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.
Attached files:
Mikes rule to detect sources of variation The Range/xbar Test
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