I agree with hc255. I do not have any experience with validation and verification processes. We know validation is the final step after verification correct? Deviations from the DSD after validation should be prohibited. However, say a sample size like ks629 stated in my opinion 100 and whatever test one is doing comes back 100% positive for a flaw. Well, it is intuitive to realize that we can make the sample size smaller so the company is not wasting money, time and energy. Verification of a medical device should not be changed or deviated unless a meeting is conducted with other professionals and be done within this phase not afterward. Also, other process groups need to be made aware of the changes as well. In general, like previously stated a meeting should be conducted so communication is not fuzzy as to what is taking place.