International SEMATECH Semiconductor Industry Standards Conformance Guidelines: Accreditation Processes and Criteria
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1 Semiconductor Industry Standards Conformance Guidelines: Accreditation Processes and Criteria
2 and the logo are registered service marks of International SEMATECH, Inc., a wholly-owned subsidiary of SEMATECH, Inc. Product names and company names used in this publication are for identification purposes only and may be trademarks or service marks of their respective companies. 2002, Inc.
3 Semiconductor Industry Standards Conformance Guidelines: Accreditation Processes and Criteria December 20, 2002 Abstract: This document from the MFGM017 project provides criteria in applying consistent processes for assuring competent, independent assessment of conformance of a product to an industry standard. Intended audiences are accreditation bodies who evaluate and accredit third-party test service providers (TSPs) and third-party TSPs to understand the processes for becoming accredited. The guideline provides criteria for accreditation bodies as well as recommended processes for thirdparty TSP candidate application and evaluation. This document complements Technology Transfers # A-ENG, ISMT Semiconductor Industry Standards Conformance Guidelines: Overview; # A-ENG, TSP Criteria; and # B-ENG, Assessment Processes. This version 1.0 is subject to change and may be revised. NOTICE: makes no warranties or representations as to the suitability or application of this guideline. The application of this guideline, in part or in whole, is the sole responsibility of the user of this guideline. Users of this guideline are cautioned to consider any manufacturer s instructions, regulatory requirements, contractual agreements, and other relevant materials in the application of the guidance provided herein. This document may undergo further development and is subject to change at the discretion of. This document is intended as a reference only. Guidance provided herein is not intended to represent or imply industry standard practices or specifications. Keywords: Procedures, Standards, Test Methods, Standards Conformance Authors: Jackie Ferrell, Lorn Christal Approvals: Lorn Christal, Author Jackie Ferrell, Program Manager, Guidelines & Standards Randy Goodall, Assoc. Director, Fab Productivity Laurie Modrey, Technical Information Transfer Team Leader
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5 iii Table of Contents REVISION HISTORY AND SCHEDULE...IV 1 INTRODUCTION Background Purpose Benefit Scope Limitations ACCREDITATION BODY Essential Element: Authorization Essential Element: Accreditation Body Company Synopsis Essential Element: Role and Responsibilities Essential Element: TSP Application and Evaluation Process Essential Element: Assessment Certification Marks and Certificates of Conformity Essential Element: TSP Audits and Reviews Essential Element: Cancellation of Accreditation Essential Element: Complaints and Appeals Essential Element: Quality Processes of an Accreditation Body...6 APPENDIX A ESSENTIAL ELEMENTS AND REQUIREMENTS...7 APPENDIX B REFERENCES AND RELATED DOCUMENTS...8 B.1 Industry Standards Organizations...8 B B.3 Additional Information...9 List of Figures Figure 1 TSP Application Process...4 List of Tables Table 1 Accreditation Body Essential Elements and Requirements...7
6 iv Acknowledgments Authors: Timothy Aanerud, Objective Solutions; George Collins, Rudolph Technologies; Guy Davis, Brooks-PRI/CCST; Jackie Ferrell, ISMT; Steve Fulton, ISMT; Tom Hogel, TRW; Walter Moore, Asyst Connectivity Technologies; Debora Ortiz, TRW: Jessee Ring, Software Quality First; Glenn Stefanski, IBM Contributors: Norman Beasley, Consultant; Jonathan Chang, TSMC; Blaine Crandell, TI; Lorn Christal, ISMT; Peter Cross, Intel; Stephen Gramlich, AMD: Les Marshall, AMD; Richard Oeschner, Fraunhofer; Craig Otteson, TI; Keith Peden, Brooks/CCST; Dave Reis, Applied Materials; Scott Rhodes, TRW; Max Tu, TSMC Revision History and Schedule Date Revision Description Comments Jul 19, 02 Rev 0.01 Preliminary Draft posted on ISMT Website Aug 7, 02 Rev 0.01a Working draft Aug 15, 02 Rev 0.01b Working draft Aug 27, 02 Rev 0.02 Working Draft Oct 22, 02 Rev 0.1 Review Draft for industry feedback on ISMT website Industry review and feedback Separated document into 4 guidelines (Overview, Accreditation, TSP and Assessment) Dec 02 Rev 1.0 Publish on ISMT Website Reformatted to clearly identify requirements (vs. recommendations or processes) 2003
7 1 1 INTRODUCTION 1.1 Background This document supports a formal testing and certification approach for accredited independent (third-party) test service providers (TSPs). The level and formality of a conformance assessment is typically determined by the customer or by an organization acting on behalf of a community of customers. The objective of the accreditation body is to establish and administer formal processes to accredit test service providers and ensure that applicants meet prescribed qualifications to perform conformance assessments of implementations relevant to semiconductor industry standards. Existing accreditation programs and registered test laboratories may address some of the products and components used in semiconductor manufacturing. In other areas, (e.g., for SEMI 300 mm equipment communication standards and safety guidelines), no formal accreditation program is in place. 1.2 Purpose This guideline is intended to provide processes and criteria that accreditation bodies should follow to administer an accreditation function. 1.3 Benefit Managed accreditation of third-party assessment resources is expected to yield a more consistent and reliable accreditation process that, in turn, should lead to uniformly high quality in accredited test service providers. 1.4 Scope The scope of this document includes criteria for organization of accreditation bodies, criteria and processes for application, evaluation and approval of third-party TSP candidates, and requirements for consistent quality, document control and reporting systems (data generation, collection, reporting and archival guidelines) of accreditation bodies. The term certification in this guideline applies only to assessments performed by a TSP under the supervision of an accreditation body. More information on the role, objectives, and operation of accreditation bodies is provided in the sections below. 1.5 Limitations This document is not intended to prescribe, supercede, or otherwise interfere with any contractual agreements or legal relationships between parties in the assessment process. The determination of requirements based on this guideline is solely the responsibility of the users of this guideline. It is anticipated that, at the time of publication, an infrastructure for formal accreditation of third-party TSPs needs to be established in the semiconductor industry. This guideline will not recommend or endorse product brands (test tools, management tools, etc.) but could possibly provide a list of known or acceptable tools, formats, and best practices.
8 2 2 ACCREDITATION BODY 2.1 Essential Element: Authorization REQUIREMENTS: 1. The accreditation body must obtain and maintain authorization. 2. Authorization to serve as an accreditation body is granted by the authorizing agency at its sole discretion. RECOMMENDED PRACTICE The accreditation body may be an existing organization that is a member of the International Accreditation Forum (IAF), an accreditation body operating under the authorization of an established and recognized accreditation program, or a special accreditation board established by the Authorizing Agency. Examples of organizations that maintain and administer recognized accreditation programs include the American National Standards Institute (ANSI), Institute of Electrical and Electronic Engineers (IEEE), International Laboratory Accreditation Conference (ILAC), International Electrotechnical Commission System for Conformity Testing to Standards for Safety of Electrical Equipment (IECEE), and National Institute of Standards and Technology (NIST). 2.2 Essential Element: Accreditation Body Company Synopsis REQUIREMENTS: 1. Ensure that personnel performing accreditation activities are knowledgeable, trained, and experienced in the activities they perform. 2. Make information about authorization, scope, and organization publicly available. 3. Be structured organizationally such that accreditation activities are totally independent of any product development or product management reporting line. RECOMMENDED PRACTICES Staff should have experience in certification, testing, auditing, and record keeping. Staffing levels should adequate to allow accreditation activities to be performed in a thorough and rigorous fashion. The accreditation activities should be performed by full-time personnel. Records should be maintained on staff qualifications. If contract employees are used, they should meet the same qualifications and requirements as regular employees and must be managed similarly. Accreditation bodies may sub-contract out accreditation activities only to qualified organizations. 2.3 Essential Element: Role and Responsibilities REQUIREMENTS: 1. Document, maintain, and administer accreditation processes. 2. Ensure that test services performed by accredited TSPs are done in a professional, rigorous, and competent fashion. 3. Maintain appropriate documents and records.
9 RECOMMENDED PRACTICES Ensure that only qualified organizations become accredited as test service providers. Document and publish a process and criteria for a TSP to achieve accreditation. Receive applications for accreditation and process them in a timely and professional manner. Issue a certificate of accreditation or identification card upon approval for accreditation. Provide a process and criteria for maintaining accreditation. Require an annual report from the accredited TSP on certification activities. Conduct periodic audits of accredited TSPs and provide an audit report to the TSP. Ensure that an organization representing itself as an accredited TSP is actually accredited. 2.4 Essential Element: TSP Application and Evaluation Process REQUIREMENT: 1. Document, publish, and administer the TSP application and evaluation process. RECOMMENDED PRACTICES: Submit the process for TSP application and evaluation to the authorizing body for approval. Ensure that the accreditation application and evaluation processes are rigorously followed. Submit change requests for the TSP application and evaluation process to the authorizing body. Maintain auditable records on each applicant. Document and publish an annual report of accreditation activities and adherence to the defined processes. Candidates applying for TSP accreditation should submit, at a minimum, the following information with their application: A list of personnel who will be doing the assessments and their qualification (education, training, experience) Information on the company history Information on the company s organizational structure Information on the organization s testing and assessment experience A list of the standards the company wants to conduct assessments for and the company s experience with those standards An explanation for how the company will keep current with changes to the standards Information on the testing and assessment tools, techniques, and methods the company will use to perform conformance assessments. Evidence of verification and validation of the test to be performed should be included. Signed Code of Conduct 3
10 4 A two-part review of applicants is recommended: 1) a desktop review and 2) an interview of the applicant. Desktop Review: The desktop review consists of a review of the application form and documentation submitted by the applicant. A set of notes should be made by the reviewer giving comments and identifying issues and questions to be addressed in the interview. Notes from the interview should be saved as part of the application documentation. Interview: An interview of the applicant should be conducted in person, either face-to-face, by phone, or in an e-meeting. During the interview, the information provided by the applicant on the application form and supporting documentation should be verified. In addition, question and issues identified in the desktop review should be addressed. Notes from the interview should be taken and saved as part of the application documentation. Figure 1 illustrates a process for applying for and receiving accreditation as a test service provider. Obtain ap plication form from Accreditation Body Fill out application form, Gather supporting documentation. Send it to the accreditation body. Accreditation body acknowledges receipt of a pplication and supportin g documentation. If any information is missing, the applicant is notified Review application and sup porting documentation. Conduct face-to-face interview with applicant. Make determination on applicant qualification. If n ot qualified, note specific deficie ncies. If applicant is denied accreditation, applicant may request a meeting with accreditation body to review the reasons. The accreditation body may, at its sole discretion, reconsider its decision. Notify applicant of results. Update records of applicants and ac credited TSP s as appropriate. Archive all application documentatio n. Applicants that are denied accreditation may reapply in six months t one year. They only need to show how the deficiencies identified previously have been rectified. Applicants that reapply twice and are not successful must wait one year after the last reapplication, and restart the application process in its entirety. Figure 1 TSP Application Process
11 5 2.5 Essential Element: Assessment Certification Marks and Certificates of Conformity REQUIREMENT: 1. Document and enforce policies on the use, content, and format of certification marks or certificates of compliance (Note: If assessing conformance to a SEMI standard, marks or certificates must comply with SEMI Policy on Marking Equipment to Denote Third Party Determination of Compliance with SEMI Standards and Safety Guidelines. ) RECOMMENDED PRACTICES The accreditation body should require that the accredited TSP provide a report of certification to the accreditation body and the supplier once assessment results have been verified. Certification marks and certificates of conformity may be used to indicate that all essential characteristics of the product have been assessed. To the extent possible, the symbols used in connection with the certification mark should be capable of being interpreted without further definition. Certification marks and accompanying certification documentation must contain the following: The name of the assessor and TSP affiliation, if applicable The standard to which the assessment was performed An assessment results summary Accompanying information, such as a certificate of conformity, should indicate the following: Any relationship that the assessor or TSP may have with the manufacturer Production information such as the lot, batch, or other to allow traceability to the production source and time of production The date the certificate was issued The assessment methodology used to determine conformance The officer of the company responsible for issuance 2.6 Essential Element: TSP Audits and Reviews REQUIREMENTS 1. Conduct an audit of accredited TSPs on a published schedule 2. Provide a formal audit report to the TSP after the audit RECOMMENDED PRACTICES An audit of the TSP is recommended at least every 2 years, and possibly more often, depending on the rate at which requirements and test methods change. The audit should follow standard quality auditing guidelines (see References). The audit verifies that the TSP is adhering to the provision of the accreditation body such as those provided in this document and Technology Transfer # A-ENG, Standards Conformance Guidelines: Assessment Criteria and Processes. A formal audit report must be provided to the TSP.
12 6 In addition, the accreditation body should request an annual report on the assessment activities of the accredited TSP. This report should include the following: The number of assessments performed during that year Changes in personnel performing assessments and their qualifications Changes in assessment method being used or scope of assessments to be perfromed Evidence that current working knowledge of the standards to which conformance assessments are performed has been maintained 2.7 Essential Element: Cancellation of Accreditation REQUIREMENT: 1. Document and deploy policies and processes for cancellation of accreditation RECOMMENDED PRACTICES: The accreditation body should cancel accreditation of a TSP with just cause, such as not adhering to the provision of the accreditation body or other actions that would undermine the integrity of the accreditation and certification processes. The TSP should be provided with the changes in writing and given a reasonable opportunity to respond to them. 2.8 Essential Element: Complaints and Appeals REQUIREMENTS: 1. Document and provide the procedure for filing complaints against accredited TSPs, assessment results, or decisions made by the accreditation body. 2. Provide a timely response to any complainant. 3. Forward appeals to a decision by the accreditation body to the authorizing agency for final decision. 2.9 Essential Element: Quality Processes of an Accreditation Body REQUIREMENT: 1. Follow requirements for reviews or quality audits by the authorizing agency. RECOMMENDED PRACTICE The accreditation body should respond to any issues that are raised as a result of a review or audit in a timely fashion as determined by the authorizing agency. The accreditation body should provide a plan to address any issues identified in the audit.
13 7 APPENDIX A ESSENTIAL ELEMENTS AND REQUIREMENTS Table 1 Accreditation Body Essential Elements and Requirements Section # Essential Element Requirements 2.1 Authorization The accreditation body must obtain and maintain authorization. Authorization to serve in the role of accreditation body is granted by the authorizing agency at its sole discretion. 2.2 Accreditation Body Company Synopsis 2.3 Role and Responsibilities 2.4 TSP Application and Evaluation Process 2.5 Assessment Certification Marks and Certificates of Conformity 2.6 TSP Audit and Review 2.7 Cancellation of Accreditation 2.8 Complaints and Appeals 2.9 Quality Processes of an Accreditation Body Ensure that personnel performing accreditation activities are knowledgeable, trained, and experienced in the activities they perform. Make information about authorization, scope, and organization publicly available. Be structured organizationally such that accreditation activities are totally independent from any product development or product management reporting line. Document, maintain, and administer accreditation processes. Ensure that test services performed by accredited TSPs are done in a professional, rigorous, and competent fashion. Maintain appropriate documents and records. Document, publish, and administer the TSP application and evaluation process. Document and enforce policies regarding the use, content, and format of certification marks or certificates of compliance. Conduct an audit of accredited TSPs on a published schedule. Provide a formal audit report to the TSP after the audit. Document and deploy policies and processes for cancellation of accreditation. Document and provide the procedure for filing complaints against accredited TSPs, assessment results or decisions made by the accreditation body. A timely response by the accreditation body must be provided to any complainant. Appeals to a decision by the accreditation body must be forwarded to the authorizing agency for final decision. Follow requirements for reviews or quality audits by the Authorizing Agency.
14 8 APPENDIX B REFERENCES AND RELATED DOCUMENTS B.1 Industry Standards Organizations (Note: Although the latest known publication date is provided, all documents cited should be the latest published version.) SEMI 1 SEMI Policy on Marking Equipment to Denote Third Party Determination of Compliance with SEMI Standards and Safety Guidelines ANSI 2 ANSI Z34.1 Third Party Certification Program ISO/IEC 3 ISO/IEC Guide 2 Standardization and Related Activities General Vocabulary, Sections ISO/IEC Guide 23:1982 Methods of Indicating Conformity with Standards for Third-Party Certification Systems. ISO/IEC Guide 28:1982 General Rules for a Model Third-Party Certification System for Products. ISO/IEC Guide 39:1988 General Requirements for the Acceptance of Inspection Bodies. ISO/IEC Guide 58:1993 Calibration and Testing Laboratory Accreditation Systems General requirements for operation and recognition ISO/IEC Guide 61:1996 General Requirements for Assessment and Accreditation of Certification/Registration Bodies ISO/IEC Guide 65 General Requirements for Bodies Operating Product Certification Systems ISO/IEC TR 17010:1998 General Requirements for Bodies Providing Accreditation of Inspection Bodies B.2 4 ISMT Semiconductor Industry Standards Conformance Guidelines: Overview, Technology Transfer # A-ENG. ISMT Semiconductor Industry Standards Conformance Guidelines: Test Service Provider Processes and Criteria, Technology Transfer # A-ENG ISMT Semiconductor Industry Standards Conformance Guidelines: Assessment Processes and Criteria, Technology Transfer # A-ENG Semiconductor Equipment and Materials International American National Standards Institute, New York Office: 11 West 42nd Street, New York, NY 10036, USA. Telephone: ; Fax: Website: International Organization for Standardization, ISO Central Secretariat, 1, rue de Varembé, Case postale 56, CH-1211 Geneva 20, Switzerland. Telephone: ; Fax: Website: Montopolis Dr., Austin TX
15 9 B.3 Additional Information Quality Audit Handbook, 2nd Edition, ASQ Quality Audit Division, J.P. Russell, editing director, ISBN X,
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