Quality-control (QC) performance measures and the QC planning process.

Abstract

Numerous outcome measures can be used to characterize and compare the performance of alternative quality-control (QC) strategies. The performance measure traditionally used in the QC planning process is the probability of rejecting an analytical run when a critical out-of-control error condition exists. Another performance measure that naturally fits within the total allowable error paradigm is the probability that a reported test result contains an analytical error that exceeds the total allowable error specification. In general, the out-of-control error conditions associated with the greatest chance of reporting an unacceptable test result are unrelated to the traditionally defined "critical" error conditions. If the probability of reporting an unacceptable test result is used as the primary performance measure, worst-case QC performance can be determined irrespective of the magnitude of any out-of-control error condition that may exist, thus eliminating the need for the concept of a "critical" out-of-control error.