Validation Sampling Plans (1-day)


Dr. Wayne A. Taylor

Course Objective

This one-day course is designed to help you select sampling sizes and acceptance criteria of one-time studies like process validation, design verification, component qualifications, CAPA effectiveness checks and validation of attribute test methods.  It covers the sampling plans in STAT-12, Verification/Validation Sampling Plans for Proportion Nonconforming, of the book Statistical Procedures for the Medical Device Industry.  It also covers the applications of these sampling plans to Process Validation (STAT-03) and Design Verification (STAT-04).

The course shows how to:

  1. Justify the sampling size and acceptance criteria selected based on the claim associated with passing a sampling plan.
  2. Select a variety of sampling plans, all of which allow this claim to be made.
  3. Select from among these sampling plans the plan offering the best balance between the number of units tested and the risk of failing the validation.

This course is task orientated in that it provides all the knowledge and tools required to accomplish the task of selecting sample sizes and acceptance criteria for one-time studies.  No prior knowledge or special background is required.

This course focuses on demonstrating the proportion nonconforming meets a defined level. Passing the sampling plans allows one to make a statement like with 95% confidence there is less than 1% nonconforming, or equivalently with 95% confidence there is more than 99% conformance.  Validation Sampling Plans II covers other statistical properties like rates, average, standard deviation, and relative standard deviation.

What You Will Learn

  • How to determine what claims can be made when passing a sampling plan.
  • How to select a sampling plan to make a specific claim.
  • How to use different types of sampling plans, including single, double and variables.
  • How to reduce the number of units tested using variables plans.
  • How to increase the chances of a good product/process passing a validation using double and variables plans.
  • How to write protocols to handle contingencies to avoid deviations.
  • Practical considerations including selecting representative samples.
  • Application to process validation, including OQ and PQ.
  • Applying to design verification, including alternatives to sampling plans. 

Primary Audience

This course is designed for those individuals who select sampling plans for verifications, validation and other one-time studies and those who manage such activities. This includes engineers, manufacturing and quality supervisors, and management. No special statistical or mathematical background is required.

Course Outline

  • Overview
  • Single Sampling Plans
  • Describing Protection – OC Curves, AQL and RQL
  • Double Sampling Plans
  • Variables Sampling Plans (and Normal Tolerance Intervals)
  • Tables of Validation Plans
  • Application to Process Validation (STAT-03)
  • Application to Design Verification (STAT-04)



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