基本工艺设计和开发控制程序.docx

1、基本工艺设计和开发控制程序 Procedure Document/程序文献Control Procedure for Process design and Development工艺设计和开发控制程序Document NO/ 编号：TY-QP7.3-01-15Revision /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：质量管理体系更改登记表Record Chart of Changes in Quality Management Syste

2、m of Quality ManualTY-QR-TQD-031A更改单编号Change Order Number文献编号Document Number处数Section Changed标志Rev更改日期Release Change更改人Change Executor Control Procedure for Process design and Development/工艺设计和开发控制程序1 Purpose/目This procedure is used to normalize the management of new product process design and devel

3、opment 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管理，保证公司新产品工艺设计和开发各项工作得到有效实行。2 Scope/范畴This procedure is applicable to control of new product process design and development of the comp

4、any. The content：The company doesnt cover the product design，just focusing on process design based on customer drawings.本程序合用于公司新产品工艺设计和开发控制。但涉及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 trans

5、formed into a series of process technical data of the process design output./工艺设计输出：指工艺或过程设计成果。通过对工艺设计和开发，将工艺设计根据转化为工艺设计输出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：对工艺设计进行正式、全面和系统审查，并把审查成果形成文献。3.3 Overall p

6、rocess 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：依照产品设计规定、生产大纲和生产能力，提出工艺技术准备详细任务和办法指引性文献。3.4 First article (batch) inspection：after the ready condition

7、 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 requirements of product drawings and technological procedure to determine whether the production process and equipm

8、ents 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，对首批试制生产零、部（组）件按产品图和工艺规程规定进行全面过程和成品检查，以拟定生产工艺和设备能否保证生产出符合设计规定产品。3.5 Process planning：responsibilities and authorities for process design are distributed and interface management at every stage

9、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进度规定，依照客户产品设

10、计图样等技术文献，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筹划进行。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归口管理部门；负责公司新产品

11、工艺设计和开发工作组织实行；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业务管理；负责新产品工艺设计和开发工作组织实行；4.3 All the related units of the company shall be responsi

12、ble for cooperation in accomplishing all the tasks on the process design and development./公司各关于单位负责配合完毕工艺设计和开发过程各项工作。5 Working Procedure/工作程序5.1Process 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来源a)After the new product contract or techn

13、ical agreement signed by Marketing Department and the customer，or market demand is reviewed，Marketing 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，

14、it shall be issued to Chief Engineer./营销部与顾客订立新产品合同或技术合同，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，经有关部门、人员拟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

15、 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，并将与新产品关于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

16、Design and Development Plan. The plan shall include the following contents:/总工程师依照上述项目来源，拟定项目负责人，将工艺设计和开发策划输出转化为工艺设计和开发筹划书。筹划书内容涉及：a)Division of the stages such as input，output，review，verification and confirmation of process design and development and main work content;/工艺设计和开发输入、输出、评审、验证、确认等各阶段划分和重

17、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，进度规定和配合单位；c)Requirement for resource allocation，e.g.，personnel，information，equipment，fund guarantee and other related content./资源配备需求，如人员、信息、设备、资金保证等及其她有关内容。5.1.3 The output document of

18、 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输出文献随着设计和开发进展，在恰当时予以修改，应执行文献控制程序关于规定。5.1.4 Interface Management between Different Groups of Proces

19、s Design and Development/工艺设计和开发不同组别之间接口管理Different groups of process design and development may concern different functions or levels of the company，and the exterior of the company.工艺设计和开发不同组别也许涉及到公司不同职能或不同层次，也也许涉及到公司外部。a)For the communication of important design and development information between

20、 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，t

21、hey cannot be harmonized until they are approved by the director of Technical Quality Department./对于组别之间重要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系单，由项目负责人审批后发给有关组别，需要技术质量部主管进行协调工作，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

22、责与顾客联系及信息传递。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涉及如下内容：a)Main characteristics and performance requirements for the product. These requirements are mainly from the demand and expectation of th

23、e customer or market，normally included in the contract，order or project recommendation;/产品重要特点、性能规定。这些规定重要来自顾客或市场需求与盼望，普通应包括在合同、定单或项目建议书中；b)Applicable laws and regulations and mandatory national standards shall be met;/合用法律、法规规定，对国家强制性原则一定要满足；c)Applicable information provided by previous similar pro

24、cess design and development;/此前类似工艺设计和开发提供合用信息；d)Other requirements necessary for process design and development./工艺设计和开发所必要其她规定。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

25、 attached./工艺设计和开发输入应形成文献，填写工艺设计和开发输入清单，并附上各类有关资料。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 requir

26、ements 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关于工艺设计和开发人员和有关部门对工艺设计和开发输入进行评审，对其中不完善、含糊或矛盾规定做出澄清和解决，保证设计开发输入满足任务书规定。5.3 Process Design and Development Output/工艺设计和开发输出5.3.1The process design and development personnel shall laun

27、ch 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依照工艺设计和开发筹划书及方案等开展工艺设计开发工作，并编制相应工艺设计和开发输出文献，即工艺设计和开发输出清

28、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 developm

29、ent 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 fixtures./

30、工艺设计和开发输出文献应以能针对工艺设计和开发输入进行验证形式来表达，以便于证明满足输入规定，为生产运作提供恰当信息。工艺设计和开发输出文献因产品不同而不同，涉及指引生产等活动参数和文献：如转换图纸、工艺文献、零件明细表、控制筹划、检查和实验筹划、检查作业指引书、物资采购清单、工装夹具设计图纸等。5.3.3Technical Quality Department shall assign a person specially for checking the process data，especially checking whether the process data meet the p

31、roduct design requirement，the content is complete and correct，the working processes are harmonized and the processing is feasible and checkable./技术质量部指定专人负责校核工艺资料，重点校核工艺资料能否满足产品设计规定；内容完整、对的；工序之间与否协调、加工可行性和可检查性。5.3.4Full (part) time standardization personnel of Technical Quality Department shall take

32、 charge of checking the data on process design and development output for standardization./技术质量部门专（兼）职原则化员负责本部门对工艺设计和开发输出资料原则化检查。5.3.5The project leader shall review the process output document and fill in List of Process Design and Development Outputs. The output document cannot be issued until it i