工艺设计和开发控制程序

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1、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：质量管理体系更改记录表Record Chart of Changes in Quality Management System of QualityManualTY-QR-TQ

2、D-031AControl 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 company so as to ensure that all the tasks on new product process design and development of the company are impl

3、emented 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 is applicable to control of new product process design and development of the company. The content: The company doesnt cover the product design, just focusing on process design based on customer drawings.

4、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 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

5、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 systemically and the 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, production program and productivity, the guidance docu

6、ment is used to put forward the technology 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 components an

7、d 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 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

8、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 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 d

9、rawing 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 Techni

10、cal 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 manag

11、ement 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 accomplishing all the tasks on the process design and develo

12、pment./ 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 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

13、 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, 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

14、，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 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 D

15、epartment./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 project sources and transform the output of process design and development planning into Process Design and Development Plan. The plan shall include the follow

16、ing 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 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 t

17、he stages, requirement of schedule and supporting 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 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

18、 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 andDevelopment/工艺设计和开发不同组别

19、之间的接口管理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 dev

20、elopment 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, they cannot be harmonized unt

21、il they are approved by the director 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 take charge of contact with the customer and information transfer to the customer./营销部负责与顾客的联系及信息传递。5.2 Proce

22、ss 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 marke

23、t, 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 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

24、 and development;/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。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 att

25、ached./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 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 Design and Development Output/ 工艺设计和开发的输出5.3.1 The process design and development personnel s

27、hall launch 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 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

28、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 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 des

29、ign and development 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

30、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。5.3.3 Technical Quality Department shall assign a person specially for checking the process data, especially checking

31、whether the process data meet the product 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 o

32、f Technical Quality Department shall take charge of checking the data on process 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

33、output document cannot be issued until 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 of process design as usual should be carried o

34、ut 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 工艺设计项目负责人提出。5.4.1.1 The instruction process documents such as process design and development planning, overall process program (process route) and production instructions should be process reviewed before concret

35、e 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 and key process (working process) and special process document shall be reviewed before first article inspection./新工艺，关键件、重要件、关键过程

36、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, 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 reviewed to determine whet

37、her 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确实定是否合理、可行；d) The bases used to determine special tooling factors shall be reviewed;/ 审查 专用工装系数确实定依据；

38、e) The bases and rationalities for new process, new technique and new equipment;/新工艺、新技术、新设备采用的依据及合理性；f) The requirements for standardization of process technical documents;/工艺 技术文件的标准化要求；g) The principles for determination and control of material consumption quota shall be reviewed./审查材料消耗定额确定及控制的原

39、则。5.422 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 for correctness, 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、

40、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 rationality and feasibility;/审查关键件、重要件中关键过

41、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 formation of quality characteristic of key process (working process) shall be reviewed 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；e) The technic

42、al breakthrough measure 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 to the reviewing units

43、./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 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 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。544.2 Responsibiliti

44、es of Review Group Chief/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, give opinions 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；544.3 Responsibiliti

45、es of Reviewer/评审人员职责a) Ready for 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;/

46、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；5.4.5.4 The review group chief shall define the items and contents to be improved on the basis of collected opinions, and summarize the review results to give his/her opinion or make a conclusion;/评审组组长在集中意见的基础上

47、，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；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 Implementation and Data Perfection/ 落实措施，完善资料Technical Quality Department shall earnestly analyze the problems and

48、improvement opinions put forward in the 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) inspection plan, propose the i

49、nspection requirement, assign a person to arrange the trial-manufacture inspection and arrange the plant implementation on the basis of issued 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

50、 Department shall trial-manufacture the first article (batch) on the basis 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, environmental condition, etc shall meet the provisions of process d

51、ocuments, 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 working process strictly in accordance with the requirements of process document, and the problems found during the trial-m

52、anufacture in each working process shall be handled 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 inspector 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 Inspection for First Article (Batch) Working Process/首件批工序鉴定5.

53、4.3.1 The article (part or component) in first article (batch) working process shall be inspected strictly in accordance with issued process document and work instructions for trial-manufacture. After it is qualified, the condition on inspection for first article (batch) working process shall be pos

54、sessed./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。5.4.3.2 When the condition on inspection for first article (batch) working process shall be possessed, Manufacturing Department shall fill in “Application Form for Inspection (Type Approval) of First Article (Batch) Working Process” and sub

55、mit 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 Part and Component in First Article (Batch) Working Process/首件 批工序零、部件鉴定5.4.4.1 Technology Quality Department shall take charg

56、e of assign the inspectors to inspect the part and component in the first article (batch) working process./ 技术部门 负责组织鉴定组成员，进行首件批零、部件鉴定。5.4.4.2 The situation on the inspection for first article (batch) working process and the processing quality of the working process shall be spot checked, with the f

57、ollowing contents verified:/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

58、置及对 产品质量控制的有效性；c) Conformance of processing in working process to process document;/ 工序力口 工与工艺文件的符合性；d) Qualities of raw material, parts and auxiliary equipment as well as blank;/ 原 材料、配套件、坯件质量；e) Whether the precision of production equipment meets the processing requirement./生产设备的精度能否满足加工要求。5.4.4.3

59、 The finished part and component in the first article (batch) shall be spot checked to affirm whether they meet the requirements of the customers production drawings./抽查首件批零、部件成品，证实其是否满足客户产品图要求。5.4.4.4 Inspection Group shall assess the result of spot check, make a conclusion and fill the conclusion

60、and found problems in corresponding columns of Checklist of Parts/Components in First Article (Batch) Working Process./ 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。5.4.5 Post-inspection Disposal/鉴定后的处置5.4.5.1 The part and component qualified through the inspection shall be circulated or stored as

61、 required./鉴定合格的零、部件按要求流转或保存。5.4.5.2 For the part and component unqualified through the inspection, the subsequent part and component can be used for re-inspection./ 鉴定未通过时，允许用后续产品 递补，重新进行鉴定。Validation of Design and Development/设计和开发的验证5.5.1 Based on the process design and development program passin

62、g through the review, Technical Quality Department shall be responsible for citing the affirmed evidence related to similar process design and development for comparison as the basis for verification of this design./ 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 le

63、ader 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 Chief Engineer for approval so as to ensure that every performance indicator and every functional indicator in

64、process design and development input have corresponding verification 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 Confirmation of Design and Development/ 设计和开发确实认The confirmation is intended to prove that the product meets expected use requirement,

65、 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 locally 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