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GMP International Good Manufacturing Practice …

1 2 5 4 3 1 CONTENTS Introduction 3 Scope of the standard 4 Food safety and the production of board 4 Process description 5 Process fl ow 7 QUALITY MANAGEMENT




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GMPInternational Good Manufacturing Practice StandardFor Corrugated & Solid Board125431CONTENTS Introduction 3 Scope of the standard 4 Food safety and the production of board 4 Process description 5 Process fl ow 7 QUALITY Hazard inventory Management responsibility Quality manual (links to ISO 9000) Document control Complaint handling Specifi cation Product recall Traceability Supplier monitoring Internal audits 16 FACTORY Site and premises Floors, walls, doors, windows and ceilings Glass and lighting Equipment and material 20 CONTAMINATION Tidying and cleaning Pest control Waste control Transport, storage and distribution 24 PERSONAL Staff premises/toilet facilities Personnel and visitors Food and drinks Jewellery Smoking Clothing Education and training 30 APPENDIX Audit protocol 33 Glossary of terms used 413INTRODUCTIONCorrugated and Solid Board are used for the packaging of a variety of goods. Both offer unique properties making them ideal for, but not limited to, transit packaging. Corrugated and Solid Board are widely used in food packaging. Corrugated Board is not mainly used for food contact. However, Solid Board is widely used for direct food the requirements for safe foodstuffs have gradually grown more precise, and although specifi c regulations are yet to be fi nalised, FEFCO & ESBO, as the representatives of the European Corrugated & Solid Board industries, realised that it was necessary to take action to anticipate their customers members of FEFCO have representatives in four major working groups that created four different hygiene standards in the period 1997 to 2001 as follows:1. Guide for good manufacturing practice of paper and board articles intended for food contact use published by the Club MCAS (France)2. Hygiene Code for Dutch Corrugated Board Industry published by Vereniging Golfkarton (Netherlands)3. Technical Standard and Protocol for Companies Manufacturing and Supplying Food Packaging Materials for Retailer Branded Products:published by BRC/IOP (UK)4. French professional code of hygiene and cleanliness for the manufacture of corrugated board packaging published by ONDEF (France).To arrive at a uniform approach FEFCO & ESBO decided to form a working group that would use the best of the existing standards, and taking into consideration other standards such as American Institute of Bakery (AIB) to produce an International GMP standard for Corrugated & Solid Board. Corrugated and solid board are referred to as Board in the rest of this working group decided that the standard has to give certifi cation bodies the possibility to audit against the standard with a pre-defi ned audit format so uniformity and transparency could be guaranteed to the users of : In the technical standard, 5 criteria are identifi ed as critical . Refer to the protocol (section 6) for the explanation of this OF THE STANDARD To cover the manufacturing of packaging made of corrugated and solid board so as to satisfy market demands for hygienic requirements such as exist in the food industry FOOD SAFETY AND THE PRODUCTION OF BOARDWhen customers began to ask whether producers of Board had carried out HACCP studies, several producers did carry out these evaluations showed that there were some potential microbiological, chemical and physical hazards but that the production of Board is completely different from the production of food. Critical Control points as found in the Food Industry were not found in the Board Industry. Because all potential Hazards can be controlled by Good Manufacturing Practices, the Board industry uses the terminology point of attention to defi ne these process of the production of board is in principle the same in all plants, and a description of the process is part of this standard. The plants however may differ in age and layout and therefore an inventory of the hazards is made on an individual GMP standard for Board does not purport to address the compulsory conformance of fi breboard articles to food contact regulations. All manufactured materials and articles intended for food contact, placed on the market is required to comply with the principles of the EU Regulation 1935/2004, and the provisions of all transposed national legislation. In the absence of harmonisation, materials and articles are required to comply with national regulations of the member state on whose territory the products are marketed, supplemented when necessary, by the appropriate provisions of other member states regulations under the principle of mutual recognition, or by other internationally recognised regulations or agreements in DESCRIPTIONManufacturing of Corrugated BoardCorrugated Board is manufactured from a number of specially conditioned layers of recycled and/or virgin papers, called Fluting Medium and Linerboard. Reels of Fluting Medium and Linerboard are fed into a machine called a Corrugator. The Fluting Medium Paper is conditioned with heat and steam and fed between large corrugating rolls that give the paper its fl uted shape in the Single Facer. Starch is applied to the tips of the fl utes on one side and the inner liner is glued to the fl uting. The corrugated fl uting medium with one liner attached to it is called single face web and travels along the machine towards the Double Backer where the single face web meets the outer liner and forms corrugated board. A number of layers of single faced web may be built up to produce double and triple wall corrugated board. The corrugated board is slit into the required widths and cut into sheets where it is then stacked or of Solid BoardSolid Board is manufactured from recycled cellulose fi bres taken from waste paper and board. The waste paper and board is mixed with water and broken down in large tanks called Pulpers. The individual cellulose fi bres are separated and cleaned by the combined action of water, chemicals, heat and mechanical energy. The resulting mixture is called pulp or stock. Contaminants such as plastic, metal, glass, polystyrene, etc. are removed from the mixture using screens and mechanical cleaners. When the stock arrives at the board machine, its water content exceeds 97%. The mixture is sprayed or layered on to a moving screen called a wire. The fi ltering action of this wire, combined with vacuum, extracts a signifi cant proportion of the water from the stock and forms a continuous sheet of board. The board is pressed between rolls to remove more water and then through a dryer where it comes into contact with large heated drums where much of the remaining water evaporates. State-of-the-art technologies such as infrared, air-knife and microwave drying are also used to ensure that the moisture content of the board is uniform. In-process checks are made on many of the important variables such as moisture content, smoothness, density and strength. The results are fed back to the control panel via computer where automatic adjustments are made. The board is slit into the required widths; it can be rewound onto reels or cut onto sheets and then (Solid Board)Whilst the thickness of the Base Board may be adjusted on the board machine, it may also be built up by laminating several layers of Base Board together. To further enhance the properties of the Board such as strength, printability, aesthetics and water resistance, a variety of Papers or Liners are glued (laminated) on to the surface of the Base Board. Laminating may be done in-line on the board machine prior to slitting, or fi nished on a separate laminating machine by the converting Corrugated and Solid Board into PackagingBoard sheets where required may be printed to a Customer s design. The most common printing process is Flexographic. The sheets are then passed through a diecutting or a fl exo folder gluer machine, where they are cut and creased to the required blank shape needed for folding into the fi nal product. The equipment for printing and die cutting varies from individual manually operated machines to fully automatic in-line cut blanks may be supplied direct to customers, or passed through a Folder Gluer for converting into a variety of Box/Packaging types. After folder gluing the product is collated, bundled and strapped prior to palletisation and wrapping where it is ready for Corrugated Board and Solid Board may be supplied to the customer at any stage of the process; as corrugated sheet, base board or laminated sheet; die cut blank; pre-converted packaging or fi nished FLOWMILLPRODUCEDSOLID BOARDPAPERREELSTORAGELAMINATORCORRUGATOR BALINGOF BOARDCUTTINGBOARD SHEETSTREATMENTOF WASTEWATERSLITTERSCORERFLATBEDDIECUTROTA RYDIECUTFOLDERGLUERBUNDLINGOFPLANO FOLDEDBOXESPALLETISATIONANDWRAPPINGOF FINISHEDGOODSSHIPMENTORSHORTTERMSTORAGEF low Chart of a Typical Corrugated or Solid Board Converting PlantPRINTERPRINTERPRINTERPRINTER OPTIONAL PROCESS8Single facer N 1Single facer N 1Single facer N 2LinerLinerStarchFlutingLinerStarchFluti ngSingle facer N 2Double backerHeating platesSlitter-scorerRotary knife9International GMP Standard101QUALITY HAZARD The Company shall make an inventory of the hazards relevant to this Standard in its plant that can affect consumer safety and product The hazard inventory shall be based on the range and the intended use of products that are The Company shall be able to demonstrate that appropriate controls and preventive measures for the identifi ed hazards, as described in this Standard, are established. Important preventive measures shall be indicated as points of attention . A review of the hazard inventory should be carried out at least once per year or when any process MANAGEMENT Senior management shall defi ne the Company s Quality and Hygiene policy ensuring that the company meets its obligation to manufacture safe product in accordance with the relevant legislation. This policy shall be documented, implemented, maintained and communicated to all The controls and procedures, resulting from the hazard inventory, shall have Senior Management commitment, and shall be implemented through the Company s documented management The company shall have a person who is responsible for maintaining the hygiene and quality The company shall periodically review customer complaints, claims, audit results and corrective The company should implement a system for continuous improvement. The policy shall be regularly The company shall include duties related to this standard in the job descriptions of the COMMENTS + HAZARD MANAGEMENT QUALITY The Company shall have a Manual that states the Company s commitment to Good Manufacturing Practice and has a scope that covers the requirements of this A Manual shall be maintained as an essential element of emonstrating compliance with this Documents shall be clearly legible, unambiguous and suffi ciently detailed to enable their correct application by appropriate personnel and shall be readily accessible at all DOCUMENT The company shall establish and maintain documented procedures to control all documents and data that relate to the requirements of this Records shall be maintained in order to prove that technical and hygiene procedures have been followed. Records shall be kept for an appropriate All documents in use shall be properly authorised and be the current All changes and amendments to documents critical to product safety or quality system procedures and covered by the Standard s requirements shall be COMPLAINT The Company shall have a system for the management of Actions appropriate to the seriousness and frequency of the problems identifi ed shall be carried out promptly and Complaint data shall, where appropriate, be used to implement ongoing improvements to safety and quality and action taken to seek actively to avoid COMMENTS + QUALITY DOCUMENT COMPLAINT The Company shall ensure that appropriate specifi cations exist for incoming materials and fi nished goods and that these specifi cations are adequate and Specifi cations shall, where appropriate, be formally agreed with relevant The Company shall operate a specifi cation review PRODUCT The company shall have an effective product recall procedure for all The Company shall provide written guidance to relevant staff regarding the type of event that would constitute an incident and a documented incident reporting procedure shall be in Procedures shall exist to ensure that customers are notifi ed should an incident take place which has potentially contaminated the product that has been delivered to the All non-conforming products shall be handled or disposed of according to the nature of the problem and/or specifi c requirements of the There shall be a person responsible for ensuring that corrective action including the review of all records of incidents are taken together with preventative The company shall adequately identify all incoming materials and be able to trace work in progress and fi nished product at all stages during manufacture, storage, despatch and, where appropriate, distribution to the The storage times for the various production records shall be appropriate to the traceability requirements and the life time of the COMMENTS + PRODUCT SUPPLIER MONITORING (INCLUDING OUTSOURCING) The Company shall operate procedures for the approval and monitoring of its suppliers. This shall include suppliers of materials, transport, warehousing and services to the Company, where appropriate, to the requirements of this Where appropriate, suppliers of materials shall comply with a Standard that meets the same objectives as this INTERNAL The Company shall have an internal audit schedule and its scope and frequency shall be established in relation to the hazard A record of all programmed internal audits and associated corrective actions shall be maintained. Corrective action shall be verifi ed to ensure satisfactory Internal audits shall be carried out by competent auditors, who should be independent of the area of operation being Results of the internal audits shall be monitored by senior management to see if the goals are COMMENTS + SUPPLIER MONITORING (INCLUDING OUTSOURCING) INTERNAL 172FACTORY SITE AND The site boundaries shall be clearly defi Measures necessary to protect the site from any potential contaminants should be in place and periodically reviewed to ensure they continue to be Both inside and outside the premises, suffi cient space shall be left between walls, furniture, equipment and products to enable effi cient FLOORS, WALLS, DOORS, WINDOWS AND The doors, walls and ceilings should prevent entry of Walls, fl oors, ceilings and pipes shall be maintained in good condition and shall be capable of being kept Where windows are designed to be opened for ventilation purposes, they shall be adequately screened to prevent the access of During maintenance activities, those carrying them out shall take into consideration that dust, metal particles or other contaminating elements may be Flaking or damaged spots shall be repainted or Doors providing access to production areas shall be kept shut when not in GLASS AND (critical) The company shall have in place a procedure for glass and hard clear plastic breakage. The procedure shall establish clear responsibilities and shall describe what actions shall be taken with the contaminated !PARA. COMMENTS + SITE AND FLOORS, WALLS, DOORS, WINDOWS AND GLASS AND Where applicable, adequate shatterproof lighting shall be The company shall remove all unnecessary glass and hard plastics from production EQUIPMENT AND Maintenance equipment shall be cleared away after use and stored in designated areas or lockers. A planned preventive maintenance programme for plant and machinery shall be in place and shall address the risks from contamination. Compressed air that comes into contact with the product should be fi ltered to prevent any Production tools used shall be clean and shall be stored in a designated Maintenance work shall be followed by a documented hygiene clearance procedure which demonstrates that contamination hazards have been removed from machinery and equipment where there is a risk of contamination to the Where appropriate, food grade lubricants shall be Hygiene and cleanliness should be taken into account when planning new equipment. Where appropriate, equipment shall be available for the effective ventilation of odours, smoke and vapour. Materials handling equipment that comes into direct contact with the product shall be kept in good Cutters with snap-off blades shall be Temporary engineering and modifi cations using adhesive tape, cardboard or similar materials shall not be permitted, except in COMMENTS + EQUIPMENT AND 21223CONTAMINATION TIDYING AND (critical) The company shall have an effective cleaning procedure and schedules in place for all equipment, production and storage Accumulated dust shall be removed on a regular basis (including corners and behind pallets and reels). A high standard of cleanliness should be maintained at all stages of storage, processing and distribution. A clean as you go policy should be in Cleaning equipment and materials should be stored and maintained in a manner to prevent product Production and other relevant staff shall be trained in Outside contractors shall be aware of and adhere to the Company hygiene All cleaning agents and disinfectants used shall be suitable for their intended purpose and used in accordance with the operating All glue, ink drainage and waste disposal devices shall be kept PEST (critical) Pest control procedures shall be documented and preferably be carried out by a competent company. Control records shall be Documentation shall detail the safe use and application of Pest control shall be in place in all areas of the premises. The control shall include Incoming materials, ancillary materials and fi nished products shall be stored so as to minimise the risk of Baits, traps and electric fl y killer units shall preferably be monitored at a minimum of four times a year. Records of checks shall also identify any actions taken.!!PARA. COMMENTS + TIDYING AND PEST The location of all pest control measures shall be identifi ed on a plan/diagram of the site. They shall not endanger the product by chemicals or dead For an effective operation, electric fl y killer units shall be regularly maintained and cleaned. The tubes shall be replaced on failure and at least once a Incoming materials that have a high risk of contamination by pests shall be examined to ensure that no pests are WASTE Systems shall be in place to minimise the accumulation of waste in production A system for structural cleaning, emptying bins and waste collection shall be in TRANSPORT, STORAGE AND All transport shall be suitable for the purpose, well maintained and in a state of good Ongoing contractual arrangements with transport companies shall include requirements for hygiene and When the material transported is susceptible to weather damage, arrangements shall be made to protect the The Company shall have a procedure for checking vehicles transporting fi nished products for cleanliness and water Incoming and outgoing vehicles shall be registered and non-conformities Contracted transport, storage and distribution shall be undertaken in such a way as to prevent raw materials or product being exposed to the risk of contamination, including taint or All pallets shall be sound, dry, clean and free from damage, visible infestation, taint and Storage including off site storage shall be controlled to ensure no cross contamination from any other material can No manufactured products shall come in direct contact with the fl COMMENTS + WASTE TRANSPORT, STORAGE AND 254PERSONAL STAFF PREMISES/TOILET All personnel and contractors likely to enter production areas shall wash their hands after using the toilet and Adequate toilet areas shall be provided and kept clean on a regular basis. Hand washing facilities shall be easily accessible and close to the production Wash basins should preferably be provided with non-scented liquid soap in dispensers. Dispensed disposable paper towels, with purpose made waste bins, provide the most hygienic way of drying hands. All towel bins shall be, lined and should be emptied regularly in accordance with a schedule. Towels bins with lids should be foot The company shall have signs at all relevant entry points with an overview of the company rules with regard to The company shall provide adequate PERSONNEL AND Staff shall have a copy of the rules on personal When visiting the company, every visitor is bound by the applicable hygiene regulations and the need for observing them. This also applies to external fi tters or Personal belongings shall not be taken into the production The company shall have a code of conduct for third parties (such as temporary employees, subcontractors, drivers). Personnel shall report if they are suffering from, or have been in contact with, any disease likely to be transmitted through food, or from infected wounds, skin complaints or diarrhoea. All personnel suffering from any of the above shall be excluded from situations involving contact with food packaging for as long as the symptoms COMMENTS + STAFF PREMISES/TOILET PERSONNEL AND Minor injuries such as cuts shall be covered with dressings that are easily visible and capable of detection in food processing FOOD AND (critical) Eating (including the eating of confectionery and chewing of gum) and drinking, shall only be allowed in designated areas that are indicated by signs in the production The company shall provide facilities for adequate storage of food and drink, including that brought from home. Drinking of water from purposemade dispensers and/or by using only disposable cups may be allowed provided it is confi ned to a designated area away from Jewellery shall not be worn, with the exception of one plain band fi nger ring and sleeper earrings. Wristwatches are allowed. Rings and studs in other exposed parts of the body such as noses and eyebrows shall not be worn, or covered with dressings which are easily visible and capable of detection in food processing (critical) Smoking shall not be allowed in the production areas. If it is impractical for personnel to leave their work area, local controlled facilities shall be provided. * Designated, enclosed and controlled smoking areas shall be isolated from production areas to an extent that ensures smoke cannot reach the product. Suffi cient extraction to the exterior of the building shall be ensured. Adequate arrangements for dealing with smokers waste shall also be provided at smoking facilities, both inside buildings and at exterior locations. Facilities shall be available, with adequate reminders, for hand washing after smoking.* Remark: A National legislation on smoking may overrule this critirium of the GMP standard and becomes in such case !!PARA. COMMENTS + FOOD AND CLOTHING (INCLUDING SUBCONTRACTORS AND TEMPORARY EMPLOYEES) Working clothes, as defi ned in the Company s procedures, shall be worn at all times in the production areas and shall not be worn outside the perimeter of the The company shall have arrangements for working clothes including laundering, for all production personnel as well as for cleanliness and proper use. Self-care shall be permitted provided adequate controls and appropriate guidelines are in Visitors and non-production staff shall wear adequate protective clothing when entering production If necessary and where appropriate hair covering shall be worn for operators who come in direct contact with the EDUCATION AND All new personnel shall receive induction training covering the company hygiene rules before starting A programme of refresher hygiene training shall be in place and records shall be maintained for all staff that have been COMMENTS + CLOTHING (INCLUDING SUBCONTRACTORS AND TEMPORARY EMPLOYEES) EDUCATION AND 31325APPENDIXAUDIT PROTOCOLFor auditing against theInternational Good Manufacturing Practice Standardfor Corrugated & Solid BoardAUDIT PROTOCOLCONTENTS1. Introduction2. Contractual arrangements and selection of the audit body3. Audit notifi cation4. Scope of the audit5. Audit fl ow6. Level determination7. Implications of results on issuing the audit report and certifi cate8. Audit frequency9. The audit report10. Distribution of the audit report11. Appeal procedure12. Complaints13. Copyright331. INTRODUCTIONThis audit protocol provides the specifi c requirements for those organisations involved with evaluations to the International Good Manufacturing Practice Standard for Corrugated & Solid protocol will: Reinforce the standards required for those organisations carrying out audits;specifi cally through accreditation against EN 45011,and Clarify for those organisations being audited, procedures to follow, ensuringcontractual agreements are those audit bodies that have accreditation to EN 45011 shall carry out audits against the International Good Manufacturing Practice Standard for Corrugated & Solid Board and issue reports and certifi cates. Organisations shall comply with the requirements of the accreditation standard, which are provided by a recognised Accreditation CONTRACTUAL ARRANGEMENTS AND SELECTION OF THE AUDIT BODYThe auditee shall appoint an appropriate body to perform the audit against the International Good Manufacturing Practice Standard for Corrugated & Solid Board preferably working with auditors who speak the native language of the audit body shall demonstrate its competence by gaining accreditation to EN 45011 and the specifi c requirements that the Accreditation Body demands for auditing against the International Good Manufacturing Practice Standard for Corrugated & Solid bodies that are in the process of becoming accredited are allowed to carry out audits prior to achieving accreditation status, where they can demonstrate all of the following: An active application for EN 45011 accreditation Accreditation status to be achieved within 12 months of the date ofapplication Individual auditor experience and qualifi cation to be in line with the demands of the International Good Manufacturing Practice Standard for Corrugated & Solid Board34It is the responsibility of the auditee to verify that these requirements are met, by either requesting a copy of the accreditation certifi cate (or acknowledgement of application) and scope, or contacting the Accreditation Body that is responsible for the accreditation process of the audit contract shall exist between the auditee and the audit body, detailing the scope of the auditee shall be in possession of an original copy of the latest version of the International Good Manufacturing Practice Standard for Corrugated & Solid Board in its full integrity, this shall be checked by the auditing body during the audit AUDIT NOTIFICATIONPreparation for the auditBefore the documentation audit the auditee is required to review the International Good Manufacturing Practice Standard for Corrugated & Solid Board. It is the responsibility of the auditee to have the latest version of the standardDocumentation auditBefore the initial visit on site, the audit body shall carry out an audit on the quality management documents, including the hazard inventory. The resulting report from this audit is for the internal use of the auditee. The audit body shall check the corrective actions that are identifi ed by the auditee, when nonconformities are found during the initial audit. A documentation audit is only required before the initial auditThe fi rst audit by the audit body will take place on a mutually convenient date. The result of the audit will have an effect on the frequency of the auditsFollow-up audits shall be carried out when the auditee did not comply with the demands of the standard during the initial audit. At the follow-up audit, the udit body shall focus on the nonconformities only. If the auditee shows that all the nonconformities have been dealt with, the audit body may issue the certifi auditsThe frequency of the repeat audit is determined by the result that was achieved at the last audit. The due date for the repeat audit will be detailed in the audit report and on the certifi is the responsibility of the auditee to contact the auditing body to ensure that a mutually convenient date for the repeat audit is arranged before the due date of that SCOPE OF THE AUDITThe scope of the audit shall be defi ned between the auditee and the audit body. The scope shall be stated in the audit report and on the certifi cate. All relevant product groups that are produced at a selected location should be audited against the standard. The audit is specifi c to the location where the audit has taken place. This shall be clearly defi ned in the AUDIT FLOWTo defi ne the time that is necessary for the audit, the audit body shall use a system that ensures suffi cient time is planned for the audit. The physical size of the site, the type of manufacturing process and the scope will determine the time required to carry out a full audit on site shall consist of four elements: Opening meeting Documentation check on site Site assessment Closing meetingDuring the audit interviews shall be carried out at both management level and operator auditor shall audit the operation using the specifi c criteria on all the subjects in the International Good Manufacturing Practice Standard for Corrugated & Solid accordance with EN 45011, the auditor can only give a preliminary judgement on the status of the company. After the receipt of the corrective action plan from the auditee, a fi nal judgement can be made, a formal audit report issued and when appropriate a certifi cate awarded. (See also Section 6 for an explanation of the level determination).366. LEVEL DETERMINATIONIn order to determine whether the requirements of a clause in the International Good Manufacturing Practice Standard for Corrugated & Solid Board has been met, the auditor shall check every item in the standard. The auditor shall rank his fi ndings as follows:A: In full compliance with the criterion in the standardB: Only partly in compliance with the criterion in the standardC: Not in compliance with the criterion in the auditor shall provide reasons for raising all B and C nonconformities in the audit to interpret minor s and ranking the audit fi ndings with an A, B or C, the auditor has to determine whether the B or C ranking is a critical, a major or stays a minor (B or C). MINOR NONCONFORMITYEvery failure to meet a requirement in the Standard that is awarded a B or C ranking is seen as a minor non-conformity if:1. The auditor does not classify it as: a substantial failure to meet all full clauses of the standard and/or a failure that can lead directly to contamination of the product (if the auditor does not classify it as a major non-conformity);2. The number of non-conformities per chapter classifi ed as a C does not exceed the limit that is prescribed (see major non-conformity).MAJOR NONCONFORMITYA substantial failure to meet all full clauses of the Standard and/or a failure that can lead directly to contamination of the product. 1. A full clause of the standard means the whole paragraph, for example clause Quality Manual. In case all the sub clauses of this clause (so sub clause to ) are classifi ed as C minors, the full clause will receive a major;2. It is the role of the auditor to judge if a situation in the operation being audited, can directly lead to contamination of the There is also a limit on the number of non-conformities classifi ed as C per chapter. If the number of C s exceeds the limit which is given in the table, the total per chapter will turn into a major non-conformity:Chapter 1 more than 15 C sChapter 2 more than 10 C sChapter 3 more than 11 C sChapter 4 more than 10 C sCRITICAL CRITERIAThe 5 critical criteria have to be in full compliance (judged as A) or in part compliance (judged as B). When an auditor fi nds a critical criterion which is not in compliance (judged as C), the audit is terminated, the auditee has to take effective corrective actions and a new audit has to be performed. Note: Critical criteria are sometimes named KNOCKOUT or KO AUDIT RESULTS AND ISSUING THE AUDIT REPORT AND CERTIFICATELevel of foundnon-conformityStatus closing meetingCorrective actionsReportCertifi cateC-ranking on a CriticalUnable to recommend certifi cationAuditee has to take corrective actions and a new audit is required to verify complianceReport confi rms statusCannot be issuedB-ranking on a Critical Recommended to certifi cation provided an acceptable corrective action plan & evidence is received Send in corrective action plan and objective evidence within 4 weeks of receiving preliminary report: major NC s shall be addressed in itThe report including a corrective action plan confi rms the only be issued in case the corrective action plan and objective evidence show solving of NC. In case corrective action plan and evidence are not adequate, certifi cate is not issued38Level of foundnon-conformityStatus closing meetingCorrective actionsReportCertifi cateMajor non-conformity at initial auditUnable to recommend certifi cationSend in action plan within 4 weeks of receiving preliminarily report: major NC s shall be addressed in it. A follow-up will take place within 6 monthsReport including corrective action plan confi rms status Cannot be issued. Certifi cate of approval can only be awarded after satisfactory evidence during a follow-up audit that NC has been eliminated. Major non-conformity at repeat audit Recommended to certifi cation provided an acceptable corrective action plan & evidence is received Send in corrective action plan and objective evidence within 4 weeks of receiving preliminary report: major NC s shall be addressed in itReport including corrective action plan confi rms status Can only be issued in case the corrective action plan and objective evidence show solving of NC. If case action plan and evidence are not adequate, certifi cate is not issuedMinor non-conformityRecommended to certifi cation provided an acceptable corrective action plan & evidence is receivedSend in corrective action plan and objective evidence within 4 weeks of receiving preliminary report: minor NC s shall be addressed in itReport including corrective action plan confi rms statusCan only be issued in case the corrective action plan and objective evidence show solving of NC. If case corrective action plan and evidence are not adequate, certifi cate is not issuedThe audit body shall send the auditee a preliminary report so that the auditee has suffi cient time to write a corrective action auditee shall always write a corrective action plan before a fi nal report is issued. This corrective action plan is incorporated into the fi nal report so that a reader of the report can see the actions that the auditee is going to take on the nonconformities AUDIT FREQUENCYThe audit frequency depends on the result of the on critical (KO) A complete new audit has to be performed. Term in which this new audit is scheduled, depends on the time the auditee needs to take effective corrective action for solving C-rankingB-ranking on critical (KO) Follow-up audit within 6 months; after that 12 months Major NC during initial audit Follow-up audit within 6 months; after that 12 monthsMajor NC during repeat audit 12 monthsMinor NC during initial 12 monthsor repeat auditThe repeat audit date shall be calculated from the date of the previous audit and not the date of certifi cate THE AUDIT REPORTFollowing each audit a full written report shall be prepared in an agreed format. The audit body is required to provide reasons for raising all critical, major and minor nonconformities. It is appreciated that sections of the report may be shortened or lengthened to meet specifi c reporting needs, but the overall format of the report shall remain unchanged and comply with specifi c audit report should provide transparency and trust for the reader. The auditee shall write a corrective action plan that is incorporated into the fi nal report. In this way the reader of a report can see the nonconformities raised but also the corrective actions that the auditee is report shall contain the following sections: Audit summary with detailed description of the scope Summary and overview of nonconformities per chapter. Corrective action plan from the auditee with the actions on all nonconformities. Detailed listing of fi ndings with reasons for critical, major and minor shall be prepared and despatched to the auditee within an agreed report format of FEFCO / ESBOFEFCO / ESBO have developed a format for writing the audit report. It s obliged to use this DISTRIBUTION OF THE AUDIT REPORTAudit reports shall remain the property of the auditee and shall not be released, in whole or part, to a third party unless the auditee has given prior consent (unless otherwise required by law)This consent for distribution can only be in written form and can exist between the auditee and the audit body and between the auditee and a customer. The audit body shall retain a copy of the audit report. The audit report shall be stored safely and securely for a period of fi ve APPEAL PROCEDUREThe audit body shall have documented procedures for the consideration and resolution of appeals against the results of audits. Procedures shall be independent of the individual auditor and shall be considered by the top management of the audit body. Appeals shall be fi nalised within 4 weeks of receiving information from the COMPLAINTSThe audit body shall have a documented procedure for dealing with complaints received from the auditee and other relevant parties. An initial response will be given within 2 weeks of receipt of the complaint. A full written response will be given after the completion of thorough investigation into a CERTIFICATEFEFCO will issue a unique number for each certifi cate. This number can be used to trace the information of the auditee on the FEFCO website If the certifi cation body has issued a certifi cate to a certifi ed fi rm, they are required to inform FEFCO. This will be done by sending or faxing the issued certifi cate to FEFCO. 14. COPYRIGHTThe copyright of the International Good Manufacturing Practice Standard for Corrugated & Solid Board is under full ownership of FEFCO. If unauthorised use of the standard and its protocol should occur, FEFCO will take the appropriate OF TERMSAudit A systematic examination to substantiate whether activities and related results comply with planned arrangements and whether these arrangements are implemented effectively and are suitable to achieve The end user of an item, commodity or / Supplier A person or organisation providing services or a) To manage the conditions of an operation to maintain compliance with established criteria, and/or,b) The state wherein correct procedures are being followed and criteria are being action Procedure to be followed when a system requirement is not A person or organisation that acquires, or is intended to acquire, ownership of the product and/or Manufacturing The combination of manufacturing and quality control Practice procedures aimed at ensuring that products are consistently manufactured to their specifi The potential to cause harm; can be a biological, chemical or physical inventory An inventory of all relevant All measures necessary to ensure the wholesomeness, quality and safety of an entity that might otherwise be An incident is any event that may potentially compromise the hygiene standard of the materials / Any base material or semi-fi nished material used by the raw materials organisation for manufacture of a The non-fulfi lment of a specifi ed product safety, legal or quality requirement or of a specifi ed system measure Any factor or activity that can be used to prevent an identifi ed Description of a particular course of recall Procedure to ensure the immediate return from the entire supply chain, including the consumer, of all products identifi ed as potentially having a non-conformity, which could present a manual Document specifying the quality management system of an system A management system to direct and control an organization with regard to Written or otherwise permanently recorded account of a fact or cation An explicit or detailed description of a material, product or Ability to trace the history, application or location of that which is under cation Confi rmation, through the provision of objective evidence, that specifi ed requirements have been fulfi Any living organism (excluding human beings) with the potential to cause physical or biological contamination within a manufacturing operation. Note: the organisms specifi cally requiring attention in board manufacturing and converting operations are rodents, birds and fl ying and crawling insects including those with the potential to cause infestations such as manufacturing Practice Corrugated &Solid BoardGMP Certifi cation StampISBN 90-77-505-06-7Published by: FEFCO (European Federation of Corrugated board manufacturers)In cooperation with ESBO and ISA250, avenue Louise - B-1050 BrusselsTelephone: + 32 2 646 40 70 - Fax: + 32 2 646 64 60e-mail: - Web site: FEFCOJanuary 2006 Second Editionstudiogoffi

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