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Multiple-stage Sampling Procedure for Lot Release With Consideration of oth Manufacturer's and Consumer's Risk

Title
Multiple-stage Sampling Procedure for Lot Release With Consideration of oth Manufacturer's and Consumer's Risk

Abstract
Sampling inspection is implemented to ensure the quality of a biological product before its release to the market. However, the existing procedures in sampling inspection for lot release focus on the manufacturer’s risk. If both risks are accounted for, a much larger sample size would be required under certain circumstances. Sometimes the sample size might be too large to be implemented in practice. This article first illustrates the sampling process using the American National Standard, and then proposes a multiple-stage sampling procedure for lot release with control of both manufacturer’s and consumer’s risks at prespecified levels. Examples are presented to illustrate the use of the proposed procedure. Issues for lot release and the use of different sampling procedures are discussed.