GP-12早期生产遏制程序

1、GP 12 EARLY PRODUCTION CONTAINMENT GP 12 早期生产遏制程序早期生产遏制程序Version updated December 2004http:2004年年12月最新版本月最新版本SCOPE: 范围GP-12 is to be used for all pre-production, production, service and accessory part requirements that;GP-12适用于下面要求的所有的试生产、生产、服务件和配件 Require Production Part Approval Process (PPAP)要求提交

2、PPAP的 Represent significant risk to the customer facility as mandated by GM GM管理的对客户的生产厂有重要影响 The purpose of GP-12 is to: GP-12 的目的的目的 Validate the suppliers production control plan验证供应商的量产控制计划 Protect our assembly and manufacturing centers and service part warehouses from quality non-conformances d

3、uring critical periods在重要时期防止我们的装配和制造中心及服务件仓库出现质量问题 Document the suppliers efforts to verify control of its processes during start-up, acceleration, after revisions to the manufacturing process, or when manufacturing runs are separated by 3 months or more记 录 供 应 商 在 开 始 生 产 、 加 速 生 产过 程 、生产过程变更后或生产停

4、产三个月或以上时 ， 为 控 制 其 过程 所 做 的努力 Ensure that any quality issues that may arise are quickly identified, contained, and corrected at the suppliers location 确保任何可能产生的质量问题在供应商的生产场所尽快的得到发现、控制和纠正 Increase involvement and visibility of suppliers top management增加最高管理层的参与和远见性 SUPPLIER RESPONSIBILITY: The suppli

5、er shall:供应商职责：供应商必须A.Validation Process: Establish a validation process that contains the following elements:A. 建立包含以下要素的确认过程1 Identify the staff person responsible for ensuring the development and implementation of the verification process.1明确保证开发和执行过程确认的责任人 2 Implement GP-12 with entry date, exit

6、 criteria, and exit date as defined by the customer2按照顾客定义执行实施GP-12 日期、结束标准和结束日期3 Establish GP-12 containment stations, which must be off-line, separate, and independent check from the normal manufacturing process and located at end of process. Additional, or when more effective, in process containm

7、ent stations may be utilized and must be documented and approved by the customer/Supplier Quality Engineer (SQE). 3设立GP-12 遏制站，遏制站必须设在生产末端而且不在生产线上的、单独和正常的制造过程分开的，另外的或更有效的或可能用到过程检查站必须文件化并且有顾客或SQE批准4 Identify additional inspections, testing, and dimensional checks required at the GP-12 containment sta

8、tion based on Key Product Characteristics (KPCs), Part Quality Characteristics (PQCs), high RPN and/or issues identified during product and process development.在GP-12检查站要识别附加的检查、试验和尺寸检验，这些检查项目来源于产品的关键特性和产品的质量特性、高RPN值以及在产品和过程开发阶段识别的问题。 5 Train personnel relative to the standardized work performed at

9、the GP-12 containment stations.培训相关人员使其满足在GP-12 检查站岗位职责6 Establish a reaction plan for single defect.建立一个针对每个缺陷反应计划7 Implement an audit process of the GP-12 containment utilizing levels of management (layered audit), including site leadership, to insure conformance to the Pre-Launch Control Plan.实施G

10、P-12审核过程，利用管理层包括现场管理人员进行分层审核，确保符合试生产控制计划8 Include subcontractor (Tier 2) in the validation process. 包括分承包方的过程确认SUPPLIER RESPONSIBILITY: The supplier shall:B. Plan Development: 开发计划 Development of a Pre-Launch Control Plan which is a significant enhancement to the production control plan and also con

11、sisting of additional controls, inspections, audits, and testing to insure conformance and capability of the manufacturing process. The plan needs to consider;试生产控制计划开发对量产控制计划有很重要得作用而且确保产品符合性和过程制造能力附加的控制、检查、审核和试验也是根据试生产控制计划而来。试生产控制计划必须考虑以下几个方面：1 Increased frequency/sample size as stated in the Produ

12、ction Control Plan.1在产品控制计划中增加的频次和样品容量2 Verification of packaging and label requirements including service and accessory part requirements, which may include country of origin labels on parts.2确认包装和标签的要求包括服务件和附件的要求，可能包括产品原产国标签3 Verification of the effectiveness of error proofing. 确认防错的有效性4 Immediate

13、 implementation of containment and irreversible corrective action when non-conformances are discovered in the GP-12 containment area or at the receiving location.4如果在接受场所或在GP-12 执行的范围内发现不符合立即执行遏制措施和纠正措施SUPPLIER RESPONSIBILITY: The supplier shall:C. Documentation: 文件Document the Pre-Launch Control Pl

14、an using the Control Plan format referenced in the AIAG Advanced Product Quality Planning and Control Plan Reference Manual or other customer approved Advanced Quality Planning reference manuals. The Pre-Launch Control Plan is not a substitute for the Production Control Plan but, is an addition to t

15、he Production Control Plan and is used to validate it根据AIAG的 APQP手册中控制计划表格和控制计划参考手册或其它顾客批准的APQP参考手册制定试生产控制计划，试生产控制计划不能替代量产控制计划，它是控制计划的附加可以用来验证控制计划1 Document additional inspections, functional testing, and dimensional checks required at the GP-12 containment station or in process check stations on th

16、e Control Plan Special Characteristics form referenced in the AIAG APQP Manual Supplement L and reference said document in the Pre-launch Control Plan as a specific operation. GP-12 遏制站要求的额外检查、功能试验和尺寸检查要文件化，控制计划过程检查项目特殊特性参考AIAG供应商 APQP 手册附录L，上述文件检查项目在试生产控制计划中作为特定的项目2 Document inspection work instruc

17、tion for the GP-12 containment station to insure standardized work.GP-12检查站要有书面的保证标准作业的检查作业指导书3 Document evidence of execution and validation of the control plan utilizing the I-chart (GM1927-66) or other format agreed upon by the customer. The data must be readily available for review by the custom

18、er/SQE.3要有文件证明执行和确认的控制计划运用了I-chart GM1927-66) 或顾客同意的其它格式，这些资料在顾客或SQE评审时要易于获得4 Document problem solving for both internal and customer quality concerns utilizing customer acceptable format; including problem description, root cause, irreversible corrective action with break points and update FMEAS an

19、d Control Plans as appropriate. The 3 x 5 Why Analysis (GM1927-84) for root cause and Read Across (GM1927-69) to apply lessons learned are to be utilized.内部和涉及到解决顾客质量问题的文件包括问题描述、根本原因、纠正措施、FMEA和控制计划的修改要用顾客接受的格式，适时利用根本原因3 x 5 Why 分析，进行Read Across培训SUPPLIER RESPONSIBILITY: The supplier shall:D. Duratio

20、n of GP-12: GP-12持续的时间 GP-12 must be implemented for a period of time or quantity of parts as specified by the customer or until the Production Control Plan has been validated, whichever is longer. If time or quantity is not specified, GP-12 will remain in effect through acceleration or a minimum of

21、 2 weeks, whichever is longer. GP-12 执行的时间和产品的数量按照顾客的规定或已经生效的控制计划，按时间长实施，如果时间和数量没有规定，在生产加速阶段执行GP-12 或至少两个周，按时间长实施GP-12 inspection is mandatory for 100% of all parts required through the GP-12 period. 在GP-12 期间所有的期间所有的产品要产品要100% 进行进行GP-12 检查。检查。Based on documented acceptable performance, which includ

22、es no issues identified at GP-12 or by the customer, the customer/SQE may approve a reduction of the 100% inspection requirements after manufacturing validation builds by the customer. This must be documented and approved by the customer/SQE. 如果文件已经接受，包括执行GP-12 或顾客没有发现问题，顾客确认完制造确认体系后，顾客或SQE可以批准降低100

23、% 的要求，但是必须有顾客或SQE书面批准Additional measurement and testing requirements must be identified by the supplier and/or customer/SQE and approved by the customer/SQE. 附加的测量和试验要求必须被供应商和顾客或顾客批准的SQE /SQE Again, for manufacturing validation builds, 100% inspection is a minimal requirement. Exit criteria noted be

24、low.对于制造确认体系至少要进行100% 检查，下面有GP-12.结束标准E. Identification: To indicate compliance with the GP-12 requirements, attach to each shipping label a green circular, sticker, approximately 25mm in diameter, signed by the staff person accountable to insure proper implementation of GP-12.为 符 合 GP-12 的 要 求 ，在每一

25、个装运标签上都应有一个直径大约25mm绿色圆形不干胶标签 ，上面由确保正确执行GP-12责任人员签名。EXIT CRITERIA: 结束标准Supplier will be eligible to exit GP-12 after validating the effectiveness of Process Control Plan and meeting the criteria listed below. If the supplier is unable to meet the exit criteria or the suppliers GP-12 plan continues to

26、 identify non-conformances the supplier shall continue the necessary containment measures to insulate the customer until the quality concerns have been resolved to the satisfaction of both the supplier and the customer and the suppliers Production Control Plan is validated.在确认过程控制计划有效和满足以下标准供应商就符合并可

27、以退出GP-12 ，如果供应商不能满足退出标准或供应商的GP-12 计划要继续识别不符合， 供 应 商 必须实施 必 要 的 遏 制 措 施 和 顾 客工厂 隔 离 开 ，直 到 质 量 问 题 被 解 决，达 到 供 应 商 和 顾 客 都 满 意 并 且 供 应 商 的 控制 计 划 得 到 确 认为 止 。A. Ship the number of pieces required to meet production requirements as specified by the customer for the GP-12 period with no problems identi

28、fied in GP-12 or by the customer. If time or quantity is not specified, the period of time is through acceleration or 2 weeks whichever is longer.装运的数量满足顾客在GP-12阶段规定的产品要求，并且在GP-12 阶段或顾客没有识别出问题，如果没有规定时间或数量，按照生产加速时间或两个周，按时间较长的一个执行B. If a problem is identified, in GP-12 or by the customer, GP-12 must r

29、emain in effect for a minimum of 2 weeks after implementation of corrective action or through the original GP-12 period, which ever is longer.如果GP-12 或顾客发现问题， 在执行纠正措施后再执行2个周或重新执行GP-12 ，按时间较长的一个执行C. If the GP-12 plan continues to identify non-conformances, the GP-12 plan must be kept in place until p

30、rocess controls and capabilities have proven effective and the Production Control Plan is validated. 如果GP-12计划要继续识别不符合 ， GP-12 计划必须保持到过程控制和能力被 证 实是有效 的，并且控制计划得到确认为止。CONSEQUENCES OF SHIPPING NONCONFORMING MATERIAL:发货的材料不符合的结论发货的材料不符合的结论 Failure to execute GP-12 will result in Controlled Shipping Leve

31、l 2 and other possible consequences.实施实施GP-12失败，执行二级发货控制失败，执行二级发货控制 或其它可能的结果。或其它可能的结果。 Shipment of non-conforming material will result in Controlled Shipping Level 2.发运不符合的材料发运不符合的材料执行二级发货执行二级发货控制控制 SUMMARY 总结Key Elements要点要点GP-12 Pre launch Control Plan GP-12 试生产控制试生产控制计划计划 Significant enhancement

32、to Production Control Plan对量产控制计划有重要的作用对量产控制计划有重要的作用 GP-12 containment station shown as operationGP-12检查站作为一个操作过程检查站作为一个操作过程 Control Plan Special Characteristics form utilized利用控制计划特殊特性表格利用控制计划特殊特性表格Key Elements GP-12 Containment Station GP-12 遏制站遏制站 Specific inspections, dimensional checks and test

33、ing特定的检查，尺寸检查和试验特定的检查，尺寸检查和试验 Off line, independent, at the end of the process离线、单独的、在过程的最后离线、单独的、在过程的最后 Operator instructions, boundary standards, training process操作指示书，界定标准，培训过程操作指示书，界定标准，培训过程Key Elements 要点要点GP-12 Period (Default period) GP-12 周期（默认周期）周期（默认周期） Thru acceleration or 2 weeks; whiche

34、ver long加速生产或加速生产或2个周，执行较长的一个个周，执行较长的一个 100% Inspection required100%检查要求检查要求 For Manufacturing Build Validation minimum至少要对制造体系确认至少要对制造体系确认 Throughout GP-12 Period 贯穿贯穿GP-12 整个周期整个周期 Reduction of 100% requirement possible, when;降低降低100% 检查的必要条件是检查的必要条件是 Documented acceptable performance书面的合格性能书面的合格性能 And documented and approved by SQE和和SQE书面的批准书面的批准Key Elements 要点要点Lay