Probabilistic Risk Assessment

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Presentation by Jan Soderstrom of Catalyst Consulting on Probabilistic Risk Assessment to ASQ Section 1508 - Tampa/St Petersburg on March 9, 2009

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Probabilistic Risk Assessment

  1. 1. Probabilistic Risk Assessment Design Requirements Test Programs Field Information Uncertainty, Legal & Regulatory
  2. 2. Safety Safety: ♦Freedom from unacceptable risk of harm ♦ Probability of a hazardous event: ♦ Probable, occasional, remote, improbable, incredible ♦ Severity of the consequence of the hazardous event: ♦ Negligible, marginal, moderate, major, critical
  3. 3. Probability Labels Qualitative labels signals a vague or uncertain probability Interpretation of Qualitative labels depends on context Users prefer quantitative data Quantitative data may result in unwarranted assumptions about precision of the data Interpretation unduly influenced by absolute numbers
  4. 4. Types of Risk ♦ Voluntary Risk: ♦ Rock climbing, race car driving, horse jumping, smoking, diving ♦ Involuntary Risk: ♦Natural disasters, sickness
  5. 5. Risk and Fear Woody Allen’s definition of major surgery: “Anything being done to me” Greater fear of Human made risks than natural risks Voluntary risk less threatening than other Highly personal
  6. 6. US Mortality Rate (per year) Mortality Rate per 100,000 Population (1996) 3000 2500 2000 1500 1000 500 0 0 to 1 1 to 4 5 to 14 15-24 25-44 45-64 64-84 Age Group
  7. 7. Frequency Scales Yearly mortality rate for 25-44 year olds in the US: 192 per 100,000 Risk of accidental death: ………………………… 33 per 100,000 1/10 th Risk of accidental death: …………………… 3.3 per 100,000 Average mortality rate: …......... 1000 per 100,000
  8. 8. Risk Tolerance Mortality Risk Disease Mortality Rate Overall Accidents Natural Hazards Perceived Benefit
  9. 9. Natural Hazards Lightning death Rate: 0.041 per 100,000 Tornadoes: 0.027 per 100,000 Natural “Ave”………. 0.1 per 100,000 One Per Million
  10. 10. US Mortality Rates Lung Cancer 56 per 100,000 Traffic Accident (Car): 22 per 100,000 10 Aircraft trips/yr: 0.1 per 100,000 (fatal and serious) Commercial Diving: 200 per 100,000
  11. 11. Consumer/Producer Risk Patients/Consumer Acute Chronic Pediatrics, geriatrics….. Donor Manufacturer • # of Devices • # of Procedures
  12. 12. Devices FD = 1/10,000 Procedures Patient/Consumer Acute 1/10,000 Chronic (/yr) 3.65/100 Pediatrics, geriatrics….. ?? Donor ?? Manufacturer • # of Devices: 2500 • # of Procedures/Device/yr: 100 • P(FD) = 1/10,000*2500*100 = 25
  13. 13. Risk Tolerance Mortality Risk 1/100 Disease 1/1000 Accidents 1/10,000 1/100,000 Natural 1/1,000,000 Hazards Perceived Benefit
  14. 14. Summary Systems, not Components Systematic failures hard to predict Manufacturers burden to determine acceptable risk levels, probability and severity Life Cycle Use environment

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