工艺设计和开发控制程序

1、Proce d ur e Do cum e nt / 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-QP7.3-01-15Revision /版本：Checked by校对：Verified by/ 审核：Approved by/批准：Co ntrolled Co nditio n/ 受控状态：Distribution No./分发号：质量管理体系更改记录表Record Chart of Chan ges in Quality Man ageme nt Syst

2、em of QualityMan ualTY-QR-TQD-031A更改单编号Change OrderNumber文件编号Docume ntNumber处数Secti onChanged标志Rev更改日期ReleaseChange更改人ChangeExecutorCon trol Procedure for Process desig n and Development 艺设计和开发控制程序1 Purpose/目 的This procedure is used to no rmalize the man ageme nt of new product process desig n and d

3、evelopme nt of the compa ny so as to en sure that all the tasks on new product process desig n and developme nt of the compa ny are impleme nted 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 con trol of new product process desig n and developme

4、nt of the company. Thecontent: The company doesn t cover the product desig n, just focus ing on process desig n based on customer draw in gs.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 desig n output: the result of process desig n. Through the process desig n and developme nt, the bases

5、 of process desig n are tran sformed into a series of process tech ni cal data of the process desig n 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 desig n is reviewed formally, ro un dly and systemically and the review result is docume nted./工艺评审

6、：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 desig n requireme nt, product ion program and productivity, the guida nee docume nt is used to put forward thetech no logy and prepare for con crete tasks and measuresX 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 F

7、irst article (batch) inspection: after the ready condition of trial-manufacture is qualified through check, the first batch of trial-ma nu factured comp onents and parts are checked for overall process and fini shed products in accorda nee with the requireme nts of product draw ings and tech no logi

8、cal procedure to determ ine whether the producti on process and equipme nts can guara ntee that the products con formi ng to desig n requireme nts 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

9、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 guara ntee that t

10、he process desig n, validati on, 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 Respo nsibility/职责4.1 Technical Quality Department shall be responsible for centralized management of process design and development and hav

11、ing the process design and development for new product impleme nted;/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 impleme n

12、ted;/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 accomplish ing all the tasks on the process desig n and developme nt 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 Worki ng Procedure/工作程序5.1 Process Desig n and Developme nt Pla nnin工艺

13、设计和开发策划5.1.1 Source of Process Desig n and Developme nt Project/ 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 Application for Setup of Process Design and Developmen

14、t Project and submit it to related departments and personnel for confirmation. After it is approved by General Manager, it shall be issued to Chief Engin eer.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

15、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./接至U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

16、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 conten ts:/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

17、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 support ing un it;/各阶段人员职责和权限，进度要求和配合单位；c) Requirement for resource

18、allocation, e.g., personnel, information, equipme nt, fund guara ntee and other related conten t./ 资源配置需求，女口 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 re

19、lated provisi ons of Con trol Procedure for Docume nt./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。5.1.4 Interface Management between Different Groups of Process Design andDevelopme nt/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 le

20、vels 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.

21、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 Tech nical Quality Departme nt./对于组别之间重要的设计和 开发信息沟通，设计

22、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 in formation tran sfer to the customer./营销部负责与顾客的联系及信息传 递。5.2 Process Desig n and Developme nt In pu工艺设计和开发输入5.2.1 The process design and development input

23、 should include the following conten ts:/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 projectrecomme ndati on;/产品主要特点、性能要求。这些要

24、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；d) Other requireme nts n ecessary for process des

25、ig n and developme nt 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 Qual

26、ity 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 requireme n

27、ts of the assig nment 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。5.3 Process Desig n and Developme nt Output工 艺设计和开发的输出5.3.1 The process design and development personnel shall launch the process designand development on the basis of Process Design and

28、Development Plan and the program, and work out corresponding document on process design and developme nt output, i.e., List of Process Desig n and Developme nt 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 。5.3.2 The document on process design and development output sh

29、ould 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 pa

30、rameters 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./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

31、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。5.3.3 Technical Quality Department shall assign a person specially for checking the process data, especially checking whether the process data meet the product design requirement, the content is c

32、omplete and correct, the working processes are harm oni zed and the process ing 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、加工的可行性和可检查性。5.3.4 Full （part） time standardization personnel of Technical Quality Department shall take charge of checking the data on proc

33、ess design and development output for standardization./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。5.3.5 The project leader shall review the process output document and fill in List of Process Design and Development Outputs. The output document cannot be issued un til it is approved by Chief Engin eer.由

34、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 Desig n and Development/!艺设计和开发的评审5.4.1 The systemic and comprehensive reviews proposed by the project leader of process design as usual should be carried out at the suitable stage of process design and developme nt./在工艺设计和开发的适当阶

35、段应系统的、综合的评审，一般由 工艺设计项目负责人提出。/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。/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 Con te nt评审内容/ 工艺总方案的评审a）The overall process program shall be reviewed for correctness,adva nceme nt, 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)

36、 The overall process program shall be reviewed to determine whether it meets the 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 product process division and route shall be determined reasonably and feasibly;/产品的工艺分工和工艺路线的确定是否合理、可行；d) The bases used to deter

37、mine special tooling factors shall be reviewed审查 专用工装系数的确定依据；e) The bases and rationalities for new process, new technique and new equipme nt;/新工艺、新技术、新设备采用的依据及合理性；f) The requireme nts for sta ndardizati on of process tech ni cal docume nts;工艺 技术文件的标准化要求；g) The principles for determination and contr

38、ol of material consumption quota shall be reviewed./审查材料消耗定额确定及控制的原则。/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 for correct ness, rati on ality and in spectability;/审查关键件、重要件中关键过程

39、 (工序)工艺文件的控制因素及内容的正确性、合理性、可检查性；b) The process capability index of key process (working process) shall be verified;/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 (working processes) of key article and important article shall be reviewed for rati on ality and fe

40、asibility;/审查关键件、重要件中关键过程(工序)的工艺方 法、检测要求的合理性和可行性；d) The setup of associated working procedure and inspection process relatedto formation of quality characteristic of key process (working process) shall be reviewed for correct ness, rati on ality 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

41、正确性、合理性、可行性；e) The technical breakthrough measure for key process (working process) shall be 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 for completeness./审查关键过程(工序)目录的完整性。/技术质量部将评审内容或有关的资料送交各参评单位。5.4.4 Orga nization and Resp on sibility of Review评审组

42、织及职责/评审组织The process review group shall be composed of reviewers of which the chief is competent 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。 /评审组长职责a) Preside over the meeti ng;/主持会议；b) Collect the problems and suggestions put forward in the review, giveopi nions a

43、nd make con clusio ns;汇集评审提出的问题和建议，写出评语和结论；c) Assig n 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；/评审人员职责a) Ready for the review in adva nee;提前做好参评准备；b) Give opi nions fully./充 分发表意见；5.4.5 Review Steps评审步骤/评审组组长作会议说明并指定记录人员； /工艺设计代表介绍工艺设计情况；/参评人员发表评审意见； /评审组组长在集中意见

44、的基础上，明确需要改进的项目和改进内容，对评审结 果总结形成评语或结论；/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 Impleme ntatio n and Data Perfectio n落实措施，完善资料Technical Quality Department shall earnestly analyze the problems and improvement opinions put forward in the review meeting, work out the measures, have them taken and perfect

45、the process data.技术质量部认真分析评审会议提出的问题和改进意见， 制定并落实措施， 完善工艺资料5.5 First Article In spectio n/首件鉴定5.4.1 Technical Quality Department shall draw up a first article （batch） inspection plan, propose the inspection requirement, assign a person to arrange the trial-manufacture inspection and arrange the plant

46、implementation on the basis of issued New Product Trial-ma nufacture Pla n.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-ma nufacture of First Article （Batch）首件（批）试制Manufacturing Department shall trial-manufacture the first article （batch） onthe basis of New Product Trial-manuf

47、acture Plan and the following requirements: 制造部根据新产品试制计划和下列要求组织进行首件（批）试制：a）The process device, production equipment, test equipment, environmental condition, etc shall meet the provisions of process documents, and the ready con diti on of trial-ma nu facture shall be qualified through check;/工艺 装置、生

48、产设备、试验设备及环境条件等满足工艺文件的规定，并经试 制准备状态检查合格；b）The article shall be processed in each working process strictly in accordance with the requirements of process document, and the problems found during the trial-manufacture in each working process shall be handled and recorded by the tech ni cia n in time;/每道工

49、序应严格按工艺文件的要求加 工，技术人员及时处理、记录每道工序试制中的问题；c）The in spector shall check the processed article and make related records检 验人员进行加工后的检测，做好相关记录。5.4.3 In spection for First Article （Batch） Worki ng Process首 件（批）工序鉴定 /首件（批）工序（零、部）件严格按照下发的试制工艺文件和作业指导书进行 检验。合格后才能具备首件（批）工序鉴定条件。/具备首件（批）工序鉴定条件时，由制造部填写“首件（批）工序（零、部）件

50、鉴定（定型）申请表”交技术质量部门组织对首件（批）的工序实施鉴定。5.4.4 In specti on of Part and Comp onent in First Article （Batch） Worki ng Process/ 件 （批）工序零、部件鉴定/技术部门负责组织鉴定组成员，进行首件（批）零、部件鉴定。/抽查首件（批）工序鉴定情况及工序加工质量，验证以下内容：a） Completeness, correctness and effectiveness of procedure document and work instructions;/ 工艺文件、作业指导书的完整、正确、有

51、效性；b） Configuration of measuring equipment like measuring tool and effectiveness of the equipment for product quality control;/ 量具等测量设备的配置及对 产品质量控制的有效性；c）Con forma nee of process ing in worki ng process to process docume nt 工序 加工与工艺文件的符合性；d）Qualities of raw material, parts and auxiliary equipme nt a

52、s well as bla nk;原 材料、配套件、坯件质量；e）Whether the precision of production equipment meets the processing requireme nt./生产设备的精度能否满足加工要求。/抽查首件（批）零、部件成品，证实其是否满足客户产品图要求。 /鉴定组对抽查结果进行评议，做出鉴定结论并将结论及问题写入首件（批） 工序（零、部）件鉴定表相应栏内。545 Post-i nspection Disposal 鉴定后的处置/鉴定合格的零、部件按要求流转或保存。 /鉴定未通过时，允许用后续产品递补，重新进行鉴定。5.5 Val

53、idation of Design and Development设计和开发的验证5.5.1 Based on the process design and development program passing through the review, Technical Quality Department shall be responsible for citing the affirmed evidence related to similar process design and development for comparis on as the basis for verific

54、atio n of this desig n.根据评审通过的工艺 设计和开发方案 ,技术质量部负责引用已证实的类似工艺设计和开发的有 关证据进行比较，作为本次设计的验证依据。5.5.2 The project leader shall summarize all the verification results, work out Report on Verification of Process Design and Development, record the verification results and traced measures and report them to Chie

55、f Engineer for approval so as to ensure that every performance indicator and every functional indicator in process design and development input have corresp onding verificati on records./项 目负责人综合所有验证结果， 编制工 艺设计和开发验证报告 ，记录验证的结果及跟踪的措施，报总工程师批 准，确保工艺设计和开发输入中每一项性能、 功能指标都有相应的验证记 录。5.6 Con firmation of Des

56、ig n and Developme nt/设计和开发的确认The confirmation is intended to prove that the product meets expected use requirement, and should be carried out before batch production as usual. If the confirmation needs to be carried out after the product is used by the user for a period, it should be realized local

57、ly within possible applicable range. Based on the product characteristics, one of the following confirmation methods can be selected.确认的目的是证明产品能够满足预期的使用要求 ，通常应在批量生产之前， 如需经用户使用一段时间才能完成确认工作的,应在可能的适用范围内实现局部确认,根据产品的特点 ,可以选择下述几种确认方式之一。5.6.1 Technical Quality Department shall arrange related personnel to

58、carry out the first article inspection for the product, i.e., the product process design and developme nt is con firmed;/技术质量部组织相关人员对产品进行首件鉴定，即对 产品工艺设计和开发予以确认；5.6.2 After the product is qualified through the acceptance, if it is delivered by Marketing Department to the customer for tryout, Marketing Department shall fill in Customer Satisfaction Questionnaire to indi