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How do you validate a test method when there's only one person in the lab?
Last Updated On May 15, 2008
There are a couple of options to consider. First, you can have another non-lab person take part in a gauge R&R study. The person does not have to be a trained technician; however they should have a basic understanding of the test to be performed. It is important to remember that a validation of this type is a test for the application of the method, and using an unfamiliar person will assess the robustness of the test method. If there are issues with variation due to this person’s inexperience, it can be overcome with training.
Secondly, you can compare your data with a round robin study, such as typically found in an ASTM test method, and you can see how close or relatively close you are to that data. If you do this, according to Annex B in AAMI TIR 22:2007, the repeatability data from your lab should be compared to the Reproducibility results from the Interlaboratory study in the existing standard.