失效模式分析管理程序

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1、失效模式效應分析管理程序FMEA MANAGEMENT PROCEDURE核 准 (APPROVED BY)審 查 (CHECKED BY)制 訂 (INITIATED BY)矽谷電子科技(東莞)有限公司SILICON VALLEY ELECTRONICS TECHNO-LOGY (DONG GUAN) CO., LTD文件編號SV-QA-D-0039版 次1.0制訂單位品保部制訂日期2004.11.29DC-001-01 矽谷電子科技(東莞)有限公司 SILICON VALLEY ELECTRONICS TECHNO LOGY(DONG GUAN) CO., LTDDOCUMENT NUMB

2、ERSV-QA-D-0039文 件 修 訂 履 歷 表日 期版次頁次修 訂 內 容修訂者2004.11.291.0新制定阮遠平 TITLE: 失效模式效應分析管理程序SHEET1 OF 1 DC-002-01 矽谷電子科技(東莞)有限公司 SILICON VALLEY ELECTRONICS TECHNOLOGY(DONG GUAN) CO., LTDDOCUMENT NUMBERSV-QA-D-00391.目的PURPOSE1.1 本程序旨在建立生產流程的風險管理程序，旨在藉由FMEA方 法的應用，以確保生產流程於新技術/新產品引進，製程變更等 各階段的風險得以在事前被適當的評估，並於事前有

3、效規劃風 險規避措施，得以於實際實行時得以有效降低/預防風險，朝向 零風險的目標邁進。 The Purpose of this procedure is to create the risk management procedure rule in manufacturing process, make sure the risk in each phase of the manufacturing process to be assessed by applying FMEA, and have action plans in advance to reduce the risk. Afte

4、r the actions are completed, we expect to see the risk reduced.1.2 FMEA方法主要是用以作事前的風險管理，藉由不同層面的評 估來評價失效模式的風險大小，以作為決策者決定改善行動優 先順序的輔助工具。The purpose of FMEA is to assess the risk in advance, and assist the decision maker to decide the priority of action plan.2.範圍SCOPE2.1 失效模式效應分析管理程序的運作範圍包括進料檢驗直到出 貨和倉儲的

5、所有過程。The scope of the FMEA management procedure in manufacturing process includes whole process of incoming inspection untilshipment and warehouse storage3.權責RESPONSIBILITY3.1研發處及工程處R&D Division & Engineering Division 審查生產流程的風險評估，並核示相關改善計劃的推行。Evaluate the risk of process steps in advance, plan and i

6、mplement improvement actions. TITLE: 失效模式效應分析管理程序SHEET1 OF 6REV.1.0DC-003-01 矽谷電子科技(東莞)有限公司 SILICON VALLEY ELECTRONICS TECHNO-LOGY (DONG GUAN) CO., LTDDOCUMENT NUMBERSV-QA-D-0039 3.2品保部QRA Department3.2.1統籌及領導FMEA Lead and coordinate FMEA activities. 3.2.2促進和輔導使用者應用FMEA。 Facilitate and consult user

7、to use FMEA. 4. 定義DEFINITION4.1FMEA : 為Failure Mode and Effect Analysis的縮寫，一般稱作 ”失效模式效應分析”。FMEA: Failure Mode and Effect Analysis.4.2 CAR : 矯正預防措施報告Corrective action report 4.3風險指標= 嚴重度x 發生度 x 難檢度RPN(Risk Potential Number) = Severity x Occurrence x Detection. 4.4發生度的定義是失效原因導致失效模式發生的機率。Definition of

8、occurrence is the possibility of failure to cause failure mode . 5. 作業內容CONTENT 5.1 並非所有生產流程一切相關活動都需要作FMEA風險評估，新建 或更新生產流程的風險管理時機為 :FMEA建立/修改:Create/Revise FMEA Not all the activities in manufacturing process need to be assessed the risk in FMEA. The opportunities to new create/revise for risk manage

9、ment are5.1.1新且關鍵製程/產品引進時。New and key technologies/product introduction . 5.1.1.1 試產以前:Before pilot run .5.1.1.2 量產以前:Before mass production .5.1.1.3 外部或是內部矯正預防措施報告因異常案例或是客訴而引發時。 TITLE: 失效模式效應分析管理程序SHEET2 OF 6 REV.1.0DC-003-01 矽谷電子科技(東莞)有限公司 SILICON VALLEY ELECTRONICS TECHNOLOGY(DONG GUAN)CO., LTDDO

10、CUMENT NUMBERSV-QA-D-0039 External or Internal CAR is triggered for abnormal cases or customer complaint.5.1.1.4 常規FMEA評審和修改時，每年的6月和12月進行FMEA 評審。Routine FMEA review and it needs to be revised. The frequency of FMEA review is every June and December.5.2組成FMEA團隊:Form FMEA team5.2.1 “經驗” 是決定風險評估適切與否的要素

11、之一，因此，評估風險時應儘可能邀集相關領域較有經驗者參與團隊合作。“Experience” is the one of the important factors to decide the risk ifit needs to be assessed. Therefore, we shall invite the expert with lots of experience as possible。因此，FMEA團隊成員應該包括以下人員: Therefore the FMEA team member should include following persons: 5.2.1.1研發處或工

12、程處的工程師Engineers from R&D Division and/or Engineering Department 5.2.1.2品保工程師QRA engineer 5.2.1.3製造部的專家Experts from Manufacture Department5.2.2品保部統籌及領導FMEA活動。QRA should lead FMEA team and coordinate all FMEA activities. 5.3 FMEA開始:Start FMEA5.3.1 FMEA 小組成員必須鑑識關鍵製程站點以作風險評估。FMEA team members shall iden

13、tify critical process steps to do risk evaluation.5.3.2 FMEA小組成員應根據最嚴重的失效影響去評估嚴重度，且若有不同的失效影響時應特別註記。FMEA team members should evaluate severity based on the mostcritical failure effect and mark it if failure mode has different failure effect . TITLE: 失效模式效應分析管理程序SHEET3 OF 6 REV.1.0DC-003-01 矽谷電子科技(東莞)

14、有限公司 SILICON VALLEY ELECTRONICS TECHNOLOGY(DONG GUAN)CO., LTDDOCUMENT NUMBERSV-QA-D-0039 5.3.3如果失效模式是不同的原因所造成，責任者應依據不同的發生原 因去評估發生度和偵測度。 If failure mode is caused by different causes , responsible personshould evaluate occurrence and detection of different cause for failure mode .5.4 制定矯正措施: Define C

15、orrective Actions.5.4.1如果RPN大於或等於30就要制訂並執行矯正措施，矯正措施執 行後須重行評估RPN. FMEA 小組須適時提供矯正措施以作為持續改善之依據。If RPN is over or equal to 30, corrective actions are needed to be defined and implemented. After corrective actions implemented , we need to re-evaluate RPN ranking . FMEA team shall issue recommend action f

16、or continuous improvement 5.4.2不論RPN大小如何，當嚴重度為10牽涉到安全，法規時，必 須要採取矯正措施以控制該風險。When the severity is 10 which is concerned about safety , laws and regulations during risk evaluation , adequate corrective actions are must to ensure that the risk is addressed regardless of RPN. 5.5 FMEA評審和修改Review and Revi

17、se FMEA 5.5.1當矯正措施執行完成後，若實際風險與當初事前評估有不同後，品保部必須更新之前的FMEA作為經驗記錄。 After the actions are completed, QRA shall update the FMEA tableversion if the risk assessment value is different from last version.5.5.2 當有異常事件發生時，表示原FMEA風險評估有不盡完善之處， 異常處理完成後，亦應進行FMEA的更新，將該異常事件處理改善傳承之。 If there are abnormal events, the

18、FMEA table shall be updatedafter disposing the abnormal event.5.6嚴重度，發生度，難檢度的定義。Definition of Severity, Occurrence, Detection.TITLE: 失效模式效應分析管理程序SHEET4 OF 6 REV.1.0 DC-003-01 矽谷電子科技(東莞)有限公司 SILICON VALLEY ELECTRONICS TECHNOLOGY(DONG GUAN)CO., LTDDOCUMENT NUMBERSV-QA-D-0039附件1為嚴重度，發生度，難檢度的定義，此為矽谷專家集體

19、 討論的結果，是FMEA團隊判斷嚴重度，發生度，難檢度的指 導準則。 Please see the attachment 1 for the definition of severity, occurrence and detection. This is the come out result from the brainstorming activity among SVE experts. This is used to be the guideline while FMEA team judge severity, occurrence and detection. 5.7記錄保存Re

20、cord Retention 所有與此程序相關之品質記錄的保存必須依【品質記錄管制程序】 執行。 All the related quality records retention should follow the rquirements defined in 【Quality Record Retention Procedure】. 6. 參考文件REFERENCE 6.1品質記錄管制程序 (SV-DC-D-0003) Quality Record Retention Procedure (SV-DC-D-0003) 7.表單FORM7.1 FMEA 表格 (QA-100-XX)FMEA form (QA-100-XX)8. 附件ATTACHMENT 8.1嚴重度，發生度，難檢度判斷標準。 Severity , Occurrence , Detection judgment table TITLE: 失效模式效應分析管理程序SHEET5 OF 6 REV.1.1DC-003-01 矽谷電子科技(東莞)有限公司 SILICON VALLEY ELECTRONICS TECHNOLOGY(DONG GUAN)CO., LTDDOCUMENT NUMBERSV-QA-D-0039 TITLE: 失效模式效應分析管理程序SHEET6 OF 6 REV.1.1