In Lecture 6 we were given examples of verification protocols and reports. One section I see missing from the report is deviations. I don’t know that I have ever been part of a verification process where we did not have to address some sort of deviation to the original protocol.

For example, one over the course of aging, the equipment used in the Time Zero testing was moved from one facility to another. In this time period a fixture was lost and had to be recreated. This had to be discussed in a deviation sections.

Another section that would need to be included in the verification report would be a failure analysis. If a product fails testing it would be important to analyze why that failure occured to determine if it is caused by some sort of special cause that could be justified.

Do you have any other examples of what might be included in a Verification report or examples of verification testing that did not go exactly as planned?