Probabilistic Risk Assessment
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Probabilistic Risk Assessment

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Presentation by Jan Soderstrom of Catalyst Consulating to ASQ 1508 section Tampa/St Petersburg on March 9, 2009

Presentation by Jan Soderstrom of Catalyst Consulating to ASQ 1508 section Tampa/St Petersburg on March 9, 2009

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    Probabilistic Risk Assessment Probabilistic Risk Assessment Presentation Transcript

    • Probabilistic Risk Assessment
      • Design Requirements
      • Test Programs
      • Field Information
      • Uncertainty, Legal & Regulatory
    • 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
    • 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
    • Types of Risk
      • V oluntary Risk:
          • Rock climbing, race car driving, horse jumping, smoking, diving
      • I nvoluntary Risk:
          • Natural disasters, sickness
    • 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
    • US Mortality Rate (per year)
    • 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
    • Risk Tolerance Mortality Risk Natural Hazards Overall Accidents Perceived Benefit Disease Mortality Rate
    • 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
    • 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
      • Commercial Diving: 200 per 100,000
      (fatal and serious)
    • Consumer/Producer Risk
      • Patients/Consumer
        • Acute
        • Chronic
        • Pediatrics, geriatrics…..
        • Donor
      • Manufacturer
          • # of Devices
          • # of Procedures
    • Devices F D = 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(F D ) = 1/10,000*2500*100 = 25
    • Risk Tolerance Mortality Risk 1/100 1/1000 1/10,000 1/100,000 1/1,000,000 Natural Hazards Accidents Perceived Benefit Disease
    • Summary
      • Systems, not Components
      • Systematic failures hard to predict
      • Manufacturers burden to determine acceptable risk levels, probability and severity
      • Life Cycle
      • Use environment