF PROCESSES 61  8.5.1.2 CHARACTERISTICS OF RAW MATERIALS, INGREDIENTS AND PRODUCT CONTACT MATERIALS a. a) biological, chemical and physical characteristics;> contamination - b. Applicable statutory and regulatory b) composition of formulated ingredients, food safety requirements are c. including additives and processing aids; c) source (e.g. animal, mineral or vegetable); d. d) place of origin (provenance); identified e. e) method of production; f) method of packaging and delivery methods; f. g) storage conditions and shelf life; h) preparation and/or handling before use or g. processing; h. I) food safety-related & i. 62  8.5.1.3 CHARACTERISTICS OF END PRODUCTS a. product name or similar identification; b. composition; Applicable statutory and regulatory food safety requirements are c. biological, chemical and physical characteristics relevant for food safety; identified d. intended shelf life and storage conditions; e. packaging; f. labelling relating to food safety and/or instructions for handling, preparation and intended use; g. method(s) of distribution and delivery 63  The intended use, including reasonably expected handling of the end product and any unintended use but reasonably expected mishandling and misuse of the end product, shall be considered and shall be maintained as documented information to the extent needed to conduct the hazard analysis 8.5.1.4 Groups of consumers/users (if applicable) shall be identified for INTENDED each product USE Groups of consumers/users known to be especially vulnerable to specific food safety hazards shall be identified 64 8.5.1.5 FLOW DIAGRAMS AND DESCRIPTION OF PROCESSES 8.5.1.5.1 PREPARATION OF THE FLOW Flow Diagrams DIAGRAMS a. the sequence and interaction of the steps Flow diagrams provide a graphic in the operation; representation of the process. They shall be b. outsourced processes; clear, accurate and sufficiently detailed to the c. where raw materials, ingredients, extent needed to conduct the hazard analysis processing aids, packaging materials, utilities and intermediate products enter the flow; 8.5.1.5.2 ON-SITE CONFIRMATION OF d. where reworking and recycling take FLOW DIAGRAMS place; e. where end products, intermediate 8.5.1.5.3 DESCRIPTION OF PROCESSES AND products, by-products and waste are PROCESS ENVIRONMENT released or removed. 65 Seasonal changes!! 8.5.2 HAZARD ANALYSIS 66  8.5.2 HAZARD ANALYSIS (BY THE FOOD SAFETY TEAM) identify and document - all food safety hazards The food safety team shall conduct a hazard analysis, based on the preliminary that are reasonably information, to determine the hazards that need to be controlled. expected to occur... identify step(s) (e.g. receiving, processing, Determine the hazards that need to be controlled delivery, etc.) at which conduct a hazard The degree of control shall ensure food safety and, where each food safety assessment for each 8.5.2.1 appropriate, a combination of control measures shall be used hazard can be present, identified food be introduced, increase safety hazard or persist Hazard identification and determination of acceptable levels determine the evaluate each food 8.5.2.2 acceptable level in the safety hazard: severity of end product of each likelihood food safety hazard its adverse of its x Hazard assessment health identified occurrence effects 8.5.2.3 identify any significant food Selection and categorization of control measure(s) safety hazards 8.5.2.4 67 8.5.2 HAZARD ANALYSIS (BY THE FOOD SAFETY TEAM) EXAMPLE OF ASSESSMENT TABLE Critical 5 5 10 15 20 25  10 Significant High 4 4 8 12 16 20 Hazards Severity Medium 3 3 6 9 12 15  10 Non- Low 2 2 4 6 8 10 Significant Hazards Negligible 1 1 2 3 4 5 1 2 3 4 5 Very Unlikely Occasional Likely Frequent Unlikely Likelihood 68 8.5.2 HAZARD ANALYSIS (BY THE FOOD SAFETY TEAM) WORKSHOP: BASED ON THE SCENARIOS, PLEASE: ❑ IDENTIFY THE FOOD SAFETY HAZARDS ❑ ASSESS THEIR LIKELIHOOD AND SEVERITY ❑ DETERMINE THE CONTROL MEASURES Scenario Food Safety Hazards Likelihood Severity Control Measure(s) (1 to 5) (1 to 5) A: A factory processes (e.g. slicing) I. Biological: pathogens I. 4 I. 2 I. Processing temp. and time control, and packages frozen raw meat (salmonella, e. coli) storage temp., cleaning and products > - animals sanitization procedures, product label II. Chemical: drug residues, II. 2 II. 4 II. Supplier/raw material control, cleaning chemical cleaning and sanitization procedures III. Physical: foreign object (bone, III. 2 III. 4 III. Foreign object control (glass policy, metal) metal detection, equipment maintenance, personal hygiene), raw material control B: A deli prepares sandwiches on- Biological: microbes growth 4 2 site for immediate consumption Chemical: pesticide 2 4 Physical: foreign object. 2 4 B C: A dairy plant produces Biological: microbes growth packaged milk products Chemical: cleaning 2 4 Physical: foreign. 2 4 object 69 D: A bakery produces baked Biological: microbes growth 4 2 goods (e.g. bread, cakes and Chemical: preservatives/cleaning 2 4 Physical: foreign pastries) object. 2 4 8.5.2.4 SELECTION AND CATEGORIZATION OF CONTROL MEASURE(S) BASED ON THE HAZARD ASSESSMENT, THE ORGANIZATION SHALL SELECT AN APPROPRIATE CONTROL MEASURE OR COMBINATION OF CONTROL MEASURES THAT WILL BE CAPABLE OF PREVENTING OR REDUCING THE IDENTIFIED SIGNIFICANT FOOD SAFETY HAZARDS TO DEFINED ACCEPTABLE LEVELS. Systematic Approach: Decision Table? Decision Tree? Select an appropriate Categorize the Identify significant control measure or selected identified food safety hazards combination of control measure(s) to control measures be managed as OPRP(s) or at CCPs OPRP(s) CCPs 70 8.5.2.4 SELECTION AND CATEGORIZATION OF CONTROL MEASURE(S) THE CATEGORIZATION SHALL BE CARRIED OUT IN A SYSTEMATIC APPROACH (E.G. DECISION TREE, DECISION TABLE, ETC.) 71  Validation shall be done prior to implementation of control measure(s) and combinations of control measures and after any change therein. 8.5.3 The food safety team shall validate that the selected control measures are capable VALIDATION OF of achieving the intended control of the CONTROL significant food safety hazard(s). MEASURE(S) AND COMBINATIONS When the result of validation shows that OF CONTROL the control measures(s) FAILED, the food MEASURES safety team shall modify and re-assess the control measure(s) and/or combination(s) of control measure(s). 72  8.5.4 HAZARD CCP OPRP CONTROL PLAN A food safety hazard(s) to be food safety hazard(s) to be controlled at the CCP controlled at the OPRP THE HAZARD CONTROL PLAN B critical limit(s) at CCP action criteria for OPRP SHALL INCLUDE THE FOLLOWING INFORMATION C monitoring procedure(s); monitoring procedure(s); FOR EACH CONTROL MEASURE D correction(s) to be made if correction(s) to be made if AT EACH CCP OR OPRP: critical limits are not met action criteria are not met E responsibilities and authorities responsibilities and authorities F records of monitoring. records of monitoring. 73 8.5.4 HAZARD CONTROL PLAN CCP OPRP Determination of Critical limits at CCPs shall be Action criteria for OPRPs shall be critical limits and specified. specified. action criteria Critical limits at CCPs shall be Action criteria for OPRPs shall be measurable. Conformance with critical measurable or observable. limits shall ensure that the acceptable Conformance with action criteria shall level is not exceeded. contribute to the assurance that the acceptable level is not exceeded. Monitoring systems At each CCP, a monitoring system shall For each OPRP, a monitoring system be established for each control shall be established for the control measure or combination of control measure or combination of control measure(s) to detect any failure to measure(s) to detect failure to meet the remain within the critical limits. The action criterion. system shall include all scheduled measurements relative to the critical 74 limit(s). 8.5.4.3 MONITORING SYSTEMS AT CCPS AND FOR OPRPS THE MONITORING SYSTEM, AT EACH CCP AND FOR EACH OPRP, SHALL DOCUMENT THE FOLLOWINGS: A) MEASUREMENTS OR OBSERVATIONS THAT PROVIDE RESULTS WITHIN AN ADEQUATE TIME FRAME; B) MONITORING METHODS OR DEVICES USED; C) APPLICABLE CALIBRATION METHODS OR, FOR OPRPS, EQUIVALENT METHODS FOR VERIFICATION OF RELIABLE MEASUREMENTS OR OBSERVATIONS (SEE 8.7); D) MONITORING FREQUENCY; E) MONITORING RESULTS; F) RESPONSIBILITY AND AUTHORITY RELATED TO MONITORING; G) RESPONSIBILITY AND AUTHORITY RELATED TO EVALUATION OF MONITORING RESULTS. At each CCP, the monitoring method and frequency shall be capable of timely detection of any failure to remain within critical limits, to allow timely isolation and evaluation of the product. For each OPRP, the monitoring method and frequency shall be proportionate to the likelihood of failure and the 75 severity of consequences.  CCP OPRP Monitoring systems a. Measurements that provide results a. measurements or observations that shall include within an adequate time frame provide results within an adequate time frame b. monitoring methods or devices used b. monitoring methods or devices used c. applicable calibration methods c. equivalent methods for verification of reliable measurements or observations d. monitoring frequency d. monitoring frequency e. monitoring results e. monitoring results f. responsibility and authority related to f. responsibility and authority related to monitoring monitoring g. responsibility and authority related to g. responsibility and authority related to evaluation of monitoring results evaluation of monitoring results - At each CCP, the monitoring method and - For each OPRP, the monitoring method frequency shall be capable of timely and frequency shall be proportionate to detection of any failure to remain within the likelihood of failure and the severity critical limits, to allow timely isolation and of consequences evaluation of the product 8.5.4 HAZARD CONTROL PLAN 76 8.5.4.4 ACTIONS WHEN CRITICAL LIMITS OR ACTION CRITERIA ARE NOT MET SPECIFY CORRECTIONS AND CORRECTIVE ACTIONS TO BE TAKEN WHEN CRITICAL LIMITS OR ACTION CRITERION ARE NOT MET AND: A) THE POTENTIALLY UNSAFE PRODUCTS ARE NOT RELEASED; B) THE CAUSE OF NONCONFORMITY (NC) IS IDENTIFIED; C) THE PARAMETER(S) CONTROLLED AT THE CCP OR BY THE OPRP IS (ARE) RETURNED WITHIN THE CRITICAL LIMITS OR ACTION CRITERIA; D) RECURRENCE IS PREVENTED. 8.5.4.5 IMPLEMENTATION OF THE HAZARD CONTROL PLAN 77 8.6 UPDATING THE INFORMATION SPECIFYING THE PRPS AND THE HAZARD CONTROL PLAN THE ORGANIZATION SHALL UPDATE THE FOLLOWINGS, IF NECESSARY: characteristics characteristics intended use flow hazard B E A C D of raw of end diagrams and control plan materials, products descriptions and/or the ingredients of processes PRP(s) and product- and process contact environment materials 78 8.7 CONTROL OF MONITORING AND MEASURING THE MONITORING AND MEASURING EQUIPMENT USED SHALL BE: A) a) calibrated or verified at specified intervals B) prior to use; b) adjusted or re-adjusted as necessary; C) c) identified to enable the calibration status D) to be determined; d) safeguarded from adjustments that would E) invalidate the measurement results; e) protected from damage and deterioration. The organization shall assess the validity of the previous measurement results when the equipment or process environment is found not to conform to requirements. The organization shall take appropriate action in relation to the equipment or process environment and any product affected by the non-conformance 79 8.8 VERIFICATION RELATED TO PRPS AND THE HAZARD CONTROL PLAN THE VERIFICATION ACTIVITIES SHALL CONFIRM THAT: hazard levels are within identified acceptable levels 3 2 4 1 Verification activities shall NOT be carried out by the person responsible for monitoring the same activities. The food safety team shall conduct an analysis of the results of 80 verification performance evaluation of the FSMS 8.9 CONTROL OF PRODUCT AND PROCESS NONCONFORMITIES 8.9.1 GENERAL 8.9.2 Corrections THE MONITORING OF OPRPs AND AT CCPs ARE EVALUATED 8.9.3 Corrective actions BY DESIGNATED PERSONS WHO ARE COMPETENT AND HAVE THE AUTHORITY TO 8.9.4 Handling of INITIATE CORRECTIONS AND CORRECTIVE ACTIONS. potentially unsafe products 8.9.5 Withdrawal/recall 81  8.9.2 CORRECTIONS 8.9.2.1 WHEN CRITICAL LIMITS AT CCP(S) AND/OR ACTION CRITERIA FOR OPRPS ARE NOT MET, THE PRODUCTS AFFECTED ARE IDENTIFIED AND CONTROLLED WITH REGARD TO THEIR USE AND RELEASE. DOCUMENT: A) A METHOD OF IDENTIFICATION, ASSESSMENT AND CORRECTION FOR AFFECTED PRODUCTS TO ENSURE THEIR PROPER HANDLING; B) ARRANGEMENTS FOR REVIEW OF THE CORRECTIONS. 82  8.9.2 CORRECTIONS 8.9.2.2 WHEN CRITICAL LIMITS AT CCPS ARE NOT MET, AFFECTED PRODUCTS SHALL BE IDENTIFIED AND HANDLED AS POTENTIALLY UNSAFE PRODUCTS 8.9.2.3 WHERE ACTION CRITERIA FOR AN OPRP ARE NOT MET: A) DETERMINATION OF THE CONSEQUENCES OF THAT FAILURE; B) DETERMINATION OF THE CAUSE(S) OF FAILURE; C) IDENTIFICATION OF THE AFFECTED PRODUCTS AND HANDLING IN ACCORDANCE WITH 8.9.4. DOCUMENT THE RESULTS OF THE EVALUATION. 83  8.9.2 CORRECTIONS 8.9.2.4 DOCUMENTED INFORMATION SHALL BE RETAINED TO DESCRIBE CORRECTIONS MADE ON NONCONFORMING PRODUCTS AND PROCESSES, INCLUDING: A) a) the nature of the nonconformity; B) b) the cause(s) of the failure; c) the consequences as a result of C) the nonconformity. 84 8.9.3 CORRECTIVE ACTIONS Specifies appropriate When: actions to identify and eliminate the cause of critical limits at CCP(s) detected NCs, to prevent and/or action criteria for recurrence, and to return the OPRPs are not met process to control after a nonconformity is identified. How??? 85  These actions shall include: a) a)complaints reviewing nonconformities identified by customer and/or consumer 8.9.3 and/or regulatory inspection reports; b) b)c) determining reviewing trends in monitoring results that can indicate loss of control; the cause(s) of nonconformities; CORRECTIVE c) d)dodetermining not recur and implementing actions to ensure that nonconformities d) e) documenting the results of corrective actions ACTIONS e) taken; f) verifying corrective actions taken to ensure that f) they are effective The organization shall retain documented information on all corrective actions. 86  8.9.4.1 General 8.9.4 The organization shall take action(s) to prevent potentially unsafe products from HANDLING entering the food chain, unless it can demonstrate that: OF POTENTIALLY a) a) the food safety hazard(s) of concern is (are) reduced to the defined acceptable levels; b) the food safety hazard(s) of concern will be reduced to identified acceptable levels prior to UNSAFE b) entering the food chain; or c) the product still meets the defined acceptable level(s) of the food safety hazard(s) of concern despite the nonconformity PRODUCTS c) If products that have left the control of the organization are subsequently determined to be unsafe, the organization shall notify relevant interested parties and initiate a 87 withdrawal/recall  EACH LOT OF PRODUCTS AFFECTED BY THE NONCONFORMITY SHALL BE EVALUATED. PRODUCTS AFFECTED BY FAILURE TO REMAIN WITHIN CRITICAL LIMITS AT CCPS SHALL NOT BE RELEASED AND SHALL BE HANDLED AS NC PRODUCTS (I.E. 8.9.4.3 DEIPOSITIONOF NONCONFORMING PRODUCTS) PRODUCTS AFFECTED BY FAILURE TO MEET ACTION CRITERION FOR OPRPS SHALL ONLY BE RELEASED AS SAFE WHEN ANY OF THE FOLLOWING CONDITIONS APPLY: A) a) evidence other than the monitoring system demonstrates that the control measures have been effective; b) evidence shows that the combined effect of the control measures for that particular product conforms to the performance intended (i.e. identified acceptable levels); B) c) the results of sampling, analysis and/or other verification activities demonstrate that the affected products conform to the identified acceptable levels for the food safety hazard(s) concerned. C) 8.9.4.2 EVALUATION FOR RELEASE 88  PRODUCTS THAT ARE NOT ACCEPTABLE FOR RELEASE SHALL BE: A) REPROCESSED OR FURTHER PROCESSED ; OR B) REDIRECTED FOR OTHER USE AS LONG AS FOOD SAFETY IN THE FOOD CHAIN IS NOT AFFECTED; OR C) DESTROYED AND/OR DISPOSED AS WASTE. 8.9.4.3 DISPOSITION OF NONCONFORMING PRODUCTS 89  Ensure the timely withdrawal/recall of lots of end products; appoint competent person(s) having the authority to initiate and carry out the withdrawal/recall Withdrawn/recalled products and end products still in stock shall be secured or held under the control … 8.9.5 WITHDRAWAL What to do: /RECALL a) notifying relevant interested parties (e.g. statutory and regulatory authorities, customers and/or consumers); b) handling withdrawn/recalled products as well as products still in stock; c) performing the sequence of actions to be taken. Verify the implementation and effectiveness of withdrawals/recalls (e.g. mock withdrawal/recall or practice 90 withdrawal/recall) and retain documented information. 8.9 CONTROL OF PRODUCT AND PROCESS NONCONFORMITIES CLASS ACTIVITIES: ANALYZE THE CASES, IDENTIFY THE ROOT CAUSE, AND PROPOSE CORRECTION AND CORRECTIVE ACTIONS TO ADDRESS THE ISSUE. Case Root Cause Correction Corrective Action Case 1: A food production factory discovers a batch of products contaminated with foreign objects (metal chips); the foreign objects foriege use another buy a new objet sieve sient match with the metal chips falling off from a broken sieve. The contamination is identified during routine quality checks. Case 2: A food manufacturing company receives a shipment of raw unsafe do not change supplier use that materials (smoked salmon) from a supplier that fails to meet the micro. standards (salmonella detected). The nonconformity is Salmon batch identified during incoming goods inspection. the calibrate the Case 3: During a routine production run, a deviation occurs in a lowe set critical control point in the process (core temperature of roasted o men over chicken below 75C due to malfunctioned ovem), resulting in a > - A Sup potential risk to food safety. higher review the Case 4: During an internal audit, it is discovered that a company's X enough take record 91 food safety management system lacks adequate documentation for documents system product recall. REQUIREMENTS OF THE STANDARD 4th 9.1 MONITORING, MEASUREMENT, ANALYSIS AND EVALUATION 9.2 INTERNAL AUDIT 9.3 MANAGEMENT REVIEW 10 IMPROVEMENT AND UPDATE IMPLEMENTING ISO22000 IN FOOD ORGANIZATIONS AUDITING AND CERTIFICATION 92 9 PERFORMANCE EVALUATION 9.1 MONITORING, MEASUREMENT, ANALYSIS AND EVALUATION THE ORGANIZATION SHALL DETERMINE: the methods for when the results from what needs to be monitoring, when the monitoring who shall analyze and measurement, analysis monitoring and evaluate the results monitored and and measuring shall measurement shall be from monitoring and measured and evaluation, as be performed analyzed and applicable, to ensure measurement valid results evaluated The organization shall evaluate the performance and the effectiveness of the FSMS. 93 9.1.2 ANALYSIS AND EVALUATION THE ANALYSIS SHALL BE CARRIED OUT: Verification activities related a) to confirm that the overall performance of the system to PRPs A) meets the planned arrangements and the FSMS requirements established by the organization B) b) to identify the need for updating or improving the FSMS Verification activities related C) c) to identify trends which indicate a higher incidence of potentially unsafe products or process failures to the hazard control plan D) d) to establish information for planning of the internal audit programme related to the status and. importance of areas to be audited E) e) to provide evidence that corrections and corrective actions are effective. Internal audits External audits 94  What to do: 9.2 INTERNAL AUDIT a) plan, establish, implement and maintain (an) audit program(s), including the frequency, methods, responsibilities, planning requirements and reporting, which shall take into consideration the importance of the processes concerned, changes in the FSMS, and the results of monitoring, measurement and previous audits; The organization shall conduct internal b) define the audit criteria and scope for each audit; audits at planned intervals to provide c) select competent auditors and conduct audits to ensure information on whether the FSMS: objectivity and the impartiality of the audit process; a) conforms to: d) ensure that the results of the audits are reported to the food 1) the organization’s own requirements safety team and relevant management; for its FSMS; e) retain documented information on the implementation of the audit 2) the requirements of the Standard; programme and the audit results ; b) is effectively implemented and f) make the necessary correction and take the necessary corrective maintained. action within the agreed time frame; g) determine if the FSMS meets the intent of the food safety policy and objectives of the FSMS. 95 Follow-up activities by the organization shall include the verification of the actions taken and the reporting of the verification results. 9.2 INTERNAL AUDIT 96  IMAGINE IF YOU WERE THE TOP MANAGEMENT OF A FOOD COMPANY, WHAT KIND OF INFORMATION WOULD YOU SEEK FROM YOUR TEAM IN ORDER TO REVIEW THE PERFORMANCE, IN TERMS OF FOOD SAFETY, OF YOUR COMPANY?? MANAGEMENT PRODUCTION? QA? REVIEW PURCHASING? ENGINEERING? HR? BUSINESS (SALES TEAM)? ETC. 97 9.3 MANAGEMENT REVIEW Top management shall review the organization’s FSMS, at planned intervals, to ensure its continuing suitability, adequacy and effectiveness. 9.3.2 MANAGEMENT REVIEW INPUT D) THE ADEQUACY OF RESOURCES; A) a) the status of actions from previous management reviews E) e) any emergency situation, incident (see 8.4.2) or withdrawal/recall (see b) changes in external and internal issues that are relevant 8.9.5) that occurred; f) relevant information obtained through external (see 7.4.2) and internal B) to the FSMS, including changes in the F) (see 7.4.3) communication, organization and its context (see 4.1); including requests and complaints from interested parties; C) c) information on the performance and the effectiveness of G) g) opportunities for continual improvement. the FSMS, including trends in: 1) result(s) of system updating activities (see 4.4 and 10.3); 2) monitoring and measurement results; 3) analysis of the results of verification activities related to PRPs and the hazard control plan(see 8.8.2); 4) nonconformities and corrective actions; 5) audit results (internal and external); 6) inspections (e.g. regulatory, customer); 7) the performance of external providers; 8) the review of risks and opportunities and of the effectiveness of actions taken to address them (see 6.1); 9) the extent to which objectives of the FSMS have been met; THE DATA SHALL BE PRESENTED IN A MANNER THAT ENABLES TOP 98 MANAGEMENT TO RELATE THE INFORMATION TO STATED OBJECTIVES OF THE FSMS 9.3.3 MANAGEMENT REVIEW OUTPUT Top management shall review the organization’s FSMS, at planned intervals, to ensure its continuing suitability, adequacy and effectiveness. The outputs of the management review shall include: a) decisions and actions related to continual improvement opportunities; b) any need for updates and changes to the FSMS, including resource needs and revision of the food safety policy and objectives of the FSMS. The organization shall retain documented information on the results of Management 99 Reviews.  PLEASE DEVELOP THE AUDIT CHECKLISTS (I.E. WRITE DOWN THE AUDIT QUESTIONS, WHAT KIND OF EVIDENCE YOU NEED TO OBTAIN, WHAT TO OBSERVE, WHAT WORKSHOP RECORDS TO REVIEW) FOR THE FOLLOWING – AUDIT DEPARTMENTS: PRODUCTION (PRODUCTION SITE, PRODUCTION LINE) CHECKLIST HR PREPARATION PURCHASING ENGINEERING 100  10.1 Nonconformity and corrective action 10 IMPROVEMENT 10.2 Continual improvement 10.3 Update of the FSMS 10.1 NONCONFORMITY AND CORRECTIVE ACTION C) IMPLEMENT ANY ACTION NEEDED; 10.1.1 WHEN A NONCONFORMITY OCCURS, THE D) REVIEW THE EFFECTIVENESS OF ANY CORRECTIVE ORGANIZATION SHALL: ACTION TAKEN; E) MAKE CHANGES TO THE FSMS, IF NECESSARY. A) REACT TO THE NC: 1) TAKE ACTION TO CONTROL AND CORRECT IT; 2) DEAL WITH THE CONSEQUENCES; CORRECTIVE ACTIONS SHALL BE APPROPRIATE TO THE EFFECTS OF THE NC ENCOUNTERED. B) EVALUATE THE NEED FOR ACTION TO ELIMINATE THE CAUSE(S) OF THE NC, IN ORDER THAT IT DOES NOT RECUR OR OCCUR ELSEWHERE: 1) REVIEW THE NC; 2) DETERMINE THE CAUSES OF THE NC; 101 3) DETERMINE IF SIMILAR NC EXIST, OR COULD POTENTIALLY OCCUR; 10.1.2 THE ORGANIZATION SHALL RETAIN DOCUMENTED INFORMATION AS EVIDENCE OF: A) THE NATURE OF THE NC AND ANY SUBSEQUENT ACTIONS TAKEN; B) THE RESULTS OF ANY CORRECTIVE ACTION. 10.2 CONTINUAL IMPROVEMENT THE ORGANIZATION SHALL CONTINUALLY IMPROVE THE SUITABILITY, ADEQUACY AND EFFECTIVENESS OF THE FSMS. TOP MANAGEMENT SHALL ENSURE THAT THE ORGANIZATION CONTINUALLY IMPROVES THE EFFECTIVENESS OF THE FSMS THROUGH THE USE OF COMMUNICATION , MANAGEMENT REVIEW, INTERNAL AUDIT, ANALYSIS OF RESULTS OF VERIFICATION ACTIVITIES, VALIDATION OF CONTROL MEASURE(S) AND COMBINATION(S) OF CONTROL MEASURE(S), CORRECTIVE ACTIONS AND FSMS UPDATING. 102  TOP MANAGEMENT SHALL ENSURE THAT THE FSMS IS CONTINUALLY UPDATED. THE FOOD SAFETY TEAM SHALL EVALUATE THE FSMS AT PLANNED 10.3 INTERVALS. THE TEAM SHALL CONSIDER WHETHER IT IS NECESSARY TO REVIEW THE HAZARD ANALYSIS, THE ESTABLISHED HAZARD CONTROL UPDATE OF PLAN AND THE ESTABLISHED PRPS. THE FOOD THE UPDATING ACTIVITIES SHALL BE BASED ON: a) input from communication, external as well as internal (see A) 7.4); SAFETY B) b) input from other information concerning the suitability, adequacy and effectiveness of the FSMS; MANAGEME C) c) output from the analysis of results of verification activities (see 9.1.2); NT SYSTEM: D) d) output from management review (see 9.3) SYSTEM UPDATING ACTIVITIES SHALL BE RETAINED AS DOCUMENTED INFORMATION AND REPORTED AS INPUT TO THE MANAGEMENT REVIEW. 103  PLEASE DEVELOP THE AUDIT CHECKLISTS (I.E. WRITE DOWN THE AUDIT QUESTIONS, WHAT KIND OF EVIDENCE YOU NEED TO OBTAIN, WHAT TO OBSERVE, WHAT WORKSHOP RECORDS TO REVIEW) FOR THE FOLLOWING – AUDIT DEPARTMENTS: PRODUCTION (PRODUCTION SITE, PRODUCTION LINE) CHECKLIST HR PREPARATION PURCHASING ENGINEERING 104  WORKSHOP – PREPARING AUDIT CHECKLIST (REFERENCE CLAUSE) Clause Audit Questions Clause Audit Questions quirh Please provide the latest internal audit records 8 5 13.. Please provide the specification of product A 85 15 Please provide the flow diagrams for product A and 3.. B. 8. 5. 4. Please provide the monitoring results of OPRP1 4 2 Who are the interested parties identified? Please provide the calibration record of the 8 7 · -. thermometer used for monitoring CCP 3 - How was CCP1, concerning the control of pathogens 8.. 8 in product A, verified? 8 9 43 Please provide the evidence on the handling (i.e. disposal) of NC product batch 20231103.. - Please provide the evidence.. 6 2 Please provide the objectives of the FSMS. Please provide the latest management review 9 3 -. record 5 3. Who is the food safety team leader? What are the external and internal issues 8 5.. 43. Please provide the monitoring results of CCP 2 4l : identified? - Have pest control measures been carried out - Is the current meat supplier - ABC an approved - 8 2. 4 according to plan? 8 2. - If supplier? - Please provide the evidence. 7 1 6 -. - Please provide the evidence. Please provide the specifications of raw materials: Please provide the SOP / WI for cleaning and 8.1 2 -4 5 8 2. - canned tuna, boneless chicken thigh, rice.. sanitation of production line. 105 5 2. Please provide the food safety policy. THE STEPS FOR IMPLEMENTING ISO22000:2018 IN FOOD ORGANIZATIONS Training and Awareness Establishing the FSMS Gap Analysis and Implementation Plan Familiarize with the Standard Top Management Commitment 106  Resistance to Change Coordination and Continual Collaboration Improvement Overcome resistance Address the challenge Maintain a continuous from employees when of coordinating and improvement mindset to implementing new collaborating with address emerging risks procedures and creating different departments and keep the a food safety culture. to ensure smooth certification up to date. implementation. COMMON CHALLENGES FACED DURING IMPLEMENTATION AND CERTIFICATION 107  BENEFITS OF ISO22000:2018 CERTIFICATION 1. ENHANCED CREDIBILITY GAIN THE TRUST OF CUSTOMERS, SUPPLIERS, AND STAKEHOLDERS BY DEMONSTRATING COMMITMENT TO FOOD SAFETY. 2. IMPROVED RISK MANAGEMENT IDENTIFY, EVALUATE, AND CONTROL POTENTIAL FOOD SAFETY HAZARDS, REDUCING THE RISK OF INCIDENTS AND PRODUCT RECALLS. 3. MARKET ACCESS ACCESS NEW MARKETS AND INCREASE EXPORT OPPORTUNITIES BY MEETING INTERNATIONALLY 108 RECOGNIZED FOOD SAFETY STANDARDS.  STANDARDS AND CERTIFICATIONS ISO22000 FSSC22000 (Food Safety System Certification) BRC (British Retail Consortium) HACCP IFS (International Featured Standards) 109 THE COMPLEXITY OF THE CERTIFICATION MARKET (ISO/TC 34/SC 17 ) SOURCE: HTTPS://COMMITTEE.ISO.ORG/FILES/LIVE/SITES/TC34SC17/FILES/SC1 7%20N825%20DRAFT%20STRATEGIC%20BUSINESS%20PLAN%2020 24%20(CLEAN).PDF 110 ~~End~~ Thank you! 111