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2007/07/06* E-mail:[email protected]
(20081208)
*
2007/07/06*
2007/07/06*1. . 1962 Duration
2007/07/06*SafetyRisk
2007/07/06* 1 2003 SARS
2007/07/06* 2IDF2008/10/20 09:40 IDF
IDF 2008/10/21IDF 2
2008/10/22 10:02 IDFS70C
2007/07/06* 2 IDF2008/10/23 15:55 IDF4
2008/10/24 IDF
2007/07/06*2. 1 - 1931Heinrich 55 129:300Accident Ratio 300
1969Byrd17511030600600
()
MANUAL
DE
SEGURIDAD
MANUAL
DE
SEGURIDAD
MANUAL
DE
SEGURIDAD
1
29
TECNICAS
TECNICAS
TECNICAS
300
60030101AccidentsNear MissIncidents
2007/07/06*2
/Fatal Accident 1/Non-fatal accidents 10/Reportable incidents 30/Unsafe acts 600
2007/07/06*3
/Heinrichs
2007/07/06*3. -(Anything that can go wrong will go wrong.)Uncertaintyx Impactlikelihood 0 < < 1Impact..
2007/07/06*4. -Engineering Ethics
Risk IdentificationImpact AnalysisStrategy SelectionPlanning
2007/07/06*:
(Crisis Management)
2007/07/06*
(Identification)
(Possibility)(Consequence)(Estimation )(Control)(Evaluation)NoYes(
2007/07/06*(Risk Analysis Techniques)Risk Matrix ()FTA Fault Tree Analysis ()FME(C)A Failure Mode Effects (Criticality) Analysis()MA - Markov AnalysisDD - Dependency DiagramsETA - Event Tree AnalysisCCA - Common Cause Analysis
2007/07/06*
112334112344122344123444233444
2007/07/06*:(1981)
2007/07/06*
2007/07/06*risk mitigation/safety/risk reduction precedence12safety devices3Caution or Warning4procedurestrainingresidual hazard risk fail safedesign feature(fail-safe)
2007/07/06*Management/Planning, Requirements, Analysis, and Assessments(ESOH Hazard Analyses)ESOHEnvironment, Safety and Occupational Health
2007/07/06*5. ?NCC MERP1Medication Error---
2007/07/06*/
47.7% 13.6 12.9 10.6 3.6 7.0 52.3% 19.4 8.1 7.5 7.0 10.3 100.0
4639.31311.197.786.876.076.054.354.354.332.610.910.910.943.4117 100.0
2007/07/06*
19901994203.84021200410200510
2007/07/06*HISPASSPACS
2007/07/06*()
2007/07/06*(ISO14971:2007) (Risk control)(Option analysis)(Implementation)(Residual risk evaluation/
Overall risk acceptance )(Risk analysis)
(Intended use/intended purpose identification)(Hazard identification)(Risk estimation (likelihood x severity))
(Risk evaluation)(Risk acceptability decisions)
(Post-production information)(Post-production experience)(Review of risk management experience)
(Risk assessment)(Risk management)ISO 14971Figure 1
2007/07/06*929394 6.
2007/07/06*1996-2005
2007/07/06*
2007/07/06*Design ApproachBoeing 747-200Electro - MechanicalSteam GaugeBoeing 777Fly by Wire/LightBoeing 747-400CRT - LCD DisplaysGlass Cockpit
2007/07/06*safety devicesCaution or WarningHoles in floors or platforms shall be properly marked and guarded
Flammable storage cabinet
36.bin
2007/07/06*safety devicesCaution or WarningEmergency Stop Function and Device
Awareness Barriers Device
2007/07/06*safety devicesCaution or WarningSafeguarding device:Interlocks
Interlock door
Awareness Barriers Device
2007/07/06*7.(Healthcare FMEA, HFMEA)1949FMEA 2003JCAHOHFMEA HFMEA
2007/07/06*Healthcare FMEA Worksheet
Step 4
1
Process Step
2
Potential Failure Mode
3
Potential Cause(s)
4
Severity
5
Probability
6
Hazard Score
7
Decision (Proceed or Stop)
(Note: If the score is 8 or higher and the decision is to Stop, document the rationale for this decision)
Step 5
8
Action (Eliminate, Control, or Accept)
9
Description of Action
10
Outcome Measure
11
Person Responsible
12
Management concurrence
(yes or no)
2007/07/06*()
2007/07/06*() ()
2007/07/06*Questions?
*
2007/07/06*
*
2007/07/06*/Operational RequirementsFault TolerantMitigating Features
2007/07/06*Risk Matrix
Intolerable Region
As Low As Reasonably Practicable Region (ALARP)
Broadly Acceptable Region (BAR)
Risk Concept According to ISO 14971
April 2001 Tony C. Chan
Probability of Occurrence
9
I
N
T
O
L
E
R
-
8
A
B
L
E
7
6
A
R
E
G
-
5
L
I
O
N
4
A
3
B
R
2
A
P
1
R
1
2
3
4
5
6
7
8
9
Severity
2007/07/06*FTA(fault trees)AND OR (root)(top event)AND OR (basic event)
2007/07/06*PHAaccidentsPotential hazardevent sequencedisciplined analysisundesirable eventsPossiblePHARisk Matrixfrequencyconsequence
2007/07/06*HAZOP1970Imperial Chemical Industryprocessengineeringdesign specificationdeviationHAZOP[1] (HAZard and Operability)(process deviation)(hazard)(deviation words)(No)(Less)(More)(Part of)(As well as)(Reverse)(Other than)
2007/07/06*
2007 CTI Copyright
2007/07/06*
- (FMEA)// // (O)(S)(D)(RPN)(O)(S)(D)(RPN)
*
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