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1、SUPPLIER QUALITY STANDARD供应商品质标准A SUPPLIER QUALITY MANAGEMENT TOOL FROMGLOBAL SUPPLIER QUALITY ENGINEERING一种供应商品质管理方式 OTPV COMPUTER CORPORATIONCOR.40.PR.SQ.1201999TABLE OF CONTENTS1.0QUALITY SYSTEM REQUIREMENTS品质系统要求41.1Quality Program品质纲要41.2Management Responsibility管理职责41.3Organization组织41.4Qualit
2、y Policies, Procedures, and Work Instructions品质方针、流程、作业指导书41.5Quality Management Plan品质管理计划51.6Internal Audit Program内部稽核计划51.7OTPV AuditsOTPV稽核61.8Training培训62.0CONTRACT REVIEW合同评审63.0DESIGN CONTROL设计变更73.1Design Development and Planning设计规划73.2Design Input设计输入73.3Design Output设计输出73.4Design Review
3、设计评审73.5Design Verification设计验证83.6Design Validation设计确认83.7Design Changes设计变更84.0DOCUMENT CONTROL文件控制84.1Red Line Drawings/Procedural Documentation“红线描述”文件85.0SUPPLIER QUALITY CONTROL供应商供货品质控制95.1Defined Quality and Technical Requirements确定品质、技术要求95.2Sub-tier Supplier Approvals分工方承认95.3Sub-tier Sup
4、plier Audits分工方稽核95.4First Article Inspections首样检验105.5Records记录106.0PRODUCT IDENTIFICATION AND LOT TRACEABILITY产品标示与批量的可追溯性107.0PROCESS CONTROL制程控制107.1Process Qualification制程条件117.2Quality Metrics品质方针117.3Continuous Improvement Program持续改善计划128.0INSPECTION AND TESTING检验与检测128.1Source/Incoming Insp
5、ection and Tests供货/进料检验与测试128.2In-Process Inspection and Testing制程检验与测试138.3Final Inspection and Testing最终检验与测试138.4Shipping Inspection (OBA Testing/Inspection)出货检验（开箱检验/测试）138.5Reliability Testing可靠性测试138.6Inspection and Testing Records检验与测试记录149.0CALIBRATION校验149.1Calibration Procedures校验流程149.2Re
6、call List召回名录149.3Calibration Records校验记录149.4Out of Tolerance (Calibration) Notices校验通知单1410.0INSPECTION AND TEST STATUS检验与测试状态1511.0CONTROL OF NONCONFORMING PRODUCT不合格品控制1511.1Review and Disposition of Nonconforming Products不合格品评审与处理1511.2Corrective Action Process改善流程1612.0HANDLING, STORAGE, PACKA
7、GING, AND DELIVERY处理、存储、包装与运输1612.1Handling处理1612.2Storage存储1712.3Packaging包装1712.4Delivery运输1713.0QUALITY RECORDS品质记录1714.0DELIVERABLES运输1714.1Quality Management Plan品质改善计划1714.2Sub-tier Supplier Management Plans分工方品质改善计划1814.3Internal Audit Program Plan内部稽核计划1815.0DEFINITIONS定义18SUPPLIER QUALITY S
8、TANDARD供应商品质标准OTPV Suppliers shall comply with the quality program requirements set forth in this document. In the event of OTPV的供应商要要按照本文的品质要求去执行conflict between the requirements contained herein and the RFQ/Contract, the RFQ/Contract shall take 本规定与RFQ/Contract相冲突的地方，依RFQ/Contractprecedent. Any ex
9、ceptions to these requirements must be approved by OTPV Global Supplier Quality Engineering (GSQE). 对本规定的任何异义都须经GSQE审核同意后才可执行1.0 QUALITY SYSTEM REQUIREMENTS品质系统要求1.1 QUALITY PROGRAM 品质纲要The Supplier is required to implement and maintain a quality program that shall assure design and manufacture of p
10、roducts is consistent with the requirements of ISO 9001 and 9002. The Supplier shall assure that ISO 9001 requirements are implemented during the design phase and that ISO 9002 requirements are implemented for the manufacturing of product. The Supplier shall notify OTPV GSQE of any changes in its qu
11、ality program prior to implementation.要求供应商制定、执行品质计划，以保证产品的设计及生产符合ISO9000的相关要求，供应商要确保产品的设计符合ISO9001的要求/产品的生产符合ISO9002 的相关要求，供应商品质计划的任何变更都要事先征得OTPVGSQE的同意1.2 MANAGEMENT RESPONSIBILITY 管理职责The Suppliers executive management will develop a company-wide quality policy. This policy will be deployed and u
12、nderstood by all employees. A management review system will be implemented. The Quality policy and system will be reviewed at prescribed intervals to assess the continuing suitability and effectiveness of the quality system. This review will include the quality policy, internal audit results, produc
13、t complaints/returns, process/product quality reports, and others as they apply. Executive management will appoint a management representative with the responsibility/authority to monitor compliance to the system, and to ensure corrective/preventive measures are implemented.供应商的行政管理层要制定公司整体的品质政策，该政策
14、要让全体员工理解/贯彻执行，要建立管理审核系统，要定期召开品质政策和系统的评审会，以保证品质系统的匹配性和有效性。评审内容包括：品质政策、内部稽核、产品抱怨/回复、产品/制程品质报告等等。管理层要任命一名管理代表负责监控系统的运行状况以保证改善/预防改善措施的导入/实施1.3 ORGANIZATION 组织The Supplier will have an organization that supports, implements and maintains the quality system at all levels.供应商要建立相关的组织机构支持、维护系统的有效运行。1.4 QUAL
15、ITY POLICIES, PROCEDURES, AND WORK INSTRUCTIONS品质政策/程序/作业指导书The Supplier shall establish and maintain a documented quality program as a means of ensuring that product and/or services comply with the requirements set forth in this standard. All work affecting the quality of products and/or services s
16、hall be documented in clear and concise policies, procedures, and work instructions. The Supplier shall ensure that these documents are deployed, effectively implemented and understood within the company.供应商要建立、维护有文件规定的品质计划以保证产品/服务能够满足本标准的要求。所有会影响到产品/服务的工作都要有都要有简明的政策、程序或作业知道书去说明。供应商要确保这些文件在公司内的得到有效的
17、管控、实施和理解。1.5 QUALITY MANAGEMENT PLAN 品质管理计划The Supplier shall submit a Quality Management Plan to the Global SQE that describes the overall quality program used for the design, manufacture, test, and inspection of product delivered to OTPV. The Plan shall, at a minimum, describe the following: 供应商要依
18、据GSQE提出全面品质规划建立适用于设计、生产、测试、检验的QMP给OTPV，计划要简单明了、如下所示：q Identification of support team for OTPV (critical contacts)q 明确针对OTPV的支援TEAM（主要联系方式）q Product differences from previous models/partsq 与以前产品/模具的差异q Quality performance goalsq 品质目标q Site matching (if multiple Supplier sites are manufacturing the sa
19、me part for OTPV use)q 坐落位置（如果两个供应商为OTPV生产相同的料件）q Manufacturing processesq 生产流程q Inspection/test strategies and processesq 检验测试方法、规定q Process control techniquesq 制程控制q First article requirementsq 首件要求q Internal change control proceduresq 内部变更控制liucheng q Procedures for handling discrepant material (
20、identification, containment, root cause, corrective action)q 品质变异料件处理流程（分析、隔离、原因、改善）q Failure analysis support for OTPVs line rejects (LRR) and field returns (IFIR)q OTPV产线、市场不良分析报告q Engineering change requirementsq 工程变更要求q Record retentionq 记录保持q Continuous Improvement Program (CIP)q 持续改善1.6 INTERN
21、AL AUDIT PROGRAM 内部稽核The Supplier shall implement an effective internal audit program that provides for the following:供应商按照以下项目开展有效的项目稽核q Gap Analysis (Audit) 隔阂分析（稽核）q System Audits 系统稽核q Process/Product Audits 程序/产品稽核 Only qualified auditors (trained) will conduct audits and will be independent fr
22、om the area being audited. The audit program shall be provided to OTPV GSQE for review and approval. All audit results shall be maintained and made available to OTPV GSQE upon request. 只有经过训练的稽核员才可以开展稽核/并要独立于被稽核对象，稽核计划要提报OTPV GSQE审核同意，所有的稽核报告都要保留，如有需要可提供OTPV GSQE1.7 OTPV AUDITS On a periodic basis,
23、OTPV may conduct audits/visits at the Suppliers manufacturing locations. The Supplier shall, at OTPVs request, permit access to manufacturing operations involved in the production and/or inspection of OTPVs products, including access to sub-contractor facilities. Periodic audits will include quality
24、 inspection data and other data related to the product being produced, or process audits to verify compliance to the contractual requirements.Under normal circumstances, the Supplier shall be given advance notice of OTPVs visits.在一定的时间内，OTPV会去供应商生产地开展稽核/拜访，供应商要遵从OTPV的要求，允许对其制造流程（包括OTPV产品的生产和检验）以及转承包
25、商的厂房开展稽核，定期稽核包括与产品生产相关的品质检验数据和其他数据，以及与协议规定相关的程序稽核。1.8 TRAINING 培训The Supplier shall establish and maintain a program for the identification of training requirements for all personnel that affect the quality of a product during production and installation. Qualification to perform assigned tasks shal
26、l be based on individual education, training and/or experience as required. The Supplier shall also assure that a system exists for the qualification, re-qualification, and disqualification of personnel. As a minimum, training for applicable personnel shall consist of quality system training, auditi
27、ng techniques, Supplier Quality Engineering processes, assembly techniques, workmanship standards, and inspection requirements. Supervisors in the production area shall also have a working knowledge of quality systems and statistics. Records of all training shall be maintained and made available for
28、 OTPV SQE to review upon request.供应商要建立在生产装配过程中与产品品质有关的所有员工的教育培训计划，依据不同的工作内容安排不同的教育计划，同时供应商也应该建立一套制度来对员工的资格进行评定、奖罚。对相应员工的培训应该包括：品质系统、稽核技能、供应商品质管理、总结能力、基本技能、以及必须的（料件）检验能力，产线的主管人员也要具备一定的品管理念。培训要保留相关记录必要时提供OTPV SQE2.0 CONTRACT REVIEW 合同评审The Supplier shall assure that an element of the quality program
29、provides for the effective and timely review of OTPV mandated or implied requirements. The Supplier shall review each contract to ensure that:供应商要保证能够及时有效的制定符合OTPV要求的品质计划中的每一项，同时供应商针对合同中的每项条款要明确以下几点：q OTPV requirements are understood.q OTPV的相关要求已经全部理解q Conflicts between specifications, drawings, and
30、 contract requirements are resolved.q SPEC、工程图、以及合同约定中有矛盾的地方已经得到解决q Assure that any requirements differing from those in the tender are resolved.q 确定略有差异的小问题也已得到解决q The Supplier has the capability to meet contractual requirements.q 供应商能够完成合同条款的相关要求Coordination of such activity is usually performed w
31、ith OTPV Worldwide Procurement and in the event of further information, the Supplier shall notify the OTPV Commodity Manager.3.0 DESIGN CONTROL设计控制The Supplier shall establish and maintain documented procedures to control and verify the design of the product, and all product sub-components, in order
32、 to ensure that specified requirements are met.供应商要建立相关的程序文件管控产品及零件的设计以使产品满足特定的要求3.1 DESIGN DEVELOPMENT AND PLANNING 设计的更新与规划The Supplier shall plan for each design and development activity. The plan shall describe or reference these activities and define responsibility for the implementation. Quali
33、fied personnel shall perform the design and development activities. Plans shall be updated and regularly reviewed with appropriate OTPV organizations as the design evolves.供应商要对产品的每次设计和变更制定规划。阐述变更内容明确变更要求，以使相关人员规范作业。规划要经OTPV的相关设计部门同意后再做更新3.2 DESIGN INPUT设计导入The Supplier shall implement a system and
34、associated processes to ensure contractual and/or customer requirements are clearly identified. In addition the Supplier shall assure that applicable statutory and regulatory requirements are also identified, documented, and their selection reviewed for adequacy.供应商要确保其系统及相关程序已经对合同条款及客户的要求做出明确规定，另外，
35、供应商还要确定相关的法令、制度已经制定、备档并经过审核。3.3 DESIGN OUTPUT 设计实施The Supplier shall implement a system and processes to assure design can be assessed for the following:供应商要制订程序保证产品设计满足以下要求：q Verification that design meets all design input requirements.q 保证产品的设计方案满足料件投入设计的要求q Contains, or make reference to, accepta
36、nce criteria as identified in specifications.q 产品的设计方案要符合SPEC的各项要求q Identification of characteristics that are crucial to the safe and proper functioning of the product.q 鉴定产品关键的结构与安全参数All design output documents shall be reviewed prior to release by the design and quality engineering function at OT
37、PV and Supplier.所有产品的设计方案都要经OTPV和供应商设计、品质部门审核后方可实施3.4 DESIGN REVIEW 设计评审The Supplier shall assure that design is reviewed at appropriate levels of development. Records of these reviews shall be kept and made available for OTPV to review upon request. In addition, formal design reviews are to be held
38、 with OTPV at key milestones in the development process.供应商要保证产品的设计达到一定的开发水平，评审记录要保留以便需要的时候提交OTPV审核。另外，产品开发过程中的重要问题点要由OTPV召开正规的评审会3.5 DESIGN VERIFICATION设计验证During the different stages of design (i.e. EVT, DVT, PMT), the Supplier shall perform verifications to ensure the design meets customer requir
39、ements as defined for the current stage of product development. Any or all design verification activities shall be recorded and functional samples made available for the OTPV SQE to review upon request.针对产品的不同设计阶段(i.e. EVT, DVT, PMT)，供应商要保证产品的设计验证结果符合客户对所开发产品的各项要求。所有的验证结果和样机都要保留以便OTPV审核。3.6 DESIGN V
40、ALIDATION 设计确定The Supplier shall perform design validation testing or analysis to ensure that product conforms to defined OTPV needs and/or requirements. Records of any or all validation testing shall be kept and functional samples made available for the OTPV SQE to review upon request.供应商要对设计方案进行测试
41、和分析保证产品满足OTPV的需要和要求，所有的测试记录和样机都要保留以便OTPV审核。3.7 DESIGN CHANGES设计变更All design changes and/or modifications shall be identified, documented, researched and approved by authorized personnel at the Supplier. Final approval for these changes shall be submitted to OTPV GSQE for written approval prior to im
42、plementation.所有的设计变更和修正都要进行分析、备档、调查，还要有供应商的权责人员进行审核。最后要经OTPV GSQE审核并给出书面承认书后方可导入实施The Supplier must have the capability to manage Engineering Change Order (ECO) levels on all assemblies and component parts. No verbal changes will be authorized; i.e., all changes must be documented either by an issue
43、d ECO, issued drawing, or an approved deviation. Change directives for non-prototype parts are not valid unless issued from OTPV Procurement. Commodity-specific requirements for change notification are listed in the Quality Agreement.供应商必须全面管理所有零件和组装件的过程变更单，不得授权口头变更；所有的变更必须有发出ECO、工程图或变更承认书并保存相关文件，除非
44、OTPV的采购合同有规定，非试跑料件的变更指示均无效。产品规格变更通知单要列入品质协议4.0 DOCUMENT CONTROL文件控制The Supplier shall assure that all documents such as software/firmware, engineering drawings, specifications, contracts, policies, procedures, and work instructions (including test procedures) are under revision control and available
45、 to all necessary personnel in the manufacturing environment. A system shall be established for the effective updating/removal of any obsolete documentation from all areas.供应商要对所有文件（包括办公用软/硬件、工程图、SPEC、合同、政策、程序、作业指导书、测试程序等）进行版本控制，明确工厂内有权使用人员。系统要及时进行更新去除无效的文件4.1 RED LINE DRAWINGS/PROCEDURAL DOCUMENTAT
46、ION程序文件的红线描述In order to expedite changes prior to completing the release cycle of documentation, the Supplier may elect to use a process. OTPV will accept Red Line documentation providing that:供应商可以使用 “Red Line”方法在文件版本变更前保证变更的实施，OTPV允许以下变更方式的Red Line文件：q such documents have been clearly marked using
47、 red inkq 用红墨水明确标识的文件q the Quality, Engineering, and Production managers have reviewed and approved those changes as evidenced by original signatures on every copy, and date of issue and expiration dates are clearly marked on all Red Line copies.q 品质、工程、制造经理对变更进行审核并在每个复印件签字核准，Red Line复印件要标明发行及截止日期。A
48、ll Red Lined documentation shall be replaced by a formal, controlled revision within 30 days.所有的Red Lined文件必须在30天内有正式版本文件替换。5.0 SUPPLIER QUALITY CONTROL供应商品质控制In addition to the requirements of ISO 9002, the Supplier shall implement a Supplier Management Plan for the control of its Suppliers. As a minimum, the Plan shall provide for quality goals, t
