Test Method Development

It is often forgotten to invest time and ressources into test methods although this is essential to understand manufacturing processes. The results we observe in experiments and validations, are first of all the results measured with the test method. Only if we have an accurate test, we will be able to read the results of the process under consideration. Test method development and test method validation should get a much higher priority in our medical device industry.

ACCEPTANCE CRITERIA FOR PROCESS CAPABILITY INDEXES GENERATED FROM STATISTICAL TOLERANCE INTERVALS AS PER ISO 16269-6

The statement on this page intends to evaluate, if acceptance criteria for Gauge R&R studies could be generated from statistical tolerance intervals calculated as per ISO 16269-6.