1、VDA6.3过程审核,Questions/Requirements/Explanations Part A: Product Development Process Product/process design in the product development process is orientated to the four phases of the planning cycle of product quality (planning, realizing, analyzing, improving). Interdisciplinary cooperation and consis
2、tent action at all phases of product development are the precondition for the realization of all requirements for the series start of a product.At the start of the product development process, all customer requirements, market trends, standards and legislation must be known and, under consideration
3、of changes during the product development period, consistently included in the main and supporting processes. Within the framework of reviews, the compliance and maintenance of established processes and targets are to be monitored at set regular intervals. Nonconformities and required changes often
4、also result in changed targets.The correct and consistent use of risk analyses and evaluation methods in the product development process gives timely knowledge of nonconformities and necessary corrective actions. They represent an essential factor in cost optimization and limitation. All employees i
5、nvolved in the project are subject to high qualification and performance requirements. Their consistent performance at all phases of the product development is the precondition for fulfilling all customer requirements and for a high quality niveau at series start.,提问/要求/说明 A部分: 产品诞生过程 在产品诞生过程中的产品开发/
6、过程开发按产品质量策划环的四个步骤（策划、落实、分析、改进）进行。在产品诞生的各个阶段中有关各部门之间的合作和始终如一的工作态度是落实产品批量投产所有要求的必要前提。 在产品诞生过程初期，必须了解所有的顾客要求、市场发展趋势、标准和法规，并且要考虑其在产品诞生过程中所发生的变化，保证这些内容能持续转化到主过程和辅助过程中去。 以设计评审方式，按规定的时间间隔来跟踪已确定的过程阶段与已定目标的落实。偏差和更改需求往往也会造成目标的改变。 在产品诞生过程中坚持并正确地应用风险分析方法和数值评价方法可及时识别偏差和采取必要的纠正措施，这是成本优化和控制成本极限的重要因素。 所有参与开发项目的员工要具
7、备良好的业务素质和办事能力，他们在产品诞生过程的所有阶段始终如一的工作态度是满足顾客所有要求和以高质量水准进行批量生产的先决条件。,Product Development (Design) Element 1:Product Development Planning The internal planning objectives of a new product, based on the customer requirements and legislation to be considered, must already be raised at the quotation phase,
8、 which are then to be put into precise terms and included in a product development plan, after receipt of contract. All necessary tasks with achievable goals and deadlines must be named in the product development plan.The requirements on the product are often higher than the customer requirements an
9、d must be analyzed and specified in detail by the supplier. Through continual reexamination of all requirements, changes can become necessary during course of the planning phase. Questions 1.1:Are the customer requirements available? 1.2:Is a product development plan available and are thetargets mai
10、ntained? 1.3:Are the resources for the realization of the productdevelopment planned? 1.4:Have the product requirements been determined andconsidered? 1.5:Has the feasibility been determined based on theavailable requirements? 1.6:Are the necessary personnel and technical conditionsfor the project p
11、rocess planned/available?,产品开发（设计） 要素产品开发计划 在报价阶段，就必须根据顾客要求和法规制定企业内部的新产品策划纲要。在接受委托后将策划纲要具体化，并制订出产品开发计划。 在产品开发计划中必须阐明所有要求的任务，可达到的目标值与时间表。 产品要求通常高于顾客要求，必须由供方仔细地分析并转化为详细的技术要求。对所有的要求不断地重新观察，可能还需在策划过程中进行必要的更改。提问： 1.1、是否已具有顾客对产品的要求？ 1.2、是否具有产品开发计划，并遵守目标值？ 1.3、是否策划了落实产品开发的资源？ 1.4、是否了解并考虑到了对产品的要求？ 1.5、是否调查了
12、以现有要求为依据的开发可行性？ 1.6、是否已计划/已具备项目开展所需的人员与技术的必备条件；,1.1：Are the customer requirements available?Requirements/Explanations:All customer requirements for the product to be developed must be known and included in the development.The following points, for example, are to be considered: -Drawings, standards,
13、 specifications, performance specification -Logistic concepts -Technical specifications, test specifications -Quality agreements, target agreements -Important product/process characteristics -Purchase order documents with parts lists and delivery dates -Legislation/Directives -Waste management plans
14、, environmental aspects. 1.2：Is a product development plan available and are the targets maintained?Requirements/ExplanationsThe product development plan is an integral part of the project plan and stands in correlation with the process development plan. All activities, including those for suppliers
15、, are to be established until start of series. The targets must be derived from the requirements and maintained at the established project phases.The following points, for example, are to be considered: -Customer requirements -Costs -Deadlines: Planning/Purchasing release, modification stoppages -Pr
16、ototype/Pilot production, start of serial production -Resources studies -Setting and monitoring the target -Regular information to the company management -Simultaneous Engineering Teams (SET).,1.1、是否已具有顾客对产品的要求？ 要求/说明 对需要开发的产品必须了解其所有的顾客要求，并使其转化到开发工作中去。 需考虑要点，例如： 图纸、标准，规范，产品建议书 物流运输方案 技术供货条件（TL），检验规范
17、； 质量协议，目标协议； 重要的产品特性/过程特性； 订货文件（包括零件清单和进度表） 法规/规定 用后鼾计划，环保要求。 1.2、是否具有产品开发计划，并遵守目标值？ 要求/说明 产品开发计划是项目计划的一部分，并与过程开发计划相互关联。必须明确规定直至批量投产前的所有活动包括与供方有关的活动必须从要求条件中得出目标值，并在规定的项目阶段遵守这一目标值。 需考虑要点，例如： 顾客要求 成本 进度表：策划认可/采购认可，更改停止，样件（样车）/试生产，批量生产起始 资源调查 目标值确定与监控 定期向企业领导汇报 同步工程小组（SET）。,1.3：Are the resources for th
18、e realization of the product development planned? Requirements/Explanations: The resources required are already to be determined and considered in the quotation phase. After award of contract, the details are to be precisely stated. When requirements are altered, an update of the resources study is
19、to be carried out, if necessary. The required means to be planned and made available. The following points, for example, are to be considered: -Customer requirements -Qualified personnel -Lost time through absenteeism -Through put/Processing times -Buildings, premises (for trial/prototype constructi
20、on) -Tools/Equipment -Test/Inspection/Laboratory equipment -CAD, CAM, CAE. 1.4：Have the product requirements been determined and considered? Requirements/Explanations: The requirements on the product are to be determined, through interdisciplinary cooperation/benchmarking, for which QFD and DOE are
21、exemplary methods. Previous experiences and future expectations must be included in the consideration. The product requirements must meet the market requirements and customer expectations, the product must be competitive.,1.3、是否策划了落实产品开发的资源？ 要求/说明 所要求的资源必须在报价阶段已调查并考虑到了。在正式委托后，这些数据必须精确化。在要求有更改时，如有必要必
22、须重新进行资源调查。必须策划并配齐必备的资源。 需考虑要点，例如： 顾客要求 具有素质的人员 缺勤时间 全过程时间 房屋，场地（用于试制及开发样件的制造） 模具/设备 试验/检验/实验室装置 CAD，CAM，CAE 1.4、是否了解并考虑到了对产品的要求？ 要求/说明 通过跨部门合作行业水准比较（Benchmarking)来了解产品的要求，可使用例如：QFD（质量功能展开）、DOE（实验设计）等方法。既往的经验与未来的期望必须予以考虑。对产品的要求必须与市场要求和顾客期望相适应，产品必须具有竞争力。,The following points, for example, are to be co
23、nsidered: -Customer requirements -Company objectives -Simultaneous Engineering -Robust design/safe process -Regular customer/supplier meetings -Important characteristics, legislation requirements -Functional measurements -Fitting measurements -Material. 1.5:Has the feasibility been determined based
24、on the available requirements? Requirements/Explanations The known requirements must be checked for feasibility through interdisciplinary cooperation, here the customer requirements have special significance. Requirements to the following points, for example, are to be considered: -Design/Engineerin
25、g -Quality -Process equipment, resources -Special characteristics -Company objectives -Directives, standards, legislation -Environmental aspects -Delivery dates/Time frames -Cost frame.,需考虑要点，例如： 顾客要求 企业目标 同步工程 坚固的设计/受控的过程 定期的顾客/供方会谈 重要特性，法规要求 功能尺寸 装车尺寸 材料 1.5、是否调查了以现有要求为依据的开发可行性？ 要求/说明 对书籍要求必须通过跨部门
26、合作来检查其开发的可行性，顾客要求在此具有重要意义。 需考虑要点，例如： 设计 质量 生产设备，资源 特殊特性 企业目标 规定，标准，法规 环境随能力 进度表时间框架 成本框架。,1.6:Are the necessary personnel and technical conditions for the project process planned/available? Requirements/Explanations: The required personnel qualifications and means are to be determined prior to the s
27、tart of the project and to be included in the project plan. The following points, for example, are to be considered: -Project management, project planning team/responsibilities -Qualified personnel -Communication means (Electronic data transfer) -Information flow from and to the customer during plan
28、ning (regular meetings, conferences) -Tools/equipment -Test/inspection/laboratory equipment -CAD, CAM, CAE.,1.6、是否已计划/已具备项目开展所需的人员与技术的必备条件； 要求/说明 对人员素质与必备资源的要求必须在项目开始前进行调查，并在项目计划中说明。 需考虑要点，例如： 项目领导、项目策划小组/职责 具有素质的人员 通讯方式（数据远程传送） 在策划期间来自/发向顾客的信息（定期碰头，会议） 模具/设备 试验/检验/实验室装置 CAD，CAM，CAE,Product Developm
29、ent (Design) Element 2:Realizing Product Development In the realization phase of product development, all defined task of the product plan are to be carried out, possible amendments are to be recognized and considered. The project manager /project management have the decisive task of involving all i
30、nterfacing areas early in all exercises and of informing the company management and if necessary, also the customer, of any problems which arise. During the realization, reviews are to be carried out at set regular intervals. When targets are not achieved, corrective actions are to be established, i
31、mplemented and monitored for their effectiveness. Questions 2.1:Is the design FMEA raised and are improvement measures established? 2.2:Is the design FMEA updated in the project process and are the established measures realized? 2.3: Is a quality plan prepared? 2.4:Are the required releases/qualific
32、ation records available at the respective times? 2.5:Are the required resources available?,产品开发（设计） 要素 2：产品开发的落实 在产品开发的落实阶段，必须实施产品策划时确定的各项任务，必须识别和考虑到可能出现的更改。项目负责人/项目领导承担着一项重要任务，就是及早地把各工作接口与各项任务有机地联系起来，出现的问题必须尽快向管理者汇报，必要时也要向顾客汇报。 在落实过程中，每相隔一段规定时间必须进行设计评审。如果不能达到预定目标，则应确定纠正措施，付之落实并监控其有效性。提问： 2.1、是否已进行了
33、设计D-FMEA，并确定了改进措施 2.2、设计D-FMEA是否在项目过程中补充更新？已确定的措施是否已落实？ 2.3、是否制订了质量计划？ 2.4、是否已获得各阶段所要求的认可/合格证明？ 2.5、是否已具备所要求的产品开发能力？,2.1:Is the design FMEA raised and are improvement measures established? Requirements/Explanations: The product risks are to be pointed out and continually reduced with appropriate mea
34、sures, through interdisciplinary cooperation, also with the customer and suppliers. For complex parts or complete function systems, the use of a system FMEA is sensible (see VDA Volume 4, Part 1 and 2). Other comparable analysis techniques are to be agreed with the customer. The following points, fo
35、r example, are to be considered: -Customer requirements/performance specifications -Function, safety, reliability, maintainability, important characteristics -Environmental aspects -Involvement of all affected areas -Trial and test results -Product-specific measures from the process FMEA. 2.2:Is the
36、 design FMEA updated in the project process and are the established measures realized? Requirements/Explanations: Amendments to the product and process must be evaluated by the project management. In agreement with the FMEA Team, a new analysis, if necessary, is to be initiated. An update is also ne
37、cessary after realization of measures (Design Review).The following points, for example, are to be considered: -Customer requirements -Important parameters/characteristics, legal requirements -Function, fitting measurements -Material -Environmental aspects -Transport (internal/external) -Product-spe
38、cific measure from the process FMEA.,2.1、是否已进行了设计D-FMEA，并确定了改进措施？ 要求/说明 通过跨部门的合作及与顾客和供方的合作必须清楚地了解产品风险，并用合适的措施不断降低产品风险。对于复杂零部件或整套功能系统，使用系统S-FMEA（见VDA4.1，VDA4.2）很有意义。要使用其他类似的分析技术，可与顾客商定。 需考虑要点，例如： 顾客要求/产品建议书 功能，安全性，可靠性，易维修性，重要特性 环保要求 各有关部门的参与 试验结果 通过过程P-FMEA确定的针对产品特定的措施。 2.2、设计D-FMEA是否在项目过程中补充更新？已确定的措
39、施是否已落实？ 要求/说明 对产品的过程的更改必须由项目负责人进行评定，在与FMEA小组商讨后，必要时必须进行新的分析。在措施落实后也要对设计D-FMEA补充更新（设计评审），使其符合现状。 需考虑要点，例如： 顾客要求 重要参数/重要特性，法规要求 功能，装配尺寸 材料 环保要求 运输（内部/外部） 通过过程P-FMEA确定的针对产品特定的措施。,2.3:Is a quality plan prepared? Requirements/Explanations: The quality plan must contain components, subassemblies, assembli
40、es, parts and materials, including the production process from prototype and pilot production phase, which belong to the product. The quality plan is a living document and must be raised/updated for new/amended products. A quality plan (according to DIN EN ISO 8402/3.13) is generally to be raised fo
41、r the following phases: a) Prototype phase A description of the dimensional, as well as material and functional inspections, which are to be carried out during the construction of the prototype (if required by the customer).b) Pilot production phase/Interface to process development A description of
42、the dimensional, as well as material and functional inspections, which are to be carried out after construction of the prototype and prior to serial production. It must give details, amongst others, about: -establishing and marking of significant characteristics -raising of an inspection and test pl
43、an -provision of equipment and fittings -timely, planned provision of measuring equipment -inspections at appropriate points during the production -clarification of acceptance criteria Comment: In addition, see also VDA Volume 4.3.,2.3、是否制订了质量计划？ 要求/说明 质量计划必须包括该产品自样件（样车）阶段到批量生产前阶段的大总成、组件、小组件、零件、材料及生
44、产过程。质量计划是一个动态文件，必须为新产品制订质量计划并在产品有更改时对其补充更新，使用符合现状。一般必须为下列阶段制订质量计划（根据DIN EN ISO8402/3.13）a)样件（样车）阶段（Prototypenphase) 这是一个描述在样件（样车）制造阶段所必须进行的尺寸、材料及功能检验的文件（若顾客要求） h）批量生产前阶段（Vorserienphase)/与过程开发的接口 这是一个描述在样件（样车）制造以后，批量生产前所必须进行的尺寸、材料及功能检验的文件。 质量计划必须详细说明下列内容： 确定、标识出重要的特性 制订检验和试验流程 配置设备和装置 及时地预先配备测量技术 在产品
45、落实的适当时间点进行的检验 澄清验收标准。 注：进一步的内容亦见VDA4.3,2.4:Are the required releases/qualification records at the respective times? Requirements/Explanations: The releases/qualification records of all individual parts, subassemblies and purchased parts are to be proven. The following points, for example, are to be
46、considered: -Product trials (e.g. fitting inspections, functional tests, durability checks, environmental simulations) Status of the prototype parts Pilot series model Production/inspection, measuring and test equipment in experimental installation. 2.5:Are the required resources available?Requireme
47、nts/Explanations:The required resources are to taken from the quotation calculation and the preplanning. They must be available, or planned and provided at the respectively appointed time. The required means for this must be included in the project.The following points, for example, are to be consid
48、ered: -Customer requirements -Qualified personnel -Lost time through absenteeism -Through put/Processing time -Buildings, premises -Experimental installation -Prototype construction -Tools/Equipment -Test/Inspection/Laboratory equipment.,2.4、是否已获得各阶段所要求的认可/合格证明？ 要求/说明 对每个零件、总成和配套件都必须进行认可/合格验证 需考虑要点，
49、例如： 产品试验（例如：装车试验，功能试验，寿命试验，环境模拟试验） 样件状态 小批量试生产样件 试制时的制造设备和检验装置/检验器具。 2.5、是否已具备所要求的产品开发能力？ 要求/说明 必须从报价核算和预规划方案中得出所要求的产品开发能力。这一产品开发能力必须具备或相应的进度表中明确规划并能按时落实。必须在项目中准备好所需的资源。 需考虑要点，例如： 顾客要求 具有素质的人员 缺勤时间 全过程时间 房屋、场地 试验装置 样件（样车）制造 模具/设备 试验/检验/实验室装置,Process Development Element 3:Process Development Planning
50、Basic planning for the manufacture of a product to customer requirements, must already have taken place at quotation stage, which must then be put into precise terms and included in a process development plan, after receipt of contract. Technical and personnel resources, already available, must be c
51、onsidered and expansions preplanned. When setting all tasks, objectives and deadlines, all interfacing areas are to be included through interdisciplinary cooperation. All tasks and responsibilities are to be clearly established.When planning and implementing processes, amendments can become necessar
52、y due to changed customer requirements or special legislative requirements, which also make a reexamination of the planning necessary. Questions 3.1: Are the product requirements available? 3.2: Is a process development plan available and are the targets maintained? 3.3: Are the resources for the realization of serial production planned? 3.4:Have the process requirements been determined and considered? 3.5: Are the necessary personnel and technical preconditions for the project process planned/available? 3.6:Is the process FMEA raised and are improvement measures established?,
