FDA QSIT Sampling Plans

Abstract: This brief uncovers a significant error in the tables of sampling plans on page 107 of the FDA’s Guide to the Inspection of Quality Systems – QSIT Quality Systems Inspection Techniques (1999). The 95% confidence table actually provides 97.5% confidence, and the 99% confidence table provides 99.5% confidence. However, the table on page 90 […]

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