nullnull FMEA
Failure Mode and Effects Analysis
失效模式與效應
分析
定性数据统计分析pdf销售业绩分析模板建筑结构震害分析销售进度分析表京东商城竞争战略分析
1 of 33陳 啟 政
中原大學品質研究中心
中原大學工業
工程
路基工程安全技术交底工程项目施工成本控制工程量增项单年度零星工程技术标正投影法基本原理
系
The Quality Research Center
Industrial Engineering Department
Chung Yuan Christian UniversitynullFMEA 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。
2 of 33null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 3 of 33null 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FMEA相關名詞解說4 of 33null 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 FailureFMEA書籍相關名詞解說5 of 33nullFMEA 型式 SYSTEM SFMEA
Design DFMEA
* Component
* Unit
* Module
Process PFMEA
Machine MFMEA
Equipment EFMEA
Service SFMEA6 of 33null組成FMEA團隊設計 FMEA 流程(DFMEA)蒐集資料完成FMEA執行
方案
气瓶 现场处置方案 .pdf气瓶 现场处置方案 .doc见习基地管理方案.doc关于群访事件的化解方案建筑工地扬尘治理专项方案下载
系統特性系統功能硬品架構分析失效模式分析設計管制方法分析失效原因分析失效效應分析嚴重度計算關鍵指數分析發生率分析難檢度建議改正行動決定關鍵性
失效模式 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 標準檢驗
程序資料 教育訓練
參考資料失效報告。分析
與改正作業系統
(FRACAS)設計改善撰寫報告 維護度分析
參考資料7 of 33null組成FMEA團隊製程 FMEA 流程(PFMEA)蒐集資料完成FMEA執行方案定義製造流程分析產品特性分析製程特性分析失效模式分析現行管制方法分析失效原因分析失效效應分析嚴重度計算關鍵指數分析發生率分析難檢度建議改正行動決定關鍵性
失效模式 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
參考資料失效報告。分析
與改正作業系統
(FRACAS)製程改善檢驗程序改善撰寫報告8 of 33nullFMEA 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Action11. 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9 of 33nullFMEA 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
10 of 33nullFailure Mode Fishbone AnalysisHi-Pot 不良
Failure
Mode
(Defect)錫面組立加工不良第一層分析
Workmanship第二層分析第三層分析第四層分析正面裝插 零件插歪斜零件面有異物無線尾零件變形零件碰case零件相碰第一層分析
Material變壓器不良PCB不良Y電容不良Power Cable破EMI不良Case不良第二層分析第三層分析絕緣tape破引腳超出base焊點過大造成tape破儀器設備儀器設定Layout 安規距離不夠Arcing 規定過嚴零件間安規距離不足第一層分析
Design第一層分析
Test第二層分析第三層分析第二層分析第三層分析鎖螺絲過長套管短零件本体大Layout 面積小測試條件設錯O/I寫錯測試線接錯11 of 33nullHi-Pot
Failure
AnalysisFault Tree Analysis For Hi-Pot Failure5.
板
邊
零
件
傾
斜
踫
Case,
造
成
安
規
距
離
不
夠b.
Socket
上
Y
電
容
線
腳
靠
近
馬
口
鐵a.
Socket
FG
線
漏
焊Process4.
錫
面
3.
正
面
裝
插2.
組
立1.
加
工
不
良d.
錫
面
短
路
︵
錫
珠,
錫
渣
︶c.
線
腳
過
長b.
漏
焊
︵
Y
電
容
︶ a.
異
物c.
零
件
插
歪
斜零
件
變
形碰
Case碰
T1碰
H/S相
互
碰
撞b.
零
件
面
有
異
物a.
無
線
尾 h.
鎖
絲
未
鎖
緊
或
漏
鎖 g.
掉
金
屬
物
進
產
品 f.
絕
緣
片
放
置
不
當
或
漏
裝d.
PCB
沒
有
卡
到位 c.
組
立
時,
B+
B-
線
壓
傷
壓
破
b.
絕
緣
片
膠
布
破a.
FG
線
有
無
Touch
任
何
零
件c.
膠
布
沒
貼
到
位Design 2.
元
件
之
間
安
規
距
離
不夠
3.
Arcing
規
格
過
嚴c.
鎖
螺
絲
過
長 b.
套
管
短a.
原
件
本
体
大
Layout
面
積
小4.
板
邊
零
件
與
Case
安
規
距
離
不
夠
1.
Layout
安
規
距
離
不
夠Material9.
變
壓
器
PFC
︵
電
感
︶
8.
膠
雜
質
過
多7.
Y
電
容
不
良6.
線
材
Power
Cable
破5.
PCB4.
EMI
Socket3.
Case 2.
接
地
小
黃
豆
電
容
耐
壓
不
夠
c.
有
毛
刺b.
耳
掛
有
凸
起a.
碎
屑 b.
本
身
耐
壓
不
夠a.
FG
線
氧
化
不
吃
錫b.
Trace
近
似
短
路
或
開
路a.
PCB
受
潮e.
絕
緣 Tape
破d.
零
件
本
体
歪
斜 c.
焊
點
過
大,
造
成
錫
間
賜
破
絕
緣
層b.
引
線
腳
超
出
basea.
絕
緣
膠
布
位
置
不
恰
當 1.
光
藕
合
器
不
良
e.
O/I
寫
錯
誤Test2.
儀
器
設
定
1.
儀
器c.
測
試
條
件
設
置
錯
誤b.
O/I
寫
錯
誤a.
測
試
線
接
錯b.
儀
器
本
身
電
壓
頻
率
誤
差
大a.
接
觸
不
良f.
本
身
繞
線
造
成
Arcing
過
大其
他2.
接
地
銅
箔
被
燒
斷
3.
接
地
跳
線
斷
4.
未
依
O/I
作
業1.
Socket
Y
電
容
線
腳
斷5.
油
墨,
黑
色
Mark
筆,
在
初
級
側
導
電
12 of 33nullPart 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
SeveritySeverityOccurrenceOccurrenceDetectionDetectionRPNRPNThis column is used to list the part name
and function. List all the functions for the functional blockFMEA 格式逐項解說1.2.10.4.3.5.6.8.7.9.12.11.15.14.13.13 of 33nullPart 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
SeveritySeverityOccurrenceOccurrenceDetectionDetectionRPNRPN2.In the failure mode column, list each of the failure
modes for the function.FMEA 格式逐項解說1.10.4.3.5.6.8.7.9.12.11.15.14.13.14 of 33nullPart 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
SeveritySeverityOccurrenceDetectionDetectionRPNRPNOccurrence3.List the effects of failure for each of the
failure modes.FMEA 格式逐項解說1.10.4.2.5.6.8.7.9.12.11.15.14.13.15 of 33nullPart 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
SeveritySeverityOccurrenceOccurrenceDetectionDetectionRPNRPNFor each one of the effects, list the
severity (scale from 1 to 10)4.FMEA 格式逐項解說1.10.3.2.5.6.8.7.9.12.11.15.14.13.16 of 33null 符合需求 ,17 of 33nullPart 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
SeveritySeverityOccurrenceOccurrenceDetectionDetectionRPNRPNThe Class column is optional. It is
typically used if the severity is 9 or 10.5.FMEA 格式逐項解說1.10.3.2.4.6.8.7.9.12.11.15.14.13.18 of 33nullPart 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
SeveritySeverityOccurrenceOccurrenceDetectionDetectionRPNRPN
In the Cause column, list the causes
for each failure mode6.FMEA 格式逐項解說1.10.3.2.4.5.8.7.9.12.11.15.14.13.19 of 33nullFMEA ModelLinking Failure Mode to
Cause and EffectCauseFailure Mode
(Defect)Effect20 of 33nullPart 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
SeveritySeverityOccurrenceOccurrenceDetectionDetectionRPNRPNEstimate the likelihood of the
“causes” happening on a “1 to
10” scale. The higher the
number the more likely the
“causes” will occur.7.FMEA 格式逐項解說1.10.3.2.4.5.8.6.9.12.11.15.14.13.21 of 33null22 of 33nullPart 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
SeveritySeverityOccurrenceOccurrenceDetectionDetectionRPNRPNList 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)8.FMEA 格式逐項解說1.10.3.2.5.4.6.7.9.12.11.15.14.13.23 of 33nullPart 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
SeveritySeverityOccurrenceOccurrenceDetectionDetectionRPNRPNEstimate the likelihood of the
detection on a “1 to 10” scale. The lower the number the more likely the cause will be detected.9.FMEA 格式逐項解說1.10.3.2.5.4.8.7.6.12.11.15.14.13.24 of 33null25 of 33nullPart 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
SeveritySeverityOccurrenceOccurrenceDetectionDetectionRPNRPNRPN (Risk Priority Number) is the
product of Severity, Occurrence,
and Detection.
The higher the number, the higher the risk.10.FMEA 格式逐項解說1.2.4.3.5.6.8.7.9.12.11.15.14.13.26 of 33nullPart 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
SeveritySeverityOccurrenceOccurrenceDetectionDetectionRPNRPNWhat actions need to be taken to prevent the Failure Mode?
If no action is taken, record “none” 11.FMEA 格式逐項解說1.10.4.3.5.6.8.7.9.12.2.15.14.13.27 of 33nullPart 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
SeveritySeverityOccurrenceOccurrenceDetectionDetectionRPNRPNAssign appropriate individual, area,
function or team.
Set a realistic target for completion
Target date could be established
by development program12.FMEA 格式逐項解說1.10.4.3.5.6.8.7.9.2.11.15.14.13.28 of 33nullPart 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
SeveritySeverityOccurrenceOccurrenceDetectionDetectionRPNRPNList the results of the actions
taken.
Always enter a reference such as data or test reports.13.FMEA 格式逐項解說1.10.4.3.5.6.8.7.9.12.11.15.14.2.29 of 33nullPart 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
SeveritySeverityOccurrenceOccurrenceDetectionDetectionRPNRPNWhen reassess