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GM Page 25 潛在失效模式分析 /PFMEA’ s ? 定義 /Definition: 潛在過程失效模式分析的目的是識別潛在問題可能對制造產品質量帶來的影響,并建立糾正措施的優(yōu)先等級計劃。 The objective of the Process Failure Mode and Effects Analysis (PFMEA) is to identify potential problems which could affect the quality of manufactured parts and develop prioritized plans for corrective actions. ? 期望 /Expectation: 有相應的控制手段以降低風險順序數(shù) RPN Reduction Process in place with demonstrated progress. ? 狀態(tài) /Status: 黃色 /Yellow ? PFMEA未及時更新。 ? 計劃 /Plan: 立即對該款皮帶的 PFMEA文件進行評審并重新發(fā)布。質量主管于 20xx年 6月 15前完成更新工作并發(fā)布。 LNJ 05 年型 LNJ SOP質量閥 GM Page 26 控制計劃 /Control Plans ? 定義 /Definition: 控制計劃是控制產品和過程質量體系的描述。它解釋了過程的每個階段操作要求,以確保輸出狀態(tài)的受控,將過程和產品波動有關的風險降至最小。 Control Plans are written descriptions of the systems for controlling the quality of parts and processes. It describes the actions required at each stage of the process to assure that outputs remain in a state of control, thus minimizing the risk associated with process and product variation. ? 期望 /Expectation: 正式生產版本的控制計劃吸取了前階段制造的經驗,重新審定了試生產文件,已經完成 Production Control Plan plete based on learning from previous build and review of the launch Control Plan. ? 狀態(tài) /Status:黃色 /Yellow 生產控制計劃需重新檢查確認。 ? 計劃 /Plan:對生產控制計劃重新進行檢查并更新。質量主管于 20xx年 6月 15日前完成。 LNJ 05 年型 LNJ SOP質量閥 GM Page 27 ? 定義 /Definition: 為了在設備調試期間有效地決定過程能力,貫徹制造質量原則并驗證產品質量,須制定詳盡的檢具計劃及采購流程.還須支持進行測量系統(tǒng)分析. In order to effectively determine process capability during machine runoff, support BuiltInQuality principles, and verify product quality, a prehensive gage plan, procurement process, and supporting measurement system strategy is required. ? 期望 /Expectation: 已訂購剩余的檢具.審核檢具交貨進度以滿足設備驗收需求.在 Gamma樣機制造的生產啟動前期控制計劃中列出檢具. Remaining gages ordered. Review gage deliveries scheduled to meet equipment qualification needs. Gages in the PreLaunch Control Plan for the Gamma build. ? 狀態(tài) /Status:綠色/ GREEN 用現(xiàn)有檢具,不用專用檢具。 ? 計劃 /Plan: 現(xiàn)階段不適用。 檢具準備 /Gage Readiness LNJ 05 年型 LNJ SOP質量閥 GM Page 28 生產件批準程序 /PPAP ? 定義 /Definition: PPAP的目的是確認制造商正確理解工程設計規(guī)范要求,并且過程有潛力在實際生產中按已定節(jié)拍連續(xù)制造出符合規(guī)范的產品。 The purpose of the Production Part Approval Process (PPAP) is to determine if all engineering design specification requirements are properly understood by the manufacturing facility and that the process has the potential to produce product consistently meeting these requirements during an actual production run at the quoted production rate. ? 期望 /Expectation: PPAP完成 / PPAP pliant. ? 狀態(tài) /Status: 未啟動。 ? 計劃 /Plan: N/A LNJ 05 年型 LNJ SOP質量閥 GM Page 29 制造工程未解決事項 \ME Open Concerns ? 定義 /Definition: 制造工程應該提出所有與其相關的問題并對項目進行支持。 Manufacturing Engineering should bring forward any concerns they have relative to their readiness to support the program. ? 期望 /Expectation: 審核所有未解決事項或需要支持的事項,期望狀態(tài)是沒有對項目帶來風險的事項 Review any open concerns or required assistance. The expectation is that there are no issues that would put the program at risk. ? 狀態(tài) /Status: 未啟動。 ? 計劃 /Plan: ? N/A. LNJ 05 年型 LNJ SOP質量閥 GM Page 30 lzp lzp lzp lzp lzp lzp May 31, 20xx N/A N/A N/A N/A LNJ 05 年型 LNJ SOP質量閥 GM Page 31 lzp lzp lzp lzp lzp May 31, 20xx LNJ 05 年型 LNJ SOP質量閥 GM Page 32 人員配備和培訓 Launch Team Staffing/Training ? 定義 /Definition: 對人員的要求包括貫穿整個產品啟動過程的產品,工藝和連續(xù)到整個產品正式生產全過程。在產品生產過程之前和過程中都必須對每一個員工的必要培訓進行識別和計劃 Requirements for staffing include coverage for both the product and process and continues throughout the entire Production Launch Process. Applicable training for each employee must be identified and scheduled prior to and during the launch process. ? 期望 /Expectation: 審閱計劃狀態(tài) /Review status to plan. ? 狀態(tài) /Status: 綠 /Green 為三班運行的新員工培訓已于 20xx年 4月 1日按計劃完成。 計劃 /Plan: 無 LNJ 05 年型 LNJ SOP質量閥 GM Page 33 工作場地有序安排和目視化控制 Workplace Org. andVisual Controls ? 定義 /Definition: 工作場地布置必須按標準制定以支持員工將浪費減到最小,并且通過提供一個安全,整潔,有效的場地安排來提高工藝質量。目視控制為標識,指導或在整個廠區(qū)如何統(tǒng)一協(xié)調各種控制. Workplace anization are standards created to support the employee, minimize waste, and promote quality workmanship by providing a safe, neat, clean, efficient arrangement of the workplace. Visual controls are the identification, instruction, or indication of how each control will be implemented uniformly throughout the plant. ? 期望 /Expectation: 所有工作按計劃開展,正式投產計劃由生產啟動經理簽署。 All activities on schedule, SOP Sign off plete by Production Launch Manager ? 狀態(tài) /Status: 綠 /Green 已經完成目視控制內容清單并已在各條生產線上運用。 ? 計劃 /Plan: 根據每周審核發(fā)現(xiàn)的問題不斷優(yōu)化工作場地和目視控制內容。 LNJ 05 年型 LNJ SOP質量閥 GM Page 34 標準化工作和員工操作實踐 Standardized Work /Best People Practices ? 定義 /Definition: 標準化工作是指工作職能按可重復次序執(zhí)行的文件,它應該符合基層制造實際情況,并由基層負責更新維護該文件。員工操作實踐是在執(zhí)行同一標準次序工作中獲得最好質量水平,安全,生產力和人機工程實際的標準化 。 Standardized work is the documentation of work functions performed in a repeatable sequence,