BS CECC 00804-1996 Harmonized system of quality assessment for electronic components - Interpretation of EN ISO 9000 1994 Reliability aspects for electronic components《电子元器件用质量评估协调.pdf

1、BRITISH STANDARD BS CECC 00804:1996 Implementation of CECC 00804:1996 Harmonized system of quality assessment for electronic components Interpretation of “ENISO 9000:1994” Reliability aspects for electronic components ICS 31.020BSCECC00804:1996 This British Standard, having been prepared under the d

2、irectionof the Management Systems Sector Board, was published under the authority ofthe Standards Board and comesinto effect on 15 July 1996 BSI 12-1999 The following BSI references relate to the work on this standard: Committee reference DS/1 Draftfor comment 93/408001 DC ISBN 0 580 26111 5 Committ

3、ees responsible for this British Standard The preparation of this British Standard was entrusted to Technical Committee DS/1, Reliability and maintainability, upon which the following bodies were represented: Association of Consulting Engineers Association of Project Managers British Gas plc British

4、 Railways Board British Telecommunications plc Chartered Institution of Building Services Engineers City University Civil Aviation Authority Consumer Policy Committee of BSI Consumers Association Cranfield University Defence Manufacturers Association Electricity Association Federation of the Electro

5、nics Industry GAMBICA (BEAMA Ltd.) Institute of Logistics Institute of Quality Assurance Institute of Risk Management Institute of Value Management Institution of Electrical Engineers Institution of Mechanical Engineers Institution of Plant Engineers London Underground Ltd. Loughborough University o

6、f Technology Mercury Communications Limited Ministry of Defence National Computing Centre Ltd. Railtrack Railway Industry Association Royal Institution of Chartered Surveyors Royal Statistical Society Safety and Reliability Society Society of Environmental Engineers Society of Motor Manufacturers an

7、d Traders Limited University of Bradford West Midlands Enterprise Board Amendments issued since publication Amd. No. Date CommentsBSCECC00804:1996 BSI 12-1999 i Contents Page Committees responsible Inside front cover National foreword ii Foreword 2 Text of CECC 00804 3BSCECC00804:1996 ii BSI 12-1999

8、 National foreword This British Standard reproduces verbatim CECC 00804:1996 Guidance document: Interpretation of “EN ISO 9000:1994” Reliability aspects for electronic components, published by the European Committee for Electrotechnical Standardization (CENELEC) and implements it as the UK national

9、standard. This British Standard is published under the direction of the Management Systems Sector Board (MSSB) whose Technical Committee DS/1 has the responsibility to: aid enquirers to understand the text; present to the responsible international committee any enquiries on interpretation, proposals

10、 for change and keep UK interests informed; monitor related international and European developments and promulgate them in the UK. NOTEInternational and European Standards, as well as overseas standards, are available from Customer Services, BSI, 389 Chiswick High Road, London, W4 4AL. A British Sta

11、ndard does not purport to include all the necessary provisions of a contract. Users of British Standards are responsible for their correct application. Compliance with a British Standard does not of itself confer immunity from legal obligations. Summary of pages This document comprises a front cover

12、 an inside front cover, pages i and ii, theCECC title page, pages2 to 20 and a back cover. This standard has been updated (see copyright date) and may have had amendments incorporated. This will be indicated in the amendment table on the inside front cover.GUIDANCE DOCUMENT DOCUMENT GUIDE LEITFADEN

13、 CECC 00804 February 1996 ICS 03.120.10 Supersedes CECC 00804:1994 Descriptors: Electronic components, ISO 9000, reliability English version Guidance document: Interpretation of “EN ISO 9000:1994” Reliability aspects for electronic components Document guide: Applicationdela“ENISO9000:1994” lafiabili

14、t des composants lectroniques Leitfaden: Anwendung von “ENISO9000:1994” KriterienfrdieZuverlssigkeit von elektronischen Bauelementen This CECC Specification was approved on 1995-11-28. This CECC Specification exists in three official versions (English, French, German). A version in any other languag

15、e made by translation under the responsibility of a CENELEC member into its own language and notified to the Central Secretariat has the same status as the official versions. CENELEC members are the national electrotechnical committees of Austria, Belgium, Denmark, Finland, France, Germany, Greece,

16、Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom. CENELEC European Committee for Electrotechnical Standardization Comit Europen de Normalisation Electrotechnique Europisches Komitee fr Elektrotechnische Normung Central Secretariat: rue

17、 de Stassart 35, B-1050 Brussels 1996 Copyright reserved to CENELEC members Ref. No. CECC 00804:1996 ECECC00804:1996 2 BSI 12-1999 Foreword This CECC Guidance Document was prepared by CLC/TC CECC WG Reliability. The text of the draft was submitted to the Unique Acceptance Procedure and was approved

18、by CENELEC as CECC 00804 on 1995-11-28. This document is a revision of CECC 00804:1994. This second issue is now consistent with ENISO9000:1994. The title has been modified to reflect this. Amendments have been made to the text to enhance clarity. The following dates were fixed: Contents Page Forewo

19、rd 2 Section A. Guide Introduction 3 0.1 General introduction to CECC 00804 3 0.2 Application of CECC 00804 by componentmanufacturers and specialistcontractors 3 0.3 Application of CECC 00804 by other organisations 3 0.4 Application of CECC 00804 by auditing bodies 3 Guidance 1 Management responsibi

20、lity 4 2 Quality system 4 3 Contract review 4 4 Design control 6 5 Documentation control 7 6 Purchasing 7 7 Purchaser supplied product 8 8 Identification and traceability 8 9 Process control 8 10 Inspection and test 9 Page 11 Inspection, measurement and test equipment 10 12 Inspection and test statu

21、s 10 13 Control of non-conforming products 10 14 Corrective action 10 15 Handling, storage, packaging and delivery 10 16 Quality records 11 17 Audits 11 18 Training 11 19 Servicing 11 20 Statistical techniques 11 Section B. Check list Introduction 12 Check list questions 12 1 Management responsibili

22、ty 12 2 Quality system 13 3 Contract review 13 4 Design control 14 5 Documentation control 14 6 Purchasing 15 7 Purchaser supplied product 15 8 Identification and traceability 16 9 Process control 16 10 Inspection and test 17 11 Inspection, measurement and test equipment 17 12 Inspection and test st

23、atus 18 13 Control of non-conforming products 18 14 Corrective action 18 15 Handling, storage, packaging and delivery 19 16 Quality records 19 17 Audits 19 18 Training 19 19 Servicing 20 20 Statistical techniques 20 latest date by which this document has to be implemented at national level by public

24、ation of an identical national standard or by endorsement (dop) 1996-06-01 latest date by which the national standards conflicting with this document have to be withdrawn (dow) 1996-06-01CECC00804:1996 BSI 12-1999 3 Section A. Guide Introduction 0.1 General introduction to CECC00804 EN 100114-1 prov

25、ides the basis for all CECC approvals. It incorporates the requirements of ENISO9000:1994 which is widely acknowledged as setting the ground rules for an organisations quality system. It may also be used as the basis for defining policy and procedures relating to product reliability. Many components

26、 fail (i.e. exhibit inadequate reliability) due to inadequate procedures in design, test, customer interface, etc. This guide assists in identifying such procedural deficiencies and provides guidance on the reliability aspects of ENISO 9000. General guidance in applying ENISO9000 to the electronics

27、components industry is under consideration. Process assessment schedules in the CECC 200000 series give additional guidance for specialist processes and services. Attention is also drawn to CECC 00809: GUIDANCE DOCUMENT, QUESTIONNAIRE FOR AUDITING IC AND ASIC MANUFACTURING LINE (based on EN 190000).

28、 CECC 00804 is intended as guidance material for use by engineers, technicians and managers throughout the industry. It is issued as a single document containing the following sections: Section A. Guide: This section helps organisations to prepare for assessment against the Section B Check List by p

29、osing secondary questions and identifying possible acceptable answers. The application of the Check List and Guide by different organisations is described in clauses 0.2 to 0.4 below. Section B. Check List: This section provides a set of questions to be used in assessing an organisations competence

30、in reliability matters. CECC 00804 is supported by CECC 00805: General Guide to Component Reliability, which describes the principles and concepts behind this guide and explains relevant terminology, objectives and “best practices” associated with component reliability. This Issue 2 is now consisten

31、t with EN ISO 9000, and the title has been modified to reflect this. Amendments have been made to the text to enhance clarity. 0.2 Application of CECC 00804 by component manufacturers and specialist contractors By applying this guidance information whilst developing and documenting those procedures

32、necessary to gain CECC approval, component manufacturers and specialist contractors can do much to ensure the reliability of their product or service. The questions are designed to focus the mind of personnel in all parts of the organisation so that appropriate reliability issues are continually con

33、sidered as objectives of their activity. The check list is thus best used for internal audit purposes to assess the current level of competence and to indicate areas for improvement. 0.3 Application of CECC 00804 by other organisations Whilst the prime use of this guide is likely to be in the assess

34、ment of component suppliers or of potential suppliers, much of the guidance given can also be used by other organisations. Attention is drawn to IEC 300-1/ISO 9000-4 “Application (of ISO 9000) for Dependability Management”, which states: “It (dependability assurance) is a responsibility to be shared

35、 by the supplier and customer.” The adoption of similar approaches and close liaison between component manufacturer and customer will do much to reduce the confusions which often lead to unreliability. 0.4 Application of CECC 00804 by auditing bodies When used by auditing bodies, whether second or t

36、hird party, this guide helps to maintain consistency between auditors.CECC00804:1996 4 BSI 12-1999 Guidance 1 Management responsibility 1.1 Does the company have a reliability policy? Has the company consciously addressed reliability? Ideally, there should be a policy statement, signed by a senior e

37、xecutive. 1.2 Who has overall responsibility for implementation of this policy? Who has responsibility is not as important as the fact that a responsible person with sufficient authority has been identified and made known. This responsibility may change through the life cycle of the product, e.g. fr

38、om design to production manager. 1.3 Can suspect reliability be used as a justification for stopping of production? Can production be stopped or other action taken to prevent suspect items from being released to the customer? Ideally continuous monitoring of reliability should prevent the need for s

39、uch action, but there is a need for a staff member of sufficient authority to warn of the risks of releasing items where reliability may not satisfy customer expectations. 1.4 Is the reliability organisational structure clearly defined? Again, the issue is not so much what the structure is, but whet

40、her that structure is defined and known to all involved. Organisational charts should clearly indicate the division of responsibilities. 1.5 Who has responsibilities for liaison with customers on reliability issues? It is important that all customer needs are understood and communicated to the desig

41、n and production teams. There is a particular difficulty with reliability since each market tends to have very specific requirements. The reliability of components supplied to a given customer depends not just upon the systems electrical and mechanical design, but also upon the environment in which

42、it will work. The relevant experience necessary to perform this function includes: a) An understanding of the product, processes and typical failure mechanisms. b) An understanding of typical customer requirements and field conditions. 1.6 How are the reliability functions integrated? It is vital th

43、at reliability functions are an integral activity with all design and manufacturing processes. This is particularly important where a separate group exists which provides the reliability expertise because only by good engineering will high reliability be achieved. Similarly, there is a close relatio

44、nship between quality and reliability and it may be beneficial in some cases for quality and reliability plans to be combined so that possible duplications and/or conflictions are avoided. 1.7 Who has responsibility for reliability verification? Within the organisation consideration should be given

45、to the verification tasks which have to be undertaken to ensure that the delivered products will satisfy its reliability objectives. 2 Quality system (Not applicable) 3 Contract review NOTEThis section only applies to contracts for component development and to production contracts in which the custo

46、mer has included reliability requirements. 3.1 Are contracts vetted for acceptable reliability clauses? As stated in 1.5, the first and most significant stage in satisfying a reliability requirement is to understand what those requirements are. At the electronic system level, it is becoming increasi

47、ngly common for contracts relating to major development projects to include penalty or bonus clauses related to reliability.CECC00804:1996 BSI 12-1999 5 Definition of reliability/performance according to the “IEC 191-02-06, Dependability Terms”: “Theability of an item to perform a required function

48、under given conditions for a given time interval”. By considering this definition it can be clearly seen that a contract must define: a) A value of intrinsic reliability usually expressed as a failure rate based on an assessment of components. b) The functions that are to be performed by the device

49、c) The environment to which the product is subjected. This includes the electrical and mechanical environment as well as temperature, vibration, and humidity aspects. d) The time interval for which a) above is applicable. In some cases there may be different reliability values for different time intervals. In particular, a shelf life, if applicable, needs to be clearly specified. It can be very useful, particularly for complex devices, to also define the functions and environments in which the device will not function, i.e. the definition of the term