The difference b/w FMEA & Risk analysis as per iso 14971

#3
This discussion has been very helpful in how FMEA fits within the risk management. Does anyone have any suggestions on best practice for keeping the risk evaluations aligned for risk acceptability levels when using a risk analysis top down approach and an FMEA bottom up approach within the same risk management system?
 

Marcelo Antunes

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#4
This discussion has been very helpful in how FMEA fits within the risk management. Does anyone have any suggestions on best practice for keeping the risk evaluations aligned for risk acceptability levels when using a risk analysis top down approach and an FMEA bottom up approach within the same risk management system?
What exactly do you mean by that? If you are talking about risk "levels" or numbers, those have nothing to do with risk acceptability in principle, so I would suggest you rethink your concepts (unfortunately, there's a spread misunderstanding of what the risk acceptability criteria is, mainly due to the spread misuse of risk matrices).
 
#5
I am thinking about that the FMEAs often are looking at probability of failure of a component or process and it doesn’t always seem to be translated to probability of a hazard leading to a hazardous situation leading to harm. In many I have seen it seems to stop well short of this. (This may be why there is so much discussion surrounding if FMEAs should be used under 14971). When this happens, there appears to be a disconnect between the two types of analysis. When they are reviewed side by side it can appear that different amounts of risk are acceptable for a product.
 

Marcelo Antunes

Addicted to standards
Staff member
Admin
#6
I am thinking about that the FMEAs often are looking at probability of failure of a component or process and it doesn’t always seem to be translated to probability of a hazard leading to a hazardous situation leading to harm. In many I have seen it seems to stop well short of this. (This may be why there is so much discussion surrounding if FMEAs should be used under 14971). When this happens, there appears to be a disconnect between the two types of analysis. When they are reviewed side by side it can appear that different amounts of risk are acceptable for a product.
FMEA was created as reliability analysis tool to verify the possible failures modes of components and the associated effect on the equipment/system.

Harm (as in patient harm) is related to things outside the equipment/system (meaning, what happens to the patient/user/etc.), so it cannot be evaluated by an FMEA.

That's the reason it's not translated, that's because it cannot be translated.

Also, the amount of risk (probability x severity), although expected to be estimated, is not the only topic in determining risk acceptability, in fact most of the time the "level"of risk has no direction implication in the risk acceptability decision - for example, when you use a good practice argument (such as a standard), the level of risk is not a part of the acceptability decision.
 

Ronen E

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#7
@Sarah_O Personally, when I conduct a risk evaluation to ISO 14971 I hardly ever apply FMEA (where it's my decision to make). It's not required by the standard, though it's suggested as one of the available analysis methods. In essence, I see ISO 14971's paradigm as a top-down one, while FMEA is a bottom-up one. Some people argue that FMEA helps identify issues that might otherwise "escape" a top-down analysis. Maybe it's true, but in my opinion for simple to moderately-complex devices the (little, if any) added value doesn't justify the hassle. FMEA is, however, important when dealing with systems and complex devices, where the effects of a seemingly minor component failure can lead, through an intricate chain of events/effects, to a disastrous outcome at the entire device or system level, and sometimes to the user/patient.

BTW, don't be misled - there is no direct correlation between the complexity of the device and the risk to the user/patient. Simple devices (even a single component devices) can pose great risks.
 

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