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Safety Analysis Profile: Applying Safety to UML Designs Bruce Powel Douglass, Ph.D. Chief Evangelist IBM Rational IBM Software Group © 2008 IBM Corporation ®
What is Safety? ,[object Object],[object Object],[object Object],[object Object],[object Object]
Safety-Related Concepts ,[object Object],[object Object],[object Object]
Safety-Related Concepts ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Hazard Analysis
Safety Fault Timeline
Safety Measures ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Fault Tree Analysis (FTA) Fault Tree Analysis determines what combinations of conditions or events are necessary for a hazard condition to occur
Example Fault Tree Analysis
Design Redundancy for Safety ,[object Object],[object Object],[object Object]
Safety Metamodel ,[object Object],[object Object]
Safety Metamodel
Safety Metamodel (Operators)
Metaclasses ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Metaclasses ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Metaclasses ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Metaclasses ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Metaclasses ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Safety Example: SleepyTime Anesthesia Machine
System Use Case Model
Alarm Requirements
Display Requirements
Ventilator Subsystem Use Case Model
Ventilator Requirements
Hazard Table (generated)
FTA Hypoxia Hazard Normal Event Transfer Operator Undeveloped Fault Hazard Basic Fault AND operator Resulting Condition OR operator
FTA Gas Flow Problem
FTA Gas Connection Problem
Fault Table
Connecting FTA to Requirements (TraceToReq)
Fault-Requirement Matrix (generated)
Analysis Model of the SleepyTime Machine
Analysis Model of the Ventilator Subsystem
FTA Hypoxia Hazard with Design Elements
FTA Connection Problem with Design Elements
Fault-Source Matrix (generated)
Fault Detection Matrix (generated)
Hazard Analysis (generated external file) Pg 1 Hazard Description Fault tolerance time Fault tolerance time units  Probability     Severity Risk Safety integrity level Hypoxia The hypoxia hazard occurs when the brain and other organs receive insufficient oxygen. In a normal 21% O 2  environment, death or irreversible injury occurs after five minutes of no oxygen. If the patient is breathing 100% for a significant period of time, this time is about 10 minutes. 5 minutes 1.00E-02 8 8.00E-02 3 Overpressure Overpressure can damage the lungs. This is an especially severe trauma, possibly fatal, to neonates.  200 milliseconds 1.00E+04 4 3.00E+04 3 Hyperoxia Hyperoxia problems are usually limited to neonates, where it can cause blindness.  10 minutes 1.00E+05 4 4.00E+05 4 Inadequate anesthesia Inadequate anesthesia leads to patient discomfort and memory retention of the surgical procedures. This is normally not life threatening but can be severely discomforting.  5 minutes 1.00E+04 2 2.00E+04 2 Over anesthesia Over anesthesia can lead to death. 3 minutes 1.00E+03 4 4.00E+03 4 Anesthesia leak into ER Anesthesia leak can lead to short or, in smaller doses, to long-term poisoning of medical staff.  10 minutes 1.00E+05 5 4.00E+05 5
Hazard Analysis (generated external file) Pg 2 Hazard Fault or event Fault type Fault description MTBF MTBF time units Probability Hypoxia Ventilator engaged NormalEvent       1 Hypoxia Gas supply fault BasicFault This fault occurs when gas from a required source is unavailable. This may be due to any number of root causes, such as a stuck or closed valve, running out of gas or a leak.  1.00E+06   1.00E-06 Hypoxia Breathing circuit leak BasicFault This fault occurs when a significant amount of gas leaks from the breathing circuit into the surrounding environment. This can lead to a poisoning hazard when the gas contains anesthetic drugs.  1.00E+03   1.00E-03 Hypoxia Ventilator pump fault BasicFault This fault occurs when the pump internal to the ventilator no longer functions to shape the breath and push gas into the breathing circuit.  1.00E+06   1.00E-06 Hypoxia Ventilator parameter setting wrong BasicFault This fault occurs when a ventilator parameter is out of range. This includes: -I:E ratio -Tidal Volume -Respiration Rate -Inspiratory Pause -Maximum inspiratory pressure -Inspiration time 1.00E+04   1.00E-04 Hypoxia Ventilator computation  incorrect BasicFault This fault occurs when an error in the software or a fault in a necessary resource (such as memory) results in an incorrect computation that in turn results in incorrect delivery of ventilation.  1.00E+05   1.00E-05
Hazard Analysis (generated external file) Pg 3 Fault or event Requirements Manifestors Detectors Extenuators Gas supply fault REQ_BCM_01 GasValve GasFlowSensor Alarm Gas supply fault REQ_VD_06       Gas supply fault REQ_VD_03       Gas supply fault REQ_VD_04       Gas supply fault REQ_VD_08                 Breathing circuit leak REQ_VD_03   PressureSensor Alarm Breathing circuit leak REQ_VD_04       Breathing circuit leak REQ_VD_06                 Ventilator pump fault REQ_VD_06 Pump PumpController PumpController           Ventilator parameter setting wrong REQ_vent_limit_range_on_patient_mode PumpController ProtectedCRCClass Alarm Ventilator parameter setting wrong REQ_vent_parameter_out_of_range_setting       Ventilator parameter setting wrong REQ_Vent_confirmation      
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Safety Analysis Profile

  • 1. Safety Analysis Profile: Applying Safety to UML Designs Bruce Powel Douglass, Ph.D. Chief Evangelist IBM Rational IBM Software Group © 2008 IBM Corporation ®
  • 2.
  • 3.
  • 4.
  • 7.
  • 8. Fault Tree Analysis (FTA) Fault Tree Analysis determines what combinations of conditions or events are necessary for a hazard condition to occur
  • 10.
  • 11.
  • 14.
  • 15.
  • 16.
  • 17.
  • 18.
  • 19. Safety Example: SleepyTime Anesthesia Machine
  • 26. FTA Hypoxia Hazard Normal Event Transfer Operator Undeveloped Fault Hazard Basic Fault AND operator Resulting Condition OR operator
  • 27. FTA Gas Flow Problem
  • 30. Connecting FTA to Requirements (TraceToReq)
  • 32. Analysis Model of the SleepyTime Machine
  • 33. Analysis Model of the Ventilator Subsystem
  • 34. FTA Hypoxia Hazard with Design Elements
  • 35. FTA Connection Problem with Design Elements
  • 37. Fault Detection Matrix (generated)
  • 38. Hazard Analysis (generated external file) Pg 1 Hazard Description Fault tolerance time Fault tolerance time units Probability     Severity Risk Safety integrity level Hypoxia The hypoxia hazard occurs when the brain and other organs receive insufficient oxygen. In a normal 21% O 2 environment, death or irreversible injury occurs after five minutes of no oxygen. If the patient is breathing 100% for a significant period of time, this time is about 10 minutes. 5 minutes 1.00E-02 8 8.00E-02 3 Overpressure Overpressure can damage the lungs. This is an especially severe trauma, possibly fatal, to neonates. 200 milliseconds 1.00E+04 4 3.00E+04 3 Hyperoxia Hyperoxia problems are usually limited to neonates, where it can cause blindness. 10 minutes 1.00E+05 4 4.00E+05 4 Inadequate anesthesia Inadequate anesthesia leads to patient discomfort and memory retention of the surgical procedures. This is normally not life threatening but can be severely discomforting. 5 minutes 1.00E+04 2 2.00E+04 2 Over anesthesia Over anesthesia can lead to death. 3 minutes 1.00E+03 4 4.00E+03 4 Anesthesia leak into ER Anesthesia leak can lead to short or, in smaller doses, to long-term poisoning of medical staff. 10 minutes 1.00E+05 5 4.00E+05 5
  • 39. Hazard Analysis (generated external file) Pg 2 Hazard Fault or event Fault type Fault description MTBF MTBF time units Probability Hypoxia Ventilator engaged NormalEvent       1 Hypoxia Gas supply fault BasicFault This fault occurs when gas from a required source is unavailable. This may be due to any number of root causes, such as a stuck or closed valve, running out of gas or a leak. 1.00E+06   1.00E-06 Hypoxia Breathing circuit leak BasicFault This fault occurs when a significant amount of gas leaks from the breathing circuit into the surrounding environment. This can lead to a poisoning hazard when the gas contains anesthetic drugs. 1.00E+03   1.00E-03 Hypoxia Ventilator pump fault BasicFault This fault occurs when the pump internal to the ventilator no longer functions to shape the breath and push gas into the breathing circuit. 1.00E+06   1.00E-06 Hypoxia Ventilator parameter setting wrong BasicFault This fault occurs when a ventilator parameter is out of range. This includes: -I:E ratio -Tidal Volume -Respiration Rate -Inspiratory Pause -Maximum inspiratory pressure -Inspiration time 1.00E+04   1.00E-04 Hypoxia Ventilator computation incorrect BasicFault This fault occurs when an error in the software or a fault in a necessary resource (such as memory) results in an incorrect computation that in turn results in incorrect delivery of ventilation. 1.00E+05   1.00E-05
  • 40. Hazard Analysis (generated external file) Pg 3 Fault or event Requirements Manifestors Detectors Extenuators Gas supply fault REQ_BCM_01 GasValve GasFlowSensor Alarm Gas supply fault REQ_VD_06       Gas supply fault REQ_VD_03       Gas supply fault REQ_VD_04       Gas supply fault REQ_VD_08                 Breathing circuit leak REQ_VD_03   PressureSensor Alarm Breathing circuit leak REQ_VD_04       Breathing circuit leak REQ_VD_06                 Ventilator pump fault REQ_VD_06 Pump PumpController PumpController           Ventilator parameter setting wrong REQ_vent_limit_range_on_patient_mode PumpController ProtectedCRCClass Alarm Ventilator parameter setting wrong REQ_vent_parameter_out_of_range_setting       Ventilator parameter setting wrong REQ_Vent_confirmation      
  • 41. References to enhance your Harmony