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

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#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

Inactive Registered Visitor
#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

Inactive Registered Visitor
#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

Problem Solver
Staff member
Moderator
#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.
 

moritz

Registered
#8
Everybody keeps saying that FMEA is a purely bottom-up methodology but the VDA/AIAG guideline on FMEA explains how it can be used on complex systems in a top-down way as well (since 1996!). You start with your system structure, identify the necessary functions of each element in that system, then the failure modes and finally the causes/effects and the evaluation. Creating FMEAs this way is maybe more difficult than a bottom-up brainstorming approach but prevents you from forgetting systemic part interactions that are not necessarily self-explanatory or easy to spot.

We use a 14971 risk analysis approach that includes user errors and forseeable device failures to generate requirements for our devices. Then, after the technical requirements have been defined, we use such a systematic FMEA to discover what could lead to the device not performing as intended. This helps us to identify and document design outputs essential for safe use, create a quality control strategy and even develop safe production processes.
We inherit the severity in that device DFMEA from our high level risk analysis (i.e. if a component failure could lead to a patient risk, its severity is identical to the respective severity within our 14971 risk analysis)
 

indubioush

Quite Involved in Discussions
#9
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.
The FMEA process can help you define the P1 probabilities. Then, using a hazard analysis or other documentation, the risk is determined by connecting the P1 from the FMEA to the P2 in the hazard analysis. If using both FMEA and another top down analysis, the two should have linkages. With that said, some companies call their document an FEMA, even when it is not a true FMEA, meaning it deviates from the IEC 60812 standard. Some of these "FMEA" documents are more like hazard analysis documents that meet the requirements of ISO 14971.

My opinion is that high risk devices benefit from bottom up and top down, but low risk devices do not.
 
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