Risk analysis and evaluation in an FMEA

[@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-yv4iu]

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

[@NaveenAgarwalPhD]

Hi Anil, good question - you should define your criteria in the risk management plan. Generally, they should not change over time for the same device unless you have a good reason to do so. However, you can use different criteria for different products based on their technological characteristics, maturity level etc.