What part of ISO 14971 does FMEA address?

RCW

Quite Involved in Discussions
#1
Do the "Potential Failure Mode" and "Potential Effects of Failure" columns of an FMEA address what is required in ISO 14971 - 4 Risk Analysis?

What about "Potential Causes / Mechanisms of Failure" and "Current Design/Process Controls" for ISO 14971 - 5 Risk Evaluation?

Any Recommended Actions should address ISO 14971 - 6 Risk Control, correct?

Note: The headings I used above were off my FMEA form which was derived from other forms found on the web. Specific names for these might vary from form to form.

Overall, I am trying to figure out how the use of the FMEA process and FMEA form fits into ISO 14971. (and yes, I already looked at Annex G in the spec)
 
Elsmar Forum Sponsor
A

arios

#2
An FMEA will help you address various parts of the Risk management process. For instance it is related to section 4.4 for risk estimation, section 5 to identify when risk reduction is necessary, it also fits into section 6.3 of the standard where you record the "appropriate" measures of control, etc.

Bottom line, an FMEA would not fit into a single part of the risk management process but several.

Hope this helps
Alberto
 

pkost

Trusted Information Resource
#3
FMEA is a process to identify risk and assign severity and probabilities; in and of itself it is insufficient to meet the requirements of ISO 14971.

ISO 14971 is to do with risk management and therefore risk analysis is only a small aspect of what it covers.

As part of your FMEA process you will presumably have a template which you fill to document your risk analysis. This can certainly be written in such a way to meet the requirements of part 4 and 5. You may struggle to use it to justify things like risk/benefit analysis as required by part 6.5 as well as 6.6 (risks arising from risk control measures)
 
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