Where does "as far as possible" stop? FMEA - EN 14971

Ronen E

Problem Solver
Staff member
Moderator
#11
You stated that you could only reduce this risk by doing a device redesign, which is not possible at this time; therefore, this risk is already as low as possible.
Not that I agree with the AFAP approach (not in the least), but this is not how AFAP (or "ALAP", as sometimes misphrased) is defined. When a member of a commercial outfit states that something "is not possible at this time", it usually means that it makes little (or no) business sense to do it, which has been de-legitimised by EN ISO 14971:2012 for AFAP purposes.
 
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Ronen E

Problem Solver
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#12
Yes I am because if you look at the risk matrix Table D.3 in EN 14971:2012, the lowest severity is defined as "inconvenience". If you've a relatively high occurrence of inconvenience, you've essentially got a business risk - you're not endangering anybody, but people will stop using your device.

What you're saying makes total sense to me, but I just can't reconcile it with 14971 which seems to be telling me to either a) redesign to drive down the occurrence of a minor risk, or b) make a statement in my risk analysis that I have reduced the minor risk to as far as possible (or per John P comment, "as far as possible usiing current state-of-the-art solutions").

My understanding of ISO-14971 is that we can stop trying to reduce risk when the risk is low (ALARP), but for the EN version, we have to keep trying until "as far as possible".
This is the only antidote to EN ISO 14971:2012 known to me:
 

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DamienL

Involved In Discussions
#13
There is no risk unless there is harm to the user or patient.
This is where I was going wrong. I was trying to assess all risks resulting from product failure or misuse. And a lot of these risks do not create hazardous situations, but rather potential for incovenience/frustration. So thanks for putting me straight on that.
 

DamienL

Involved In Discussions
#14
This is the only antidote to EN ISO 14971:2012 known to me:
This document is great. I hand't come across it before. My reading of EN 14971 had been that I needed to consider reducing all risks as far as possible - even the accepable ones (content deviation 2b). However, the consensus paper states that "the manufacturer can justify ceasing further risk reduction where it is determined that the risk is acceptable". I must say I don't really understand why the consensus paper says that. It seems to contradict deviation 2b, but I'm happy to go along with it and start focusing on the reals risks instead!!
 

Ronen E

Problem Solver
Staff member
Moderator
#15
I must say I don't really understand why the consensus paper says that.
Call it "politics" or "power struggle" or whatever.
When EN ISO 14971:2012 came out there was a big outroar that never fully died out since. Initially there were a lot of fierce debates for and against (Elsmar holds some of that good stuff), but at some point there was nothing else left to say, and we got a little weary, and it seemed like the trench-lines have pretty much settled, so we started waiting for 1918 to come so we could all go home.
Anyway, the point is that there seem to have never been a broad agreement, and there still isn't, and everyone is just trying to get along somehow - not by means of clear rationales across the board, but more through negotiating agreement case-by-case (i.e. specific company and NB).
The "consensus paper" doesn't really represent a consensus. First, not all NBs subscribed to it. Second, it was never endorsed by any official arm of the EU (let alone the Commission).
If your NB subscribed to it / goes by it, good on you. If not, it'll at least give you some ammo, and some reassurance that you're not crazy or stupid, despite what your NB says.
 

Tidge

Trusted Information Resource
#16
This is where I was going wrong. I was trying to assess all risks resulting from product failure or misuse. And a lot of these risks do not create hazardous situations, but rather potential for inconvenience/frustration. So thanks for putting me straight on that.
With the possibility of confusing things: while user annoyances and dissatisfaction are unlikely to contribute to unacceptable risks (in the sense that safety = freedom from unacceptable risk), I expect that such (low severity) concerns will play a role in the usability analysis of medical devices. Our experience with our European NB has been that there is minimal (at present) concern on this front; they have been primarily focused on ALAP.

For the time being, I would appropriately rate the annoyances in terms of severity (almost certainly at the lowest end of your severity scale) and proceed as you would with all your other risks. This would allow a jumping off point for a usability analysis, and if your quality system requires you to analyze customer complaints through the lens of risk analysis you will have levers to exercise.
 

DamienL

Involved In Discussions
#17
Thanks all for the insights, and esp the historical perspective. I might not have the gold standard for dealing with this 'As Far As Possible' mullarkey, but at least I'm now comfortable with that, and know how to formulate a defendable position!
 

indubioush

Quite Involved in Discussions
#18
Not that I agree with the AFAP approach (not in the least), but this is not how AFAP (or "ALAP", as sometimes misphrased) is defined. When a member of a commercial outfit states that something "is not possible at this time", it usually means that it makes little (or no) business sense to do it, which has been de-legitimised by EN ISO 14971:2012 for AFAP purposes.
Fully agree with you, Ronen. You cannot limit risk control because of economic factors. However, the OP made it seem like the device would need a redesign to fix the minor annoyance. And of course this would not be done for such a minor issue. This combined with the expectation that manufacturers label all risk as "ALAP or "AFAP" causes a conundrum. If I was forced to include the annoyance in my risk analysis, I would have no problem labeling it as AFAP. Maybe it is a minor fudge on the requirement, but when it comes to risk management, you have to keep reminding yourself to keep things reasonable.
 

DamienL

Involved In Discussions
#19
If I was forced to include the annoyance in my risk analysis, I would have no problem labeling it as AFAP.
Going fwd we will try to ensure our risk analysis is dealing with real hazards, not annoyance/nuisance. However, where these do crop up, this is exactly how we will handle it. Thanks.
 

Watchcat

Trusted Information Resource
#20
Don't know what kind of device you are dealing with, but there are devices for which annoyance/nuisance can create a real hazard, if they lead to the device not being used as intended. This is most commonly seen with products with which compliance/non-compliance with IFU is clinically important to safety and/or effectiveness. There is also the business risk of why buy your device if there is another one available that is less annoying.
 
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