tribe-清癯
Version
：
Revised
Version
B/1
：
B/0
Revision
File Name
：
设计和开发控制程序
Design and
Development Procedure
Effective Date
：
Edited
by
：
ISO Office
1.
目的：对产品设计开发全过程进行控制，确保设计和开发的新
产品满足规定的要求。
Purpose
：
Control
the whole process of product design and
development to ensure that the design and
development of
new product meet the
stated requirements.
2.
适用范围：适用于产品设计和开发的全过程。
Applicable
Scope
：
Apply to the whole
process of product design and development.
3.
职责
Responsibility
：
3
.1
董事总经理负责设计开发项目的立项、设计输入及试产交接会的组织和批准工作。<
/p>
The Director General shall
be responsible for approving the establishment of
design and development project, design
input and organizing the meeting for
hand-over of pre-production .
3.2
技术总监领导负责产品的设计开发全过程的组织协调及审批工作。
The C.T.O will organize and coordinate
the overall process of design and development of
product, take charge of
audit and
approval as well.
3.3
项目工程师负责
统筹产品的设计开发、型式试验及组织设计开发过程中产品的装配测试工作。
The project engineer shall be in charge
of coordinating the design and development and
type-test of product, organize
the work
related to assembly and test during the process of
design and development.
3.4
生产技术部负责配合执行产品测试及试验工作，组织产品试产，组织生产装配工艺文件和检验文件的编
制及审核工作。
The Production
Technique Dept.
shall
provide
cooperation
for
test
and
inspection,
organize
the
pre-production,
in
addition, prepare and
approve the production and assembly technology and
inspection documents.
3.5
品保部
负责编制检验标准
/
规程，参与新产品样品的验证及试产过程中
各阶段的检验测试工作。
The QC Dept.
will draft the test criterion/ instruction,
involve in verification for the sample of new
product, also the
test and inspection
at every stage of pre-production.
3.6
采购部负责协调设计开发过程中所需物资的采购工作。
The Purchasing Department will
involve in ordering of material needed in the
process of design and development .
3.7
生产技术部负责设计开发过程的样品试制和工艺协作。
The Production Technique Dept. shall be
responsible for building prototypes in the design
and development process
also the
collaboration of technology.
3.8
其他各部门负责完成董事总经理交办的产品配套性开发项目的协作和完善工作。
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设计和开发控制程序
Desig
n and Development Procedure
Effective Date
：
Edited
by
：
ISO Office
Other Departments shall be responsible
for completing job of coordinating and perfecting
the Production Assembling
Development
Project which is ordered by Director General.
4.
工作程序
Procedures for work
4.1
设计方案制定流程
Procedures for formulating the
“Design Brief”
<
/p>
4.1.1
市场部或其它部门人员通过整理市场调查，提出产品开
发建议，编写
“
产品开发建议书
”
，报董事总经
理审批
.
Marketing
Dept. or other party may, through the collation of
market intelligence, evolve a product concept
.When
this happens, a
“Product Development Proposal” is
submitted
to the Director General for
approval.
4.1.2
董事总经理根据公司人力
资源情况，以及通过对竞争对手的产品分析，审批
“
产品开发建
议
”
；必要时，
召集技术总监、营运总
监、市场总监、及其它各部门主管进行会议分析讨论，以确认
“
产品开发建议书
”
的可
行性，决定是否
批准开发建议书。
The Director
General shall approve the
“
Production Development
Proposal
”
according to the
actual human resource
and the
competitor analysis; if necessary, convene a
meeting with C.T.O., C.O.O., Chief Officer of
Marketing and
Directors
of
other
department
to
consult
on
the
viability
of
the
“
Production
Development
Proposal
”
and
decide
whether to approve it.
4.1.3
董事总经理根据国内外市场发展趋势审批
“
产品开发建议书
”
，并抄送技术总监或指定开发部门主管。
If the “Product Development
Proposal” is approved by the Director General, a
copy of it will be forwarded to the
C.T.O. or appointed Development Dept.
Director.
4.1.4
技术总监或部门主管收到
“
产品开发建议书
”
后，
委派一名产品项目工程师，
对
“
产品开发建议书
”
的要求，
进行可行性分析，并编写
“
产品开发可行性报告<
/p>
”
报请技术总监或部门主管审核、董事总经理批准。
“
产品开发可行性报告
”
应提出以下数据和资料。
Upon
receipt of “Product Development Proposal”,
t
he C.T.O. or Dept. Director will
appoint a project engineer who
will be
responsible for conducti
ng a
feasibility study of the “
Product
Development Proposal”, and the
“Development
Feasibility Report” is
required
subsequently, which is to be
checked by C.T.O. or Dept. Director, and approved
by the
Director General.
The object of the
“Development Feasibility
Report”
is to provide data on the
following:
4.1.4.1
开发该产品的技术可行性：各结构特点和技术指标。
The
Technical
possibility
of
developing
the
product
described
in
the
Product
Development
Proposal
< br>：
structure
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：
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设计和开发控制程序
Desig
n and Development Procedure
Effective Date
：
Edited
by
：
ISO Office
features and technical parameters.
4.1.4.2
开发进度和时间
The general time frames involved in the
development process.
4.1.4.3
开发成本统计，包括人员，经费等其他资源。
A
general
estimate
of
the
resources
required
for
the
development
of
the
proposed
product
including
personnel,
financial and
other resources.
4.1.5
如果依据
“
产品开发建议书
”
的要求所作
“
产品开发可行性报告
”
结论表明该产品开发可行，则由董事总经
理负责组织制定
“
设计方案
”
草案下
发至各相关部门主管，该
“
设计方案
”
应包括开发部开发该产品的所有细节
和所需的资料。
Based on the “Product
Development Proposal” and the findings of the
“Development Feasibility Report” were the
later to report that the former was
feasible, the Director General must organize the
formulation of the draft
“Design
Brief”,
and
issue
to
involved
heads
of
department.
The
“Design
Brief”
should
include
all
manner
of
details
and
information necessary
for the product development department to design a
product.
4.1.5.1
产品的操作规范
Product performance criteria
4.1.5.2
产品的功能特性
Product functional features
4.1.5.3
产品的物理（外观）特性
Product physical
(appearance) features
4.1.5.4
经费标准和开发预算
Economic and
financial criteria and development budgets
4.1.5.5
开发进度和期限
Development time
scales and deadlines
4.1.6
“
设计方案
”
经由董事总经理召集技术总
监，市场总监、营运总监、生产技术部主管和成套工程部主管在
内的各部门主管，进行会
议讨论，确认后，形成书面文件，报技术总监或部门主管审核，董事总经理批准后
实施。
The
draft
“Design
Brief”
should
be
made
available
to
C.T.O.,
Chief
Marketing
Dept.,
Chief
Operation
Officer,
manager
of
Production
Technique Dept.
and head
of
commercial
contracts
department,
the
Director
General shall
consult
with
these
parties
before
finalizing
the
“Design
Brief”.
The
written
“Design
Brief”
will
be
audited
by
the
C.T.O or Dept.
Director and issued to the Director General for
approval before performance.
4.1.7.
如涉
“
设计方案
”<
/p>
的内容的任何一项更改，
均应报请技术总监或部门主管审核，
董事总经理批准后，
并重
新发放。
Any subsequent changes to the
contents of the “Design Brief” must come in the
format of the publication of a new
Author
：
Checked
by
：
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by
：
3/15
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：
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：
B/0
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me
：
设计和开发控制程序
Desig
n and Development Procedure
Effective Date
：
Edited
by
：
ISO Office
revision to the “Design
Brief”
, as long as C.T.O. or Dept.
Director check it before submitting it to Director
General
for approval.
4.2
产品开发程序
Procedures
for product development stage
4.2.1
开发部收到
“
设计方案
”
后，技术总监或部门主管应编制
< br>“
产品开发任务书
”
发放至项目
组组长。
Upon the receipt of the
“Design Brief”
the C.T.O. or
Dept. Director
must formulate and issue
a “Development Project
Instruction”
to
the
appointed
Project
Team
Leader.
The
“
Development
Project
Instruction
”
includes
the
following
information but is
not limited to them:
4.2.1.1
产品开发项目组成员（对项目组长负责并报告工作）
。
The members of the product development
team who will report to the project team leader.
4.2.1.2
项目工程师根据开发和图纸的编号规则确定项
目或产品名称，以将当前项目和其他正在进行的开发项
目的零件和图纸区别开来。
The
Project
Engineer
shall
determine
the
project
or
product
name
according
to
the
numbering
regulations
of
development and drawings,
and distinguishes the component and drawings of
current project and other developing
projects
4.2.1.3
产品的技术参数和功能（参照设计方案和其他相关资料）
。
Technical parameters and
functions of the product (refer to the
“Design Brief” and other relevant
data
)
4.2.1.4
项目所需经费和产品成本预算
Financial and economic objectives of
the product as well as of the whole project
itself.
4.2.1.5
分项目（如有）需要的特别开发和设计验证程序
Sub-projects (if any) requiring special
research and design verification processes.
4.2.1.6
“
设计建议书
”
的明细表，产品样本，产品技术条件，型式试验样品、操作使用说明
书及产品成本预算
等其他文件。
A
list
of
“
Design
Proposal
”
,
Product
Prototypes,
product
technical
condition,
Type-Test
prototypes,
other
Documentations such as operations
Manual etc.(refer to section), projected product
costs.
4.2.2
对
“
产品开发任务书
”
，所含的任何特定项目的更
改均应由技术总监或部门主管修改，并重新发放。更改
的内容可能涉及以下几方面：
Changes
to
the
“Development
Project
Instructions”
pertaining
to
any
particular
Project
must
come
in
the
form
of
revisions, and may be
issued by the C.T.O or Dept. Director in response
to but not limited to the following:
Author
：
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by
：
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by
：
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：
Revised Version
B/1
：
B/0
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me
：
设计和开发控制程序
Desig
n and Development Procedure
Effective Date
：
Edited
by
：
ISO Office
4.2.2.1
“
设计方案
”
的更改
Changes in the
“Design Brief”
4.2.2.2
开发过程中相关标准或对现有标准解释的更改。
Changes in relevant standard or
interpretation of existing standards during the
development stage
4.2.2.3
执行开发项目所需的资源或技术的更改或开发小组成员的变动
Changes in the structure of the
development team or the available resource or
technology necessary for the execution
of the development project
4.2.2.4
开发过程中产生的新技术或形成的新资料，导
致原任务书的作废。
When new knowledge
or information arises in the development process,
the original instructions will be obsolete.
4.2.3
项目组长根据技术总监或部门主管下达的
“
产品开发任务书
”
编
制
“
产品开发计划
< br>”
，报请技术总监或部
门主管审批。
“
产品开发计划
”
应包括：
The project team
leader shall draft the
“
Product Development
Plan
”
according to the
“Product
Development
Order
”
,
and then
convey to C.T.O. or Dept. Director for approval.
This plan must include:
4.2.3.1
产品开发各阶段的任务，每个阶段的参与人员
，每个阶段的工作，预期目标及完成时间。
开发阶段一般应包
括起草设计建议书，具体的技术设计，试制样品，和样品检验阶段。必要时，开发阶段还
将包括其他工作或分项目的开发。
Tasks in
each phrase of product development, involved staff
in each phrase, work in each phrase, anticipated
goal and
accomplish time
The development phases should generally
include a draft Design Proposal, a technical
detailing stage, prototyping
stage and
a stage involving the testing of the prototype.
Other sub-phases and sub-projects may be included
as when
necessary.
4.2.3.2
详细列出每个阶段要求配备的资源和设备
Specify the resources and facilities
required at each stage of the plan.
4.2.3.3
每个阶段可能涉及的外部支援
(
外部顾问或公司内部其他部门人员
)
External supports which may possibly
involved in each phrase (external consultants or
staff from other departments
in the
company)
4.2.3.4
项目小组每个成员的具体职责
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设计和开发控制程序
Desig
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Specific Responsibilities of each
member in project team
4.2.3.5
< br>成品，部件装配或个别零件等的检验计划，以充分验证设计的完整性。
The inspection plan of finished
product, sub-assemblies, or other individual
components, will verify satisfactorily the
soundness of the design.
4.2.4
对
“
项
目开发计划
”
所包含的任何内容的更改应采用新版本，并经技术
总监或部门主管批准后由项目组长
发放，更改的内容可能涉及以下几方面：
Changes to the “Project
Development Plan” pertaining to any particular
project must come in the form of revisions
to
be
approved
by
the
C.T.O
or
Dept. Director
and
may
be
issued
by
the
project
team
leader
in
response
to
but
not
limited to the following
situations:
4.2.4.1
产品开发任务书的修改
Revision of the “Development Project
Instructions”
4.2.4.2
开发过程中相关标准或对现有标准解释的更改。
Changes in the relevant standard or the
interpretation of existing standards during the
development stage
4.2.4.3
执行开发项目所需的资源或技术的更改或开发小组成员的变动
Changes on the structure of the
development team or the available resources or
technology
4.2.4.4
开发过程中产生的新技
术或形成的新资料，导致原计划书的作废。
When new
knowledge or information arises in the duration of
or due to the development process itself, the
original
plan will be obsolete.
4.3
样品设计程序
Procedures for generating the prototype
design
4.3.1
开发小组应编制
“
设计建议书
”
和
“
设计评审报告
”
，并报部门
主管审核及技术总监批准。
“
设计建议书
”
包
括图纸起草，样机制作和实物制作等。
< br>“
设计评审报告
”
包括参与评审
人员，评审的具体内容记录及评审结论
等。
The development team proceeds to
generate
the “Design Audit Report”
together with the “
Design
Proposal
”
, which
will be submitted to Dept. Director for
reviewing and C.T.O. for approving.
“
Design Proposal
”
includes a set of draft
drawings
and
draft
data
sheets,
simulation
moulds,
mock-up
samples.
While,
the
“Design
Audit
Report”
includes
involved parties, detailed audit
contents and conclusion, etc.
4.3.2
技术总监参照
“
设计方案
”
确认
“
设计建议书
”
是否满足要求，
“
设计评审
报告
”
的结论是否充分，必要时对
建议
书和报告提出针对性的更改意见或要求。
The
CTO
will
decide
if
the
“
Design
Proposal
”
meets
the
conditions
stated
in
the
“Design
Brief”
,
and
make
the
Author
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设计和开发控制程序
Desig
n and Development Procedure
Effective Date
：
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by
：
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assessment on
whether the
conclusion of “Design Audit Report” is sufficient,
a
nd approve of the pertinent proposal
and or request for a revision of the
Design Proposal and report as may be the case.
4.3.3
项目开发小组根据技术总监的审批意见，开展具体的设计开
发工作：
Once the approval has
been made by the C.T.O, the development team
proceeds to detailed product development.
This includes generating of the
following:
4.3.3.1
绘制具体的零件图，
含所有零件的部装，总装图，产品标识和包装要求。
Detailed component drawings, sub-
assembly drawings and main assembly drawings of
all the components, labeling
and
packaging of the product.
4.3.3.2
列出具体的资料清单包括技术材料清单，含技术条件，产品材料明细表，装配和校验指导书。
Data
sheet
in
detail
including
technical
data
sheet,
including
technical
condition,
material
list,
and
assembly
and
calibration instructions.
<
/p>
4.3.4
技术总监负责组织具体产品技术图纸的评审及最终审批
确认
The
C.T.O
will
be
responsible
for
organizing
an
audit
of
the
detailed
engineering
drawings.
He
will
have
final
approving authority for drawings.
4.4.
样品制作
The Prototypes and
Samples
4.4.1
技术图
纸设计完成后，经由部门主管审核，技术总监或其授权人批准后，统一记录于
“
技术图纸发放登
记表
”
中，方可发放至相关部门。
The
finished
development
drawings
must
be
audited
by
Dept.
Director
and
approved
by
the
C.T.O,
or
person
empowered,
fill in the
“Technical Drawing Issuance Record”
before they may be issued to departments
concerned.
4.4.2
采购部依技术资料要求，协
助开发部开展样品零部件的采购工作。
The
procurement department will be responsible for
acquiring the components necessary to build the
prototypes with
as required by the
technical data.
4.4.3
开发小组负责
样品制作，必要时，组织相关部门或人员参与协助。
The
development team is responsible for building the
product prototype, or for organizing other
department members
to assist in the
prototype building process if necessary.
4.4.4
当样品试制过程中需对零部件图纸作部分改动时，由项目开发组填写
“
技术图纸修改通知单
”
< br>，详细注明
修改原因和内容，随图纸一起报请技术总监批准后方为有效。
If
minor
drawing
modifications
are
deemed
to
be
necessary
during
the
prototype
building
stage,
the
development
Author
：
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by
：
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by
：
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：
Revised Version
B/1
：
B/0
Revision
File Na
me
：
设计和开发控制程序
Desig
n and Development Procedure
Effective Date
：
Edited
by
：
ISO Office
team must write a
“D
rawing C
hange
Request”,
indicating the causes and
change content, which have to be approved
by the C.T.O before becoming effective.
4.4.5
当样品试制过程中，需对产品作部分改动时，应重新
评审
“
设计建议书
”
< br>，更改
“
设计评审报告
”
并报请技
术总监审批。
但出现产品的重大更改
时，须报请董事总经理批准。
（产品重大更改指该设计更改将导致最后成
品与设计方案的要求不符）
If major
product modifications are found to be necessary
during the prototype building stage, the
“
Design
Proposal
”
must be
reviewed, and a revised
“Design Audit
Report”
must be completed and submitted
to the C.T.O for approval.
The major
modification is to be approved by the Director
General (
A design modification will be
deemed as “major”
when the modification
affects the end product’s compliance with the
“Design Brief”
.)
4.5
检验
Testing
4.5.1
检验贯
穿于样品试制的全过程。包括零部件检查，成品及半成品的检验。
Testing
may
occur
at
any
stage
of
building
prototypes
，
including all
testing
of
components,
finished
product
and
semi-
finished products.
4.5.2
零部件的
检查由品保部根据技术图纸进行
,
并将检验结果提交开发组及技
术总监确认并归档
.
The
inspection
of
components
must
be
taken
by
the
QC
Dept.
under
technical
drawings;
the
outcome
must
be
submitted to development team, before
the C.T.O. checks and approves it.
4.5.3
样品的最终检验
Final test for sample
4.5.3.1
内部检验由开发组根据
“
设计方案
”
和
“
设计建议书
”
的参数要求，填写
“
样品试验计划
”
，经技术总监审
核，董事总经理批准后，组织品保及相关人员
进行，并将检验结果记录于
“
样品测试记录
”
中。
The
development team shall write the
“Sample Test Plan” in accordance with
the parameters given in the “Design
Brief” and “
Design
Proposal
”, which
is to be
checked by the C.T.O and approved by the Director
General, before the
QC proceeds to in-
house test.
The outcome of test must be
recorded in the “Sample Test Record”.
<
/p>
4.5.3.2
必要时，对部分项目可安排外送检验确认。对外送
检验样品，由开发组填写“样品试验计划”
，报技术
总监审核，
董事总经理批准后执行。
Where necessary,
external testing may be carried out on the
prototypes. When this happens, the development
team
shall fill in the “Sample Test
Plan” which to be checked by the C.T.O and
a
pproved by the Director General.
4.5.3.3
样品内外检验结果均应报请技术总监审批，以确认试验结果
的有效性和改善对策。
The test outcome
from both the external and in-house audit must be
submitted to C.T.O for audit, and the validity of
Author
：
Checked
by
：
Approved
by
：
8/15
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