ISO 22000:2018 Checklist [PDF]

Zitiervorschau

FSSC 22000 Version 5.1 Audit Checklist

ISO 22000:2018 Food Safety Management System (Requirements of any organization in the food chain) ITEM 4 Context of the Organization 4.1 Understanding the organization and its context What are the internal and external issues that are relevant to the organization’s purpose and affect its ability to achieve intended result of its food safety management system? How does the organization review and monitor the relevant internal and external issues? 4.2 Understanding the needs and expectations of interested parties Who/what are the interested parties that are relevant to the food safety a management system? How does the organization review and monitor the requirements of relevant b interested parties? 4.3 Determining the scope of the food safety management system What is the scope of the food safety management system? What are the boundaries applicable to the organization’s scope? How were external and internal issues and the expectations of interested a-b parties, relevant to the organization’s requirements, considered when the organization’s scope was established? 4.4 Food safety management system How does the organization maintain documented information to support the operation of its processes and retain documented information to provide confidence that the processes are being carried out as planned? 5 Leadership 5.1 Leadership and commitment How are policies and objectives established? Do they align with the strategic a direction of the organization? How are the requirements of the FSMS integrated into the business b processes? c How are resources determined? How do you communicate the importance of effective FSMS and conforming d to its requirements? e How do you ensure that the FSMS achieves its intended results? How do you engage, direct and support people who contribute to the f effectiveness of the FSMS? g How is continual improvement promoted? How are other relevant management roles supported to demonstrate h leadership in their areas of responsibility? 5.2 Policy Does the organization have a food safety policy that is appropriate to the 5.2.1 a-f context of the organization and its purpose? How is your messaging used to communicate policies and objectives to all 5.2.2 a-c employees?

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WHAT TO LOOK FOR

AUDIT EVIDENCE

CONFORMITY Y/N?

5.3 Organizational roles, responsibilities and authorities 5.3.1

How do you ensure that the responsibilities and authorities for relevant roles are a) assigned? b) communicated? and c) understood in the organization?

5.3.2 Who is the appointed food safety team leader and food safety team? 5.3.2 What kind of training is given to food safety team? How does the organization ensure that all problems with regards to the 5.3.3 FSMS are reported to the identified persons? 6 Planning 6.1 Actions to address risks and opportunities When planning for our quality management system, did you consider the issues referred to in 4.1 and the requirements referred to in 4.2 and determine all risks and relevant new opportunities that need to be addressed to: 6.1.1 a-d a) Give assurance that the management system can achieve its intended results b) Enhance desirable effects c) Prevent, or reduce, undesired effects d) Achieve improvement 6.1.2 a What are the planned actions to address these risks and opportunities? How do you demonstrate the integration and implementation of these actions 6.1.2 b into the management processes? 6.1.2 b How do you evaluate the effectiveness of these actions? Are the actions taken to address risks and opportunities aproportionate to a) the impact on food safety requirements, b) the conformity of food products 6.1.3 a-c and services to customers and c) to the requirements of interested parties in the food chain? Do the options to address all to our organization relevant risks include avoiding risk, taking risk in order to pursue an opportunity, eliminating the risk 6.1.3 source, changing the likelihood or consequences, sharing the risk, or retaining risk by informed decision? Has any opportunity led to the adoption of new practices, launching new products, opening new markets, addressing new customers, building 6.1.3 partnerships, using new technology and other desirable and viable possibilities to address the food safety needs of the organization or its customers? 6.2 Objectives of the food safety management system and planning to achieve them Has the organization established objectives for the management system that 6.2.1 is connected with the organization's relevant functions and levels? Whether the chosen objectives of the management system: a) consistent with the food safety policy b) measurable c) take into account food safety applicable requirements, including statutory, 6.2.1 a-f regulatory and customer requirements d) monitored and verified e) communicated f) maintained and updated

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When planning how to achieve the objectives, does our organization determine: a) What will be done 6.2.2 a-e b) What resources will be required c) Who will be responsible d) When it will be completed e) How the results will be evaluated 6.3 Planning of changes When our organization determines the need for changes to the management system, are the changes carried out in a planned manner? Does the organization consider: a) The purpose of the changes and their potential consequences b) The integrity of the FSMS c) The availability of resources to effectively implement the changes d) The allocation or reallocation of responsibilities and authorities 7 Support 7.1 Resources 7.1.1 General How does the organization determine the resources needed for the establishment, implementation, maintenance and continual improvement of the FSMS? Has our organization considered: a) The capabilities of, and constraints on, existing internal resources b) The need for external resources 7.1.2 People How does the organization allocates its staff in order to achieve the required outcome? Does the organization required the assistance of external experts for the development, implementation, operation or assessment of the FSMS? If yes, are records of agreement or contracts defining the competency, responsibility and authority of extenal experts available? 7.1.3 Infrastructure What is the status of the following infrastructure? a) Buildings and workspaces b) Gas, water, electricity, etc. c) Transportation resources d) Information and communication technology 7.1.4 Work environment How does the organization demonstrate a work environment that allows the achievement of conformity with the requirements of the management system? What is the status of the following environmental factors: a) Social (e.g. non-discriminatory, calm, non-confrontational) b) Psychological (such as stress-reducing, burnout prevention, emotionally protective) c) Physical (e.g. temperature, heat, humidity, light, airflow, hygiene, noise) 7.1.5 Externally developed elements of the food safety management system

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Has the organization acquire externally developed elements? How do you ensure its conformity to the requirements? How do you determine that the provided elements are applicable to the sites, b processess and products of the organization? How do you ensure that the provided elements are specifically adopted to the c process and products of the organization by the food safety team? How do you ensure that it is implemented, maintainted and updated as d-e required by the standard? 7.1.6 Control of externally provided processes, products or services How does the organization ensure that all externall provided processes, products and services that have an impact to food safety are evaluated, a selected, and re-evaluated to demonstrate compliance with the requirements? How does the organization ensure that all externally provided processes, a products and services that have an impact to food safety are monitored to assure continued service provider approval status? b How are requirements communicated to the the external providers? How does the organization ensure that all externally provided processes, c-d products and services that have an impact to food safety are managed in conformance with the requirements of the FSMS? 7.2 Competence How does the organization identify the necessary competencies for a-b personnel whose activities have an impact on food safety (including external providers)? Who are the designated food safety team members? How do you c demonstrate that the food safety team has the required multi-disciplinary knowledge and experience? What are the actions taken to acquire the necessary competence? How do d-e you evaluate its effectiveness? 7.3 Awareness How does the organization demonstrate awareness of food safety policy to a all relevant personnel doing work under the organization's control? How do you ensure that personnel are aware of the objectives of the FSMS b relevant to their task? How do you ensure that they are aware on the individual contribution to the c effectiveness of the FSMS, including the benefits of improved food safety performance? How do you ensure that they are aware of the implication of not conforming d with the FSMS requirements? 7.4 Communication 7.4.1 General Do your consider the following when determining the internal and external communications relevant to the FSMS: a on what it will communicate b when to communicate c with whom to communicate d how to communicate e who communicates a

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7.4.2 External Communication Who is the responsible and authorized person to communicate any information concerning food safety externally? How are information on issues/requirements concerning food safety communicated to: a external providers and contractors? b customers/consumers? c statutory and regulatories? other organizations that have an impact on, or will be affected by, the d effectiveness or updating of the FSMS 7.4.3 Internal Communication Does the organization have an effective communication system in place? How do you ensure that the food safety team is informed in a timely manner whenever there are changes in the FSMS (a-m)? 7.5 Documented Information 7.5.1 General 7.5.2 Creating and Updating How are documented information: a) identified and described (e.g. title, date, author, reference number) 7.5.2 a-b b) format (e.g. language, software version, graphics) and on appropriate media (e.g. paper, electronic Are documented information reviewed and approved for its suitabulity and 7.5.2 c adequacy? Who can review and approve the FSMS documents? 7.5.3 Control of documented information 7.5.3.1 What type of information should be controlled? How are they controlled? 7.5.3.1

How does the organization demonstrate the arrangements for controlling documented information for its a) availability b) suitablity and c) protection?

How does the organization demonstrate the arrangements for controlling documented information (printed and electronic copy) for the ff. activities: a) distribution, access, retrieval and use 7.5.3.2 b) storage and preservation, including preservation of legibility c) control of changes d) retention and disposition 8 Operation 8.1 Operational Planning and Control Has our organization planned, implemented and controlling the processes needed for the realization of safe products ad to implement the actions determined in Clause 6? Are you doing these by: a) Establishing criteria for the processes b) Implementing control of the processes in accordance with the criteria c) Keeping documented information to the extent necessary to have the confidence to demonstrate that the processes have been carried out as planned How does your organization is controlling planned changes and reviewing the consequences of unintended changes, taking action to mitigate any adverse effects?

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8.2 8.3

8.4 8.4.1

8.4.2 a

How does your organization ensure that outsourced processes are controlled? Pre-requisite Programmes (PRPs) Refer to ISO/TS 22002-1:2009 Audit Checklist Traceability System How does the organization identify products (conforming and nonconforming) throughout the manufacturing processes (lots of received materials, ingredients and intermediate products to the end products)? How do you identify incoming material from the immediate suppliers? What is the traceability system for reworked products? How about for the bulk ingredients and re-palletized items? How about the initial distribution route of the end product? How do you ensure that mandatory labelling information required by the client and regulatory bodies in relation to traceability were in place? What is the retention period of the traceability records? How do you verify the effectiveness of the traceablity system? Emergency Preparedness and Response General What are the identified potential accidents and emergency situations relevant to the organization? How does the organization managed these potential emegency situations or incidents that can have an impact on food safety? Who are the responsible persons to handle emergency situations and accidents? Handling of emergencies and incidents Are there any applicable regulatory and statutory used in the establishment of the food safety emergency preparedness and response procedures?

In case of emergency, how do the responsible personnel communicate internally? In case of emergency, how do the responsible personnel communicate a externally? b What are the measures to be taken in the event of accidental release? c How often do you test your incident management procedure? How do you evaluate the potential risks to food safety based on the result of d an emergency occurrence or tests? 8.5 Hazard control 8.5.1 Preliminary steps to enable hazard analysis 8.5.1.1 General 8.5.1.2 Characteristics of raw materials, ingredients and product contact materials Are there detailed product specifications for raw materials, ingredients and Product Characteristics for product contact materials? RM, PM and PCM a

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Does the specifications contain the following information, to facilitate hazard analysis: a) Biological, physical and chemical characteristics b) Composition of formulated ingredients, including additives and processing tools c) source (e.g animal, mineral or vegetable) d) Place of origin (provenance) e) Method of production f) Method of packaging and delivery g) Storage conditions and shelf-life h) Preparation and/or handling before use or processing i) Acceptance criteria related to food safety or specifications of purchased materials and ingredients appropriate to their intended use What are your basis for the acceptance criteria of the identified specifications? 8.5.1.3 Characteristics of end products

Product Characteristics for RM, PM and PCM

Literature, Statutory and Regulatory

Are there detailed product specifications for end products? Do they contain the following information: a. Product name or similar identification b. Composition c. Biological, chemical and physical characteristics relevant for food safety Product Description d. Intended shelf life and storage conditions e. Packaging f. Labelling relating to food safety and/or instructions for handling, preparation and usage g. Methods of distribution and delivery 8.5.1.4 Intended Use Is the intended use, reasonably expected handling of end product and any unintended but reasonably expected mishandling and misuse documented? Does it identifies in each product the groups known to be vulnerable to specific food safety hazards?

Product Description Allergen Advise (See sample product label)

8.5.1.5 Flow diagrams and description of processes 8.5.1.5.1 Preparation of the flow diagrams Does all products/categories have process flow? Are flow diagrams clear, accurate and sufficiently detailed to include the following: a. The sequence and interaction of all steps in the operation b. Any outsourced processes c. Where raw materials, ingredients, processing aids, PMs, utilities and intermediate products enter the flow d. Where reworking and recycling take place e. Where end products, intermediate products, by-products and waste are released or removed? 8.5.1.5.2 On-site confirmation of flow diagrams

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Process Flow Diagram

How does the food safety team confirm the accuracy of the flow diagrams?

Records of process flow verification conducted by Food Safety team

8.5.1.5.3 Description of processes and process environment Does the organization describe the ff. to the extent needed to conduct hazard analysis: a. the layout of premises, including food and non food handling areas b. processing equipment and contact materials, processing aids and flow of Process Description of materials a-d processes and process c. existing PRPs, process parameters, control measures (if any) and/or the environment strictness with which are applied, or procedures that can influence food safety d. external requirements that can impact the choice and the strictness of the control measures 8.5.2 Hazard Analysis 8.5.2.1 General Risk Assessment and Hazard Analysis How do you determine which hazards need to be controlled? (Preliminary, Experience Historical data, Hazards from the food chain) 8.5.2.2 Hazard Identification and Determination of Acceptable Levels 8.5.2.2.2 Are the steps (from raw materials, processing, distribution and delivery) at a-c which each food safety hazard may be introduced indicated? 8.5.2.2.3a How do you determine the acceptable level in the end product of each food -c safety hazard identified? 8.5.2.3 Hazard Assessment

Risk Assessment and Hazard Analysis (Process) Determination of acceptable levels and itsjustification

Risk Matrix and Risk Is a risk assessment performed to identify which hazards are significant and Assessment and Hazard which are not? What methodology is used? Analysis 8.5.2.4 Selection and categorization of control measures For significant hazards, has there been an identified control measure or Result of the selection and 8.5.2.4.1 combination of control measure to prevent or reduce it to defined acceptable categorization of the a-b levels? control measures 8.5.2.4.2 How are these control measures selected and categorized? Decision Tree a-b 8.5.3 Validation of control measure(s) and combinations of control measures Validation of Food Safety Is the effectiveness of the control measure against the hazard reviewed? Control Measure 8.5.4 Hazard control plan (HACCP/OPRP plan) 8.5.4.1 General a-b

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Does the Hazard Control Plan include the ff. information for each control measure at each CCP or OPRP: a. food safety hazards to be controlled at the CCP or by the OPRP b. critical limits at CCP or action criteria for OPRP a-f c. monitoring procedures d. corrections to be made if critical limits or action criteria are not met e. responsibilities and authorities f. records of monitoring 8.5.4.2 Determination of critical limits and action criteria Have critical limits for each CCP and acion criteria for OPRPs have been established? Are the rationale of determining critical limits documented? 8.5.4.3 Monitoring systems at CCPs and for OPRPs Has a monitoring system been established for each control measure to detect any failure remain within critical limits? Are the monitoring methods and frequency capable of determining when critical limit have been exceeded in time for the product to be isolated before it is used or consumed? Are critical limits based on subjective data (such as visual inspection, process, handling, etc.) supported by instructions or specifications and/or education and training? 8.5.4.4 Actions when critical limits or action criteria are not met What are the corrections and corrective actions to be taken when critical limits or action criterion are not met? Are they specified in the Hazard Control Plan? 8.5.4.5 Implementation of the hazard control plan

Hazard Control Plan (HACCP/OPRP Plan)

Hazard Control Plan (HACCP/OPRP Plan) Validation Study Monitoring procedures for CCPs Monitoring Records for CCPs Monitoring procedures and records for OPRP Sample Corrective Action Report with exceeded critical limit

Verification of corrective actions 8.6 Updating the information specifying the PRPs and the hazard control plan Is there a defined frequency to review and update (if necessary) the a-d preliminary information to establish the Hazard Control Plan? 8.7 Control of monitoring and measuring What are the specified monitoring and measuring methods and equipment available? How do you demonstrate that these specified methods and equipment are adequate to ensure the performance of the monitoring and measuring procedures? How do you ensure that the said actions are implemented and will not recur?

What documented information does our organization retains as evidence of: a calibrated or verified at specified intervals prior use? b adjusted or re-adjusted as necessary? c identified to enable the calibration status to be determined? safeguarded from adjustments that would invalidate the measurement d results? e protected from damage and deterioration? If no standard exist, what is the basis used for calibration or verification?

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How do you assess the validity of the previous measurement results when the equipment or process environment is found not to conform to requirements? What are the actions to be taken if the measuring equipment is found not to conform to requirements? Are there softwares used for monitoring and measuring equipment? 8.8 Verification related to PRPs and the hazard control plan 8.8.1 Verification Do the verification activities to confirm the following: a The PRPs are implemented and effective b The hazard control plan is implemented and effective c Hazard levels are within identified acceptable levels d Input to the hazard analysis is updated e Other actions determined by the organization are implemented and effective 8.8.2 Analysis of results of verification activities Are the result of the verification analyzed? What is done with the analyzed data? 8.9 Control of product and process nonconformities 8.9.1 General Who is the identified person responsible for evaluating the data derived from the monitoring of OPRPs and CCPs? 8.9.2 Corrections What are the methods to identify, assess and correct the affected end 8.9.2.1 a products to determine their proper handling? 8.9.2.1 b How are corrections carried out reviewed? 8.9.2.2 How does the organization handle nonconforming products? 8.9.2.3 aWhat does the organization do if OPRP are not met based? c 8.9.2.4 What documented information does our organization retains as evidence of: a nature of nonconformity b cause of the failure c consequences as a result of the nonconformity 8.9.3 Corrective Actions How does the organization identify and eliminate the cause of nonconformities, to prevent recurrence and to return the process back into control after a nonconformity is encountered? a

Does these actions include reviewing non-conformities identified by customer and/or consumer complaints and/or regulatory inspection reports?

Does these actions include reviewing trends in monitoring results that can indicate loss of control? c Does these actions include determining the causes of non-conformities? Does these actions include determining and implementing actions to ensure d that non-conformities do not recur? b

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Does these actions include documenting the results of corrective actions taken? Does these actions include verifying corrective actions taken to ensure that f they are effective? 8.9.4 Handling of potentially unsafe products 8.9.4.1 General What are the actions to be taken to prevent PUPs from entering the food chain? How do you demonstrate that the food safety hazards of concerns are a reduced to the defined acceptable levels? How do you demonstrate that the food safety hazrds of concern will be b reduced to identified acceptable levels prior to entering the food chain? e

c

How do you demonstrate that the product still meets the defined acceptable levels of the food safety hazards of concern despite non-conformity?

Are potentially unsafe products identified and retained by the organization? 8.9.4.2 Evaluation for Release What are the parameters considered for the nonconforming product to be a-c released after evaluation? 8.9.4.3 Disposition of nonconforming products How do you handle the nonconforming batch if not acceptable for release a-c (reprocessed, redirected, dispose and/or destroyed as waste)? 8.9.5 Withdrawal/Recall Who is the appointed personnel having the authority to initiate and carry out the withdrawal/recall? Does the organization have a documented information for notification to a relevant interested parties (eg. statutory and regulatory authorities, customers, consumers)? How do you managed withdrawn/recalled products as well as products still in b stock? c What are actions to be taken for the withdrawn products? How do you verify the effectiveness of withdrawals/recall? 9 Performance Evaluation 9.1 Monitoring, measurement, analysis and evaluation 9.1.1 General Has our organization determined: a What needs to be monitored and measured within your management system The methods for monitoring, measurement, analysis and evaluation of your management system needed to ensure valid results When the monitoring and measuring of your management system shall be c performed When the results from monitoring and measurement shall be analyzed and d evaluated e Who analyse and evaluate the results from monitoring and measurement 9.1.2 Analysis and evaluation How is your food safety performance measured? b

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Do you use the results of analysis to evaluate: a

To confirm that the overall performance of the system meets the planned arrangements and the FSMS requirements established by the organization?

b To identify the need for updating or improving the FSMS? To identify trends which indicate a higher incidence of PUPs or process c failures? To establish information for planning of the IA program related to the status d and importance of areas audited? e To provide evidence that corrections and corrective actions are effective? 9.2 Internal Audit 9.2.1 Does the organization conduct internal audit at planned intervals? Does the organization conduct internal audit according to the latest version of approved standards? a-b

How do you determine whether the FSMS conforms to the requirements of ISO 22000:2018 and to the other requirements established by organization? Are they effectively implemented and maintained?

9.2.2 Does the organization: plan, establish, implement and maintain an audit program including the frequency, methods, responsibilities, planning requirements and reporting, a which takes into consideration the importance of the processes concerned, changes affecting our organization, and the results of previous audits? b define the audit criteria and scope for each audit? select competent auditors and conduct audits to ensure objectivity and the c impartiality and the audit process? ensure that results of the audits are reported to the food safety team and d relevant management? retain documented information as evidence of the implementation of the e audit program and the audit results? make necessary correction and take the necessary corrective action within f the agreed time frame? determine if the FSMS meets the intent of the food safety policy and g objectives of the FSMS? 9.3 Management Review 9.3.1 General Is there a set review of the organization's FSMS? Who and when is this conducted? 9.3.2 Management Review Input a-g What is the scope of the said review? 9.3.3 Management Review Output a-b What are the results of the management review inputs? Are there any findings raised from the management review? What are the actions taken? 10 Improvement

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10.1 Nonconformity and corrective action When a nonconformity occurs, including any nonconformity arising from a complaints, whether internal or external complaint nature, how do you react to it? How do you evaluate the need for action to eliminate the cause of the b nonconformity? How do you demonstrate that actions are implemented to solve the c nonconformity? Are there any follow-up done to check whether the d corrective actions were effective? 10.1.2 What documented information does our organization retains as evidence of: a the nature of the non-conformities and any subsequent actions taken b the results of any corrective action 10.2 Continual Improvement Who's involved in improvement efforts? How does the organization demonstrate continual improvement? What tools are used to pursue continual improvement? How do you review your "near-misses: and use this information to drive improvements in your food safety system? How are ideas for improvement prioritised? How employees are made aware of improvement efforts and successes? 10.3 Update of the food safety management system How does top management demonstrate that the management system is continually updated? How does the food safety team evaluate the management system to achieve that it is continually updated? a-d What are the scope of the evaluation and updating activities

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