I have a historical dataset as a baseline (key product measure) for a manufacturing process, then the process has changed due to optimization. How do I: 1) estimate sample size and power for a comparability study? 2) use TOST to establish if the product from the optimized process produced the same/comparable product? (assuming equal variance between the 2 datasets)
For the 1) my current approach is to use std dev from the baseline dataset, set alfa = 0.05 and 'difference in mean' using delta between 'baseline mean' and 'the failure value/lower spec' , from that I can chose a power to get the sample size from DOE>Design and Diagnostics>Sample Size and Power>Two Sample Means. Is this approach correct?
For the 2) I have never done it so I am seeking an expert answer please.
Thanks a lot,
Ed