Validation: When is a Test Method Not a Test Method?

How can one site conduct and pass several gage Repeatability and Reproducibility (R&R) studies on a product, yet another site fails the gage R&R on the same product using the same gage and the same test methods?  In his presentation to industry professionals at the 23rd Annual Validation Week, Mohit Malkani, Director of Engineering Services at BioTeknica, provided an in-depth look on how to “Plan and Execute a Successful Test Method Validation (TMV).”

During this interactive workshop, Mohit covered several topics, including the importance of language measurement, learning how to perform a Variable and an Attribute TMV, and interpreting the results.  As Mohit explained, “The purpose of a Test Method Validation is to demonstrate that the measurement system is delivering a result that is true and the Test Method actually performs as intended.”

Some of the areas covered in the workshop:

• Classification of Test Methods
• Understanding when a TMV is required and what are its prerequisites
• Sources of process variation
• Planning, designing, and performing a Gage R&R study; interpreting the results and improving the gage
• Guard banding
• Destructive tests
• Attribute TMV

BioTeknica provides this comprehensive TMV training on site.