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Hi, I have a question about aligning risk analysis techniques such as task analysis with 14971. The cognitive task analysis for our purpose is to identify possible task failures and hazards so we can compare the differences between our generic drug/device combination product and the reference.
My procedure is to consider all potential hazards but the ones that are acceptable don't need to be entered into my risk table. I'd like to know if anyone has guidance on how to understand the relationship between user error and 14971. For example:
Hazard = in this case we're looking at use errors caused by perception, cognition or actions.
Hazardous situations = I think we should be looking at the identified task failures in our task analysis as the cause of the hazardous situation?
Harm = clinician is available to advise
Foreseeable sequence of events = to me this is pretty much inherent in the task analysis exercise since the idea is to identify the primary operating functions and work through all the user steps.
Maybe another way of asking the question is if the identified task failures or use errors are considered the cause / hazardous situation? Or simply if it seems I'm on the right track?
I appreciate any feedback, thanks!
My procedure is to consider all potential hazards but the ones that are acceptable don't need to be entered into my risk table. I'd like to know if anyone has guidance on how to understand the relationship between user error and 14971. For example:
Hazard = in this case we're looking at use errors caused by perception, cognition or actions.
Hazardous situations = I think we should be looking at the identified task failures in our task analysis as the cause of the hazardous situation?
Harm = clinician is available to advise
Foreseeable sequence of events = to me this is pretty much inherent in the task analysis exercise since the idea is to identify the primary operating functions and work through all the user steps.
Maybe another way of asking the question is if the identified task failures or use errors are considered the cause / hazardous situation? Or simply if it seems I'm on the right track?
I appreciate any feedback, thanks!