Task analysis and ISO 14971

h689e2NR2ok4mceQ

Starting to get Involved
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!
 

Marcelo

Inactive Registered Visitor
Failures or use errors are part of the sequence or combination of events that lead to the hazardous situation, so no,k they are not the hazardous situation.

The hazardous situation is the patient/user/other exposure to the hazard.
 

h689e2NR2ok4mceQ

Starting to get Involved
Thanks Marcelo, that's exactly the sort of guidance I was looking for!

Use errors are a bit difficult but I found some examples in 62366 annex B that I overlooked because they're mixed in under 'hazard-related use scenarios'.
 

h689e2NR2ok4mceQ

Starting to get Involved
Failures or use errors are part of the sequence or combination of events that lead to the hazardous situation, so no,k they are not the hazardous situation.

The hazardous situation is the patient/user/other exposure to the hazard.

One more question, does that apply to FMEA as well? Are there any fast rules as to how the failure effects and causes line up?

Thanks!
 

sagai

Quite Involved in Discussions
Fast rule is to involve a loads of common sense and medical domain expertiese for all of these wanderings.
Regards
 

sagai

Quite Involved in Discussions
Sorry to here that my wording received condescending. It was not the purpose at all.

More was on that all these risk analysis activities are in a universe of immense uncertainties. Reassurance that the works we have done for all of these were appropriate and effective matures over the years.
 

h689e2NR2ok4mceQ

Starting to get Involved
Thanks for following up, I took that I was asking too many and unrelated questions about risk analysis techniques and 14971. You are correct about the uncertainties involved and we're at the point of setting up a new risk management program for a new type of product, so it's doubled.

Good advice, thanks and cheers :beers:
 

Marcelo

Inactive Registered Visitor
One more question, does that apply to FMEA as well? Are there any fast rules as to how the failure effects and causes line up?

Quick answer is you should not use FMEA as a basis for fulfilling ISO 14971. Causes and effects on an FMEA are, usually, part of the sequence of events in the ISO 14971 model. The effects (on the device) are not hazardous situations, because the hazardous situations are the exposure of the patient/user/etc. to the harm.
 

h689e2NR2ok4mceQ

Starting to get Involved
Quick answer is you should not use FMEA as a basis for fulfilling ISO 14971. Causes and effects on an FMEA are, usually, part of the sequence of events in the ISO 14971 model. The effects (on the device) are not hazardous situations, because the hazardous situations are the exposure of the patient/user/etc. to the harm.

Thank you, it's helpful to think about causes and effects that way. Yes, I understand FMEA is not a basis for fulfilling ISO 14971. I'm looking at FMEA in terms of identifying a hazardous situation from a sequence of events and managing the risk in 14971.

Thanks again
 
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