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1、wordProcedure Document/程序文件Control Procedure for Process design and Development工艺设计和开发控制程序Revision /版本：Checked by/校对：Verified by/ Approved by/ Controlled Condition/受控状态：Distribution No./分发号： / 质量管理体系更改记录表Record Chart ofChanges in Quality Management System of Quality ManualTY-QR-TQD-031A更改单编号Change O
2、rder Number文件编号Document Number处数Section Changed标志Rev更改日期Release Change更改人Change ExecutorControl 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 pany so as to ensure that all th
3、e tasks on new product process design and development of the pany are implemented effectively.本程序为了规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/围he content: The pany doesnt 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。但包括产品进展设计和开发。3
4、 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
5、: the process design is reviewed formally, roundly and systemically and the review result is documented./工艺评审：对工艺设计进展的正式、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 technol
6、ogy 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 ponents and parts are checked for overall process and
7、 finished products in accordance with the 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展全面的过程和成品检查
8、，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 sch
9、edules 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展分工，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展。4 Responsibility/职责4.1 Technical Quality Department shall be responsible for c
10、entralized 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
11、 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 pany shall be responsible for cooperation in acplishing 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
12、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 Department shall fill in Applica
13、tion 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 Chief Engineer./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
14、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
15、.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。计划书容包括：a) Division of the stages such as input, output, review, verification and confirmation of process design and development an
