I had occasion to view a presentation about FMEA, presented at the 2006 CLSI forum. It may be viewed at http://www.fmeainfocentre.com/presentations/FMEA_clinical.pdf. There are some serious issues with this advice on how to perform a FMEA, which can be summarized as follows.
Detection is listed as an item to be classified (added to severity and probability of occurrence). I have advised against this previously.
The RPN (risk priority number) is examined after mitigations have been put in place. See this essay, as to why this can cause problems.
And perhaps worst of all, patient safety events and potential non patient safety events are in the same classification scheme. For example, 10 = injury or death, 9 = regulatory non compliance. This means that in a Pareto chart, one could be worrying about documentation issues more so than killing someone – sorry but that’s a fact.
Severity = 10, probability of occurrence = 1, detection = 5, RPN = 50 Severity = 9, probability of occurrence = 8, detection = 5, RPN = 360
I covered this in detail in my book, Managing risk in hospitals.