1 Appendix A manual Example of a food company quality Contents Date: 13/03/95 RME-QLMN-OO Page 1 of 3 Section Title ISO 9001 reference 01 In trod uction 02 Purpose 03 Scope 04 Definitions 05 Management responsibility Quality policy 5.2 Organisation 5.3 Resources 5.4 Management representative 5.5 Management review 06 Quality Management System Document and data control General 7.2 Issue and withdrawal of controlled core documents 7.3 Change or modification of controlled core documents 7.4 Reference documents 08 Quality record control Internal quality audit Training Contract review and customer service 4.3, Contract review 11.2 Customer service 12 Product and process development Planning
2 APPENDIX A 245 Contents Date: 13/03/95 RME-QLMN-OO Page 2 of 3 Section Title ISO 9001 reference 12.2 Organisational and technical interfaces 12.3 Design input 12.4 Design review 12.5 Design output 12.6 Design verification 12.7 Design validation 12.8 Design changes 13 Purchasing General 13.2 Evaluation of suppliers 13.3 Supplier verification 14 Customer supplied product Product identification and traceability Process control Production documentation 16.2 Process control 16.3 Food safety and hygiene management 16.4 Process change 16.5 Engineering services 17 Inspection and testing General 17.2 Receiving, inspection and testing 17.3 In-process inspection and testing 17.4 Final inspection and testing 17.5 Inspection and test records 17.6 Customer complaints 18 Inspection and test status Product preservation and control Handling 19.2 Storage 19.3 Packing 19.4 Preservation 19.5 Despatch 20 Calibration Control of nonconforming product 4.13
3 246 QUALITY MANAGEMENT SYSTEMS FOR THE FOOD INDUSTRY Contents Date: 13/03/95 RME-QLMN-OO Page 3 of 3 22 Corrective and preventive action General 22.2 Corrective action 22.3 Preventive action 23 Control of statistical techniques 4.20 Description of changes: Authorised by: Date:
4 APPENDIX A 247 In trod uction Date: 13/03/95 RME-QLMN-01 Page 1 of RME Foods Ltd began operations in 1982, employing six people and manufacturing frozen pizzas for catering outlets, principally public houses and clubs throughout the West Midlands. Since then the company's product range has expanded to include chilled pizzas, chilled and frozen French bread pizzas, and a variety of pasta dishes. The company employs some 125 people in manufacturing and distribution, supplying branded and own-label products to retail multiples and catering outlets throughout the United Kingdom, as well as having a thriving export trade to Italy. Description of changes: Authorised by: Date:
5 248 QUALITY MANAGEMENT SYSTEMS FOR THE FOOD INDUSTRY Purpose Date: 13/03/95 RME-QLMN-02 Page 1 of This manual defines requirements for the operation and maintenance of RME Foods Ltd's Quality Management System, which exists to ensure: (a) achievement of the company's quality policy (b) compliance with food safety legislation. 2.2 This is the primary document of the Quality Management System. The requirements stated here are mandatory and shall be adhered to by all personnel. Description of changes: Authorised by: Date:
6 APPENDIX A 249 Scope Date: 13/03/95 RME-QLMN-03 Page 1 of The scope of RME Food's Quality Management System and the scope for registration to ISO 9001:1994 is: The development, manufacture, storage and despatch of chilled and frozen convenience foods and ready meals. 3.2 Although the company distributes its products, the distribution operation shall not be covered by the scope of the Quality Management System at the present time. The company's distribution operation shall, in effect, be classed as a subcontracted service. 3.3 The Quality Management System shall conform to the requirements of ISO 9001:1994 (BS EN ISO 9001:1994)(EN ISO 9001:1994) and shall routinely be audited by a NACCB accredited quality assurance certification body. Description of changes: Authorised by: Date:
7 250 QUALITY MANAGEMENT SYSTEMS FOR THE FOOD INDUSTRY Definitions Date: 13/03/95 RME-QLMN-04 Page 1 of Analytical method A document describing the requirements and method for carrying out the analysis of food products and materials associated with the manufacture of food products. Analysis may concern physical, chemical and microbiological characteristics, as well as aspects such as shelf-life. 4.2 Certificate of analysis A certificate provided by a supplier, which confirms that an identified batch of ingredients or materials conforms to the agreed product specification. 4.3 Cleaning instruction A work instruction applied specifically to cleaning operations. 4.4 Controlled document A document which is regulated within the Quality Management System. 4.5 Core document A document created within the Quality Management System and which can be changed or deleted under the authority of the Quality Management System. 4.6 Consumer A person who consumes final product. 4.7 Customer A person or organisation, normally a retailer, wholesaler or caterer, who buys final product for sale to the consumer. 4.8 Customer concession A customer's written authorisation to release an identified batch of final product which does not conform to the product specification. 4.9 Final product A food product which, having completed manufacture and final inspection and testing, has been confirmed as suitable for release to customers.
8 APPENDIX A 251 Definitions Date: 13/03/95 RME-QLMN-04 Page 2 of Ingredient An edible material (including additives and processing aids) used in the formulation of a food product In-process control A system of inspections carried out during the manufacture of a food product to ensure that ingredients, materials, in-process product and the process comply with stated requirements Inspection Activities such as examining, gauging, measuring and testing one or more characteristics of a product or service and comparing these with specified requirements to determine conformity In-process product A partly processed food product which requires further processing before it can be classed as final product Internal quality audit A quality audit applied specifically to the Quality Management System for the purposes of defecting deficiencies in the system ISO 9001 The International Organisation for Standardisation's quality system standard: Quality system-model for quality assurance in design, development, production, installation and servicing, ISO 9001: 1994; which equates to BS EN 9001:1994 and EN ISO 9001: Job description A core document which identifies the job holder's responsibility and authority for quality Management representative A manager who, irrespective of other responsibilities, has the responsibility and authority for: (a) the implementation and maintenance of the quality management system in accordance with ISO 9001:1994 (b ~ assessing and reporting on the performance of the quality system at management review, so that improvement of the system may be undertaken.
9 252 QUALITY MANAGEMENT SYSTEMS FOR THE FOOD INDUSTRY Definitions Date: 13/03/95 RME-QLMN-04 Page 3 of Management review A formal review of the operation, effectiveness and adequacy of the quality system, in relation to the requirements of customers and ISO 9001:1994, carried out by senior managers after defined intervals so that improvement of the quality system may be undertaken Material A material, other than an ingredient, used in the production of a final product and which constitutes part of the final product, e.g. packaging materials NACCB National Accreditation Council for Certification Bodies Nonconforming product A product which is believed, or has been demonstrated, not to conform to specification Order A customer's request for the sale of final product which, when agreed, is considered to be a contact Procedure A core document defining the method of management control of an activity within the quality system Quality The totality of features and characteristics of a product or service that bear on its ability to satisfy stated or implied needs Quality record A structured form used for recording data and information resulting from an activity or process of the quality system or the manufacture of a food product Quality system The organisational structure, responsibilities, procedures, processes and resources for implementing quality management Quarantine The physical isolation of a known quantity of product.
10 APPENDIX A 253 Definitions Date: 13/03/95 RME-QLMN-04 Page 4 of Reference document A document generated outside the quality system and which cannot be changed or modified under the authority of the system, but which is essential to the effective operation of the system Segregation The separation of a known quantity of product from similar product or other materials, by means of labels, indicators, barriers, etc. but not necessarily by isolation as implied by the term quarantine Supplier A person or organisation which provides for sale products, ingredients, materials and services. A subcontractor in the terms of ISO 9001: Traceability The ability to relate a final product to its production date, the ingredients and materials used in its production, the processes used for production, the process conditions by which it was made and associated analytical data Training document A core document which defines the method for carrying out correctly an activity, against which personnel shall be trained Work instruction A core document which defines the key requirements for carrying out correctly an activity or set of operations used in the manufacture of final product. Description of changes: Authorised by: Date:
11 254 QUALITY MANAGEMENT SYSTEMS FOR THE FOOD INDUSTRY Management Responsibility Date: 13/03/95 RME-QLMN-05 Page 1 of Quality policy The commitment of RME Foods Ltd to quality, food safety and its customers is defined in the company's Quality Policy, authorised by the Chief Executive, as follows: RME Foods Ltd is committed to meeting continuously its customers' stated needs, and striving ceaselessly to meeting its customers' implied needs, through the manufacture of chilled and frozen convenience foods and ready meals which comply consistently with the requirements of specifications, contracts and food safety legislation. A.N. Other, Chief Executive The executives and management of RME Foods shall ensure achievement of the quality policy through: (a) the implementation and maintenance of a Quality Management System registered to ISO 9001:1994 (b) ensuring that all personnel are aware of the company's quality policy and commitment to quality and food safety adequately trained and skilled to meet the operational and maintenance requirements of the Quality Management System. 5.2 Organisation Ultimate responsibility and authority for the Quality Management System lies with the Chief Executive who shall ensure that the responsibility and authority of executives, managers and personnel who perform and verify quality activities are defined and documented in job descriptions Job descriptions shall be defined for personnel who need the organisational freedom and authority to ensure: (a) the initiation of actions designed to prevent product, process and Quality Management System nonconformities
12 APPENDIX A 255 Management Responsibility Date: 13/03/95 RME-QLMN-05 Page 2 of 4 (b) the identification and recording of product, process and Quality Management System problems and defects (c) the initiation, recommendation and provision of solutions to the nonconformities at (a) and the problems and defects at (b) (the channels by which recommendations and solutions are transmitted shall be defined in Quality Management System documentation) (d) verification of the implementation and adequacy of solutions (e) controls over the further processing, despatch and delivery of nonconforming product until such time that the nonconformance has been rectified The organisational structure of RME Foods Ltd is: Chief Executive t---- Quality Director 11-- Technical Manager Operations Director Production Manager Purchasing Manager t---- Sales and Marketing Director I Sales Manager 1... Marketing Manager 1-- Finance Director t Company Accountant ' Company Secretary 5.3 Resources Resource requirements shall be identified for the management and performance of manufacturing operations, the maintenance of the Quality Management System and for the conduct of verification activities, which shall include:
13 256 QUALITY MANAGEMENT SYSTEMS FOR THE FOOD INDUSTRY Management Responsibility Date: 13/03/95 RME-QLMN-05 Page 3 of 4 purchased and manufactured product inspection and testing - process inspection and monitoring - plant and equipment hygiene inspection and monitoring - internal quality auditing - assessment of the implementation and suitability of preventive actions - assessment of the implementation and suitability of corrective actions Adequate resources shall be provided for these activities and, as required, the personnel undertaking these activities shall be suitably trained. 5.4 Management representative A management representative shall be appointed who, irrespective of other responsibilities, shall have responsibility and authority for: (a) the implementation and maintenance of the Quality Management System according to the requirements of ISO 9001:1994 (b) collating and reporting at management review, information and data concerning the effectiveness and suitability of the Quality Management System for realising the company's quality policy, meeting customer requirements and adhering to legal requirements (c) recommending necessary changes, modification and improvements to the Quality Management System (d) liaising with certification bodies, customers and suppliers in relation to the operation of the Quality Management System The management representative for the Quality Management System shall be identified in the relevant job description.
14 APPENDIX A 257 Management Responsibility Date: 13/03/95 RME-QLMN-05 Page 4 of Management review Scheduled management reviews shall be held to assess the continuing suitability and effectiveness of the quality management system in: - complying with the requirements ofiso 9001: realising the company's quality policy meeting customer requirements - adhering to legal requirements Management reviews shall be managed according to the procedure for Management Review. Description of changes: Authorised by: Date:
15 258 QUALITY MANAGEMENT SYSTEMS FOR THE FOOD INDUSTRY Quality Management System Date: 13/03/95 RME-QLMN-06 Page 1 of The Quality Management System shall be implemented and maintained to ensure achievement of the company's quality policy. 6.2 The structure, organisation and maintenance of the Quality Management System shall comply with the requirements ofiso 9001: The Quality Management System shall be defined and controlled by means of documented quality procedures, of which work instructions shall be a class, and by product and process specifications. 6.4 The documentation of the Quality Management System shall conform to the requirements ofiso 9001: Quality planning shall be integral to the operation of the quality management system and shall ensure that: quality plans (of which this manual shall be the primary plan) are established the facilities, personnel, process and inspection equipment, etc. required to achieve quality are identified and provided. product designs, production processes, delivery, customer service, inspection and test procedures, and associated documents, shall be compatible insofar as the requirements for achieving quality are concerned as necessary, quality control, inspection and testing techniques are revised and improved measurement and verification requirements are identified, assessed and met at all stages of the business process standards of acceptability of products and services are identified, clarified and defined quality records are maintained to support the operation of the Quality Management System, through the recording of information and data relevant to the achievement of quality.
16 . APPENDIX A 259 RME FOODS-QUALITY MANUAL Revision: 0 I Quality Management System Date: 13/03/95 RME-QLMN-06 Page 2 of2 6.6 A nominated deputy shall exist for each management position identified in the Quality Management System documentation. Identification of nominated deputies may not occur in the documentation, but shall be delegated ad hoc in writing by a deputy's manager, e.g. in the form of a list of nominated deputies. Description of changes: Authorised by: Date:
17 260 QUALITY MANAGEMENT SYSTEMS FOR THE FOOD INDUSTRY Document and Data Control Date: 13/03/95 RME-QLMN-07 Page 1 of General The Quality Management System shall be documented A document control system shall exist to control all documents and data which relate to the requirements of ISO 9001: The requirements of the document control system shall be defined in the procedure for Document Control The document control system shall ensure that: (a) current issues of controlled documents are available in the place of use (b) obsolete documents are removed from use, or prevented from use within the quality system (c) obsolete documents retained in compliance with legislation or for reference purposes are suitably identified and prevented from inappropriate use Controlled documents shall be coded to identify their issue status Designated managers shall be assigned responsibility for the review, revision and reissue, as relevant, of controlled documents Controlled documents shall be authorised by designated managers The Document Controller shall be responsible for document control, as identified in the relevant job description. 7.2 Issue and withdrawal of controlled core documents The core documents of the Quality Management System shall consist of: (a) Quality manual (b) Procedures (c) Work instructions (d) Manufacturing process specifications (e) Job descriptions (f) Training documents Core Document Master Registers shall be maintained for core documentation, recording authorship and issue details.
18 APPENDIX A 261 Document and Data Control Date: 13/03/95 RME-QLMN-07 Page 2 of Master copies of all core documents shall be retained and the master copies of obsolete core documents shall be archived Master circulation lists shall be maintained for core documents Core documents shall only be issued or withdrawn according to the procedure for Document Control. 7.3 Change or modification of controlled core documents Changes or modifications to core documents shall constitute revisions Revisions of core documents shall be made via designated managers (see 7.1.5) and the Document Controller according to the procedure for Document Control The position of revisions shall be identified in the document and the revision description shall be recorded The original designated manager shall normally review and authorise revised core documents A revision shall equate to an issue, so documents shall be reissued after each revision has been made The need to revise a document may, at times, be of considerable urgency. Handwritten changes to controlled core documents shall be acceptable, provided the changes are made by designated authorities and the changes are authorised and dated. Handwritten changes shall be made to all issues of a document and shall be made formal, according to the procedure for Document Control. 7.4 Reference documents Documents and data which relate to the requirements of ISO 9001: 1994, other than core documents, shall be termed reference documents Reference documents shall be controlled according to the procedure for Document Control. As authority for the issue and revision of reference documents lies outside the quality system, requirements for control shall not be as rigid as those for core documents Reference Document Registers shall be maintained as the means of control.
19 262 QUALITY MANAGEMENT SYSTEMS FOR THE FOOD INDUSTRY RME FOODS-QUALITY MANUAL Document and Data Control RME-QLMN-07 Revision: 01 Date: l3/03/95 Page 3 of Reference documents shall include: (a) Internal product specifications (b) Customer product specifications (c) Purchased product specifications (d) Legislation, e.g. the Food Safety Act (1990) (e) Standards, e.g. ISO 9001:1994, BSI test methods. (t) Codes-of-practice, e.g. IFST Guide to GMP and its Responsible Management (1991) (g) Internal laboratory test methods (h) HACCP plans (i) Subcontracted pest control standards. Description of changes: Authorised by: Date:
20 APPENDIX A 263 RME FOODS-QUALITY MANUAL Revision: 02 Quality Record Control Date: 21/04/95 RME-QLMN-OS Page 1 of 2 S.l Quality records shall be maintained to demonstrate the achievement of product specifications, compliance with relevant legislation, standards and codes of practice and the effective operation of the Quality Management System. S.2 Records shall be maintained according to the requirements of procedures and work instructions, and may cover:. (a) calibration of inspection, measuring and test equipment (b) control of nonconforming product (c) corrective action 12 (d) customer orders (e) customer service and customer complaints 12 (f) design changes, inputs, outputs, validation and verification (g) final inspection and testing results (h) hygiene and housekeeping audits (i) in-process inspection and testing results G) internal quality audits (k) management reviews (1) pest control (m) preventive action (n) processes and equipment approval (0) process change (p) production data and processing parameters ( q) purchase orders (r) purchased product inspection and testing results (s) stores records (t) supplier assessment and audit (u) supplier performance and capability monitoring (v) training. S.3 Quality records shall be legible and identifiable to the product or activity involved, readily retrievable and suitably stored so as to minimise deterioration or damage and to prevent loss. S.4 Quality records relating to Document Control, Management Review, Internal Audit, Corrective and Preventive Action and Training shall be retained for a minimum of three years.
21 264 QUALITY MANAGEMENT SYSTEMS FOR THE FOOD INDUSTRY RME FOODS-QUALITY MANUAL Revision: 02 Quality Record Control Date: 21/04/95 RME-QLMN-08 Page 2 of 2 Other quality records shall be retained for periods specific to product, customer, company or legal requirements. 8.5 Records shall be maintained of the retention times for quality records. 8.6 On issue of a revised quality record, all unused copies of the previous version shall be removed from use and destroyed. 8.7 The identification, collection, indexing, filing, storage, maintenance and disposition of quality records shall be defined in the procedure for Quality Record Control. 8.8 Computerised quality records shall be safeguarded by routine backup procedures, defined in the procedure for Quality Record Control. Otherwise the control and retention requirements for computerised quality records shall be as stated for hard copy record. 8.9 Subcontractor records relating to the achievement of product quality or the effective operation of the Quality Management System shall be collected, filed and stored in such a way as to minimise deterioration, damage or loss. The retention times and the disposition of such records shall be defined in a Register of Subcontractor Records. Records of subcontracted services may arise, for example, from: (a) pest control services (b) calibration services (c) laundry services At the time of contract, it may be agreed that customers, or their representative, have the right to examine relevant quality records. In such a case, the terms of agreement shall be contained in the contract. Description of changes: Minor additions to paragraph 8.2 Authorised by: Date:
22 APPENDIX A 265 RME FOODS-QUALITY MANUAL Revision: 03 Internal Quality Audit Date: 15/06/95 RME-QLMN-09 Page 1 of Internal quality audits shall be undertaken to verify: (a) that quality activities and related results comply with the requirements of the Quality Management System (b) the Quality Management System is effective and adequate for its purposes. 9.2 Internal quality audits shall be scheduled. The status and importance of activities shall influence the frequency with which they are audited. Activities shall be audited at least annually. An internal audit schedule shall be established and maintained. 9.3 Internal quality audits shall be carried out by trained personnel who are neither directly responsible for the area audited, nor responsible to the manager of the area audited. 9.4 Managers responsible for the area audited shall review and agree audit findings. Deficiencies shall be rectified through timely and appropriate corrective action. 9.5 The effectiveness of corrective action shall be ascertained through the completion of follow-up audits. 9.6 The results of internal quality audits and follow-up audits shall be documented and records shall be kept. 9.7 Internal quality audits shall be carried out according to the procedure for Internal Quality Audit. 9.8 The results of internal quality audits shall be reported at management reviews. Description of changes: Re-wording of paragraph 9.3 Authorised by: Date:
23 266 QUALITY MANAGEMENT SYSTEMS FOR THE FOOD INDUSTRY Training Date: 13/03/95 RME-QLMN-10 Page 1 of Personnel performing specified assigned tasks (unless under close supervision) shall be qualified on the basis of appropriate education, training and/or experience as required. No person shall perform critical tasks until such training and/or experience has been undertaken and verified External training shall be provided by approved individuals or organisations Training documents shall be revised whenever there is a change in the operation described Individual training records shall be established and maintained for all staff Training needs shall be identified for all personnel whose activities affect quality. They shall be reviewed at least annually and recorded in individual training records The management of training shall be carried out according to the procedure for Training. Description of changes: Authorised by: Date:
24 APPENDIX A 267 Contract Review and Customer Service Date: 13/03/95 RME-QLMN-ll Page 1 of Contract review All enquiries and orders shall be received and processed according to the procedure for Contract Review and Customer Service Telephone orders shall be documented at the time of receipt Orders shall be accepted only when: (a) a documented product specification exists (b) agreement of the product specification is reached with the customer (c) capability to manufacture and deliver according to specification and any other requirements of the customer is confirmed. (d) the methods required for inspecting and testing product are available and can be carried out satisfactorily Product specifications shall define the parameters to which the product is required to conform, e.g.: - chemical, microbiological and physical parameters - weights and/or volumes - packaging and legal requirements Product specifications shall include or be accompanied by a document identifying the test methods by which product shall be approved for release to the customer Product specifications shall be authorised for use Variations to orders shall be reviewed according to the requirements given at The documentation arising from a variation to an order shall be reconciled with the original documentation and changed or new requirements shall be made known to all relevant functions.
25 268 QUALITY MANAGEMENT SYSTEMS FOR THE FOOD INDUSTRY Contract Review and Customer Service Date: 13/03/95 RME-QLMN-ll Page 2 of Customer service Customer service activities may be undertaken even though no such requirement has been specified in contract. In such a case, services shall be directed significantly to providing aftersales support, as well as to fulfilling marketing objectives with regard to further business opportunities When after-sales service is a requirement of the customer, the nature of the service required and the terms and method of delivery shall be documented and agreed at the time of contract. The requirements for reporting the delivery and outcomes of after-sales service shall also be defined and documented, as shall requirements for verification Customer service shall be carried out according to the procedure for Contract Review and Customer Service. Description of changes: Authorised by: Date:
26 APPENDIX A 269 Product and Process Development Date: 13/03/95 RME-QLMN-12 Page 1 of Planning Product and process development activities shall be planned. The requirements of plans shall be documented, and either describe or reference the activities to be undertaken. Plans shall identify the responsibility and authority of personnel for product and process development activities Product and process development activities shall be assigned to qualified personnel who shall be equipped with resources adequate to meet the requirements of plans As necessary, plans shall be updated as product and process development evolves Organisational and technical interfaces The nature of organisational and technical interfaces existing between the groups involved in product and process development, e.g. sales, marketing and technical, shall be defined, agreed and documented. The responsibility and authority of the different groups shall be identified Definition of the organisational and technical interfaces existing between groups shall be circulated to all involved parties and reviewed at agreed times Design input The design inputs required to undertake product and process development shall be identified and documented. Design inputs shall include: - requirements identified and agreed at contract review - statutory and regulatory requirements Design inputs shall be reviewed for adequacy at the point of selection and any incomplete, ambiguous or conflicting requirements shall be resolved at source Design review Formal reviews of product and process development activities and results shall be undertaken at scheduled times and the outcomes of reviews shall be documented and recorded.
27 270 QUALITY MANAGEMENT SYSTEMS FOR THE FOOD INDUSTRY Product and Process Development Date: 13/03/95 RME-QLMN-12 Page 2 of All functions involved with the stage(s) of product and process development under review shall be represented. The participation of specialists shall be according to need Design output The required outputs of product and process development shall be defined in verifiable terms which ensure: (a) outputs comply with input requirements (b) output requirements either contain or reference acceptance criteria (c) requirements for the proper and effective use, handling, storage and preservation of product are identified (d) review of the adequacy of design output documents before either the documents or product are released or processes are operated Design verification Design verification shall be undertaken at appropriate stages throughout product and process development. Verification activities shall ensure that design outputs comply with the requirements of design inputs at the relevant stage of development The requirements for design verification and the methods of verification shall be documented Design validation Design validation shall be carried out to ensure the suitability of products and processes developed, and compliance with either internal or customer requirements Design validation shall normally be carried out after design verification. Requirements for design validation shall be documented. They may be influenced by the results of design verification.
28 APPENDIX A 271 Product and Process Development Date: 13/03/95 RME-QLMN-12 Page 3 of Design changes Design changes and modifications shall not be made without authorisation Design changes and modifications shall be identified, documented, reviewed and approved before implementation A review of the market readiness of all involved parties shall be made prior to the launch of new products. New products shall not be launched until the readiness of all involved parties is confirmed to have achieved the required standards Control of product and process development shall be managed according to the procedure for Product and Process Development. Description of changes: Authorised by: Date:
29 272 QUALITY MANAGEMENT SYSTEMS FOR THE FOOD INDUSTRY Purchasing Date: 13/03/95 RME-QLMN-13 Page 1 of General Purchased products shall be purchased: (a) according to requirements defined in purchased product specifications (b) from approved suppliers Purchased product specifications shall document the parameters against which products are required to conform. Certificates of analysis shall be obtained when necessary, in order to confirm precisely the quality of specific batches of purchased products Purchased product specifications shall be agreed with suppliers and approved for use Purchasing shall be made only on the basis of written purchase documents which clearly identify the goods or service ordered by a unique product code or product name. Product codes or product names shall be used on all purchasing documentation When a quality system standard is applied to the manufacture of a purchased product then the title, number and issue of the standard shall be recorded on all relevant purchase documentation Purchase orders shall be reviewed and authorised prior to release to the supplier Purchase orders placed by telephone shall subsequently be confirmed by sending appropriate purchase documentation to the supplier A list of approved suppliers of purchased products shall be maintained Purchasing shall be carried out according to the procedure for Purchasing.
30 APPENDIX A 273 Purchasing Date: 13/03/95 RME-QLMN-13 Page 2 of Evaluation of suppliers Suppliers of purchased products shall have a demonstrated capability to meet the requirements of purchased product specifications and purchase orders. The type and extent of control exercised over a supplier shall be dependent on the nature of product purchased and its potential to impact adversely on quality Only when required shall the assessment of new suppliers or auditing of existing suppliers be carried out Registration to ISO 9000:1994 shall be acceptable as a demonstration of supplier capability, provided the scope of the registration is suitable for the products provided The capability and performance of suppliers shall be monitored and assessed continuously. Corrective action shall be taken in the case of suppliers who fail to perform to the required standards, such that the supplier either improves or is de-listed for the products provided The evaluation of suppliers shall be carried out according to the procedure for Supplier Approval and Performance Monitoring Supplier verification Verification procedures and methods for product release shall be stated in purchase documents when verification of purchased products is carried out at the supplier's premises The customer (or his representative) shall have the right to verify purchased product at the supplier's premises, when agreed and recorded at the time of contract according to the procedure for Purchasing. Verification by the customer shall not suffice as evidence of effective control of quality by the supplier. Description of changes: Authorised by: Date:
31 274 QUALITY MANAGEMENT SYSTEMS FOR THE FOOD INDUSTRY Customer Supplied Product Date: 13/03/95 RME-QLMN-14 Page 1 of Customer supplied product shall be: (a) verified to be correct on receipt, according to requirements agreed in product specifications and contracts (b) stored and maintained in a satisfactory condition according to documented requirements agreed with the customer Customer-supplied product which is lost, damaged, pest infested or found in any other way to be unsuitable for use shall be segregated to prevent inadvertent use. The customer shall immediately be notified of the problem and a course of action shall be agreed Customer-supplied product shall be managed according to the procedure for the Receipt and Control of Customer Supplied Product. Description of changes: Authorised by: Date:
32 APPENDIX A 275 Product Identification and Traceability Date: 13/03/95 RME-QLMN-15 Page 1 of The route and extent of traceability of final product shall be identified Final product shall be identified and coded to display: (a) the product type (b) the production and packing line (c) the date of production and packing Records of final product identification shall be maintained Ingredients and food contact packaging shall be reconciled with final product and records shall be maintained When the route of traceability is broken during the production process, in-process product shall be cleared positively before being allowed to move forward in the process Batches of ingredients and food contact packaging shall be identified by a unique identification code, e.g. a batch or lot code Product identification and traceability shall be managed according to the procedure for Product Identification and Traceability In the event of a product recall being necessary, then this activity shall be managed accordingw the procedure for Product Recall. Description of changes: Authorised by: Date:
33 276 QUALITY MANAGEMENT SYSTEMS FOR THE FOOD INDUSTRY Process Control Date: 13/03/95 RME-QLMN-16 Page 1 of Production documentation Manufacturing requirements for each product shall be defined in process specifications, product specifications, work instructions and inspection and test methods Work instructions shall define the requirements for carrying out process control activities which have a direct bearing on product quality Specifications, work instructions and inspection and test methods shall be available in the place of use Process control Products shall be manufactured only according to the requirements of a production plan Manufacture shall be managed according to requirements defined in the procedure for Process Control The characteristics of processes and products shall be monitored and controlled during production, to ensure compliance with product specifications Standards and methods for the operation of special processes, e.g. CIP systems, shall be documented. Requirements for monitoring and verifying compliance with the standards shall be defined in the procedure for Process Control Products manufactured by a special process which is subsequently demonstrated to have been operating unsatisfactorily shall be handled as nonconforming product until proven otherwise Product released to a customer, but made by a special process which is subsequently demonstrated to have been operating unsatisfactorily, shall be handled according to the procedures for Control of Nonconforming Product and Product Recall Standards for workmanship shall be as the criteria defined in product specifications Food safety and hygiene management Food safety and hygiene shall be managed according to requirements defined in the procedure for Hygiene Control.
34 APPENDIX A 277 Process Control Date: 13/03/95 RME-QLMN-16 Page 2 of The maintenance of hygienic operations shall be routinely audited, according to requirements defined in the procedure for Hygiene Control Process change Process changes shall be authorised before they occur Process changes shall result from: (a) the introduction of new processes or products (b) the introduction of new technology or equipment in the manufacture of existing products (c) the transfer of production to the factory (d) the introduction of a change in product formulation and/ or packaging which affects quality The introduction of new processes or changes to existing processes affecting critical control points shall be evaluated, formally reported and authorised Process change shall be carried out according to the procedure for Process Change Engineering services The servicing and maintenance of food processing plant and equipment shall be planned Servicing, maintenance and repair, either on-line or off-line, shall be carried out in a controlled manner to prevent the direct or indirect contamination of food by microbiological, chemical or foreign body agents The planned maintenance and repair of plant and equipment shall be carried out according to the procedure for Engineering Services. Description of changes: Authorised by: Date:
35 278 QUALITY MANAGEMENT SYSTEMS FOR THE FOOD INDUSTRY Inspection and Testing Date: 13/03/95 RME-QLMN-17 Page 1 of General Inspection and testing shall be managed according to the procedure for Product Inspection and Control. Requirements for inspection and testing at different stages of the production process shall be defined in quality plans Laboratory tests shall be carried out according to documented inspection and test methods Tests carried out by production operators shall be documented as either laboratory methods or work instructions and shall form a key part of operator training Receiving, inspection and testing Upon receipt, ingredients and materials shall be inspected for: (a) damage (b) completeness (c) product identification (d) pest infestation or contamination (e) compliance with purchase orders Ingredients and materials shall be withheld from production and identified as such, until inspection and test requirements have been completed and the products have been authorised for use Ingredients and materials which have been cleared for use shall be identified as such Ingredients and materials rejected on receipt, due to failure of compliance tests, shall be identified as unsuitable for use. Such goods shall only be disposed of according to written instruction When circumstances require the use of ingredients or materials prior to the completion of inspections and tests, then such product shall only be released under an internal concession. Such product shall be positively identified Requirements for the inspection and testing of purchased products shall be defined in the quality plan for purchased products.
36 APPENDIX A 279 Inspection and Testing Date: 13/03/95 RME-QLMN-17 Page 2 of In-process inspection and testing The control of quality during production shall be maintained by process monitoring and product inspection In-process inspection and testing shall be carried out in accordance with requirements documented in work instructions Production of records shall be available at the point of use to record: (a) ingredients and materials used during production (b) process control data (c) the results of in-process inspection and testing In-process product shall normally be held until the completion of all in-process inspection and tests. When circumstances require the release of in-process product prior to the completion of inspections and tests, then such product shall be released only under an internal concession. Such product shall be positively identified Product which does not meet in-process inspection and test requirements shall be treated as nonconforming product Requirements for the inspection and testing of in-process product shall be defined in the quality plan for in-process product Final inspection and testing The requirements for final product inspection and testing and release shall be identified in product specifications and the final product quality plan Final product shall be inspected and tested in accordance with the final product quality plan. The results of in-process inspection and testing may be used where appropriate Final product shall not be despatched until all inspection and testing is complete, unless agreed with the customer (see ) The completion of final inspection and testing and the clearance of product shall be authorised Product which does not meet final inspection and testing requirements shall be treated as nonconforming product.
37 280 QUALITY MANAGEMENT SYSTEMS FOR THE FOOD INDUSTRY Inspection and Testing Date: 13/03/95 RME-QLMN-17 Page 3 of Where agreement with the customer permits product release prior to completion of all tests, a request for a customer concession shall be made when product is subsequently found not to conform to specification but represents no risk to the consumer. Product which represents a hazard to the consumer shall be recalled The release of product prior to completion of all inspections and tests shall be authorised Inspection and test records Records of the results of inspection and testing shall be kept. They shall be used to provide evidence that product conforms to specification Customer complaints In the event that customer complaints are received concerning the quality of products, they shall be handled according to the procedure for Customer Complaints. Description of changes: Authorised by: Date:
38 APPENDIX A 281 Inspection and Test Status Date: 13/03/95 RME-QLMN-18 Page 1 of The inspection and test status of product shall be demonstrated by means of: (a) purchase records (b) stores records (c) production records (d) laboratory records (e) status indicators, e.g. labels, on purchased products, final product awaiting clearance and cleared final product Authority for the inspection and release of conforming product shall be identified clearly in procedures Product which has not completed all inspections and tests may be released under the authority of a customer concession. If it is found subsequently that such product represents a hazard to the consumer, it shall be managed according to the procedure for Product Recall The inspection and test status of product shall be demonstrated through procedures, specifically the procedures for: (a) Process Control (b) Product Control (c) Inspection and Control of Nonconforming Product. Description of changes: Authorised by: Date:
39 282 QUALITY MANAGEMENT SYSTEMS FOR THE FOOD INDUSTRY Product Preservation and Control Date: 13/03/95 RME-QLMN-19 Page 1 of Handling Product shall be handled at all stages of the production process in a manner suitable to prevent damage, deterioration or contamination. When specific requirements for the handling of product exist, they shall be defined in relevant documentation Storage Product shall be stored according to requirements stated in product specifications, process specifications and relevant documentation Storage areas shall be designated and shall be suitable to prevent the damage, deterioration or contamination of products The release of product from storage areas shall be authorised Product in store shall routinely be audited to detect damage, deterioration or contamination, according to requirements defined in the procedure for Product Inspection and Control Packing Requirements for the packing of product and details of packaging materials shall be defined in relevant purchased product specifications, final product specifications, process specifications and work instructions Preservation The preservation of product shall be achieved by maintaining product according to requirements stated in purchased product specifications, final product specifications, process specifications and work instructions As necessary, the segregation of product shall be used as a means of preservation Despatch Only approved hauliers or their approved subcontractors shall be used for the transporting of final products. When required, the approved subcontractors of hauliers shall be able to demonstrate capability and shallingness to maintain product under specified conditions and shall be agreeable to verification of the purchased service.
40 APPENDIX A 283 Product Preservation and Control Date: 13/03/95 RME-QLMN-19 Page 2 of Product shall only be made available for despatch to a customer when it has passed final inspection and testing, according to the quality plan, unless otherwise agreed with the customer (see ) Requirements for the management of final product despatch are defined in the procedure for Product Despatch. Description of changes: Authorised by: Date:
41 284 QUALITY MANAGEMENT SYSTEMS FOR THE FOOD INDUSTRY Calibration Date: 13/03/95 RME-QLMN-20 Page 1 of Inspection, measuring and test equipment used to demonstrate the compliance of products with specifications, whether in production or laboratory testing, shall be selected on the basis of the measurement to be made and the accuracy and precision required Such equipment shall be calibrated and adjusted after defined intervals. Calibration checks shall be carried out between calibrations. Requirements and schedules for calibrations and calibration checks shall be documented. The acceptance criteria for calibrations and calibration checks shall be defined Inspection, measuring and test equipment shall be identified uniquely and the identifier and location shall be recorded When practical, inspection, measuring and test equipment shall be identified with an indicator to show the calibration status. When indicators cannot be used, then calibration status shall be demonstrated by means of records Records shall be maintained of the calibrations and calibration check adjustments of inspection, measuring and test equipment The validity of previous inspection and test results shall be assessed when inspection, measuring and test equipment is found to be out of calibration. Where inspection and test results are proven to be invalid, a customer concession shall be sought, except for product which represents a hazard to the consumer. Product which represents a hazard shall be managed according to the procedure for Product Recall Inspection, measuring and test equipment shall be protected from inadvertent adjustments which would invalidate the calibration settings Calibrations of inspection, measuring and test equipment shall be carried out in a suitable environment Inspection, measuring and test equipment shall be handled, preserved and stored in a way suitable to maintain accuracy and fitness for use.