UNIT 10 CLAUSE-WISE INTERPRETATION OF ISO 22000: 2005

Transcription

1 ISO 22000:2005 UNIT 10 CLAUSE-WISE INTERPRETATION OF ISO 22000: 2005 Structure 10.0 Objectives 10.1 Introduction 10.2 Clause-wise Explanation of the Standard Clause 1: Scope Clause 2: Normative References Clause 3: Terms and Definitions Clause 4: Food Safety Management System Clause 5: Management Responsibility Clause 6: Resource Management Clause 7: Planning and Realization of Safe Products Clause 8: Validation, Verification and Improvement of the FSMS 10.3 Let Us Sum Up 10.4 Key Words 10.5 Answers to Check Your Progress Exercise 10.6 Suggested Reading 10.0 OBJECTIVES After studying this unit, we shall be able to: state the requirements of each clause of ISO 22000: 2005; deduce the interrelationship between different clauses; explain the mandatory procedures required to be maintained; and specify the mandatory records required to be maintained INTRODUCTION The ISO 22000:2005 is Food Safety Management System Standard which has been designed and formulated to ensure safety in whole food chain. Its requirements for any organisation in the food chain provide a framework of internationally harmonized provisions for the global approach. The interpretation of ISO 22000:2005 requirements such as scope, normative references, terms and definitions, broad coverage of the system, management responsibility, resource management, planning and realization of safe products and validation, verification and improvement of the food safety management system are manifested in different clauses with an aim of suitably deploying the same in respective food safety related application area. Further, the contents of each clause are broadly explained followed by detailed interpretation of contents therein CLAUSE-WISE EXPLANATION OF THE STANDARD Clause 1: Scope Broad coverage Purpose, applicability and enabling effect Contents and interpretation

2 The Standard specifies requirements for a food safety management system. By applying the standard a food processor in the food chain demonstrate its ability to control food safety hazards in order to ensure that food is safe at the time of human consumption. It is applicable to all food processors, irrespective of size, which are involved in any aspect of food chain and want to implement systems that consistently provide safe products. The standard specifies requirements to enable a food processor to: 1) Plan, implement, operate, maintain and update a food safety management system aimed at providing products that, according to their intended use, are safe for the consumer, 2) Demonstrate compliance with applicable statutory and regulatory food safety requirements, 3) Evaluate and assess customer requirements and demonstrate conformity with those mutually agreed customer requirements that relate to food safety, in order to enhance customer satisfaction, 4) Effectively communicate food safety issues to their suppliers, customers and relevant interested parties in the food chain, 5) It ensures that the food processor conforms to its stated food safety policy, 6) Demonstrate such conformity relevant interested parties, and 7) To seek certification or registration of its food safety management system by an external food processor, or make a self-assessment or self declaration of conformity to ISO Clause -wise Interpretation of ISO 22000: Clause 2: Normative References Broad Coverage The standards referenced in the main body. Contents and interpretation The standard to be referred is ISO 9001: Quality Management Systems - Fundamentals and vocabulary. (ISO 9001:2000 has been superceded by ISO 9001:2005) Clause 3: Terms and Definitions Broad Coverage The key terms associated with crucial food safety related concepts are explained. Contents and interpretation Term Critical Control Point (CCP) Control Measure Correction Definition Step at which control can be applied and is essential to prevent or eliminate food safety hazard or reduce it to acceptable limits. Food safety action or activity that can be used to prevent or eliminate food safety hazard or reduce it to acceptable limit. Action to eliminate detected non-conformity. (in connection with this standard, a correction relates to the handling of potentially unsafe 39

3 ISO 22000:2005 Term Definition products, and can therefore be made in conjunction with a corrective action). A correction may be for example reprocessing; further processing, disposal for other use, specific labelling or discarding. Corrective Action Critical Limit End Product Flow Diagram Food Chain Food Safety Food Safety Hazard Food Safety Policy Monitoring OPRP (Operational Prerequisite Program) PRP (Prerequisite Program) Updating Validation Verification Action to eliminate the cause of a detected non-conformity or other undesirable condition. Criterion which separates acceptability from unacceptability. Product that will undergo no further processing or transformation by the food processor. Schematic and systematic presentation of the sequence and interactions of the steps of production. Sequences of stages and operations involved in the production, processing, distribution, storage and handling of food and its ingredients, from primary production to consumption. (e.g. farm to fork) Concept that food will not cause harm to the consumer when it is prepared and/or consumed according to its intended use. Biological, chemical or physical agent in the food, or condition of food, with a potential to cause an adverse health effect on the consumer. Overall intentions and direction of a food processor related to food safety (3.1) as formally expressed by Food processor. Conducting a planned sequence of observations or measurements to assess whether the control measures are operating as intended. PRP as identified by the Hazard analysis as essential in order to control the likelihood of introducing food safety hazards, contamination or proliferation to the products or the processing environment. Basic conditions and activities that are necessary to maintain a hygienic environment throughout the food chain suitable for the production, handling and provision of safe end products and safe food for human consumption. Immediate and/or planned activity to ensure application of most recent information. Obtaining evidence that the control measures managed by the HACCP plan and by the OPRPs are capable of being effective. Confirmation, through the objective evidence, that specified requirements have been fulfilled Clause 4: Food Safety Management System Broad coverage: General requirements including system documentation. Contents and Interpretation A. General Requirements The food processor is required to establish, document, implement and maintain an effective food safety management system and update it when necessary. The food processor is required to define the scope. The scope is required to specify the relevant products or product categories, processes and production sites. 40

4 The food processor is required to: Identify, evaluate and control the associated food safety hazards in such a manner that the products of the food processor do not, directly or indirectly, harm the consumer. Internally and externally communicate information concerning development, implementation and updating of the food safety management system. Periodically evaluate and update the food safety management system. Control the outsourced processes (if any). Clause -wise Interpretation of ISO 22000:2005 B. Documentation Requirements (i) General The FSMS documentation is required to include: Food safety policy and related objectives. Required procedures and records. Other documents to ensure effective development, implementation and updating of the FSMS. (ii) Control of documents FSMS documents are required to be controlled. The controls is required to ensure that all proposed changes are reviewed prior to implementation. A documented procedure is required to be established to define the controls needed for: Approval and re-approval of documents, Identification of changes in current documents, Availability at point of use, Legibility of documents, Control over documents of external origin, and Prevention of unintended use of obsolete documents. (iii) Control of Records A documented procedure is required to be established to define the controls needed for the identification, storage, protection, retrieval, retention time and disposition of records Clause 5: Management Responsibility Broad Coverage Management commitment Food safety policy FSMS planning Role definition Food safety team leader Communication 41

5 ISO 22000:2005 Emergency preparedness and response Management review Contents and interpretation A. Management Commitment Food processor is required to provide evidence of its commitment to FSMS and continually improve its effectiveness through supportive business objectives Communicating the importance of meeting requirements of standard, customer, government and regulations, Establishing food safety policy, Conducting management reviews, and Ensuring the availability of resources. B. Food Safety Policy Food processor is required to define, document and communicate its food safety policy and ensure that the food safety policy: Is appropriate to the role of the food processor. Conforms to requirements of standard, customer, government and regulations. Is communicated, implemented and maintained at all levels. Is reviewed for continual suitability. Adequately addresses communication. Is supported by measurable objectives. C. Food Safety Management System Planning Food processor is required to ensure that: Planning of the FSMS is carried out. The integrity of FSMS is maintained. D. Responsibility and Authority Food processor is required to ensure that roles are properly defined and communicated. Designated personnel are required to have responsibility and authority to initiate and record actions. E. Food Safety Team Leader Food processor is required to appoint a food safety team leader. to manage and train the food safety team, to ensure that the FSMS is established, implemented, maintained and updated, to report on the effectiveness and suitability of FSMS, and to interface with external parties on FSMS. 42 F. Communication (i) External Communication The food processor is required to establish, implement and maintain effective arrangements for communicating with:

6 Suppliers and contractors, Customers or consumers, Statutory and regulatory authorities, and Others having an impact on/of FSMS. Designated personnel are required to have defined responsibility and authority to communicate. (ii) Internal Communication The food processor is required to establish, implement and maintain effective arrangements for communicating with internal personnel. In order to maintain effectiveness of FSMS, the food processor is required to ensure that the food safety team is informed in a timely manner of changes, including but not limiting to the following: raw materials, ingredients, products and services, production premises, systems and equipment, cleaning and sanitation programs, packaging, storage and distribution systems, personnel qualification, responsibilities and authorities, statutory and regulatory requirements, knowledge regarding hazards and control measures, customer, sector and other applicable requirements, enquiries from external interested parties, complaints indicating hazards associated with the product, and other conditions that have an impact on food safety. The food safety team is required to ensure that this information is used to update FSMS. G. Emergency preparedness and response Food processor is required to establish, implement and maintain procedures to manage emergency situations that can impact food safety. H. Management Review (i) General Food processor is required to review FSMS at planned intervals to ensure its continuing suitability, adequacy, effectiveness and maintain records. (ii) Review Input The input data for management review is required to include: Follow-up actions from previous management reviews, Analysis of results of verification activities, Changing circumstances that can affect food safety, Emergency situations, accidents and withdrawals, Review of results of system updating activities, Review of internal and external communication activities, and External audits or inspections. Clause -wise Interpretation of ISO 22000:

7 ISO 22000:2005 (iii) Review Output Output from the management review is required to include decisions and actions related to: assurance of food safety, improvement of the effectiveness of the FSMS, resource needs, and revisions of food safety policy and related objectives Clause 6: Resource Management Broad Coverage Provision of competent human resources, Provision of necessary infrastructure, and Provision of required work environment. Contents and interpretation A. Provision of Resources The food processor is required to provide adequate resources for establishing, implementing, maintaining and updating FSMS. B. Human Resources (i) General The food safety team and other relevant personnel are required to have appropriate education, training, skills and experience. (ii) Competency, awareness and training The food processor is required to: a) identify the competencies of relevant personnel, b) ensure that the personnel have necessary competence, c) evaluate the implementation and effectiveness of training, d) ensure that the personnel are aware of the relevance and importance of their activities including effective communication, and e) maintain records of training and other actions. (iii) Infrastructure The food processor is required to provide infrastructure needed to implement the standard. (iv) Work Environment The food processor is required to provide work environment needed to implement the standard Clause 7: Planning and Realization of Safe Products 44 Broad Coverage Prerequisite program Pre steps to Hazard Analysis Hazard Analysis OPRP

8 Establishment of HACCP plan Updating PRP and HACCP plan Verification Traceability Control of non-conforming product Contents and interpretation: General The food processor is required to plan and develop the processes needed for realization of the safe products. A. Prerequisite programs (PRPs) (i) The food processor is required to establish, implement and maintain PRPs for controlling. Likelihood of introducing hazards to the products. Biological, chemical and physical contamination of products. Hazard levels in the product and processing environment. (ii) The PRPs are required: to be appropriate to food safety needs, to be appropriate to the size and type of the operation and the nature of the products, to be implemented across the entire production system, and to be approved by the food safety team. The food processor is required to identify statutory and regulatory requirements related to above. (iii) When selecting and/or establishing PRPs, the food processor is required to consider and utilize appropriate information (e.g. Statutory and regulatory requirements, customer requirements, recognized guidelines, Codex Alimentarius Commission (Codex) principles and codes of practices, national and international or sector standards). The food processor is required to consider following while establishing these programs: Construction and lay-out of buildings and associated utilities, Lay-out of premises, including workspace and employee facilities, Supplies of air, water, energy and other utilities, Supporting services, including waste and sewage disposal, The suitability of equipment and its accessibility for cleaning, maintenance and preventive maintenance, Management of purchased materials, supplies (e.g. water, steam, ice etc.), disposals (e.g. waste and sewage) and handling of product (e.g. storage and transportation), Measures for prevention of cross contamination, Cleaning and sanitization, Pest control, Personnel hygiene, and Other aspects as appropriate. Clause -wise Interpretation of ISO 22000:

9 ISO 22000:2005 Verification of PRPs is required to be planned and PRPs are required to be modified as necessary. Records of verifications and modifications are required to be maintained. Documents should specify how activities included in the PRPs are managed. B. Preliminary steps to enable Hazard Analysis General Information needed to conduct hazard analysis is required to be collected, maintained, updated and documented. Records are required to be maintained. (i) Food Safety Team A food safety team is required to be appointed. The food safety team is required to have a combination of multi-disciplinary knowledge and experience in developing and implementing the FSMS. (ii) Product Characteristics a) Raw Materials, ingredients and product-contact materials All raw materials, ingredients and product-contact materials are required to be described in revise it to conduct the hazard analysis, including the following, as appropriate: biological, chemical and physical characteristics; composition of formulated ingredients, including additives and processing aids; origin; method of production; packaging and delivery methods; storage conditions and shelf life; preparation and/or handling before use or processing; and food safety-related acceptance criteria or specifications of purchased materials and ingredients appropriate to their intended uses. The food processor is required to identify statutory and regulatory food safety requirements related to the above. b) Characteristics of end products The characteristics of end products is required to be described in documents including information on the following: product name or similar identification; composition; biological, chemical and physical characteristics relevant for food safety; intended shelf life and storage conditions; packaging; labelling relating to food safety and/or instructions for handling; preparation and usage; and method of distribution. 46 The food processor is required to identify statutory and regulatory food safety requirements related to the above.

10 c) Intended use The intended use, the reasonably expected handling of the end product, and any unintended but reasonably expected mishandling and misuse of the end product is required to be considered and is required to be described in documents. Groups of users and, where appropriate, groups of consumers is required to be identified for each product, and consumer groups known to be especially vulnerable to specific food safety hazards is required to be considered. d) Flow diagrams, process steps and control measures (i) Flow diagrams are required to be prepared for the products or process categories covered by the food safety management system. Flow diagrams is required to provide a basis for evaluating the possible occurrence, increase or introduction of food safety hazards. Flow diagrams is required to include the following: sequence and interaction of all steps in the operation; any outsourced processes and subcontracted work; where raw materials ingredients and intermediate products enter the flow, are released or removed, and where reworking and recycling take place. The food safety team is required to verify the accuracy of the flow diagrams by on-site checking. Verified flow diagrams is required to be maintained as records. (ii) Description of process steps and control measures The existing control measures, process parameters and/or the rigorousness with which they are applied, or procedures that may influence food safety, is required to be described. External requirements (e.g. from regulatory authorities of customers) that may impact the choice and the rigorousness of the control measures is also required to be described. C. Hazard Analysis (i) General The food safety team is required to conduct a hazard analysis to determine which hazards need to be controlled, the degree of control required to ensure food safety, and which combination of control measures is required. (ii) Hazard identification and determination of acceptable levels A. All food safety hazards that are reasonably expected to occur in relation to the type of product, type of process an actual processing facilities is required to be identified and recorded. The identification is required to be based on: the preliminary information and data collected; experience; external information including, epidemiological and other historical data; and information from the food chain on food safety hazards that may be of relevance for the safety of the end products, intermediate products and the food at consumption. Clause -wise Interpretation of ISO 22000:

11 ISO 22000:2005 The step(s) (from raw materials, processing and distribution) at which each food safety hazard may be introduced is required to be indicated. B. When identifying the hazards, consideration is required to be given to: the steps preceding and following the specified operation, the process equipment, utilities/services and surroundings, and the preceding and following links in the food chain. C. For each of the food safety hazards identified, the acceptable level of the food safety hazard in the end product is required to be determined whenever possible. The determined level is required to take into account established statutory and regulatory requirements, customer food safety requirements, the intended use by the customer and other relevant data. The justification for, and the result of the determination is required to be recorded. (iii) Hazard Analysis A hazard assessment is required to be conducted to determine, for each hazard identified, whether its elimination or reduction to acceptable levels is essential to the production of a safe food, and whether its control is needed to enable the defined acceptable levels to be met. Each hazard is required to be evaluated according to the possible severity of adverse health effects and the likelihood of their occurrence. The methodology used is required to be described, and the results of the hazard assessment is required to be recorded. (iv) Selection and assessment of control measures Based on the hazard assessment an appropriate combination of control measures is required to be selected. In this selection, each of the control measures is required to be reviewed with respect to its effectiveness against the identified hazards. The control measures selected is required to be categorized as to whether they need to be managed through operational PRP(s) or by the HACCP plan. The selection and categorization is required to be carried out using a logical approach that includes assessments with regard to the following: a) its effect on identified hazards relative to the strictness applied; b) its feasibility for monitoring; c) its place within the system relative to other control measures; d) the likelihood of failure and/or variability in its functioning; e) the severity of the consequence(s) in the case of failure; f) whether the control measure is specifically established and applied; and g) synergistic effects (i.e. interaction that occurs between two or more measures resulting in their combined effect being higher the sum of their individual effects). 48 The methodology and parameters used for this categorization is required to be described in documents, and the results of the assessment is required to be recorded.

12 D. Establishing the operational prerequisite programs (OPRPs) The operational PRPs is required to be documented and is required to include the following information for each program: hazards to be controlled by the program; control measures; monitoring procedures that demonstrate that OPRPs are implemented; corrections and corrective actions to be taken if monitoring shows that OPRPs are not in control; responsibilities and authorities; and record of monitoring. E. Establishing the HACCP plan (i) HACCP plan The HACCP plan is required to be documented and is required to include the following information for each identified critical control point (CCP). food safety hazards to be controlled at the CCP; control measures; critical limits; corrections and corrective actions to be taken if monitoring shows that OPRPs are not in control; responsibilities and authorities; and record of monitoring. (ii) Identification of critical control points (CCPs) For each hazard that is to be controlled by the HACCP plan, CCPs are required to be identified for the control measures identified. (iii) Determination of critical limits for critical control points Critical limits is required to be determined for the monitoring established for each CCP. Critical limits is required to be established to ensure that the identified acceptable level of the food safety hazard in the end product is not exceeded. The rationale for the chosen critical limits is required to be documented. Critical limits based on subjective data (such as visual inspection of product, handling, etc.) is required to be supported by instructions or specifications and/or education and training. (iv) System for the monitoring of critical control points A monitoring system is required to be established for each CCP to demonstrate that the CCP is in control. The system is required to include all scheduled measurements of observations relative to the critical limits. The monitoring system is required to consist of relevant procedures, instructions and records that cover the following: measurements or observations that provide results within an adequate time frame; monitoring devices used; applicable calibration methods; monitoring frequency; Clause -wise Interpretation of ISO 22000:

13 ISO 22000:2005 responsibility and authority related to monitoring and evaluation of monitoring results; and record requirements and methods. The monitoring methods and frequency is required to be capable of determining when the critical limits have been exceeded in time for the product to be isolated before it is used or consumed. (v) Actions when monitoring results exceed critical limits Planned corrections and corrective actions to be taken when critical limits are exceeded is required to be specified in the HACCP plan. The actions is required to ensure that the cause of non-conformity is identified, that the parameters controlled at the CCP are brought back under control, and that recurrence is prevented. Documented procedures is required to be established and maintained for the appropriate handling of potentially unsafe products to ensure that they are not released until they have been evaluated. F. Updating of preliminary information and documents specifying the PRPs and the HACCP plan Following the establishment of OPRPs and/or the HACCP plan, the food processor is required to update the following information: product characteristics; intended use, flow diagrams, process steps, and control measures. The HACCP plan and the procedures and instructions specifying the PRPs are required to be amended. G. Verification planning Verification planning is required to define the purpose, method, frequencies and responsibilities. The verification activities are required to confirm that : the PRPs are implemented, input to the hazard analysis is continually updated, the OPRPs and the elements within the HACCP plan are implemented and effective, hazard levels are within identified acceptable levels, and other procedures required by the food processor are implemented and effective. The output of the planning is required to be in a form suitable for the food processor s method of operations. Verification results are required to be recorded and are required to be communicated to the food safety team. Verification results is required to be provided to enable the analysis of the results of the verification activities. 50 If system verification is based on testing of end product samples, and where such test samples show non-conformity with the acceptable level of the hazard, the affected lots of product is required to be handled as potentially unsafe.

14 H. Traceability system The food processor is required to establish and apply a traceability system that enables the identification of product lots and their relation to batches of raw materials, processing and delivery records. The traceability system is required to be able to identify incoming material from the immediate suppliers and the initial distribution route of the end product. Traceability record is required to be maintained for a defined period for system assessment to enable the handling of potentially unsafe products and in the event of product withdrawal. I. Control of Non-conformity (i) Corrections The food processor is required to ensure that when critical limits for CCPs are exceeded or there is a loss of control of OPRPs, the products affected are identified and controlled with regard to their use and release. A documented procedure is required to be established and maintained defining: the identification and assessment of affected end products to their proper handling; and a review of the corrections carried out. Products manufactured under conditions where critical limits have been exceeded are potentially unsafe products. Products manufactured under conditions where OPRPs have not been conformed with is required to be evaluated with respect to the causes of the non-conformity and to the consequences thereof. The evaluation is required to be recorded. (ii) Corrective Actions Data derived from the monitoring of OPRPs and CCPs is required to be evaluated by designated persons with sufficient knowledge and authority to initiate corrective actions. Corrective actions are required to be initiated when critical limits are exceeded or when there is a lack of conformity with OPRPs. The food processor is required to establish and maintain documented procedures that specify appropriate actions to identify and eliminate the cause of detected non-conformities, to prevent recurrence, and to bring the process of system back into control after non-conformity is encountered. These actions include: reviewing non-conformities (including customer complaints), reviewing trends in monitoring results that may indicate development towards loss of control, determining the causes of non-conformities, evaluating the need for action to ensure that non-conformities do not recur, determining and implementing the actions needed, recording the results of corrective actions taken, and reviewing corrective actions taken to ensure that they are effective. Clause -wise Interpretation of ISO 22000:2005 Corrective actions are required to be recorded. 51

15 ISO 22000: (iii) Handling of potentially unsafe products General The food processor is required to handle non-conforming products by taking actions to prevent it from entering the food chain unless it is possible to ensure that: a) The food safety hazards of concern have been reduced to the defined acceptable levels, b) The food safety hazards of concern will be reduced to identified acceptable levels prior to entering into the food chain, and c) The product still meets the defined acceptable levels of the food safety hazards of concern despite the non-conformity. All lots of food product that may have been affected by a non-conforming situation is required to be held under control of the food processor until they have been evaluated. If products that have left the control of the food processor are subsequently determined to be unsafe, the food processor is required to notify relevant interested parties and initiate a withdrawal. The withdrawal includes recall. The controls and related responses and authorization for dealing with potentially unsafe products is required to be documented. Evaluation for Release Each lot of product affected by the non-conformity is required to be released as safe only when any of the following conditions apply: evidence other than the monitoring system demonstrates that the control measures have been effective; evidence shows that the combined effect of the control measures for that particular product complies with the performance intended (i.e. identified acceptable levels as identified in accordance with); and the results of sampling analysis and/or other verification activities demonstrate that the affected lot of product complies with the identified acceptable levels for the food safety hazards concerned. Disposition of non-conforming products Following evaluation, if the lot of product is not acceptable for release it is required to be handled by one of the following activities: reprocessing or further processing within or outside the food processing area to ensure that the food safety hazard is eliminated or reduced to acceptable levels; and destruction and/or disposal as waste. (iv) Withdrawals To enable and facilitate the complete and timely withdrawal of lots of end products which have been identified as unsafe. Food processor is required to appoint personnel having the authority to initiate a withdrawal and personnel responsible for executing the withdrawal, The food processor is required to establish and maintain a documented procedure for notification to relevant interested parties (e.g. statutory and regulatory authorities, customers and/or consumers),

16 Handling of withdrawn products as well as affected lots of the products still in stock, and The sequence of actions to be taken. Withdrawn products is required to be secured or held under supervision until they are destroyed, used for purposes other than originally intended, determined to be safe for the same (or other) intended use, or reprocessed in a manner to ensure they become safe. The cause, extent and result of a withdrawal is required to be recorded and reported as input to the management review. The food processor is required to verify and record the effectiveness of the withdrawal program through the use of appropriate techniques. Clause -wise Interpretation of ISO 22000: Clause 8: Validation, Verification and Improvement of the FSMS Broad coverage Validation of control measure combinations Monitoring and measurement FSMS verification Improvement Contents and interpretation General The food safety team is required to plan and implement the processes needed to validate control measures and/or control measure combinations, and improve the food safety management system. A. Validation of control measure combinations Prior to implementation of control measures to be included in OPRPs and the HACCP plan and after any change therein, the food processor is required to validate that: the selected control measures are capable of achieving the intended control of the food safety hazards for which they are designated, and the control measures are effective and capable of, in combination, ensuring control of the identified food safety hazards to obtain end products that meet the defined acceptable levels. If the result of the validation shows that one or both of the above elements cannot be confirmed, the control measure and/or combinations thereof is required to be modified and re-assessed. B. Control of monitoring and measuring The food processor is required to provide evidence that the specified monitoring and measuring methods and equipment are adequate to ensure the performance of the monitoring and measuring procedures. Where necessary to ensure valid results, the measuring equipment and methods used: 53

17 ISO 22000:2005 are required to be calibrated or verified at specified intervals, or prior to use, against measurement standards traceable to international or national measurement standards; where no such standards exist, the basis used for calibration or verification is required to be recorded, are required to be adjusted or re-adjusted as necessary, are required to be identified to enable to the calibration status to be determined, are required to be safeguarded from adjustments that would invalidate the measurement results, and are required to be protected from damage and deterioration. Records of the results of calibration and verification is required to be maintained. In addition, the food processor is required to assess the validity of the previous measurement results when the equipment or process is found not to conform to requirements. If the measuring equipment is non-conforming, the food processor is required to take appropriate action for the equipment and any product affected. Records of such assessment and resulting actions is required to be maintained. When used in the monitoring and measurement of specified requirements, the ability of computer software to satisfy the intended application is required to be confirmed. This is required to be undertaken prior to initial use and is required to be reconfirmed as necessary. C. Food safety management system verification Internal audit The food processor is required to conduct internal audits at planned intervals to determine whether the food safety management system: conforms to the planned arrangements, to the food safety management system requirements established by the food processor, and to the requirements of this international standard, and is effectively implemented and updated. An audit program is required to be planned. The audit criteria, scope frequency and methods are required to be defined. Selection of auditors and the conduct of audits is required to ensure the objectivity and impartiality of the audit process. Auditor is required not to audit their own work. The management responsible for the area being audited is required to ensure that actions are taken without undue delay to eliminate detected nonconformities an their causes. Follow-up activities is required to include the verification of the actions taken and the reporting of the verification results. 54 D. Analysis of results of verification activities The food safety team is required to analyze the results of verification activities, including the results of the internal audits and external audits. The analysis is required to be carried out in order: to confirm that the overall performance of the system meets the planned arrangements and the food safety management system requirements established by the food processor,

18 to identify the need for updating or improving the FSMS, to establish information for planning of the internal audit program, and to provide evidence that any corrections and corrective actions that have been taken are effective. The results of the analysis and the resulting activities is required to be reported as input to the management review. Clause -wise Interpretation of ISO 22000:2005 E. Improvement (i) Continual improvement Food processor is required to ensure that the food processor continually improves the effectiveness of the FSMS through the use of communication, management review, internal audit, evaluation of individual verification results, analysis of results of verification, validation of control measure combinations, corrective actions and FSMS updating. (ii) Updating the FSMS Food processor is required to ensure that the FSMS is continually updated. In order to achieve this, the food safety team is required to evaluate the FSMS at planned intervals. The team is required to consider then whether it is necessary to review the hazard analysis the established OPRPs and the HACCP plan. The evaluation and updating the activities is required to be based on: input from communication, external as well as internal. input from other information concerning the suitability, adequacy and effectiveness of the FSMS. output from the analysis of results of verification activities. output from management review. System updating activities is required to be recorded and reported, in an appropriate manner, as an input to the management review. Check Your Progress Exercise 1 Note: a) Use the space below for your answers. b) Compare your answers with those given at the end of the unit. 1) List ten constituents of the food chain to which ISO is applicable? 2) List seven essential internal communication aspects? 55

19 ISO 22000:2005 3) Give reference of clauses from standard for at least five review inputs for conducting management review meeting? 4) Explain the similarity and difference between OPRP and HACCP plan? 5) Explain the main purpose of verification planning? 6) List the inputs essential for conducting activity for updating food safety management system? 10.3 LET US SUM UP ISO 22000: 2005 standard, which covers all Food safety related applicable areas in an industry which is a part of supply chain. The standard harmonize its structure with other management system standards like ISO 9001:2000 and ISO 14001: The standard consists of eight clauses further divided into thirty three sub-clauses. This structure follows PDCA approach in the organisation and sequence of the clauses. 56 The intent of the clauses and the internal congruence between the clauses has been explained. The contents cover mandatory documents including plans, procedures and records. The overall focus is on prevention of hazards likely to occur in the operation during food processing. Emphasis has been given on

20 internal and external communication, emergency preparedness and response, classifying control measures according to the impact they have on the potential hazards. Clause -wise Interpretation of ISO 22000: KEY WORDS Critical Control Point (CCP) Control Measure Corrective Action Critical Limit Food Safety Hazard Prerequisite Programme (PRP) : Steps at which control can be applied and is essential to prevent or eliminate food safety hazard or reduce it to acceptable limits. : Food safety action or activity that can be used to prevent or eliminate food safety hazard or reduce it to acceptable limit. : Action to eliminate the cause/s of a detected nonconformity or other undesirable condition. : Criterion which separates acceptability from unacceptability. : Biological, chemical or physical agent in the food, or condition of food, with a potential to cause an adverse health effect on the consumer. : Basic conditions and activities that are necessary to maintain a hygienic environment throughout the food chain suitable for the production, handling and provision of safe end products and safe food for human consumption ANSWERS TO CHECK YOUR PROGRESS EXERCISE Your answer should include following points: Check Your Progress Exercise 1 1) Primary food processors Food manufacturer Secondary food manufacturer Wholesaler Retailer Producers of packaging material Transportation and storage operators Producers of equipment Producers of Fertilizers Producers of sanitizing agents 2) Raw material, ingredients and products Production premises, production system, equipment, equipment location 57

21 ISO 22000:2005 Cleaning and sanitation programs Packaging, storage and distribution systems Statutory and regulatory requirements Knowledge regarding food safety hazards and control measures Complaints indicating food safety hazards associated with the product 3) Analysis of results of verification activities (Clause 8.2.3) Changing circumstances that can affect food safety (Clause 5.6.2) Emergency situations, accidents and withdrawals (Clause 5.7 & ) Reviewing results of system updating activities (Clause 8.5.2) Review of communication activities, including customer feedback (Clause 5.6.1) 4) Similarities: Both need to specify hazards they control and associated control measures. Both need to be documented. Both require monitoring procedures. Records of monitoring of both need to be maintained. Responsibilities and authorities for both need to be specified. Differences: Critical limits are required to be mentioned only in HACCP plan and not in OPRP. For HACCP plan corrections and corrective actions need to be taken if critical limits are exceeded whereas for OPRP they are to be taken if monitoring shows that OPRPs are not in control. In case of OPRP, monitoring procedures need to demonstrate that OPRPs are implemented. 5) Confirming that PRPs are implemented. Confirming that input to hazard analysis is continually updated. Confirming that OPRPs and HACCP elements are implemented and effective. Confirming that the hazard levels are within the identified acceptable limits. Confirming that procedures required by the organisation are implemented and effective. 58 6) Confirming that PRPs are implemented. Input from internal and external communication Analysis of results of verification activities Result of management reviews Input information about suitability, adequacy and effectiveness of FSMS.

22 Multiple Choice Questions 1) Food safety system audits are used to verify a) the number of persons who wash their hands. b) the extent to which audit criteria are fulfilled. c) that all suppliers to the organisation have ISO certification. d) all of the above. e) none of the above. Clause -wise Interpretation of ISO 22000:2005 2) A third party audit is a) an internal audit. b) an audit by the customer or client. c) an audit by an independent organisation. d) all of the above. e) none of the above. 3) ISO includes: a) health and safety requirements. b) food safety planning. c) food safety system costing. d) all of the above. e) none of the above. 4) Which of the following activities must be carried out by someone who does not perform the activity being evaluated? a) a hazard analysis. b) a food inspection. c) an internal audit. d) all of the above. e) none of the above. 5) A system based on the requirements of ISO aims to a) meet regulatory requirements. b) demonstrate an organisation s ability to consistently supply safe food. c) prevent cross contamination. d) all of the above. e) none of the above. 6) Data supporting the existence or verity of something is called: a) objective evidence. b) a deficiency. c) a non-conformity report. d) all of the above. e) none of the above. 59

23 ISO 22000:2005 7) What information is being sought during a third party audit of a food safety system? a) a list of non-conformities to ISO b) objective evidence of conformity with ISO c) a management commitment to public safety. d) all of the above. e) none of the above. 8) To act as an auditor of a food safety system a person has to a) be registered as a certificated auditor. b) have a detailed knowledge of the product or service of the organisation to be audited. c) be a food safety team member. d) all of the above. e) none of the above. 9) Action or activity that can be used to prevent or eliminate a food safety hazard is called: a) a critical control point. b) corrective action. c) a control measure. d) all of the above. e) none of the above. 10) The extent of documentation of the food safety system should be determined by: a) top management. b) the requirements of ISO c) the culture of the organisation. d) all of the above. e) none of the above. Answers: 1) b 2) c 3) b 4) c 5) d 6) a 7) b 8) e 9) c 10) b 10.6 SUGGESTED READING Codex Alimentarius Food Hygiene Basic Texts, Food and Agricultural Organisation of the United Nations, World Health Organisation, Rome, ISO / TS 22004: Food System Management Systems - Guidance on the application of ISO 22000:

24 ISO 19011: Guidelines for Quality and /or Environmental Management Systems Auditing. ISO 15161: Guidelines on the Application of ISO 9001:2000 for the Food and Drink Industry. Clause -wise Interpretation of ISO 22000:2005 ISO 9000: Quality Management Systems- Fundamentals and Vocabulary. CAC/RCP (Rev ), Recommended International Code of Practice- General Principles of Food Hygiene. 61