Risk management for analytical methods based on the total error concept: Conciliating the objectives of the pre-study and in-study validation phases

A crucial point is to ensure that the decisions taken at the pre-study stage and in routine use are coherent. More precisely, a laboratory should not see its method rejected in routine use when it has been proved to be valid and remains so. This paper shows how this goal may be achieved by choosing compatible validation parameters at both pre- and in-study levels.