Professional Documents
Culture Documents
Alan Wassyng
McMaster Centre for Software Certification
COMP
January 2014
ALARA/ALARP
Regulatory Regimes
NRC:
What is a hazard?
! Its a property or condition that has the
potential to cause {harm or damage} = loss
Medical Devices
! ISO 14971 Application of risk management
to medical devices lists hazards for medical
devices
Energy hazards: Electromagnetic energy,
radiation energy, thermal energy, etc.
Operational hazards: Erroneous data transfer,
loss or deterioration of function, incorrect
measurement, use error, etc.
HA Flavours
! Lots to choose from
HA Flavours
! And ones I see in use regularly
HA Flavours
! And ones I see in use regularly
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FTA
! Top down
! Process
Define the TOP event to be analyzed
Identify the lower level events which may lead to
the TOP event and complete the gates
(optional) Find minimal cut sets (qualitative)
(optional) Calculate the failure rate of TOP event
(quantitative)
! Aside: Good for identifying single points of failure
! Cut set = events that together cause the top event
(sometimes called a fault path)
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Graphics?
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FMEA
! Bottom up approach need to know all
details
! Was not designed to consider combination
failure initiating events
! Performed on both processes and products
! Many people use RPN to prioritize so
mitigate only those hazards with RPN > x
RPN = Risk Priority Number
= Severity * Probability of Occurrence * Detection Rating
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STPA
From Nancy Leveson
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NRC View
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STPA
From Nancy Leveson
! For me, this is an important breakthrough there is some idea of completeness that
helps us consider all possibilities
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Zoomed-in
extract
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Useful References
! There is a pretty good book on the subject that
discusses (too) many different kinds of hazard
analyses:
Hazard Analysis Techniques for System Safety by Clifton
A. Ericson II, (2005)
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HAR
Requirements
Review
Report
Hazard analysis
is iterative over the
life of the project!
Formal
Requirements
Documents
HAR
Software Integration
Test Report
Software
Design
Document
Unit Test
Report
HAR
Legend:
Documents produced in the
forward going development process
Documents produced for
verifications, reviews and
testing
Activities and data flow
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HAR
HAR
Code
Code Review and
Verification Reports
HAR
Requirements
Review
Report
Formal
Requirements
Documents
HAR
Software Integration
Test Report
Software
Design
Document
Unit Test
Report
HAR
Legend:
Documents produced in the
forward going development process
Documents produced for
verifications, reviews and
testing
Activities and data flow
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HAR
HAR
Code
Code Review and
Verification Reports
Acknowledgements
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Acceptably Safe?
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