Potential Risks and Real Problems

I’ve never been that good at making up potential problems – so here’s a real one: “Roche Diagnostics Announces Nationwide Recall on Medical Device Used to Determine Blood Clotting Time” see – http://www.fda.gov/oc/po/firmrecalls/roche10_06.html .

It’s not my intention to criticize Roche as problems occur across all companies. What’s more of interest is to illustrate some observations of standard’s groups, particularly as there is one standard in development (CLSI EP 22) which attempts to allow manufacturers to reduce QC (quality control) frequency of diagnostic assays by using risk management techniques.

Although (as an advisor to the group) I have not been to any of the face-to-face meetings, I have participated in EP22 teleconferences and have been at many other CLSI face-to-face meetings. Such meetings are often held in hotel conferences rooms, where there are comfortable chairs, an ample supply of fresh coffee, croissants, and the promise of lunch around the corner. As one relaxes, one might hear how through fault tree analysis, the potential problem ABC has mitigation XYZ applied to it so that it will never occur.

Yet in the real world, things are not that simple (or slow paced). Using the formal language of risk management, one must also consider

  • have all potential problems been identified
  • are all mitigations 100% effective – many are not
  • what about the softer, non technical issues that hardly ever appear in a fault tree regarding staff, materials, and the working environment

One of the advantages of quality control is that for some problems, quality control will expose problems, regardless of whether one has knowledge of the problem source. Ironically, as a consultant I have heard during discussions where a problem has occurred – “that shouldn’t be an issue if customers run QC”.




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