Company License to STAT-12 Verification/Validation Sampling Plans for Proportion Nonconforming
STAT-12 of the book Statistical Procedures for the Medical Device Industry 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 criteria. They make confidence statements like 95% confidence the process or device is more than 99% reliable or conforming. These sampling plans are often referred to as confidence reliability sampling plans. They are for the statistical property proportion conforming or nonconforming. They require that requirements be established for individual units of product. They apply to design verification (STAT-04), process validation (STAT-03), validation of a pass/fail inspections (STAT-08) and CAPA effectiveness checks (STAT-07).
This is a company license granting limited copyrights to the procedure allowing a company to incorporated all or part of the procedure into their own internal procedures.