供应商管理规范.doc

supplier quality standard 供应商品质标准供应商品质标准 a supplier quality management tool from global supplier quality engineering 一种供应商品质管理方式 otpv computer corporation cor.40.pr.sq.120 1999 supplier quality standardcor.40.pr.sq.120/rev1.0 otpv computer corporation 19992 table of contents 1.0quality system requirements 品质系统要求4 1.1quality program品质纲要 4 1.2management responsibility管理职责.4 1.3organization组织 4 1.4quality policies, procedures, and work instructions品质方针、流程、作业指导书4 1.5quality management plan品质管理计划.5 1.6internal audit program内部稽核计划.5 1.7otpv auditsotpv稽核 6 1.8training培训. 6 2.0contract review合同评审.6 3.0design control设计变更7 3.1design development and planning设计规划.7 3.2design input设计输入 7 3.3design output设计输出 7 3.4design review设计评审. 7 3.5design verification设计验证 8 3.6design validation设计确认 8 3.7design changes设计变更. 8 4.0document control 文件控制 8 4.1red line drawings/procedural documentation“红线描述”文件.8 5.0supplier quality control 供应商供货品质控制.9 5.1defined quality and technical requirements确定品质、技术要求.9 5.2sub-tier supplier approvals分工方承认.9 5.3sub-tier supplier audits分工方稽核. 9 5.4first article inspections首样检验. 10 5.5records记录 10 6.0product identification and lot traceability 产品标示与批量的可追溯性10 7.0process control 制程控制10 7.1process qualification制程条件 11 7.2quality metrics品质方针 11 7.3continuous improvement program持续改善计划12 supplier quality standardcor.40.pr.sq.120/rev1.0 otpv computer corporation 19993 8.0inspection and testing 检验与检测.12 8.1source/incoming inspection and tests供货/进料检验与测试.12 8.2in-process inspection and testing制程检验与测试.13 8.3final inspection and testing最终检验与测试.13 8.4shipping inspection (oba testing/inspection)出货检验（开箱检验/测试）13 8.5reliability testing可靠性测试 13 8.6inspection and testing records检验与测试记录.14 9.0calibration 校验 .14 9.1calibration procedures校验流程. 14 9.2recall list召回名录 14 9.3calibration records校验记录. 14 9.4out of tolerance (calibration) notices校验通知单.14 10.0inspection and test status 检验与测试状态.15 11.0control of nonconforming product 不合格品控制15 11.1review and disposition of nonconforming products不合格品评审与处理15 11.2corrective action process改善流程.16 12.0handling, storage, packaging, and delivery 处理、存储、包装与运输.16 12.1handling处理 16 12.2storage存储. 17 12.3packaging包装 17 12.4delivery运输. 17 13.0quality records 品质记录17 14.0deliverables运输 17 14.1quality management plan品质改善计划.17 14.2sub-tier supplier management plans分工方品质改善计划18 14.3internal audit program plan内部稽核计划.18 15.0definitions 定义 18 supplier quality standardcor.40.pr.sq.120/rev1.0 otpv computer corporation 19994 supplier quality standard供应商品质标准供应商品质标准 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/contract precedent. any exceptions 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 1.0quality system requirements 品质系统要求品质系统要求 1.1quality program 品质纲要 the supplier is required to implement and maintain a quality program that shall assure design and manufacture of products 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 quality 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 1.2management responsibility 管理职责 the suppliers executive management will develop a company-wide quality policy. this policy will be deployed and understood 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, product 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 1.3organization 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。 1.4quality 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 shall 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. supplier quality standardcor.40.pr.sq.120/rev1.0 otpv computer corporation 19995 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： identification of support team for otpv (critical contacts) 明确针对 otpv 的支援 team（主要联系方式） product differences from previous models/parts 与以前产品/模具的差异 quality performance goals 品质目标 site matching (if multiple supplier sites are manufacturing the same part for otpv use) 坐落位置（如果两个供应商为 otpv 生产相同的料件） manufacturing processes 生产流程 inspection/test strategies and processes 检验测试方法、规定 process control techniques 制程控制 first article requirements 首件要求 internal change control procedures 内部变更控制 liucheng procedures for handling discrepant material (identification, containment, root cause, corrective action) 品质变异料件处理流程（分析、隔离、原因、改善） failure analysis support for otpvs line rejects (lrr) and field returns (ifir) otpv 产线、市场不良分析报告 engineering change requirements 工程变更要求 record retention 记录保持 continuous improvement program (cip) 持续改善 1.6internal 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 gap analysis (audit) 隔阂分析（稽核） system audits 系统稽核 process/product audits 程序/产品稽核 supplier quality standardcor.40.pr.sq.120/rev1.0 otpv computer corporation 19996 only qualified auditors (trained) will conduct audits and will be independent from 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 gsqe 1.7otpv audits on a periodic basis, 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 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。 1.8training 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 shall 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, auditing 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 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 提供提供 otpv sqe 2.0contract review 合同评审合同评审 the supplier shall assure that an element of the quality program 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： otpv requirements are understood. otpv 的相关要求已经全部理解 conflicts between specifications, drawings, and contract requirements are resolved. spec、工程图、以及合同约定中有矛盾的地方已经得到解决 assure that any requirements differing from those in the tender are resolved. 确定略有差异的小问题也已得到解决 the supplier has the capability to meet contractual requirements. 供应商能够完成合同条款的相关要求 supplier quality standardcor.40.pr.sq.120/rev1.0 otpv computer corporation 19997 coordination of such activity is usually performed with otpv worldwide procurement and in the event of further information, the supplier shall notify the otpv commodity manager. 3.0design control 设计控制设计控制 the supplier shall establish and maintain documented procedures to control and verify the design of the product, and all product sub-components, in order 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 3.1design 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. qualified 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 3.2design input 设计导入 the supplier shall implement a system and 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，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。 3.3design 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： verification that design meets all design input requirements. 保证产品的设计方案满足料件投入设计的要求 contains, or make reference to, acceptance criteria as identified in specifications. 产品的设计方案要符合 spec 的各项要求 identification of characteristics that are crucial to the safe and proper functioning of the product. 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 otpv 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 3.4design 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 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 supplier quality standardcor.40.pr.sq.120/rev1.0 otpv computer corporation 19998 3.5design 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 requirements 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。 3.6design validation 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。 3.7design 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 implementation. 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 issued 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 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 4.0document control 文件控制文件控制 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 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 4.1red line drawings/procedural documentation 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： such documents have been clearly marked using red ink supplier quality standardcor.40.pr.sq.120/rev1.0 otpv computer corporation 19999 用红墨水明确标识的文件 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. 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。 all 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。 5.0supplier quality control 供应商品质控制供应商品质控制 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, the performance of site surveys/audits, quality program requirements, change/revision control requirements, test/inspections, first article inspections and data package reviews. 除了 iso 9002 的相关要求外，供应商还要建立供应商管理计划管控自己的供应商。该计划包括： 品质目标、稽核/调查状况、品管程序的要求、需求变更控制、测试/检验、首样检验和数据审核 5.1defined quality and technical requirements 明确品质和技术要求 the supplier shall develop and implement a system that will provide for an effective process to define quality and technical requirements to their suppliers. quality and technical requirements are defined as quality programs, engineering drawings, specifications and functions to be performed by sub-tier suppliers. the supplier may elect to use a contract, purchase order or other suitable means in defining these requirements. however, otpv requires that quality and technical requirements are fully documented and that the supplier verify understanding and implementation of such requirements. 供应商应建立相应的体系去有效的规定（供应商的）供应商的品质/技术要求，品质/技术要求要 在 sub-tier suppliers 推行的品质纲要、工程图、spec、及其相关职责中明确给出。供应商可以使 用合同、订单或其他合适的方法去规定这些要求，给 sub-tier suppliers 规定的品质技术要求要完 全包括 otpv 的品质技术要求，还要推动 sub-tier suppliers 理解执行 otpv 的品质技术要求 5.2sub-tier supplier approvals 承认 the supplier shall perform a quality review of its proposed suppliers prior to the placement of purchasing documents and acceptance of parts/product. the approval of suppliers shall be based on review of sub-tier suppliers quality programs and ability to meet otpv expectations. records of supplier approval shall be maintained in a central location and made available for the otpv sqe to review upon request. 供应商要对提议的 sub-tier 在签定购买合同、购买料件前进行品质稽核，依据 sub-tier 的品质计 划及能力可否满足 otpv 的要求来评定厂商，厂商承认的记录要保留以便 otpv sqe 要求审核。 5.3sub-tier supplier audits 稽核 the supplier shall implement a system to assure sub-tier suppliers are audited periodically. the suppliers audit process should also provide for re-assessments when quality levels drop below established quality goals or as warranted by the otpv sqe. supplier 要定期对 sub-tier 进行稽核，当供应商的品质水准低于即定目标或 otpv sqe 有授权时 均需对供应商的稽核程序重新评定 supplier quality standardcor.40.pr.sq.120/rev1.0 otpv computer corporation 199910 in the event that a sub-tier supplier is responsible for final production and packing of the product (subcontractor shipping directly to otpv on behalf of the supplier), the supplier shall facilitate access to these sites so that otpv may conduct audits as per section 1.7 of