Validation Sampling Plans II (1-day)

Instructor

Dr. Wayne A. Taylor

Course Objective

This course is a continuation of Validation Sampling Plans that shows how to cover other statistical properties like rates, average, standard deviation and relative standard deviation.  This includes reliability testing and demonstrating homogeneity.  It covers the following procedures from Statistical Procedure for the Medical Device Industry:

  • 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. 
  • STAT-17     Statistical Techniques for Reliability Life Testing

It also covers equivalency testing:

The course shows how to:

  1. Justify the sampling size and acceptance criteria selected based on the claim that can be made by 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 that plan which offers 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 samples sizes and acceptance criteria for one time studies.  No prior knowledge or special background is required.

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 and double.
  • How to increase the chances of a good product/process passing a validation using double sampling plans.
  • How to write protocols to handle contingencies so to avoid deviations.
  • Practical considerations including selecting representative samples.

Primary Audience

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

Course Outline

  1. Overview
  2. Nonconformities per Quantity
  3. Average
  4. Standard Deviation
  5. Relative Standard Deviation
  6. Equivalency Testing
  7. Difference Between Two Averages
  8. Ratio of Two Standard Deviations

Software

Excel file STAT-12 to 16 – Confidence Intervals and Equivalence Tests.xlsx from book Statistical Procedures for the Medical Device Industry.

Prerequisites

Related Courses