供应商管理规范

SUPPLIER QUALITY STANDARD

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

TABLE OF CONTENTS

1.0

1.1

1.2

1.3

1.4

1.5

1.6

1.7

1.8

2.0

3.0

3.1

3.2

3.3

3.4

3.5

3.6

3.7

4.0

4.1

5.0

5.1

5.2

5.3

5.4

5.5

6.0

7.0

7.1

7.2

7.3 QUALITY SYSTEM REQUIREMENTS品质系统要求 ................................................................. 4 Quality Program品质纲要 .................................................................................................................... 4 Management Responsibility管理职责 ................................................................................................... 4 Organization组织 .................................................................................................................................. 4 Quality Policies, Procedures, and Work Instructions品质方针、流程、作业指导书 ........................ 4 Quality Management Plan品质管理计划 ............................................................................................. 5 Internal Audit Program内部稽核计划 .................................................................................................. 5 OTPV AuditsOTPV稽核 ........................................................................................................................ 6 Training培训 ......................................................................................................................................... 6 CONTRACT REVIEW合同评审 .................................................................................................. 6 DESIGN CONTROL设计变更 ..................................................................................................... 7 Design Development and Planning设计规划 ........................................................................................ 7 Design Input设计输入 ........................................................................................................................... 7 Design Output设计输出 ........................................................................................................................ 7 Design Review设计评审 ........................................................................................................................ 7 Design Verification设计验证 ................................................................................................................ 8 Design Validation设计确认 .................................................................................................................. 8 Design Changes设计变更 ..................................................................................................................... 8 DOCUMENT CONTROL文件控制 .............................................................................................. 8 Red Line Drawings/Procedural Documentation“红线描述”文件 ..................................................... 8 SUPPLIER QUALITY CONTROL供应商供货品质控制 ............................................................... 9 Defined Quality and Technical Requirements确定品质、技术要求 .................................................... 9 Sub-tier Supplier Approvals分工方承认 ............................................................................................... 9 Sub-tier Supplier Audits分工方稽核 ..................................................................................................... 9 First Article Inspections首样检验 ....................................................................................................... 10 Records记录 ........................................................................................................................................ 10 PRODUCT IDENTIFICATION AND LOT TRACEABILITY产品标示与批量的可追溯性 ............ 10 PROCESS CONTROL制程控制 ............................................................................................... 10 Process Qualification制程条件 ........................................................................................................... 11 Quality Metrics品质方针 .................................................................................................................... 11 Continuous Improvement Program持续改善计划 .............................................................................. 12

8.0

8.1

8.2

8.3

8.4

8.5

8.6

9.0

9.1

9.2

9.3

9.4 INSPECTION AND TESTING检验与检测 ................................................................................. 12 Source/Incoming Inspection and Tests供货/进料检验与测试 ............................................................ 12 In-Process Inspection and Testing制程检验与测试 ........................................................................... 13 Final Inspection and Testing最终检验与测试 .................................................................................... 13 Shipping Inspection (OBA Testing/Inspection)出货检验（开箱检验/测试） .................................... 13 Reliability Testing可靠性测试 ............................................................................................................ 13 Inspection and Testing Records检验与测试记录 ............................................................................... 14 CALIBRATION校验 ................................................................................................................... 14 Calibration Procedures校验流程 ........................................................................................................ 14 Recall List召回名录 ............................................................................................................................ 14 Calibration Records校验记录 ............................................................................................................. 14 Out of Tolerance (Calibration) Notices校验通知单 ........................................................................... 14

10.0 INSPECTION AND TEST STATUS检验与测试状态 ................................................................. 15

11.0 CONTROL OF NONCONFORMING PRODUCT不合格品控制 ................................................ 15

11.1 Review and Disposition of Nonconforming Products不合格品评审与处理....................................... 15

11.2 Corrective Action Process改善流程 .................................................................................................... 16

12.0 HANDLING, STORAGE, PACKAGING, AND DELIVERY处理、存储、包装与运输 ................ 16

12.1 Handling处理 ...................................................................................................................................... 16

12.2 Storage存储 ......................................................................................................................................... 17

12.3 Packaging包装 .................................................................................................................................... 17

12.4 Delivery运输 ........................................................................................................................................ 17

13.0 QUALITY RECORDS品质记录 ................................................................................................. 17

14.0 DELIVERABLES运输 ................................................................................................................ 17

14.1 Quality Management Plan品质改善计划 ......................................................................................... 17

14.2 Sub-tier Supplier Management Plans分工方品质改善计划............................................................... 18

14.3 Internal Audit Program Plan内部稽核计划 ....................................................................................... 18

15.0 DEFINITIONS定义 .................................................................................................................... 18

SUPPLIER QUALITY STANDARD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

1.0 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 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

1.2 MANAGEMENT RESPONSIBILITY 管理职责

The Supplier’s 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

1.3 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

书 QUALITY POLICIES, PROCEDURES, AND WORK INSTRUCTIONS品质政策/程序/作业指导

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.

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 OTPV’s 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

1.6 INTERNAL 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



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：



1.6 INTERNAL 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



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

1.7 OTPV AUDITS

On a periodic basis, OTPV may conduct audits/visits at the Supplier’s manufacturing locations. The

Supplier shall, at OTPV’s request, permit access to manufacturing operations involved in the production and/or inspection of OTPV’s 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 OTPV’s 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。

1.8 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 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 SQE

2.0 CONTRACT REVIEW 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

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.

3.0 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 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. 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

3.2 DESIGN 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。

3.3 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：

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

3.4 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 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 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。

3.6 DESIGN 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。

3.7 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 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

4.0 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 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 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

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。

5.0 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, 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

5.1 DEFINED 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

5.2 SUB-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。

5.3 SUB-TIER SUPPLIER AUDITS稽核

The Supplier shall implement a system to assure sub-tier Suppliers are audited periodically. The

Supplier’s 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

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 this document.

对于负责供应商产品最后生产和包装的sub-tier（转承包商代替供应商直接出货到OTPV），供应商可以授权OTPV依照本文1.7节稽核sub-tier

5.4 FIRST ARTICLE INSPECTIONS 首样检验

The Supplier shall perform First Article Inspection on units from the first production run or for design changes that affect form, fit, or function. First Article Inspections shall be performed to verify built-as-designed configuration and shall include 100% dimensional verification, electrical testing, raw material certification, and compliance with drawing notes. First Article data shall be maintained and submitted for the OTPV SQE to review upon request.

供应商要对首次量产或有外型、制造、结构的设计变更的机器推行首样检验。首样检验要去核实产品的设计构型，还包括100%的尺寸确认、电气测试、原材料认证以及制图注解核实。首样检验的数据要保留，以备OTPV SQE审核。

5.5 RECORDS 记录

All records that provide evidence of Supplier activity such as Source Inspections and First Article

Inspections shall be maintained in a central location and made available for the OTPV SQE to review

upon request.

供应商所以的相关记录都要集中保留以备OTPV SQE审核。

6.0 PRODUCT IDENTIFICATION AND LOT TRACEABILITY

产品鉴定以及产品的可追溯性

The Supplier shall establish and maintain procedures and processes for the identification and lot

traceability of critical items during all stages of production, delivery, and installation. This is to be

traceable through the finished product serial number or equivalent method.

供应商要建立产品生产、运输、安装等阶段关键项目的鉴定/可追溯程序，以便通过成品序列号等参数对产品进行追溯

7.0 PROCESS CONTROL 程序控制

The Supplier shall ensure that all manufacturing processes that affect the quality of a product are carried out in a controlled condition. OTPV defines controlled conditions as:

供应商要保证所有的会影响到产品品质的生产过程都在受控的条件下进行，OTPV定义受控条件如下；



 Documented work instructions that provide clear and concise direction for the assembly, inspection, tests, and acceptance criteria of products. 指导组装、检验、测试以及产品允收标准的作业指导书要简洁明了 Identification of critical parameters, implementation of statistical process controls, and initiation of corrective actions when necessary. Additionally, triggers shall be defined and documented for the purpose of initiating a stop build and/or stop shipment action. 关键参数的鉴定、统计控制程序的推行、改善措施的导入。还要明确定义停产、停止出货的的启动条件。 Proofing out the manufacturing, inspection and test processes prior to mass production. 产品量产前验证生产、检验、测试程序



 Validation that manufacturing equipment (including fixtures) can produce a product meeting design intent and customer requirements. This should include formal gage repeatability and reproducibility (GR&R) studies where appropriate. 校验生产设备以使产品满足设计及客户的要求，适当时候导入GR&R Detailed workmanship criterion that stipulates the highest standard of quality. 详细制订作业标准以保证产品的高品质 Preventive maintenance program for all equipment used in the manufacturing, inspection, and test of products. 生产、检验、测试产品的设备的定期检修

7.1 PROCESS QUALIFICATION 制程限定

All processes shall be qualified by OTPV as outlined in the following paragraphs before commencement of volume production. The Supplier must obtain written approval from OTPV prior to any change to a qualified manufacturing process or material.

产品量产前所有的程序都要按照OTPV表格的格式制订, Supplier所有制程/原材料的变更都要事先有OTPV书面的承认书才可以导入。

Special test or burn-in requirements may be necessary to assure delivery of product to provide zero

defects. This request may occur based on the process evaluation presented, and also the prior

performance of the product.

必须保证产品零缺陷运输,以便通过相关的测试和burn-in试验评估产品当前和后续的品质状况

Process qualification shall include Supplier-generated process capability assessments.

制程评价应包括供应商制程能力评估

OTPV expects that process stability is demonstrated and maintained. In this endeavor, sound statistical methods should be utilized, particularly control charts and analysis by variables. In some cases, specific control chart data or a certificate of conformance may be a required attachment to the Supplier’s

shipment.

OTPV希望制程的稳定性能够得到验证和维护.使用正确的统计方法\特别是控制图和变量分析.对于有些统计数据和验证资料应要求Supplier在出货检验报告中给出

7.2 QUALITY METRICS品质政策

The Supplier shall use quality metrics as a basis to monitor the quality of its products and processes.

Additionally, the Supplier’s quality program shall define the metrics for a stop ship and/or stop build

action. Quality metrics, as a minimum shall include:

Supplier应把品质政策作为监控产品/制程品质状况的基本依据, Supplier的品质计划应明确停止出货/停产条件.品质政策至少应包含以下内容:



 Incoming Quality Assurance (IQA) results 进货品质保证结果 Manufacturing Yields量产通过率 Test Station Yields测试通过率 Inspection Yields 检验通过率 Mean Time Between Failures (MTBF) demonstration data MTBF验证数据 Out of Box Audits (OBA) 开箱检查 Annualized Failure Rate (AFR)/Annualized Return Rate (ARR) performance 年不良率/年退货率 Reliability test results可靠性测试结果 OTPV Initial Field Incident Rate (IFIR) and Line Reject Rate (LRR) 早期市场不良率/产线批退率

7.3 CONTINUOUS IMPROVEMENT PROCESS持续改善过程

The Supplier shall develop and implement a Continuous Improvement Process (CIP) that will provide for a cost-effective reduction in process-related excursions. The progrsam at a minimum shall include:

供应商应该主动开展持续改善计划降低产品品质异常，该计划应包括以下内容：

A documented, systematic approach for identifying CIP focus areas

 有系统的文件和方法追溯CIP所关注的问题点

 Design for quality initiative (i.e., HALT, FMEA, Margin Analysis, Tolerance Stack-up Analysis)

 产品设计品质参数

 Supplier management strategy

 供应商管理策略

 Manufacturing process controls

 制程控制

 LRR and IFIR reduction plans to achieve OTPV goals

 降低LRR和IFIR计划以达成客户要求

The Supplier shall provide status of the implementation and results upon OTPV SQE request. 

供应商应依照客户SQE要求及时提供相关计划的完成状况和验证状况

8.0 INSPECTION AND TESTING检验与测试

The Supplier shall develop and maintain processes and procedures for the effective quality assessment of product and equipment through the utilization of inspection and testing techniques. As a minimum, the Supplier shall implement the following:

供应商应该利用相关的检验和测试技术去有效的评估产品品质，并建立和保持相关的流程和程序。供应商至少应该完成以下几项内容：

Source/Receiving Inspection and Tests

 进料检验和测试

 In-Process Inspections and Testing

 制程检验和测试

 Final Inspection and Testing

 最终检验和测试

 Shipping Inspection (OBA Testing/Inspection)

 出货检验

 Reliability Testing

 信赖性测试

 Maintain Inspection and Test Records

 检验和测试记录

Testing implemented at Supplier manufacturing sites shall assure product meets OTPV’s LRR and IFIR goals. 

供应商制程中的测试手段应该保证产品品质满足客户要求

8.1 SOURCE/INCOMING INSPECTION AND TESTS进料检验与测试

The Supplier shall implement a Source/Incoming Inspection program that will provide for the

verification of components and subassemblies to design drawings and specifications.

供应商进料检验项目应该保证零部件品质符合工程图和SPEC的要求

Source/Incoming Inspections shall be conducted using clear and concise work instructions that define

parameters to be verified, measuring tools, sample size, etc. In the event the Supplier chooses to utilize sampling inspection techniques, the Supplier shall document the sample plan and process to be used for normal, tightened, reduced, and/or skip lot inspections. Additionally, the Supplier shall inform OTPV

GSQE of any sampling plan changes with supporting data. This is considered an informal notification; formal approval from OTPV is not required if these changes are part of the documented sample plan. The Supplier shall maintain records of all inspections to be made available for the OTPV SQE to review upon request.

进料检验应该依据简明的作业指导书作业（说明需要验证的相关参数、测试仪器、抽样样本大小等），供应商应该依据抽样计划制订抽样检验流程明确检验状态（正常、加严、减量、免验），另外抽样计划的相关标准有任何变化都应事先知会客户，经得正式同意后方可导入。供应商须应客户要求保留所有检验数据。

8.2 IN-PROCESS INSPECTION AND TESTING制程检验与测试

The Supplier shall inspect and test product as defined in the quality plan and procedures. As a minimum, the Supplier shall assure that products are manufactured in accordance with approved processes, work, and disposition instructions. Workmanship and functionality of products shall be the main focus of such inspections and tests. The Supplier may elect to perform in-process inspections utilizing process-auditing techniques or sample inspections as provided for in documented procedures. Products shall not be

released for shipment until all necessary in-process inspections and tests are performed. In the event of a nonconformance, product shall be identified per documented procedures and segregated.

供应商应依据产品品质计划和相关程序得规定对产品进行检验和测试。至少供应商应该保证产品的制程、作业、部署都是经过相关部门审核认可的（即可控性），产品的制造工艺和功能特性应是主要的检验测试项目，

8.3 FINAL INSPECTION AND TESTING最终检验与测试

The Supplier shall ensure that all inspections and tests are performed as described in the quality plan and documented procedures. All products shall undergo a final inspection and test prior to shipment,

including OTPV specific requirements, if applicable. As a minimum, the final inspections and tests shall ensure workmanship, assembly verification, and functionality to test requirements. Product not meeting specified requirements shall be identified and segregated per documented procedures. Products shall not be released for shipment to OTPV without completion of all final inspections and tests.

供应商应保证品质计划和相关程序文件内规定的所有检验与测试项目都要得到执行，所有产品都要在最终检验和测试后方可出货（包括客户的一些特定要求），至少，最终检验与测试应保证人员操作、装配流程、产品功能符合客户要求。在每个流程中应明确规定对不符合要求的产品要做标示和隔离，没有完成最终检验与测试的产品不可以出货给客户

8.4 SHIPPING INSPECTION (OBA TESTING/INSPECTION)出货检验（开箱检验与测试）

Prior to shipment, the Supplier shall assure that the lot passes OBA testing and all applicable

miscellaneous hardware such as cables and power cords, user material, OTPV unique labeling

requirements, and packaging are verified.

出货前，供应商应保证产品已通过开箱检测，信号线、电源线、说明书、客户标示及包装等配件都已经过验证。

8.5 RELIABILITY TESTING可靠性测试

Prior to, or during shipment to OTPV, the Supplier shall ensure that the lot passes extended reliability testing. If product is shipped before completion of testing, the Supplier will ensure proper controls are in place for identification and recall of any failed lots. Any failed lots are required to be contained by

Supplier until released by OTPV SQE.

出货给客户前供应商应保证该批产品已通过相关的可靠性测试。如果在完成测试前产品已出货，供应商应保证及时进行相关验证，（除非OTPV SQE同意不采取行动）在验证结果异常时应有能力保证召回所有不良批次产品（包括供应商的在制不良批次）。

8.6 INSPECTION AND TESTING RECORDS检验测试记录

The Supplier shall maintain records of all inspection and test activity, which will provide the objective evidence that products have passed acceptance criteria. These records shall be made available for the

OTPV SQE to review upon request.

供应商应保留产品所有相关验证项目的结果与标准。这些记录应在OTPV SQE要求审核时及时给出

9.0 CALIBRATION仪器校验

The Supplier shall develop and maintain a system to assure all equipment used for the acceptance of

product is calibrated with traceability to an internationally/nationally recognized Standards Institute such as the National Institute of Standards and Technology. Paragraph 4.10 of ISO 9002 may be used as a

reference in developing a calibration system. Where appropriate, this should also include formal GR&R studies. These records shall be made available for the OTPV SQE to review upon request.

供应商应建立一套系统确保所有检测产品的设备都有国际或国内标准组织可追溯性的校验（像国家标准技术研究所）ISO9002 4.10条款有如何建立校验系统的说明。适当的时候，还应进GR&R测试。这些记录应在OTPV SQE要求审核时给出。

9.1 CALIBRATION PROCEDURES校验程序

Calibration procedures shall be established that define the measurements to be made, accuracy required, temperature/humidity required, and test equipment to be used in performing metrology verifications.

校验程序应明确测量用途，精度要求，温度/湿度要求以及用来校验的仪器设备

9.2 RECALL LIST产品召回LIST

The Supplier shall maintain a listing of all equipment requiring calibration and shall identify them by

assigned tracking number, location, and re-calibration frequency. As a minimum, the recall system shall provide for early notification that an instrument is due for calibration.

供应商应建立仪器设备校验名录，并注明每台设备的追溯号、所在位置、重校频次，应有系统提前通知需要重校的设备名单。

9.3 CALIBRATION RECORDS校验记录

The Supplier shall maintain records of all calibrations performed. Calibration records shall as a minimum address the calibration procedure used, personnel performing the calibration, results, calibration status, and traceability to a Primary or Secondary Standard. These records shall be made available for the OTPV SQE to review upon request.

供应商应保留校验记录，校验记录应标明所使用的校验程序、校验人员、校验结果、校验状态、校验标准等，这些记录都应及时存档，待OTPV SQE审核时应即刻给出。

9.4 OUT OF TOLERANCE (CALIBRATION) NOTICES超出校验期通知单

In the event that tools or equipment used for product manufacturing, testing, or inspection are found to be out of tolerance or out of calibration, the Supplier shall implement a system that will provide for the

review of all product produced and accepted by the defective instrument. The Supplier shall also

implement a plan to repair/replace the equipment. The OTPV SQE will be notified of the results of any such review and determination will be made at that time as to status of products built for OTPV.

在生产、测试、检验产品的设备或制具超出校验允许公差范围时，供应商应有一套系统保证在仪器不能准确测试的情况下产品品质稳定，供应商应有计划的维修/替换设备。OTPV SQE非常注意其产品在上述情况下的处理状况。

10.0 INSPECTION AND TEST STATUS检验测试状态

The Supplier shall assure that a system exists that will readily discern the inspection and test status of

components, subassemblies and assemblies. That is, the Supplier shall be capable of tracing the

acceptance status of such items and assuring that nonconforming product is not co-mingled with

acceptable product. The Supplier may use tags, electronic bar codes, routing cards, or other suitable

means for tracking status.

供应商应有一套系统监控零件、组件及成品的品质状况，也就是说供应商应该有能力控制产品生产状况保证不合格品不会混入合格品中，供应商可以利用标签、电子条码、记录卡或其他追踪方式

11.0 CONTROL OF NONCONFORMING PRODUCT不合格品控制

The Supplier’s quality program shall have an effective system for controlling nonconforming product. The system shall provide for the identification, documentation, evaluation, segregation, and timely

disposition of nonconforming products. The Supplier’s system shall include controls for product returned from OTPV.

供应商的品质计划应建立一个有效的管控不合格品的系统，系统应对不合格品及时标示、备档说明、评估、隔离和处理，供应商的系统应包括对OTPV退回货品的管控

11.1 REVIEW AND DISPOSITION OF NONCONFORMING PRODUCTS不合格品处理

The Supplier shall establish, document and implement a process for the effective review and disposition of nonconforming products. The Supplier’s process shall include the following dispositions:

供应商应建立并施行一套有效的评审、处理不合格品的流程。包括以下处理措施;

Rework – product reworked to meet specified requirements

 重工-对产品重新制作以使之符合特定的要求

 Use as Is – no actions taken on product, product does not meet specified requirements, but is

functional

 继续使用-对产品不采取措施，产品不符合指定要求，但功能正常

 Repaired – product has been reworked to be functional but does not meet specified requirements

 修理-产品重工并具备相应功能，但不符合指定的要求

 Scrap – product not useable and does not meet specified requirements

 报废-产品不能使用也不符合特定要求

 Screen – additional product test/inspection to meet specification

 清仓-需要某些附加的测试/检测以符合要求

The Supplier shall implement a Material Review Board (MRB) to review and disposition nonconforming product. As a minimum, the MRB shall consist of representatives from Design Engineering,

Manufacturing Engineering, Procurement, and Quality Engineering. When assigning the “Use As Is”

disposition the OTPV SQE will be contacted for final approval. All MRB records shall be maintained by the Supplier and made available for the OTPV SQE to review upon request. 

供应商应利用材料评审会评审和处理不合格品。MRB与会者应由设计工程部、生产工程部、采购部和品保部人员参加，当需要克服使用时须先征得OTPV SQE同意方可实行

11.2 CORRECTIVE ACTION PROCESS矫正预防措施

The Supplier shall develop and implement a corrective action process that utilizes structured problem

solving techniques to:

供应商应利用一些解决问题的方法建立有效的改善流程

Investigate the root causes of nonconforming product and identify the corrective actions needed to

prevent a recurrence.

 调查不合格品根因，确定预防问题再发生的改善措施

 Analyze all processes, work operations, quality records, service reports, and OTPV complaints to

detect and eliminate potential causes of nonconforming product.

 分析所有流程、作业指导书、品质记录、维修报告和OTPV对相关问题的抱怨排除出现不合

格品的潜在因素

 Apply controls to ensure that corrective actions are taken and that they are effective.

 保证改善措施的导入实施并验证措施的有效性

 Implement and record change in procedures as a result of corrective actions taken.

 当导入改善措施时应及时保留制程变更记录

Additionally, the Supplier’s corrective action process shall provide for documentation that identifies the following: 

另外，供应商的改善流程应有文件记录以下内容

Specific defect 明确问题点

 Technical investigation/analysis 技术调查/分析

 Root cause 确定不良根本原因

 Containment for defect 不良影响

 Corrective action plan 改善计划

 Preventive actions to preclude a recurrence 防止问题再发生的预防措施

 Verification of effectiveness of actions 改善措施有效性验证

Implementation of corrective actions shall be done in less than 30 days from the issuance of a

nonconformance document from OTPV unless otherwise directed by OTPV GSQE. The Supplier shall utilize its CIP procedures to address cases of “regular” product nonconformance issues contained within the Supplier production line. 

改善措施必须在OTPV发出不良通报30天内导入，除非OTPV GSQE有其他指示，供应商应利用持续改善流程立案处理不合格品（包括供应商产线上的不良品）

12.0 HANDLING, STORAGE, PACKAGING, AND DELIVERY处理、存储、包装和运输

The Supplier’s quality program shall provide for the establishment, documentation, and maintenance of procedures for handling, storage, packaging, and delivery of product.

供应商的品质计划应建立、说明、及时更新产品的处理、存储、包装和运输流程

12.1 HANDLING处理

The Supplier shall provide for methods of handling product during all stages of inventory and production to prevent damage and deterioration. As a minimum, component, subassemblies and assemblies shall be protected from the environment, Electrostatic Discharge (ESD), and from damage incurred during

shipment and transfer within stages of manufacture.

对所有的货品供应商应采取相应的措施以避免其变质、损坏。零件、组件及装配件都应有相应的防静电保护措施，防止在出货、产线装运时的损伤

12.2 STORAGE存储

The Supplier shall ensure that provisions are in place to provide for secure storage areas or stock rooms to prevent damage or deterioration of product prior to consumption and/or delivery to OTPV. The

Supplier shall use appropriate methods to protect product from the environment, ESD, and from damage incurred during shipment and transfer within all stages of manufacturing. The Supplier shall implement a First In First Out (FIFO) system for disbursement of product from storage.

供应商要保证为所供货品提供安全的存储区防止在送达OTPV客户前损坏，供应商应采取有效措施防止产品受环境，静电，以及搬运过程中的损伤。供应商应执行先进先出的发货原则。

12.3 PACKAGING包装

The Supplier shall ensure all parts/products are packed, marked and preserved as defined in

specifications. Parts/products shall be packaged to prevent damage and/or deterioration while facilitating usage requirements on the OTPV manufacturing lines. The Supplier shall ensure conformance to OTPV packaging requirements and shall identify, preserve and segregate all products until delivered to OTPV. 供应商应确保所有的货品都已按照OTPV的要求包装、标示清楚，并要确保在出货到OTPV前隔离、保护、标示到位

12.4 DELIVERY运输

OTPV requires the Supplier to be responsible for product quality until point of issue to OTPV

manufacturing sites.

OTPV要求供应商对产品在OTPV生产线前发生的所有问题负责

13.0 QUALITY RECORDS品质记录

The Supplier shall establish and maintain procedures for identification, collection, indexing, filing,

storage, maintenance, and disposition of quality records. Records shall be kept either the entire warranty period, or the period established in the specification – whichever is longer – and made available for the OTPV SQE to review upon request.

供应商应对品质记录建立审核、收集、索引、保留、处理流程，所有记录都应在规定的时期内保留，以便OTPV SQE稽核提供

14.0 DELIVERABLES运输

The Supplier shall provide OTPV with the required documentation on request (or have it readily

available for review).

供应商应按照OTPV相关文件所要求的规定保证运输质量

14.1 QUALITY MANAGEMENT PLAN品质管理计划

The Supplier shall jointly own with OTPV Supplier Quality Engineering, the Quality Management Plan (QMP) for each OTPV part number prior to RTS at OTPV.

供应商应协助OTPV SQE在每个料号出货前建立QMP(品质管理计划)

The Supplier shall provide input to the QMP on its proposed quality plan for each part number. The Plan shall address the requirements in Section 1.5 of this document. OTPV SQE will review and provide

approval authority.

供应商应为每个料号的产品提供自己的品质管理计划，品质计划在本文件1.5节有详细介绍，

OTPV SQE 将审核并给与相关授权。

14.2 SUB-TIER SUPPLIER MANAGEMENT PLAN 供应商供货品质管理

In accordance with Section 4.0, the Supplier shall provide the OTPV SQE with its Supplier Management Plans for review. These plans shall be submitted within 30 days from notification of contract award.

与第4节一致，供应商应向OTPV的SQE提供供应商管理计划，这些计划应在合同授权前30内给出

14.3 INTERNAL AUDIT PROGRAM PLAN内部稽核

The internal audit program plan shall be submitted to the OTPV SQE for review. This plan may be

included as a subset of the overall quality plan. Submittal of this plan is required within 30 days from

notification of contract award.

内部稽核计划应作为整个品质计划的一部分交OTPV SQE审核，要求该计划在合同授权前30天内给出

15.0 DEFINITIONS定义

AFR – Annualized Failure Rate年不良率

ARR – Annualized Return Rate年退回率

CIP – Continuous Improvement Program持续改善计划

DPPM – Defective Parts Per Million 每百万不良率

DVT – Design Validation Testing设计验证测试

ECO – Engineering Change Order工程变更单

ESD – Electro Static Discharge静电泻放

EVT – Engineering Validation Testing 工程验证测试

FAI – First Article Inspection首样检验

FIFO – First In First Out先进先出

FMEA – Failure Mode Effects Analysis失效模式分析

GR&R – Gage Repeatability & Reproducibility计量的精确性与准确性

GSQE – Global Supplier Quality Engineer全球供应商品质工程

HALT – Highly Accelerated Life Test寿命加速试验

IFIR – Initial Field Incident Rate早期市场不良率

IQA – Incoming Quality Assurance进料检验保证

LRR – Line Reject Rate产线不良率

MRB – Material Review Board 材料评审会

MTBF- Mean time between failure 平均无故障时间

OBA- Out of Box Audit开箱检验

ORT – On-going Reliability Testing可靠性试验

PMT – Process Maturity Testing 制程完备度测试

RFQ – Request for Quote (also called RFI or Request for Information)询价

RTS – Ready To Ship 准备出货

SPRT – Sequential Probability Ratio Test