Wayne Taylor

Dr. Wayne A. Taylor The best that I can determine is that the rule probably had its origin in the USDA in the 1920-30’s.  But no confirming documents exist.   There are actually three versions of the rule: Take the square root of the lot size to get the sample size.  Accept on zero defects.   This …

“Square Root of N plus one” Sampling Rule Read More »

Suppose the single sampling plan with sample size n=50 and accept number a=1 is being used.  If a lot is accepted, one can state with 90% confidence that the lot is less than 7.56% defective.  Likewise, if the lot is rejected, one can state with 95% confidence that the lot is above 0.715% defective. The …

Confidence Statements Associated With Sampling Plans Read More »

INTRODUCTION Form 483 is used by the Food & Drug Administration (FDA) for reporting adverse findings resulting from one of their inspections.  Numerous 483’s have cited sampling plans as not being “statistically valid” or as lacking statistical justification.  So what does it take for a sampling plan to be statistically valid? Selecting statistically valid sampling …

Selecting Statistically Valid Sampling Plans Read More »

Dr. Wayne A. TaylorJoyce M. Hansen ABSTRACT ISO 11137 (1995), “Sterilization of Health Care Products – Requirements for Validation and Routine Control – Radiation Sterilization”, provides sampling plans for performing initial verification dose experiments and quarterly dose audits.  Alternative sampling plans are presented which provide equivalent protection.  These sampling plans can significantly reduce the cost …

Alternative Sample Sizes for Verification Dose Experiments and Dose Audits Read More »