P6：Process analysis/production 过程和产品分析 | P6：Production process analysis 过程和产品分析 |
P6.1 What goes into the process? Process input 过程输入是什么？过程输入 | P6.1 What goes into the process? Process input 过程输入是什么？过程输入 |
P6.1.1 Has the project been transferred from development toserial production and is a reliable start guaranteed?是否在开发和批量生产之间进行了项目交接，以确保生产顺利启动？ | P6.1.1* Has the project been handed over from development toseries production and is a reliable start guaranteed?是否在开发和批量生产之间进行了项目交接，以确保生产顺利启动？启动保障是否得到策划？ |
The project transfer to serial production has been carried out.If necessary, unresolved issues are followed up on and implemented on schedule. The responsibilities for the entire handover process are regulated and acknowledged.项目已移交至批量生产阶段。必要时，对未关闭的问题点进 行继续跟踪，并按期落实。对整个移交过程的职责归属要加 以规定并得到认同。 | The project handover to series production has been documented according to the specified criteria.The responsibilities for the entire handover process are specified and acknowledged. Unresolved issues are followed up on, and the necessary measures are implemented on schedule 根据规定的标准，向批量生产的项目移交已经记录在案。 指定并确认整个移交过程的责任。.对未解决的问题采取后续 行动，并按时执行必要的措施。在首次量产交货前， |
A complete production process and product release (PPA) including the documentation required must take place before the first production shipment.在首次量产交货前，必须首先完成产品和生产过程全面批准/放行（PPA），所有所需的文件均到位。 | A complete production process and product release (PPA) including the documentation required must take place before the first production shipment.必须首先完成产品和生产过程全面批准/放行（PPA），所有所需的文件均到位。 |
Measures are taken to secure the launch of produc-tion. 已落实旨在保障投产的措施。 | Measures to secure the production start-up have been implemented on the basis of a risk analysis.在风险分析的基础上实施了保障投产的措施启动。 |
The updating and further development of the risk analysis (e.g. process FMEA/product FMEA) is en-sured.制定流程来进一步完善产品/过程FMEA，该流程受控。 |
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Tools, test and measuring equipment are available in the necessary quantities. 所需数量的工装模具、检验和测量设备均已经到位。 | Tools, transport and series packaging, inspection and measuring equipment are available in the necessary quantities.必要数量的工具、运输和量产包装、检测和测量设备到位。 |
| Analysis options for failure analysis are available已有失效分析的分析流程 |
| The product software corresponds to the latest release versions.产品软件对应最新的发布版本。 |
P6.1.2 Are the necessary quantities/production batch sizes of incoming materials available at the agreed upon time and atthe correct storage location/ work-station?来料是否在约定的时间按所需数量/生产批次大小被送至正确的存放位置/工位？ | P6.1.2 Are the necessary quantities/production batch sizes of production materials available at the agreed upon time and at the correct storage location/workstation?生产材料是否在约定的时间按所需数量/生产批次大小被送至正确的存放位置/工位？ |
The correct product (incoming material, part, component etc.) must be provided to the agreed quality, in the correct quantity and the correct packing, with the correct documentation, at the agreed time and at the agreed place. Parts/components must be available at defined storage areas/work-stations.正确的产品（来料、零件、部件...）必须以约定的质量、正确的数量、正确的包装、随附正确的文件、在约定的时间送至正确的地点。必须在指定的仓储位置/工位，准备好零件/部件。 | The production material must be of the agreed quality and must be provided in the correct quantity and the correct packaging, with the correct documentation, at the agreed time and at the agreed place. Parts/components must be available at defined storage areas/workstations. 生产材料必须以约定的质量、正确的数量、正确的包装、随 附正确的文件、在约定的时间送至约定的地点。必须在指定 的仓储位置/工位，准备好零件/部件。 |
At the workplace, parts and materials are provided as needed, taking into account the order quantity/lot size (for example, KANBAN, Just in time, FIFO). Up-stream processes are taken into account.考虑到订单数量/生产批次大小（例如， Kanban、JIT、FIFO），根据需求给所在工位提供零部件/原材料。同时也考虑 到上游工序。 | At the workplace, parts and primary materials are provided as needed, taking into account the order quantity/lot size in accordance with the logistics concept.按需求给所在工位提供零部件/原材料，根据物流概念考虑 订单数量/生产批次大小。 |
After order completion, the return of unneeded parts (surplus) including their quantity is regulated.在订单生产结束后，对不需要的零部件（剩余料）的返还必 须加以控制，包括数量的登记。 | The reuse of residual quantities, separated parts, reworked parts, reused parts from product audits, inspected items, etc. and their traceability must be clearly defined.剩余数量零部件，分离的零部件，返工零部件，产品审核中 重复使用的零部件，检查项目等的零部件等，这些重复使用 零部件的可追溯性必须明确定义。 |
| Regulations for reintroducing parts from outsourced processes (e.g. sorting service) must be available.必须制定从外包过程（例如分拣服务）重新引入零件的规定 |
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P6.1.3 Are incoming materials stored appropriately and are the means of transport means/packing facilities suitable for the special characteristics of the incoming materials? 是否对来料进行了适当的存储，所使用的运输工具/包装设备是否适合来料的特定特性？ | P6.1.3 Are materials stored appropriately and are the means of transport/packaging facilities suitable for the special characteristics of the materials? 是否对材料进行了适当的存储，所使用的运输工具/包装设备是否适合材料的特殊特性？ |
Packaging requirements must be consistently taken into account/implemented (also in the production stages).必须考虑并落实包装规范要求（包括在生产过程中）。 | Packaging requirements must be consistently taken into account/fulfilled.必须考虑并满足包装规范要求。 |
During manufacture and internal transport and also when being transported to and from service compa-nies, suitable transport units must be used to protect the products from damage and contamination.在生产和组织内部的运输过程中，以及往返于服务提供商的运输过程中，必须使用合适的运输工具，以免产品受到损坏和污染。 | During manufacture and in-house transport and also when being transported to and from service providers, suitable transport units must be used to protect the products from damage and contamination.在生产和组织内部的运输过程中，以及往返于服务提供商的 运输过程中，必须使用合适的运输工具，以免产品受到损坏 和污染。 |
Store areas/work-stations/containers must be appro-priate for the tidiness and cleanliness required for the parts/products. Cleaning cycles are defined and monitored.仓储区/加工工位/容器必须达到零部件/产品所需的必要的 整洁/清洁要求。要定义清洁周期，并且加以监控。 | Storage areas/workstations/containers must be appropriate for the tidiness and cleanliness required for the material. Cleaning cycles are defined and monitored.仓储区/加工工位/容器必须达到材料所需的必要的整洁/清 洁要求。要定义清洁周期，并且加以监控。 |
The supply of parts/materials at the work-station/on the assembly line must allow for safe handling.加工工位/装配线上的零部件/物料的供应必须便于安全操作 | The supply of materials at the workstation/on the assembly line must allow for safe handling.加工工位/装配线上的材料的供应必须便于安全操作。 |
Specified storage times and use-by dates for special materials/parts must be monitored by appropriate methods (maximum and minimum storage times, specified interim storage times).必须通过合适的方法，监控为特殊材料/零部件规定的仓储 时间以及使用有效期（最长、最短仓储时间，规定的中间临 时仓储时间）。 | Specified storage times and use-by dates for special materials must be monitored by means of appropriate methods必须通过合适的方法，监控为特殊材料规定的仓储时间以及 使用有效期。 |
Critical operating and consumable materials for plant and machinery with a direct effect on the prod-uct/product quality must be monitored accordingly.机器和设备所需的关键生产资料和辅料，如果对产品/产品 质量有直接影响的话，那么，就必须对它们开展相应的监控 | Operating and auxiliary materials for plants and machinery that have a direct effect on the product/product quality must be monitored accordingly.必须相应地监控对产品/产品质量有直接影响的工厂和机器 所需的运行辅助材料。 |
Parts/incoming materials/critical operating and con-sumable materials must be protected against envi-ronmental and climatic influences.对于零部件/来料/关键的生产资料和辅料，要采取措施，防 止它们受到环境/气候的影响。 | Materials, operating and auxiliary materials must be protected against environmental and climatic influences.对于材料和运行辅助材料，要采取措施，防止它们受到环境/气候的影响。 |
P6.1.4 Are the necessary identifications/records/releases available and allocated appropriately to the incoming materials? 来料是否具备必要的标识/记录/放行，并且得以适当地体现 | P6.1.4 Are the necessary labels/records/releases available and allocated appropriately to the materials?材料是否具备必要的标签/记录/放行，并且得以适当地体现 |
Released incoming materials must be clearly identi-fied and recognizable. The release status must be identifiable and the release identification on bun-dles/batches/load containers/parts must be defined.对放行的来料必须加以清楚地标识，放行状态清楚地体现在 标识中。包装袋/批次/装运设备/零部件上的放行标识必须进行规范。 | Released materials must be clearly identifiable. The release identification on bundles/batches/load carriers/parts must be defined.对放行的材料必须加以清楚的标识。包装袋/批次/装运设备/零部件上的放行标识必须进行规范。 |
It must be ensured that only released materials/parts are forwarded to production/the next process stage and used.必须确保只有放行的材料/零部件才能被提供给生产/下道工 序使用。 | It must be ensured that only released materials/parts are forwarded to production/the next production stage and used.必须确保只有放行的材料/零部件才能被提供给生产/下道工 序使用。 |
The traceability of the units produced must be ensured within a reasonable framework (e.g., documentation, batch installation).确保合理的可追溯范围（例如，按批次记录追溯）。Depending on the product risk, traceability must be guaranteed across the entire process chain, from sub-supplier to the customer.根据产品风险，必须在从供方到顾客的整个过程链上确保可 追溯性。 | Traceability from the sub-supplier to the customer must beguaranteed according to a defined traceability concept.根据定义的可追溯性概念，必须确保从次级供应商到顾客的 可追溯性。 |
Customer identification and traceability requirements must be taken into account.Legal and regulatory requirements are taken into ac-count. 必须考虑到顾客在可追溯性和标识方面要求。必须考虑到法律法规要求。 | Customer requirements as well as statutory and regulatory requirements regarding labeling are taken into account.必须考虑到与标识相关的顾客要求和法律法规要求。 |
Test results of characteristics with special requirements for documentation and archiving are recorded accordingly.对于有特殊存档要求的特性的检测结果，必须相应做好记录 |
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P6.1.5* Are changes to the product or process in the course of serial production tracked and documented?6.1.5* 在量产过程中，是否对产品或者过程变更开展了跟踪和记录？ | P6.1.5* Are product or process changes during series production tracked and documented?在量产过程中，是否对产品或者过程变更开展了跟踪和记录？ |
Change management, meaning from the change request tothe implementation, must be clearly documented.Responsibilities must be regulated.变更管理，即从变更申请一直到变更实现，必须加以明确描 述。相应的责权关系必须加以规范。必须落实一道旨在规范 变更审批的流程。
According to customer requirements changes to the product and process are to be agreed upon, approved and released bythe customer (including software changes). If necessary a new PPA must be carried out. 对于影响到顾客的变更，必须与顾客协商沟通，并且得到顾 客批准和放行。必要时，需要重新进行PPA (PPAP)。这适用于产品变更和过程变更（也包括软件变更）。 | Changes to the product and the production process are implemented in accordance with the change management described. Changes to the product and process are agreed upon with the customer, approved and released (including software changes) in accordance with customer requirements. A PPA must be carried out. The history of change statuses must be fully traceable.对产品和生产过程的变更是根据所描述的变更管理实施的。对产品和过程的变更须与顾客商定，根据顾客的要求批准和 发布（包括软件变更）。必须进行PPA。变更等级的历史记录必须自始至终具备可追溯性。 |
Documentation of change statusmust be fully traceable.变更等级的记录必须自始至终具备可追溯性。 | The correct, released version of the material / software must be used. 必须使用材料/软件的正确发布版本。 |
It must be ensured that, at all times, the correct de-sign level of the incoming materials or software is used and the correct design level of the finished product is manufactured and shipped to the custom-er.必须确保在任何时候，使用的是正确的工程变更等级的来料 或软件，加工制造并交付给顾客的是正确的工程变更等级的 产品。 | After changes have been made, it must be checked whether the risk analyses need to be updated.进行变更后，必须检查风险分析是否需要更新。 |
