企业经营管理

1、Section I : ISO 9000 BasesRequi r e m e nt sMan ageme nt Resp on sibility Eleme ntQualityThe supplier s management with executive responsibilityshalldefine and document itspolicyfor quality, in clud ing objectives forquality and its commitmentto quality. Thequality policyshall be releva nt to the su

2、pplier sorganizationalgoals and the expectations andneeds of its customers. The supplier shall ensure that this policy is un derstood, impleme nted and mai ntai ned at all levels of the orga ni zati on.Responsibility andresp on sibility,authorityand the in terrelati on of pers onnel who man age, per

3、form and verify work affect ing quality shall be defined and documented, particularly for pers onnel who n eed the orga ni zati onalfreedom andauthority to :a) initiateaction to prevent the occurrenee ofany nonconformitiesrelating to product,process and quality system ；NOTE： It is recommended that t

4、he personnel responsible for quality have the authority to stop production, if necessary to correctqualityproblems.b ) ide ntify and record any problems relat ing tothe produce, process and quality system ；c) initiate,recommend or provide solutionsthough desig nated cha nn els ；d) verify the impleme

5、 ntati on of soluti ons；e) con trolfurther process ing, delivery orin stallati on of noncon form ing product un tilthe deficie ncy or un satisfactory con diti on has bee n corrected.f) represent the needs of the customer ininternal fun cti ons in address ing QS-9000 requireme nts selecti on of speci

6、al characteristics,setting quality objectives,training, corrective & preve ntive acti ons, product desig n and developme nt).Thesupplier shall identify resource requirements and provide adequate resources, includingtheassig nment of trained pers onnel (see .for management,performanee of work and ver

7、ification activities in cludi ng internal quality audits.The supplier s management with executive responsibilityshall appoint a member of thesupplier s own management who, irrespective of otherresponsibilities,shall have definedauthority fora) ensuring that a quality system is established, impleme n

8、ted and maintained in accorda nee with this intern ati onal Stan dard, andb) reporting on the performanee of the quality system to the supplier s management for review and as a basis for improveme nt of the quality system.管理责任一品质政策一供货商负经营责任之管理阶层应界定 并明文记载其对品质所持之政策，包含品质目标与对品质之承诺。该品质政策必须相关于供货商之组 织目标与顾客

9、需求与期望。供货商应确保该组织内之所有阶层均了解、实施与维持此品质政策。 组织一责任与授权一 从事影响品质之管理、执行与验证等工作人员均应 了以界定和明文记载其责任，授权与相互关系，尤 其是那些需要组织赋予自由度和授权以从事下列 活动之人员：a）发起行动以预防任有关产品、流程、品质 系统不合格情事的发生；备注：建议负有品质责任的人员，如需处理品 质问题时，可被授予停止生产的权限。b）鉴定并记录任何有关产品、流程及品质系 统的问题：c）循既定管道发起、建议或提供解决d）验证解决方案之执行；e）管制不合格产品被进一步加工、交货或安 装，直到缺点或不满意情况被矫正为止。f）在内部组织机能中代表顾客的

10、需求以对应 QS-9000的要求（即管制特性的选择，设定 品质目标，训练，矫正与预防行动，产品 设计与发展）。资源一供货商应鉴定资源的需求，并提供适当资源包 括指派经训练的人员（参阅以从事管理、执行工 作与包含内部品质稽核在内的各项验证活动 管理代表一供货商负经营责任之管理阶层应指派供货商管 理阶层其中一员，明定其授权且不受其它职务 责任影响以从事下列活动a）确保品质系统依本国际标准建立、实施与 维持，及b）将品质系统的运作成效向供货商管理阶 层报告以供其审查，并作为品质系统改善 之依据。NOTE 5 : The responsibility of a management represent

11、ativemay alsoin clude liais on with exter nal parties on matters relating to the supplier squality system.The supplier shall have systems in place to ensure management of appropriate activities during concept development through production to Advanced Product Quality Planning and Control Plan refere

12、nce manual）. The supplier shall use a multi-disciplinary approach for decision-making and have theabilitytocommunicate necessary informationand data inthe customer-prescribed format.NOTE Typical functions to be included are: Engineering/Technical Manufacturing/Production Industrial Engineering Purch

13、asing/Materials ManagementQuality/ReliabilityCost EstimatingProduct ServiceManagement Information Systems/Data ProcessingPackaging EngineeringTooling Engineering/Maintenance Marketing and SalesSubcontractors, as necessaryManagement with responsibility and authority for corrective action shall be pro

14、mptly informed of products or processes which become noncompliant with specified requirements.Management Review - Management Review should be conducted with a multi-disciplinary approach（see Glossary）.Busin essPla n - supplier shallutilize a formal, documented, comprehensive business plan. this Busi

15、ness Plan shall be a controlled document. The content of the Business plan is not subject to third party audit.This plan may typically include as applicable:Market-related issuesFinancial Planning and costGrowth projectionsPlant/facilities plansCost objectivesHuman resource developmentR & D plans, p

16、rojections, and projects with appropriate funding备注5 :管理代表的责任亦可包含就供货商品质系统 有关事务与外界团体的联系组织联系接口供货商于概念研发直到生产等阶段，应建立系统确保 对各项适当活动的管理（参考先期产品品质规划和管 制计划参考手册）。供货商决策时应采用跨功能群组讨 论模式，且有能力使用顾客规定格式沟通必要的信息 和数据。备注：典型的组织机能包括：1. 工程/技术2. 制造/生产3. 工业工程4. 采购/物料管理5. 品质/可靠度6. 成本预估7. 产品服务8. 管理信息系统/数据处理9. 包装工程10. 工模具工程/保养11. 市

17、场及行销12. 分包商（必要时）通知管理阶层当产品或制程无法符合特定要求时，该项信息应迅即 通知负责与授权矫正行动的管理阶层。管理审查 -供货商负经营责任之管理阶层每隔 规定期间应审查品质系统，且其间隔应足以确保品质 系统持续适切与有效符合本国际标准要求及供应既定 之品质政策及目标（参阅。此项审查的记录应予维持 （参阅。管理审查本项管理审查应包括整体品质系统的所有要项，而非仅限于如预防行动)要项中所特别指定者。备注：管理审查需以跨功能的团队方式来举行(参阅词汇)。经营计划-供货商必须应用一份正式明文规定且完整的经营计划。此项经营计划为管制文 件。经营计划的内容不提供了第三者稽核。这个计划通常可

18、能包含下列适用项目：1. 市场相关的事务2. 财务规划与成本3. 企业成长预期4. 工厂/设施计划5. 成本目标6. 人力资源开发7. 研发计划，企业，项目及其适当的财源Projected sales figuresQuality objectives Customer satisfaction plans Key internal quality and operational performance measurableHealth, Safety and Environmental issuesGoals and plans should cover short-term (1-2 ye

19、ars) and longer-term(3 years or more). The goals and plans should be based on analysis of competitive products and on benchmarking inside and outside the automotiveindustryand the supplier scommodity. Methods to determine current and future customer-expectations shall be in place. An objective proce

20、ss shall be used to define the scope and collection information, including the frequency and methods of collection.Methodstotrack,update,revise,andreviewtheplan shallbedocumentedtoensurethatthe planisfollowedandcommunicatedthroughouttheorganizationas appropriate.NOTE Data and information should driv

21、e process improvement plans.NOTE The supplier should provide meansfor employee empowerment in meeting business goals.An alysis and Use of Compa nyLevel Data supplier shall document trends in quality,operationalperformance (productivity,efficiency,effectiveness, cost of poor quality) and current qual

22、ity levels for key product and service features. These should be compared with those of competitors and/or appropriate benchmarks.Trends in data and information should be compared with progress toward overall business objectives and lead to action to support :1) Development of priorities for prompt

23、solutions to customer-related2) Determination of key customer-related trends and correlations to support status review, decision-making and longer-term planning.Customer Satisfaction -The supplier shall have a documented process for determining customer satisfaction, including frequency of determina

24、tion, and how objectivity and validity are assured. Trends in customer satisfaction and key indicators of customer dissatisfaction shall be documented and supported by objective information. These trends should be compared to those of competitors, or appropriate benchmarks, and reviewed by senior ma

25、nagement.NOTE Consideration should be given to internal, external and finalCustomersA supplier shall notify their certification body/registrar in writing within five （5） working days when a customer places the site in any of the following statuses:Chrysler “ Needs Improvement ”Fork Q-1 Revocation Ge

26、neral Motors Level II Containment8. 预期销售成果9. 品质目标10. 顾客满意计划11. 内部品质和作业绩效的主要指针12. 安全卫生及环保议题目标和计划须包含短程（1-2年）和长程（3年或以上）。 这些目标和计划的拟定需依据竞争产品的分析，汽车 工业内外的标竿以及供货商自身的商品。须建立衡量 目前和未来顾客期望的方法。应采用客观的流程来定 义范围及收集信息，包括收集信息的频次及方式。 追踪，检讨，更新及修订计划的方法应以明文规定， 以确保该计划在整体组织中被适当的贯彻与沟通。 备注：数据和信息需促进流程的改善计划。备注：供货商为达成经营目标可赋予员工充分的

27、授权。 公司层级数据的分析和应用-供货 商针对品质，作业绩效（生产力、效率、效益、低劣品 质的成本）及产品和服务主要特性目前的品质水准，明文记载其趋势。并以此与竞争者和/或适当企业标竿 来比较。数据和信息中所显示之趋势应与整体经营目标的的进 展相比较，转化成据以行动的信息以支持：1）顾客相关问题解决方案的优先级。2）决定与顾客相关的重要趋势和对等比较以支持现状 检讨、决策及长规划。顾客满意-供货商应制定一套决定顾客满意的 书面程序，程序包括决定的频次及如何确保其客观性 和有效性。顾客满意的趋势以及顾客不满意的主要指 针，应书面记载且具客观信息予以证实。这些趋势需 与竞争厂商，或适当的企业标竿来

28、比标，并经高层管 理阶层审查。备注：顾满意考量可顾及内部，外部和最终顾客。 通知认证团体当顾客将处所（site）置于下列状态时，供货商应于（5） 个工作天内以书面通知他的认证团体：1）Chrysler“Needs Improvement ”2）Fork Q-1 Revocation3) General Motors Level II ContainmentQuality System - ElementGeneral - supplier shall establish, document and main tain a quality system as amines of en suri

29、ng that product con forms to specified requirements.The supplier shall prepare aquality man ual coveri ng the requireme nts of thisInternationalStandard. The qualityman ual shall in clude or make refere nee to thequality system procedures and outline the structure ofthe docume ntati onused in the qu

30、ality system.NOTE6： Guida nee on quality man uals is give n in ISO 10013.Quality System Procedures - supplier shalla) prepare docume nted procedures con siste ntwith therequireme nts oftheIn ter nati onal Stan dardandthesupplier s-stated quality policy, andb) effectively impleme nt the quality syste

31、m and its docume nted procedures.For the purposes of thisIn ter nati onalStandard, the range and detailof theprocedures that form part of the quality system shall be dependent upon the complexity of the work, the methods used, and the skills and training n eeded by pers onnel in volved in carry ing

32、out the activity.NOTE 7 : Documented procedures may make refere nee to work in structi ons that defi ne how an activity is performed.Quality Planning - supplier shall define and document owthe requirementsfor quality will bemet. Quality planning shall be consistent with all other requirements of a s

33、 upplier s quality system and shall be documentedin a format to suit the supplier methoebf operation. Thesupplier shall give con siderati on to the followi ng activities, asappropriate, in meeti ngthe specified requireme nts for products, projects or con tracts:a. the preparati on of quality pla ns:

34、b. the identificationand acquisition of anycon trols,processes,equipme nt(in cludi ngin specti onand testequipme nt),fixtures, resources andskills that maybe n eeded to achieve the required quality :c. en sur ing the compatibility of the desig n,the production process, installation, servic ing,in sp

35、ecti onand testprocedures and the applicable docume ntati on;d. the updatingas necessary of qualitycon trol,in specti onandtest ingtech ni ques, in cludi ng the developme nt of new in strume ntati on;e. the identificationof any measurementrequireme ntin volv ingcapability then eeded capability to be

36、 developed;f. theide ntificati onof suitable verification at appropriate stages in the realizati on of product;g. the clarificati on ofsta ndardsofacceptability for all features and requireme nts, in clud ing those which contain a subjective eleme nt;品质系统概述-供货商应建立与维持一个书面化的品质系统做 为确保产合规定要求的手段。供货商应准备一份

37、涵盖 本国际标准要求的品质手册。品质手册应包含或照品 质系统的书面程序，并对品质系统所采用文件其架构 予以概要说明。备注6：品质手册的指导纲要请参阅ISO 10013品质系统程序-供货商应：a. 拟定符合本国际标准要求与供货商既定品质 政策之各项书面程序，及b. 有效实施品质系统及其各项书面程序。为达到本国际标准之目的，构成品质系统之程序其范 围与详细程度，端赖工作复杂性、采用的方法及执行 业务参与人员所需技巧与训练等因素而定。备注7：书面程序可参考对应那些界定作业如何执行的 工作指导书。品质规划-供货商应界定与书面化各项品质要求是如 何违成。品质规划应与供货商品质系统的所有其它要 求一致，并

38、以适合供货商作业方法的格式将其文书化。 供货商应适当考量下列活动以达成产品、项目或合约 的规定要求：a. 拟定各项品质计划；b. 鉴定与取得为违成需求品质所需之任何管制、流程、设备（含检验及测试设备）、治具、资源及技 术；c. 确保设计、生产流程、安装、服务、检验与测试 等程序，与适用文件间彼此之一致性；d. 必要时，得更新质量管理、检验与测试技术，含 新仪器的开发；e. 鉴定任何量测需求其能力超岀现有已知技术水 准者，应有充裕的时间开发所需能力；f. 在产品实现的各适当阶段鉴定其适切的验证；g. 厘清所有性能与要求的允收标准，包括那些具主 观因素者；h. the identification

39、 and preparation of quality records （seeThe supplier shall establish and implement an advanced product quality planning process. The suppliershouldconveneinternalmulti-disciplinaryteams to prepare forproduction of new or changed products. These teams should use appropriate techniques identified in t

40、he Advanced Product Quality Planning and Control Plan reference manual. Similar techniques that accomplish the intent are acceptable.Team actions should include :Development/finalizationof specialcharacteristics （see Appendix C）Development and review of FMEAs Establishment of actions to reduce the p

41、otential failure modes with high risk priority numbersDevelopment or review of Control PlansThe supplier s process control guidelines and similar documents FMEA s, Control Plans, Operation Instructions) shall be marked with the customer s special characteristic symbol (or the supplier s equivalent s

42、ymbol or notation) to indicate those process steps that affect Special characteristics, when Special Characteristics are identified on the customer design record (see Glossary) (see Appendix C)NOTE Initially, the customer may determineSpecial Characteristics and identify them. Special Characteristic

43、s may be identified from any product characteristics category, dimensional,material,appearance,performance.)The supplier shall investigate and confirm the manufacturing feasibilityof proposedproducts prior to contracting to produce those products. Feasibility isan assessment of thesuitability of a p

44、articular design, material, or process for production, while conforming to all engineering requirements at the required statisticalprocess capability and atspecified volumes.Feasibility reviews should be documented using the Team feasibility commitment in the Advanced Product Quality Planning and Co

45、ntrol Plan Reference manual.Due care and product safety shall be considered in the supplier s design control （element and process control（elementpolicies andpractices. The supplier should promote internal awareness of safety consideration relative to the supplier s product.h. 品质记录之鉴别与调制（参阅备注8 :上述之品质

46、计划成参阅其形式可以构成 供货商品质系统之适当书面程序对照的方式表 示。先期产品品质规划 供货商应建立和实施先期产品品质规划流程。供货商须召集内部的跨功能小组，以准备新产品或变更产品的量产。这些小组须采用规定在先期产品品质 规划和管制计划参考手册的各种适当的但也可采用能达成本项意图的类似技术。小组的工作须包括：1. 各项管制特性的发展/定案（见附录C）。2. 各项失效模式与效应分析的发展和检讨。3. 制定行动方案以降低高风险优先指数的潜在失 效模式。4. 各项管制计划的发展和检讨。管制特性 当顾客的设计记录（参阅词汇）有标明管制特性时， 供货商的各项制程管制指导书及类似的档 -（FMEA、 管

47、制计划，操作说明），使用顾客指定的管制特性 符号（或者供货商对等的符号或标记 ）来标明那些 会影响管制特制的制程步骤（参见附录C）o备注：初期时，顾客可能会确定管制特性并加 以标识。管制特性可能来自任何产品特性的种 类，即尺寸、材质、外观，功能。可性审查供货商在签定合约以生产产品之前，应对所规划的产 品探讨及确认制造的可行性。可行性是指在既定的统 计制程能能力，产能且符合所有工程要求的前提下， 评定某特定产品其设计、材料或生产制程的迫切性。 可行性审查结果的记载须使用先期产品品质规划和管 制计划参考手册里的小组可行性承诺 产品安全性 供货商的设计管制及制程管制，其政策与实务应考量 关注产品的安

48、全性。供货商需在内部推广对其产品安 全性考量的认知。Process Failure Mode and Effects Analysis (Process FMEAs)Process FMEAs shall consider all Special Characteristics. Efforts shall be taken to improve the process to achieve defect prevention rather than defect detection. Certain customers have FMEA review and approval requir

49、ements that shall be met prior to production part approval (see Section II). Refer to thePotential FailureMode and Effects Analysis reference manual.The supplier shall utilize appropriate mistake proofing methodologies during the planning of processes, facilities, equipment and tooling.The supplier

50、shall develop Control Plans at the system, subsystem, component and or material level, as appropriate for the product supplied.The Control Plan shall include the information required in the Control plan form in Appendix J.The Control Plan requirement encompasses process producing bulk materials . st

51、eel, plastic resin, paint)as well as those producing parts.The output of the advanced quality planning process,beyond thedevelopmentofrobustprocesses, is a Control Plan. Control Plans shall be revised or updates when products or processes differ significantly from those in current production.The Con

52、trol Plan should list the controls used for processes control (see .The Control Plan shall cover three distinct phases as appropriate:Prototype- A description of thedimensionalmeasurements and materialandperformance tests that will occur during Prototype build (see APQPreference manual). The supplie

53、r shall have a prototype control plan if there are required by the customer. Pre-launch - A description of the dimensional measurements and material and performance tests that will occur Prototype and before full Production.Production- Documentation ofproduct/process characteristics, process control

54、s, tests, and measurement systems that occur during mass production. The supplier shall use a multi-disciplinary approach to develop Control Plans.NOTE A multi-disciplinary approach typically includes the supplier s Design, manufacturing, engineering, quality, production, and other Appropriate perso

55、nnel. For external suppliers, it may include the customer s Purchasing, quality, Engineering customer plant personnel as well as subcontractors.Control Plans shall be reviewed and updated as appropriate when any of thefollowing occur:The product is changed.The processes are changed.The processes bec

56、ome unstable.The process become non-capable.Inspection method, frequency, etc. is revised.Refer to the Production Part Approval Process manual.制程的失效模式与效应分析制程的失效模式与效应分析应考虑所有的管制特 性，应致力于改善制程，以做到预防不良胜于找岀 不良。某些顾客要求在产品认可核准前要先完成 FMEA审查及核准（参阅雇客特定要求章节）。参考潜 在失效模式与效应分析参考手册。错误防止供货商应于制程，设施，仪器，工模具等规划过程中，使用适当的错误防止

57、方法论。管制计划供货商应对所供应产品的系统、子系统、组件及（或）物料等各层次适当的制定管制计划。管制计划包含附录J管制计划表格内的所有信息（细项）O此项管制计划要求含盖生产散装材料的制程（譬如：钢铁、塑料树脂、油漆）及零组件生产。除了稳健制程的开发以外，管制计划亦是先期品质 规划流程的结果。当产品或制程显着不同于现行量 产时，则管制计划应加以修订或更新。管制计划需列岀制程管制（参照所使用的各项管制，管制计划应涵括下列三种不同阶段：原型样品一说明在原型样品试制期间，所发 生的各项尺寸量测、材料及性能测试等（参阅 APQP参考手册）。顾客如是要求时，供货商 应有原型样品管制计划。量产前一说明介于原型样品和全面量产之 间，所发生的各项尺寸量测、材料及性能测 试等。量产一完整描述在大量生产过程中，所涉及 的各项产品/制程特性、制程管制、测试和 量测系统等的文件。供货商应运用跨功能团 的方式以发展管制计划。备注：跨功能小组的成员，通常须包括供货商的设 计、制造工程、品质、生产及其它相关