Assessing Hazard-Related Use Scenarios where control measures exist through standards

ThatSinc

Involved In Discussions
#11
To understand whether I'm on the right track, for the use scenario of "acknowledgement of alarm signals" the following:

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It seems redundant to include one for every potential alarm condition as the causes are the same, and therefore recommendations and subsequent control measures are relevant to all - however the effect and severity would differ between a low battery alarm, and an over-delivery alarm.
In my 60601-1-8 documentation for assignment of alarms each alarm condition is designated by the potential harm the condition could cause and onset etc. so it again feels like double documenting everything.


As a side note, as this has gone off of my original subject, Is it possible for a moderator to change the title to something more appropriate such as "Usability integration with DIRs and RMF"
 
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indubioush

Quite Involved in Discussions
#12
This looks good, but hard to know if you are fully on the right track without looking at all documentation. I think maybe don't worry about doing things in the hypothetical right way. Just know the requirements of the standards and try to think about compliance to ALL risk-related standards as you are creating these documents.

I get your worry about double documenting things. For me, hazard-related use scenarios ARE hazardous situations. I just ensure that I provide the detail needed to be compliant with IEC 62366-1. At the same time, these hazard-related use scenarios are analyzed, evaluated, and controlled just like any other risk per ISO 14971. Same scoring and connected to the hazard analysis in the same way as other FMEA documents.

Considering your example of the alarms, each of these is a unique risk. Therefore, each unique risk should go through the ISO 14971 process. This means that either in your uFMEA or hazard analysis, you need to add in associated harms, risk control measures, occurrence, risk level, etc. Example: Do you really need a "recommended actions" column, or could this instead be "risk control measures"?

Also, I'm not familiar with 60601-1-8, but if possible, you should integrate this into your existing documentation. You can set up an easy way to extract the 60601-1-8 information if needed.

Just my OPINION.
 

ThatSinc

Involved In Discussions
#13
Thanks for the feedback, it's given me a lot to think about.

Agreed on recommended actions, the uFMEA could incorporate the same elements as the hazard analysis and then be summarised with the hazard analysis in the risk report, rather than being rolled up into the hazard analysis.

That removes a decent amount of double documenting, whilst simultaneously allowing the uFMEA the freedom to document the analysis of use hazards clearly.

I'll attempt to sleep on it and see how it goes tomorrow.

Thanks
 

Tobias_HF

Starting to get Involved
#14
So for your uFMEA you use different scoring criteria to your "main" risk file?
Yes, but its only one kind of scoring. Either its a risk --> goes to the RA. In there, the RA scoring criteria apply.
Or its not a risk --> stays in there for further observation and proove we had thought about that. And it may become a risk in the future, for example when during a formative study / Post Market surveillance one of these Ooops! moments happens... :-/
...enter the harsh reality of usability tests... ;-)

Is this criteria documented as a part of your usability engineering process?
Yes, but its a 2021 goal for me... still needs some alignment.

As any identified hazard/hazardous situation from a hazard use scenario is mapped forward/upward into the 14971 risk file and assessed there for probability and severity, is there any requirement to document an occurrence rate within the uFMEA?
I would do severity only, in the uFMEA, like risk/no risk.
Have seen this probability (and detectability!!) as well, I don`t like it. Someone tried to argue "but it happened only twice in the formative study!" but yeah, definitely no.
However, I might use PMS data in the future, if its trustworthy, to raise something up to a risk level. We all know if something small, annoying happens frequently, users will somehow find a workaround. And this might be bad, so it could lead to a hazardous situation. In this case, I would have a look at probability / occurence, but only in our PMS usability review (yes we do that annualy).
 

Tobias_HF

Starting to get Involved
#15
Agreed on recommended actions, the uFMEA could incorporate the same elements as the hazard analysis and then be summarised with the hazard analysis in the risk report, rather than being rolled up into the hazard analysis.

That removes a decent amount of double documenting, whilst simultaneously allowing the uFMEA the freedom to document the analysis of use hazards clearly.
Another thing to consider: we should also document known use errors from previous / competitor devices. I found this helpful to be in the uFMEA (written) report. It somehow never really fit into the RA.... because especially the competitor devices use errors come in all different formats, I have no idea how they were classified by the competitors... so the uFMEA report gives me a bit more freedom to document, analyse them and draw our conclusions.
For my cases, this really prooved to be very practical.
 
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