企业经营管理中英文

Section I：ISO 9000─Bases Requirements

Management Responsibility─Element 4.1

Quality Policy-4.1.1

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

to

any

the

of

of

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

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

流

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,

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

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

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。

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

The

or

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

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

and

the

any

the

be

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

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

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

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。

)

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)

Eng

The supplier shall verify that changes are properly validated See 4.12,4.16 And PPAP

NOTE ：This applies equally to

characteristics.

NOTE ：Cost elements or price should be one of the key indicators within a continuous improvement system.

NOTE ：F

The supplier shall develop a

prioritized action plan for continuous

improvement

in

processes that have demonstrated stability, acceptable capability and performance. NOTE:

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。

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

P rocess 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

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

修

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

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

T ool change programs for perishable tools

T ool 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