企业经营管理 中英文

Section I：ISO 9000─Bases R e q u i r e m e n t s
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).
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. 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─
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─
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─
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.
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 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
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
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 - 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质政策及目标(参阅。

此项审查的记录应予维持(参阅4.16)。

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 - 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
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.
NOTE：Consideration should be given to internal, external and final
Customers
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：
●Chrysler “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、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 - 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 - 4.2.2
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 - 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(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)
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 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.)
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.
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)。

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)。

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书。

产品安全性
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)
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.
The supplier shall utilize appropriate mistake proofing methodologies during the planning of processes, facilities, equipment and tooling. 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, 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 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
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)。

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。

管制计划需列出制程管制(参照4.9)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─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─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。

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
The supplier shall fully comply with all requirements set forth in the Production Part Approval Process (PPAP) manual.
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)
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
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：
The supplier shall develop a prioritized action plan for continuous improvement in processes that have demonstrated stability, acceptable capability and performance.
NOTE:
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
供货商应完全符合量产零组件核准程序(PPAP)手册里规定的所有要求。

分包商的要求
供货商需对其分包商业(参阅词汇)导入零零件核准程序。

(即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)。

工程变更的认认
供货商负责验证工程变更被适当的确认。

参见4.12，4.16及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
供货商应为所有的顾客持续不断地改善品质、服务(包括时效、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。

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，如果计数质的结果不是零缺点时，则依定此为不合格产品(参阅，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
品质和生产力的改进
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. 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
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。

持续改善的技术
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
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：供货商需确认与定义适当的指数以监督目前作业的有效性。

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：
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 responsib le status. Consult your customer for further clarification if needed.
工模具管理
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(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
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：除非顾客特别规定，领应商不需签回采购订单承认书。

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)之前，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，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)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，则定义该供货商有设计责任。

顾客对供货商产品的核准，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。

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. 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.
The supplier’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. The supplier shall have appropriate resources。