Where does FMEA fit in your ISO 14971 Risk Management process?

[Daniel Cruz]

After reading the FAQ and an article titled "Why FMEA is Not ISO 14971 Risk Management," I get that FMEA is only one tool in the process, but I'm trying to understand where FMEA fits in a typical medical device risk management process, and what additional tasks are needed (and in which order they are performed) in order to comply with ISO14971.

Is anyone willing to share a broad outline of their risk management process, or a template (with specific analyses mentioned) that they would follow to meet the standard's requirements? How does an FMEA performed for risk management purposes differ from a DFMEA performed presumably earlier in the design process in terms of scope and timing?

Thanks in advance.

 

[Marcelo]

FMEA is usually used as part of risk analysis, to identify hazards and mostly sequence of events leading to a hazardous situation. You can take a look at the annexed text I suggested tio include in the revision of ISO TR 24971 (the whole text was too much, we will probably include a figure or two only).

 

[yodon]

The System Hazard Analysis is a top down look and the FMEAs provide bottom-up looks. Depending on the product, we do a variety of FMEAs: use FMEA, software FMEA, design FMEA (and process FMEA). So your design FMEA is one part of the whole risk management process.

 

[Daniel Cruz]

Thank you for the replies. What non-FMEA tasks comprise the rest of your risk management process? Fault Tree Analysis? Hazard Analysis?

 

[yodon]

It depends. Certainly the hazard analysis. I've seen Fault Trees used to support the FMEAs.

I see a lot of overlap with Usability Engineering (62366) and a lot of the characterization activities between 14971 and 62366 contribute to the risk analysis. (And if your product has / is software, 62304 requires software-centric risk analysis which also incorporates the SOUP assessment.)

Remember that risk management doesn't stop. You are continually collecting production and post-production data and using that to improve your risk analysis and product.

And, of course, the risk report wraps it all up.

 

[Daniel Cruz]

Thank you replying. Your answer is very helpful.

 

[650_pgk]

My preference would be to eliminate FMEAs entirely from the 14971 RM process.
First, they do not address the normal condition. Second, it seems they are rarely performed well--compare typical results and online examples (e.g. 'component failure' is listed as a failure mode) to the stipulations of and samples in IEC 60812:2018 or :2006.
However, given their pervasivenss, FMEAs can be useful as a familiar means to associate fault conditions and their consequences.

 

[racglobal]

From my experience in two of the companies I've worked at, FMEA is to further break down your hazard analysis. Start with a preliminary hazard analysis (or PHA) to give you a sense of where the hazards are. From there, you do a much more in-depth analysis through an FMEA, to find the causes, the hazardous situations that give rise to the hazards, and the harm. FMEA requires team work and it's better to gather all your design people in one room and brain storm. Finally, for each risk identified, you decide what type of mitigation measure should be conducted. Let me know if this is clear. Anyone else has better suggestions, I would be interested to know.

 

[racglobal]

From my experience in two of the companies I've worked at, FMEA is to further break down your hazard analysis. Start with a preliminary hazard analysis (or PHA) to give you a sense of where the hazards are. From there, you do a much more in-depth analysis through an FMEA, to find the causes, the hazardous situations that give rise to the hazards, and the harm. FMEA requires team work and it's better to gather all your design people in one room and brain storm. Finally, for each risk identified, you decide what type of mitigation measure should be conducted. Let me know if this is clear. Anyone else has better suggestions, I would be interested to know.

Also, it's important to get the vocabulary right. I have read instances where people do not know the difference between a hazard and a hazardous situation.

 

[TorstenKn]

I like this discussion as this reflects my experience in that field.

I would agree that the term FMEA should be eliminated in the context of Risk Management. It is often used as a synonym for the risk analysis, however, if the Risk Management File only includes documents like dFMEA, pFMEA, etc. I already would judge that this Risk Management process is not well understood.

The basic principle is that at least two methods should be used (a bottom-up and a top-down method). In practice, you should look from the hazard-perspective (e.g., which hazards are relevant for my product, which hazardous situations could occur) and from the sequence of events perspective (how is the product being used, what can go wrong or what can happen if nothing goes wrong). This would ensure sufficient coverage of the risks.

I agree with what was said about the vocabulary. This is one of the significant issues that the terms hazard, hazardous situation, and harm are not considered when performing the risk analysis.
Even the examples for hazards in the current ISO 14971 are always compatible with the definition. E.g., the hazards related to labeling are from my perspective not in line with the definition. Therefore I am happy that in the 2019 revision this will be fixed.