EP23 is much improved from its initial state. Skimming it prompted the following comment.
A university comes up with a new marker. It is picked up by a manufacturer, who starts development to commercialize it. This is an opportunity for FMEA. There are no results reported and no observed errors, only the probability of errors.
Towards the end of development, the manufacturer tests the system both in-house and in clinical laboratories (clinical trials). There are still no reported results because the assay is not yet released, although errors can now be “observed” through suitable classification and FRACAS can be used.
The assay is approved and sold. A clinical laboratory buys the assay and before reporting results, can perform FMEA because no results have yet been reported.
Note that the above is for a single assay.
The clinical laboratory starts using the assay and reporting results. The clinical laboratory can track observed errors through FRACAS, and typically, FRACAS is performed for the entire laboratory not just one assay.
Clinical laboratories need to use both FMEA and FRACAS, with FRACAS as probably the major tool used. There is virtually no mention of FRACAS in EP23. Reducing the rate of observed errors reduces risk.