工艺设计和开发控制程序.docx
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工艺设计和开发控制程序.docx
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工艺设计和开发控制程序
Procedure Document/程序文件
Control Procedure for Process design and Development
工艺设计和开发控制程序
Document NO/ 编号:
TY-QP7.3-01-15
Revision /版本:
Checked by/校对:
Verified by/审核:
Approved by/批准:
Controlled Condition/受控状态:
Distribution No./分发号:
更改单编号
Change Order
Number
文件编号
Document
Number
处数
Section
Changed
标志
Rev
更改日期
Release
Change
更改人
Change
Executor
TY-QR-TQD-031A
质量管理体系更改记录表
Record Chart of Changes in Quality Management System of Quality
Manual
No./编号
TY-QP7.3-01-15
Procedure Document/程序文件
Page/页码
25sheets/共 25 页
Control Procedure for Process design and Development/工艺设计和开发控制程序
Control Procedure for Process design and Development/工艺设计和开发控制程序
1 Purpose/目的
This procedure is used to normalize the management of new product process
design and development of the company so as to ensure that all the tasks on new
product process design and development of the company are implemented effectively.
本程序为了规范公司新产品工艺设计和开发的管理,确保公司新产品工艺
设计和开发的各项工作得到有效实施。
2 Scope/范围
This procedure is applicable to control of new product process design and
development of the company. The content:
The company doesn’t cover the product
design, just focusing on process design based on customer drawings.
本程序适用于公司新产品工艺设计和开发的控制。
但包括产品进行设计和开发。
3 Terms/术语
3.1 Process design output:
the result of process design. Through the process design
and development, the bases of process design are transformed into a series of process
technical data of the process design output./工艺设计输出:
指工艺或过程设计的结
果。
通过对工艺设计和开发,将工艺设计的依据转化为工艺设计输出的一系列工
艺技术资料。
3.2 Process review:
the process design is reviewed formally, roundly and systemically
and the review result is documented./工艺评审:
对工艺设计进行的正式、全面和系
统的审查,并把审查结果形成文件。
3.3 Overall process program:
based on product design requirement, production
program and productivity, the guidance document is used to put forward the
technology and prepare for concrete tasks and measures./工艺总方案:
根据产品设计
要求、生产纲领和生产能力,提出工艺技术准备具体任务和措施的指导性文件。
3.4 First article (batch) inspection:
after the ready condition of trial-manufacture is
qualified through check, the first batch of trial-manufactured components and parts
are checked for overall process and finished products in accordance with the
1
Procedure Document/程序文件
Page/页码
25sheets/共 25 页
Control Procedure for Process design and Development/工艺设计和开发控制程序
requirements of product drawings and technological procedure to determine whether
the production process and equipments can guarantee that the products conforming to
design requirements are produced./首件(批)鉴定:
在生产试制准备状态检查合格后,
对首批试制生产的零、部(组)件按产品图和工艺规程的要求进行全面的过程和
成品检查,以确定生产工艺和设备能否保证生产出符合设计要求的产品。
3.5 Process planning:
responsibilities and authorities for process design are distributed
and interface management at every stage of product process design is defined on the
basis of technical documents such as product design drawing of the customer in
accordance with schedules of product design and development, in order to guarantee
that the process design, validation, etc are carried out as scheduled./工艺策划:
按照
产品设计和开发的进度要求,根据客户产品设计图样等技术文件,对产品工艺设
计职责和权限进行分工,明确产品工艺设计各阶段接口管理,保证工艺设计和验
证等活动按计划进行。
4 Responsibility/职责
4.1 Technical Quality Department shall be responsible for centralized management of
process design and development and having the process design and development for
new product implemented;/技术质量部是公司工艺设计和开发过程的归口管理部
门;负责公司新产品工艺设计和开发工作的组织实施;
4.2 Technical Quality Department shall be responsible for business management of
process design and development and having the process design and development for
new product implemented;/技术质量部门负责工艺设计和开发过程的业务管理;负
责新产品工艺设计和开发工作的组织实施;
4.3 All the related units of the company shall be responsible for cooperation in
accomplishing all the tasks on the process design and development./公司各有关单位
负责配合完成工艺设计和开发过程的各项工作。
5 Working Procedure/工作程序
5.1 Process Design and Development Planning/工艺设计和开发策划
5.1.1 Source of Process Design and Development Project/工艺设计和开发项目的来
源
a)After the new product contract or technical agreement signed by Marketing
Department and the customer, or market demand is reviewed, Marketing
2
Procedure Document/程序文件
Page/页码
25sheets/共 25 页
Control Procedure for Process design and Development/工艺设计和开发控制程序
Department shall fill in Application for Setup of Process Design and
Development Project and submit it to related departments and personnel for
confirmation. After it is approved by General Manager, it shall be issued to
ChiefEngineer./营销部与顾客签订的新产品合同或技术协议,或市场需
求,通过评审后,由营销部填写《工艺设计开发立项申请书》,经相关部门、
人员确定后报总经理批准后下发到总工程师。
b) After receiving Application for Setup of Process Design and Development
Project, Chief Engineer shall transmit Assignment Book for Process Design
and Development to lower levels and send the technical data concerning new
product to Technical Quality Department./接到《工艺设计开发立项申请书》
后由总工程师下达《工艺设计和开发任务书》,并将与新产品有关的技术
资料转交技术质量部。
5.1.2 Chief Engineer shall determine the project leader based on the above project
sources and transform the output of process design and development planning into
Process Design and Development Plan. The plan shall include the following contents:
/
总工程师根据上述项目来源,确定项目负责人,将工艺设计和开发策划的输出转
化为《工艺设计和开发计划书》。
计划书内容包括:
a)Division of the stages such as input, output, review, verification and
confirmation of process design and development and main work content;/工
艺设计和开发的输入、输出、评审、验证、确认等各阶段的划分和主要工
作内容;
b) Responsibilities and authorities at all the stages, requirement of schedule and
supporting unit;/各阶段人员职责和权限,进度要求和配合单位;
c)Requirement for resource allocation, e.g., personnel, information, equipment,
fund guarantee and other related content./资源配置需求,如人员、信息、设
备、资金保证等及其他相关内容。
5.1.3 The output document of process design and development planning shall be
revised appropriately with the schedule of design and development in accordance with
the related provisions of Control Procedure for Document./工艺设计和开发策划的
输出文件随着设计和开发的进展,在适当时予以修改,应执行《文件控制程序》的
有关规定。
3
Procedure Document/程序文件
Page/页码
25sheets/共 25 页
Control Procedure for Process design and Development/工艺设计和开发控制程序
5.1.4 Interface Management between Different Groups of Process Design and
Development/工艺设计和开发不同组别之间的接口管理
Different groups of process design and development may concern different
functions or levels of the company, and the exterior of the company.
工艺设计和开发的不同组别可能涉及到公司不同职能或不同层次,也可能
涉及到公司外部。
a)For the communication of important design and development information
between the groups, the design and development personnel shall fill in
Contact Form for Process Design and Development Information. After the
contact form is approved by the project leader, it shall be issued to the groups.
If some tasks need to be harmonized by the director of Technical Quality
Department, they cannot be harmonized until they are approved by the
director of Technical Quality Department./对于组别之间重要的设计和开
发信息沟通,设计开发人员填写《工艺设计开发信息联络单》,由项目负
责人审批后发给相关组别,需要技术质量部主管进行协调工作的,由技
术质量部主管审批后组织协调。
b) Marketing Department shall take charge of contact with the customer and
information transfer to the customer./营销部负责与顾客的联系及信息传递。
5.2 Process Design and Development Input/工艺设计和开发输入
5.2.1 The process design and development input should include the following
contents:
/工艺设计开发输入应包括以下内容:
a)Main characteristics and performance requirements for the product. These
requirements are mainly from the demand and expectation of the customer or
market, normally included in the contract, order or project recommendation;/
产品主要特点、性能要求。
这些要求主要来自顾客或市场的需求与期望,
一般应包含在合同、定单或项目建议书中;
b) Applicable laws and regulations and mandatory national standards shall be
met;/适用的法律、法规要求,对国家强制性标准一定要满足;
c)Applicable information provided by previous similar process design and
development;/以前类似的工艺设计和开发提供的适用信息;
4
Procedure Document/程序文件
Page/页码
25sheets/共 25 页
Control Procedure for Process design and Development/工艺设计和开发控制程序
d) Other requirements necessary for process design and development./工艺设计
和开发所必须的其他要求。
5.2.2 The process design and development input shall be documented, List of Process
Design and Development Inputs shall be completed and all kinds of relevant data
shall be attached./工艺设计和开发的输入应形成文件,填写《工艺设计和开发输入
清单》,并附上各类相关的资料。
5.2.3 The director of Technical Quality Department shall arrange the related process
design and development personnel and associated departments to review the process
design and development input and clarify the imperfect, vague or inconsistent
requirements in order to ensure that the design and development input meets the
requirements of the assignment book./技术质量部主管组织有关工艺设计和开发人
员和相关部门对工艺设计和开发输入进行评审,对其中不完善、含糊或矛盾的要
求做出澄清和解决,确保设计开发的输入满足任务书的要求。
5.3Process Design and Development Output/工艺设计和开发的输出
5.3.1The process design and development personnel shall launch the process design
and development on the basis of Process Design and Development Plan and the
program, and work out corresponding document on process design and development
output, i.e., List of Process Design and Development Outputs./工艺设计和开发人员
根据《工艺设计和开发计划书》及方案等开展工艺设计开发工作,并编制相应的
工艺设计和开发输出文件,即《工艺设计和开发输出清单》。
5.3.2The document on process design and development output should be expressed
in the form that it can be verified for process design and development input to
prove that the input requirement is met and to provide suitable information for
the production. The document on process design and development output shall
vary with different products, including the parameters and documents for
production guidance, e.g., conversion drawing, process document, part list,
control plan, inspection and test plan, inspection work instructions, list of
purchased materials and design drawings of tooling and fi
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- 关 键 词:
- 工艺 设计 开发 控制程序