SQ 901 Version D. Railway Application Quality Specification REQUIREMENTS FOR THE QUALITY MANAGEMENT SYSTEM AND QUALITY PLAN

Transcription

1 SQ 901 Version D Railway Application Quality Specification OBTAINING QUALITY OF PRODUCTS PURCHASED BY SNCF REQUIREMENTS FOR THE QUALITY MANAGEMENT SYSTEM AND QUALITY PLAN Issue date March 2004 This English translation is provided for information only. Only the french original version constitues contractual documents. Issued by the Supplier Quality Department

2 DOCUMENT HISTORY Version Grounds for Modification Date D 1 st edition Document complementing SQ 900 for certain products. 03 / 2004 Creation in version D to reflect an overall change in SNCF's strategy on obtaining quality Quality specification approved on 03/2004 Procurement Department (AF) - 2 -

3 TABLE OF CONTENTS Page FOREWORD SCOPE AND FIELD OF APPLICATION TERMINOLOGY - REFERENCE DOCUMENTS TERMINOLOGY REFERENCE DOCUMENTS PRINCIPLES QUALITY MANAGEMENT SYSTEM GENERAL REQUIREMENTS DOCUMENTATION REQUIREMENTS MANAGEMENT RESPONSIBILITY MANAGEMENT COMMITMENT CUSTOMER FOCUS QUALITY POLICY PLANNING RESPONSIBILITY, AUTHORITY AND COMMUNICATION MANAGEMENT REVIEW RESOURCE MANAGEMENT PROVISION OF RESOURCES HUMAN RESOURCES INFRASTRUCTURE WORK ENVIRONMENT

4 TABLE OF CONTENTS (next)) Page 7 PRODUCT REALISATION PLANNING OF PRODUCT REALISATION CUSTOMER-RELATED PROCESSES DESIGN AND DEVELOPMENT PURCHASING PRODUCTION CONTROL OF MONITORING AND MEASURING DEVICES MEASUREMENT, ANALYSIS AND IMPROVEMENT GENERAL MONITORING AND MEASUREMENT CONTROL OF NONCONFORMING PRODUCT ANALYSIS OF DATA IMPROVEMENT QUALITY PLAN GENERAL PRESENTATION AND CONTENT OF THE QUALITY PLAN IMPLEMENTATION OF THE QUALITY PLAN SIGNING OF THE QUALITY PLAN MONITORING OF THE QUALITY PLAN CHANGING AND UPDATING THE QUALITY PLAN DISTRIBUTION OF THE QUALITY PLAN...15 FEEDBACK FORM

5 FOREWORD In view of the safety or strategic nature of a part of, SNCF feels it is necessary to ensure the quality of the products that it procures by requiring its suppliers to implement and maintain a quality management system meeting the requirements of NF EN ISO SCOPE AND FIELD OF APPLICATION This document complements document SQ 900 and sets out the arrangements to be applied by an SNCF supplier when a quality management system is required by the contract or through the contractual documents. The requirements of NF EN ISO 9001 apply in full and are complemented by the provisions set out in Chapters 4 to 8. For convenience, the paragraphs in this Quality Specification have the same numbering as those of standard NF EN ISO 9001, even where no additional requirements are specified. 2 - TERMINOLOGY - REFERENCE DOCUMENTS TERMINOLOGY The terms used to those from SQ REFERENCE DOCUMENTS - NF EN ISO 9001 : Quality Management System Requirements ; - SQ 900 : Relations between SNCF and its suppliers Supplier's obligations SNCF operations ; - SQ 906 : Requirements for Procurement Control by the contract-holder and operations by SNCF ; - SQ 908 : Supplies' review. 3 - PRINCIPLES The scope of the system shall cover all activities having an effect on the quality of the product supplied to SNCF, including, where appropriate, design, development, procurement, production and additional services required. In particular, if the realisation activities come under several different quality management systems for example: research, design, development, marketing, production, distribution, delivery the supplier shall indicate how he ensures that all the different activities combine to obtain conformity of the product to SNCF's requirements. The arrangements (organisation, processes, resources) that the supplier implements for the product intended for SNCF and in order to meet all the contractual requirements pertaining to the product are described in the quality plan, as described in Chapter 9 of this specification

6 If the supplier uses sub-contractors or service providers for products or realisation processes having an effect on the quality of the product supplied to SNCF, the quality planning that he has defined shall ensure the conformity of the product to SNCF's requirements. Should the effectiveness of the supplier's quality system and implemented arrangements described in the quality plan prove to be insufficient, SNCF will be entitled to apply the measures described in SQ 900 in the event of failure, and particularly to decide the application of special monitoring arrangements. Where this specification is referred to in the contract, the supplier shall present a certificate of conformity to standard NF EN ISO 9001 issued by an accredited body. The certificate shall cover all the requirements corresponding to the product to be supplied to SNCF. In certain cases, system approvals issued by major purchasers or other rail networks may also be accepted. 4 - QUALITY MANAGEMENT SYSTEM GENERAL REQUIREMENTS The supplier shall indicate to SNCF any outsourced processes and how it controls them and provides overall supervision DOCUMENTATION REQUIREMENTS General The documentation for the quality management system shall be made available to SNCF. The products shall be the subject of a quality plan approved by SNCF and drawn up in accordance with Chapter Quality manual The documentation (quality manual or quality plan) shall include a description of the processes with their internal and external interfaces Control of documents The supplier shall maintain the statutory and regulatory documentation Control of quality records The statutory and regulatory requirements and the contract requirements shall be taken into account (e.g. nature, duration or preservation requirements). The quality plan will state of nature, duration and conditions of storage. The nature and form of the media shall be stated

7 5 - MANAGEMENT RESPONSIBILITY MANAGEMENT COMMITMENT The management shall communicate within the organisation the importance of meeting SNCF's requirements as well as statutory and regulatory requirements CUSTOMER FOCUS The supplier's attention to SNCF's needs and expectations (subsequently converted into requirements) shall not be limited to the views of the users or buyers alone. The focus on SNCF's needs extends to the whole of the organisation that has awarded a contract, and also, in certain cases, to the end customer (traveller, shipper, owner of the network) QUALITY POLICY PLANNING Quality objectives Planning of the quality management system RESPONSIBILITY, AUTHORITY AND COMMUNICATION Responsibility and authority Responsibilities in terms of relations with SNCF shall be defined and communicated to it. For structures relating specifically to a project, all of the responsibilities regarding the project shall be defined and communicated to SNCF Management representative The supplier shall appoint a member of management responsible for relations with SNCF. This management representative shall, irrespective of other responsibilities, have the responsibility and authority for : - ensuring that the requirements of this document are implemented and maintained in operation ; - ensuring the promotion of awareness of SNCF's requirements throughout the organisation Internal communication - 7 -

8 5.6 - MANAGEMENT REVIEW General The records from management reviews shall be made available to SNCF's representatives with the exception of confidential information Review input The input to management review shall include SNCF's feedback, irrespective of its nature Review output 6 - RESOURCE MANAGEMENT The quality plan shall include or make reference to the resources required for realisation of the contract PROVISION OF RESOURCES HUMAN RESOURCES The supplier shall ensure that the personnel used are, as far as is necessary, aware of the requirements and particular conditions of the railway field (safety, braking, electromagnetism, vibration, etc) General Competence, awareness and training INFRASTRUCTURE The supplier shall maintain the infrastructure needed to achieve permanent conformity of the product. Where applicable, special installations needed for working in the railway field shall be provided. These are indicated in the quality plan WORK ENVIRONMENT If the work takes place on railway premises, the special working conditions and current rules shall be applied

9 7 - PRODUCT REALISATION PLANNING OF PRODUCT REALISATION The supplier shall plan and develop the processes needed for product realisation and provision of the service intended for SNCF. In planning product realisation, the supplier shall determine, as appropriate : - quality objectives and requirements for the product intended for SNCF ; - the need to establish processes, documents, and provide resources specific to the product ; - required verification, validation, monitoring, inspection and test activities specific to the product and the criteria for product acceptance ; - records needed to provide evidence that the realisation processes and resulting product meet the requirements. The output of this planning shall be communicated to SNCF and shall form the basis of the quality plan. This plan shall be adapted according to the nature of the product CUSTOMER-RELATED PROCESSES Determination of requirements related to the product Review of requirements related to the product Customer communication DESIGN AND DEVELOPMENT Design and development planning During the design and development planning, the supplier shall determine the review, verification and validation activities that are appropriate to each design and development stage, and requiring the participation or information of SNCF. The quality plan includes or makes reference to the description of the design planning. Interfaces between the different groups involved (SNCF, supplier, co-contractor or sub-contractors sites) shall be clearly indicated Design and development inputs Design and development outputs The supplier shall ensure that parts required for maintenance (including the corresponding defining documents required in the contract) can be easily procured throughout the lifetime of the product ordered. The characteristics and particular precautions for use and maintenance of the product shall be indicated to SNCF

10 Design and development review SNCF shall have access to the records of the design and development reviews. Where problems are identified, the supplier shall give particular attention to maintenance and re-procurement problems Design and development verification Design and development validation Design and development validation shall be performed in accordance with the planned arrangements to ensure that the resulting product is capable of meeting the requirements for the specified railway use. If the design and development verification and validation are not completed before the product is put into service, the supplier shall obtain the agreement of SNCF. If stipulated in the contract, SNCF will approve the validation methods for the product design and development. SNCF shall have access to the records of the design and development verification and validation actions. The results The results, including results of tests carried out by the notified bodies, may be supplied Control of design and development changes Where changes are made to the design and development, SNCF shall be notified of the content of the changes and of the treatment applied by the supplier PURCHASING Any requirements on purchasing control in addition to those from standard NF EN ISO 9001 are set out in SQ Purchasing process Evaluations of sub-contractors carried out by the supplier will be made available to SNCF. During evaluation and selection of sub-contractors, the supplier shall take into account the continuing availability of supplies for product realisation and subsequent maintenance, whether performed by himself or by SNCF Purchasing information Purchasing information shall describe the product to be purchased, including requirements for approval of product, procedures, processes and equipment, for qualification of personnel and, where applicable, SNCF participation in these operations. They shall also include any requirements for demonstration of conformity with the regulatory requirements Verification of purchased product The supplier shall state the intended verification arrangements and method of product release. He shall notify his sub-contractors of the relevant SNCF requirements (SQ 906)

11 7.5 - PRODUCTION Control of production Particular attention shall be given to the production start-up phases. Arrangements shall be made to ensure continuing quality of large-scale production Validation of production processes Production processes requiring validation shall be identified and mentioned in the quality plan. This shall also indicate : - the validation procedures ; - requirements for records ; - SNCF operation arrangements where specified in the contract (SQ 908) ; - re-validation methods Identification and traceability Customer property Preservation of product The supplier shall take into account the particular conditions of use of the products by SNCF (yards, handling conditions, extended storage times, multiple-point distribution, re-packaging, etc.) for defining the preservation conditions. Preservation shall also apply to the data released by the supplier (formatting, data packaging or storage) CONTROL OF MONITORING AND MEASURING DEVICES This control includes instruments, devices and software, as well as the personnel and conditions for carrying out measurements

12 8 - MEASUREMENT, ANALYSIS AND IMPROVEMENT GENERAL MONITORING AND MEASUREMENT Customer satisfaction Internal audit Monitoring and measuring processes Monitoring and measurement of product CONTROL OF NONCONFORMING PRODUCT ANALYSIS OF DATA SNCF may specify in the contract the monitoring of some process data or product characteristics that it considers important (e.g. risk of deviation). In this case, the arrangements are set out in the quality plan IMPROVEMENT Continual improvement Corrective action The documented procedure shall define the requirements for reviewing nonconformities, including complaints by SNCF. SNCF may participate in the review (implementation, effectiveness) of the corrective action in consultation with the supplier. When analysing the effects of nonconformities, the supplier shall take into account those relating to SNCF (use of the product, also procurement, delivery, etc.). In the event of a complaint by SNCF, it shall be informed of the corrective action applied and its effect on the product and service provided Preventive action

13 9 - QUALITY PLAN GENERAL A quality plan is required whenever the contract or its related documents refer to this specification. It is the contractual basis for SNCF.operation. The purpose of the quality plan for products supplied to SNCF is to describe the arrangements applied by the supplier for obtaining and controlling the quality of the product supplied. The specifial arrangements for inspection of products may be the subject of one or more inspection plans attached to or referenced in the quality plan. The quality plan is drawn up by reference to the quality manual and complements it with additional information on the product or service concerned and the requirements stipulated by SNCF. It takes into account the particular features of each organisation PRESENTATION AND CONTENT OF THE QUALITY PLAN The form in which the quality plan is presented is at the discretion of the supplier, so that he can adapt it to his documentary arrangements and principles. However, the quality plan shall be presented in a practical, clear and concise form to facilitate its understanding, maintenance and use. The quality plan gives details of the arrangements made in order to : - meet the requirements of SQ 900 ; - fulfil the requirements from Chapters 4 to 8 of this specification ; - meet special contract requirements. The quality plan shall in addition : - describe the nature of the products concerned ; - state the contract number where this relates to a single contract ; - state the SNCF contract documents (Quality Specification, Technical Specification, standards and regulatory requirements ) ; - describe the arrangements for management of the quality plan and methods of notification to SNCF following a change ; - list, where appropriate, the parts, supplies or tools provided by SNCF for the realisation of the products ; - describe the features of the organisation implemented for product realisation and inspection (creation of special teams, layout of production lines, premises, etc.) ; - provide references to the documents - instructions, procedures, specifications, inspection plans, test programmes, data sheets - used for ensuring the quality of the product and recording the results

14 9.3 - IMPLEMENTATION OF THE QUALITY PLAN The implementation of the quality plan is automatically stipulated in the contract by reference to this specification. The quality plan applies to a product or family of products obtained under equivalent conditions. However, where a product has special requirements or features, these shall be indicated. The supplier shall himself evaluate the effectiveness of the arrangements set out in the quality plan and provide evidence of this evaluation. Unless otherwise stated by SNCF, the quality plan is applicable for the duration of the contract. It may be renewed, by tacit agreement, for all subsequent contracts covering identical products obtained under the same conditions. The drawing up, updating and monitoring of the application of the quality plan are the responsibility of the management representative appointed as the liaison with SNCF for quality. The quality plan shall give his/her name and position. The provisions of the quality plan shall be compatible with those of the manual, or take precedence over the latter SIGNING OF THE QUALITY PLAN The quality plan shall be presented before beginning of the required activities, and be approved and signed by a member of the supplier's management. It is drawn up in consultation with SNCF and signed by both parties : SNCF and the supplier. The signing of the quality plan by SNCF does not release the supplier from his responsibility for quality. Any changes shall be notified to SNCF, who will decide whether a new validation is required during execution of the contract. In addition, in the case of disputes concerning the products, the tests or inspections defined by the technical conditions of contract shall take precedence over the provisions of the quality plan MONITORING OF THE QUALITY PLAN The management representative responsible for relations with SNCF and appointed by the supplier will ensure the total and effective application of the plan for the product concerned. To this end, he will make all necessary arrangements to ensure that this application is effective and to correct any insufficiencies as quickly as possible

15 9.6 - CHANGING AND UPDATING THE QUALITY PLAN Changes shall be made to the quality plan if : - the supplier modifies the arrangements relating to the product (particularly as a result of corrective action) ; - the contractual requirements change. The quality plan is then updated, reviewed by all the relevant personnel of the supplier and submitted to SNCF. The traceability of changes shall be ensured. Atable of content will be given in the introduction to the document DISTRIBUTION OF THE QUALITY PLAN The distribution of the quality plan takes place in a controlled manner. SNCF's Procurement Department (AF) will receive at least one copy. Further copies may be requested in special cases (technical departments, project managers, etc.). The various documents mentioned in the quality plan will be attached to these copies or made available to the recipients

16 SUPPLIER QUALITY DEPARTMENT FEEDBACK FORM All proposals for updates shall be accompanied by a photocopy of the FEEDBACK form, addressed to the département AF, pôle AFO 23 rue d'alsace PARIS Cedex 10, proposing a : Comment, Idea, Suggestion, Modification, Error, Improvement Non-SNCF firm Address : SNCF department Address : Date : Name : : Fax : Internet : : Fax : Intranet : Signature : Subject of the Feedback Form : Continued overleaf or on separate sheet (1) ACKNOWLEDGEMENT OF RECEIPT BY POLE AFO FEEDBACK FORM NUMBER : This feedback form was received on : We are examining the action to be taken on your suggestions. You will be informed as soon as possible. Thank you for sending us your Feedback Form. Head of the Pôle AFO Date : Signature : Copy : (1) Delete as appropriate