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企业经营管理中英文

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2021-02-11 20:24
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2021年2月11日发(作者:rejects)


Section


I



ISO


9000



Bases


Requirements



Management Responsibility



Element



4.1



Quality Policy-4.1.1




The


supplier’s


management


with


executive


responsibility


shall


define


and


document


its


policy


for quality, including objectives for quality and


its


commitment


to


quality.


The


quality


policy


shall


be


relevant


to


the


supplier’s


organizational


goals


and


the


expectations


and


needs


of


its


customers.


The


supplier


shall


ensure


that


this


policy


is


understood,


implemented


and


maintained


at


all


levels of the organization.



Organization-4.1.2



Responsibility and Authority-4.1.2



The


responsibility,


authority


and


the


interrelation


of


personnel


who


manage,


perform


and


verify


work


affecting


quality


shall


be


defined


and


documented,


particularly


for


personnel


who


need


the


organizational freedom and authority to




a)



initiate action to prevent the occurrence of


any


nonconformities


relating


to


product,


process and quality system




NOTE



It


is


recommended


that


the


personnel


responsible


for


quality


have


the


authority


to


stop


production,


if


necessary


to


correct


quality


problems.



b


)


identify


and


record


any


problems


relating


to


the


produce, process and quality system




c)



initiate,


recommend


or


provide


solutions


though designated channels





d)



verify the implementation of solutions





e)



control


further


processing,


delivery


or


installation of nonconforming product until


the


deficiency


or


unsatisfactory


condition


has


been corrected.



f)



represent


the


needs


of


the


customer


in


internal


functions


in


addressing


QS-9000


requirements(e.g


selection


of


special


characteristics, setting quality objectives,


training,


corrective


&


preventive


actions,


product design and development).



Resources-4.1.2.2



The supplier shall identify resource requirements


and


provide


adequate


resources,


including


the


assignment


of


trained


personnel


(see


4.18).for


management, performance of work and verification


activities including internal quality audits.



Management representative-4.1.2.3



The


supplier’s


management


with


executive


responsibility


shall


appoint


a


member


of


the


supplier’s own


management who, irrespective of


other


responsibilities,


shall


have


defined


authority for



a)



ensuring


that


a


quality


system


is


established,


implemented and maintained in accordance with


this international Standard, and



b)



reporting on the performance of the quality


system


to


the


supplier’s


management


for


review


and as a basis for improvement of the quality


system.










管理责任─


4.1



品质政策─


4.1.1



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─


4.1.2



责任与授权─


4.1.2.1



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

< br>


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─


4.1.2.2



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

< p>
(


参阅


4.18)


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─


4.1.2.3



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


representative


may


also


include


liaison


with


external


parties


on


matters


relating


to


the supplier’s quality system.



Organizational Interfaces



4.1.2.4



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


reference


manual).


The


supplier


shall


use


a


multi-disciplinary


approach


for


decision-making


and


have


the


ability


to


communicate


necessary


information and data in the customer- prescribed


format.



NOTE



Typical functions to be included are:




Engineering/Technical




Manufacturing/Production




Industrial Engineering




Purchasing/Materials Management




Quality/Reliability




Cost Estimating




Product Service




Management


Information


Systems/Data


Processing




Packaging Engineering




Tooling Engineering/Maintenance




Marketing and Sales




Subcontractors, as necessary



Information to Management-4.1.2.5



Management with responsibility and authority for


corrective action shall be promptly informed of


products or processes which become noncompliant


with specified requirements.



Management Review



4.1.3



The


supplier’s


management


with


executive


responsibility shall review the quality system at


defined


intervals


sufficient


to


ensure


its


continuing


suitability


and


effectiveness


in


satisfying the requirements of this international


Standard


and


the


supplier’s


stated


quality


policy


and


objectives.(See


4.1.1).


Records


of


such


reviews


shall be maintained.(See 4.16).



Management Review



4.1.3.1



This Management Review requirement shall include


all


elements


of


the


entire


quality


system,


not


only


those


specifically


required


in


other


elements


(e.g.


4.14.3.d).



NOTE



Management


Review


should


be


conducted


with


a


multi-disciplinary approach(see Glossary).




Business Plan



4.1.4



The supplier shall utilize a formal, documented,


comprehensive business plan. this Business 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 issues




Financial Planning and cost




Growth projections




Plant/facilities plans




Cost objectives




Human resource development




R & D plans, projections, 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


- 4.1.2.4



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.



市场及行销



12.



分包商


(


必要时


)



通知管理阶



- 4.1.2.5



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


- 4.1.3



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

< br>质政策及目标


(


参阅


4.1. 1)


。此项审查的记录应


予维持


(


参阅


4.16)






管理审查


- 4.1.3.1



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


4.14.3.d(


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


(



阅词汇


)





经营计划


- 4.1.4



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


< br>7.


研发计划,企业,项目及其适当的财源





Projected sales figures




Quality objectives




Customer satisfaction plans




Key


internal


quality


and


operational


performance measurable




Health, Safety and Environmental issues



Goals and plans should cover short-term (1-2


years) 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


automotive


industry


and


the


supplier’s


commodity.


Methods


to


determine


current and future customer-expectations shall


be in place. An objective process shall be used


to


define


the


scope


and


collection


information,


including


the


frequency


and


methods


of


collection.



Methods


to


track,


update,


revise,


and


review


the


plan


shall


be


documented


to


ensure


that


the


plan


is


followed


and


communicated


throughout


the


organization as appropriate.



NOTE



Data


and


information


should


drive


process


improvement plans.



NOTE



The


supplier


should


provide


means


for


employee


empowerment


in


meeting


business


goals.



Analysis and Use of Company Level Data



4.1.5



The supplier shall document trends in quality,


operational


performance


(productivity,


efficiency,


effectiveness,


cost


of


poor


quality)


and current quality 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


solutions to customer-related



2)



Determination


of


key


customer- related


trends and correlations to support status


review,


decision-making


and


longer-term


planning.



Customer Satisfaction



4.1.6



The


supplier


shall


have


a


documented


process


for


determining


customer


satisfaction,


including


frequency


of


determination,


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 management.


< br>NOTE



Consideration


should


be


given


to


internal, external and final



Customers



Certification


Body/Registrar


Notification



4.1.6.1



A


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





Ch


rysler “Needs Improvement”




Fork Q-1 Revocation




General Motors Level II Containment





8.


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



)


和长程


(3


年或以



)



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


授权。



公司层级数


据的分析


和应用


- 4.1.5



供货商针对品质,


作业绩 效


(


生产力、


效率、

< br>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

< br>/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

< p>
现状检讨、决策及长规划。




顾客满意


- 4.1.6



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 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


- 4.1.6.1



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 Revocation



3)



General Motors Level II Containment





Quality System



Element 4.2



General



4.2.1



The


supplier


shall


establish,


document


and


maintain


a


quality


system


as


amines


of


ensuring


that


product


conforms to specified requirements. The supplier


shall


prepare


a


quality


manual


covering


the


requirements of this International Standard. The


quality manual shall include or make reference to


the


quality


system


procedures


and


outline


the


structure


of


the


documentation


used


in


the


quality


system.



NOTE 6



Guidance on quality manuals is given in


ISO 10013.




Quality System Procedures



4.2.2



The supplier shall



a)



prepare


documented


procedures


consistent


with


the


requirements


of


the


International


Standard


and


the


supplier’s


-stated


quality


policy,


and


b)



effectively implement the quality system and


its documented procedures.





For the purposes of this International Standard,


the range and detail of the procedures that form


part


of


the


quality


system


shall


be


dependent


upon


the complexity of the work, the methods used, and


the


skills


and


training


needed


by


personnel


involved in carrying out the activity.




NOTE 7



Documented procedures may make reference


to work instructions that define how an activity


is performed.



Quality Planning



4.2.3



The


supplier


shall


define


and


document


how


the


requirements for quality will be met. Quality planning


shall be consistent with all other requirements of a


supplier’s quality system and shall be documented in a


format to suit the supplier’s method


of operation. The


supplier


shall


give


consideration


to


the


following


activities,


as


appropriate,


in


meeting


the


specified requirements for products, projects or


contracts




a.



the preparation of quality plans





b.



the identification and acquisition of


any


controls,


processes,


equipment


(including


inspection


and


test


equipment),


fixtures,


resources


and


skills that may be needed to achieve


the required quality





c.



ensuring


the


compatibility


of


the


design,


the


production


process,


installation,


servicing,


inspection


and


test


procedures


and


the


applicable


documentation;



d.



the


updating


as


necessary


of


quality


control,


inspection


and


testing


techniques,


including


the


development


of new instrumentation;



e.



the identification of any measurement


requirement


involving


capability


the


needed capability to be developed;



f.



the


identification


of


suitable


verification at appropriate stages in


the realization of product;



g.



the


clarification


of


standards


of


acceptability


for


all


features


and


requirements,


including


those


which


contain a subjective element;



品质系统


4.2



概述


- 4.2.1



供货商应建立与维持一个书面化的品质系统做为< /p>


确保产合规定要求的手段。供货商应准备一份涵


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

< p>
文件其架构予以概要说明。






备注


6< /p>



品质手册的指导纲要请参阅


ISO 10013





品质系统程



- 4.2.2



供货商应:


< p>
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< /p>



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


- 4.2.3



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


(

< p>
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

< br>仪器的开发;




e.



鉴定任何量测需求其能力超出现 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


and


preparation


of


quality


records (see 4.16)




NOTE


8:The


quality


plans


referred


to


[see


4.2.3a]


may


be


in


the


form


of


a


reference


to


the


appropriate


documented


procedures


that


form


integral part of the supplier's quality system.



Advanced Product Quality Planning



4.2.3.1



The


supplier


shall


establish


and


implement


an


advanced


product


quality


planning


process.


The


supplier


should


convene


internal


multi-disciplinary


teams


to


prepare


for


production


of new


or changed


products.


These


teams should


use


appropriate techniques identified in the


Advanced


Product



Quality


Planning


and


Control


Plan


reference


manual.


Similar


techniques


that


accomplish the intent are acceptable.



Team actions should include






Development/finalization


of


special


characteristics (see Appendix C)




Development and review of FMEAs




Establishment


of


actions


to


reduce


the


potential


failure


modes


with


high


risk


priority numbers




Development or review of Control Plans



Special Characteristics



4.2.3.2



The


supplier’s


process


control


guidelines


and


similar


documents


(e.g


FMEA’s,


Control


Plans,


Operation Instructions) shall be marked with the


customer’s special characteristic symbol (or the


supplier’s


equivalent


symbol


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


determine


Special Characteristics and identify them.


Special Characteristics may be identified


from any product characteristics category,


(e.g


dimensional,


material,


appearance,


performance.)



Feasibility Reviews



4.2.3.3



The supplier shall investigate and confirm


the


manufacturing


feasibility


of


proposed


products


prior


to


contracting


to


produce


those


products.


Feasibility


is


an


assessment


of the suitability of a particular design,


material, or process for production, while


conforming


to


all


engineering


requirements


at


the required statistical process capability


and at specified volumes.




Feasibility


reviews


should


be


documented


using the Team feasibility commitment in the



Advanced


Product


Quality


Planning


and


Control


Plan


Reference manual.



Product Safety



4.2.3.4



Due


care


and


product


safety


shall


be


considered


in


the


supplier’s


design


control


(element 4.4) and process control (element


4.9)


policies


and


practices.


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


4.16)




备注


8



上述之品质计划成参阅< /p>


(4.2.3a)


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




4.2.3.1



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技


术。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)


。< /p>



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




4.2.3.2



当顾客的设计记录


(


参阅词汇


)


有标明管制特性

< p>
时,供货商的各项制程管制指导书及类似的档


-(FMEA



管制计划,


操作说明


)



使用顾客指定的管制特性符号


(



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)






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、



质、 外观


,


功能。





可性审查




4.2.3.3



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书。< /p>




产品安全性




4.2.3.4



供货商的设计管制


(4.4)


及制程管制


(4.9)


,其政策与实


务应考量关注产品的安全性 。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)


-4.2.3.5



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


requirements


that


shall


be


met


prior


to


production


part


approval (see


Section


II).


Refer to the


Potential Failure Mode and Effects


Analysis


reference manual.




Mistake Proofing



4.2.3.6



The


supplier


shall


utilize


appropriate


mistake


proofing


methodologies


during


the


planning


of


processes, facilities, equipment and tooling.



The Control Plan



4.2.3.7



The supplier 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


(e.g.


steel,


plastic


resin,


paint)as well as those producing parts.



The


output


of


the


advanced


quality


planning


process,


beyond the development of robust processes, is a


Control Plan. Control Plans shall be revised or


updates


when


products


or


processes


differ


significantly


from


those


in


current


production.



The


Control


Plan


should


list


the


controls


used


for processes control (see 4.9).The Control


Plan


shall


cover


three


distinct


phases


as


appropriate





Prototype




A


description


of


the


dimensional


measurements


and


materialand


performance


tests


that


will


occur during Prototype build (see APQP


reference manual). The supplier 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


of


product/process


characteristics,


process


controls,


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


personnel.


For external suppliers, it may include the


customer’s


Purchasing,


quality,


Eng


ineering


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 become 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




4.2.3.5




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


出不良。某些顾客要求在产品 认可核准前要先完



FMEA


审查及核 准


(


参阅雇客特定要求章节


)




考潜在失效模式与效应分析参考手册。






错误防止




4.2.3.6



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方法论。




管制计划




4.2.3.7



供货商应对所供应产品的系统、子系统、组件及


(


或< /p>


)



料等各层次适当的制定管制计划。< /p>




管制计划包含附录

< br>J


管制计划表格内的所有信息


(




)



< /p>


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。当产品或制程显著不同于现行量产时,则


管制计划应加以修订或更新。





管制计划需列出制程管制


(


参照


4.9)


所使用的各项管

< br>制,管制计划应涵括下列三种不同阶段:





原型样品─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

< p>
APQP



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─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─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、生产及其它相关人员。对于外部供货


商,也可包括顾客的采购、品质、产品工程、顾客工厂


人员和分包商的人员。< /p>





当下列任 何一项情况发生时,管制计划应进行适当地检


诗和更新:



1.



产品变更时



2.



制程变更时



3.



制程不稳定时



4.



制程能力不足时



5.



检验方法,频度等被变更



参照量产零组件核准程序手册



Product Approval Process



4.2.4



General



4.2.4.1



The


supplier


shall


fully


comply


with


all


requirements


set


forth


in


the


Production


Part


Approval Process (PPAP)


manual.



Subcontractor Requirements



4.2.4.2



Suppliers should utilize a part approval process


(e.g. PPAP) for Subcontractors (see Glossary).



NOTE



Certain customers require their supplier


use


PPAP



with


Their


subcontractors (see


Section


II)




Engineering Change Validation



4.2.4.3



The


supplier


shall


verify


that


changes


are


properly


validated See 4.12,4.16 And PPAP



NOTE



This


applies


equally


to


suppliers


and


subcontractors




Continuous Improvement



4.2.5



General



4.2.5.1



The supplier shall continuously improve in


quality,


service


(including


timing,


delivery)


and price that benefit all customers. This


requirement


does


not


replace


the


need


for


innovative improvements.




NOTE



A


continuous


improvement


philosophy


should be fully Deployed throughout the


supplier’s organization.




Continuous


improvement


shall


extend


to


product


characteristics with the highest priority on


special characteristics.




NOTE



Cost


elements


or


price


should


be


one


of the key indicators within a continuous


improvement system.




NOTE



For


those


product


characteristics


and


process parameters that can be evaluated


using


variable


data,


continuous


improvement


means


optimizing


the


characteristics


and


parameters


at


a


target


value and reducing variation around that


value. For those product characteristics


and process parameters that can only be


evaluated


using


attribute


data,


continuous


improvement


is


not


possible


until


characteristics


are


conforming.


If


attribute data results do not equal zero


defects,


it


is


by


definition


nonconforming


product


(see


4.10.1.1,


4.13,


4.14)


Improvements made in these situations are


by


definition


corrective


actions,


not


continuous improvement.



The


supplier


shall


develop


a


prioritized


action


plan


for


continuous


improvement


in


processes that have demonstrated stability,


acceptable capability and performance.




NOTE:


Processes


with


unacceptable


capability


/


performance


require


corrective action (see 4.14.2).




Quality and Productivity Improvements



4.2.5.2



The


supplier


shall


identify


opportunities


for


quality


and


productivity


Improvement


and


implement appropriate improvement projects.



量产零组件


核准程序




4.2.4



概述




4.2.4.1



供货商应完全符合量产零组件核准程序


(PPAP)



册里规定的所有要求。




分包商的要





4.2.4.2



供货商需对其分包商业


(


参阅词汇

)


导入零零件核


准程序。


(



PPAP)



备注 :


某些顾客要求供货商对其分包商引用


PPAP


(


参阅第二章


)


< p>



工程变更的


认认




4.2.4.3



供货商负责验证工程变更被适当的确认。参见


4.12



4.16



PPAP




备注:


本项要求适用于供 货商与分包商。





持续改善




4.2.5



概述




4.2.5.1



供货商应为所有的顾客持续不断地改善品质、服务


(



括时效、


交货


)


及价格。


本项要求并不取代创新改进的需


要 。





备注 :


需将持续改善的理念全面地展开到整个组织。




持续改善拓展至那些管制特性中距较高优先的产品特


性。




< p>
备注:


成本因赤或价格需是持续改善系统中的重要指


针之一。




备注:


对于那些能够用计量值数据评估的产品特性和


制程参数,


持续不断改善意味将特性和参数对目标值


的最佳化,


并减少其 对目标值的变异。


对于那些只能


用计数值数据来评估的产品特性 和制程参数,


在特性


不符合前,


持续改 善是不可能的,


如果计数质的结果



















(

< br>参



4.10.1.1



4.13



4.14)


在此情况下,所谓改善意指


矫正行动而非持续改善。







制程一旦显示相当稳定且制程能力合乎要求时,供货商


应研拟贝体优 先的持续改善计划。






备注:


制程能力不足或续效不佳时,


需执行矫正行动


(


参阅


4.14.2)




品质和生产


力的改进




4.2.5.2



供货商应明确定出对品质和生产力改进的机会,并报行


适当的改进计划。





NOTE



Examples


of


situations


which


might


lead


to


improvement Projects are





Unscheduled machine downtime




Machine


setup,


die


change


and


machine


changeover



times




Excessive cycle time




Scrap, rework and repair




Non value-added use of floor space




Excessive variation




Less than 100% first run capability




Process


averages


not


centered


on


target


values



(bilateral tolerance)




Testing requirements not justified by


accumulated



results




Waste of labor and materials




Cost of poor quality




Difficult assembly or installation of


the product




Excessive handling and storage




New target values to optimize customer


processes




Marginal measurement system capability


(see MSA



and ISO 10012-1)




Customer


dissatisfaction,


e.g.


complaints,


repairs,


returns,


mis-shipments,


incomplete


orders,


customer


plant


concerns,


warranty,


etc.



Techniques


for


Continuous


Improvement




4.2.5.3



The supplier shall demonstrate knowledge of


appropriate continuous improvement measures


and


methodologies


and


shall


use


those


that


are


appropriate




NOTE



The following list shows examples of


possible


techniques


Which


might


be


used.


There may be many other methods which meet


Specific supplier needs more appropriately.




Control Charts (Variables, Attributes,


CUSUM)




Design of experiments (DOE)




Theory of constraints




Overall equipment effectiveness




Parts per million (PPM) analysis




Value analysis




Benchmarking




Analysis of motion/ergonomics




Mistake proofing




Facilities and Tooling Management



4.2.6



Facilities,


Equipment,


and


Process


Planning


Effectiveness



4.2.6.1



The supplier shall use a multi-disciplinary


approach


for


developing


facilities,


processes


and


equipment


plans


in


conjunction


with the advanced quality planning process.


Plant


layouts


should


minimize


material


travel


and


handling,


facilitate


synchronous


material flow, and maximize value-added use


of


floor


space.


Methods


shall


be


developed


for


evaluating


the


effectiveness


of


existing


operations


and


Processes


considering


the


following


factors:


overall


work


plan,


appropriate


automation,


ergonomics


and


human


factors, operator and line balance, storage


and


buffer


inventory


levels,


value-added


labor contents.




NOTE



The


supplier


should


identify


and


define


appropriate


metrics


to


Monitor


the


effectiveness


of


existing operations.




备注:


可能导致改善项目的情况其例 如下:




1.



非计划排定的停机时间



2.



机器设定櫯模及换线时间




3.



过长作业周期时间



4.



报废、重工及修理



5.



无附加价值的空间的使用



6.



过度的变异



7.



首批制程能力低于


100%



8.



制程平均值未集中于目标值


(


双边公差


)




9.



测试的必要无法被累积的结果来判定结果



10.



人工、材料的浪费



11.



不良品质的成本



12.



产品装配或安装困难



13.



过多的搬运和储存



14.



以新目标值优化顾客流程



15.



量测系统能力接近边缘值


(


参阅


MSA


及< /p>


ISO


10012-1)



16.



顾客的不满意,


譬如,


抱怨、


修理、


退货、


误送、


交货不足、顾客工厂的意见、索赔等。

< br>


持续改善的技术




4.2.5.3



供货商应展示具有下列衡量和方法论的知识,并加以适


当应用之:




备注:


以下所列为可能 运用的各种技术例子,


可能存


有其它的方法更能贴切满足供货商 的特定需要:




1.



管制图


(


计量值,计数值,累积总和图


)



2.



实验计划法


(DOE)



3.



限制理论



4.



设备综合效益



5.



零组件百万分不良分析



6.



价值分析



7.



竞争标竿



8.



动作分析/人体工学



9.



错误防止




设施与工模


具管理


- 4.2.6



设施、设备


及制程规


划和效益




4.2.6.1




供货商应采用跨功 能小组并结合先期品质规划流程的做


法,以制定制程、设施及设备计划。工厂的布置须将 物


料的流动和搬运程度减到最小以促进物料的同步流动,


且将工 厂空间的使用附加价值提升到最大。应制定评估


目前作业和制程有效性的方法,并考虑下 列因素:总体


工作计划、适当的自动化、人体工学和人性因素、作业

员和生产线的平衡、


储存和库存量多寡及增值人工成份。






备注< /p>



供货商需确认与定义适当的指数以监督目前作

< br>业的有效性。




Tooling Management



4.2.6.2



The supplier shall establish and implement a


system for tooling management including





Maintenance


and


repair


facilities


and


personnel




Storage and recovery Setup




Tool change programs for perishable tools




Tool modification, including tool design


documentation



The


supplier


shall


provide


appropriate


technical resources for tool (see Glossary)


and


gage


design,


fabrication


and


full


dimensional inspection. the supplier shall


implement a system to track and follow-up on


these


activities


if


any


of


this


work


is


subcontracted.



NOTE



Tooling Management (4.2.6.2)


is


not


required of warehouses or distributors.



Contract Review



Element 4.3



General



4.3.1



The


supplier


shall


establish


and


maintain


documented


procedures


for


contract


review


and


for the coordination of these activities.



NOTE



The


supplier


is


not


requires


to


return


signed


Purchase


Order


Acknowledgements


unless


otherwise


specified


by


the


customer.




Review



4.3.2



Before the submission of a tender, or the


acceptance of a contract or order (statement


of


requirement),


the


tender,


contract


or


order shall be reviewed by the supplier to


ensure that


:



a)



the requirements are adequately defined


and


documented;


where


no


written


statement


of


requirement


is


available


for


an order received by verbal means, the


supplier


shall


ensure


that


the


order


requirements


are


agreed


before


their


acceptance;



b)



any difference between the contract or


order


requirements


and


those


in


the


tender are resolved;



c)



The supplier has the capability to meet


contract or order requirements.



d)



all


customer


requirements,


including


those in Section


II


of


this document,


shall be met.




Amendment to a Contract



4.3.3



The supplier shall identify how an amendment


to


a


contract


is


made


and


correctly


transferred


to


the


functions


concerned


within


the supplier’s organization.




Records



4.3.4



Records


of


contract


reviews


shall


be


maintained (see 4.16).



NOTE



9



Channels


for


communication


and



interfaces with the customer’s organization in


these contract matters should be established.




Design Control



Element 4.4



NOTE



THIS


ELEMENT


APPLIES


TO


DESIGN


RESPONSIBLE


SUPPLIER


ONLY.


A


supplier


is


defined


as


design-responsible


if


it


has


the


authority


to


establish a new, or change an existing product


specification


for


any


product


shipped


to


a


customer.



Customer


approval


of


a


design


responsible supplier’s product does not waive


the


supplier’s


design


responsible


statu


s.


Consult your customer for further clarification


if needed.



工模具管理


- 4.2.6.2



供货商应制定和执行一套工具管理的制度,内容包括:



1.



保养和修理的设施和人员



2.



储存和修复



3.



设定条件



4.



损耗性工具修改,包括工模具设计



供 货商应具备适当的技术资源,


以从事工模具


(

< br>参阅词汇


)


和量具之设计、制造和完整的尺寸检查。如果 任何这方


面的的工作系属外包者,则需有一套追踪和跟摧违些工


作系统。




备注

:对仓库或配销商不要求工模具管理


(4.2.6.2)



合约审查


- 4.3



概述


- 4.3.1



供货商应制定与维持合约审查及该类作业间协调的书面


程序。




备注


< br>除非顾客特别规定,


领应商不需签回采购订单


承认书。< /p>





审查


- 4.3.2



供货商在提出标单,或接受合约或订单


(


需求的陈述


)



前,都应加以审查以确保:





a)



各项要求均被适切的界定与面记 载;


当订单其需


求无书面陈述而以口头方式接获时,

< p>
供货商应确


保在订单接受前己同意其需求;




b)



合约 或订单上任何与标单内容不同的需求,


皆已


解决;



c)



供货商具有能力违成合约或订单需求。





d)


< /p>


能够违成顾客所有的要求,


包括本文第


2


节的部


份。




合约变更


- 4.3.3



供货商应明示合约如何变更,及如何正确地传达于供货


商组织内各相关部 门。





记录


- 4.3.4



合约审查的记录应予维持


(


参阅

4.16)




备注


9



应建立与客户组织协商合约事务的沟通管道


与接口。





设计管制


- 4.4



备注:


本要项仅适用于供货商负有设计责任者。


如果 供货商对运送顾客的任何产品,被授权建


立新产品,或更改目前产品的规格,则定义该< /p>


供货商有设计责任。


顾客对供货商产品的核准,

< br>并不豁免供货商的设计责任。必要时咨询您的


顾客以作进一步的澄清。

< p>




General



4.4.1



The


supplier


shall


establish


and


maintain


documented procedures to control and verify


the design of the product in order to ensure


that the specified requirements are met.




Use of Design Data



4.4.1.1



The supplier shall have a process to deploy


information


gained


from


Previous


design


projects to current and future projects of a


similar nature.




Design and Development Planning



4.4.2



The supplier shall


prepare


plans


for each


design and development activity. The plans


shall


describe


or


reference


these


activities,


and


define


responsibility


for


their


implementation. The design and development


activities


shall


be


assigned


to


qualified


personnel equipped with adequate resources.


The plans shall be updated, as the design


evolves.



Required Skills



4.4.2.1



The


su


pplier’s


design


activity


should


be


qualified


in


the


following


skills


as


appropriate






Geometric dimensioning and tolerancing


(GD&T)




Quality function deployment (QFD)




Design for manufacturing (DFM)/Design


for assembly (DFA)




Value engineering (VE)




Design of experiments (DOE)




Failure


mode


and


effects


analysis


(DFMEA / PFMEA ,etc.)




Finite element analysis (FEA)




Solid modeling




Simulation techniques




Computer


aided


design(CAD)/Computer


aided engineering(CAE)




Reliability engineering plans



Organizational and Technical Interfaces



4.4.3



Organizational


and


technical


interfaces


between


different


groups


which


input


into


the


design


process


shall


be


defined


and


the


necessary


information


documented,


transmitted and regularly reviewed.



Design Input



4.4.4



Designed


input


requirements


relating


to


the


product,


including


applicable


statutory


and


regulatory


requirements, shall be identified, documented and


their


selection


reviewed


by


the


supplier


for


adequacy.


Incomplete,


ambiguous


or


conflicting


requirements


shall


be


resolved


with


those


responsible for imposing these requirements.




Design


input


shall


take


into


consideration


the


results of any contract review activities.



Design Input



Supplemental



4.4.4.1



The supplier shall have appropriate resources and


facilities to utilize computer



aided product


design,


engineering


and


analysis.


If


these


functions are subcontracted, the supplier shall


provide technical leadership. The CAD/CAE systems


shall


be


capable


of


two


way


interface


with


customer






概述


-4.4.1



为确保符合规定要求,供货商应制定与维持各项书面程


序,以管制及验证产品 之设计。





设计数据的


运用


- 4.4.1.1



供货商应有一流程将先前设计项目所获得的信 息展开至


目前或未来类似性质的项目。





设计与开发


规划


4.4.2



供货商应对每一设计与开发活动拟定计划,计划应 描述


或参照的各项作业,并界定其执行责任。设计与开发各


项作 业应指合格人员并给予适切的资源。计划应随设计


的进展加以更新。





所需技能


- 4.4.2.1



供货商的设计活动须有能力适当地运用下列各项技术:




1.



几何尺寸及公差


(GD&T)



2.



品质机能展开


(QFD)



3.



制造设计


(DFM)


/装配设计


(DFA)




4.



价值工程


(VE)



5.



实验计划


(DOE)



6.



失效模式和效应分析

< p>
(DFMEA



PFME



)




7.



有限元城分析法


(FEA)



8.



实体造型法



9.



模拟技术法



10.



计算机辅助设计/计算机辅助工程




11.



可靠度工程计划



组织与技术


的接口


- 4.4.3



设计过程中提供输入的不同群组间其组织与技术的 接口


应予以界定,并将必要信息书面化,互相传递与定期检


讨。




设计输入


- 4.4.4.4



供货商应鉴定、书面记载与产品有关的各 项设计


输入需求,含适用法规要求,并审核其选用的适


切性。凡 不完备、混淆不清或相抵触之需求事项,


应与提出需求者共同加以解决。





任何合约审查作业的结果应纳入设计输入的考


量。



设计输入


-




-4.4.4.1



供应应具备适当的资源和设施,以利用计算 机辅


助产品设计、工程和分析。如果这些工作由分包


商承担时, 供货商应提供技术指导。


CAD



CA E



统应能跟顾客的计算机系统做双向沟通,不过,

< p>
顾窗亦可声明免除对此计算机辅助系统的要求。






Design Output



4.4.5



Design


output


shall


be


documented


and


expressed in terms that can be verified and


validated


against


design


input


requirements.


Design output shall





a)



meet the design input requirements




b)



contain or make reference to acceptance


criteria





c)



identify


those


characteristics


of


the


design


that


are


crucial


(“Special


Characteristics”




see


Appendix


C)


to


the


safe


and


proper


functioning


of


the


product,


(e.g.


operating,


storage,


handling,


maintenance and disposal requirements).



Design


output


documents


shall


be


reviewed


before release.




Design Output



Supplemental



4.4.5.1



The supplie


r’s design output shall be the


result of a process that includes






Efforts to simplify, optimize, innovate,


and


reduce


waste


(e.g.,


QFD,


-


DFM/DFA,


VE,


DOE, tolerance studies, response surface


methodology, or appropriate automotives)



Utilization


of geometric


dimensioning


and


to learning as applicable




Analysis


of


cost/performance/risk


trade




offs




Use of feedback from testing, production,


and the field




Use of design FMEAs



4.4.6 Design Review



4.4.6



At


appropriate


stages


of


design,


formal


documented


reviews


of


the


design


Results


shall


be


planned


and


conducted.


Participants


at


each


design


review


shall


include


representatives of all functions concerned


with


the


design


stage


being


reviewed,


as


well


as other specialist personnel, as required.


Records of such reviews shall be maintained



(see 4.16)



Design Verification



4.4.7



At


appropriate


stages


of


design,


design


verification


shall


be


performed


to


ensure


that


the


design stage output meets the design stage input


requirements.



The


design


verification


measures


shall


be


recorded


(see 4.16)



NOTE


10



In


addition


to


conducting


design


reviews


(see


4.4.6),


design


verification


may


include


activities such as the following






Performing alternative calculations,




Comparing


the


new


design


with


a


similar


proven


design, if available,




Undertaking tests and demonstration, and




Reviewing the design stage documents before


release.



Design Validation



4.4.8



Design validation shall be performed to ensure


that product conforms to defined user needs and/


or requirements.



Design Validation



Supplement



4.4.8.1



Design


validation


shall


be


performed


in


conjunction


with


customer


program


timing


requirements.


Validation results shall be recorded (see 4.16).


Design


failures


shall


be


documented


in


the


validation records. Procedures for corrective and


preventive action shall be followed in addressing


such design failures.





设计输出


- 4.4.5



设计输出应予以书面化,且其表达方式能相对设计输入


的需求予以验证及 确认。设计输出应:




a)



符合设计输入需求;



b)



包含或引述对应之允收标准;



c)



鉴定那些对产品安全与适当功能 的重要的设计


特性,


(


诸如操作、储存 、搬运、维护和处置的


需求


)






设计输出文件在分发前应经审。




设计输出


-




- 4.4.5.1



供货商的设计输出应是包括下列过程的结果:




1.



致力 于简化、


最佳化、


创新及减少浪费


(< /p>


如品质


机能展开,制造的设计/装配的设计,价值工


程,实验计划,公差研究、表面响应法或其它


适当方法


)



2.



适当的采用几何尺寸和公差技术




3.



成本/性能/风险的权衡析



4.



从测试、生产及市场回馈信息的应用



5.



设计失效模式与效应分析的应用



设计审查


- 4.4.6



于设计的适当阶段中应规划,举行正式的设计结果审查


并将其书面记载。 参与各次设计审查的成员应包括所有


与该设计阶段相关的部门代表以及其它必要的专业人


员。审查的记录应予以维持


(


参阅


4.16)





设计验证


- 4.4.7



在设计的适当阶段,应实施设计验以确保设计各


阶段的输出符合该阶段设 计输入的要求,设计验


证的量度应予以记录


(

< br>参阅


4.16)






备注


10


:除了举行设计审查外


(


参阅


4.4.6)



设计验证可包括下列活动如:< /p>




1.



它种计算方法,



2.



可能时,将新设计和已被证实之 类似设计


相互比较,



3.



进行测试和示范展示,及



4.



设计阶段文件在分发前先经审查。



设计确认


- 4.4.8



设计确认应被执行,


以确保产品符合界定的使用


者需要与/或要求。




设计确认


-




- 4.4.8.1



设计确认的执行应配合顾客项目计划的时程要


求,确认的结果应被记录下来


(


参阅< /p>


4.16)


。设计


失败的情形应书写于设 计确认记录中,针对此等


设计失败应有程序追踪其矫正与预防行动。






NOTES



11



Design


validation


follows


successful


design verification (see 4.4.7).



12



Validation is normally performed under


defined operating conditions.



13



Validation


is


normally


performed


on


the


final product, but may be necessary in


earlier


stages


prior



to


product


completion.



14



Multiple


validation


may


be


performed


if


there are different intended uses.




Design Changes



4.4.9



All


design


changes


and


modifications


shall


be


identified,


documented,


reviewed


and


approved


by


authorized


personnel


before


their


implementation.



Design Changes



Supplemental



4.4.9.1



All


design


changes,


including


those


proposed


by subcontractors, shall have



Written customer approval, or waiver of such


approval,


prior


to


production


Implementation.


See


the


Production


Part


Approval


Process



manual


and


the


Customer-specific


pages


of


this document.




For


proprietary


designs,


impact


on


form,


fit,


function,


performance,


and/or


durability


shall


be


determined


with


the


customer


so


that


all effects can be properly evaluated.




Design Change Impact



4.4.9.2



The


supplier


shall


consider


the


impact


of a


design


changes


on


the


system


in


which


the


product


is


used.




Customer Prototype Support



4.4.10



When required by the customer, the supplier shall


have


a


comprehensive


prototype


program.


The


supplier


shall


use


the


same


subcontractors,


tooling


and


processes,


as


will


be


used


in


production


wherever possible.



Performance tests shall consider and include as


appropriate


product


life,


reliability


and


durability.


All


performance


testing


activities


shall be tracked to monitor timely completion and


conformance to requirements.




While


these


services


may


be


contracted,


the


supplier shall provide technical leadership.




Confidentiality



4.4.11



The


supplier


ensure


the


confidentiality


of


customer


-



contracted


products


under


development


and


related product information.




Document and Data Control



Element 4.5



General



4.5.1



The


supplier


shall


establish


and


maintain


documented


procedures


to


control


all


documents


and


data


that


relate


to


the


requirements


of


this


International standard including, to the extent


applicable, documents of external origin such as


standards and customer drawings.



NOTE


15



Documents


and


data


can


be


in


the


form


of


any type media, such as hard copy or electronic


media.





备注:



11



设计确认应在设计验证之后


(



4.4.7)




12



设计确认通常在界定的操作条件下实施




13



设计 确认通常在最终产品上实施,但如需要也可


在产品完成前稍早阶段实施。




14


< br>如有不同的预期使用状况时,


亦可实施多次确认。




设计变更


- 4.4.9



所有设计变更和修改在实施以前,均应予以鉴明、 书面


化,并经权责人员审查与核准。




设计变更


-




- 4.4.9.1



所有的设计变更,包括分包商所提出的建议, 在量产实


施前应获得顾客书面的核准或同意免除此项要求。参阅


量产零组核准程序手册,以及本文件中顾客特定要求章


节。






对于具 有专利权的设计,设计变更对外形、装配、


性能、功能及/或耐久性的影响,应与客户共 同


商议,以便适当评估变更的影响程度。




设计变更的


影响


- 4.4.9.2



供货商应考量设计变更对使用该产品的系统之 影


响。




顾客原型样


品的配合


- 4.4.10



当顾客要求时,供货商应有一个完整的原型样品


计划。供货商应尽可能采用与将来量产相同的分


包商、工模具及 制程。




性能测试应考量及包括适当 的产品寿命,可靠度


与耐用性。应追踪所有性能试验的各项活动,以

监督试验是否及时完成并符合要求。





上述工作项目可能分包时,供货商英提供技术指


导。




保密性


- 4.4.11



与顾客合约发展中的产品及其相关产品信息,供


货商应确保机密性。





文件与数据管制


- 4.5



概述


- 4.5.1



供货商应制定与维持书面程序,以管制与本国际


标准要求有关的所有文件及数 据。其适用范围,


应涵盖外部的档原稿,


例如各类标准和客户图 样。




备注


15



文件与数据其形式可为任何形态的介

体,例如实体文稿或电子媒体。




Document and Data Approval and Issue



4.5.2



The documents and data shall be reviewed and


approved


for


adequacy


by


authorized


personnel


prior to issue. A master list or equivalent


document control procedure identifying the


current


revision


status


of


documents


shall


be


established


and


be


readily


available


to


preclude the use of invalid and/or obsolete


documents.




This control shall ensure that




a)



the


pertinent


issues


of


appropriate


documents


are


available


at


all


locations


where


operations


essential


to


the


effective


functioning


of


the


quality


system are performed





NOTE



Examples of appropriate documents


include





Engineering drawings




Engineering standards




Math(CAD) data




Inspection instructions




Test procedures




Work instructions




Operations sheets




Quality manual




Operational procedures




Quality assurance procedures




Material specifications



b)



invalid


and/or


obsolete


documents


are


promptly


removed from all points of issue or use, or


otherwise assured against unintended use




c)



any


obsolete


documents


retained


for


legal


and/or


knowledge-


preservation


purposes are


suitably identified.



Engineering Specification



4.5.2.1



The


supplier


shall


establish


a


procedure


to


assure


the


timely


review


(e.g.


business


“days”,


not


weeks or months), distribution and implementation


of


all


customer


engineering


standards/


specifications


and


changes. the


supplier


hall maintain a record of the date on which each


change is implemented in production (subject to


record control, see 4.16). implementation shall


include updates to all appropriate documents.




NOTE



A change in these specifications should


be required an updates PPAP Record when these


specifications are referenced on the design


records (see Glossary) or if they affect PPAP


documents


(e.g.


Control


Plan,


FMEAs,,


etc).


See


PPAP.



Document and Data Changes



4.5.3



Changes


to


documents


and


data


shall


be


reviewed


and


approved by the same functions/organizations that


performed


the


original


review


and


approval,


unless


specifically



designated



otherwise.


The


designated


functions/organizations


shall


have


access to pertinent background information upon


which to base their review and approval.




Where practicable, the nature of the change shall


be identified in the document or the appropriate


attachments.





文件与数据


之核准与


发行


- 4.5.2


< /p>


文件与资料在分发之前,应经权责人员审查与核准其适


切性。应建 立文件总览表或相当的文件管制程序以鉴定


文件现行修订状态,


该总览表或程序应易于取得,


以免〞


无效〞及/或〞作废〞的文 件被误用。





本项管制应保:



a)



对品质系统之有效运作至为重要 之所有作业


场所,应具有适切版本的适当档;





备注:


适用此类的档包括:




1.



工程图面



2.



工程标准



3.



CAD


数据资料



4.



检验指导书



5.



测试程序书



6.



工作指导书



7.



品质手册



8.



品质手册



9.



作业程序书



10.



品质保证程序书



11.



物料规范



b)



无效/及或作废之档应迅即从分 发单位或使


用地点撤除,或其它确保避免误用的方式;



c)


任何作废文件因法令及/或保存认知等目的



而留存时应予适当的鉴别。




工程规范


- 4.5.2.1



供货商应制定一套书面作业程序,以确保所有顾


客的工程标准/规格 及变更,


能被及时的审


(


查即


工作天,而不是周或月份、分发及执行。供货商


应记录每项生产中实施变 更的日期并加以保存折



4.16


记录 管制


)


。前述变更的实施应包括所有


相 关档的更新。






备注:


此种规格的变系属于设计记录


(


参阅词



)


的规格,或会影响到


PPAP


的数据即 管制


计划,


FMEA



)


,则须更新


PPAP


记录。 参阅


PPAP





文件及数据


变更


- 4.5.3



除非另有特别指定,文件与数据变更应由执行原< /p>


始审查及核准之同一职能/位加以审查及核准。


若指下其它职能/ 单位审查与核准时,其应可取


得审查与核准时,其应可取得审查与核准依据的

< p>
适切背景资料。






实际可行时,应在文件或适当附件上明示变更的


内容。





Purchasing



Element 4.6



General



4.6.1



The


supplier


shall


establish


and


maintain


documented


procedures


to


ensure


that


purchased


product


(see


3.1)


conforms


to


specified requirements.



NOTE



The reference


above “see 3.1”, is


to Section 3.1 in ISO 9001 or 9002 where


“product” is defined.





Approved


Materials


for


Ongoing


Production




4.6.1.1



Where


the


customer


has


an


approved


subcontractor


list,


the


supplier


shall


purchase


the


relevant


materials


from


subcontractors on the list. Any additional


subcontractors may only be used after they


have


been


added


to


the


list


by


the


customer’s


Materials Engineering activity.




NOTE



To


be


added


to


any


existing


customer


“approved


subcontractor


list”,


a


company


should


contact


the


appropriate


customer


engineering


function


to


be


considered.


These


lists exist only for certain commodities and,


where they do exist, they may be found in the


customer design record (see Glossary).




Government,


Safety


and


Environmental


Regulations




4.6.1.2



All purchased materials used in part manufacture


shall


satisfy


current


governmental


and


safety


constraints


on


restricted,


toxic


and


hazardous


materials



as


well


as


environmental,


electrical


and


electromagnetic considerations applicable to the


country of manufacture and sale (see Glossary




Approved Materials).




Evaluation of Sub- contractors



4.6.2



The supplier shall




a)



evaluate


and


select


subcontractors


on


the


basis


of


their


ability


to


meet


subcontract


requirements including the quality system and


any specific quality assurance requirements





b)



define


the


type


and


extent


of


control


exercised


by


the


supplier


over


subcontractors.


This


shall


be


dependent


upon


the


type


of


product,


the


impact


of


subcontracted


product


on


the


quality


of


final


product


and,


where


applicable,


on


the


quality


audit


reports


and/or


quality


records


of


the


previously


demonstrated


capability


and


performance of subcontractors




c)



establish


and


maintain


quality


records


of


acceptable subcontractors (see 4.16).





NOTE



Methods


other


than


an


“approv


ed


subcontractors


list”


may


be


utilized


to


meet this requirement.




Subcontractor Development



4.6.2.1



The


supplier


shall


perform


subcontractor


(see


Glossary)


quality


system


development


with


the


goal


of


subcontractor


compliance


to



QS-9000



using


Sections I of


QS-9000


as the


fundamental


quality


system


requirement.


assessments


if


part


of


subcontractor


development,


should


occur


at


supplier


specified


frequency.


Subcontractor


assessments


to


QS-9000



by


the


OEM


customer,


and


OEM


customer- approved





采购


- 4.6



概述


- 4.6.1



供货商应制定和维持书面程序以确保所采购之产品


(




3.1)


符合规定要求。




备注:


以上所谓〞 参阅


3.1


〞是指


ISO9001



9002


的第三段〞产品〞的定义。




量产中的核


准物料


- 4.6.1.1



如果顾客已有一份核准的分包商名单时,供货 商应从名


单所列之分包商采购各项相关材料。任何其它分


包商唯 有在经顾客的材料工程部门增列到核准名


单后,方可被采用。





备注


:欲 加入任何顾客目前的〞核准分包商名


单〞,供货商需与适当的顾客工程部门联系。


这类名单仅针对某些商品,而且可能附在顾客


的设计数据中

< p>
(


参阅词汇


)







政府,安全


与环境法



- 4.6.1.2



所有用于零组件制造的材料,应符合目前政府 和


安全法规对于列管、毒性及危险性材料的要求;


以及考虑在制 造和销售国家有关环境、电力及电


磁方面的规定。


(

< p>
参阅词汇


-


核准材料


)< /p>






分包商之评



- 4.6.2



供货商应



a.



根据分包商达成分包合约要求< /p>


(


包括品质系


统及任何品质保证规定的要 求


)


之能力来评


估和选择分包商;




b.



界定加诸分包商管制的方法与程度。


这必须


依 产品的类别,


分包商之产品对最终成品品


质的影响以及,


可行的话,


视分包商的品质


稽核报告与/或分 包商往昔展示的能力与


绩效的品质记录而定;





c.


< /p>


建立与维持合格分包商的品质记录


(


参阅


4.16)





备注:


也可使用不同于〞分包商核准 清单〞


的其它方法以满足本要求。





分包商的开



- 4.6.2.1



供货商应采用


QS 9000


的第


I


节,当作品质系统< /p>


的基本要求,以进行分包商品质体系的开发。如


果评鉴是开发分包 商的方式之一时,供货商须按


规定的频度实施。分包商经由


OE M


顾客依照


QS


9000

< p>
的合格供货商评鉴,或经由认可的第三者认


证机构评鉴,

< br>均被承认并视同供货商对其的稽核。






second party, or an accredited third party


certification


body/registrar


(see


Appendix


B)


will be recognized in lieu of audits by the


supplier.




NOTE



Acceptance


of


the


above


audits


or


ISO


900/9002 registration is not intended to


limit


more


specific


supplier/


subcontractor quality system and product


development.




NOTE



The prioritization of subcontractors for


development is dependent upon the needs of the


subcontractor relative to the requirements of


QS-9000 and the importance of the product or


service they supply.




The


use


of


customer- designated


subcontractors


does


not


relieve


the


supplier


of


the


responsibility


for


ensuring


the


quality


of


subcontracted


parts,


materials and services.




Scheduling Subcontractors



4.6.2.2




The supplier shall require 100% on-time delivery


performance


from


subcontractors.


The


supplier


shall


provide


appropriate


planning


information


and


purchase commitments to enable subcontractors to


meet this expectation.




The


supplier


shall


implement


a


system


to


monitor


the


delivery


performance


of


subcontractors


with


corrective


actions


taken


as


appropriate.


Records


of


premium freight shall include both supplier and


subcontractor paid charges.




Purchasing Data



4.6.3



Purchasing documents shall contain data clearly


describing the product Ordered, including where


applicable






a)



the


type,


class,


grade


or


other


precise


identification






b)



the


title


or


other


positive


identification,


and


applicable


issues


of


specifications,


drawings,


process


requirements,


inspection


instructions


and other relevant technical data, including


requirements for approval or qualification of


product,


procedures,


process


equipment


and


personnel




c)



the


title,


number


and


issue


of


the


quality


system standard to be applied.




The supplier shall review and approve purchasing


documents for adequacy of specified requirements


prior to release.




Verification of purchased product



4.6.4



Supplier verification at subcontractor’


s premises –



ISO 4.6.4.1



Where the supplier proposes to verify purchased


product


at


the


sub-


contractor’s


premises,


the


supplier shall specify verification arrangements


premises and the method of product release in the


purchasing document.









备注:


接受上述各项稽核或


ISO


的登录,并不


意图针对供货商/分包商品质系统及产品开发


作更明确的限制。




< /p>


备注:


分包商发展的先后乃取决于


QS- 9000



分包商相关要求的需要,以及所提供产品或服


务的重要性而定。






采用顾客指定的分包商,并不能免 除供货商对分


包商的零组件,材料和服务品质确保的责任。





分包商交货


日程规划


- 4.6.2.2




供货商应要求各分 包商达成百分之百的如期交货


绩效。供货商应供必要的计划信息和采购承诺,

< p>
以确保分包商达成这项愿望。






供货商应执行一项监测分包商交货 绩效的系统以


及采行必要的矫正行动,记录应包括由供货商与


分 包商所支付的超额运费。





采购数据


- 4.6.3



采购文件包含之资料应明确说明所订购之产品,


如适用时,包含:





a.



型式、类别、等级或其它精确之识别;




b.



品名 或其它明确标识,以及适用版本的规格、


图样、制程要求、检验规定及其它相关技术数< /p>


据,包含产品、程序、制程设备与人员之核准


或资格检定等需求;





c.



适用之品质系统标准之名称、< /p>


编号及发行版次。



< br>供货商在采购档发出之前,应先审查及核准其所


规定需求之适切性。





采购产品的


验证


- 4.6.4



供货商在分


包商处的


验证


- ISO 4.6.4.1



当合约规定时,供货商的顾客或其代表有权在分


包商与供货商的处所 ,验证分包商所提供的产品


是否符合规定要求。此等验证不得被供货商做为


分包管制品质之证明。




Customer


verification


of


subcontracted


product



ISO 4.6.4.2



Where


specified


in


the


contract,


the


supplier’s


customer


or


the


customer’s


representative


shall


be


afforded


the


right


to


verify


at


the


subcontractor’s


premises


and


supplier’s premises that sub


-contracted product


conforms


to


specified


requirements.


Such


verification shall not be used by the supplier as


evidence of effective control of quality by the


subcontractor.




Verification


by


the


customer


shall


not


absolve


the


supplier


of


the


responsibility


to


provide


acceptable


product,


nor


shall


it


preclude


subsequent rejection by the customer.




Control of Customer-Supplied Product



Element


4.7



The


supplier


shall


establish


and


maintain


documented


procedures


for


the


control


of


verification,


storage


and


maintenance


of


customer-supplied


product


provided


for


incorporation


into


the


supplies


or


for


related


activities.



Any


such


product


that


is


lost,


damaged


or


is


otherwise


unsuitable


for


use


shall


be


recorded


and


reported to the customer (see 4.16).




Verification by the supplier does not absolve the


customer


of


the


responsibility


to


provide


acceptable product.




NOTE



Customer- owned


returnable


packaging


is


included in this element (see 4.15.4).




Customer Owned Tooling



4.7.1



Customer-owned


tools


and


equipment


shall


be


permanently marked so that the ownership of each


item is visually apparent.




NOTE



An


affixed


tag


specifically


containing


the


part number and/or customer name to identify


ownership is the preferred approach. However,


this requirement may be met by using a supplier


designated number cross-referenced with clear


tractability back to the customer.




Product Identification and Tractability



Element 4.8



Where


appropriate,


the


supplier


shall


establish


and


maintain


documented


procedures


for


identifying


the


product by suitable means from receipt and during


all


stages


of


production,


delivery


and


installation.




NOTE



For


QS-9000


,


the


works


“where


appropriate” above are not applicable.





Where and to the extent that tractability is a


specified


requirement,


the


supplier


shall


establish and maintain documented procedures for


unique


identification


of


individual


product


or


batches.


This


identification


shall


be


recorded


(see


4.16).



Process Control



Element 4.9



The


supplier


shall


identify


and


plan


the


production,


installation


and


servicing


processes which directly affect quality and


shall


ensure


that


these


processes


are


carried


out under controlled conditions. Controlled


conditions shall include the following






顾客对分包


商产品的


验证


-ISO 4.6.4.2



当合约规


定时,供< /p>


货商的


顾客或



代表有权


在分包商



供货商的


处所,验


证分包


商所提



的产品是


否符合规



要求。此


等验证不


得被供


货商 作



分包商有


效管制品



之证明。







顾客之 验证并未解除供应提供允收产品之责任,


亦未豁免顾客嗣后之拒收。




顾客提供产品之管制


- 4.7


< /p>


供货商应制定与维持各项书面程序以管制验证、


储存与维护顾客所 提供用以组合成供应品或相关


活动所需之产品。任何此等产品若有遗失、损坏

< p>
或其它不适用等情事时,应予以记载并报告给顾



(


参阅


4.16)






供货商 所作之验证并未豁免顾客提供允收产品之


责任。




备注:


本要项包括那些属于客户之可 回收包装


材料。


(


参阅


4.15.4)




顾客所有之


工模具


- 4.7.1



顾客所拥有的工具和设备应赋予永久标记,以便< /p>


其所有权能一目了然。





备注:


一个标示有零件号码与/或顾 客名称的


固定标签来确认所有权是较好的方法,但是这


样的要求 ,供货商也可用设定的号码清楚追溯


比对到顾客来达成。





产品之识别


与追溯性


- 4.8



适当时,供货商应制定并维持书面程序从收料与


生产、交货及安装内所有阶段均运用适切的方法


鉴别产品。

< p>




备注:

< p>
上述的〞适当时〞在


QS-9000


并不适用。< /p>





当追溯性 被列入指定要求时,供货商应制订与维


持书面的程序,


对个别产 品或批次做特定的识别,


该识别标志应予以记载


(


参阅


4.16)





制程管制


- 4.9



供货商应鉴定与规划直接影响品质之生产,安装与服务


诸流程,并应确保此等流程在管制状况之下进行。管制


状况包括 下述各项:






a.



documented


procedures


defining


the


manner


of


production. installation and servicing, where


the absence of such procedures could adversely


affect quality




b.



use


of


suitable


production,


installation


and


servicing


equipment,


and


a


suitable


working


environment (see Glossary)





Cleanliness of Premises



4.9.b.1



The supplier


shall


maintain


premises


in a state


of


order,


cleanliness


and


repair


appropriate


to


the product(s) manufactured.




Contingency Plans



4.9.b.2



The


supplier


shall


prepare


contingency


plans


(e.g. utility interruptions, labor shortages,


key


equipment


failure)


to


reasonably


protect


the


customer’s supply of product in the event of


emergency, excluding natural disaster and acts


of God.




c.



compliance


with


reference


standards/codes,


quality plans and/or documented procedures





d.



monitoring


and


control


of


suitable


process


parameters and product characteristics






Designation of Special Characteristics



4.9.d.1



The


supplier


shall


comply


with


all


customer


requirements


for designation,


documentation


and


control of Special characteristics the supplier


shall


provide


documentation


showing


compliance


with these customer requirements as requested by


and customer.




NOTE



All product and process characteristics


are


important


and


need


to


be


controlled.


However,


some


characteristics,


herein


referred


to


as


“special”,


need


extra


attention


because


excessive


variation


in


them


might


affect


product’s safety, compliance with government


regulations,


fit,


function,


appearance


or


quality


of


subsequent


manufacturing


operations.




e.



the


approval


of


processes


and


equipment,


as


appropriate





f.



criteria


for


workmanship,


which


shall


be


stipulated,


in the clearest


practical


manner


(e.g.


written


standards,


representative


samples


or illustrations)




g.



suitable


maintenance


of


equipment


to


ensure


continuing process capability.




Preventative Maintenance



4.9.g.1



The


supplier


shall


identify


key


process


equipment and provide appropriate resources


for


machine/equipment


maintenance


and


develop


an


effective


planned


total


preventive


maintenance


system.


At


a


minimum,


this


system


shall include






A


procedure


that


describes


planned


maintenance activities




Scheduled maintenance activities






a.



以书 面程序界生产,安装与服务的诸方式,缺


乏此等程序书将对品质造成不利影响;





b.



使用适当的生产,安装与服务设 备,及适当的


工作环境;





作业场所的清洁


- 4.9.b.1



供货商应维持与修护作业场所的整齐与清洁,


以适当配合产品的制造。





紧急应变计划


- 4.9.b.2



除天然灾害及上帝旨意之外,供货商应准备各


项紧急应变计划


(


即公共设施中断,劳 工短缺,


主要设备故障


)


以在紧急状况 下合理保护产品


对顾客的供应。





c.



符合 所参照的标准/法规,品质计划与/或书


面程序;



d.



应对合适的制程参数与产品特性 ,加以监督与


管制;




管制特性的


指定


- 4.9.d.1



供货商在相关管制特性的确定、档化及管制应 遵


守顾客所有的要求。当顾客要求时,供货商应提


供书面数据以 左证符合顾的各项要求。








备注:


虽然所有的产制程特性都很重要且需加


以管制,但是在此所提到 的〞管制〞特性尤需


格外小心,因为这些特性的过度变异可能会影


响到产品的安全、


政府法规符合、


装配、

功能、


外观或后绩制程作业的品质。






e.



适当时,对各项制程及设备加以认可;




f.



工作 技艺基准应以最清楚的实际方式予以规定


(


诸如:书面标准、代 表样品或图解


)





g.



适当地维护设备以确保制程的持续能力



-


-


-


-


-


-


-


-



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