C
codename47
In a recent validation the robustness testing for a new method failed which indicated either the method or the equipment was not capable producing results consistently. The study was done using two instruments that were of the same brand but different model number. So I was told to figure out why the test failed. I was told to execute a Gage R&R which admittedly I'm not that familar with so I've been reading up on the matter but I'm still not for sure it is the right tool for the job. Basically I want to compare the two pieces of equipment to ensure they are both giving results that are the same or within a slight margin of error. Originally, I started by using Minitab and generating a random ordered test with 2 operators, 2 Parts (instruments), and 8 duplicates. I was going to have one operator perform the assay dilutions and then each operator use that solution to test on each piece of equipment. My boss suggested running a high and low standard instead of just a single sample to get more distinct categories.
After reading more there were comments on the net about using an attribute Gage R&R but then I started thinking maybe a different hypothesis test might be better suited. Any ideas how to compare these instruments and get the best information possible on the ability of these two instruments to measure a known value?
After reading more there were comments on the net about using an attribute Gage R&R but then I started thinking maybe a different hypothesis test might be better suited. Any ideas how to compare these instruments and get the best information possible on the ability of these two instruments to measure a known value?