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FMEA Failure Mode and Effects Analysis 失效模式與效應分析

1 of 33. FMEA Failure Mode and Effects Analysis 失效模式與效應分析. Prepared by : James.Zhou Issue date : April 12,2001. 2 of 33. FMEA 意義說明. FMEA 是不良預防的工具 , 是一種 有條理程序可藉由一張包含所有 的失效模式的表 , 並以數據來表 示風險的大小和預先採取預防改 善措施。. 3 of 33. 導入 FMEA 的優點.

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FMEA Failure Mode and Effects Analysis 失效模式與效應分析

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  1. 1 of 33 FMEA Failure Mode and Effects Analysis 失效模式與效應分析 Prepared by : James.Zhou Issue date : April 12,2001

  2. 2 of 33 FMEA 意義說明 • FMEA 是不良預防的工具,是一種 • 有條理程序可藉由一張包含所有 • 的失效模式的表,並以數據來表 • 示風險的大小和預先採取預防改 • 善措施。

  3. 3 of 33 導入FMEA的優點 • Team work 方式提高部門或Function 間連繫溝通,共同預防改善問題 • 腦力激盪方式,讓每一成員在同一議題上發揮想像力, 經由有系統整合 • 提出有效之預防改善對策 • 徹底了解產品功能架構圖或產品製造組合流程圖 • 以魚骨圖分析方式列出失效模式每一種可能因子 • 以失效樹分析(FTA)方法了解產品失效模式各種組合型式 • 把失效模式量化針對Top Failure Mode 優先採取對策預防 • 確保所有想像得到失效模式和影響,在正常操作情況之下均被考慮到 • 藉由過去的資料給未來參考, 協助分析失效的範圍和影響性 • 提供設計產品或製程管制預防採取對策時使用

  4. 4 of 33 FMEA相關名詞解說 • Core team :列出與FMEA team 相關人員名字,部門與職責 • Failure mode :失效模式種類 • Effect :失效後對產品產生影響 • Cause :造成失效模式之原因 • Severity :失效模式發生之嚴重程度等級(1～10) • Occurrence :失效模式之發生頻度等級(1～10) • Detection :失效模式發生可被偵測程度等級(1～10) • RPN : Risk Priority Number 指評估風險及優先處理指數 • 是Severity * Occurrence * Detection 之乘積 • FTA :Fault tree analysis 是失效樹分析是導果為因由頂端 • 事件利用邏輯(OR 或 AND) 持續分析第1.2…層直 • 至真正Root cause 將這些原因謀求徹底改善

  5. 5 of 33 FMEA書籍相關名詞解說 • QFD : Quality Function Deployment • DOE : Design of Experiments • VOC : Voice of Customer • VOE : Voice of Engineering • SOP : Standard Operation Procedure • SIP : Standard Inspection Procedure • FRACAS : Failure Report Analysis and • Corrective Action System • SPC : Statistic Process Control • TQM : Total Quality Management • DVT : Design Valuation Test • MTBF : Mean Time Between Failure

  6. 6 of 33 FMEA 型式 • SYSTEMSFMEA • DesignDFMEA • * Component • * Unit • * Module • Process PFMEA • MachineMFMEA • Equipment EFMEA • ServiceSFMEA

  7. 設計 FMEA 流程(DFMEA) 7 of 33 組成FMEA團隊 蒐集資料 完成FMEA執行方案 硬品架構 系統特性 系統功能 失效報告。分析 與改正作業系統 (FRACAS) 分析失效模式 分析失效原因 分析設計管制方法 分析失效效應 分析發生率 分析難檢度 分析嚴重度 計算關鍵指數 決定關鍵性 失效模式 設計改善 建議改正行動 撰寫報告 設計審查 評估資料 設計改善 參考資料 可靠度分析 參考資料 維護度分析 參考資料 標準檢驗 程序資料 教育訓練 參考資料

  8. 製程 FMEA 流程(PFMEA) 8 of 33 組成FMEA團隊 蒐集資料 完成FMEA執行方案 分析製程特性 定義製造流程 分析產品特性 失效報告。分析 與改正作業系統 (FRACAS) 分析失效模式 分析失效原因 分析現行管制方法 分析失效效應 分析發生率 分析難檢度 分析嚴重度 計算關鍵指數 決定關鍵性 失效模式 製程改善 建議改正行動 檢驗程序改善 撰寫報告 設計審查 評估資料 設計改善 參考資料 新製程設計 參考資料 標準檢驗 程序資料 教育訓練 參考資料

  9. 9 of 33 FMEA 實施步驟 1.決定FMEA 對象 2. 成立&組成FMEA team members 3. 收集&準備相似產品之歷史資料 4. 列出產品方塊圖或製程流程圖 5. 列出Failure mode 各種可能情況 6. 列出Failure mode 對產品/機器之 影響 (Effect) 7. 魚骨圖分析造成此Failure mode 之可能原因 (Cause) 8. 根據相關產品之歷史資料定義出 Severity /Occurrence Detection 之等級 9. 根據 S/O/D 的定義定出每個 Failure mode 之 S/O/D 值 10. 列出相似Model 目前採行之Action 11. 計算出 RPN=S*O*D 值 12. 取 RPN 值 ≧100 (值大小需定義) or Top 20% 優先採取對策 13. 針對 RPN 值超出上述定之項目提 出Action 再改善 14. 定出 Action item 之 owner 及完成 日期 15. Action 切入後檢視其效果及切入時 間點 16. 重新計算Action 後之 RPN 值 17. 若 RPN 值未達定義要求 RPN ≧100 or Top 20% 回覆到 item 13 重提 Action 18. 若 RPN 達到要求完成 FMEA 表格

  10. 10 of 33 FMEA Team Members DFMEA (Design) Chairperson * Program Manager (PM) * Electronic Engineer (EE) * Mechanical Engineer (ME) * Quality Engineer (QE) * Quality Engineer (QA) * Manufacturing (MES) Support Team * Purchasing (Buyer) if Need PFMEA (Process) Chairperson * Program Manager (PM) * Quality Engineer (QA) * Industry Engineer (IE) * Mechanical Engineer (MFG ME) * Test Engineer (TE) * Manufacture Supervisor (MFG) * Electronic Engineer (EE) if Need * Mechanical Engineer (ME) if Need

  11. 11 of 33 Failure Mode Fishbone Analysis 第一層分析 Material 第一層分析 Workmanship 第二層分析 第三層分析 第四層分析 第三層分析 第二層分析 正面裝插 錫面 變壓器不良 零件插歪斜 零件變形 絕緣tape破 PCB不良 零件面有異物 零件碰case 引腳超出base 組立 無線尾 零件相碰 焊點過大造成tape破 Y電容不良 Power Cable破 Hi-Pot 不良 Failure Mode (Defect) EMI不良 加工不良 Case不良 Layout 安規距離不夠 儀器設備 Arcing 規定過嚴 測試條件設錯 測試線接錯 鎖螺絲過長 儀器設定 O/I寫錯 零件間安規距離不足 套管短 零件本体大Layout 面積小 第三層分析 第二層分析 第二層分析 第三層分析 第一層分析 Test 第一層分析 Design

  12. 12 of 33 Fault Tree Analysis For Hi-Pot Failure Hi-Pot Failure Analysis Process Design Material Test 其 他 2. 接 地 銅 箔 被 燒 斷 3. 接 地 跳 線 斷 4. 未 依 O/I 作 業 1. 加 工 不 良 2. 組 立 3. 正 面 裝 插 4. 錫 面 5. 板 邊 零 件 傾 斜 踫 Case, 造 成 安 規 距 離 不 夠 1. Layout 安 規 距 離 不 夠 2. 元 件 之 間 安 規 距 離 不夠 3. Arcing 規 格 過 嚴 4. 板 邊 零 件 與 Case 安 規 距 離 不 夠 1. 光 藕 合 器 不 良 2. 接 地 小 黃 豆 電 容 耐 壓 不 夠 3. Case 4. EMI Socket 5. PCB 6. 線 材 Power Cable 破 7. Y 電 容 不 良 8. 膠 雜 質 過 多 9. 變 壓 器 PFC ︵ 電 感 ︶ 1. 儀 器 2. 儀 器 設 定 1. Socket Y 電 容 線 腳 斷 5. 油 墨, 黑 色 Mark 筆, 在 初 級 側 導 電 a. Socket FG 線 漏 焊 b. Socket 上 Y 電 容 線 腳 靠 近 馬 口 鐵 c. 膠 布 沒 貼 到 位 a. FG 線 有 無 Touch 任 何 零 件 b. 絕 緣 片 膠 布 破 c. 組 立 時, B+ B- 線 壓 傷 壓 破 d. PCB 沒 有 卡 到位 e. O/I 寫 錯 誤 f. 絕 緣 片 放 置 不 當 或 漏 裝 g. 掉 金 屬 物 進 產 品 h. 鎖 絲 未 鎖 緊 或 漏 鎖 a. 無 線 尾 b. 零 件 面 有 異 物 c. 零 件 插 歪 斜 a. 異 物 b. 漏 焊 ︵ Y 電 容 ︶ c. 線 腳 過 長 d. 錫 面 短 路 ︵ 錫 珠, 錫 渣 ︶ a. 原 件 本 体 大 Layout 面 積 小 b. 套 管 短 c. 鎖 螺 絲 過 長 a. 碎 屑 b. 耳 掛 有 凸 起 c. 有 毛 刺 a. FG 線 氧 化 不 吃 錫 b. 本 身 耐 壓 不 夠 a. PCB 受 潮 b. Trace 近 似 短 路 或 開 路 a. 絕 緣 膠 布 位 置 不 恰 當 b. 引 線 腳 超 出 base c. 焊 點 過 大, 造 成 錫 間 賜 破 絕 緣 層 d. 零 件 本 体 歪 斜 e. 絕 緣 Tape 破 f. 本 身 繞 線 造 成 Arcing 過 大 a. 接 觸 不 良 b. 儀 器 本 身 電 壓 頻 率 誤 差 大 a. 測 試 線 接 錯 b. O/I 寫 錯 誤 c. 測 試 條 件 設 置 錯 誤 相 互 碰 撞 碰 H/S 碰 T1 碰 Case 零 件 變 形

  13. 13 of 33 FMEA 格式逐項解說 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14. 15. Severity Severity Occurrence Detection Occurrence RPN RPN Detection Part Failure Mode Effect(s) Cause(s) Current or Action(s) to Area or Action(s) Name * Control(s) be taken Individual taken Function responsible Energy Management Cannot Customer Software Monitor dissatisfaction Failure Monitor Battery Battery alert Battery user of status connections spec. wrong Incorrect battery used Cannot Customer Software accurately dissatisfaction failure ID status Battery Connections damage spec. wrong Unable to detect battery Faults This column is used to list the part name and function. List all the functions for the functional block

  14. FMEA 格式逐項解說 14 of 33 2. 1. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14. 15. Severity Severity Occurrence Detection Occurrence RPN RPN Detection Part Failure Mode Effect(s) Cause(s) Current or Action(s) to Area or Action(s) Name * Control(s) be taken Individual taken Function responsible Energy Management Cannot Customer Software Monitor dissatisfaction Failure Monitor Battery Battery alert Battery user of status connections spec. wrong Incorrect battery used Cannot Customer Software accurately dissatisfaction failure ID status Battery Connections damage spec. wrong Unable to detect battery Faults In the failure mode column, list each of the failure modes for the function.

  15. FMEA 格式逐項解說 15 of 33 3. 1. 2. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14. 15. Severity Severity Occurrence Detection RPN RPN Detection Occurrence Part Failure Mode Effect(s) Cause(s) Current or Action(s) to Area or Action(s) Name * Control(s) be taken Individual taken Function responsible Energy Management Cannot Customer Software Monitor dissatisfaction Failure Monitor Battery Battery alert Battery user of status connections spec. wrong Incorrect battery used Cannot Customer Software accurately dissatisfaction failure ID status Battery Connections damage spec. wrong Unable to detect battery Faults List the effects of failure for each of the failure modes.

  16. 16 of 33 FMEA 格式逐項解說 4. 1. 2. 3. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14. 15. Severity Severity Occurrence Detection RPN RPN Detection Occurrence Part Failure Mode Effect(s) Cause(s) Current or Action(s) to Area or Action(s) Name * Control(s) be taken Individual taken Function responsible Energy Management Cannot Customer Software Monitor dissatisfaction Failure Monitor Battery Battery alert Battery user of status connections spec. wrong Incorrect battery used Cannot Customer Software accurately dissatisfaction failure ID status Battery Connections damage spec. wrong Unable to detect battery Faults For each one of the effects, list the severity (scale from 1 to 10)

  17. 17 of 33 符合需求 ,

  18. FMEA 格式逐項解說 18 of 33 5. 1. 2. 3. 4. 6. 7. 8. 9. 10. 11. 12. 13. 14. 15. Severity Severity Occurrence Detection Occurrence RPN RPN Detection Part Failure Mode Effect(s) Cause(s) Current or Action(s) to Area or Action(s) Name * Control(s) be taken Individual taken Function responsible Energy Management Cannot Customer Software Monitor dissatisfaction Failure Monitor Battery Battery alert Battery user of status connections spec. wrong Incorrect battery used Cannot Customer Software accurately dissatisfaction failure ID status Battery Connections damage spec. wrong Unable to detect battery Faults The Class column is optional. It is typically used if the severity is 9 or 10.

  19. FMEA 格式逐項解說 19 of 33 6. 1. 2. 3. 4. 5. 7. 8. 9. 10. 11. 12. 13. 14. 15. Severity Severity Occurrence Detection Occurrence RPN RPN Detection Part Failure Mode Effect(s) Cause(s) Current or Action(s) to Area or Action(s) Name * Control(s) be taken Individual taken Function responsible Energy Management Cannot Customer Software Monitor dissatisfaction Failure Monitor Battery Battery alert Battery user of status connections spec. wrong Incorrect battery used Cannot Customer Software accurately dissatisfaction failure ID status Battery Connections damage spec. wrong Unable to detect battery Faults In the Cause column, list the causes for each failure mode

  20. 20 of 33 FMEA Model Linking Failure Mode to Cause and Effect Cause Failure Mode (Defect) Effect

  21. 21 of 33 FMEA 格式逐項解說 7. 1. 2. 3. 4. 5. 6. 8. 9. 10. 11. 12. 13. 14. 15. Severity Severity Occurrence Detection Occurrence RPN RPN Detection Part Failure Mode Effect(s) Cause(s) Current or Action(s) to Area or Action(s) Name * Control(s) be taken Individual taken Function responsible Energy Management Cannot Customer Software Monitor dissatisfaction Failure Monitor Battery Battery alert Battery user of status connections spec. wrong Incorrect battery used Cannot Customer Software accurately dissatisfaction failure ID status Battery Connections damage spec. wrong Unable to detect battery Faults Estimate the likelihood of the “causes” happening on a “1 to 10” scale. The higher the number the more likely the “causes” will occur.

  22. 22 of 33

  23. FMEA 格式逐項解說 23 of 33 8. 1. 2. 3. 4. 5. 6. 7. 9. 10. 11. 12. 13. 14. 15. Severity Severity Occurrence Detection Occurrence RPN RPN Detection Part Failure Mode Effect(s) Cause(s) Current or Action(s) to Area or Action(s) Name * Control(s) be taken Individual taken Function responsible Energy Management Cannot Customer Software Monitor dissatisfaction Failure Monitor Battery Battery alert Battery user of status connections spec. wrong Incorrect battery used Cannot Customer Software accurately dissatisfaction failure ID status Battery Connections damage spec. wrong Unable to detect battery Faults • List the prevention, design validation/ • verification, or other activities which • will assure the design adequacy for the • failure mode and/or cause / mechanism • under consideration. • Tests • Design reviews, • Mathematical studies, • Fail/safe (Example: redundant • power supplies)

  24. FMEA 格式逐項解說 24 of 33 9. 1. 2. 3. 4. 5. 6. 7. 8. 10. 11. 12. 13. 14. 15. Severity Severity Occurrence Detection Occurrence RPN RPN Detection Part Failure Mode Effect(s) Cause(s) Current or Action(s) to Area or Action(s) Name * Control(s) be taken Individual taken Function responsible Energy Management Cannot Customer Software Monitor dissatisfaction Failure Monitor Battery Battery alert Battery user of status connections spec. wrong Incorrect battery used Cannot Customer Software accurately dissatisfaction failure ID status Battery Connections damage spec. wrong Unable to detect battery Faults Estimate the likelihood of the detection on a “1 to 10” scale. The lower the number the more likely the cause will be detected.

  25. 25 of 33

  26. 26 of 33 FMEA 格式逐項解說 10. 1. 2. 3. 4. 5. 6. 7. 8. 9. 11. 12. 13. 14. 15. Severity Severity Occurrence Detection Occurrence RPN RPN Detection Part Failure Mode Effect(s) Cause(s) Current or Action(s) to Area or Action(s) Name * Control(s) be taken Individual taken Function responsible Energy Management Cannot Customer Software Monitor dissatisfaction Failure Monitor Battery Battery alert Battery user of status connections spec. wrong Incorrect battery used Cannot Customer Software accurately dissatisfaction failure ID status Battery Connections damage spec. wrong Unable to detect battery Faults RPN (Risk Priority Number) is the product of Severity, Occurrence, and Detection. The higher the number, the higher the risk.

  27. 27 of 33 FMEA 格式逐項解說 11. 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 12. 13. 14. 15. Severity Severity Occurrence Detection Occurrence RPN RPN Detection Part Failure Mode Effect(s) Cause(s) Current or Action(s) to Area or Action(s) Name * Control(s) be taken Individual taken Function responsible Energy Management Cannot Customer Software Monitor dissatisfaction Failure Monitor Battery Battery alert Battery user of status connections spec. wrong Incorrect battery used Cannot Customer Software accurately dissatisfaction failure ID status Battery Connections damage spec. wrong Unable to detect battery Faults What actions need to be taken to prevent the Failure Mode? If no action is taken, record “none”

  28. 28 of 33 FMEA 格式逐項解說 12. 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 13. 14. 15. Severity Severity Occurrence Detection Occurrence RPN RPN Detection Part Failure Mode Effect(s) Cause(s) Current or Action(s) to Area or Action(s) Name * Control(s) be taken Individual taken Function responsible Energy Management Cannot Customer Software Monitor dissatisfaction Failure Monitor Battery Battery alert Battery user of status connections spec. wrong Incorrect battery used Cannot Customer Software accurately dissatisfaction failure ID status Battery Connections damage spec. wrong Unable to detect battery Faults Assign appropriate individual, area, function or team. Set a realistic target for completion Target date could be established by development program

  29. 29 of 33 FMEA 格式逐項解說 13. 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 14. 15. Severity Severity Occurrence Detection Occurrence RPN RPN Detection Part Failure Mode Effect(s) Cause(s) Current or Action(s) to Area or Action(s) Name * Control(s) be taken Individual taken Function responsible Energy Management Cannot Customer Software Monitor dissatisfaction Failure Monitor Battery Battery alert Battery user of status connections spec. wrong Incorrect battery used Cannot Customer Software accurately dissatisfaction failure ID status Battery Connections damage spec. wrong Unable to detect battery Faults List the results of the actions taken. Always enter a reference such as data or test reports.

  30. 30 of 33 FMEA 格式逐項解說 14. 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 15. Severity Severity Occurrence Detection Occurrence RPN RPN Detection Part Failure Mode Effect(s) Cause(s) Current or Action(s) to Area or Action(s) Name * Control(s) be taken Individual taken Function responsible Energy Management Cannot Customer Software Monitor dissatisfaction Failure Monitor Battery Battery alert Battery user of status connections spec. wrong Incorrect battery used Cannot Customer Software accurately dissatisfaction failure ID status Battery Connections damage spec. wrong Unable to detect battery Faults • When reassessing SEVERITY, the • only factors that will influence a • change will be: • new experience • change in regulations • design change • change in customer priorities

  31. 31 of 33 FMEA 格式逐項解說 15. 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14. Severity Severity Occurrence Detection Occurrence RPN RPN Detection Part Failure Mode Effect(s) Cause(s) Current or Action(s) to Area or Action(s) Name * Control(s) be taken Individual taken Function responsible Energy Management Cannot Customer Software Monitor dissatisfaction Failure Monitor Battery Battery alert Battery user of status connections spec. wrong Incorrect battery used Cannot Customer Software accurately dissatisfaction failure ID status Battery Connections damage spec. wrong Unable to detect battery Faults If this RPN is not significantly less than previous, then ACTION taken has been ineffective.

  32. 32 of 33 <<範例>>

  33. 33 of 33 <<範例>>

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