VDA63过程审核规范.xls

最低要求最低要求/重要评审重要评审 Minimum requirement/assessment-relevant 给予产品风险，要求和证明的可能性事例给予产品风险，要求和证明的可能性事例 Possible examples of requirements and evidence, depending on product risk 备注（输入备注（输入-输出）和参考资料输出）和参考资料 Notes (input-output) and references P2. P2.1 项目管理有能力满足顾客要求。The project management is in a position to meet the customers requirement. 设计了一个组建项目管理的过程。A process for establishing the project mangement exists. 确定了项目负责人和团队成员的权限以及与组织机构的归口。在这其中，包括各方面必要的实现权限。The authority of the project leaders and team members is specified, together with links to the organisation. All the expertise required for implementation is established. 供方自始至终被纳入了项目管理。The suppliers are engaged in the project management throughout. - 针对具体的过程技术，提供资源证明（专业人员） evidence of resources (specialists) for specific technologies - 确定项目负责人/项目团队的任务，权限以及权责 specification of tasks, expertise and responsibilities of the project leader/project team - 针对国际项目，建立项目网络（组织）project network for international projects (organisation) - 项目组织机构图project organisation chart - 项目团队的组成make-up of the project team - 顾客要求customers requirements - 内部销售internal sales - 顾客customer - 内部专业部门internal specialist departments - 供方suppliers - 互联网入口internet portals - VDA vol.4 - VDA vol.4 part 3 - VDA vol.4, Product process) - 顾客要求Customer requirements - 法律法规要求Legal requirements - 采购条件Purchasing conditions - 涉及质量管理的要求QM-specific requirements - 质量协议Quality agreements - 手册记录方面的要求Documentation requirements - 物流要求（JIT,JIS,合同）Logistics requirements (JIT, JIS, on consignment) - 时间表；技术交货条件Timing plans; technical delivery conditions - 互联网上信息平台的访问入口（顾客/供方）Access to portals (customer/supplier) information platform in internet - 在职能归口的框架范围内，和顾客一起定义针对下级 供方/服务提供商的责权关系（例如资格、原型件技术 放行程序、审批、检验）Definition of responsibilities for sub-supplier/service providers jointly with the customer (e.g., qualification, sample submission, approvals, tests,.) within the framework of a performance interface - 检验规范Test regulations - 产品/过程特性Product/process characteristics - 订货文件，内容包括数量/时间安排Order documents with parts lists, timings - 法律/法令（针对具体国家和地区） Legislation/regulations (country-specific) - 环境保护，回收利用要求Environmental aspects; recycling requirements - 性能证明Evidence of capability 产品开发Product development - 技术规范，图纸specifications, drawings - 特殊特性special characteristics - 在过去产品上积累的经验experience with previous products 过程开发Process development - 设备、工具、检验设备的适用性suitability of facilities time frames - 针对下级供方权责关系的定义Definition of responsibilities for sub-suppliers - 规范、标准、法律、环保regulations, standards, legislation, environmental compatibility - 顾客规范customer regulations - 产品责任要求product liability requirements - 产能capacities - 原材料到位情况availability of incoming materials - 负责开发的有资格的人员qualified development personnel - 生产制造可能，生产地点manufacturing facilities, production locations - 建筑、空间building, space - 设备、模具、生产/检验设备、辅助工具、实验室设备 、运输工具、容器、仓库facilities, tools, produciton, test and inspection equipment; auxiliary tools, laboratory facilities, transport, facilities, containers, stores - CAM，CAQ 标准化生产系统的方法标准化生产系统的方法 Standardised production system methods: - 标杆，实践比较Benchmarking, comparison with practice - 顾客质量传感器customer quality sensor - 从过去产品上积累的经验 Experience with previous products - 生产计划安排Production programme planning - VDA vol.4: “Economical process design and process control“ - VDA vol.4: “Manufacturing feasibility analysis“ - VDA vol. “Maturity level assurance for new parts“ - Product/process innovations - Innovation assessment - SPICE 产品和过程开发的策划产品和过程开发的策划PLANNING THE PRODUCT AND PROCESS DEVELOPMENT 是否已经具有产品和过程的特定要求？是否已经具有产品和过程的特定要求？Are the product and process-specific requirements laid down? 对于开发的产品，所有相关的要求都已经到位。All requirements regarding the product to be developed are known. 组织制定了一道过程，用以识别顾客的一般质量管理要求以及开发和过程要求。The organisation has implemented a process for identifying the customers general QM requirements and also development and process requirements. 对询价和合同文本的完整性进行了检查。Enquiry and contract documents are checked to make sure they are complete. 在不满足要求的情况下，必须通知顾客，或者由顾客对不符合项进行“放行”/同意（在合同的情况下）。If the requirements cannot be achieved, the customer must be informed. Deviations may be “released“/agreed by the customer (in the event of a contract). 顾客在下级供方或者原材料选择方面的要求必须被记录下来。Customer requirements regarding the choice of sub-suppliers and/or materials to be used must be documented. 必须在自身要求、顾客要求、法律法规要求、生产制造过程以及取决于产品用途/使用的特性的基础上，识别 特殊特性。Special characteristics must be identified on the basis of in-house requirements, customer requirements, legal requirements, production technology and characteristics arising from the application/use of the product. 针对由顾客指定的供方（指定供方），签署了归口协议。There are interface agreements for suppliers (appointed suppliers) specified by the customer. 标准化生产系统的方法 Standardised production system methods: - 标杆，实践比较Benchmarking, comparison with practice - VDA vol.4: “Economical process design and process control“ - VDA vol.4, part 3 - VDA vol. “Maturity level assurance for new parts“ 基于所确定的产品和过程要求，是否以多功能小组的形式，对制造可行性进行了评审？基于所确定的产品和过程要求，是否以多功能小组的形式，对制造可行性进行了评审？Has manufacturing feasibility been assessed in a cross-functional manner, based on the requirements which have been determined for product and process? ISH-SP-QMS-003-03-B 最低要求最低要求/重要评审重要评审 Minimum requirement/assessment-relevant 给予产品风险，要求和证明的可能性事例给予产品风险，要求和证明的可能性事例 Possible examples of requirements and evidence, depending on product risk 备注（输入备注（输入-输出）和参考资料输出）和参考资料 Notes (input-output) and references P3.3 - 顾客要求customer requirements - 顾客的时间安排（里程碑、前提）customer timings (milestones, premises) - 系列生产时间安排，原型件技术放行程序时间安排 serial production date, dates for sample submissions - 开发阶段样件的时间安排、生产测试、模具的时间安 排、准备时间dates for development phase samples, production tests, tools, lead times - 方法（QFD、DOE、FMEA、统计试验策划，） methods (QFD, DOE, FMEA, statistical test planning,.) - 质量管理策划（可靠性测试、功能测试、检验计划） QM planning (reliability tests, function tests, trialling plan) - 产能研究capacity studies - 原型件/试生产prototypes/pre-production - 确定目标以及监控实现程度setting and monitoring targets for maturity levels - 定期询问开发进度状态（评审）regular status checks on the progress of the development (reviews) - 向项目管理层提供信息/汇报information/reporting to project management - 针对投资计划的项目计划（建筑和设备、生产设施， ）project plans for investment items, facilities (structures and equipment, production machinery, etc.) - 顾客变更时间和产量情况下的应对方法procedure if the customer changes dates and quantities - 物流方面的策划要求，时间安排：策划/采购审批、原 型件/试生产及开始批量生产logistics planning covering dates, for supply approval, prototypes & pre- production and start of full production - 模具时间表tool timing plans - 生产/检验设备、软件、包装的提供provision of production, test and inspection facilities, software, packing - 变更的保障方案（投产问题等）security concept for changes (launch problems, etc.) P3.4 必须对确定资源的程序加以规范。所谓的确定资源具体指的是具备资格的人员、预算、基础设施、试验设施、 实验室用品、机器、设备等都是否已经到位（机器和设备的负荷情况）。A procedure for determining resources must be controlled. This includes determining the availability of qualified personnel, budgets, infrastructure, test equipment, laboratory facilities, machines, plant, etc. (loading on machines and plant). 每次启动开发前，都需要首先确定对人员资格的要求以及需要提供的工具，并且加以记录。针对原型件制造、 样件制造、试生产、生产测试和批量生产所需的产能以及具体的实现，必须加以策划。Personnel qualification requirements and the facilities to be made available must be dtermined and documented before starting any development. Capacities for building prototypes, samples, 0-production, productio tests and serial production must be planned. 在开发过程中，针对可能产生的瓶颈和额外的需求，应定期开展需求分析。Regular demand analyses must be carried out during the develeopment regarding possible bottlenecks & additional demand. 应定期根据项目中的变更，对资源策划加以调整。外包的过程和服务应被考虑在内。Resource planning must be adapted regularly to changes in the project. Outside processes and services must be taken into account. - 生产地点、模具、生产和检验设施Production locations, tools, production, test & inspection facilities - 内部及外部用测试/检验/实验室用品 Test/inspection/laboratory equipment (internal & external) - CAD、CAM、CAE设备CAD、CAM、CAE equipment - 材料的到位情况Availability of materials - 针对不同的任务，相关有资格的人员的到位情况 Availability of qualifies personnel for the various tasks - 沟通联络可能（例如数据远程传输）Communication facilities (e.g. remote date transmission) - 开发阶段解决问题所需要的资源Resources for problem-solving processes in the development phases 标准化生产系统的方法标准化生产系统的方法 Standardised production system methods: - VDA vol. “Maturity level assurance for new parts“ P3.5 需要实现一道过程，对必要的供方活动开展策划和检验。着其中也包括发包策略，发包范围以及发包时间。潜 在供方包括已经确定下来的供方都已经公开。A process must be implemented to plan and check essential supplier activities. This also includes the strategy for awarding the contracts, the extent of the contracts and the target date for the contracts. 在各个部门之间已经就最晚的发包时间达成了一致。Protential supliers are known, including those already appointed. 负责设备、机器、模具、服务和过程的供方应参与到过程开发当中。Suppliers of plant, machinery, tools, services and procedures are intefrated in the process development. 必须通过合适的手册记录，确保供方合同的可追溯性。合同、评审以及验收的时间应记录到过程开发计划当中 。It must be possible to trace the awards of contracts to suppliers via appropriate documentation. Timing dates for awarding contracts, reviews, and acceptance checks are included in the process development plan. - 决定是制造还是采购make-or-buy decision - 采购市场分析analysis of the supply market - 供方的活动计划activity plan for suppliers - 供方管理描述description of supplier management - 零部件分类component classification - 配件供方/供方的风险评价risk assessment for bought-in parts/suppliers - 必要时，在与下级供方签署的一份职能归口协议的框 架下，和顾客一起共同定义下级供方（供方链）和服务 提供商的责权关系（例如在资格认证，、原型件技术放 行程序、审批、检验、等过程中）。尤其要考虑到 制定供方（由顾客指定的供方）definition (if relevant) jointly with the customer of responsibility for sub- suppliers (supply chain) and service providers (e.g., covering qualification, sample submissions, releases, checks, etc.) within the framework of a performance interface agreement with the sib-supplier. Particular attention to be given to suppliers specified by the customer. - 负责提供服务的供方（开发、实验室、维护保养等） suppliers of services (development, laboratory, maintenance, etc.) 标准化生产系统的方法标准化生产系统的方法 Standardised production system methods: - VDA vol.2 - VDA vol.4 - VDA vol.6, part 7 - VDA vol. “Robust production process“ - VDA vol. “Maturity level assurance for new parts“ 标准化生产系统的方法标准化生产系统的方法 Standardised production system methods: - 供方质量管理Quality management of suppliers - 去顶采购审批，供方审批和变更 停止的时间安排setting dates for supply release, supplier approval and stop on changes - 验证/确认质量关卡的过程审核 process audits to verify/validate quality gates - VDA vol.3 part 1 - VDA vol.4 - VDA vol.4: “Product & process FMEAs“ - VDA vol.4 part 3 - VDA vol.13 - VDA vol. “Maturity level assurance for new parts“ 针对产品和过程开发，是否考虑到了所需的资源针对产品和过程开发，是否考虑到了所需的资源？Have the necessary resources been taken into account for the product and process development? 针对外包采购的产品和服务，是否安排了质量管理策划针对外包采购的产品和服务，是否安排了质量管理策划？Is QM planning arranged for sourcing bought-in products and services? 是否为产品和过程开发编制了相关的计划？是否为产品和过程开发编制了相关的计划？Are there plans for the product and process development? 在项目计划下，还应为产品和过程开发编制专门的计划。这些计划中包含有特定开发和策划活动的具体时间点 /持续时间，里程碑，生产测试等相关信息。At a level below the project plan, specific plans are drawn up for the development of the product and process. These plans contain details of timing dates and periods for certain development and planning activities, milestones, production tests, etc. 里程碑应和顾客的里程碑协调一致。为各里程表确定考量指标，并且确定关键路径。The milestones are aligned with the customers milestones. Metrics (RGA) are laid down for the individual milestones and the critical path is identified. 内部开发计划应与对应的项目事件表协调一致。尤其是针对各个里程碑的考量指标，必须确保开发计划始终处 于更新状态。The internal development plans are aligned with the relevant project timing plan, particularly with regard to metrics for the individual milestones. It is ensured that development plans are always up-to- date. 在开发计划中，应包括一套质量管理策划，其内容应涉及检验策划、检验设备策划以及风险分析。QM planning must be integrated in the development plans, including test/inspection planning, the planning of test and inspection facilities and risk analyses. 在开发阶段，必须使用合适的方法，为产品开发提供保证，使得产品在系列生产时能够满足使用条件（功能、 可靠性、安全性）。In the development phase, suitable methods must be used to secure the product development so that when the product goes into serial production it fulfils the installation consitions (function, reliability, safety, security). 产品和过程FMEA是质量管理策划的组成部分。Product & process FMEAs are part of the QM planning. 针对批量生产，提供具备相关过程技术经验的证明。Experience in technology for serial production is demonstrated. 外包的过程和服务也是项目策划的组成部分。External processes and services are an integral part of the project planning. ISH-SP-QMS-003-03-B 最低要求最低要求/重要评审重要评审 Minimum requirement/assessment-relevant 给予产品风险，要求和证明的可能性事例给予产品风险，要求和证明的可能性事例 Possible examples of requirements and evidence, depending on product risk 备注（输入备注（输入-输出）和参考资料输出）和参考资料 Notes (input-output) and references P4. P4.1 在开发阶段，应借助FMEAs确保产品和过程在功能、可靠性等方面符合顾客的要求。产品和过程一旦发生变 更，就必须重新进行评价。必要时，还需要和FMEAs团队以及项目负责人协商，启动一次新的分析。在措施 实现后，必须进行更新，即需要对发生频度以及发现概率重新进行评价，而在此过程中，重点是要对项目中的 产品加以验证/确认。In the development phase, it must be ensured by means of FMEAs that the product and process meet the customers requirements in terms of function, reliability etc. Changes to the product and process must be evaluated afresh. If appropriate, a new analysis should be carried out in agreement with the FMEA team and the project manager. Once actions have been completed, and updated FMEA is required in regard to the probability of occurrence and the probability of detection, with the focus on the verification/validation of the product in the project. FMEA必须是开发计划的内容。The FMEAmust be part of the development plan. 启动阶段，与过程FMEA之间的归口、更新周期等都必须从中得出。The start phase, the interface to the Process FMEA updating loops, etc. must be clear from the Product FMEA. 对FMEAs的实现必须加以确定。The execution of FMEAs must be controlled. 定义了与顾客/供方之间的归口，另外也包括内部归口。Interfaces to customer and suppliers are defined. 对顾客可能的评价要求进行了记录并且加以应用。Any evaluation requirements set by the customer are documented and applied. 生产计划和将来将要负责生产的厂区是FMEA团队的成员。Personnel from production planning and the future production locations are members of the FMEA team. 在编制FMEA时，应让被指定负责制造的生产基地参与其中。When drawing up the Product FMEA the proposed production location must be involved. 识别了特殊特性（SCs），在FMEA中进行了标记，并且通过措施进行了保障。Special characteristics (SCs) are identified, highlighted in the FMEA and secured by appopriate actions. 必须证明措施的有效性。The effectiveness of the actions must be demonstrated. 对产品和过程FMEAs的归口应加以规范。Interfaces between Production and Process FMEAs are controlled. There is a control loop for updating FMEAs (frequency and reasons). - 顾客要求、特殊特性、重要的参数Customer requirements, special characteristics, important parameters - 功能、安装尺寸、材料functions installation dimensions, materials - 环境因素environmental aspects - 顾客在评价方面的要求customer requirements for assessment - 法律法规要求legal requirement - 来自以前项目的经验experience from previous projects - 从正在系列生产的类似产品上获得的经验experience from similar products already in serial production - 来自于过程FMEA中所涉及具体产品的措施product- specific actions from the Process FMEA - 来自于产品FMEA（设计FMEA）中所涉及具体过程 的措施process-specific actions from the Product FMEA (Design FMEA) - 运输（内部/外部）及其对产品特性的影响transport (internal/external) and its effect on product characteristics - 措施跟踪tracking actions - FMEA会议的记录documentation of FMEA meetings - 变更历史change record - 经验教训lessons learned 标准化生产系统的方法标准化生产系统的方法 Standardised production system methods: - 过程FMEA Process FMEA - VDA vol.4 - VDA vol.4: “Product and Process FMEAs“ - VDA vol.14 - VDA vol. “Maturity level assurance for new parts“ P4.2 通过质量策划，是的在开发新产品和过程的时候，从一开始就会把产品的使用条件考虑在内。In the development of new products and processes, quality planning takes account of installation requirements for the product from the very earliest stages. 在开发策划中确定的产品开发的方法得到了应用，从而在时限要求之后，系列生产的产品能够满足使用要求 （功能、可靠性、安全性）。The methods set out in the development planning for product development are used so that, after accumulated experience has been implemented and the product has fone into serial production, it will meet the specified installation conditions in terms of dunctino, reliability and safety/security. 在质量管理策划中，必须包含一份涉及零件、分总成和材料，以及原型件和试生产阶段生产制造过程的试运行 计划。The QM planning must include a trialling plan for the parts, sub-assemblies and materials, including the manufacturing processes from the prototype and pre-production phases. 为原型件和试生产阶段编制质量管理计划（参照DIN EN ISO 9000）。There is a QM plan (to DIN EN ISO 9000) for the prototype and pre-production phases. 对从原型件和试生产阶段所取得的知识进行了记录，以便能够将它们应用于系列生产阶段。There are records of knowledge gained from the prototype phase and pre-production phase, to be taken into account in the serial production phase. 测试、检查和检验设备策划是质量管理策划的组成部分。The planning of test, checking and inspection equipment is part of the QM planning. Requirements covering this equipment have been laid down and implemented. - 项目流程策划project sequence planning - 试验策划trial planning - 方法（QFD、DOE、FMEA、统计试验策划，） methods (QFD, DOE, FMEA, statistical trial planning,.) - 安装试验和系统测试，零部件可靠的装配fitment trials and system tests, more secure installation of individual components - 整个供应链上的应用use in the entire supply chain - 防错原则poka yoke principles - 使用寿命测试life/endurance tests - 环境模拟测试environment stimulation test,. - 针对环境保护和废弃处置的调查environmental copatibility investigations, inc. disposal - 检验计划test/inspection plan - 涉及质量管理策划编制的过程描述process description to permit QM planning 标准化生产系统的方法标准化生产系统的方法 Standardised production system methods: - 产品FMEA Product FMEA - 过程FMEA Process FMEA - VDA vol.4 - VDA vol.4: “Product and Process FMEAs“ - VDA vol.5 - VDA vol.14 - VDA vol.: “Robust production process“ - VDA vol. “Maturity level assurance for new parts“ - DIN EN ISO 9000 P4.3 必须具有过程以确定资源。There must be a process covering general personnel planning. 必须为具体确定的时间策划人力资源并且保证到位。The personnel resources must be planned and available at the specified timing dates. 针对具体的任务，人力资源必须具备相应的资格。上述要求同样适用于在产品开发过程中投入的服务人员，必 须出具相关的证明材料。Personnel must be qualified for the relevant tasks. This also applies to the service personnel employed in the product development process. Appropriate certification must be available. 在这里，资源调查具体设计的是具备资格的人员是否能够到位。Determining resources is associate with the availability of qualified personnel. 在开发过程中，针对可能产生的瓶颈和额外的需求，应定期开展需求分析。外包的过程和服务应被考虑在内。 During product development, a regular analysis must be carried