UNI EN ISO 22000:2005 STANDARD CHECK-LIST

Size: px
Start display at page:

Download "UNI EN ISO 22000:2005 STANDARD CHECK-LIST"

Transcription

1 RINA AUDIT CHECKLIST (Nr.... of...) Audit of the Food Safety Management System Company Production site: Audit type: Preaudit: Stage 1 Stage 2: Surveillance: Recertification: Other:. Report Nr. Date: Auditor: Nr. Par UNI EN ISO 22000:2005 STANDARD CHECK-LIST Verified PREVIOUS INSPECTION 1 Have the corrective actions specified in relation to previous remarks been implemented? 2 Is the RINA certification logo used in compliance with the Rule and is the FSMS properly publicized? 3 Have changes been made to the FSMS? 4 Food Safety Management System (FSMS) 4.1 General Requirements: 4 Has the organisation established, documented, implemented and maintained an effective FSMS, updated when necessary in accordance with the requirements of the international standard? 5 Has the organisation defined the scope of the FSMS? 6 Does the scope specify the products or products categories, the processes and the production sites to which the FSMS is aimed? Has the organisation: 7 a) ensured that the hazards for safety that can be reasonably expected are identified, assessed and verified so that the products of the organisation do not directly or indirectly harm consumers? 8 b) conveyed, through the food supply chain, appropriate information about the safety aspects associated to its products? 9 c) conveyed information concerning the development, implementation and update of the FSMS within the organisation with the diffusion required to ensure the food safety required by this international standard? 10 d) periodically assessed, and updated when necessary, the FSMS to ensure that the system reflects the activities of the organisation and includes the most recent information about the hazard for food safety subject to inspections? 11 If the organisation has resorted to outsourcing for products or processes affecting the conformity of the finished product, has the organisation ensured that these products and processes are subject to inspection? 12 The inspection of these outsourced products /processes has been identified and documented in the FSMS? 4.2 Documentation Requirements General Does the FSMS documentation include: 13 a) documented statements about the food safety policy and the objectives (5.2)? 14 b) documented procedures and records required by this international standard? 15 c) documents required by the organisation to ensure effective development, implementation and update of the FSMS? Document control 16 Is the documentation required by the FSMS controlled? 17 Are records, which are a special type of documents, controlled in accordance with the requirements of point 4.2.3? 18 Do controls ensure that all the proposals of changes are reviewed before their implementation to verify their effect on food safety and their impact on the FSMS? Has a documented procedure been established to define the controls required: 19 a) to approve the documents, about their appropriateness, before use? 20 b) to review and update the documents when necessary, and to re-approve them? 21 c) to ensure that the changes and the current revision status of the documents are identified? 22 d) to ensure that the pertaining versions of applicable documents are available at the locations where they are used? 23 e) to ensure that documents remain readable and easily identifiable? 24 f) to ensure that the documents of external origin are identified and that their distribution is controlled? 25 g) to prevent involuntary use of obsolete documents and to ensure proper identification of the same if they are to be retained for any reason? 26 Is an updated copy of the RINA Rules about FSMS certification available? Record control 27 Have records been arranged and retained to provide evidence of the conformity to requirements and of the effective working of the FSMS? Form FORM-SYS03-FSMS-02_EN_ /1

2 28 Are quality records readable, easily identified and traceable? 29 Has a documented procedure establishing procedures for record identification, fining, protection, traceability, preservation duration and destruction been arranged and implemented? 5 Management Responsibility 5.1 Management Commitment Has the High Management provided evidence of it commitment to the development and implementation of the FSMS and to the continuous improvement of its efficiency: 30 a) proving that food safety is supported by the commercial objectives of the organisation? 31 b) communicating to the organisation the importance of meeting the requirements of the international standard, all the legislative and regulatory requirements, as well as the client requirements connected to food safety? 32 c) establishing the food safety policy? 33 d) performing reviews by the management? 34 e) ensuring the availability of resources? 5.2 Food Safety Policy 35 Has the High Management defined, documented and communicated its food safety policy? Has the High Management ensured that the food safety policy: 36 a) is appropriate to the role of the organisation within the food supply chain? 37 b) is compliant with the legislative and regulatory requirements, and to the food safety requirements reciprocally agreed with the clients? 38 c) is communicated, implemented and maintained at all levels of the organisation? 39 d) is reviewed to ensure its continuous suitableness (5.8)? 40 e) appropriately dealing with communication (5.6)? 41 f) is supported by measurable objectives? 5.3 Food Safety Management System Planning Has the High Management ensured that: 42 a) FSMS planning is performed to meet the requirements reported in 4.1 and to achieve the organisation objectives supporting food safety? 43 b) the integrity of the FSMS is maintained when changes to the system itself are planned and implemented? 5.4 Responsibility and Authority 44 Has the High Management ensured that responsibilities and authorities have been defined and made public within the organisation to ensure the effective operativeness and maintenance of the FSMS? 45 Are all the personnel aware of their responsibility to refer any FSMS trouble to the identified personnel? 46 Have the appointed personnel the definite responsibility and authority to start and to record the appropriate actions? 5.5 Food Safety Team Manager Has the High Management appointed a Food Safety Team Manager who, regardless of other responsibilities, has the responsibility ad the authority to: 47 a) manage the Food Safety Team (7.3.2) and to organise its work? 48 b) ensure pertaining training for the members of the Food Safety Team (6.2.1)? 49 c) ensure that the FSMS is arranged, implemented, retained and updated? 50 d) report to the High Management of the organisation about the efficiency and suitableness of the FSMS? 5.6 Communication External Communication In order to guarantee that enough information about the subjects regarding food safety is available along the whole food supply chain, has the organisation arranged, implemented and retained effective measures to communicate with: 51 a) suppliers and contractors? 52 b) clients and consumers, in particular in relation to product information (including the instructions about its envisaged use, specific storage requirements and, if appropriate, shelf life), to the researches, to the contracts and to order management, including the changes and client feedback information, including complaints? 53 c) the legislative and regulatory authorities? 54 d) other organisations affecting the efficiency or the update of the FSMS, or which are affected by it? 55 Does such communication provide information about the aspects of the food safety of the organisation products that could be relevant for other organisation within the food supply chain, in particular as regards to the hazards for known food safety hazards that must be checked by other organisations within the food supply chain? 56 Are records of these communications retained? 57 Are the food safety requirements of legislative and regulatory authorities and of clients available? 58 Has the appointed personnel clear responsibility and authority to communicate to the outside all the information regarding food safety? 59 Has information obtained by means of external communication been included as input elements for system update (8.5.2) and for review by the management (5.8.2)? Internal Communication Form FORM-SYS03-FSMS-02_EN_ /2

3 60 The organisation must arrange, implement and maintain effective communication measures with its personnel as regards to the news affecting food safety. In order to maintain the efficiency of the food safety management system, the organisation must ensure that the food safety team is promptly informed of any change, including, but not limited to, the following: 61 a) products or new products? 62 b) raw materials, ingredients and services? 63 c) production systems and equipment? 64 d) production spaces, equipment location, surrounding environment? 65 e) cleaning and sanitisation plans? 66 f) packaging, storage and distribution systems? 67 g) personnel qualification levels and/or responsibility and authorisation attribution? 68 h) legislative and regulatory requirements? 69 i) knowledge related to hazards for food safety and control measures? 70 j) client, sectors and other requirements observed by the organisation? 71 k) relevant researches from other interested external parties? 72 l) complaints related to hazards for food safety associated to the product? 73 m) other conditions affecting food safety? 74 Has the food safety team ensured that this information have been included in the FSMS update (8.5.2)? 75 Has the High Management ensured that pertaining information is used as input elements for the management review (5.8.2)? 5.7 Emergency Preparedness and Response 76 Has the High Management established, implemented and kept active procedures for the management of potential emergencies and of accidents that could affect food safety and that are relevant to the role of the organisation within the food supply chain? 5.8 Management Review 77 Has the High Management reviewed, at regular intervals, the FSMS of the organisation to make sure of its continuous suitableness, appropriateness and efficiency? 78 Does the review include the assessment of the possibilities for improvement and of the requirements for changed to the FSMS, including the food safety policy? 79 Have the records of the reviews performed by the management been retained (4.2.3)? 5.8 Review Input Elements Do the input elements for the management review include information, not limited to: 80 a) actions following previous reviews performed by the management? 81 b) analyses of the results of audit activities (8.4.3)? 82 c) changes of the circumstances that may affect food safety (5.6.2)? 83 d) emergencies, accidents (5.7) and withdrawals (and recalls) (7.10.4)? 84 e) results of the review of the system update activities (8.5.2)? 85 f) review of the communication activities, including client feedback information (5.6.1)? 86 g) external audits or inspections? 87 Have data been set out to allow the high management to relate the information with the objectives indicated by the FSMS? Review Output Elements Do the output elements of a management review include decisions and actions associated to: 88 a) assurance of food safety (4.1)? 89 b) FSMS efficiency improvement (8.5)? 90 c) required resources (6.1)? 91 d) revisions of the food safety policy of the organisation and of the relevant objectives (5.2)? 6 Resource Management 6.1 Resource Availability 92 Has the High Management made available suitable resources to establish, implement, maintain and update the FSMS? 6.2 Human Resources 93 Are the Food Safety Team and the other personnel performing activities affecting food safety skilled and are they in possession of suitable training, skills and experience? 94 When the assistance of external experts is required for the development, implementation, operation or auditing of the FSMS, have records of the agreements or contracts defining the responsibility and authority of external experts been made available? Has the organisation: 95 a) identified the required skills for the personnel whose activities affect food safety? 96 b) provided the training or undertook other actions to make sure that the personnel are in possession of the required skills? 97 c) ensured that the personnel responsible for FSMS monitoring, corrections and corrective actions are properly trained? 98 d) assessed the implementation and efficiency of a), b) and c)? Form FORM-SYS03-FSMS-02_EN_ /3

4 99 e) ensured that the personnel are aware of the relevance and importance of their individual activities as a contribution to food safety? 100 f) ensured that the effective communication requirement (5.6) has been understood by all the personnel whose activities affect food safety? 101 g) retained proper records about the training and actions described under b) and c)? 6.3 Infrastructures 102 Has the organisation provided the resources to establish, manage and maintain the infrastructure required for the implementation of the requirements of the international standard? 6.4 Work Environment 103 Has the organisation provided the resources to establish and maintain the work environment required for the implementation of the requirements of the international standard? 7 Planning and realisation of safe products 7.1 General 104 Has the organisation planned and developed the procedures required to realise safe products? 105 Has the organisation implemented, managed and ensured the efficiency of the planned activities and of all the changes to these activities? 106 Does this include the PRP(s) as well as the operational PRP(s) and/or the HACCP plan? 7.2 Pre-Requisite Programs (PRPs) Has the organisation established, implemented and maintained active the PRP(s) to help checking: 107 a) the probability of introducing hazards for food safety in the product through the work environment? 108 b) the biological, chemical and physical contamination of the product(s), including cross-contamination between products? 109 c) the hazard levels for food safety in the product and in the product work environment? Is/Are the PRP(s): 110 a) suited to the requirements of the organisation in relation to food safety? 111 b) suited to the operation size and type and to the nature of the manufactured and/or handled products? 112 c) implemented through the whole production process, either as generally applicable programs or as programs applicable to a certain product or operational line? 113 d) approved by the Food Safety Team? 114 Has the organisation identified the legislative and regulatory requirements related to the foregoing? 115 Has the organisation considered and used suitable information to select and/or establish the PRP(s) [for example: legislative and regulatory requirements, client requirements, acknowledged guidelines, principles of the Codex Alimentarius Commission and practice codes, national, international or sector regulations] See also Appendix C of the Standard When it has established these programs, has the organisation considered what follows: 116 a) construction and planning of buildings and associated services? 117 b) site planning, including workspaces and structures for the employees? 118 c) supply of air, water, power and other services? 119 d) support services, including waste and sewage disposal? 120 e) equipment suitableness and accessibility for cleaning, maintenance and preventive maintenance? 121 f) management of purchased materials (for example, raw materials, ingredients, chemical agents and packaging), supplies (for example, water, air, steam and ice), disposal (for example, waste and sewage) and product management (for example, storage and transportation)? 122 g) measures for preventing cross-contamination? 123 h) cleaning and sanitisation? 124 i) infestation control? 125 j) personnel hygiene? 126 k) other appropriate aspects? 127 Has the PRP(s) review been planned and has/have it/they been modified as required (7.7)? 128 Have the records of the inspections and modifications been retained? 129 Do the documents specify how are the activities included in the PRP(s) managed? (optional) 7.3 Preliminary stages to allow hazard analysis General 130 Have all the pertaining information required to perform hazard analysis been collected, maintained, updated and documented? 131 Have the appropriate records been retained? Food Safety Team Has a Food Safety Team been appointed? 132 Does the Food Safety Team possess a combination of multi-discipline knowledge and experience in FSMS development and implementation? 133 Does this include, without being necessarily limited to them, the products, processes, equipment of the organisation and the hazards for food safety falling within the scope and field of application of the FSMS? 134 Are the records proving that the Food Safety Team is in possession of the required knowledge and experience (6.2.2) available? Product Characteristics Form FORM-SYS03-FSMS-02_EN_ /4

5 Raw Materials, Ingredients and Materials in contact with the Product 135 Have all the raw materials, the ingredients and the materials in contact with the product been described as required to perform hazard analysis (7.4), including the following elements, if necessary: 136 a) biological, chemical and physical characteristics? 137 b) composition of formulation ingredients, including additives and technological adjuvants? 138 c) origin? 139 d) production method? 140 e) packaging and distribution methods? 141 f) storage conditions and shelf life? 142 g) preparation and/or handling before use or processing? 143 h) acceptance criteria related to food safety or specifications of purchased materials and ingredients suited to the envisaged uses? 144 Has the organisation identified the legislative and regulatory requirements for food safety related to the foregoing? 145 Are description kept updated including, when requested, what envisaged in compliance with point 7.7? Characteristics of finished products Have the characteristics of finished products been described as required to perform hazard analysis (7.4), including information about the following elements, if necessary: 146 a) product name or similar identification? 147 b) composition? 148 c) biological, chemical and physical characteristics pertaining to food safety? 149 d) expected shelf life and storage conditions? 150 e) packaging? 151 f) labelling associated to food safety and/or instructions for product handling, preparation and use? 152 g) distribution method(s)? 153 Has the organisation identified the legislative and regulatory requirements for food safety related to the foregoing? 154 Are description kept updated including, when requested, what envisaged in compliance with point 7.7? Envisaged Use 155 Have the envisaged use, the handling of the finished product that could be reasonably expected and any unintentional but reasonably expectable mishandling or misuse of the finished product been considered and described in the documents as required to perform hazard analysis (7.4)? 156 Have user groups and, if necessary consumer groups been identified for each product and have consumer groups known to be especially vulnerable to specific hazard for food safety been considered? 157 Are description kept updated including, when requested, what envisaged in compliance with point 7.7? Flow charts, process stages and control measures Flow charts 158 Are flow charts available for product categories or processes covered by the FSMS? 159 Do flow charts provide a basis for the assessment of the possible occurrence, increase or introduction of hazards for food safety? 160 Are flow charts clear, accurate and sufficiently detailed? Do flow charts include, when appropriate, what follows: 161 a) the sequence and interaction of all the operational stages? 162 b) all the contracted processes and contracted work? 163 c) where raw materials, ingredients and intermediate products enter the flow? 164 d) where reworking and recycles take place? 165 e) where finished products, intermediate products, secondary products and waste are released or removed? 166 Has the Food Safety Team checked the accuracy of flow charts by means of an on-site check, in compliance with point 7.8? 167 Are kept flow charts retained as records? Description of the process stages and of control measures 168 Have the existing control measures, process parameters and/or the severity with which they are applied or the procedures that can affect food safety been described as required to perform hazard analysis (7.4)? 169 Have the external requirements (for example, by regulation authorities or clients) which can affect the choice and the severity of control measures also been described? 170 Are descriptions kept updated in compliance with point 7.7? 7.4 Hazard Analysis General 171 Has the Food Safety Team performed a hazard analysis to determine what hazards must be controlled, the control degree required to ensure food safety and what combination of control measures is necessary? Hazard identification and determination of acceptable levels 172 Have all the hazard for food safety that can be reasonably expected to occur in relation to product type, process type and to the current work structures been identified and recorded? Has identification been based on: 173 a) preliminary information and data collected according to point 7.3? Form FORM-SYS03-FSMS-02_EN_ /5

6 174 b) experience, 175 c) external information, including, as much as possible, epidemiologic data and other historical data? 176 d) information from the food supply chain about the hazards for food safety that could be relevant for the safety of finished products, of intermediate products and of the food when consumed? 177 Has/Have the stage(s) (from raw materials, processing and distribution) in which every hazard for food safety can be introduced been indicated? During hazard identification, what follows has been considered: 178 a) previous and subsequent stages with respect to the specified operativeness? 179 b) process equipment, connected structures and services and surrounding environment? 180 c) upstream and downstream connections in the food supply chain? 181 Has, when possible, the acceptable hazard level for food safety in the finished product been determined for each identified hazard for food safety? 182 Has the determined level taken into account the established legislative and regulatory requirements, the client food safety requirements, the envisaged use by the client and the other relevant data? 183 Have the results of the determination and the relevant justifications been recorded? Hazard assessment 184 Has a hazard assessment been performed to determine, for every identified hazard for food safety (7.4.2), if its elimination or reduction to acceptable levels is essential to produce a safe food and if it is necessary to control it to allow the meeting of the defined acceptable levels? 185 Has every hazard for food safety been assessed according to the possible severity of harmful effects to human health and to the probability of their occurrence? 186 Has the methodology used been described and have the results of the assessments of the hazards for food safety been recorded? Selection and assessment of control measures 187 Has an appropriate combination of control measures capable of preventing, eliminating or reducing to the defined acceptable levels (according to the hazard assessment under 7.4.3) such hazards for food safety been selected? 188 Has every control measure, as described under , been reviewed in relation to its effectiveness against identified hazards for food safety? 189 Have the selected control measures been divided into categories, according to whether they must be managed through operational PRPs or though the HACCP plan? Has the selection and the division into categories been performed using a logical approach including the following assessments: 190 a) its effect on identified hazard for food safety with respect to applied severity? 191 b) its monitoring feasibility (for example, the possibility of being monitored in time to allow immediate correction)? 192 c) its position within the system with respect to other control measures? 193 d) the probability of a failure of the control measure operation or of significant processing variability? 194 e) the severity of the consequence(s) in case of operation failure? 195 f) if the control measure is specifically established and applied to eliminate or to significantly reduce the hazard level(s)? 196 g) synergic effects (i.e. the interaction occurring between two or more measures, producing a combined effect greater than the sum of their single effects)? 197 Have control measures divided into categories as pertaining to the HACCP plan been implemented in accordance with point 7.6? 198 Have other control measures been implemented as operational PRPs in accordance with point 7.5? 199 Has the methodology and the parameters used for this subdivision been described in documents and have the results of the assessment been recorded? 7.5 Establishment of operational pre-requisite programs (PRPs) Have operational PRPs been documented and do they include for each program the following information: 200 a) hazard(s) for food safety to be controlled by means of the program (7.4.4.)? 201 b) control measure(s) (7.4.4)? 202 c) monitoring procedures proving that operational PRPs have been implemented? 203 d) corrections and corrective actions to be undertaken if the monitoring shows that operational PRPs are not under control ( and )? 204 e) responsibility and authority? 205 f) monitoring record(s)? 7.6 Establishment of the HACCP plan HACCP Plan 206 Has the HACCP plan been documented and does it include the following information for each identified critical control point (CCP): 207 a) hazard(s) for food safety to be controlled by means at the CCP (7.4.4.)? 208 b) control measure(s) (7.4.4)? 209 c) critical limit(s) (7.6.3)? 210 d) monitoring procedure(s) (7.6.4)? Form FORM-SYS03-FSMS-02_EN_ /6

7 211 e) corrections and corrective actions to be undertaken if critical limits are exceeded (7.6.5)? 212 f) responsibility and authority? 213 g) monitoring record(s)? Identification of critical control points (CCP) 214 Have CCPs for identified control measures been identified for every hazard controlled by the HACCP plan (7.4.4)? Determination of critical limits for critical control points 215 Have critical limits been determined for the monitoring established for every CCP? 216 Have critical limits been established to ensure that the identified acceptable level of hazard for food safety in the finished product (7.4.2) is not exceeded? 217 Are critical limits measurable? 218 Has the explanation for the choice of critical points been documented? 219 Are critical limits based on subjective data (such as visual inspection of the product, process, handling, etc) been supported by instructions or specifications and/or training? Monitoring system for critical control points 220 Has a monitoring system been defined for every CCP capable of proving that the CCP is under control? 221 Does the system include all the planned measurements or observation in relation to the critical limit(s)? Does the monitoring system consist of pertaining procedures, instructions and records covering the following: 223 a) measurements or observations providing results in a suitable time interval? 224 b) monitoring devices used? 225 c) applicable calibration methods (8.3)? 226 d) monitoring frequencies? 227 e) responsibilities and authorities related to the monitoring and to the assessment of monitoring results? 228 f) recording requirements and methods? 229 Are monitoring method and frequency capable of determining when critical limits are exceeded in time to be able to isolate the product before it is used or consumed? Actions when monitoring results exceed critical limits 230 Have planned corrections and corrective actions to be undertaken when critical limits are exceeded been specified in the HACCP plan? 231 Do such actions ensure that the cause of the non-conformity is identified, that the parameter(s) controlled by the CCP is/are brought back under control and that its reiteration is prevented (7.10.2)? 232 Have documented procedures for proper management of potentially unsafe products been established and maintained, to ensure that they are not released before they have been controlled (7.10.3)? 7.7 Update of specific information and preliminary documents for PRPs and for the HACCP plan Once the PRP(s) (7.5) and/or the HACCP plan (7.6) have been arranged, has the organisation updated, if necessary, the following information: 233 a) product characteristics (7.3.3)? 234 b) envisaged use (7.3.4)? 235 c) flow-charts ( )? 236 d) process stages ( )? 237 e) control measures ( )? 238 Where necessary, have the HACCP plan (7.6.1) and the procedures and instructions specifying the PRP(s) (7.2) been modified? 7.8 Audit Planning 239 Does audit planning define the scope, methods, frequencies and responsibilities for audit activities? Do audit activities confirm that: 240 a) the PRP(s) has/have been implemented (7.2)? 241 b) input information for hazard analysis (7.3) is continuously updated? 242 c) the operational PRP(s) (7.3) and the elements in the HACCP plan (7.6.1) are implemented and effective? 243 d) hazard levels fall within acceptable identified levels (7.4.2)? 244 e) all other procedures requested by the organisation are implemented and effective? 245 Are the results of such planning presented in a form suited to the operational method of the organisation? 246 Have the results of the audit been recorded and transmitted to the food safety team? 247 Do audit results allow the analysis of the results of audit activities (8.4.3)? 248 If system audit is based on tests of finished product samples, and where these test samples show nonconformity with the acceptable hazard level for food safety (7.4.2), are the involved product lots handled as potentially unsafe in accordance with point ? 7.9 Traceability system 250 Has the organisation established and applied a traceability system allowing the identification of product lots and their relation with lots of raw materials and process and shipment records? 251 Is the traceability system capable of identifying the incoming material from direct suppliers and the initial distribution path of the finished product? Form FORM-SYS03-FSMS-02_EN_ /7

8 252 Are traceability records retained for a defined period for system assessment to allow the management of potentially unsafe products and in case of product withdrawal? 253 Are records in accordance with legislative and regulatory requirements and with client requirements and could they revolve, for example, around the identification of the finished product lot? 7.10 Non-conformity Control Corrections 254 Does the organisation ensure that, when critical limits for the CCP(s) (7.6.5) are exceeded or a control loss of the operational PRP(s) occurs, the involved products are identified and controlled in relation to their use and release? Has a documented procedure being established and maintained, defining the: 255 a) identification and assessment of the involved finished products to determine proper handling (7.10.3)? 256 b) review of the corrections performed? 257 Are products manufactured under conditions in which critical limits have been exceeded managed as potentially unsafe products, in accordance with point ? 258 Have products manufactured under conditions to which the operational PRP(s) has/have not been conformed been assessed in relation to the non-conformity cause(s) and to the related consequences in terms of food safety and are they, where necessary, managed in accordance with point ? 259 Has such assessment been recorded? 260 Have all the correction been approved by the responsible person(s), and have they been recorded together with information about the nature of the non-conformities, to the relevant cause(s) and consequence(s), including the information required for the traceability of non-conform lots? Corrective Actions 261 Are the data deriving from the monitoring of operational PRPs and CCPs assessed by person(s) with sufficient knowledge (6.2) and authority (5.4) to activate corrective actions? 262 Are corrective actions activated when critical limits for the CCP(s) (7.6.5) are exceeded or a non-conformity with the operational PRP(s) occurs? 263 Has the organisation established and maintained documented procedure specifying the appropriate actions to identify and to eliminate the cause of the detected non-conformities, to prevent their occurrence and to bring the process or system back under control after the non-conformity has been discovered? Do such actions include: 264 a) non-conformity review (including client complaints)? 265 b) examination of the trends of monitoring results that can indicate a development towards control loss? 266 c) determination of non-conformity cause(s)? 267 d) assessment of the necessity to adopt actions to make sure that non-conformities does not repeat themselves? 268 e) identification and determination of the required actions? 269 f) recording of the results of the corrective actions undertaken? 270 g) review of the corrective actions undertaken to make sure that they are effective? 271 Are corrective actions recorded? Management of potentially unsafe products General Does the organisation manage nonconforming products through the implementation of action(s) preventing nonconforming products from entering the food supply chain, provided that it is not possible to ensure that: 272 a) the hazard(s) for food safety in question has/have been reduced to the defined acceptable levels? 273 b) the hazard(s) for food safety in question has/have been reduced to the identified acceptable levels (7.4.2) before entering the food supply chain? or 274 c) the product still falls within the acceptable defined levels for the hazard(s) for food safety in question in spite of the non-conformity? 275 Have all the lots that could have been affected by a non-conformity situation been monitored by the organisation until they have been assessed? 276 If products that are no more under the control of the organisation are subsequently recognised as unsafe, has the organisation informed the relevant involved parties and has it started the withdrawal (and recall) (7.10.4)? 277 Have the controls, the relevant responses and the authorisation to treat potentially unsafe products been documented? Assessment for release Is every product lot affected by non conformity released as safe only when one of the following conditions has been applied: 278 a) evidence other than the monitoring system proves that control measures have been effective? 279 b) evidence proves that the combined effect of control measures for that particular product is conforming to the expected performance (i.e. acceptable levels identified in accordance with point 7.4.2)? 280 c) the results of sampling, analysis and/or other assessment activities prove that the affected product lot is conforming to the identified acceptable levels for the hazard for food safety in question? Instructions for nonconforming products After the assessment, if the product lot is not acceptable for release, has it been managed according to one of the following activities: Form FORM-SYS03-FSMS-02_EN_ /8

9 281 a) reworking or further working inside or outside the organisation to ensure that the hazard for food safety is eliminated or reduced to acceptable levels? 282 b) destruction and/or disposal as waste? Withdrawals (and recalls) 283 In order to allow and to facilitate complete and prompt withdrawal of finished product lots that have been identified as unsafe: 284 a) has the High Management appointed the personnel having the authority to start a withdrawal and the personnel responsible for the execution of the withdrawal? and 285 b) has the organisation established and maintained a documented procedure for 286 1) the notification to the pertaining involved parties (for example, legislative and regulatory authorities, clients and/or consumers)? 287 2) the management of withdrawn products as well as of involved product lots still stored in its warehouses? and 288 3) the sequence of actions to be undertaken? 289 Have withdrawn products been put in a safe place, or have they been kept under monitoring up to their destruction, used for purposes differing from the originally envisaged ones, judged as safe for the same (or other) envisaged use, or reworked to ensure that they have become safe? 290 Have the cause, the extension and the result of a withdrawal been recorded and reported to the High Management as input information for the management review (5.8.2)? 291 Has the organisation verified and recorded the efficiency of the withdrawal program through the use of appropriate techniques (for example, simulated withdrawal or withdrawal practice)? 8 Validation, Verification and Improvement of the Food Safety Management System 8.1 General 292 Has the Food Safety Team planned and implemented the processes required to validate control measures and/or the combination of control measures to verify and to improve the FSMS? 8.2 Validation of the combinations of control measures Before implementing the combinations of control measures to be included in the operational PRP(s) and in the HACCP plan and after every change occurred (8.5.2) has the organisation validated that (3.15): 293 a) the selected control measures are capable of achieving the envisaged control of the hazard(s) for food safety for which they have been designed? 294 b) the control measures are effective and capable, in combination among them, to ensure control of the identified hazard(s) for food safety to obtain finished products meeting the defined acceptable levels? 295 If the result of validation shows that one or both the above elements cannot be confirmed, has the control measure and/or the combination of them been modified and re-assessed (7.4.4)? 296 Have the modification included changes to the control measures (i.e. process parameters, severity and/or their combination) and/or changes in raw materials, manufacturing technologies, finished product characteristics, distribution methods and/or expected use of the finished product? (optional) 8.3 Monitoring and Measurement Control 297 Has the organisation provided evidence that the methods and the specific monitoring and measurement equipment are suited to ensure the performance of the monitoring and measurement procedures? When it is necessary to ensure effective results, have the measurement methods and equipment used been: 298 a) calibrated or verified at specific intervals or before being used, in comparison with reference measurements referable to international or national standards? If such standard do not exist, have the bases used for calibration or verification been recorded? 299 b) adjusted or re-adjusted, when necessary? 300 c) identified to allow knowing their calibration status? 301 d) protected against calibrations that could invalidate the results of the measurements? 302 e) protected from damage and wear? 303 Have the records of the results of calibrations and verifications been retained? 304 Has the organisation assessed the validity of previous measurement results if it is found that the equipment or the process do not result to be conforming to the requirements? 305 If measurement equipment is not conforming, has the organisation adopted appropriate actions for the equipment and for all the involved products? 306 Have the records of these assessments and of the ensuing actions been retained? 307 If software is used to monitor and to measure specified requirements, has their suitability to meet the expected application been confirmed? 308 Did such suitability precede initial use of the software and, when necessary, has it been confirmed? 8.4 Audit of the Food Safety Management System Internal Audits Has the organisation performed, at planned intervals, internal audits to determine if the FSMS: 309 a) is conforming to what planned, to the FSMS requirements established by the organisation and to the requirements of the international standard? 310 b) is effectively implemented and updated? 311 Has an internal audit program been planned, taking into account the status and the importance of the processes and of the areas subject to audit, and also the update actions that are the result of previous audits (8.5.2 and 5.8.2)? Form FORM-SYS03-FSMS-02_EN_ /9

10 312 Have audit criteria, scopes, frequency and methods been defined? 313 Do auditor selection and audit performance ensure the objectivity and impartiality of the audit process? 314 Do auditors not perform audits about their own work? 315 Have the responsibilities and the requirements for audit planning and performance, and for result report and record retaining, been defined in a documented procedure? 316 Does the manager for the area subject to audit ensure that the actions required to eliminate any nonconformities found and their causes are adopted without undue delay? 317 Do subsequent actions envisage the verification of implemented actions and the report of the results of this verification? Assessment of single audit results 318 Has the food safety team systematically assessed the single results of planned audits (7.8)? 319 If audits do not prove the conformity to arranged requirements, does the organisation undertake actions with the aim of achieving the required conformity? Do such actions include, without being limited to them, the review of 320 a) existing procedures and communication channels (5.6 and 7.7)? 321 b) the findings of hazard analysis (7.4), the defined operational PRP(s) (7.5) and the HACCP plan (7.6.1)? 322 c) the PRP(s) (7.2)? 323 d) the efficiency of the management of human resources and training activities (6.2)? Analyses of the Results of Audit Activities 324 Has the food safety team analysed the results of audit activities, including the results of internal audits (8.4.1) and those of the external audits? Is the analysis performed with the aim of 325 a) confirming that the general performance of the system meet what planned and the requirements of the FSMS as planned by the organisation? 326 b) identifying the need to update or to improve the FSMS? 327 c) identifying the trends that indicate a greatest incidence of potentially unsafe products? 328 d) establishing information for the planning of the internal audit program regarding the status and the importance of the areas to be subject to audit? 329 e) providing evidence that all the corrections and corrective actions implemented are effective? 330 Have the results of the analysis and of the resulting activities been recorded and reported, through suitable procedures, to the High Management as input information for the management review (5.8.2)? 331 Have these been used as input information for the update of the FSMS (8.5.2)? (optional) 8.5 Improvement Continual Improvement 332 Does the High Management ensure that the organisation continuously improves FSMS effectiveness through use of communication (5.6), management review (5.8) internal audits (8.4.1), assessment of the single audit results (8.4.2), analysis of the results of audit activities (8.4.3), validation of the combinations of control measures (8.2), corrective actions (7.10.2) and FSMS update (8.5.2)? Update of the Food Safety Management System 333 Does the High Management ensure that the FSMS is continuously updated? 334 To achieve this, has the food safety team assessed the FSMS at planned intervals? 335 Has the group therefore considered and, when necessary, reviewed hazard analysis (7.4), the established operational PRP(s) (7.5) and the HACCP plan (7.6.1)? Are assessment and update activities based on: 336 a) input information deriving from the both internal and external communication, as indicated under point 5.6? 337 b) input information deriving from other information concerning the suitableness, appropriateness and efficiency of the FSMS? 338 c) output information deriving from the analysis of the results of audit activities (8.4.3)? 339 d) output information deriving from the management review (5.8.3)? 340 Have system update activities been reported, through suitable procedures, as input information for the management review (5.8.2)? Annexes: Nr.... sheets for Audit Observation Recording Auditor Signature: Form FORM-SYS03-FSMS-02_EN_ /10