Risk analysis and evaluation in an FMEA

Failure mode effect analysis (FMEA) is routinely used in the medical device industry for risk analysis, However, when it is the only technique utilized for analyzing the risk of harm in the context of ISO 14971, we run into a lot of problems.

The main issue is that the probability of occurrence of an individual failure mode estimated in an FMEA is not the same as the probability of occurrence of a potential harm that may occur due to that failure mode.

Second, the purpose of an FMEA is to identify potential failure modes, their causes and effects on requirements. An FMEA is primarily a tool to support decisions about treatment actions that may be required to alleviate the impact of potential adverse effects.

It is not an appropriate tool for hazard/harm analysis in the context of ISO 14971.

In this video, I describe an approach to linking your FMEA to harm/hazard analysis and to making risk acceptability decisions.

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