Test Method Validation (TMV) Made Easy – Part 2

Part 2 of 2


Click here for Part 1 »
Note. It is not a requirement to attend both TMV webinars.

Course description

In the previous webinar we asked: “How do you know you have quality if you cannot reliably measure what you are doing?” This second webinar will focus on Attribute Measurement Systems – that is, the subjective inspection of items to see if they satisfy requirements. Since humans are the “gauges”, attribute measurement systems can have high variation. How do you evaluate this human judgement and how can you improve their results? And how is it “made easy”? This webinar will provide simple metrics to evaluate the human performance and industry best practices to reduce variation. It’s as simple as that!

Test Method Validation (TMV), also known as: Measurement System Analysis (MSA) and Gauge R&R (GR&R). The name is not important, the application of this very valuable statistical methodology is essential for a quality system. The material covered in this webinar is completely independent of the first webinar on Variable TMV. Thus, attending the first webinar on Variable TMV is NOT a requirement to attend this webinar.

Attribute measurements typically end up with a “Pass/Fail” or “Accept/Reject” decision. This webinar provides a very practical approach to conducting Attribute TMVs. Participants will gain a working knowledge of how to organize an Attribute TMV, collect data, analyze the results, and improve the measurement system.

The presenter’s “keep-it-simple” approach will avoid statistical complexity – participants do NOT need to have a background in statistics.

This webinar is targeted to professionals concerned with the application of valid statistical methods and tools to satisfy the requirements of the FDA’s Quality System Regulation and ISO 13485:2016. In particular, the Attribute TMV methodology is important for Design Control and Process Validation.

Program objectives

This webinar will provide a working knowledge of the principles and application of Attribute TMV/MSA/GR&R. As such, participants will:

  • Learn the quality metrics and industry standards used to evaluate the effectiveness of a measurement system
  • Understand how to quickly analyze results, diagnose problems, and improve a measurement system
  • Understand how to apply this valuable methodology in Design Control and Process Validation
  • Learn some techniques to deal with destructive testing


  • Review of Questions from Part 1 Webinar on Variable TMV
    • Destructive Testing – Four Techniques from Industry
    • Address Emailed Questions
  • Fundamentals of Attribute TMV/MSA/GR&R
    • Definitions & Terminology
    • Quality System Regulation & Guidance Documents
    • Significant Trends and FDA Warning Letters
  • How to Run an Attribute TMV
    • Organizing an TMV
    • Conducting an TMV
    • Improving an Attribute Measurement System
    • Industry Best Practices
  • Technical Details
    • Attribute TMV Metrics
    • Sample Size
  • Question and Answer Period

Who should attend

This webinar is targeted to professionals concerned with the application of valid statistical tools and methods to meet requirements of regulatory agencies and industry standards. As such, the content should have great value to individuals in industry who are involved with: research and development; new product development; process development; manufacturing, process, and quality engineering; operations; quality assurance; and regulatory compliance. In addition, managers and members of the leadership team will see how value is added to a product or process by applying this valuable methodology.


There are no prerequisites for these webinars. No background in statistics is necessary. That is the foundation of our “keep-it-simple” approach.


IndustryMedical Device
LevelBasic, Intermediate

Peter L. Knepell




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