京都府 リスクマネジメント R2 0 - pref.kyoto.jp

1 30 1 22 H30-1-22 2H30-1-22 3 H30-1-22 4 Risk Management harm 1 17 41 H30-1-22 5 2 H30-1-22 6 risk management risk assessment (harm) (Hazard) (Hazardous situation) risk residual risk.

2 Safety use error H30-1-22 7 QMS QMS 26 ISO 31 ISO H30-1-22 8H30-1-22 JIS T14971 9 IEC62304 JIS t2304 H30-1-22 1 * * 2 * 3 * 4 * * * * * 5 * * * * * * * * 6 * * * 7 * * 8 * * * * 9 * A B C D JA 10 H30-1-22 11 STEP STEP STEP STEP STEP STEP STEP STEP

3 STEP STEP 10 STEP 11 STEP 12 STEP 13 H30-1-22 JIS T14971 2012 12 H30-1-22 13 : PHA Preliminary Hazard Analysis IEC 60300-3-9:1995 FTA Fault TreeAnalysis IEC 61025 FMEA Failure Mode and Effects Analysis IEC 60812 G H30-1-22 14 H30-1-22 10-3 10-4 10-3 10-5 10-4 10-6 10-5 10-6 5 CBAAA CCBBA DDCBB DDDCC DDDDD

4 A,B,C D6 15H30-1-22 16 STEP1 / C STEP2 D STEP3 = H30-1-22 17 STEP ABC / / (STEP1)H30-1-22 1) 2) C

5 18 ( ) H30-1-22 19 ( )X X X OFF ( ) (STEP2)H30-1-22 20 (STEP1) (STEP2)H30-1-22 D X ( ) 1 5 21 (FTA (STEP2) D FTA Fault Tree Analysis H30-1-22 22 FMEA (STEP2))

6 FMEA Failure Mode and Effect Analysis H30-1-22 II III23 STEP (STEP3) = H30-1-22 24P1 P2 E P1 P2P1 P2 H30-1-22 25 = (STEP4) ( ) and/or H30-1-22 (STEP3) ALARP 26 (6) 6 12 18 24 30 (5) 5 10 15 20 25 (4) 4 8 12 16 20 (3) 3 6 9 12 15 (2) 2 4 6 8 10 (1) 1 2 3 4 5 (1) (2) (3) (4) (5) 10 ; 4 = 9 5=ALARP.

7 STEP3 STEP4 ALARP H30-1-22 (STEP3) 27H30-1-22 STEP 5 STEP3 STEP DA E28 ( ) ( )X X X OFF ( ) STEP3 STEP4 H30-1-22 (STEP3) (STEP4)29H30-1-22 30 STEP 5 STEP STEP STEP STEP 7 DAFGE (STEP5) ( ) (STEP6) (STEP7) (STEP8) H30-1-22 31 H30-1-22 32 (6) 6 12 18 24 30 (5)

8 5 10 15 20 25 (4) 4 8 12 16 20 (3) 3 6 9 12 15 (2) 2 4 6 8 10 (1) 1 2 3 4 5 (1) (2) (3) (4) (5) 10 5 ALARP 4 H30-1-22 33 > X ( 8)H30-1-22 34H30-1-22 STEP 9 13 FGE 7 7 8 9 CB 9 35 (STEP9) (STEP10) (STEP11) (STEP12) (STEP13) H30-1-22 36 ( ) PCB ( ) (State of the art) ( )H30-1-22 37H30-1-22 38 H30-1-22 JIS T14971:2012 ISO14971.

9 2007 JIS T0993-1:2012 ISO 10993-1 2009 a) b) c) d) e) f) JIS Q14971-1:2001 ISO 14971-1 1998 JIS Q0073:2010 ISO Guide73 2009 JIS Q31000:2010 ISO 31000 2009 JIS Q31010:2012 IEC/ISO 31010 2009 JIS Q 31000 39 R-MAPH30-1-22 R-MAP 40 R-Map NITE R-Map FTA 100 NITE 100 ICH Q9: Quality Risk Management ICH-Q9 ( 41 H30-1-22 42