Test Method Validation (TMV) Made Easy – Part 2 Attribute Measurements

Part 2 of 2


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

Course description

How do you know you have quality if you cannot reliably measure what you are doing? Worse yet, are you rejecting good product because of errors in test methods? One company rejected US$40,000,000 per year of acceptable product due to a poor measurement system!

These two webinars will help you to evaluate your measurement systems, diagnose problems, AND fix them. How is it “made easy”? Your will use graphical tools and simple metrics to evaluate a measurement system and quickly identify areas to improve the measurement system. It’s as simple as that!

We will cover the details of application together with some examples of best practices in industry. Analysis results and graphics from popular statistical software programs will be illustrated. Participants will gain a working knowledge of how to organize a 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 a background in statistics.

Participants receive a working knowledge of Test Method Validation (TMV), also known as: Measurement System Analysis (MSA) and Gauge R&R (GR&R). Concepts covered are also applicable to Analytical Procedures. The names are not important, the application of this very valuable statistical methodology is essential for a quality system. Thus, the valid statistical techniques satisfy requirements of: the US FDA’s QS and cGMP Regulations, and ISO 13485:2016. In particular, the methodology covered is vitally important for Design Control, Process Validation and Validation of Analytical Procedures.

Part 1: This 2-hour webinar will cover Variable Measurements.
Part 2: This 2-hour webinar will cover Attribute (e.g., pass/fail) Measurements.

Participants who work in laboratories or with certain diagnostic devices may also want to attend the follow-on webinar on Validation of Analytical Procedures.

Program objectives

This webinar will provide a working knowledge of the principles and application of TMV. As such, participants will:

  • Be able to quickly analyze results, diagnose problems, and improve a measurement system
  • Learn the quality metrics and industry standards used to evaluate the effectiveness of a measurement system
  • Know how to interpret the output from popular statistical software tools
  • Understand how to apply this valuable methodology in Design Control, Process Validation, and certain parts of Validation of Analytical Procedures.

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 control; 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