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 […]
FDA QSIT Sampling Plans Read More »
This is part of a series of articles covering the procedures in the book Statistical Procedures for the Medical Device Industry. Purpose This procedure provides tables and instructions for selecting sampling plans for FDA process validation and design verification to ensure they are based on a valid statistical rationale. These determine the samples size and acceptance
STAT-12: Verification/Validation Sampling Plans for Proportion Nonconforming Read More »
Copyright © 2019 Taylor Enterprises | All rights reserved.
