PRE-ASSESSMENT QUESTIONNAIRE FSMS SYSTEM CERTIFICATION SCHEME GUIDELINES FOR COMPLETING THE QUESTIONNAIRE (1) A separate questionnaire shall be completed for each location for which certification is required. (2) Any information detailed in the FSMS document are not required to reproduce in the questionnaire but reference to the FSMS document must be made. (3) The SLSI will ensure the confidentiality of all information furnished by the applicant in this questionnaire. This information is only disclosed to the designated auditors who are required to sign a confidentiality agreement. The names of auditors and a copy of their confidentiality agreement will be sent to the applicant prior to audit. (4) Please tick the relevant box given under each question. (5) Upon completion questionnaire shall be returned with any other additional information to system Certification Division of the Sri Lanka Standards Institution. Doc No: FSMS – F 11.0 – 02A Issue: 04 Date of Issue: Aug. 2011 Page 1 0f 26 1.0 1.1 COMPANY PROFILE Name of the Applicant : Postal Address : Tel : Phone : ……………………… Fax : ……………………... GENERAL REQUIREMENT Position in the food chain Yes No Farming (Breeding) ? Farming (Growing) ? Processing (Animal perishable product) ? Processing (Vegetable perishable product) ? Feed production ? Processing (Stable products) ? Catering/Retail ? Services ? Equipment manufacture ? (Bio) chemical manufacturer ? Packaging material manufactures ? Yes No Has the organization established, documented, implemented and maintained an effective food safety management system and updated it when necessary in accordance with ISO 22000 :2005 standard? Has the scope of the food safety management system defined covering the products or product categories, process and production sites that are addressed by food safety management system? Are the food safety hazards identified, evaluated and controlled in such a manner that the products of the organization do not directly or indirectly harm the consumer? Has the appropriate information regarding safety issues related to its products been communicated through out the food chain? Doc No: FSMS – F 11.0 – 02A Issue: 04 Date of Issue: Aug. 2011 Page 2 0f 26 Has the information concerning development, implementation and updating of the food safety management system been communicated through out the organization? Does the organization evaluate periodically, and update when necessary, the food safety management system to ensure that the system reflects the organization’s activities and incorporate the most recent information on the food safety hazards subject to control? Does the organization “outsource” any process that effects product conformity? If yes, has the organization identified and documented such process and established adequate controls? 1.2 Documentation Requirements Does the food safety management system documentation include the following: Yes 1.3 Statement of food safety policy and related objectives? HACCP Manual Documented procedures and records required by ISO 22000 : 2005 Documents needed to ensure effective development Implementation and updating of the food safety management system Have the documented procedures been established, Implemented and maintained? No Control of documents Yes No Are there written down procedures for control of documents? Does procedure demand approval of documents for adequacy prior to issue? Are there revision status clearly shown in all documents? Are these documents maintained in a legible and readily identifiable manner Do provisions exist to review & re-approve of documents? Does the control of documents ensure that relevant versions of Doc No: FSMS – F 11.0 – 02A Issue: 04 Date of Issue: Aug. 2011 Page 3 0f 26 applicable documents are available at points of use? Does the food safety team leader have a track of all controlled documents? Are controlled copies of HACCP Manual available with each divisional head? Is there a mechanism to control external origin documents? Do the controls exist to prevent the unintended use of obsolete documents and to apply suitable identification to them if such documents are retained? 1.4 Control of Records Yes No Is there a written procedure for maintaining and control of records? Does the procedure specify the controls needed for the identification, storage, protection & retention of records? Are these records easily retrievable? Are these records maintained in such a manner so as to provide evidence of Conformity to requirements and the effective operation of the Food Safety Management System? 2. MANAGEMENT RESPONSIBILITY 2.1 Management Commitment Has the top management provided evidence of conformity to the development, implementation and continual improvement of the Food Safety Management system by : Yes Showing food safety supported by the business objectives of the Organization? Communicating to the organization the importance of meeting the requirement of ISO 22000 : 2005, any statutory and regulatory requirements as well as customer requirements ? Establishing the food safety policy ? Conducting management reviews ? Ensuring the availability of resources ? Doc No: FSMS – F 11.0 – 02A Issue: 04 Date of Issue: Aug. 2011 No Page 4 0f 26 2.2 Food Safety Policy Has the Top management ensured that the food safety policy; Yes Is appropriate to the role of the organization ? Confirms to both statutory and regulatory requirements and with mutually agreed food safety requirements of customers ? Is communicated, implemented and maintained at all levels of the Organization ? Is reviewed for continuing suitability ? Adequately addresses communication ? No 2.3 Food Safety Management System Planning Has the Top Management ensured that; 2.4 Planning of the Food Safety Management System is carried out to meet requirements given in 4.1 of the standard and the objectives of the organization that support food safety ? The integrity of the food safety management system is maintained during changes ? Yes No Yes No Yes No Responsibility and Authority Has the Top Management defined the Responsibilities and Authorities Are these Responsibilities and authorities communicated within the organization ? Have all personnel made responsible to report problems with the food Safety management system to identified person(s) ? Has designated personnel made responsible and authorized to initiate and record actions 2.5 Food safety team leader Has the Top Management appointed a Food Safety Team Leader Does the Responsibilities & Authorities of Food Safety Team Leader include provisions: Doc No: FSMS – F 11.0 – 02A Issue: 04 Date of Issue: Aug. 2011 Page 5 0f 26 To manage a food safety team and organize its work To ensure relevant training and education of the food safety team member ? To ensure that the food safety management system is established, implemented, maintained and updated ? To report to the organization’s top management on the effectiveness and suitability of the food safety management system? To Liaise with external parties on matters relating to the food safety management system ? 2.6 Communication 2.6.1 External Communication Yes No Has the Top Management ensured that sufficient information on issues Concerning food safety is available through out the food chain ? Has the organization established, implemented and maintained effective Arrangements for communicating with ? Suppliers and contractors ? Customers or consumers, in relation to product information ? Safety and regulatory authorities ? Other organizations that have an impact on, or will be affected by, the effectiveness or updating of the food safety management system ? Does such communication provide information on food safety aspects of the organization’s products that may be relevant to other organizations in the food chain ? Are the records of communication maintained ? Has designated personnel been made responsible and authorized to communicate externally ? 2.6.2 Internal Communication Yes No Has the organization established, implemented and maintained effective arrangements for communicating with personnel ? Doc No: FSMS – F 11.0 – 02A Issue: 04 Date of Issue: Aug. 2011 Page 6 0f 26 Has the organization ensured that the food safety team is informed in a timely manner of changes, including but not limited to ; Products or new products ? Yes Raw materials or ingredients and services Production systems and equipment ? Production premises, location of equipment, surrounding environment ? Cleaning and sanitation programmes ? Packaging, Storage and distribution systems ? Personnel qualification levels and/or allocation of responsibilities and Authorizations ? Statutory and regulatory requirements Knowledge regarding food safety hazards and control measures ? Customer, sector and other requirements that the organization observes ? Relevant enquires from external interested parties ? Complaints indicating food safety hazards associated with the product ? Other conditions that have an impact on food safety ? 2.7 No Emergency preparedness and response Yes No Has the top management established implemented and maintained procedures to manage potential emergency situations and accidents ? 2.8 Management Review 2.8.1 General Has the Top Management reviewed the organization’s Food Safety Management System at planned intervals, to ensure its continuing suitability, adequacy and effectiveness Doc No: FSMS – F 11.0 – 02A Issue: 04 Date of Issue: Aug. 2011 Page 7 0f 26 Yes No Has the review assessed the opportunities for improvement and the need for changes to the food safety management system including the food safety policy ? 2.8.2 Review input Has the input to Management Review included information on; Follow-up actions from previous managements reviews ? Analysis of results of verification activities Changing Circumstances that can affected food safety ? Emergency situations, accidents and withdrawals ? Reviewing results of system – updating activities ? Review of communication activities including customer feed-back ? External audits or inspections 2.8.3 Yes No Yes No Review output Has the outputs of the Management Review actions related to the following; Assurance of food safety ? Improvement of the effectiveness of food safety management system ? Resource needs ? Revisions of the organizations food safety policy and related objectives ? 3.0 Resource Management 3.1 Provision of resources Yes No Has the organization provided adequate resources for the establishment, implementation, maintenance and updating of the food safety management system? Doc No: FSMS – F 11.0 – 02A Issue: 04 Date of Issue: Aug. 2011 Page 8 0f 26 3.2 Human Resources 3.2.1 General Yes Are competent personnel assigned to work affecting food safety? Does the organization consider the education, training, skills and experience in assigning personnel? Does the organization maintain records of agreement or contacts defining the Responsibility and authority of external experts No 3.2.2 Competence, awareness and training Has the organization; 3.3 Identified the necessary competencies for personnel whose activities have an Impact on food safety ? Provided training or take other actions to satisfy these needs Ensured that personnel responsible for monitoring, corrections and corrective actions are trained ? Evaluated the implementation and the effectiveness ? Ensured that personnel are aware of the relevance and importance of their Individual activities ? Ensured that requirements for effective communication is understood by all personnel whose activities have an impact on food safety ? Maintained appropriate records of training and actions taken ? Yes No Yes No Infrastructure Has the organization provided the resources for the establishment and Maintenance of the infrastructure needed to implement the requirements of ISO 22000 : 2005 ? 3.4 Work Environment Yes No Has the organization provided the resources for the establishment and maintenance of the work environment needed to implement the requirements of ISO 22000 : 2005 ? Doc No: FSMS – F 11.0 – 02A Issue: 04 Date of Issue: Aug. 2011 Page 9 0f 26 4.0 Planning and realization of safe products 4.1 General Yes No Yes No Yes No Has the organization planned and developed the process needed for the realization of safe products ? 4.2 Pre-requisite Programmes (PRPs) Has the organization established, implemented and maintained PRP(s) to assist in controlling : The like hood of introducing food safety hazard to the product through the work environment ? Biological, chemical and physical contamination of the product(s) including cross contamination between products Food safety hazard levels in the product and product processing environment ? Are the PRP(s) appropriate to the organizational needs with regard to food safety ? Appropriate to the size and type of the operation and the nature of the products being manufactured and/or handled ? Implemented across the entire production system, either as programmes applicable in general or as programmes applicable to a particular product or operational line ? Approved by the food safety team ? Has the organization identified statutory and regulatory requirements related to the PRP(s) ? Does the organization consider and utilize appropriate information when selecting and/or establishing PRP(s) ? (Eg. Statutory and regulatory requirements, customer requirements, recognized guidelines codex principles and codes of practices, national, international or sector standards)? Does the organization consider the following when establishing PPR programmes; Construction and lay-out of buildings and associated utilities ? Lay-out of premises, including workplace and employee facilities ? Suppliers of air, water, energy and other utilities ? Doc No: FSMS – F 11.0 – 02A Issue: 04 Date of Issue: Aug. 2011 Page 10 0f 26 Supporting services, including waste and sewage disposal ? The suitability of equipment and its accessibility for cleaning, maintenance and preventive maintenance? Management of purchased material supplies, disposals and handling of products? Measures for the prevention of cross contamination ? Cleaning and sanitizing ? Pest control ? Personnel Hygiene ? Other aspects as appropriate ? Has the PRP(s) planned and verified as necessary ? Are the records of verification and modification maintained ? Does the documents specify how activities included in the PRO(s) are managed ? 4. 3 Yes No Yes No Yes No Yes No Preliminary steps to enable hazard analysis 4.3.1 General Does the organization collect, maintain update and document all relevant information needed to conduct the hazard analysis ? 4.3.2 Food Safety team Has the organization appointed a multi – disciplinary knowledged and experienced food safety team in developing and implementing food safety management system ? Does the organization maintain records to demonstrate that the food safety team has the required knowledge and experience ? Doc No: FSMS – F 11.0 – 02A Issue: 04 Date of Issue: Aug. 2011 Page 11 0f 26 4.3.3 Product Characteristics 4.3.3.1 Raw materials, ingredients and product – contact materials Has the organization described all raw materials, ingredients and product – contact materials 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 ? Food safety – related acceptance criteria or specifications of purchased materials and ingredients appropriate to their intended uses ? Has the organization identified statutory and regulatory food safety requirements related to the above ? Yes No Yes No 4.3.3.2 Characteristics of end products Has the organization described in documents, the characteristics of end products to the extent needed to conduct the hazard analysis including information on the following, as appropriate ? Product name or similar identification ? Composition ? Biological, Chemical and physical characteristics relevant to food safety ? Intended shelf life and storage conditions ? Packaging ? Labeling relating to food safety and/or instructions for handling, preparation and usage ? Doc No: FSMS – F 11.0 – 02A Issue: 04 Date of Issue: Aug. 2011 Page 12 0f 26 Methods(s) of distribution ? Has the organization identified the statutory and regulatory food safety requirements Related to the above ? 4.3.4 Intended use Yes No Has the organization described in documents, the reasonably expected handling of the end product, and any unintended but reasonably expected mishandling and misuse of the end product ? Has the organization identified, groups of users and, where appropriate, groups of consumers for each product, and consumer groups known to be especially vulnerable to specific food safety hazards ? 4.3.5 Flow diagrams, process steps and control measures 4.3.5.1 Flow diagrams Has the organization prepared clear, accurate and sufficiently detailed flow diagrams for the products or process categories including the following as appropriate ? Yes The sequence and interaction of all steps in the operation ? Any outsourced process and subcontracted work ? Where raw materials, ingredients and intermediate products enter the flow ? Where reworking and recycling take place ? Where end products, intermediate products, by-products and waste are released or removed ? Verify the accuracy of the flow diagram by on-site checking ? Availability of records of verified flow diagrams ? No 4.3.5.2 Description of process steps and control measures Has the organization described; Yes No The existing control measures, process parameters and/or the rigorousness with which they are applied or procedures that may influence food safety ? Doc No: FSMS – F 11.0 – 02A Issue: 04 Date of Issue: Aug. 2011 Page 13 0f 26 External requirements that may impact the choice and the rigorousness of the control measures ? (eg. From regulatory authorities or customers) 4.4 Hazard analysis 4.4.1 General Yes No Yes No Yes No Yes No Does the food safety team conduct a hazard analysis to determine which hazards need to be controlled, the degree of controls required to ensure food safety, and which combination of control measures is required ? 4.4.2 Hazard identification and determination of acceptable levels 4.4.2.1 Has the organization identified and recorded all food safety hazards that are reasonably expected to occur in relation to the type of product, type of process and actual processing facilities ? Is the identification based on the following ? The preliminary information and data collected according to 4.3 of this questionnaire ? Experience ? External information including. to the extent possible, epidemiological and other historical data ? Information of 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 ? Are the step(s) (from raw materials, processing and distribution) at which each food safety hazard may be introduced indicated) ? 4.4.2.2 Has the organization considered the following when identifying the hazards; The steps preceding and following a specified operation ? The process equipment, utilities/services and surroundings ? The preceding and following links in the food chain ? Doc No: FSMS – F 11.0 – 02A Issue: 04 Date of Issue: Aug. 2011 Page 14 0f 26 4.4.2.3 For each of the food safety hazards identified has the organization determined; Yes The acceptable level of the food safety hazard in the end product? The established statutory and regulatory requirements ? Customer food safety requirements ? The intended use by the customer ? Other relevant data ? No 4.4.3 Hazard assessment Does the organization conduct hazard assessment for each food safety hazard Identified to determine; Yes Whether its elimination or reduction to acceptable level is essential ? Whether its control is needed ? No Has the organization evaluated each food safety hazard according to; Severity of adverse health effects ? The likelihood of their occurrence ? Has the organization described the methodology used for hazard assessment ? Does the organization record the results ? Yes No Yes No 4.4.4 Selection and assessment of control measures Has the organization selected an appropriate combination of control measures which is capable at preventing eliminating or reducing food safety hazards to defined acceptable level? Does the organization review each at the control measures described in 4.3.5.2 with respect to its effectiveness ? Has the organization categorized the control measures as to whether they need to be managed through operational PRP(s) or by the HACCP plan Doc No: FSMS – F 11.0 – 02A Issue: 04 Date of Issue: Aug. 2011 Page 15 0f 26 Has the categorization carried out using a logical approach that includes assessments with regard to the following; Yes Its effect on identified food safety hazards relative to the strictness applied ? Its feasibility for monitoring (Eg. Ability to be monitored in a timely manner to enable immediate corrections)? Its place within the system relative to other control measures ? The likelihood of failure in the functioning of a control measure or Significant processing variability ? The severity of the consequence(s) in the case of failure in its functioning ? Whether the control measure is specifically established and applied to eliminate or significantly reduce the level of hazards(s) Synergistic effects (i e interaction that occurs between two more measures Resulting in their combined effect being higher than the sum of their individual effects)? Has the methodology and parameters used for categorization described in Documents and the results of the assessment recorded ? 4.5 No Establishing the operational pre-requisite programmes (PRPs) Do the operational PRPs documented include the following information for each programme; Yes Food safety hazards(s) to be controlled by the programme ? Control measure(s) Monitoring procedures that demonstrate that the operational PRPs are implemented? Corrections and corrective actions to be taken if monitoring, shows that the operational PRPs are not in control? Responsibilities and authorities ? Records of monitoring ? Doc No: FSMS – F 11.0 – 02A Issue: 04 Date of Issue: Aug. 2011 No Page 16 0f 26 4.6 Establishing the HACCP plan 4.6.1 HACCP plan Does the HACCP plan documented include the following information for each identified critical control point (CCP); Yes No Food safety hazard(s) to be controlled at the CCP ? Critical limits ? Monitoring procedures ? Corrections and corrective action(s) to be taken if critical limits do exceed? Responsibilities and authorities ? Records of monitoring ? 4.6.2 Identification of Critical control points (CCPs) Yes No Has the organization identified control measures for each hazard that is to be controlled by the HACCP plan ? 4.6.3 Determination of critical limits for critical control points Has the organization; Yes Determined the critical limits for each CCP established? Established critical limits to ensure that the identified acceptable level of the food safety hazard in the end product is not exceeded ? Established measurable critical limits ? Documented the rationale for the chosen critical limits ? Determined the critical limits based on objective data (such as visual Inspection of product, process, handling, etc) and supported by instructions or specifications and/or education and training? No 4.6.4 System for the monitoring at critical control points Yes No Has the organization established a monitoring system for each CCP to Demonstrate that the CCP is in control ? Doc No: FSMS – F 11.0 – 02A Issue: 04 Date of Issue: Aug. 2011 Page 17 0f 26 Does the monitoring system consist of relevant procedures, instructions and records that cover the following; Yes Measurements or observations that provide results within an adequate time frame ? Monitoring devices used ? Applicable calibration methods ? Monitoring frequency ? Responsibility and authority related to monitoring and evaluation of monitoring results? Record requirements and methods ? Does the monitoring methods and frequency capable of determining when the critical limits have been exceeded in time for the product to be isolated before it is used or consumed ? No 4.6.5 Actions when monitoring results exceed critical limits Yes No Does the HACCP plan specify the planned corrections and corrective actions to be taken when critical limits do exceed ? 4.7 Updating of preliminary information and documents specifying the PRPs and the HACCP plan Does the organization update the following information, if necessary ; Yes Product characteristics ? Intended use ? Flow diagrams ? Processes steps ? Control measures ? Doc No: FSMS – F 11.0 – 02A Issue: 04 Date of Issue: Aug. 2011 No Page 18 0f 26 4.8 Verification planning Yes No Does the verification planning define the purpose, methods, frequencies and responsibilities for the verification activities ? Does the verification activities confirm that The PRP(s) are implemented ? Input to the hazard analysis is continually updated ? The operational PRP(s) and the elements within the HACCP plan are implemented and effective ? Hazard levels are within identified acceptable level ? Other procedures required by the organization are implemented and effective ? Does the output of this planning is in a form suitable for the organization’s method of operations ? Are the verification results recorded and communicated to the food safety team Yes No Yes No 4.9 Traceability system Has the organization established and applied a traceability system that enables the identification of product lots and their relation to batches of raw materials processing and delivery records ? Is the traceability system able to identify incoming material from the immediate suppliers and the initial distribution route of the end product ? Are the traceability records maintained for a defined period for system assessment to enable the handling of potentially unsafe products and in the event of product withdrawal ? Are the records in accordance with statutory and regulatory requirements and customer requirements (eg: based on the end product lot identification) ? 4.10 Control of nonconformity 4.10.1 Corrections Does the organization ensure that when critical limits for CCP(s) are exceeded or there is a loss of control of operational PRP(s), the products Doc No: FSMS – F 11.0 – 02A Issue: 04 Date of Issue: Aug. 2011 Page 19 0f 26 affected are identified and controlled with regard to their use and release ? Is there a documented procedure established and maintained defining the Identification and assessment of affected end products to determine their proper handling and a review of the corrections carried out ? Are all corrections approved by the responsible person(s) ? Are all corrections recorded together with information on the nature of the nonconformity, its cause(s) and consequence including information needed for traceability purposes ? Yes No Yes No 4.10.2 Corrective actions Are the data derived from the monitoring of operational PRPs and CCPs evaluated by designated person(s) with sufficient knowledge and authority to initiate corrective actions ? Are the corrective actions initiated when critical limits exceeded or when there is a lack of conformity with operational PRP(s) Is there a documented procedure available to identify and eliminate the cause of detected nonconformities, to prevent recurrence, and to bring the process or system back in to control after nonconformity is encountered ? Are these actions include; Reviewing nonconformities (including customer complaints) ? Reviewing trends in monitoring results that may indicate development towards loss of control ? Determining the causes(s) of nonconformities ? Evaluating the need for action to ensure that nonconformities do not recur ? Determining and implementing the actions needed ? Recording the results of corrective actions taken ? Are the corrective actions recorded ? 4.10.3 Handling of potentially unsafe products 4.10.3.1General Does the organization handle nonconformity products by taking action(s) to prevent the nonconformity product from entering the food chain ? Doc No: FSMS – F 11.0 – 02A Issue: 04 Date of Issue: Aug. 2011 Yes No Page 20 0f 26 Does the organization ensure that ; The food safety hazard(s) of concern has(ve) been reduced to the defined acceptable levels ? The food safety hazard(s) of concern will be reduced to identified acceptable levels prior to entering into the food chain ? The product still meets the defined acceptable level(s) of the food safety hazard(s) of concern despite the nonconformity ? Yes No Yes No Are the all lots of product that have been affected by a nonconforming situation held under control of the organization until they have been evaluated ? Does the organization notify relevant interested parties and initiate a withdrawal if products that have left the control of the organization are subsequently determined to be unsafe ? Does the organization maintain documents regarding the controls and related responses and authorization for dealing with potentially unsafe products ? 4.10.3.2 Evaluation for release ? Does the organization take actions to release each lot of product affected by the nonconformity, when any of the following conditions apply ; Evidence other than the monitoring system demonstrates that the control measures have been effective ? Destruction and/or disposal as waste ? Evidence shows that the combined effect of the control measures for that particular product complies with the performance intended ? The results of the sampling, analysis and/or other verification activities demonstrate that the affected lot of product complies with the identified acceptable levels ? 4.10.3.3 Disposition of nonconforming products Does the organization evaluate, if the lot of product is not acceptable for release is it handled by one of the following ? Reprocessing or further processing within or outside the organization to ensure that the food safety hazard is eliminated or reduced to acceptable levels ? Doc No: FSMS – F 11.0 – 02A Issue: 04 Date of Issue: Aug. 2011 Page 21 0f 26 Yes No Destruction and/or disposal as waste ? 4.10.4 Withdrawals Has the top management appointed personnel having the authority to initiate a withdrawal and personnel responsible for executing the withdrawal ? Is there a documented procedure for ; Notification to relevant interested parties (eg:- statutory and regulatory authorities, consumers and/or consumers) ? Handling of withdrawn products as well as affected lots of the products still in stock ? The sequence of actions to be taken ? Yes No Yes No Are the withdrawn products ; 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 ? Reprocessed in a manner to ensure they become safe ? Are the cause, extent and result of a withdrawal record and report to the top management as input to the management review ? Does the organization verify and record the effectiveness of the withdrawal programme through the use of appropriate technique (eg: mock withdrawal or practice withdrawal) 5. Validation, verification and improvement of the food safety management system 5.1 General Yes No Does the food safety team plan and implement the processes needed to validate control measure combinations, and to verify and improve the food safety management system? Doc No: FSMS – F 11.0 – 02A Issue: 04 Date of Issue: Aug. 2011 Page 22 0f 26 5.2 Validation of control measure combinations Prior to implementation of control measures to be included in operational PRP(s) and the HACCP plan and after any changes, does the organization validate that; The selected control measures are capable of achieving the intended control of the food safety hazard(s) for which they are designated ? The control measures are effective and capable of in combination, ensuring control of the identified food safety hazard(s) to obtain end products that meet the defined acceptable levels? Are the control measures and/or combinations modified and re-assessed the if the result of the validation shows any deviation ? Yes No Yes No 5.3 Control of monitoring and measuring Does the organization capable of providing evidence so that the specified monitoring and measuring methods and equipment are adequate to ensure the performance of the monitoring and measuring procedures ? Are monitoring and measuring equipment calibrated or verified at specified intervals, or prior to use, against measurement standards traceable to international or national measurement standards ? Is the basis used for calibration recorded when traceability to international Or national standards cannot be done, since no standards exist ? Are monitoring or measuring equipment; Adjusted or re-adjusted as necessary ? Identified to enable the calibration status to be determined ? Safeguarded from adjustments that would invalidate the measurement results ? Protected from damaged and deterioration ? Does the organization; Yes Maintain records of the results of calibration and verification ? Assess the validity of the previous measurement results when the equipment results when the equipment or process is found not conform to requirement ? Doc No: FSMS – F 11.0 – 02A Issue: 04 Date of Issue: Aug. 2011 No Page 23 0f 26 Yes Take appropriate action for the equipment and any product affected, if the Measuring equipment id nonconforming ? Maintain records of such assessment and resulting actions ? Confirm the ability of computer software to satisfy the intended application when used in the monitoring and measurement of specified requirements ? No 5.4 Food safety Management System verification 5.4.1 Internal audit Yes Does the organization conduct periodic audits of the food safety management system ? Do the periodic audits evaluate the conformity of the food safety managements of ISO 22000:2005 ? Do the periodic audits evaluate the degree to which the food safety management system has been effectively implemented and updated ? Does the organization plan the audit programme taking into consideration the importance of the process and areas to be audited ? Does the organization plan the audit programme taking into consideration the updating actions resulting from previous audits ? Are the audit criteria, scope, frequency and methodology defined ? Does the audit process and auditor assignment ensure objectivity and Impartiality ? Is there a documented procedure that includes the responsibilities and requirements for conducting audits ? Is there a documented procedure for reporting results and marinating records ? Is timely corrective actions taken on deficiencies found during the audit ? Do follow-up actions include the verification of the implementation of corrective action ? Do follow-up actions include the reporting of verification results ? Doc No: FSMS – F 11.0 – 02A Issue: 04 Date of Issue: Aug. 2011 No Page 24 0f 26 5.4.2 Evaluation of individual verification results Yes Does the food safety team systematically evaluate the individual results of planned verification ? Does the organization take action to achieve the required conformity, if verification does not demonstrate conformity with the planned arrangements ? No 5.4.3 Analysis of results of verification activities Yes No Does the food safety team analyze the results of verification activities, including the results of the internal audits and external audits ? Are the analysis 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 organization ? To identify the need for updating or improving the food safety management system ? To identify trends which indicate a higher incidence of potentially unsafe products ? To establish information for planning of the internal audit programme concerning the status and importance of areas to be audited ? To provide evidence that any corrections and corrective actions that have been taken are effective ? 5.5 Improvement 5.5.1 Continual Improvement Yes Does the organization plan and manage processes necessary for the continual improvement of the Food Safety Management System ? Does the organization use communication, management review, I internal audit, evaluation of verification results, audit, evaluation of verification results, analysis of results of verification activities, validation of control measure combinations corrective actions and food safety management system updating to facilitate the continual improvement of the food safety management system ? Doc No: FSMS – F 11.0 – 02A Issue: 04 Date of Issue: Aug. 2011 No Page 25 0f 26 5.5.2 Updating the food safety management system Yes Does the top management ensure that the food safety management system is continually updated ? Does the food safety team evaluate the food safety management system at planned intervals? No Are the updating activities based on; Input from other information concerning the suitability, adequacy and effectiveness of the food management system ? Output from the analysis of results of verification activities ? Output from the management review ? Doc No: FSMS – F 11.0 – 02A Issue: 04 Date of Issue: Aug. 2011 Page 26 0f 26
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