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.

[ReliaMitch]

Very nice discussion Dr. Agarwal. Your overview is very instructive for those trying to learn how FMEA fits into a robust Risk Management architecture. One of the key takeways was needing to know the hazard (or hazards) associated with the failure of the system to achieve a function. Doing this can greatly help the engineers conducting the Design Analysis to focus on what they are experts at, how often will the design fail rather than trying to guess how often that failure will result in harm. The variety of outcomes and harm severities frequently trips up engineers trying to assign occurrences in FMEA and can make those meetings much more tedious than necessary. Focus on the occurrence of the failure mode, not the harm. The harm 'math' can be done later in the Risk Analysis.

[AnilKumar-yviu]

Does probability of occurrence scoring criteria changes every time we revise FEMA