Validating destructive test methods

by  |  22-Sep-2018 16:31

The test set up must be installed based on the protocol (IQ) The test results must give you consistently exceeding the required mechanical requirement, over the test samples that are taken up for this activity.Tests can be done by one qualified engineer and you are all done.

The Global Harmonization Task Force (GHTF) defines process validation as a term used in the medical device industry to indicate that a process has been put to such scrutiny that the result of the process (a product, a service or other outcome) can be practically guaranteed.

One must also be aware of the definition of verification.

Thanks for any hint Waeller If you have a lot of variation in your test method making it hard to validate and you can't reduce that anymore, but you insist your method works and can detect what it is supposed to detect, then I suggest trying an attribute type data test method validation.

Your sample size will be quite significant because its an attribute test (binary results like pass/fail).

The criteria to pass the test will be vague most likely due to the nature of attribute data, thus requiring a lot of samples to have any kind of confidence that your test is valid.

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