2007/07/06* E-mail:alexsj.yin@msa.hinet.net

(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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