-
Section
I
:
ISO
9000
─
Bases
Requirements
Management Responsibility
─
p>
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
p>
(
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
(
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
层
-
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
(
p>
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
(
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
< 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
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、
< 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
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
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
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<
/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
(
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
p>
(
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
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
)
p>
,
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
–
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
p>
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
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。
p>
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>
)
物
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
(
细
项
)
。
<
/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
APQP
参
考手册
)
p>
。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)
手
册里规定的所有要求。
分包商的要
求
–
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。
(
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
–
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
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
–
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
(
包
括时效、
交货
)
p>
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
p>
,
则
依
定
此
为
不
合
格
产
品
(
< br>参
阅
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。
p>
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
p>
(
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
p>
(
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
p>
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
)
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)
<
/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
p>
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。
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
(DFMEA
/
PFME
等
)
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
-
补
充
-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
系
统应能跟顾客的计算机系统做双向沟通,不过,
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
-
补
充
-
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
p>
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
-
补
充
-
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
p>
(
见
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
-
补
充
-
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。
p>
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
p>
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
见
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
汇
)
的规格,或会影响到
PPAP
的数据即
管制
计划,
FMEA
等
)
,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
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
(
参
阅
3.1)
符合规定要求。
备注:
以上所谓〞
参阅
3.1
〞是指
ISO9001
p>
或
9002
的第三段〞产品〞的定义。
p>
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
(
参阅词汇
)
。
政府,安全
与环境法
规
-
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。
(
参阅词汇
-
核准材料
)<
/p>
分包商之评
诂
-
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;
p>
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
发
-
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
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.
p>
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
对
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,
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
p>
验证
- ISO 4.6.4.1
p>
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
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
作
为
分包商有
效管制品
质
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
或其它不适用等情事时,应予以记载并报告给顾
客
(
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。
备注:
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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