GP-12早期生產(chǎn)遏制程序

1、GP 12 EARLY PRODUCTION CONTAINMENT GP 12 早期生產(chǎn)遏制程序早期生產(chǎn)遏制程序Version updated December 2004http:2004年年12月最新版本月最新版本SCOPE: 范圍GP-12 is to be used for all pre-production, production, service and accessory part requirements that;GP-12適用于下面要求的所有的試生產(chǎn)、生產(chǎn)、服務(wù)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管理的對客戶的生產(chǎn)廠有重要影響 The purpose of GP-12 is to: GP-12 的目的的目的 Validate the suppliers production control plan驗(yàn)證供應(yīng)商的量產(chǎn)控制計(jì)劃 Protect our assembly and manufacturing centers and service part warehouses from quality non-conformances d

3、uring critical periods在重要時期防止我們的裝配和制造中心及服務(wù)件倉庫出現(xiàn)質(zhì)量問題 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記 錄 供 應(yīng) 商 在 開 始 生 產(chǎn) 、 加 速 生 產(chǎn)過 程 、生產(chǎn)過程變更后或生產(chǎn)停

4、產(chǎn)三個月或以上時 ， 為 控 制 其 過程 所 做 的努力 Ensure that any quality issues that may arise are quickly identified, contained, and corrected at the suppliers location 確保任何可能產(chǎn)生的質(zhì)量問題在供應(yīng)商的生產(chǎn)場所盡快的得到發(fā)現(xiàn)、控制和糾正 Increase involvement and visibility of suppliers top management增加最高管理層的參與和遠(yuǎn)見性 SUPPLIER RESPONSIBILITY: The suppli

5、er shall:供應(yīng)商職責(zé)：供應(yīng)商必須A.Validation Process: Establish a validation process that contains the following elements:A. 建立包含以下要素的確認(rèn)過程1 Identify the staff person responsible for ensuring the development and implementation of the verification process.1明確保證開發(fā)和執(zhí)行過程確認(rèn)的責(zé)任人 2 Implement GP-12 with entry date, exit

6、 criteria, and exit date as defined by the customer2按照顧客定義執(zhí)行實(shí)施GP-12 日期、結(jié)束標(biāo)準(zhǔn)和結(jié)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設(shè)立GP-12 遏制站，遏制站必須設(shè)在生產(chǎn)末端而且不在生產(chǎn)線上的、單獨(dú)和正常的制造過程分開的，另外的或更有效的或可能用到過程檢查站必須文件化并且有顧客或SQE批準(zhǔn)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檢查站要識別附加的檢查、試驗(yàn)和尺寸檢驗(yàn)，這些檢查項(xiàng)目來源于產(chǎn)品的關(guān)鍵特性和產(chǎn)品的質(zhì)量特性、高RPN值以及在產(chǎn)品和過程開發(fā)階段識別的問題。 5 Train personnel relative to the standardized work performed at

9、the GP-12 containment stations.培訓(xùn)相關(guān)人員使其滿足在GP-12 檢查站崗位職責(zé)6 Establish a reaction plan for single defect.建立一個針對每個缺陷反應(yīng)計(jì)劃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.實(shí)施G

10、P-12審核過程，利用管理層包括現(xiàn)場管理人員進(jìn)行分層審核，確保符合試生產(chǎn)控制計(jì)劃8 Include subcontractor (Tier 2) in the validation process. 包括分承包方的過程確認(rèn)SUPPLIER RESPONSIBILITY: The supplier shall:B. Plan Development: 開發(fā)計(jì)劃 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;試生產(chǎn)控制計(jì)劃開發(fā)對量產(chǎn)控制計(jì)劃有很重要得作用而且確保產(chǎn)品符合性和過程制造能力附加的控制、檢查、審核和試驗(yàn)也是根據(jù)試生產(chǎn)控制計(jì)劃而來。試生產(chǎn)控制計(jì)劃必須考慮以下幾個方面：1 Increased frequency/sample size as stated in the Produ

12、ction Control Plan.1在產(chǎn)品控制計(jì)劃中增加的頻次和樣品容量2 Verification of packaging and label requirements including service and accessory part requirements, which may include country of origin labels on parts.2確認(rèn)包裝和標(biāo)簽的要求包括服務(wù)件和附件的要求，可能包括產(chǎn)品原產(chǎn)國標(biāo)簽3 Verification of the effectiveness of error proofing. 確認(rèn)防錯的有效性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如果在接受場所或在GP-12 執(zhí)行的范圍內(nèi)發(fā)現(xiàn)不符合立即執(zhí)行遏制措施和糾正措施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根據(jù)AIAG的 APQP手冊中控制計(jì)劃表格和控制計(jì)劃參考手冊或其它顧客批準(zhǔn)的APQP參考手冊制定試生產(chǎn)控制計(jì)劃，試生產(chǎn)控制計(jì)劃不能替代量產(chǎn)控制計(jì)劃，它是控制計(jì)劃的附加可以用來驗(yàn)證控制計(jì)劃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 遏制站要求的額外檢查、功能試驗(yàn)和尺寸檢查要文件化，控制計(jì)劃過程檢查項(xiàng)目特殊特性參考AIAG供應(yīng)商 APQP 手冊附錄L，上述文件檢查項(xiàng)目在試生產(chǎn)控制計(jì)劃中作為特定的項(xiàng)目2 Document inspection work instruc

17、tion for the GP-12 containment station to insure standardized work.GP-12檢查站要有書面的保證標(biāo)準(zhǔn)作業(yè)的檢查作業(yè)指導(dǎo)書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要有文件證明執(zhí)行和確認(rèn)的控制計(jì)劃運(yùn)用了I-chart GM1927-66) 或顧客同意的其它格式，這些資料在顧客或SQE評審時要易于獲得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.內(nèi)部和涉及到解決顧客質(zhì)量問題的文件包括問題描述、根本原因、糾正措施、FMEA和控制計(jì)劃的修改要用顧客接受的格式，適時利用根本原因3 x 5 Why 分析，進(jìn)行Read Across培訓(xùn)SUPPLIER RESPONSIBILITY: The supplier shall:D. Duratio

20、n of GP-12: GP-12持續(xù)的時間 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 執(zhí)行的時間和產(chǎn)品的數(shù)量按照顧客的規(guī)定或已經(jīng)生效的控制計(jì)劃，按時間長實(shí)施，如果時間和數(shù)量沒有規(guī)定，在生產(chǎn)加速階段執(zhí)行GP-12 或至少兩個周，按時間長實(shí)施GP-12 inspection is mandatory for 100% of all parts required through the GP-12 period. 在GP-12 期間所有的期間所有的產(chǎn)品要產(chǎn)品要100% 進(jìn)行進(jìn)行GP-12 檢查。檢查。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. 如果文件已經(jīng)接受，包括執(zhí)行GP-12 或顧客沒有發(fā)現(xiàn)問題，顧客確認(rèn)完制造確認(rèn)體系后，顧客或SQE可以批準(zhǔn)降低100

23、% 的要求，但是必須有顧客或SQE書面批準(zhǔn)Additional measurement and testing requirements must be identified by the supplier and/or customer/SQE and approved by the customer/SQE. 附加的測量和試驗(yàn)要求必須被供應(yīng)商和顧客或顧客批準(zhǔn)的SQE /SQE Again, for manufacturing validation builds, 100% inspection is a minimal requirement. Exit criteria noted be

24、low.對于制造確認(rèn)體系至少要進(jìn)行100% 檢查，下面有GP-12.結(jié)束標(biāo)準(zhǔn)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.為 符 合 GP-12 的 要 求 ，在每一

25、個裝運(yùn)標(biāo)簽上都應(yīng)有一個直徑大約25mm綠色圓形不干膠標(biāo)簽 ，上面由確保正確執(zhí)行GP-12責(zé)任人員簽名。EXIT CRITERIA: 結(jié)束標(biāo)準(zhǔn)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.在確認(rèn)過程控制計(jì)劃有效和滿足以下標(biāo)準(zhǔn)供應(yīng)商就符合并可

27、以退出GP-12 ，如果供應(yīng)商不能滿足退出標(biāo)準(zhǔn)或供應(yīng)商的GP-12 計(jì)劃要繼續(xù)識別不符合， 供 應(yīng) 商 必須實(shí)施 必 要 的 遏 制 措 施 和 顧 客工廠 隔 離 開 ，直 到 質(zhì) 量 問 題 被 解 決，達(dá) 到 供 應(yīng) 商 和 顧 客 都 滿 意 并 且 供 應(yīng) 商 的 控制 計(jì) 劃 得 到 確 認(rèn)為 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.裝運(yùn)的數(shù)量滿足顧客在GP-12階段規(guī)定的產(chǎn)品要求，并且在GP-12 階段或顧客沒有識別出問題，如果沒有規(guī)定時間或數(shù)量，按照生產(chǎn)加速時間或兩個周，按時間較長的一個執(zhí)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 或顧客發(fā)現(xiàn)問題， 在執(zhí)行糾正措施后再執(zhí)行2個周或重新執(zhí)行GP-12 ，按時間較長的一個執(zhí)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計(jì)劃要繼續(xù)識別不符合 ， GP-12 計(jì)劃必須保持到過程控制和能力被 證 實(shí)是有效 的，并且控制計(jì)劃得到確認(rèn)為止。CONSEQUENCES OF SHIPPING NONCONFORMING MATERIAL:發(fā)貨的材料不符合的結(jié)論發(fā)貨的材料不符合的結(jié)論 Failure to execute GP-12 will result in Controlled Shipping Leve

31、l 2 and other possible consequences.實(shí)施實(shí)施GP-12失敗，執(zhí)行二級發(fā)貨控制失敗，執(zhí)行二級發(fā)貨控制 或其它可能的結(jié)果?；蚱渌赡艿慕Y(jié)果。 Shipment of non-conforming material will result in Controlled Shipping Level 2.發(fā)運(yùn)不符合的材料發(fā)運(yùn)不符合的材料執(zhí)行二級發(fā)貨執(zhí)行二級發(fā)貨控制控制 SUMMARY 總結(jié)Key Elements要點(diǎn)要點(diǎn)GP-12 Pre launch Control Plan GP-12 試生產(chǎn)控制試生產(chǎn)控制計(jì)劃計(jì)劃 Significant enhancement

32、to Production Control Plan對量產(chǎn)控制計(jì)劃有重要的作用對量產(chǎn)控制計(jì)劃有重要的作用 GP-12 containment station shown as operationGP-12檢查站作為一個操作過程檢查站作為一個操作過程 Control Plan Special Characteristics form utilized利用控制計(jì)劃特殊特性表格利用控制計(jì)劃特殊特性表格Key Elements GP-12 Containment Station GP-12 遏制站遏制站 Specific inspections, dimensional checks and test

33、ing特定的檢查，尺寸檢查和試驗(yàn)特定的檢查，尺寸檢查和試驗(yàn) Off line, independent, at the end of the process離線、單獨(dú)的、在過程的最后離線、單獨(dú)的、在過程的最后 Operator instructions, boundary standards, training process操作指示書，界定標(biāo)準(zhǔn)，培訓(xùn)過程操作指示書，界定標(biāo)準(zhǔn)，培訓(xùn)過程Key Elements 要點(diǎn)要點(diǎn)GP-12 Period (Default period) GP-12 周期（默認(rèn)周期）周期（默認(rèn)周期） Thru acceleration or 2 weeks; whiche

34、ver long加速生產(chǎn)或加速生產(chǎn)或2個周，執(zhí)行較長的一個個周，執(zhí)行較長的一個 100% Inspection required100%檢查要求檢查要求 For Manufacturing Build Validation minimum至少要對制造體系確認(rèn)至少要對制造體系確認(rèn) Throughout GP-12 Period 貫穿貫穿GP-12 整個周期整個周期 Reduction of 100% requirement possible, when;降低降低100% 檢查的必要條件是檢查的必要條件是 Documented acceptable performance書面的合格性能書面的合格性能 And documented and approved by SQE和和SQE書面的批準(zhǔn)書面的批準(zhǔn)Key Elements 要點(diǎn)要點(diǎn)Lay