FMEA失效模式的基本概念介紹 - skh.org.tw

1 FMEA FMEA( ) FMEA FMEA RCA FMEA FMEA FMEA HFMEA HFMEA HFMEA FMEA FMEA ( failure Mode & effect analysis ) RCA RCA FMEA FMEA ( )OR ( ) ? ? ?RCA FMEA RCA( ) Q ? ? FMEA( ) Q ? ? ? RCA FMEA ( )RCAFMEA ( ) -- FMEA ( ) ( ) (RPN,Risk Priority Number) , , , , , , , / A-1( ) 1.

2 ( )D: E: 2. ( )D: , E: 3. ( )D: E: D( ) , E( ) ? ( ) , 1. ( ) : : : : , 2. , , ( ) (1) ;(2) ;(3) : : 4M1E(man, material, machine, method, environment) , FMEA FMEA(Design) DFMEA / ( ) FMEA(Process) PFMEA / HFMEA FMEA FMEA(Healthcare) HFMEA HFMEA ( ) ? ?

3 ? 1 ? ( ) (input) 99% 11%2522%5039%10063% 1 99% 25 25 = (22%) JCAHO (1995~2004/12/31) 1 / / / / / .. 2,966100 ? ? ?HFMEA ? ? OR OR HFMEA 10 HFMEA SOP protocols SOP protocols A.

4 B. C. D. E. E. E-1 E-2 E-3 E-1-1 E-1-2 E-1-3 E-1-4 E-3-1 E-3-2 E-3-3 / E-4 ?E-4-1 A AE-5 E-6 E-8 E-9 E-7 E-6-1 E-6-1-1 E-6-1-2 E-6-1-3 E-6-2 (Hazard analysis ) HFMEA ( ) (4) (3) (2) (1) 1. 2. 3. 4. 5. 6. 7. 1. 2. 3. 1. 2. 1~2 HFMEA ( ) (4) (3) (2) (1) 1.

5 2. 3. 1. 2. 3. 1. 2. 1. 1. 2. 1. 1. 100 1. 2. 1. 2. 1. 2. 1. HFMEA (Frequent)4 (Occasional)3 1~2 (Uncommon)2 2~5 (Remote)1 5~30 HFMEA (4) (3) (2) (1) (4)161284 (3)12963 (2)8642 (1)4321 41 ( ) (A)2 A1 3 A1a A1b A1c A1d 4 (Severity)333335 (Probability)424436 (Hazard Score)126121297 ( )( 8 ) HFMEA 2. ( )1. ( 8)3.

6 3. HFMEA 5 HFMEA 5 STOP HFMEA 41 ( ) (A)2 A1 3 A1a A1b A1c A1d 4 (Severity)333335 (Probability)424436 (Hazard Score)126121297 ( )( 8 ) HFMEA (eliminate) (control) (mitigate) / How When Who ( ) Where How communicated (control variability) (standardization) (optimizing redundancy) / (automation/technology) (fail-safe design) (documentation) 41 ( ) (A)2 A1 3 A1a A1b A1c A1d 4 (Severity)333335 (Probability)424436 (Hazard Score)

7 126121297 ( )( 8 ) 58 ( ) 9 10 11 12 (Yes or No)HFMEA ( ) ( )HFMEA ( ) HFMEA KM HFMEA RCA HFMEA HFMEA HFMEA HFMEA GOHFMEA .. ( ) .. ( ) HFMEA.

8 ( )1 ( )2 HFMEA HFMEA .. ( ) HFMEA ( )1 ( )2 2 2 1 9 HFMEA HFMEA HFMEA HFMEA .. ( ) SOP SOP ..GE ? ? ? TC ABCDF A. A-1 A-2 A-3 A-4 A-2 (1) (2)(2)B. (2)B1 A B2 A ?(1) A (3) C. C1: B C2: B (3)(5)C3: C4: C5: C6: C4-1: C5-1: C5-2-1 C5-2-2 C5-3: (4) (4) (4) (4) C7:: C (4)C8:: ?

9 (5) D. D-1 ?AD-2 D-2-1 TC D-3 AAE. E-1 E-2 E-3 E-1-1 E-1-2 E-1-3 E-1-4 E-3-1 E-3-2 E-3-3 / E-4 ?E-4-1 A AE-5 E-6 E-8 E-9 E-7 E-6-1 E-6-1-1 E-6-1-2 E-6-1-3 E-6-2 .. / / / A-1( ) 1. ( )D: E: 2.

10 ( )D: , E: 3. ( )D: E: D( ) , E( ) , 1. ( ) : : : : , 2. , , ( ) (1) ;(2) ;(3) : : 4M1E(man, material, machine, method, environment) , !!~ RPN RPN 8 RPNA-11. ( )D: 313E: 3262. ( )D: 313E: 2483. ( )D: 212E: 248 .. 2. ( )1. ( 8)3. 3.