工艺设计和开发控制程序

1、Procedure Document/ 程序文件Con trol Procedure for Process desig n and Developme nt 工艺设计和开发控制程序Document NO/ 编号：TY-QP7.3-01-15Revisi on 版本：Checked by校对：Verified by/Approved by/Con trolled Co nditio n/ 受控状态：Distribution No./ 分发号:1 / 28质量管理体系更改记录表Record Chart ofCha nges in Quality Man ageme nt System of Qu

2、ality ManualTY-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Change ExecutorCon 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 design and developme

3、nt of the pany so as to ensure that all the tasks on new product process desig n and developme nt of the pany are impleme nted 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This procedure is applicable to control of new product process design and development of the pany.Theeont

4、ent: The pany doesn'cover the product design, 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。但包括产品进展设计和开发。3 Terms/术语3.1 Process desig n output: the result of process desig n. Through the process desig n and development, the bases of process design are transf

5、ormed 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：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

6、文件。3.3 Overall process program: based on product desig n requireme nt, product ion program and productivity, the guidanee document is used to put forward the tech 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 First article (batch) inspection

7、: after the ready condition of trial-manufacture is qualified through check, the first batch of trial-ma nu factured ponents and parts are checked for overall process and finished products in accordanee with the requireme nts of product draw ings and tech no logical procedure to determ ine whether t

8、he product ion 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 求进展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 distribu

9、ted and in terface man ageme nt at every stage of product process desig n is defi ned on the basis of tech ni cal docume nts such as product desig n draw ing of the customer in accorda nee with schedules of product desig n and developme nt, i n order to guarantee that the process design, validation,

10、 etc are carried out as scheduled.工 艺筹划：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方案进展。4 Respo nsibility/职责4.1 Tech ni cal Quality Departme nt shall be resp on sible for cen tralized man ageme nt of process desig n and developme nt and hav ing the process desig n

11、and developme nt 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 Tech ni cal Quality Departme nt shall be resp on sible for bus in ess man ageme nt of process desig n and developme nt and hav ing the process desig n and developme nt for new product implemented;/技术质量部门

12、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 un its of the pany shall be resp on sible for cooperati on in acplish ing 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 Worki ng Procedure/X 作程序5.1 Process Desig n and Developme nt Pla nningT 艺设计和开发筹划5.1.

13、1 Source of Process Desig n and Developme nt Project 艺设计和开发工程的来源a) After the new product con tract or tech ni cal agreeme nt sig ned by Market ing Departme nt and the customer, or market dema nd is reviewed, Marketi ng Department shall fill in Application for Setup of Process Design and3 / 28Develop

14、ment 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 recei ving Applicatio n for Setup of Process Desi

15、g n and Developme nt Project, Chief Engineer shall transmit Assignment Book for ProcessDesign and Developme nt to lower levels and send the tech ni cal 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

16、determine the project leader based on the above project sources and tran sform the output of process desig n and developme nt pla nning into Process Design and Development Plan. The plan shall include the following conten ts:/总工程师根据上述工程来源，确定工程负责人，将工艺设计和开发筹 划的输出转化为？工艺设计和开发方案书？。方案书容包括：a) Divisi on of

17、the stages such as in put, output, review, verificati on and con firmati on of process desig n and developme nt and main work conten t;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容；b) Responsibilities and authorities at all the stages, requirement of schedule and supporti ng un it;/各阶段人员职责和权限，进度要求和配合单位；c) Re

18、quirement for resource allocation, e.g., personnel, information, equipment, fund guarantee and other related content./资源配置需求，女口人 员、信息、设备、资金保证等及其他相关容。5.1.3 The output document of process design and development planning shall berevised appropriately with the schedule of desig n and developme nt in acc

19、orda nee with the related provisions of Control Procedure for Document./ 工艺设计和开发筹 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 In terface Man ageme nt betwee n Differe nt Groups of Process Desig n 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 di

20、fferent fun cti ons or levels of the pany, and the exterior of the pany.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 munication of important design and development information between the groups, the design and development personnel shall fill in Con tact Form for ProcessDesig n and Developme

21、nt In formatio n. After the con tact 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

22、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？，由工程 负责人审批后发给相关组别，需要技术质量部主管进展协调工作的，由 技术质量部主管审批后组织协调。b) Marketi ng Departme nt shall take charge of con tact 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 put工 艺设计和开发输入5.2.1 The process desi

23、g n and developme nt in put should in clude the follow ing con te nts:/工艺设计开发输入应包括以下容：a) Mai n characteristics and performa nee requireme nts for the product. These requireme nts are mai nly from the dema nd and expectati on of the customer or market, n ormally in cluded in the con tract, order or p

24、roject reme ndatio n;/ 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、定单或工程建议书中；b) Applicable laws and regulati ons and man datory n ati onal sta ndards 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 developme nt;/以前类似的工艺设计和开发提供的适用信息；d) Ot

25、her requireme nts n ecessary for process desig n and developme nt.工 艺设计和开发所必须的其他要求522 The process desig n and developme nt in put shall be docume nted. List of Process Desig n and Developme nt In puts shall be pleted and all kinds of releva nt 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?

26、, 并附上各类相关的资料。5.2.3 The director of Tech ni cal Quality Departme nt shall arrange the related processdesign and development personnel and associated departments to review the process desig n and developme nt in put and clarify the imperfect, vague or incon siste nt requireme nts in order to en sure t

27、hat the desig n and developme nt in put 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展评审，对其中不完善、模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 desig n and developme nt pers onnel shall la unch the proc

28、ess desig nand developme nt on the basis of Process Desig n and Developme nt Pla n and theprogram, and work out corresp onding docume nt on process desig n and developme nt output, i.e., List of Process Desig n and Developme nt OutputsX 艺设 计和开发人员根据？工艺设计和开发方案书？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

29、和开发输出清单？。5.3.2 The docume nt on process desig n and developme nt output should be expressed in the form that it can be verified for process design and developme nt in put to prove that the in put requireme nt is met and to provide suitable in formati on for the producti on. The docume nt on process

30、desig n and developme nt output shall vary with differe nt products, in clud ing the parameters and docume nts for product ion guida nee, e.g., conv ersi on draw ing, process docume nt, part list, con trol pla n, in specti on and test pla n, in spect ion work instructions, list of purchased material

31、s 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展验证的形式来表达，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、控制方案、检验和 试验方案、检验作业指导书、物资采购清单、工装夹具设计图纸等。533 Technical Quality Department shall assign a person specially for checking the process data, e

32、specially check ing whether the process data meet the product desig n requireme nt, the content is plete and correct, the worki ng 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；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 standar

33、dization personnel of Technical Quality Department shall take charge of check ing the data on process desig n and developme nt 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 Desig n and D

34、evelopme nt Outputs. The output docume nt cannot be issued un til it is approved by Chief Engin eer.由工程负责人对输出工艺文件进展审核并填 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 Developmen工 艺设计和开发的评审5.4.1 The systemic and prehe nsive reviews proposed by the project leader of process design as

35、 usual should be carried out at the suitable stage of process design and 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 设计工程负责人提出。541.1 The in struct ion process docume nts such as process desig n and developme nt pla nning, overall process program (process route) and producti on in struct ions should b

36、e process reviewed before concrete process design and development./工艺设计和 开发筹划、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展。5.4.1.2 Tech no logical procedure for new process, key article, importa nt article and key process (working process) and special process document shall be reviewed before first a

37、rticle inspection./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展。5.4.2 Review Con te nt评审容542.1 Review of Overall Process Prograrn/ 艺总方案的评审a) The overall process program shall be reviewed for correct ness, adva nceme nt, eco nomy 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

38、 shall be reviewed to determine whether it meets the requireme nts of product desig n and product ion 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 divisi on and route shall be determ ined reas on ably and feasibly;/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

39、factors shall be reviewed;审查 专用工装系数确实定依据；e) The bases and rati on alities for new process, new tech nique 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 prin ciples for determ in ati on and con trol of mater

40、ial con sumpti on quota shall be reviewed./审查材料消耗定额确定及控制的原那么。5.4.2.2 Review of Key Article and Importa nt Article/关键件、重要件的评审a) The con trol factors and contents of the process docume nts on key processes (worki ng processes) of key article and importa nt article shall be reviewed for correct ness, r

41、ati on ality and in spectability;/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 (worki ng processes) of key article and importa nt a

42、rticle shall be reviewed for rati on ality and feasibility;/审查关键件、重要件中关键过程(工序)的工艺方 法、检测要求的合理性和可行性；d) The setup of associated working procedure and inspection process related to formatio n of quality characteristic of key process (work ing process) shall be reviewed for correct ness, rati on ality an

43、d 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；e) The tech ni cal breakthrough measure for key process (work ing 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 pleteness./审查关键过程(工序)目录的完整性。543.1 Technical Quality Dep

44、artment shall issue the review content or related data to the reviewi ng un its./技术质量部将评审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评审组织及职责5.441 Review Orga nizatio n评审组织The process review group shall be posed of reviewers of which the chief is pete nt tech ni cal leader or his

45、/her represe ntative.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 Respo nsibilities of Review Group Chief/2 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 and make con clusio ns;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

46、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 Respo nsibilities of Reviewer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

47、记录人员；5.4.5.2 The process desig n represe ntative shall in troduce the process design工 艺设 计代表介绍工艺设计情况；5.4.5.3 The reviewers shall give the opinions on the review;/ 参评人员发表评审意 见；545.4 The review group chief shall define the items and contents to be improved on the basis of collected opinions, and summa

48、rize the review results to give his/her op in io n or make a con clusio n;/评审组组长在集中意见的根底上，明确需要改良的 工程和改良容，对评审结果总结形成评语或结论；5.4.5.5 The recorder shall sort the meeting records and fill in Report on Process Design 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 Impleme ntatio n and Data

49、Perfectio n落实措施，完善资料Technical Quality Department shall earnestly analyze the problems and improveme nt opinions put forward in the review meeti ng, work out the measures, have them take n 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 In spectio n/首件鉴定5.4.1 Tec

50、hnical Quality Department shall draw up a first article (batch) inspection plan, propose the inspection requirement, assign a person to arrange the trial-ma nu facture in specti on and arrange the pla nt impleme ntati on 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方 案

51、，拟订首件批鉴定方案，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) on the basis of New Product Trial-ma nu facture Pla n and the followi ng requireme nts: 制造部根据新产品试制方案和以下要求组织进展首件批试制：a) The process devic

52、e, producti on equipme nt, test equipme nt, en vir onmen tal condition, etc shall meet the provisions of process documents, and the ready condition of trial-manufacture shall be qualified through check;/ 工艺 装置、生产设备、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 worki ng p

53、rocess strictly in accorda nee with the requireme nts of process docume nt, and the problems found duri ng the trial-ma nu facture in each work ing process shall be han died and recorded by the technician in time;/每道工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 a

54、rticle and make related records检 验人员进展加工后的检测，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543.1 The article (part or ponent) in first article (batch) working process shall be in spected strictly in accorda nee with issued process docume nt and work in struct ions for tri

55、al-manufacture. After it is qualified, the condition on inspection for first article (batch) working process shall be possessed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展检验。合格后才能具备首件批工序鉴 定条件。5.4.3.2 When the condition on inspection for first article (batch) working process shall be possessed, Manufacturing Depa

56、rtment shall fill in “ApplicatiorForm for In specti on (Type Approval) of First Article (Batch) Worki ng Process" and submit it to Technical Quality Department to inspect the first article (batch) working process./ 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 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 Inspection of Pa

57、rt and ponent in First Article (Batch) Working Proces首件批 工序零、部件鉴定5.441 Tech no logy Quality Departme nt shall take charge of assig n the in spectors to inspect the part and ponent in the first article (batch) working process./ 技术部门负 责组织鉴定组成员，进展首件批零、部件鉴定。5.4.4.2 The situation on the inspection for fi

58、rst article (batch) working process and the processing quality of the working process shall be spot checked, with the following contents verified:/抽查首件批工序鉴定情况及工序加工质量，验证以下容：a) pleteness, correctness and effectiveness of procedure document and work in structio ns;/工艺文件、作业指导书的完整、正确、有效性；b) Con figurati on of measuri ng equipme nt like measuri ng tool and effectiv