Table 4.

Implementation of FMEA in analytical phase

Failure mode	Effect	SI	Cause	PI	Control measure	DI	RPI	Proposed action
Malfunction of reagent	Useless result	9	Expired	3	Check expiration date	1	27	None
Malfunction of reagent	Useless result	9	NC storage temperature	6	Visual check of reagent	10	540	Add temperature monitoring system
Malfunction of reagent	Useless result	9	Contaminated	8	QC before run	10	720	Add QC after run
Malfunction of calibrator	Calibration failure	8	Expired	3	Check expiration date	2	48	None
Malfunction of calibrator	Calibration failure	8	NC storage temperature	6	Visual check of calibrator	2	96	None
Malfunction of calibrator	Calibration failure	8	Contaminated	8	Visual check of calibrator	2	128	Freeze single doses and use once

SI severity index, PI probability index, DI detectability index, RPI risk probability index