1、EIA STANDARD Assessment Guide for Process Certification EIA-681 JULY 1996 (Reaffirmed May 2001) ELECTRONIC INDUSTRIES ALLIANCE GOVERNMENT ELECTRONICS AND INFORMATION TECHNOLOGY ASSOCIATION A SECTOR OF Electronic Industries Alliance COPYRIGHT Electronic Industries AllianceLicensed by Information Hand
2、ling Services, NOTICE EIA Engineering Standards and Publications are designed to serve the public interest through eliminating misunderstandings between manufacturers and purchasers, facilitating interchangeability and improvement of products, and assisting the purchaser in selecting and obtaining w
3、ith minimum delay the proper product for his particular need. Existence of such Standards and Publications shall not in any respect preclude any member or nonmember of EIA from manufacturing or selling products not conforming to such Standards and Publications, nor shall the existence of such Standa
4、rds and Publications preclude their voluntary use by those other than EIA members, whether the standard is to be used either domestically or internationally. Standards and Publications are adopted by EIA in accordance with the American National Standards Institute (ANSI) patent policy. By such actio
5、n, EIA does not assume any liability to any patent owner, nor does it assume any obligation whatever to parties adopting the Standard or Publication. This EIA Standard is considered to have International Standardization implication, but the International Electrotechnical Commission activity has not
6、progressed to the point where a valid comparison between the EIA Standard and the IEC document can be made. This Standard does not purport to address all safety problems associated with its use or all applicable regulatory requirements. It is the responsibility of the user of this Standard to establ
7、ish appropriate safety and health practices and to determine the applicability of regulatory limitations before its use. (From Project Number 4967, formulated under the cognizance of the Quality and Reliability Engineering Standards (QRE) Committee.) (This document was reaffirmed by the EIA in May 2
8、001) Published by ELECTRONIC INDUSTRIES ALLIANCE 1996 Technology Strategy & Standards Department 2500 Wilson Boulevard Arlington, VA 22201 PRICE: Please refer to the current Catalog of EIA Electronic Industries Alliance Standards and Engineering Publications or call Global Engineering Documents, USA
9、 and Canada (1-800-854-7179) International (303-397-7956) All rights reserved Printed in U.S.A. COPYRIGHT Electronic Industries AllianceLicensed by Information Handling Services. COPYRIGHT Electronic Industries AllianceLicensed by Information Handling ServicesEIA-68 1 Assessment Guide for Process Ce
10、rtification Table of Contents l. FOREWORD 2. INTRODUCTION 3. PURPOSE 4. SCOPE 5. REFERENCE DOCUMENTS 6. DEFINITIONS 7. ASSESSMENT OBJECTIVES O 8. ASSESSMENT SCHEMES 8.1. First Par Assessment 8. l. l. Pre-Assessment Review 8.1.2. Performing an Assessment 8.1.3. Process Validation 8.1.4. Qualification
11、 8. l. 5. Approval 8.2. Second Party Assessment 8.3. Third Party Assessment 8.3.1. Independent Registrar 8.3.2. Manufacturing Line Approval 8.3.3. Technology Approval 9. AUDITING 9.1. Roles and Responsibilities 9. l. l. Auditors 9.2. Audit Procedure 9.2.1. Initiating the Audit 9.2.2. Preparing the A
12、udit 9.2.3. Executing the Audit 9.2.4. Corrective Action follow-up 1 2 2 2 3 3 5 6 8 8 8 10 11 12 12 12 14 14 16 17 19 i COPYRIGHT Electronic Industries AllianceLicensed by Information Handling ServicesEIA-681 IO. QUALITY SYSTEM MATURITY ASSESSMENT 11. VALIDATION 11.1. Process Certification 11.2. Ad
13、ministration 11.3. Design 11.4. Manufacturing 12. QUALIFICATION OF PRODUCTS 13. CERTIFICATION 14. MAINTENANCE 14.1. Change Notification 14.2. Decertification 19 .1 20 e 20 21 21 21 22 23 23 23 24 11 COPYRIGHT Electronic Industries AllianceLicensed by Information Handling Services. EIA-68 1 Page 1 As
14、sessment Guide for Process Certification 1. Foreword The widespread use of the IS0 9000 series of standards demonstrates that the industry has recognized the need for a comprehensive set of requirements that provides a model for evaluating a producers Quality System . Many companies around the world
15、 have used these standards as a means for evaluating their own quality systems development and have made improvements by correcting deficiencies found during their own assessment process. At the same time, many companies supplier management programs have incorporated the requirement for IS0 9000 com
16、pliance by suppliers in lieu of using their own set of quality systems requirements. A major driving force in the rapid growth in the use of the standards has been the acceptance, by OEMs , of IS0 9000 registration by an independent accredited registrar instead of conducting their own audits. Some c
17、ompanies consider registration of their suppliers a requirement for doing business. Producers gain a third-party certification and subsequent registration by making an arrangement to be audited by an independent registrar. The registrar grants certification and lists the company in its register of c
18、ompanies with certified quality systems when their quality systems documentation and implementation meet the requirements of the applicable IS0 9000 standard,. Although widespread use of third party certifications of the quality systems has been achieved, many -companies have supplemented them with
19、a second- party (purchaser) assessment that has requirements that go beyond the requirements of the IS0 9000 series of standards. Certain market -segment certification schemes, such as in the automotive industry, have added requirements which are considered necessary to satisfy their particular qual
20、ity verification needs. These ISO- 9000 “plus” systems generally focus on adding continuous improvement and customer satisfaction with the supplied product or service. Recently, the concept of allowing a “certified company to qualifj an entire process rather than individual parts has been introduced
21、 and has achieved growing success . Based on this concept , the Electronics Industries Association ( EIA) in the United States produced a generic standard on Process Certification that combined the IS09000 “plus” principles with a process validation requirement for product qualification. The Nationa
22、l Electronic Process Certification Standard, EIA-599, was produced in August 1992 and has been recognized as a comprehensive and non- prescriptive set of requirements that , when achieved , results in a producer that consistently provides a product or service that meets or exceeds the purchasers req
23、uirements. The principles of EIA-599 have been introduced into international assessment schemes for Manufacturing Line Approval under the IEC and Technology Approval under CECC and IECQ. EIA-599, like IS0 9000, provides only the model for process certification and other alternative schemes may be us
24、ed to achieve it. COPYRIGHT Electronic Industries AllianceLicensed by Information Handling ServicesEIA-681 Page 2 It has long been recognized that most companies go through a maturity process of continuous improvement. Many companies start out with a basic means of process control and produce good p
25、roducts. Because of market pressures, a competitive company must introduce ways of reducing cost, and reliability risk to their customers. Previous qualification systems have failed to take into account this natural maturity progression. As outlined in this guide, a producer adhering to the principl
26、es of Process Certification (EIA-599) should receive less external auditing and rely more and more on internal audits and controls as the company follows their maturity progression. The trade offs between maturity level and audit frequency will be discussed in more detail in Section 10 and in Annex
27、A. 2. Introduction The focus of process certification is on the collection of processes that combine to produce products and services to the customers satisfaction. This guide has been developed for use in a variety of assessment schemes to evaluate a producers compliance to the requirements of Proc
28、ess Certification. A common thread used in all of these schemes is the emphasis on the use of the EIA-599 requirements for validation and qualification to confirm and demonstrate that the total system produces the expected results. The goal of this assessment guide is to provide a consistent method
29、for first, second, and third party assessments of a producers facility. . The approach used throughout this guide is that the producers own systems be used to demonstrate, with objective evidence, that the intent and purpose of the particular requirement under evaluation has been satisfied. Variatio
30、n in implementation and technique from producer to producer is acceptable. The elements of this guideline are based on the use of a non-prescriptive approach. In addition to providing a method for assessing compliance ,an option is presented for judging the level of maturity in quality systems devel
31、opment . This is aided by the use of a Quality System Maturity Matrix described in Annex A. Annex B provides flowcharts of the various assessment schemes that are used. A generic checklist for use by either internal or external auditors is provided in Annex C . Annex D provides an example of a check
32、list for combining an IS0 9001 audit with Process Certification in a specific technology. Since compliance to the IS0 9000 series standards is required in EIA-599, it is intended that this Assessment Guide be consistent with the applicable IS0 Standards. 3. Purpose It is the purpose of this document
33、 to provide guidance for companies and registrars to achieve a consistent assessment of a producers compliance to the requirements of Process Certification (EIA-599). In addition , a technique is provided as an option for the assessment of a producers level of quality system maturity. 4. Scope This
34、Afsessment Guide is applicable to any assessment technique that wishes to embrace the principles and concepts presented in the EIA-599 National Electronic Process Certification Standard. COPYRIGHT Electronic Industries AllianceLicensed by Information Handling Services. EIA-68 1 Page 3 5. Reference D
35、ocuments ANSEIA-599 National Electronic Process Certification Standard ISO-9001 Quality Systems-Model for Quality Assurance in Design, Development, Production, Installation and Servicing ISO-9002 Quality Systems- Model for Quality Assurance in Production and Installation ISO-9004 Quality Management
36、and Quality System Elements-Guidelines IS0 100 1 1 - 1 Guidelines for Auditing Quality Systems - Part 1 : Auditing IS0 1001 1-2 Guidelines for Auditing Quality Systems- Part 2: Qualification criteria for quality systems auditors IS0 1001 1-3 Guidelines for Auditing Quality Systems- Part 3 : Manageme
37、nt of audit programs ISO-8402 Quality Management and Quality Assurance- Vocabulary IECQ Rules of Procedure QC O01 002-3 Clause 2 (Organization Approval ) and Clause 6 ( Technology Approval ) JESD3 9-A Quality System Assessment MST Malcolm Baldrige National Quality Award Criteria IEC 1739 Integrated
38、Circuits -Procedures for Manufacturing Line Approval and Quality Management 6. Definitions Assessment A systematic examination of the extent to which an entity is capable of fulflling specified requirements A systematic and independent assessment to determine whether quality activities and related r
39、esults comply with planned arrangements and whether these arrangements are implemented effectively and are suitable to achieve objectives. An organization being audited. A person qualified to perform quality audits. - Audit Auditee Auditor COPYRIGHT Electronic Industries AllianceLicensed by Informat
40、ion Handling ServicesEIA-681 Page 4 Audit Observation A statement of fact made during quality audit and substantiated by objective evidence. A process that, through demonstration and validation, has been determined to produce product capable of consistently achieving or exceeding customer requiremen
41、ts. A person or organization requesting the audit The recipient of a product provided by the supplier. Information which can be proved true, based on facts obtained through observation, measurement, test or other means. A specified way to perform an activity The organization that provides a product
42、to the customer The result of activities or processes A set of interrelated resources and activities which transform inputs into outputs. The determining of relationships between process parameters and process outputs or product characteristics. The process of demonstrating whether an entity is capa
43、ble of hlfilling specified requirements. Quality Evaluation A systematic examination of the extent to which an entity is capable of lfilling specified requirements. All activities of the overall management function that determine the Quality Policy, objectives and responsibilities and implement them
44、 by means such as quality planning, quality control, quality assurance and quality improvement , within the quality system. The organizational structure, responsibilities, procedures, processes, and resources needed to implement quality management. The results generated by activities at the interfac
45、e between the supplier and the customer and by supplier internal activities, to meet the customer needs. Certified Process Client Customer Objective Evidence Procedure Producer Product Process Process Characterization Qualification Process Quality Management Quality System Service COPYRIGHT Electron
46、ic Industries AllianceLicensed by Information Handling Services. EIA-68 1 Page 5 Total Quality Management A management approach of an organization, centered on quality, based on the participation of all its members and aiming at long term success through customer satisfaction, and benefits to the me
47、mbers of the organization and to society. A description of the quality management system. Note: Documentation of this description may take different forms and may be called the Quality Manual or imbedded in the producers operations procedures. It is not the intent of this document to dictate specifi
48、c terminology. However, the terminology of referenced standards will be followed to the extent possible. The Technical ( Technology ) Review Board is the management structure responsible for the process under review. A “RB shall consist of representatives of all fknctions described in the TQM Flan,
49、such as marketing, sales, design, technology development, fabrication, testing and quality assurance as applicable. Confirmation by examination and provision of objective evidence that the particular requirements for a specific intended use are fulfilled. A person certified to perform process validations Confirmation by examination and provision of objective evidence that specified requirements have been fulfilled. TQM Plan TRB or equivalent organization Validation Validator Verification 7. Assessment Objectives The assessment objectives for process certification should be establ
