Guide to Validation Sampling Plans
THIS BOOK IS NOT YET AVAILABLE AND DOES NOT HAVE A PUBLICATION DATE SET.
This book focuses on applications of acceptance sampling plans for one-time protocol studies including design verification, process validation and effectiveness checks. These sampling plans make confidence statements like 95% confidence more than 99% of product is conforming to the requirement. Also 95% confidence the relative standard deviation is below 2%. It serves as a basic introduction to acceptance sampling intended for the practitioner. It avoids complex mathematical formulas. Instead, it includes extensive tables.
It will cover the content of the 1-day course Validation Sampling Plans.
It explains the following procedures from the book Statistical Procedures for the Medical Device Industry:
- STAT-12: Verification/Validation Sampling Plans for Proportion Nonconforming
- STAT-13 Verification/Validation Sampling Plans for Rate of Nonconformities
- STAT-14 Verification/Validation Sampling Plans for Average
- STAT-15 Verification/Validation Sampling Plans for Standard Deviation and RSD