Abstract
ABSTRACT The analysis of product inspection data indicates that the yearly lot rejection rate decreased and stabilized to = 4.5% following the implementation of the Quality Management Program (QMP) in Canada in 1992. For both high and low risk process categories, subsequent QMP inspections resulting in a lower rating have a significantly higher mean time between inspection value. QMP inspections conducted by regulatory staff affected overall QMP performance and the occurrence of deficiencies and unacceptable product increased with the length of time between QMP inspections. It is suggested that the mean time between failure (MTBF) can be used in the scheduling of subsequent QMP inspections providing a just-in-time approach for the deployment of regulatory staff.
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