产品设计和开发控制程序

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1、文件名称:产品设计和开发控制程序文 件 编 号02-03版本号/修订号2/ 0页 码1 / 51 目的： Purpose规范对各种产品的设计、开发、试制、试验、验证、鉴定、确认、取得专业合格证等过程的控制；实现生产的所有技术准备充分有效，以确保制造的产品能满足顾客的要求。Standardize the control for processes of design, development, trial produce, testing, verification, identification, validation and obtaining professional certificat

2、e. Adequacy and effective technical preparation for production realization, to ensure the compliance to customer requirements.2 适用范围： Applicable scope本程序所指的产品，主要是新产品，即：产品在工作机理、原材料、结构、特性及应用领域等有一个或多个方面的实质性改变的；在尺寸或参数上有显著变更或扩展的、工艺过程有较大变化的产品。重要顾客要求的产品以及公司认定的重要产品可比照为新产品。非新产品从简参照执行。The products mentioned h

3、ere are mainly new products, that is, theres substantial transformation on one or more aspects; obvious alteration or expanding on dimensions or parameters, great change on technological process. Products ordered by important customer and the important products identified by company could be treated

4、 as new products. Those not belonging to new products should implement by short.3 职责：Responsibility31 总经理最终负责批准产品任务的承接。General Manager is in charge of the final approving of product.32 技术副总经理或总经理授权的负责人全面负责产品合同性评审，批准和组织设计与开发的控制。Deputy General Manager of technology or authorizer by General Manager sho

5、uld comprehensively take charge of contract review, control of approving and organization for design and development.33 市场部负责新产品开发前与顾客的沟通，保证顾客要求的充分性、有效性。在取得顾客要求的文件（如技术规范书等）或图样后做出任务提交。Marketing Department is in charge of the communication with the customer before new product development, to ensure th

6、e adequacy and effectiveness of customer requirements. Submit the mission after obtaining the document (like technical specification) or drawing required by customer.34 技术部负责产品设计与开发的策划；进行从设计输入及评审到产品确认的设计开发全过程的实施和控制；负责全过程的对顾客的技术跟踪。Technical Department is in charge of the planning of product design an

7、d development, implement and control the whole process from design input and review to product validation, in charge of the technological trace for whole process.35 质控部负责过程的控制，对完工产品的负责试验、验证，记录并出具报告；负责委托型式试验及获取专业合格证工作。Quality Department is in charge of the process control, for finished products, it i

8、s responsible for inspection, validation, recording and issuing report, as well as authorize type test and obtain professional certificate.36 生产部负责试制及试生产的生产技术准备和组织实施。Manufacturing Department is in charge of the technical preparation of trail production and pilot manufacturing, also the organization

9、and implementation.37 采购部门负责产品制造中所有合格供方可提供材料的采购。Purchasing Department is in charge of the purchasing of available materials from all qualified suppliers.38 车间负责新产品试制以及实施产品生产过程控制Workshop is in charge of the control for trail production of new product and production process.4程序：Procedure41 产品开发中与产品有关要

10、求评审的控制The control related to product and required for review in product development产品开发中与产品有关要求评审按销售管理制度4.2.1、42.2执行。.Implement as clauses 4.2.1 and 4.2.2 of Sales Management Institution.411 市场部门及技术部门与顾客沟通要考虑产品技术要求、工况要求、参数规范、标准、交货期、交付要求、数量、价格、付款方式、标志、包装等方面要素，保证沟通尽可能充分、有效。For the communication with c

11、ustomer, Management Department and Technical Department should consider technical requirements, conditions requirements, specification, standard, delivery time, delivery requirements, quantity, price, payment term, mark, packaging, to ensure the adequacy and effective communication.412 市场部门在初步确认了顾客要

12、求的文件、图样或样品后，填写“合同要求评审单”，随顾客文件一并提交给技术部门。After Marketing Department primarily confirms the document, drawing and sample required by customer, fill in Review Form for Contract Requirements, submit to Technical Department with customer documents together.编制2009/12/28文件名称:产品设计和开发控制程序文件编号-02-03版本号/修订号2 /

13、0页 码2 / 5413 技术部门在接到市场部提交的文件后，组织实施对与产品有关要求中的技术要求、参数规范、外观要求、交货期、法律法规要求等的可满足性评审。并填写“合同评审单”。如通过评审，则正式确定合同。“合同评审单”由总经理批准。批准后确认为新产品，则市场部门正式下达“新产品设计开发任务单”或“生产通知单”，与顾客文件一起下达到给技术部门。进入设计开发阶段。After Technical Department receives the documents from Marketing Department, organize to conduct the compliance review

14、 for product related requirements like technical requirements, parameters, appearance requirements, delivery, statutory and regulatory requirements. If pass the review, officially confirm it as a contract. Contract Review Form is approved by General Manager, after being approved, it could be confirm

15、ed as a new product, Marketing Department formally issue the Design and Development Mission Form of New Product or Production Notification, distribute to Technical Department with customer documents together. It goes into design and development stage.414 生产部门组织对合同产品生产线及设备工程能力、生产能力、以确保交货期完成的保证性评审，其中采

16、购人员组织采购材料，零部件可能性和进度保证性评审，并填写“合同评审单”。Manufacturing Department organizes to review production line of contract products, equipment engineering capacity, production capacity to make sure the delivery term. Purchasing Department organizes to review purchasing materials, parts and progress insurance, and

17、 fill in Contract Review Form.42 产品设计控制 Control of product design 421 设计的策划和输入的控制 Control of design planning and input4211 技术部门或项目负责人负责设计的策划和输入评审。主要对顾客图样及产品的技术参数、技术要求可实现性、可满足性和完整性、准确性给予确认。设计输入评审按表记录签字。同时，根据任务性质策划：分解设计和开发的阶段，确定工作内容、进度要求、规定项目人员和责任，编制“产品设计与开发策划及分解任务进度表”。Technical Department or project

18、manager is in charge of the review for design planning and input. Mainly confirm the realization ability, compliance and completeness, correctness for customer drawing, parameters and technical requirements of product. Design input review should sign for records according to the form. Meanwhile, pla

19、n as the property of missions, break down design and development stages, determine the working content, progress requirements, define project members and responsibility, formulate Planning and Decomposition Mission Progress Form of Product Design and Development.4212 顾客产品的技术参数、技术要求，不被确认时认应由技术部门指定的产品

20、项目负责人与顾客进一步沟通。如取得充分且必要的设计输入后，再予以确认。Before the confirmation of technical parameters, technical requirements of customer product, the project manager appointed by Technical Department should communicate with customer further. Confirm after obtaining adequacy and necessary design input.4213产品总体设计方案图原则上

21、应送顾客确认。Overall design layout of product should be submitted to customer for confirmation in principal.422 设计输出的控制 Control of design output4221 符合4.2.1.1、4.2.1.3条的被确认的图样、技术参数和技术要求由项目负责人进行工程设计和产品图样设计，形成设计输出，用于过程开发的输入。The drawing, technical parameters and technical requirements complying with 4.2.1.1,

22、4.2.1.3 should be used for engineering design and product design, and form the design output for the input of process development.4222 设计输出文件主要是产品图样（含零件图）、工程设计计算书、安装使用说明书、原材料及外购、外协件清单、产品图样技术文件清单等。根据顾客要求可输出其它设计文件。Design output documents mainly include product drawing (part drawing), calculation sheet

23、 of engineering design, installation operation instruction, list of raw materials, outsourcing parts, list of product drawing technical document. Output other design document as customer requirements. 4223 设计输出必须进行设计输出评审与验证控制 Design output must conduct design output review and verification controla.

24、 通常产品设计输出评审，按图样或文件的设计绘图校对工艺标准化审核批准过程进行并责任签字，在适用时作出记录。其中设计、审核、批准为必要过程。Design output review for normal products should conduct as the following process, design as drawing or document-drawing-check-technology-standardization-review-approve, relevant responsible personnel should sign, and record when ap

25、plicable. Design, review and approving are necessary processes.“设计”：签字者为工程设计计算的设计人员，一般为项目负责人。签字者应确定产品主导结构、参数、尺寸、技术要求及其它标注，对设计规范、图样工程标准等的符合性、完整性、正确性负责。 Design: the person to sign should be the designer of engineering, normally its project manager. The signer should determine the product main structur

26、e, parameters, dimensions, technical requirements and other marks, be responsible for the conformity, completeness and correctness of design specification and drawing engineering standard.“绘图”签字者为通过AUTO或其它手段，将工程设计变为图样文件的设计人员。签字者应对图样反映的产品结构、尺寸、技术要求、其它标注等对工程设计、图样规范标准的符合性、完整性、正确性负责。“绘图”可以和“设计”为一人。 Sign

27、er of drawing is the designer that transfer engineering design to drawing document by AUTO CAD or other means. Signer should be responsible for the compliance, completeness and correctness of product structure, dimensions, technical requirements and other remarks to engineering design and drawing sp

28、ecification standard. Drawing and design could be completed by one person.编制日期2009/12/28文件名称:产品设计和开发控制程序文件编号版本号/修订号2 /0页 码3 / 5“工艺”：签字者为主管本项目产品过程开发人员。其签字对产品工艺可行性、可保证性负责。Technology: signer should be the product process development person who take charge of this project. Sign means that he is responsi

29、ble for feasibility and assurance of product technology.“校对”：签字者为产品设计资格人员，其签字与绘图签字者共用承担“绘图”款中规定的责任。在某些情况下，“校对”与“审核”合二为一是允许的。Check: signer should be qualified person for product design, he should be responsible for the duties regulated in drawing with signer of drawing together. In some conditions, i

30、ts permitted that check and review are the same.“标准化”：签字者为（专）、兼职标准化人员，其签字应对图样工程标准、标注标准化、材料、标准件标注引用，技术条件标准引用等的正确性负责。“标准化”允许与“校对”为一人。Standardization: signer should be (full-time) part-time standardization person, he should be responsible for the correctness of drawing engineering stand, standardizatio

31、n of remarks, materials, remark quote of standard parts, quote of technical requirements standard. Standardization and check are permitted to be the same.“审核”：签字者为技术指定人员。其签字应对图样或技术文件的图面表达、标准化、工艺、规范应用等方面的设计的符合性、图面完整性、正确性、工艺可实现性负责。Review: signer should be someone appointed by Technical Department. He

32、should be responsible for the compliance of expression of drawing or technical documents, standardization, technology, specification application design, completeness, correctness of drawing, realization possibility of technology.“批准”：签字者为公司级技术负责人，应对图样及技术文件的可公布性、实施合法性负责。“批准”后图样或技术文件方可发放、执行。Approve: s

33、igner should be manager of Technical Department, should be responsible for the publish possibility of drawing and technical documents, legality of implementation. After approve, drawing and technical documents could be released and implemented.b. 对特殊的、结构复杂的、技术难度较大的、在全新领域应用的新产品的设计输出，可由公司技术负责人如召集有关人员共

34、同评审，做出“设计输出评审书”。For the design output of new products with special, complicated structure, difficult technology and applied in new field, manager of Technical Department could call for relevant persons to review, complete Review Form of Design Output.4224 须经顾客确认的产品图样（总图），应于“审核”后，“批准”前提交顾客确认。顾客确认须是书面

35、文件或在被确认图样上签署书面文字确认，并返还。确认文件或被直接确认图样均应按外来技术文件规范管理。The product drawing (overall drawing) needed to be conformed by customer should be submitted to customer after review and before approve. Customer conformation should be written document or sign in the drawing been confirmed, and return to the company

36、. Confirmation document or the drawing been confirmed directly by signing should all be managed by technical document specification.4225 顾客未确认的图样，结合顾客修正意见，按4.2.1、4.2.2条款规定重新进行设计。以最终获得顾客确认。If customer doesnt confirm the drawing, combine amendment suggestions of customer, redesign as clauses 4.2.1 and

37、 4.2.2, to get the customer confirmation finally.4226 产品图样及技术文件必须得到批准，批准后图样和技术文件按规定发放范围发放和保存，并严格执行受控技术文件签收手续，签收的图样和文件由签收人负责控制。Product drawing and technical document have to be approved, after being approved, distribute and store as the regulated release scope of drawing and technical documents, stri

38、ctly implement the signing process of controlled technical documents, signer is responsible for the control of drawing and technical documents he signed and received.43 产品过程开发与制造的控制 Control of product process development and manufacturing431 产品过程开发控制 Control of product process development4311 产品过程开发

39、控制由技术部门负责。Technical Department is in charge of the control of product process development.4312 在产品设计完成后，由项目负责人将新产品图样和技术文件发给项目产品过程开发人员，实施了任务分解下达。After finishing the product design, project manager is responsible for the issuing of new product drawing and technical documents to product process develop

40、ment engineer.4313 过程开发人员接收任务后进行过程设计编制，输出产品加工（组装）工艺文件并验证评审责任签字。规定其过程顺序、工序内容、工艺参数、技术要求、检验规范、设备及工装要求。Process development engineer conducts the product design formulation after receiving the mission, output production technological documents, verify and sign. Define its process sequence, procedure cont

41、ent, technical parameters, technical requirements, inspection specification, equipment and fabrication requirements.4314 过程开发人员依据“工装要求”，编制工装清单。由项目负责人向工装设计人员或采购部门下达工装设计或采购任务。Process development engineer formulate the fabrication list according to fabrication requirements. Project manager issue the fa

42、brication design or purchasing mission to fabrication designer or purchasing department.431 工装设计人员接受工装设计任务后，在充分理解产品要求和工序过程要求后设计工装图样。工装图样按设计校对审核批准过程验证评审责任签字。正式形成有效的，可发放的工装图样。签字责任类同于4.2.2.3 a) 条款规范，工装图样发放给工装制造班和质控部Fabrication designer receives the design mission, design fabrication drawing after thoro

43、ughly understand product requirements and process requirements. Fabrication drawing should be reviewed and signed according the sequence design-check-review-approve. Formally create the effective and issuable fabrication drawing. Sign responsibility is the same as specification in clause 4.2.2.3 a),

44、 the fabrication drawing should be issued to fabrication workshop and Quality Control Department.文件名称:产品设计和开发控制程序文件编号-02-03版本号/修订号2 / 0页 码4 / 54316 过程开发人员和工装设计人员输出的首轮工艺文件，应加盖“试制”章。过程中应如实记录各工序实际过程及试制工装的全部更改内容。也允许在“试制”工艺卡上以档案书写笔划改并标识记录。Process development engineer and designer output the initial workm

45、anship documents and shall put stamp TRIAL. It shall record the practical fabrication process and any changed content. Also it is allowed to use pen to do mark or record in the workmanship card.4317 在产品全部过程结束后，由过程开发人员和工装人员，对“试制”工艺卡片、“试制”工装图样，按更改记录内容进行修改并反馈到设计负责人员处对产品图样修改。修改后进行编制（设计）校对（工艺）审核批准过程的责任签字

46、评审。形成下一轮生产用产品图样和工艺文件。签字责任类同于4.2.2.3 a) 条款规范。After the product completion, process development engineer and designer shall according to any changed content, make revision and put into drawing feedback. Then follow the procedure: edition to review to approve to approve. Signature responsibility is sim

47、ilar with Clause 4.2/4.3432 产品过程控制 Product process control4321 原材料、外购件、外协件采购、进货应按采购技术要求并执行进货检验、验收。按采购控制程序和物资库存管理制度控制。According to technical requirement inspection and test shall be done to raw materials, outsourcing components and other products based on purchase control procedure and warehousing re

48、gulations.4322 各工序按“工艺卡片”及过程控制文件内容控制，检查控制责任人为操作者及专职检验员。重要工序的首件要得到质控部门确认。Each procedure is according to Workmanship Card and other control documents. The responsible persons shall be operator and inspectors. Important procedure shall be confirmed by QC department.4323 产品设计与开发的验证：样品完成后的全项目检验和性能试验（型式试验

49、）由质控部门负责并出具报告以对产品满足规定要求进行验证。报告一式二份，一份提交、一份自存。Product design and development prove: after product completion and property test, QC department shall issue report to satisfy regulations. The report is in duplicate, one for submit and the other is for keeping in record.4324 产品全项目检验规范按产品相关标准执行。All items

50、of inspection shall be carried out according to relevant regulations.4325 产品过程控制细则按“生产作业过程管理办法”。Product control rules are referred by Production Process Management Measures.4326 产品专业合格证由技术部负责联络、送样、直至取证。Product qualificate is coordinated by technical department until the certificate is issued.433 产品的

51、验证和确认 Verification and validation of product4331新产品的确认必要时通过厂内验证和鉴定确认。厂内鉴定由技术负责人召集专题（鉴定）会议进行。一般由技术部负责人、设计和开发人员、检验人员、市场部人员参加。一般产品，质控部验证合格后即对产品初步确认，可出厂交付顾客。New product confirmation if necessary shall be confirmed at factory. Responsible persons call meetings. Normally design and development engineers,

52、inspectors and marketing persons all participate. In general once the product is qualified, the new product shall be delivered to customer.4332 厂内鉴定材料包括：试制产品、顾客提供的产品（如有）、产品图样、试制用工艺卡片、文件更改记录、产品验证的检验报告和试验报告，必要时还需要有试制总结。Appraise documents include test products, drawings, workmanship card, document chan

53、ge records and inspection reports, if necessary and trial summary documents.4333 厂内鉴定的目的：一是对新产品符合性质量进行工厂确认，二是对图样、文件的有效性确认；三是对产品能够满足规定的使用要求或预期用途及水平评价。厂内鉴定时由技术负责人指定人员完成“新产品工厂鉴定报告”，并进行责任签字。Appraise purpose : 1) new product quality confirmation; 2) effective confirmation of drawings and documents; 3) us

54、age requirement or expected application which can meet requirements. When do factory appraise, persons appointed by technical department will finish New Product Factory Appraise Report and do signature. 文件名称:产品设计和开发控制程序文件编号版本号/修订号2 / 0页 码5 / 54334 通过厂内鉴定的新品，即被初步确认。可以销售并跟踪。小型产品有条件的，可保留一件同批、同条件加工品，作为样

55、品保存，由技术部标识、防护和管理。To new products which pass factory appraise, once they are confirmed, products can be sole and traced. If it is allowed, factory can save some samples for keeping record and management.4335 顾客接到新品后，技术和市场部门应注意跟踪并要求顾客书面确认。书面确认文件收到或产品交付长期无不良反馈后，新产品可正式工厂确认，由技术副总经理批准。则新产品开发终结。After the c

56、ustomer receive new products, technical and marketing departments shall follow and keep eyes and require customer written confirmation. If there is not bad feedback, new product can be confirmed by factory formally. After the approval of chief director, new product research job can be completed.44产品

57、开发文件控制 Control of product development document441 试样产品图样及工艺文件下发时，必须标识“试制”；正式生产产品图样及工艺文件必须标识“生产”；临时性产品图样及工艺文件必须标识“临时”。三者均为受控文件。After the issue of sample drawings and workmanship documents, it must mark TRIAL. When in forma production, all technical and workmanship documents shall be marked PRODUCTION

58、. Temporary drawings and documents shall be marked as TEMPORARY. All of them shall be controlled.442 首轮工艺卡片和首轮工艺图样在试制过程中允许由过程开发人员按实际情况直接划改，但必须有划改标志和人员签字。标志以字母或数字序号为好。Initial workmanship card and drawings shall allow engineers to change when in practical situation and mark by letter.443 产品开发的产品图样、工艺文

59、件、工装图样及其它技术文件皆受控文件。其发放、修改、保存、回收、作废、作废保留、销毁按文件控制程序进行。Product drawings, workmanship documents and other technical documents shall be controlled. Handout, revision, save, recycling and damaged shall be carried according to relevant regulation.45 产品开发的反馈和纠正Feedback and correction of product development过

60、程开发（含检验、试验）和确认中发现的各类技术问题，以及顾客确认中指出的不符合项，均应确保反馈和有效交流，由相关人员评审，提出纠正措施。由技术部门负责人监督实施。During the research process, all the technical and other problems shall be settled under the supervision of technical department.5.相关文件 Relevant documents文件控制程序 document control procedure G-02-016.相关记录: Relevant records图

61、样与技术文件发放/回收登记表 drawing and technical documents handout/ registration form retrieve -04-03-01图样与技术文件更改申请及通知单 drawing and technical documents revision application and inform letter 03-02图样与技术文件作废/销毁登记表 drawing and technical documents destroy/destroy registration form table ZG-04-03-03外来文件登记表 external

62、document registration table G-04-03-04新产品设计开发任务单 new product design and research development task ZG-04-03-05产品设计与开发策划及分解任务进度表 product design and research task scheme table ZG-04-03-06产品设计输入评审表 Product design input assessment table ZG-04-03-07新产品设计输出评审书 New product output assessment table G-04-03-08产品图样及技术文件清单 product drawing and technical document list D-04-03-09产品过程用工艺装备需求清单 equipment need list 04-03-10产品原材料/外购件清单 raw materials/outsourcing equipments list D-04-03-11新产品工厂鉴定报告 New product factory appraise reprot G-04-03-12