I was at the Quality in the Spotlight conference in Antwerp, Belgium, which as always was enjoyable. There were several talks about risk management, and the CLSI guideline EP23. (My main talk was about error grids). I found it strange that several people referred to me as the expert in risk management. Now I have studied risk management techniques such as FMEA, fault trees, and FRACAS, attended conferences such as RAMS (Reliability and Maintainability Symposium), practiced all of these techniques for years, and consider myself competent, but not an expert.
I think the problem is that many people in clinical chemistry have little knowledge or experience with formal risk management techniques so relatively speaking I appear as an expert to them.
This reminds me of an EP23 phone conference meeting several years ago, where one of the subcommittee members said “now let me get this straight, when you’re performing risk management, you’re ….” and this person tried to go through the steps of a FMEA pretty much like a person trying to understand football – so if you make 10 yards, then you keep the ball, right? Of course, the problem was that this person was a member of the committee – most of the other members were at a similar knowledge level – but committees are generically called a committee of experts.
If there is a subcommittee on a statistical topic, then it is understandable that not all committee members are competent in the statistics at hand but risk management is different. There is nothing complicated about risk management – anyone can learn it.
But anyone can also not learn it with the result that a committee can easily go astray. So the CLSI risk management documents are:
EP18A2 – the formal techniques of FMEA, fault trees and FRACAS. The examples in EP18 are poor because no one could contribute real examples and that it what is needed.
EP23A – is a deviation from the formal techniques, IMHO because no one knew enough about the formal techniques and hence they did what thought seemed ok. The example was also poor because it was constructed.
And now there is the EP23 workbook – the book to explain the book – always a bad sign, although I have not seen this yet.