Introduction to iso22000 101106 !!!!
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The document provides an overview of ISO 22000, an international food safety management standard. It describes key aspects of ISO 22000 such as its emphasis on controlling food safety hazards along the entire food chain. It also summarizes several sections of the ISO 22000 standard which establish requirements for food safety management systems, including documentation, management responsibility, and resource management.
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Introduction to iso22000 101106 !!!!
- 1. FOOD SAFETY MANAGEMENT SYSTEM INTRODUCTION TO ISO 22000:2005 Food Safety Training Courses on International Standards & Regulations PAK/AIDCO/2002/0382/13 A project funded by European Union URS/FS/007 Implemented By
- 2. Food Safety Assurance that food will not cause harm to the consumer when it is prepared and/or eaten according to its intended use. Source: Codex Alimentarius (WHO) Food Safety Training Courses on International Standards & Regulations PAK/AIDCO/2002/0382/13 A project funded by European Union URS/FS/007 Implemented By
- 3. Food Safety Protecting People Keeping the Employees and Customers Preventing Food Safety Errors Food Safety Training Courses on International Standards & Regulations PAK/AIDCO/2002/0382/13 A project funded by European Union URS/FS/007 Implemented By
- 4. Food Safety – Historical Background First food law written in 2500 B.C. Pakistan food laws are dated back 1876. First HACCP system was developed between NASA and Pillsbury in 1971. Become a regulatory requirements in EU since 1998. US FDA also adopted the HACCP approach as part of control mechanism for food safety. Food Safety Training Courses on International Standards & Regulations PAK/AIDCO/2002/0382/13 A project funded by European Union URS/FS/007 Implemented By
- 5. Food Safety Management System Why it is required? Intense farming and processing of food Increase in meals consumed outside home Increase in ready to eat foods More traveling across the world Increased amount of exotic imported foods Increase in number of susceptible people Food Safety Training Courses on International Standards & Regulations PAK/AIDCO/2002/0382/13 A project funded by European Union URS/FS/007 Implemented By
- 6. Food Safety Management System FAMI-QS GMO ISO 9001 GMP standard for Corrugated & Solid Board EFSIS IFS GFSI Guide SQF AG 9000 McDonalds system Kraft food system Nestlé NQS Eurepgap Friesland Coberco FSS DS 3027 BRC-IoP BRC-Food Ducth HACCP Irish HACCP M&S system Aldi system GMP GTP Food Safety Training Courses on International Standards & Regulations PAK/AIDCO/2002/0382/13 A project funded by European Union URS/FS/007 Implemented By
- 7. ISO 22000:2005 A management system designed to enable organizations to control food safety hazards along the food chain in order to ensure that food is safe at the time of consumption ISO 22000:2005, clause 1 Food Safety Training Courses on International Standards & Regulations PAK/AIDCO/2002/0382/13 A project funded by European Union URS/FS/007 Implemented By
- 8. ISO 22000:2005 Features; First global food safety standard. Harmonizes the voluntary international standards. Employs proven management system principles. Enables a common understanding of what a food safety management system is. Food Safety Training Courses on International Standards & Regulations PAK/AIDCO/2002/0382/13 A project funded by European Union URS/FS/007 Implemented By
- 9. ISO 22000:2005 Features; Requires legal compliance checking Integrates existing good practice Internal and external monitoring Food Safety Training Courses on International Standards & Regulations PAK/AIDCO/2002/0382/13 A project funded by European Union URS/FS/007 Implemented By
- 10. ISO2000:2005 Benefits; Overcomes many of the limitations of traditional approaches to food safety control. Potential to identify all conceivable, reasonably expected hazards. Capable of accommodating the changes. Food Safety Training Courses on International Standards & Regulations PAK/AIDCO/2002/0382/13 A project funded by European Union URS/FS/007 Implemented By
- 11. ISO2000:2005 Benefits; • Help to target or manage resources to the most critical part of the food operation. • Can promote international trade by equalizing food safety control and by increasing confidence in food safety. • Applicable to whole food chain. Food Safety Training Courses on International Standards & Regulations PAK/AIDCO/2002/0382/13 A project funded by European Union URS/FS/007 Implemented By
- 12. Food chain Food Safety Training Courses on International Standards & Regulations PAK/AIDCO/2002/0382/13 A project funded by European Union URS/FS/007 Implemented By
- 13. Entry of Hazards in Food Chain Food Safety Training Courses on International Standards & Regulations PAK/AIDCO/2002/0382/13 A project funded by European Union URS/FS/007 Implemented By
- 14. Food chain and process approach Consideration to effect of the food chain on organization’s operation Identification, application and management of a system of processes within the organization Ongoing control over linkage, combination and interaction of individual processes within the system of processes Food Safety Training Courses on International Standards & Regulations PAK/AIDCO/2002/0382/13 A project funded by European Union URS/FS/007 Implemented By
- 15. Plan•What to do? •How to do it? Do•Do what was planned Check•Did things happen according to plan? Act•How to improve next time? Process Approach A desired result is achieved more efficiently when related resources and activities are managed as a process Food Safety Training Courses on International Standards & Regulations PAK/AIDCO/2002/0382/13 A project funded by European Union URS/FS/007 Implemented By
- 16. Process Approach Resource Processes Product Design Process Design Project Planning Production Management Processes Measurement,Analysis,andImprovement OI IO I O I O I O I O I O I O Resource Processes Product Design Process Design Project Planning Production Management Processes Measurement,Analysis,andImprovement OI IOIO I OI O I OI O I OI O I OI O I OI O I OI O Food Safety Training Courses on International Standards & Regulations PAK/AIDCO/2002/0382/13 A project funded by European Union URS/FS/007 Implemented By
- 17. Process Approach Benefits; Lower costs and shorter cycle times through effective use of resources Improved, consistent and predictable results Focused and prioritised improvement opportunities Food Safety Training Courses on International Standards & Regulations PAK/AIDCO/2002/0382/13 A project funded by European Union URS/FS/007 Implemented By
- 18. FSMS Process model Food Safety Training Courses on International Standards & Regulations PAK/AIDCO/2002/0382/13 A project funded by European Union URS/FS/007 Implemented By
- 19. Key elements Interactive Communication Systems Approach to FSM Pre-requisite Programs HACCP Principles ISO 22000:2005 Control Food Safety Hazards Food Safety Training Courses on International Standards & Regulations PAK/AIDCO/2002/0382/13 A project funded by European Union URS/FS/007 Implemented By
- 20. ISO 22000 standard Scope Normative references Terms and definitions Requirements Annex(s) Food Safety Training Courses on International Standards & Regulations PAK/AIDCO/2002/0382/13 A project funded by European Union URS/FS/007 Implemented By
- 21. Application All requirements of this International Standard are generic and are intended to be applicable to all organisations in the food chain, regardless of type, size and complexity. This includes organizations directly or indirectly involved in one or more steps of the food chain The standard allows small and/or less developed organization to implement an externally developed combination of control measures Food Safety Training Courses on International Standards & Regulations PAK/AIDCO/2002/0382/13 A project funded by European Union URS/FS/007 Implemented By
- 22. ISO 22000 standard - Requirements Section 4: Food Safety Management System (FSMS) – General Requirements Section 5: Management Responsibility Section 6: Resource Management Section 7: Planning and Realization of Safe Products Section 8: Validation, Verification and Improvement of the Food Safety Management System Food Safety Training Courses on International Standards & Regulations PAK/AIDCO/2002/0382/13 A project funded by European Union URS/FS/007 Implemented By
- 23. Section 4 – General Requirements Scope of the Food Safety Management System Documentation requirements More than twenty six types of documents required by ISO 22000:2005 Twenty eight mandatory records required by ISO 22000:2005 Documents needed by the organization to ensure effective development, implementation and updating of the FSMS Food Safety Training Courses on International Standards & Regulations PAK/AIDCO/2002/0382/13 A project funded by European Union URS/FS/007 Implemented By
- 24. Section 4 – Documentation requirement Mandatory documented procedures specified by ISO 22000:2005 – Control of documents – Control of records – Corrections – Corrective actions – Handling potentially unsafe product – Withdrawals – Internal audits Food Safety Training Courses on International Standards & Regulations PAK/AIDCO/2002/0382/13 A project funded by European Union URS/FS/007 Implemented By
- 25. Section 5 – Management Responsibility Management commitment Food Safety Policy Food safety management system planning Responsibility and authority Food Safety Training Courses on International Standards & Regulations PAK/AIDCO/2002/0382/13 A project funded by European Union URS/FS/007 Implemented By
- 26. Section 5 – Management Responsibility Food safety team leader External communication – Suppliers and contractors – Customers/consumers – Statutory and regulatory authorities – Other organizations Internal communication Food Safety Training Courses on International Standards & Regulations PAK/AIDCO/2002/0382/13 A project funded by European Union URS/FS/007 Implemented By
- 27. Section 5 – Management Responsibility Emergency preparedness and response – Documented procedures to manage potential emergency situations and accidents Management Review – Review input: Food safety related requirements – Review output Food Safety Training Courses on International Standards & Regulations PAK/AIDCO/2002/0382/13 A project funded by European Union URS/FS/007 Implemented By
- 28. Section 6 – Resource Management The organization shall provide adequate resources for; Establishment Implementation Maintenance Updating Food Safety Training Courses on International Standards & Regulations PAK/AIDCO/2002/0382/13 A project funded by European Union URS/FS/007 Implemented By
- 29. Section 6 – Resource Management Human Resource – Food safety team and personnel impacting food safety – External experts Competence, Awareness and Training Infrastructure – Buildings – Process equipment – Utilities – Surrounding areas – Supporting services Food Safety Training Courses on International Standards & Regulations PAK/AIDCO/2002/0382/13 A project funded by European Union URS/FS/007 Implemented By
- 30. Section 6 – Resource Management Work Environment – Measures to prevent cross contamination – Work space requirements – Protective work wear requirements – Availability and location of employee facilities Food Safety Training Courses on International Standards & Regulations PAK/AIDCO/2002/0382/13 A project funded by European Union URS/FS/007 Implemented By
- 31. Section 7 Planning and Realization of Safe Products The organization shall plan and develop the processes needed for the realization of safe products The organization shall implement, operate and ensure the effectiveness of the planned activities and any change to those activities including; – Pre-requisite programmes ( PRPs) – Operational PRPs – HACCP plan Food Safety Training Courses on International Standards & Regulations PAK/AIDCO/2002/0382/13 A project funded by European Union URS/FS/007 Implemented By
- 32. Section 7 Planning and Realization of Safe Products Prerequisite programmes (PRPs) Preliminary steps to enable hazard analysis Hazard analysis Establishing the operational prerequisite programmes (PRPs) Establishing the HACCP plan Food Safety Training Courses on International Standards & Regulations PAK/AIDCO/2002/0382/13 A project funded by European Union URS/FS/007 Implemented By
- 33. Planning of safe food Food Safety Training Courses on International Standards & Regulations PAK/AIDCO/2002/0382/13 A project funded by European Union URS/FS/007 Implemented By
- 34. Decision tree Food Safety Training Courses on International Standards & Regulations PAK/AIDCO/2002/0382/13 A project funded by European Union URS/FS/007 Implemented By
- 35. Updating PRPs and HACCP plan The organization shall update the following information; – Product characteristics – Intended use – Process steps – Control measures – HACCP plan – Procedures instructions specifying PRPs Food Safety Training Courses on International Standards & Regulations PAK/AIDCO/2002/0382/13 A project funded by European Union URS/FS/007 Implemented By
- 36. Verification planning Shall define the purpose, methods, frequencies and responsibilities for the verification activities Output of planning suites to organization’s method of operation Verification results enables analysis of the result of verification activities Food Safety Training Courses on International Standards & Regulations PAK/AIDCO/2002/0382/13 A project funded by European Union URS/FS/007 Implemented By
- 37. Traceability system The system shall enables the identification of product lots and their relation to batches of raw material, processing and delivery records. The system shall be able to identify incoming material from the suppliers and the initial distribution route of the product. Food Safety Training Courses on International Standards & Regulations PAK/AIDCO/2002/0382/13 A project funded by European Union URS/FS/007 Implemented By
- 38. Control of non conformity • Corrections • Corrective actions • Handling potentially unsafe products • Evaluation of release • Disposition of Nonconforming products • Withdrawals Food Safety Training Courses on International Standards & Regulations PAK/AIDCO/2002/0382/13 A project funded by European Union URS/FS/007 Implemented By
- 39. Validation, Verification and Improvement The food safety team shall plan and implement the processes needed to validate control measures, its combination, and to verify and improve the FSMS. Validation of control measure combination Control of monitoring and measuring Food Safety Training Courses on International Standards & Regulations PAK/AIDCO/2002/0382/13 A project funded by European Union URS/FS/007 Implemented By
- 40. Validation, Verification and Improvement FSMS verification – Internal audits – Evaluation of individual verification results – Analysis of results of verification activities Improvement Updating the Food safety management system Food Safety Training Courses on International Standards & Regulations PAK/AIDCO/2002/0382/13 A project funded by European Union URS/FS/007 Implemented By
- 41. FSMS Overview Food Safety Training Courses on International Standards & Regulations PAK/AIDCO/2002/0382/13 A project funded by European Union URS/FS/007 Implemented By
Editor's Notes
- The Codex Alimentarius Commission was created in 1963 by FAO and WHO to develop food standards, guidelines and related texts such as codes of practice under the Joint FAO/WHO Food Standards Programme. The main purposes of this Programme are protecting health of the consumers and ensuring fair trade practices in the food trade, and promoting coordination of all food standards work undertaken by international governmental and non-governmental organizations.
- Protecting People: People may get sick if the food products are not handled carefully Keeping the Employees and Customers: Keeping Customers and Co-workers safe helps make the industry better place to work and a place where customer returns Preventing Food Safety Errors: Due to food handling errors during industrial operations any food product can become dangerous
- INTENSE FARMING, INTENSE PRODUCTION-INCREASE RISK OF PATHOGENS AND HAZARDEOUS CHEMICALS ON RAW FOOD INCREASE IN NUMBERS OF SUSCEPTIBLE PEOPLE-ELDERLY.
- collecting and examining sufficient number of samples, -high cost, -time,-identification of problems without understanding the causes,-limitations of “snap-shot” inspection
- Consideration: effect of the food chain prior to and subsequent to organization’s operation while developing and implementing FSMS. ISO22000 promotes the adoption of a food chain approach when developing, implementing and improving the effectiveness and efficiency of a food safety management system. In this regard, in ISO22000 the organization is required to consider the effects of the food chain prior to and subsequent to its operations when developingand implementing the food safety management system.For an organization to function effectively and efficiently, it has to identify and manage numerous linkedactivities. An activity using resources, and managed in order to enable the transformation of inputs into outputs,is considered as a process. Often the output from one process directly forms the input to the next.The application of a system of processes within an organization, together with the identification of interactionsand the management of these processes can be referred to as the “process approach.”An advantage of the process approach is the ongoing control that it provides over the linkage between theindividual processes within the system of processes, as well as their combination and interaction.When used within a food safety management system, such an approach emphasizes the importance ofa)understanding and fulfilling the requirements,b)the need to consider processes in terms of food safety and traceability,c)obtaining results of process performance and effectiveness, andd)continual improvement of processes based on objective measurement. Interested parties play a significant role in defining requirements as inputs. Monitoring the satisfaction of interested parties requires evaluation of information relating to their perception of whether the organization has met their requirements or not.
- “Plan” Establish the objectives and processes necessary to deliver results in accordance with customer requirements and the organization's policies; “Do” Implement the processes; “Check” Monitor and measure processes and product against policies, objectives and requirements for the product and report the results; “Act” Take actions to continually improve process performance;”
- Examples of indirectly involved organizations; suppliers of equipment, cleaning and sanitizing agents, packaging material and other food contact materials. Example of small or less developed organization: small farm, small packer-distributor, small retail or food service outlet. ISO22000 allows any organization, in particular a small and/or less developed organization, to implement an externally developed and established combination of prerequisite programme(s) [PRP(s)], operational PRP(s) and Hazard Analysis and Critical Control Point (HACCP) plans provided that it can be demonstrated that a)this combination has been developed in compliance with the requirements of ISO22000 specified for the hazard analysis, PRP(s) and HACCP plan, b)specific measures have been undertaken to adapt the externally developed combination to the organization, and c)this combination has been implemented and is operated in accordance with the other requirements of ISO22000.
- Scope: Shall specify the products, or product categories, processes and production sites that are addressed by the FSMS. Food safety policy, Business objectives (food safety related), Business plan (food safety related),Supplier/Vendor agreement or contracts,Specifications/Drawings,Organization chart,Job description/Specification,Legislation, codes of practice, guidelines, food safety requirements from statutory and regulatory authorities including correspondence,Food safety requirements from customers including correspondence,Emergency preparedness and response plan,Technical Expert agreements or contracts, if applicable,Training plan,Site map showing utilities, water etc.,Employee surveys, if applicable,Hazard study,Risk Assessment study,Product descriptions (raw material and end product),Flow diagrams,Operational PRPs,HACCP Plan,Maintenance /Calibration/ Sanitization -Cleaning programmes,Process equipment documents,Licenses,HACCP Plan,Audit programme Mandatory documents required by ISO 22000:2005,Other documents deemed necessary by the organization
- Evidence of top management commitment includes the setting of awareness and leadership initiatives linked to the development and implementation of the system. By showing that food safety is supported by business objectives. By communicating the to the organization the importance of meeting the requirements i.e. of standard, statutory and regulatory & customer requirements related to food safety.
- The purpose of any communication is to ensure that the necessary interactions occur. ISO 22000 requires that both external and internal communication takes place as part of the food safety management system. External communication aims to exchange information in order to ensure that any relevant hazard is controlled at one step through the food chain by interaction, for example, a) up and down the food chain, for food safety hazard(s) that may not or cannot be controlled by the organization and which consequently need(s) to be controlled at other steps in the food chain, b) with customers as the basis for mutual acceptance of the level of food safety required (by the customer), and c) with statutory and regulatory authorities and other organizations. External communication is the method whereby the organization and the external organization agree by contract or other means upon the level of food safety required and on the capability of delivering to the agreed requirements. Channels of communication with statutory and regulatory authorities and other organizations should be established as a basis for providing public acceptance of the level of food safety and for ensuring the reliability of the organization. Training of designated personnel in communication skills may be an important aspect as well. The internal communication system of the organization should ensure that sufficient and relevant information and data are available to all personnel involved in the various operations and procedures. The food safety team leader has a major role in the area of the internal communication of food safety issues within the organization. Communication to personnel within in the organization should be carried out in a clear and timely manner on the development and launch of new products, as well as intended changes in raw materials and ingredients, production systems and processes and/or customers and customer requirements. In particular, attention should be given to the communication of changes in statutory and regulatory requirements, new or emerging food safety hazards, and the method of control of these new hazards. Any member of the organization seeing something which may have an impact on food safety should know how to report this event.
- The organization should be aware of potential emergency situations which may include, for example, fire, flooding, bioterrorism and sabotage, energy failure, vehicle accidents and contamination of the environment.
- The organization shall identify necessary competencies. Ensure that the requirement for effective communication is understood by all. Training should be maintained at a level that ensures that all employees know their responsibilities to maintain the food safety management system. Details of training sessions should include, for example, programme content, name and qualifications of the trainer, final assessment of trainees, and establishment of the requirement for retraining.
- The core element of the planning is the conduct of the hazard analysis to determine those hazards that need to be controlled (see 7.4.3 of ISO 22000:2005), the degree of control required to meet acceptable levels and the combination of control measures that can deliver this (see 7.4.4 of ISO 22000:2005). To enable this, preliminary steps are needed (see 7.3 of ISO 22000:2005) to furnish and organize relevant information The hazard analysis determines the appropriate control measures and permits their categorization into those that are to be managed by the HACCP plan and/or operational PRPs, respectively, and will assist in thesubsequent design of the details on how the measures are to be implemented, monitored, verified and kept updated (see 7.5 to 7.8 of ISO 22000:2005). ISO 22000 reorganizes the traditional concept of dividing control measures into two groups [prerequisites and measures applied at critical control points (CCPs)] in a logical order for the development, implementation and control of the food safety management system. Control measures are grouped into three groups. a) prerequisite programmes (PRPs) that manage the basic conditions and activities; the PRPs are not selected for the purpose of controlling specific identified hazards but for the purpose of maintaining a hygienic production, processing and/or handling environment (see 7.2 of ISO 22000:2005); b) operational prerequisite programmes (operational PRPs) that manage those control measures that the hazard analysis identifies as necessary to control identified hazards to acceptable levels, and which are not otherwise managed by the HACCP plan; c) a HACCP plan to manage those control measures that the hazard analysis identifies as necessary to control identified hazards to acceptable levels, and which are applied at critical control points (CCPs). Purchased material; RM,PM, ingredients, chemicals. Supplies; water, air, steam and ice Disposals; waste and sewage. Handling of products; storage and transportation Categorization of control measures facilitates the application of different management strategies to each group with respect to validation, monitoring, and verification of measures to control nonconformities, including handling of resulting products Traceability system: In developing the traceability system, consideration should be given to the activities of the organization that might impact on system complexity, such as the types of ingredient and their number, re-use of product, product contact material, batch versus continuous production, aggregation. The organization should also give consideration to the extent of its traceability system to identify better any potentially unsafe products that may need to be withdrawn. The organization shall establish and apply a traceability system that enables the identification of product lots and their batches of RM, processing and delivery records
- Critical limits should be designed to ensure control of the food safety hazard(s) for which they have been designated. For CCPs intended to control more than one food safety hazard, the critical limit(s) should be established relative to each food safety hazard.
- Verification activities shall confirm that; PRPs are implemented. Input to the hazard analysis is continually updated. Operational PRPs and the elements within HACCP plan are implemented and effective. Hazard levels are within identified acceptable levels. Other procedures required by the organization are implemented and effective. The concepts of validation, verification and monitoring are often confused. — Validation is an assessment prior to operation, the role of which is to demonstrate that individual (or a combination of) control measures are capable of achieving the intended level of control. — Verification is an assessment carried out during and after the operation, the role of which is to demonstrate that the intended level of control has actually been achieved. — Monitoring is a procedure to detect any failures in the control measure. The frequency of verification depends on the degree of uncertainty in the effect(s) of the control measure(s) applied relative to the determined acceptable level(s) of food safety hazard(s) or predetermined performance(s), as well as on the ability of the monitoring procedures to detect loss of control. Hence, the frequency required will depend on the uncertainties associated with the result of validation and the functioning of the control measure (e.g. process variability). For instance, where validation demonstrates that the control measure delivers a hazard control significantly higher than the minimum required to meet acceptable levels, verification of the effectiveness of that control measure may be reduced or might not be required at all.
- In developing the traceability system, consideration should be given to the activities of the organization that might impact on system complexity, such as the types of ingredient and their number, re-use of product, product contact material, batch versus continuous production, aggregation. The organization should also give consideration to the extent of its traceability system to identify better any potentially unsafe products that may need to be withdrawn. Further guidance will be given in ISO 22005.
- Corrections: the organization shall ensure that when critical limits for CCPs are exceeded, or there is a loss of control of operational PRPs, the products affected are identified and controlled with regard to their use and release. Documented procedure shall be established defining Identification and assessment of affected products to determine their proper handling. A review of corrections carried out. Products manufactured under conditions where critical limits have been exceeded are potentially unsafe products and shall be handled in accordance with 7.10.3. products manufactured under conditions where operational PRPs have not been conformed with shall be evaluated with respect to cause(s) of the NCs and to the consequences thereof in terms of food safety and shall, where necessary be handled in accordance with 7.10.3. Records. All corrections shall be approved by the responsible person(s) and shall be records together with information on the nature of the NC, its cause, consequence(s), including information needed for traceability purposes related to the NC lots. Data derived from the monitoring of PRPs and CCPs shall be evaluated by the designated person with sufficient knowledge and authority to initiate CAs. CAs shall be initiated when critical limits are exceeded or when there is lack of conformity with operational PRPs. Documented procedure that specify appropriate actions to identify and eliminate the cause of detected NCs, to prevent recurrence and to bring the process or system back into control after NC is encountered. these include; Reviewing NCs, reviewing trends in monitoring results that may indicate development towards loss of control, determining the cause of NCs, evaluating the need for action to ensure that NC do not recur, determining and implementing the actions needed, recording the results of actions taken, and reviewing CAs to ensure that they are effective. NC product shall handled such to prevent entering it into food chain unless; Food safety hazard of concern have been reduced to defined acceptable levels, or will be reduced to the defined acceptable level prior to entering into food chain, or the product still meets the limits of food safety hazard despite NC. The organization shall notify the interested parties and initiate withdrawal if a unsafe product left the control of the organization. NC product may only be released if the evidences; demonstrate that control measures have been effective, that the combined effect of the control measures for that particular product complies with the performance intended use or identified acceptable levels, through results of sampling, analysis and other verification activities that the affected lot of product complies with the identified acceptable levels. Disposition: reprocess to ensure that food safety hazard is eliminated or reduced, destruction and/or disposal as waste. Authorize personnel only to initiate the withdrawal and execution, documented procedure for notification, handling of withdrawn products and sequence of actions to be taken. The cause extent and results of withdrawal and effectiveness of the withdrawal programme shall be recorded
- The requirements in Clause 8 of ISO 22000:2005 address those activities that are needed to demonstrate that the food safety management system, as designed, is reliable, is able to deliver and actually delivers the level of control that is expected of it. It is the responsibility of the organization's management to make certain that the food safety management system is designed to produce the desired controls, is operated as designed, and is updated as new information is provided. The food safety management system should be developed using sound scientific principles. The means to collect the necessary information for the system design can usually be obtained from academic institutions, regulatory agencies, trade associations, consultants, or any party that has educated expertise in the food process and product. Once the control measure combination is designed on paper, it must be validated. The validation process provides assurance that the combination will deliver products that meet identified acceptable levels. The validation usually includes such activities as a) reference to validations carried out by others, to scientific literature, or to historical knowledge, b) experimental trials to simulate process conditions, c) biological, chemical and physical hazard data collected during normal operating conditions, d) statistically designed surveys, e) mathematical modelling, and f) use of a guide approved by competent authorities. If relying upon validations carried out by others, care should be taken to ensure that the conditions of the intended application are consistent with those identified in the referenced validations. Generally accepted industrial practices may be used. Scaling up of laboratory-based experimental trials in a pilot plant may be required to ensure that the trials properly reflect actual processing parameters and conditions. Intermediate and/or finished product sampling and testing based on the use of statistical sampling plans and validated testing methodology may be used. Validations may be conducted by external parties, and microbiological or analytical testing can effectively be used to verify that a process is in control and that acceptable product is being produced. If additional control measures, new technology or equipment, changes in the control measures, product (recipe) changes, identification of new or emerging hazards or changes in their frequency of occurrence, or unexplained failures of the system occur, revalidation of the system might be necessary. Validation: Prior to implementation of control measures to be included in PRPs and HACCP plan and any change therein; the capability of achieving the intended control of the designated hazards, and that the control measures are effective and capable of ensuring the control of identified food safety hazards to obtain end products that meet acceptable levels. Control measures and/or its combinations shall be modified and reassessed if previously mentioned elements are not conformed through validation results. The concept of calibration is complex and can depend on the type of process, type of equipment and how prone they are to loose calibration. Thermometers and metal detection units are commonly used in the food industry and can be used as examples. Calibration of thermometers may differ depending on a) the type of thermometer, b) the degree of accuracy needed, or c) the thermometer range over which the thermometer will operate. Thermometers should be checked against a traceable reference thermometer. Electronic thermometers can be adjusted, whilst mercury thermometers should be labelled with the deviation from the reference. It may be sufficient to calibrate annually or biannually. Metal detection units can be verified or calibrated by the use of metal dummies with a known topography/mass/iron content and adjusted on site. The frequency of verification/calibration can be substantially higher than for thermometers due to unit stability and changes in the monitored product (e.g. moisture content). Optimal calibration frequency depends on the type, condition and past performance of the monitoring instrument. ISO/IEC 17025 gives further guidance on inter calibration surveys and other laboratory quality assurance techniques. Verification of the food safety management system assures that it is functioning as designed and is updated based upon currently available information. A food safety system that is functioning properly minimizes the need for extensive product sampling and testing. Verification occurs in two stages that may be loosely classified as ongoing and periodic. Ongoing activities use methods, procedures or tests separate from, and in addition to, those used in monitoring of the system. Verification reports should include information about — the system, — the persons administering and updating it, — the status of records associated with monitoring activities, — certification that monitoring equipment is properly calibrated and in working order, and — results of records review and any samples analysed. Training records of the personnel should be reviewed and the results should be documented as well. A schedule of verification activities is developed as part of the food safety management system (planned according to 7.8 and evaluated according to 8.4.2 of ISO 22000:2005). This schedule should include the procedures or methods to be utilized, the frequency and the person(s) responsible for performing the activity. Examples of verification activities that should be considered as part of the system include — reviewing monitoring records, — reviewing deviations and their resolution or corrective action, including the handling of affected product, — calibrating thermometers or other critical measuring equipment, — visually inspecting operations to observe if control measures are under control, — analytically testing or auditing monitoring procedures, — randomly collecting and analysing samples of in-process or end product, — sampling for environmental and other concerns, and — reviewing consumer or customer complaints to determine whether they relate to the performance of the control measures or reveal the existence of unidentified and/or need for additional control measures. When conducting internal audits (see 8.4.1 of ISO 22000:2005) for these verification activities, sound audit principles should be observed. Auditors should be competent to perform the audit. They should be independent of the work or processes being audited, although they may be from the same work area or department. For example, in a small business where there might be only one or two people in the management structure, this requirement may not be achievable. It is suggested that, in such cases, in carrying out the duties of an auditor, the manager tries to step back from direct involvement in the business operations and to be very objective about the audit. Another approach might be to seek the cooperation of another small business and each provide the internal audit for the other. This can prove attractive if there are good relations between the two businesses. Alternatively, external parties (e.g. chamber of commerce, consultant, inspection agencies) might be able to provide independent auditors. The periodic verification activities involve the overall assessment of the system (see 8.4.3 of ISO 22000:2005). This is usually performed during a management or verification team meeting, and all the above evidence over a period of time is reviewed to ascertain if the system is functioning as planned and if updating or improvement is necessary. Notes of the meeting should be kept and should include any decisions made regarding the system. At a minimum, verification of the entire system in this manner should take place on an annual basis. Organization ensures continual improvement through the use of communication, management review, internal audits, evaluation of individual verification results, analysis of results of verification activities, validation of control measure combinations, corrective actions and FSMS updating, use of ISO 9004 as guide. Updating the FSMS: shall evaluate the FSMS at planned intervals, activitied shall be based on; Input from external and internal communication, 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 shall use as input to the management review.