Risk Management and the Obstructionists

I have been peripherally involved in a CLSI standard about risk management, which IMHO is floundering. My suggestion to right things by simply using standard FMEA and FRACAS methods was rebuffed as too complicated and that quantifying error rates wasn’t needed. It was suggested that taking “baby steps” are needed.

Well there’s nothing more fundamental – I wouldn’t call them baby steps – than measuring an error rate. Without quantifying where you are, there’s no way to know when you’re done or how effective your improvement program is.

And rather than trying to measure 27 different error rates, one can combine all errors into one rate by classifying each error type as to its severity. This is how FRACAS works:

1. Observe and classify errors
2. Measure the error rate
3. Rank errors using a Pareto
4. Propose fixes for the errors at the top of the Pareto
5. Go back to step 1

And these steps are not complicated!