Abstract

[Please note: This article was also published in the Annual Quality Conference with the QICID number of 10477. Do not order both articles.]

Numerous 483's issued by the FDA have cited sampling plans as not being "statistically valid." So what does it take for a sampling plan to be statistically valid? Selecting statistically valid sampling plans is a two-part process. First, one must clearly define the objective of the inspection. Second, one must demonstrate that the sampling plan allows this objective to be met. This process will be demonstrated through a series of examples.