设计控制程序 (2)

1、1 目的Objective 明确设计输出满足设计输入的要求，确保本公司的设计项目符合顾客要求，使设计过程处于受控状态。Objective is to ensure design output equals design input, to ensure AICQs design projects conform to customers requirements, and ensure design process is in control.2 适用范围Applicable Scope 适用于本公司产品设计/开发的策划、输入、输出、评审、验证及确认。This is applicable to

2、 AICQ product design/development planning, input, output, audit, verification, and confirmation.3 职责Responsibility3.1 总经理负责审批新产品设计/开发立项申请。并任命横向协调项目经理。General Manager responsible for examining and approving design/development application, appointing horizontal coordination Project Manager.3.2技术工程部经理负

3、责执行新产品的设计工作并负责对设计过程进行控制。 Engineering Manager is responsible for implementing new product design and design process control.3.3 设计小组负责 Design Project Team responsible for:a. 制订和确定新产品设计、开发活动进度计划并具体实施。Formulating and determining new product design, development schedule and implementing plan. b. 开发和评审设计

4、失效模式及后果分析。Developing and auditing Design Failure Mode and Effect Analysis (DFMEA).c. 制定措施优先减少风险大的潜在失效模式。Formulating actions to prioritize avoidance of potential failure mode with high risk identified in DFMEA.d. 制订与评审样件控制计划。Formulating and auditing sample part control plan. e. 确定关键特性和特殊特性。Determinin

5、g critical and special characteristics.f. 进行设计验证、设计评审和设计确认。Implementing design verification, design audit and design confirmation.g. 工程图样、工程规范、材料规范。Engineering sample drawing, engineering specifications, and material specifications.4 4 工作程序Work Procedures 4.1当有新产品开发或产品改型任务时，横向协调小组按产品质量先期策划管理程序完成项目前期

6、准备和项目的计划定义工作后，就进入了产品的设计和开发阶段。技术工程部负责产品的设计开发工作。由项目经理任命设计开发小组成员，并任命设计小组组长。也可由项目经理担任设计小组组长。When there are tasks of new product design and product remodeling, the coordination team shall, according to APQP Management Procedure, complete project initial preparations and definition about project plans, th

7、en it comes to stage of product design and development, during which engineering manager is responsible for design and development. Design and development team members and the team leader are appointed by project manager, who can be team leader as well.4.2 新产品的设计与开发一般可分为设计策划阶段、设计开发阶段 、样件试制阶段和设计确认（定型

8、鉴定）阶段。产品的改进设计,视需要对上述阶段和各阶段工作任务进行调整。New product design and development are normally divided into stages of design planning, design development, prototype trial making and design validation( design model validation review). As for product improving design, based on actual needs, adjustments will be ma

9、de to the above-mentioned stages and jobs and tasks.4.3 产品设计和开发的策划 Product design and development planning4.3.1 设计小组组长负责制订产品开发计划，报项目经理批准。产品开发时间应先于顾客提出的时间表，并和该项目的APQP进度计划一致。该计划也可体现在APQP进度计划中。开发计划应包括开发阶段工作任务、责任人员、进度要求等内容。Design team leader is responsible for working out product development plan and su

10、bmitting to project manager for approval. Product development timing should precede the time raised by customers, and accord with the projects APQP Timing. Design plan can be embodied in APQP Timing. Development plan should include tasks, responsible people and timing requirements etc. at the develo

11、pment stage. 4.3.2 在实施中若需要对计划内容进行修改，应由设计小组组长提出申请，按4.3.1规定批准后实施。 If design needs to be changed in the course of execution, design team leader is to raise the application, which will be implemented after being approved of according to regulations in 4.3.1.4.3.3 产品设计和开发活动应由具备实现设计要求资格的人员担任. Product desi

12、gn and development activities are to be in the charge of people who are qualified for realizing design requirements.4.3.4 技术部门在设计过程中适当运用下列适用的技能：During development, Engineering Department may choose following applicable techniques:a. 几何尺寸和公差（GD&T）；Geometric Dimension and Tolerance (GD & T)b. 制造设计（DFM

13、）/装配设计（DFA）；Design for Manufacture (DFM) / Design for Assembly (DFA)c. 价值工程（VE）；Value Engineering (VE)d. 试验设计（DOE）；Design of Experiments (DOE)e. 失效模式及后果分析（DFMEA/PFMEA等）Failure Mode and Effect Analysis (DFMEA/PFMEA，etc.)f. 计算机辅助设计（CAD）/计算辅助工程（CAE）；Computer Aided Design (CAD) / Computer Aided Engineer

14、ing (CAE)4.4 组织和技术接口Organizational & Technical Interfaces4.4.1 设计小组在编制产品开发方案及计划时，应明确规定参与设计各过程的各部门/人员在组织上和和技术上的接口。When formulating product development program and plan, Engineering Design project team shall clearly specify organizational and technical liaison for participating departments and people

15、in design process. 4.4.2 与外单位协作进行设计时，设计项目小组须签订协作合同/协议，明确组织和技术上的接口。并将必要的设计信息形成文件，予以及时传送并定期评审。When cooperating with outside organizations in design, design project team shall sign contract/agreement, specify organizational and technical liaison, and document necessary design information, pass them tim

16、ely and audit regularly. 4.5 设计输入的确定和评审Design Input Validation and Review4.5.1 设计人员负责收集和汇总设计输入文件和资料,并形成设计开发任务书。设计输入资料包括以下内容： Designers are responsible for collecting design input documents and data, and working out design & development task statement. Design input data include the following contents

17、:a) 顾客提供的图纸、技术规范、样件等；Customer-provide drawing, technical specifications, samples etc.b) 设计目标、可靠性和质量目标； Design target, reliability and quality target; c） 初始材料清单 Initial BOM; d） 特殊产品和过程特性的初始清单 Initial list of special product and process characteristics; e） 初始过程流程图 Initial process flow chart;f) 有关法令、法规

18、、行业要求；Relevant laws, rules, regulations and trade requirements;g) 原有类似设计项目中的适用资料。 Applicable data of original similar projects;4.5.2 设计小组组长组织相关人员对设计开发任务书的适宜性进行评审；对不完整的、含糊的、或矛盾的要求，应在设计前与要求的责任单位共同协商解决，其结果记录于设计评审报告中。 Design team leader is to organize relevant people to review the applicability of Desig

19、n &Development Task Statement. As for incomplete, vague or contradictory requirements, the team leader should discuss with required responsible departments to solve them, and keep the result in product design input report.4.6 设计阶段 Design Stage4.6.1 顾客没有书面放弃对使用计算机辅助系统的要求时，公司应配置适当的资源及设施以进行计算机辅助产品设计、分析

20、，并与顾客建立双向接口。如设计工作委外时，工程技术部须提供相应的技术指导。When customers dont raise written statement saying they want to give up using computer-aid system, the company should provide necessary resources and facilities to conduct computer-aid product design and analysis, and establish two-way interface with customers. I

21、f outside organizations are entrusted to design, engineering department must supply relevant technical instructions. 4.6.2 设计组长负责召集相关部门人员成立DFMEA小组，列出DFMEA小组清单，并由项目经理批准。DFMEA小组按照FMEA指导书评审和更新设计失效模式和后果分析。Design team leader is responsible for summoning people from relevant departments to build DFMEA tea

22、m, and work out team member list, of which the project manager must approve. Based on FMEA Guide, DFMEA team is responsible for reviewing and updating design failure mode and result analysis.4.6.3 横向协调小组应使用设计FMEA检查表评审公司制订的DFMEA，顾客提供的DFMEA或设计协作者提供的DFMEA。Coordination team should, according to DFMEA Ch

23、ecklist, review the DFMEA s made by the company, provided the customers and the deign cooperators.4.6.4 依据产品设计开发计划和设计任务书的要求，贯彻简化、优化、创新和减少浪费的原则，并使用试验、生产现场的反馈信息，组织和实施产品设计，形成设计输出文件。Engineering department is to organize and carry our product design and work out output documents according the Product D &

24、 D Plan and requirements of design task statement, implementing the principle of simplification, optimizing, creativeness and decreasing waste and using the feedback from test and production site. 4.6.5 若设计外包，则工程技术部必须将相关的设计输入资料和设计任务书转交给设计外包方。并要求设计外包方进行DFMEA，设计外包方设计完毕后，将相关资料转交工程技术部。由设计组长组织人员进行按4.8进行设

25、计评审。If outside organization is entrusted to design, engineering department must transfer the relating design input data and design task statement to the entrusted contractor, and ask them to work out DFMEA. After the contractor completes the job, they should pass the relevant data to engineering dep

26、artment. The design team leader is responsible for organizing people to conduct design review according to 4.8.4.7 设计输出Design Output 设计输出包括以下资料：Design Output includes the following data:4.7.1 产品图； product drawing4.7.2 根据相关行业标准和设计要求制订产品标准；to work out product standard according to relevant trade stand

27、ard and design requirements;4.7.4 材料标准；material standard4.7.5 材料清单 BOM4.8 设计评审 Design Audit4.7.3 设计试验和验证计划（DVP）；Design teat and validation plan;4.8.1 设计评审应在设计输出文件发放前进行，在重大设计更改时也须进行设计评审。Design audit should be conducted before the design output documents are released. When there are great design chang

28、es, design audit must be made as well.4.8.2 设计评审的内容：Contents of design audit:a) 设计输出是否满足设计输入的要求；whether design output meets the requirements of design input;b) 满足顾客要求的程度及与产品标准的符合性；the degree how it satisfies customers requirements and how it complies with product standard;c) 设计的合理性、工艺性、安全性和可靠性；ratio

29、nality, technics, safety and reliability of design;d) 设计的经济性，包括价格、成本（材料、工时和管理费等项目）；economic effectiveness of design, including price, cost (material, labour time and overheads etc.);e) 新技术、新工艺、新材料、新结构采用的必要性和可能性；necessity and probability of using new technology, new process, new material and new stru

30、cture;f) 产品技术水平与同类产品性能的对比；benchmark in terms of product technology and function;h) 是否符合有关法令、法规、相关标准与惯例；whether it accords with relevant laws, rules, regulations, standard and common practice;i) 产品标准化程度。the degree of how prodcuts are standarized;4.8.2 设计评审的组织Design audit organizing 设计评审由工程技术部经理组织，参加设

31、计评审的成员应由不直接承担设计责任人和参与设计的相关 部门的有丰富实践经验的人员组成，责任人可列席。 Engineering manager is responsible for organizing design audit with involvement of responsible people, who are not directly responsible for design, and experienced people from relevant departments. All responsible persons can participate in it.4.8.4

32、 设计评审报告书 Design Audit Report设计小组组长根据产品设计的评审情况，整理产品的设计评审报告。设计小组依据评审结论，修订完善产品设计输出文件并发放设计输出文件，转入样件试制阶段。Design team leader shall, based on the result of design audit, work out Product Design Audit Report. Design team, according to audit result, revise and improve product design output documents and rele

33、ase them, then it comes to stage of prototype trial making. 4.9 样件制造和设计验证阶段prototype trial making and design validation4.9.1 顾客要求有样件支持时，由横向协调小组负责制订全面的样件控制计划，并尽可能使用与正式生产过程中相同的供应商、工装和工艺过程；When customers need sample support, the coordination team is responsible for formulating comprehensive sample cont

34、rol plan, and try to use the same suppliers, tooling and process as being used in formal production process;4.9.2 采购部门负责完成原材料的采购；Purchase department is responsible for raw material purchase:4.9.3 制造、采购、质量部门相互配合完成新原材料的供货和验收； Manufacture, purchase and quality departments should cooperate in new raw ma

35、terial supply, inspection and acceptance;4.9.4 由制造部组织样件制造；Manufacture department is responsible for arranging prototype manufacturing;4.9.5 由质量部和制造部共同组织样件检验；Manufacture and quality departments jointly arrange prototype inspection and acceptance:4.9.6 设计小组负责按照设计验证计划和产品试验规范进行产品试验验证，并监控所有的试验活动能按试验计划及时完

36、成，外包的试验由工程技术部负责提供技术协调；所有的设计验证试验结果应形成设计验证报告。 Design team is responsible for conducting product test and validation according to Design Validation Plan, and monitoring all test activities to ensure punctually completing based on test plan. For the tests which are entrusted to outside organization, eng

37、ineering department is to offer technical coordination. All test results are to be made in test report.4.10 样件提交Prototype Delivery4.10.1 试用：样件及其相关记录由市场销售部送交顾客，由顾客按照其程序试用。 Try-out: prototype and the relevant records are delivered to customers by sales department, and are used by customers according t

38、heir procedure. 4.10.2 反馈：顾客试用后反馈试用报告。 Feed-back: try-out report will be given back from customers after try-out.4.10.3 评定：横向协调小组对顾客反馈的试用报告进行评审，报告样件对顾客要求的适应程度。 Assessment: coordination team is to assess the try-out report and report how the prototype applies to customers requirements.4.10.4 改进：横向协调小

39、组根据评审意见，给出改进意见。 Improvement: coordination team shall, according the assessment, raise opinions about improvement.4.11 设计确认 Design Confirmation 根据型试试验和道路试验的结果进行设计确认。 Deign confirmation is made according results of model test and road test.4.11.1 确认内容：Contents to be confirmed:a) 产品的技术要求和质量特性是否达到“设计任务书

40、”规定的要求；whether product technical requirements and quality characteristics are up to the requirements stipulated by Design Task Statement;b) 产品图样和技术文件的是否完整；Whether product drawing and technical documents are complete;c) 产品加工及装配工艺是否合理。Whether product processing and process procedure are reasonable.4.1

41、1.2 按照顾客项目时间要求由横向协调项目经理或总经理组织。 According to project timing raised by customers, coordination project manager or General Manager are to make arrangement.4.11.3 确认记录 Record Confirmation4.11.3.1应由项目经理负责将确认意见进行整理，相成设计确认报告，设计确认报告必须包括设计失效； Project manager is responsible for sorting out confirmed opinions.

42、 Confirmation report must include design failure;4.11.3.2项目小组根据纠正和预防措施控制程序对设计失效进行原因分析，制定、实施、验证纠正预防措施。 Project team shall, according to Corrective and Preventive Measures Control Procedure, analyze the reason of design failure, and work out, implement and validate corrective and preventive measures.4

43、.11.3.设计确认文件由工程技术部归档保存。 Engineering department is to file the confirmed design documents;4.11.4 依据确认结论，由项目小组视情况选择以下处理方式之一后执行。 According to confirmed conclusion, project team shall, based on actual situation,choose one the following ways and then carry it out.4.11.4.1完成产品开发，转入并实施产品质量先期策划控制程序下一阶段工作。 C

44、omplete product development, and come to the next step of implementing APQP Control Procedure.4.11.4.2重新组织产品开发过程，按照结论进行相应设计工作。 Rearrange product development process, and conduct relevant design according the conclusion.4.12 设计更改管理 Design change management4.12.1 设计更改理由：Reasons for design change:a) 设计

45、缺陷影响产品功能或互换性；Design failure affects product function or exchangeability;b) 标准或规范的变更；Standard or specifications change;c) 设计评审、设计验证和设计确认发现的不符合项；Nonconformities found in design audit, design validation and design confirmation;d) 顾客或供方要求更改；Customer or suppliers change their requirements; e) 产品特性提高；Prod

46、uct characteristics are improved; f) 其他原因。Other reasons4.12.2 设计更改由设计人员填写产品更改单，申请单中须注明对顾客装配过程及顾客使用的影响，经工程技术部经理审核、总经理批准后实施。设计更改如果是重大变更，还需进行设计评审和试验验证。 For design change, engineer shall fill in Product Change Form, on which effects resulted to customers in the course of assembly and use should be clear

47、ly stated. With engineering managers review and General Managers approval, design change can be put into practice. If the design change is great, it is essential to make design review and test to validate it.4.12.3 顾客没有放弃批准设计更改时，设计更改（包括由分承包方提出的更改），在生产实施之前必须由工程技术部报顾客进行书面批准。 When customers dont give up approving of design change, the design change (including the changes raised by suppliers) must be passed to customers by engineering department for written approval before it is applied in production.4.12.4 对有专有权的设计更改，设计小组组长必须与顾客共同确