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1、Procedure Document/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-QP-01-15Revision/版本：Checked by/校对：Verified by/Approved by/Controlled Condition/受控状态：Distribution No./分发号：学习文档 仅供参考质量管理体系更改记录表质量管理体系更改记录表Record Chart of Changes in Quality Manage
2、ment System of QualityRecord Chart of Changes in Quality Management System of QualityManualManualTY-QR-TQD-031A更改单编号Change OrderNumber文件编号DocumentNumber处数SectionChanged标志Rev更改日期ReleaseChange更改人ChangeExecutor学习文档 仅供参考Control Procedure for Process design and Development/工艺设计和开发控制程序1 Purpose/目的This pro
3、cedure is used to normalize the management of new product processdesign and development of the company so as to ensure that all the tasks on newproduct process design and development of the company are implemented effectively.本程序为了标准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
4、is applicable to control of new product process design anddevelopment of the company.The content:The company doesnt cover the productdesign,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 processdesign.Th
5、rough the process designand development,the bases of process design are transformed into a series of processtechnical 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 systemicallyand th
6、e 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,productionprogram and productivity,the guidance document is used to put forward thetechnology 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
7、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 isqualified through check,the first batch of trial-manufactured components and partsare checked for overall process and finished products in accordance with therequirements of product drawings and tech
8、nological procedure to determine whether学习文档 仅供参考the production process and equipments can guarantee that the products conforming todesign 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 author
9、ities for process design are distributedand interface management at every stage of product process design is defined on thebasis of technical documents such as product design drawing of the customer inaccordance with schedules of product design and development,in order to guaranteethat the process d
10、esign,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 ofprocess design and development and having the process design
11、 and development fornew 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 ofprocess design and development and having the process design and development fornew product implemented;/技术质量部门负责工艺设计和开发过程的业务管理；
12、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 inaccomplishing 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 Desi
13、gn 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 MarketingDepartment and the customer,or market demand is reviewed,MarketingDepartment shall fill in Application for Setup of Process Design and学习文档 仅供参考Development Project and submit it to relate
14、d departments and personnel forconfirmation.After it is approved by General Manager,it shall be issued toChief 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 Application for Setup of Process Design and DevelopmentProject,Chief Engineer shall t
15、ransmit Assignment Book for Process Designand Development to lower levels and send the technical data concerning newproduct 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 projectsource
16、s and transform the output of process design and development planning intoProcess 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 andconfirmation of pr
17、ocess 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 andsupporting 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
18、 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 berevised appropriately with the schedule of design and development in accordance withthe 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
19、当时予以修改，应执行文件控制程序的有关规定。5.1.4 Interface Management between Different Groups of Process Design and学习文档 仅供参考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 differentfunctions 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
20、次，也可能涉及到公司外部。a)For the communication of important design and development informationbetween the groups,the design and development personnel shall fill inContact Form for Process Design and Development Information.After thecontact form is approved by the project leader,it shall be issued to the group
21、s.If some tasks need to be harmonized by the director of Technical QualityDepartment,they cannot be harmonized until they are approved by thedirector 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
22、take charge of contact with the customer andinformation 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 followingcontents:/工艺设计开发输入应包括以下内容：a)Main characteristics and performance requirement
23、s for the product.Theserequirements are mainly from the demand and expectation of the customer ormarket,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 bemet
24、;/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 anddevelopment;/以前类似的工艺设计和开发提供的适用信息；d)Other requirements necessary for process design and development./工艺设计和开发所必须的其他要求。学习文档 仅供参考5.2.2 The process design and development input shall be documented,List of P
25、rocessDesign and Development Inputs shall be completed and all kinds of relevant datashall 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 processdesign and development personnel and associated departments to review t
26、he processdesign and development input and clarify the imperfect,vague or inconsistentrequirements in order to ensure that the design and development input meets therequirements 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
27、 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 designand development on the basis of Process Design and Development Plan and theprogram,and work out corresponding document on process design and developmentoutput,i.e.,List of Process Desig
28、n 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 expressedin the form that it can be verified for process design and development input toprove that the input requirement is met and to pr
29、ovide suitable information forthe production.The document on process design and development output shallvary with different products,including the parameters and documents forproduction guidance,e.g.,conversion drawing,process document,part list,control plan,inspection and test plan,inspection work
30、instructions,list ofpurchased materials and design drawings of tooling and fixtures./工艺设计和开发输出文件应以能针对工艺设计和开发输入进行验证的形式来表达，以便于证明满足输入要求，为生产运作提供适当的信息。工艺设计和开发输出文件因产品不同而不同，包括指导生产等活动的参数和文件：如转换图纸、工艺文件、零件明细表、控制计划、检验和试验计划、检验作业指导书、物资采购清单、工装夹具设计图纸等。学习文档 仅供参考5.3.3Technical Quality Department shall assign a perso
31、n specially for checking theprocess data,especially checking whether the process data meet the product designrequirement,the content is complete and correct,the working processes areharmonized 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要求；内容完整、正确；工序之间是否协调、加工的可行性和
32、可检查性。5.3.4Full(part)time standardization personnel of Technical Quality Departmentshall take charge of checking the data on process design and development output forstandardization./技术质量部门的专兼职标准化员负责本部门对工艺设计和开发输出资料标准化检查。5.3.5The project leader shall review the process output document and fill in List
33、 ofProcess Design and Development Outputs.The output document cannot be issueduntil it is approved by Chief Engineer./由项目负责人对输出工艺文件进行审核并填写工艺设计和开发输出清单，总工程师批准输出文件后才能发放。5.4 Review of Process Design and Development/工艺设计和开发的评审5.4.1 The systemic and comprehensive reviews proposed by the project leader ofp
34、rocess design as usual should be carried out at the suitable stage of process designand development./在工艺设计和开发的适当阶段应系统的、综合的评审，一般由工艺设计项目负责人提出。5.4.1.1 The instruction process documents such as process design and developmentplanning,overall process program(process route)and production instructions shoul
35、dbe process reviewed before concrete process design and development./工艺设计和开发策划、工艺总方案工艺路线及生产说明书等指令性工艺文件的工艺评审应在工艺具体设计和开发前进行。5.4.1.2 Technological procedure for new process,key article,important article andkey process(working process)and special process document shall be reviewed beforefirst article in
36、spection./新工艺，关键件、重要件、关键过程工序的工艺规程以及特殊工艺文件的评审在首件鉴定前进行。5.4.2 Review Content/评审内容5.4.2.1 Review of Overall Process Program/工艺总方案的评审a)The overall process program shall be reviewed for correctness,advancement,学习文档 仅供参考economy and feasibility;/审查工艺总方案的正确性、先进性、经济性和可行性；b)The overall process program shall be
37、 reviewed to determine whether it meetsthe requirements of product design and production program;/审查工艺总方案是否满足客户产品设计及生产纲领的要求；c)The productprocessdivision and route shall be determined reasonablyandfeasibly;/产品的工艺分工和工艺路线确实定是否合理、可行；d)The bases used to determine special tooling factors shall be reviewed
38、;/审查专用工装系数确实定依据；e)The bases and rationalitiesfor newprocess,newtechniqueand newequipment;/新工艺、新技术、新设备采用的依据及合理性；f)The requirements forstandardizationof processtechnical documents;/工艺技术文件的标准化要求；g)The principles for determination and control of material consumption quotashall be reviewed./审查材料消耗定额确定及控制
39、的原则。5.4.2.2 Review of Key Article and Important Article/关键件、重要件的评审a)The control factors and contents of the process documents on key processes(working processes)of key article and important article shall be reviewed forcorrectness,rationality and inspectability;/审查关键件、重要件中关键过程(工序)工艺文件的控制因素及内容的正确性、合理
40、性、可检查性；b)The processcapability index of key process(workingprocess)shallbeverified;/核实关键过程(工序)的工序能力指数；c)The process methods and detection requirements for key processes(workingprocesses)of key article and importantarticle shallbe reviewed forrationality and feasibility;/审查关键件、重要件中关键过程(工序)的工艺方法、检测要求的
41、合理性和可行性；d)The setup of associated working procedure and inspection process related toformation of quality characteristic of key process(working process)shall bereviewed for correctness,rationality and feasibility;/审查与关键过程(工序)的质量特性形成，涉及的关联工序及检验工序设置的正确性、合理性、可行性；学习文档 仅供参考e)The technical breakthrough me
42、asure for key process(working process)shallbe reviewed;/审查关键过程(工序)的技术攻关措施；f)The content of key process(working process)shall be reviewed forcompleteness./审查关键过程(工序)目录的完整性。5.4.3.1 Technical Quality Department shall issue the review content or related data tothe reviewing units./技术质量部将评审内容或有关的资料送交各参评单
43、位。5.4.4 Organization and Responsibility of Review/评审组织及职责5.4.4.1 Review Organization/评审组织The process review group shall be composed of reviewers of which the chief iscompetent technical leader or his/her representative.由参评人员组成工艺评审组，组长由主管技术领导或由他指定的委托人担任。5.4.4.2 Responsibilities of Review Group Chief/
44、评审组长职责a)Preside over the meeting;/主持会议；b)Collect the problems and suggestions put forward in the review,giveopinions and make conclusions;/聚集评审提出的问题和建议，写出评语和结论；c)Assign a recorder to sort and work out the process review reports;/指定记录人员整理、写出工艺评审报告；5.4.4.3 Responsibilities of Reviewer/评审人员职责a)Ready fo
45、r the review in advance;/提前做好参评准备；b)Give opinions fully./充分发表意见；5.4.5 Review Steps/评审步骤5.4.5.1 The review group chief shall describe the meeting and assign a recorder;/评审组组长作会议说明并指定记录人员；5.4.5.2 The process design representative shall introduce the process design;/工艺设计代表介绍工艺设计情况；5.4.5.3 The reviewers
46、 shall give the opinions on the review;/参评人员发表评审意见；5.4.5.4 The review group chief shall define the items and contents to be improved onthe basis of collected opinions,and summarize the review results to give his/heropinion or make a conclusion;/评审组组长在集中意见的基础上，明确需要改良的项目和改良内容，对评审结果总结形成评语或结论；学习文档 仅供参考5
47、.4.5.5 The recorder shall sort the meeting records and fill in Report on ProcessDesign and Development Review./记录人员整理会议记录，填写工艺设计和开发评审报告。5.4.6 Measure Implementation and Data Perfection/落实措施，完善资料Technical Quality Department shall earnestly analyze the problems andimprovement opinions put forward in t
48、he review meeting,work out the measures,have them taken and perfect the process data.技术质量部认真分析评审会议提出的问题和改良意见，制定并落实措施，完善工艺资料。5.5 First Article Inspection/首件鉴定5.4.1 Technical Quality Department shall draw up a first article(batch)inspectionplan,proposetheinspectionrequirement,assignapersontoarrangethe
49、trial-manufacture inspection and arrange the plant implementation on the basis ofissued New Product Trial-manufacture Plan./技术质量部根据下达的新产品试制计划，拟订首件批鉴定计划，提出鉴定要求，明确试制鉴定组织人员，并组织实施。5.4.2 Trial-manufacture of First Article(Batch)/首件批试制Manufacturing Department shall trial-manufacture the first article(batc
50、h)on thebasis of New Product Trial-manufacture Plan and the following requirements:制造部根据新产品试制计划和以下要求组织进行首件批试制：a)The process device,production equipment,test equipment,environmentalcondition,etc shall meet the provisions of process documents,and the readycondition of trial-manufacture shall be qualif