基本工艺设计和开发控制程序.docx

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-QP7.3-01-15Revision /版本： Checked by/校对： Verified by/审核： Approved by/同意： Controlled Condition/受控状态：Distribution No./分发号：质量管理体系更改统计表Record Chart of Changes in Quality Management System of Quality ManualTY-QR-TQD-031A更改单编号Change Order Number文件编号Document Number处数Section Changed标志Rev更改日期Release Change更改人Change ExecutorControl Procedure for Process design and Development/工艺设计和开发控制程序1 Purpose/目标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 implemented effectively.本程序为了规范企业新产品工艺设计和开发管理，确保企业新产品工艺设计和开发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.本程序适适用于企业新产品工艺设计和开发控制。但包含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：指工艺或过程设计结果。经过对工艺设计和开发，将工艺设计依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、全方面和系统审查，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 document is used to put forward the technology and prepare for concrete tasks and measures./工艺总方案：依据产品设计要求、生产纲领和生产能力，提出工艺技术准备具体任务和方法指导性文件。3.4 First article (batch) inspection: after the ready condition of trial-manufacture is qualified through check, the first batch of trial-manufactured components 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 equipments can guarantee that the products conforming to design requirements are produced./首件（批）判定：在生产试制准备状态检验合格后，对首批试制生产零、部（组）件按产品图和工艺规程要求进行全方面过程和成品检验，以确定生产工艺和设备能否确保生产出符合设计要求产品。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 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：根据产品设计和开发进度要求，依据用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，确保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 of process design and development and having the process design and development for new product implemented;/技术质量部是企业工艺设计和开发过程归口管理部门；负责企业新产品工艺设计和开发工作组织实施；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 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 development./企业各相关单位负责配合完成工艺设计和开发过程各项工作。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标起源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 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./营销部和用户签署新产品协议或技术协议，或市场需求，经过评审后，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同意后下发到总工程师。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 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，并将和新产品相关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 following contents:/总工程师依据上述项目起源，确定项目责任人，将工艺设计和开发策划输出转化为工艺设计和开发计划书。计划书内容包含：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、确定等各阶段划分和关键工作内容；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、资金确保等及其它相关内容。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 related provisions of Control Procedure for Document./工艺设计和开发策划输出文件伴随设计和开发进展，在合适时给予修改，应实施文件控制程序相关要求。5.1.4 Interface Management between Different Groups of Process Design and Development/工艺设计和开发不一样组别之间接口管理Different groups of process design and development may concern different functions or levels of the company, and the exterior of the company.工艺设计和开发不一样组别可能包含到企业不一样职能或不一样层次，也可能包含到企业外部。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. 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 Technical Quality Department./对于组别之间关键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，由项目责任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，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./营销部负责和用户联络及信息传输。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包含以下内容：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 project recommendation;/产品关键特点、性能要求。这些要求关键来自用户或市场需求和期望，通常应包含在协议、定单或项目提议书中；b) Applicable laws and regulations and mandatory national standards shall be met;/适用法律、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;/以前类似工艺设计和开发提供适用信息；d) Other requirements necessary for process design and development./工艺设计和开发所必需其它要求。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 requirements 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相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、含糊或矛盾要求做出澄清和处理，确保设计开发输入满足任务书要求。5.3 Process Design and Development Output/工艺设计和开发输出0.0.1 The process design and development personnel shall 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依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，并编制对应工艺设计和开发输出文件，即工艺设计和开发输出清单。0.0.2 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 design 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 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形式来表示，方便于证实满足输入要求，为生产运作提供合适信息。工艺设计和开发输出文件因产品不一样而不一样，包含指导生产等活动参数和文件：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。0.0.3 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 complete and correct, the working processes are harmonized and the processing is feasible and checkable./技术质量部指定专员负责校核工艺资料，关键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、加工可行性和可检验性。0.0.4 Full (part) time standardization personnel of Technical Quality Department shall take charge of checking the data on process design and development output for standardization./技术质量部门专（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验。0.0.5 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 until it is approved by Chief Engineer./由项目责任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，总工程师同意输出文件后才能发放。5.4 Review of Process Design and Development/工艺设计和开发评审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 development./在工艺设计和开发合适阶段应系统、综合评审，通常由工艺设计项目责任人提出。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 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、关键件、关键过程（工序）工艺规程和特殊工艺文件评审在首件判定前进行。5.4.2 Review Content/评审内容5.4.2.1 Review of Overall Process Program/工艺总方案评审a) The overall process program shall be reviewed for correctness, advancement, economy and feasibility;/审查工艺总方案正确性、优异性、经济性和可行性；b) 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用户产品设计及生产纲领要求；c) The product process division and route shall be determined reasonably and feasibly;/产品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；e) The bases and rationalities for new process, new technique and new equipment;/新工艺、新技术、新设备采取依据及合理性；f) The requirements for standardization of process technical documents;/工艺技术文件标准化要求；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标准。5.4.2.2 Review of Key Article and Important Article/关键件、关键件评审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、关键件中关键过程(工序)工艺文件控制原因及内容正确性、合理性、可检验性；b) The process capability index of key process (working process) shall be verified;/核实关键过程(工序)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、关键件中关键过程(工序)工艺方法、检测要求合理性和可行性；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;/审查和关键过程(工序)质量特征形成，包含关联工序及检验工序设置正确性、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)技术攻关方法；f) The content of key process (working process) shall be reviewed for completeness./审查关键过程(工序)目录完整性。5.4.3.1 Technical Quality Department shall issue the review content or related data to the reviewing units./技术质量部将评审内容或相关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她指定委托人担任。5.4.4.2 Responsibilities 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;/聚集评审提出问题和提议，写出评语和结论；c) Assign a recorder to sort and work out the process review reports;/指定统计人员整理、写出工艺评审汇报；5.4.4.3 Responsibilities 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./充足发表意见；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统计人员；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 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基础上，明确需要改善项目和改善内容，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./统计人员整理会议统计，填写工艺设计和开发评审汇报。5.4.6 Measure Implementation and Data Perfection/落实方法，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 the process data.技术质量部认真分析评审会议提出问题和改善意见，制订并落实方法，完善工艺资料。5.5 First Article Inspection/首件判定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 p