L
I have a question concerning estimating the liklihood of a hazard occuring. Is it the likelihood that the cause of the hazard will occur or the the likelihood the effect will occur that is being estimated?
Theoretically the failure or hazard could could be present but there needs to be a combination of events to occur before the hazard could realistically result in a risk to the patient.
As an example:
A surgeon mis-deploys a lega clip into an artery. Hemostasis is not achieved. (so the the effect is blood loss) He can detect the problem and corrects it. Verses, he doesn't see it during the surgery, closes the patient and has to re-operate at a later time to prevent an internal bleeding situation ( high severity rating).
Do I, a) evaluate the likelihood that the mis-deployment happened or b) evaluate that the mis-deployment couldl result in a re-operation at a higher severity risk? Scenario (a) will have a higher likelhood of ocurrance than would scenario (b).
My inclination is to use (a) becasue I can control an mitigate it in the design.
My associates says it must be (b) to reflect the real world and not to inflate the risk assessment.
I welcome other's opinions or if someone point me to a guidance document, it would be great. The ISO 14971 or Ammendment I (application guidance) is not this specific.
Thanks,
Larry
Theoretically the failure or hazard could could be present but there needs to be a combination of events to occur before the hazard could realistically result in a risk to the patient.
As an example:
A surgeon mis-deploys a lega clip into an artery. Hemostasis is not achieved. (so the the effect is blood loss) He can detect the problem and corrects it. Verses, he doesn't see it during the surgery, closes the patient and has to re-operate at a later time to prevent an internal bleeding situation ( high severity rating).
Do I, a) evaluate the likelihood that the mis-deployment happened or b) evaluate that the mis-deployment couldl result in a re-operation at a higher severity risk? Scenario (a) will have a higher likelhood of ocurrance than would scenario (b).
My inclination is to use (a) becasue I can control an mitigate it in the design.
My associates says it must be (b) to reflect the real world and not to inflate the risk assessment.
I welcome other's opinions or if someone point me to a guidance document, it would be great. The ISO 14971 or Ammendment I (application guidance) is not this specific.
Thanks,
Larry