ENSURING YOUR MEASURING SYSTEM CONSISTENTLY

PROVIDES VALID MEASUREMENTS

When you need to perform test method validation (TMV) in design verification or process validation, I can help you do the following:

• Prepare and execute a Master Test Method Validation Plan that will describe the test methods to be validated within a project, and the logistics and validation methodology. 

• Prepare and execute Test Method Validation Protocols that will describe how test methods would be validated, required test equipment, acceptance criteria, gage R&R studies, etc.

• Prepare Test Method Validation Reports that will summarize TMV outcome and address non-conformances or deviations.

Typical pre-requisites before the test method validation can begin would be:

• Installation Qualifications (IQs) were completed for equipment and fixtures.

• All equipment is traceable in the asset database.

• Equipment documentation is current and approved.

• Maintenance procedures for all equipment are up to date.

• Equipment that requires calibration is calibrated.

• Calibration range, frequency, and resolution are suitable for the intended use.

• Software validations are complete for testing or data collection software, where applicable.

Test method validation acceptance criteria must meet the pre-established by the company’s procedure Gage R&R percent precision to tolerance evaluation (%P/T) for one-sided and two-sided specifications. Usually, a Minitab software is used to calculate %P/T, which must be less than 30% to be acceptable, with less than 10% being excellent.

Click here to learn about my hands-on experience with non-destructive test method validations - probably your company already uses this approach and I could successfully replicate it at your company.

To discuss how I can help you with Test Method Validation, contact me here.