Risk Management Course

I see that my colleague Jim Westgard is providing a risk management course. I’m sure he’ll do well with this, as he has done with all of his other programs but here are some of the challenges:

No perceived need – To engage in a formal risk management program requires a commitment of resources. My perception is that most managers believe they already have a handle on risk management partly because everybody does know something about risk management even though it may not include formal methods. Moreover, the benefit of risk management is preventing problems, which is less appealing to management than revenue generating ideas. (Of course, preventing problems reduces cost, but …).

Moreover, clinical laboratories are used to evaluating things like average bias, imprrecision, and linearity. Even when total error methods are used such as Bland Altman, what’s assessed is the location of 95% of the differences. Risk management looks at a tiny fraction of the results – much less than 5%. And it is not restricted to the analytical properties of the assay. A patient sample mix-up could be just as deadly as an interfering substance.

Along these lines, for industry and clinical laboratories that pass all inspections, there is the notion that everything is ok.

For industry products, where a FMEA or fault tree analysis (FTA) is required by the FDA for product approval, these FMEAs and FTAs are often documentation of the design rather than true FMEAs and FTAs that challenge the design.

Lack of resources – Whereas a formal risk management program is not expensive, it is not free either and today there is a tremendous pressure not to spend. Purchasing software tools is optional. The cost of risk management is mainly time – people spending time in meetings. A couple of times in industry, I was asked to conduct risk management activities during lunch because management couldn’t spare time away from projects. This was a bad sign and had a bad outcome.

Beware of the management of risk management – This is a somewhat tricky subject – full disclosure – Krouwer Consulting provides consulting on risk management. Risk management that encompasses FMEA, FTA, FRACAS, and reliability growth management originated in the defense industry and these methods are widely used in aerospace and automotive besides defense. These methods have been adapted to healthcare and in vitro diagnostics. They are not hard to learn or apply (in my case I knew nothing about these methods until I had guidance from a newly hired expert) but I have encountered people who have either not studied these methods (or have no experience) but are in positions to oversee their use, including writing guidance documents.


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