BS-QC-001002-3-1997.pdf

BRITISH STANDARD BS QC 001002-3:1997 Rules of Procedure of the IEC Quality Assessment System for Electronic Components (IECQ) Part 3: Approval procedures, including a new clause on Technology Approval ICS 31.020 Licensed Copy: London South Bank University, London South Bank University, Sat Dec 09 01:23:37 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS QC 001002-3:1997 This British Standard, having been prepared under the direction of the Electrotechnical Sector Board, was published under the authority of the Standards Board and comes into effect on 15 March 1997 © BSI 11-1998 The following BSI references relate to the work on this standard: Committee reference L/9/3 Announced in BSI Update February 1997 ISBN 0 580 27309 1 Committees responsible for this British Standard The preparation of this British Standard was entrusted by Technical Committee L/9, Electronic components policy committee, to Subcommittee L/9/3, Quality assessment procedures, upon which the following bodies were represented: Federation of the Electronics Industry National Supervising Inspectorate (BSI PC) Amendments issued since publication Amd. No.DateComments Licensed Copy: London South Bank University, London South Bank University, Sat Dec 09 01:23:37 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS QC 001002-3:1997 © BSI 11-1998i Contents Page Committees responsible Inside front cover National forewordii 1Approval of a National Supervising Inspectorate1 2Requirements for the approval of an organization1 3Qualification approval of electronic ocmponents1 4Capability approval of an electronic component manufacturing facility1 5Approval of specialist contractors processes and/or products within the electronic components industry1 6Technology approval of electronic component manufacturers1 6.1Definitions1 6.2General procedures2 6.3Management responsibility2 6.4TA requirements2 6.5Verification4 6.6Product documentation4 6.7Procedure for TA5 Annex A Application for Technology Approval7 Annex B IECQ Audit. Statement of readiness. Company Declaration8 Annex C Form and content of a Technology Approval Declaration Document (TADD)9 List of references Inside back cover Licensed Copy: London South Bank University, London South Bank University, Sat Dec 09 01:23:37 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS QC 001002-3:1997 ii © BSI 11-1998 National foreword This British Standard reproduces verbatim QC 001002-3:1995 and implements it as the UK national standard. This British Standard is published under the direction of the Electrotechnical Sector Board whose Technical Committee L/9 has the responsibility to: aid enquirers to understand the text; present to the responsible international/European committee any enquiries on interpretation, or proposals 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 Standard 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. Cross-references Publication referred toCorresponding British Standard QC 001002:1986BS QC 001002:1991 Rules of Procedure of the IEC Quality Assessment System for Electronic Components (IECQ) QC 001002-2:1995BS QC 001002-2:1997 Documentation, including a new clause on regulations for Technology Approval Schedules QC 001005:1995BS QC 001005:1995 Register of firms, products and services approved under the IECQ system, including ISO 9000 ISO 9001:1994BS EN ISO 9001:1994 Quality systems. Model for quality assurance in design, development, production, installation and servicing ISO 9002:1994BS EN ISO 9002:1994 Quality systems. Model for quality assurance in production, installation and servicing Summary of pages This document comprises a front cover, an inside front cover, pages i and ii, pages 1 to 12, an inside back cover 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. Licensed Copy: London South Bank University, London South Bank University, Sat Dec 09 01:23:37 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS QC 001002-3:1997 © BSI 11-19981 1 Approval of a national supervising inspectorate See QC 001002:1986 clause 9 and Amendment 2:1994. 2 Requirements for the approval of an organization See QC 001002:1986 clause 10 and Amendment 2:1994. 3 Qualification approval of electronic components See QC 001002:1986 clauses 11 and 12, and Amendment 2:1986. 4 Capability approval of an electronic component manufacturing facility See QC 001002:1986 clauses 11 and 12, and Amendment 2:1986. 5 Approval of specialist contractors processes and/or products within the electronic components industry Under consideration 6 Technology approval of electronic component manufacturers Introduction Technology Approval is a method of approving a complete technological process (design, process realization, product manufacture, test and shipment) covering the approval aspects common to all products as determined by the technology under consideration. This method has evolved to meet the needs of users and manufacturers and incorporates many of the latest principles and techniques in the management of quality, that is to say TQM. It extends the existing approval concepts by adding the following principles as mandatory aspects of Technology Approval: 1) the use of in-process control methods (of which SPC is an example) as defined in the TAS and tools to demonstrate adequate control of processes and products. SPC methods shall be in operation at the initial approval to this clause or within a period of 12 months from approval being granted; 2) continuous quality improvement strategy and its demonstration; 3) monitoring the overall technologies and operations associated with the design and manufacturing processes as well as the components themselves; 4) procedural flexibility due to the approval being based on a companys own quality assurance management system and market sector requirements; 5) the acceptance of a manufacturers operational documentation to provide a means for rapid approval or extension of approval. 6.1 Definitions The terms and definitions specific to this clause are as follows: 6.1.1 control site the location of the manufacturer having overall responsibility for operation of the IECQ System and all quality related matters within the approved organization, and in which the manufacturer is capable of operating at least one of the processes within the scope of the Technology Approval 6.1.2 quality indicator a statistical measure of the relative quality of a process 6.1.3 test vehicle the generic term for a product-related device or test structure used to verify, analyze or monitor engineering processes or electrical/physical features 6.1.4 critical process step a step which has a major influence on the outcome of the process 6.1.5 technology approval declaration document (TADD) a document describing the manufacturers organization and scope of technology. The content of a TADD is fully described in annex C to this clause 6.1.6 technology approval schedule (TAS) a technology dependent document, written in accordance with the requirements of QC 210000 describing the minimum declarations, technical requirements and controls to be demonstrated and maintained under a manufacturers Technology Approval Licensed Copy: London South Bank University, London South Bank University, Sat Dec 09 01:23:37 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS QC 001002-3:1997 2 © BSI 11-1998 6.2 General procedures 6.2.1 Eligibility for Technology Approval 6.2.1.1 Relationship between Organization Approval and Technology Approval (TA) TA may only be granted to a manufacturer who already holds Manufacturers Approval in accordance with the requirements of QC 001002-3, clause 2 including, as appropriate, those of ISO 9001 or ISO 9002 and, additionally, the requirements of this clause. These approvals may also be carried out in parallel, although TA shall not be granted in advance of Manufacturers Approval. NOTE 1Organization approval with respect to TA is based on a Technology Approval Schedule (TAS) and not on a Generic specification. 6.2.1.2 Off-site operations Design, manufacture and test may take place in any geographic location provided that the TA is managed from an IECQ approved manufacturing facility, which shall act as the Control Site. 6.2.1.3 Control Site The Control Site shall have local capability to perform at least one of the main technical processes, as defined in the TAS, within the scope of the TA. 6.2.2 Application for TA The manufacturer shall apply in writing to the National Certification Body (NCB), with a copy to the National Supervising Inspectorate (NSI), stating the scope of the proposed TA, as defined in the appropriate TAS, or draft TAS, and clearly defining the activities and technologies for which the approval is sought. An example of the application form is given in annex A. 6.3 Management responsibility 6.3.1 Management commitment The manufacturer shall provide a statement of his corporate managements commitment to continuous quality improvement and customer satisfaction. This statement shall be supported by evidence of its implementation. The statement shall be included in the manufacturers Technology Approval Declaration Document (TADD). 6.3.2 Operational infrastructure In addition to the manufacturers Quality Manual, as covered by QC 001002-3, clause 2, the TADD shall define his operational infrastructure (if not already contained within the manufacturers Quality Manual). This infrastructures shall include a) Management structure. The manufacturer at the Control Site shall establish a declared organization called, for example, Technical Review Board (TRB). The TRB shall manage the TA and ensure the conduct of periodic system reviews. A TRB, or equivalent, shall control, stabilise, monitor and improve the approved manufacturing line. The TRB shall have a methodology in place for assessing the current status of the quality and reliability of its components. The TRB shall be responsible for the global optimization of the controlled technology. b) Additional responsibilities of the Designated Management Representative (DMR) The DMR shall be responsible, on behalf of the manufacturers corporate management, for providing leadership and facilitating progress in all sites covered by the TA. The DMR shall ensure that corporate management policy relevant to the TA is reviewed and revalidated internally on an annual basis, as a minimum. The DMR, as a part of the management structure, shall be a member of the TRB. c) Technical decision-making The manufacturer at the Control Site shall declare the procedures by which decisions are made on all matters related to the TA. 6.4 TA requirements 6.4.1 TADD The manufacturer shall generate a TADD as part of his application for TA. The TADD shall relate to the entire scope of the proposed TA and be fully maintained during the life of the approval. 6.4.2 Requirements for a TADD The manufacturer shall produce a TADD which gives a detailed amplification of each of the following items: a) management commitment to quality; b) description of the technology and processes; c) definitions of the relevant sites and operations; d) test vehicles; e) internal audit plan; f) quality improvement programme; g) statistical methods of evaluation; h) management of non-conforming products or activities; i) new product introduction programme; j) inter-relationship with subcontractors; k) company definitions and symbols; l) reference to the register of components covered by TA. Licensed Copy: London South Bank University, London South Bank University, Sat Dec 09 01:23:37 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS QC 001002-3:1997 © BSI 11-19983 NOTE 2It is not intended that the TADD should duplicate existing company documentation. It is therefore permissible for the TADD to make reference to existing documents under each individual clause heading. 6.4.3 Use of specialist contractors and subcontracting 6.4.3.1 Any stage of manufacturing may be carried out by specialist contractors or, under certain conditions, subcontracted to non-approved organizations (see 6.4.3.3, 6.4.3.4 and 6.4.3.6). 6.4.3.2 The TAS may allow all forms of subcontracting, or forbid it on technical grounds. The TAS may, if necessary, include any special requirements, for example for specific successive stages to be performed by the same manufacturer. 6.4.3.3 When subcontracting is permitted by the TAS, this may be undertaken provided that the DMR is able to demonstrate to the NSI that the process(es) concerned is (are) a) performed in a manner which satisfies the appropriate requirements of the relevant Process Assessment Schedule(s) (PAS(s) in the QC 200000 series, or, b) carried out satisfactorily in accordance with criteria defined, or referred to, in the TADD. 6.4.3.4 To verify the satisfactory conduct of subcontracted operations in accordance with 6.4.3.3 a) or 6.4.3.3 b), the manufacturer shall ensure that when quality conformance testing is performed under his control in an approved laboratory, it shall be located in an IECQ member country, or exceptionally in accordance with 6.4.3.7. 6.4.3.5 The manufacturer, when applying for TA, shall state whether stages of the manufacturing process are carried out by one or more specialist contractors in accordance with 6.4.3.1, or are subcontracted in accordance with 6.4.3.3, and shall identify the stages. 6.4.3.6 If subcontractors not approved within the IECQ System are used, the manufacturer shall describe the method of control of all the subcontracted stages or operations. 6.4.3.7 Where tests are carried out by test laboratories not approved within the IECQ System, the approved manufacturer shall produce a document which describes the surveillance arrangements by which he shall ensure that the testing to be carried out shall comply with the specification. Where possible, the nominated test laboratory shall be approved to ISO/IEC Guide 25 by a nationally recognized accreditation body. The document shall define how the nominated test laboratory a) ensures that its relevant staff possesses the necessary competence and its relevant test facilities are completely adequate for purpose; b) proposes to operate the test; c) ensures that it has an adequate system for the calibration of its relevant measurement and test equipment and can provide adequate traceability to national standards. In establishing the degree of surveillance necessary, account shall be taken of any current approvals and/or registrations held by the nom