1、DRAFT FOR DEVELOPMENT DD ENV 190000-6:1994 Generic Specification: Monolithic integrated circuits Procedurefor approvaland qualitymanagementDD ENV 190000-6:1994 This Draft for Development, having been prepared under thedirection of the Electronic Components Standards PolicyCommittee, was publishedund
2、er the authorityofthe StandardsBoardand comesintoeffect on 15August1994 BSI12-1999 The following BSI reference relates to the work on this Draft for Development:92/27858 DC Committee reference ECL/24/3 ISBN 0 580 23393 6 Cooperating organizations The European Committee for Electrotechnical Standardi
3、zation (CENELEC), under whose supervision this European Prestandard was prepared, comprises the national committees of the following countries: Austria Italy Belgium Luxembourg Denmark Netherlands Finland Norway France Portugal Germany Spain Greece Sweden Iceland Switzerland Ireland United Kingdom A
4、mendments issued since publication Amd. No. Date CommentsDD ENV 190000-6:1994 BSI 12-1999 i Contents Page Cooperating organizations Inside front cover National foreword ii Foreword 2 Text of ENV190000-6 3 National annex NA (informative) Committees responsible Inside back cover National annex NB (inf
5、ormative) Cross-references Inside back coverDD ENV 190000-6:1994 ii BSI 12-1999 National foreword This Draft for Development has been prepared under the direction of the Electronic Components Standards Policy Committee. It is identical with European Prestandard ENV190000-6:1993 Generic Specification
6、: Monolithic integrated circuits. Procedure for approval and quality management published by the European Committee for Electrotechnical Standardization (CENELEC). The UK actively participated through BSI Technical Committee ECL/24. This publication is not to be regarded as a BritishStandard. It is
7、being issued in the Draft for Development series of publications and is of a provisional nature because the subject matter is still under technical development requiring wider exposure. It should be applied on this provisional basis so that information and experience of its practical application may
8、 be obtained. Comments arising from the use of this Draft for Development are requested so that UK experience can be reported to the European organization responsible for its conversion to a European Standard. A review of this publication will be initiated2years after its publication by the European
9、 organization so that a decision can be taken on its status at the end of its three-year life. The commencement of the review period will be notified by an announcement in BSINews. According to the replies received by the end of the review period, the responsible BSI Committee will decide whether to
10、 support the conversion into a European Standard, to extend the life of the prestandard or to withdraw it. Comments should be sent in writing to the Secretary of BSI Technical Committee ECL/24, at2Park Street, LondonW1A2BS giving the document reference and clause number and proposing, where possible
11、, an appropriate revision of the text. Summary of pages This document comprises a front cover, an inside front cover, pagesi andii, theENV title page, pages2 to16, an inside back cover and a back cover. This standard has been updated (see copyright date) and may have had amendments incorporated. Thi
12、s will be indicated in the amendment table on the inside front cover.EUROPEAN PRESTANDARD PRNORME EUROPENNE EUROPISCHE VORNORM ENV190000-6 November1993 UDC Descriptors: Quality, electronic components, monolithic integrated circuits English version Generic Specification: Monolithicintegratedcircuits
13、Procedureforapprovalandqualitymanagement Spcification gnrique: Circuits intgrs monolithiques Procdure pour lagrment et la gestion de la qualit Fachgrundspezifikation: Monolithische integrierte Schaltungen Anerkennungsverfahren und Qualittslenkung This European Prestandard (ENV) was approved by the C
14、ENELEC Electronic Components Committee (CECC) on28October1992 as a prospective standard for provisional application. The period of validity of this ENV is limited initially to three years. After two years the members of the CENELEC Electronic Components Committee (CECC) will be requested to submit t
15、heir comments, particularly on the question whether the ENV can be converted into a European Standard (EN). CENELEC Electronic Components Committee (CECC) members are required to announce the existence of this ENV in the same way as for an EN and to make the ENV available promptly at national level
16、in an appropriate form. It is permissible to keep conflicting national standards in force (in parallel to the ENV) until the final decision about the possible conversion of the ENV into an EN is reached. CENELEC members are the national electrotechnical committees of Austria, Belgium, Denmark, Finla
17、nd, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom. The membership of the CECC is identical, with the exception of the national electrotechnical committees of Greece, Iceland and Luxembourg. CECC European Com
18、mittee for Electrotechnical Standardization Comit Europen de Normalisation Electrotechnique Europisches Komitee fr Elektrotechnische Normung Central Secretariat: rue de Stassart 35, B-1050 Brussels 1993 Copyright reserved to CENELEC members Ref. No. ENV190000-6:1993 EENV 190000-6:1994 BSI 12-1999 2
19、Foreword The CENELEC Electronic Components Committee (CECC) is composed of those member countries of the European Committee for Electrotechnical Standardization (CENELEC) who wish to take part in a harmonized System for electronic components of assessed quality. The object of the System is to facili
20、tate international trade by the harmonization of the specifications and quality assessment procedures for electronic components, and by the grant of an internationally recognized Mark, or Certificate, of Conformity. The components produced under the System are thereby acceptable in all member countr
21、ies without further testing. This European Prestandard was prepared by CECCWG9, Integrated Circuits. The text of the draft based on document CECC(Secretariat)3117 was submitted to the formal vote; together with the voting report, circulated as document CECC(Secretariat)3251, it was approved by CECC
22、as ENV190000-6 on28October1992. The following dates were fixed: Contents Page Foreword 2 1.1 Introduction 3 1.2 Scope 3 2 General 7 2.1 Related documents 7 2.1.1 Documents 7 2.1.2 Conflicting requirements 7 2.2 General procedure 7 2.2.1 Purpose 7 2.2.2 Process capability demonstration 7 3 TQM progra
23、mme 7 3.1 Technology Review Board (TRB) Organizationand duties 7 3.1.1 Organizational structure 7 3.1.2 TRB Duties 7 3.2 TQM Plan 8 4 EQML certification 8 4.1 EQML documentation 8 4.2 Process capability demonstration 9 4.3 Management/technology validation 10 Page 4.3.1 Management validation 10 4.3.2
24、 Technology validation 10 4.4 Task certification 10 5 Audits 11 5.1 Associated experts 11 5.2 Experts skills and know-how 11 5.3 Rules for use of external experts 11 5.3.1 Responsibilities 11 5.3.2 Choice and acceptance 11 5.3.3 References and experts correlation 11 6 EQML qualification 12 6.1 Eligi
25、bility 12 6.2 Demonstration vehicles 12 6.3 Test plan 12 6.4 Test report 12 6.5 Test failures 12 6.6 Listing 12 7 Release of certified products 12 7.1 Standard quality conformance testing (option1) 13 7.2 In-line control testing (option2) 13 7.3 Certification of conformity and acquisition traceabili
26、ty 14 8 EQML maintenance 14 8.1 Maintenance/retention of EQML 14 8.2 Status report 14 8.3 Change procedure 15 8.3.1 Change to TQM programme 15 8.3.2 Technology change procedures 15 8.4 EQML removal 15 8.5 EQML line shut-down 15 Annex 1 Suggested outline for the TQM plan 16 Annex 2 List of abbreviati
27、ons 16 Figure 1 Example of manufacturing line flowdiagram 4 Figure 2 Example of routes for EQML approval 6 latest date of announcement of the ENVat national level (doa)1994-01-11ENV 190000-6:1994 BSI 12-1999 3 1.1 Introduction Products dedicated to one application and produced in (relatively) small
28、quantities cannot be fully identified in a QA system and do not lend themselves to cost effective sampling systems for assessed quality. Qualification Approval or Capability Approval can be used in “Product Oriented Manufacture” (POM) processes whereas “Design Oriented Manufacture” (DOM) processes r
29、equire the adoption of a non “Product Oriented” Qualification System. This has resulted in the consideration of a new standard for ICs and ASICs based on QA systems already in use in the CECC and National organizations. The new system being based on built-in quality from the design phase to the fabr
30、ication. This is the aim of the so called “QML” US approach, this forms the basis of the current standard which proposes European QML (EQML: European Qualified Manufacturing Line) as a third way for implementing Quality Assurance in Europe (as an alternative to QPL and Capability Approval systems).
31、This approach puts the emphasis on: application of the Total Quality Management principles; built-in quality; constant improvement plan for Quality and Reliability; responsibility of the manufacturer/design centre for quality; use of statistical process control (SPC) techniques, where applicable, fo
32、r process quality management and improvement; delivery of suitable components with the suitable quality for all the market segments; changes to be permitted, more so they are recommended as a fundamental way of improving process quality. 1.2 Scope This specification establishes the general requireme
33、nts for components and the quality and reliability assurance requirements which shall be met for their acceptance within Europe. Detail requirements, specific characteristics of components and other provisions which are sensitive to the particular use intended shall be specified in the detail specif
34、ication. The foundation of the manufacturing process approval is the basis of Total Quality Management (TQM) within the manufacturing environment. TQM requires that all levels of management be actively involved in the commitment to quality. A Technology Review Board (TRB) shall be established to con
35、trol, stabilize, monitor and improve the qualified technology. The TRB shall develop a Total Quality Management Plan that outlines how the manufacturing operation for a given manufacturing flow is controlled, monitored and improved throughout its entire “Life Cycle”. Key aspects of this plan are the
36、 establishment of Statistical Process Control, Field Failure Return Programmes, Corrective Action Procedures, Quality Improvement and any other approaches required to control and improve product quality, reliability and service. These requirements are detailed in this document. Quality assurance req
37、uirements outlined herein are for all components built on a manufacturing line which is controlled through a manufacturer Total Quality Management (TQM) programme and has been certified and qualified as per the requirements herein. The manufacturing line shall be a continuous process flow for all co
38、mponents. A single level of product assurance is provided for in this specification. The certification and qualification requirements found herein are the requirements which allow manufacturers to be registered in the list of qualified manufacturers (EQML). The manufacturer Process Qualification lea
39、ding to EQML requires a manufacturing line or technology flow certification and qualification. On-going monitoring techniques will be used to maintain EQML status. The manufacturing line consists of facilities and procedures appropriate to accomplish the design, specific tool making, fabrication, ma
40、terial procurement, testing, packing and delivery of components and the customer support (see Figure 1). After registration on the EQML list, the manufacturer shall continually meet the baseline certified/qualified procedures, the TQM Programme, the TRB, the Status Reporting and specific requirement
41、s for all EQML products of the appropriate technology. The tests which shall be performed on each product built are defined in the relevant CECC specification.ENV 190000-6:1994 4 BSI 12-1999 Figure 1 Example of manufacturing line flow diagramENV 190000-6:1994 BSI 12-1999 5 Further, this ENV describe
42、s the procedures and requirements for EQML Registration. Registered manufacturers will be able to produce components without the need for extensive end-of-manufacturing qualification testing and quality conformance inspections on each component. The reduction of the end-of-manufacturing testing will
43、 be replaced with in-line monitoring and testing and Statistical Process Control (SPC). Also, surrogate devices, such as the Standard Evaluation Circuit (SEC) will be used to assess the technologys reliability. Introduction of this methodology shifts the emphasis from the need of individual componen
44、t Qualification Approval to process (technology) certification and qualification and thereby will accelerate the component insertion cycle of high quality and reliable components. The requirements defined by this ENV provide a baseline for all manufacturers. As the technology matures and reliability
45、 and quality data are gathered, the manufacturer through the TQM programme and Technology Review Board (TRB) may modify, substitute or delete tests. Notification of such actions shall be detailed in the Status Report submitted to the ONS and related documents shall demonstrate the efficiency of such
46、 actions and shall be accessible to the ONS. The procedure for manufacturer Process Approval is accomplished in two stages: certification and qualification. The process of certification is the recognition of evidence by the ONS that the manufacturer is capable of producing and delivering components
47、of high quality that comply with the requirements of this document. Qualification is the actual demonstration of the certified manufacturing line capabilities by producing “first pass” components complying with the requirements of this document or related specific documents and the device specificat
48、ion. In Figure 2, each task can be individually reviewed, but shall be certified as a flow. The only process flow which would be qualified (EQML listed) would be the group of tasks which are linked together and validated during approval. The letters “A” and “B” indicate an EQML task where qualificat
49、ion testing has qualified a complete path. The other paths are not EQML approved until certification and qualification testing of the processes has been completed. NOTEIn the case of a task being subcontracted to a third party, the company involved shall also be certified for the line involved. This implies similar requirements for the subcontractor such as TRB, line capabilities etc. and interface on each side under TRB control. TQM does not stop when a manufacturer is listed on EQML. This ENV identifies the necessary screening which
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