Another thing that might be included in a verification report is sample traceability. In the reports used at my company, there is a place to fill out part numbers, lot numbers, and production date of the samples that are used in the test. This allows for better traceability if there is a failure, and other defective parts will be able to be identified.

Another example in deviation can be in sample size. One time I was testing an initial sample of an injection molded part for which the protocol called for a certain sample size. However, upon learning that the supplier was using 3 different molding cavities for the part, it was decided that the sample size would be increased to include samples from each cavity. The justification for this increase in sample size was explained in the "Deviations from Test Protocol" section which you have described.

Hey,
I also think that information that is discovered once the verification is over should also be discussed. This could lead to additional or updated reports that would be necessary, especially if discrepancies are discovered. Sometimes, the verification process might miss something vital and therefore, even though it might have technically passed verification, it is necessary to update the information.

Currently, I work with the Process Validation aspect of our Cardio Surgery devices where I validate test methods. Deviations from protocol do occur every now and then but it is best to avoid them at all cost. One deviation I am facing right now is the incorrect revision of the test method instruction in protocol. This occurred because a change was made to the procedure while my protocol was being approved. Another deviation that I also had to report was the incorrect documentation of calibration for one of the fixtures that I plan to use in my validation. Quality was not happy with the way the calibration was reported in the report so I had to fill out a deviation form stating the two deviations that occurred from the procedure.

Finding deviations before executing a validation is always better than finding it during the validation as it can hinder or halt the validation until a solution is reached.

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.

I agree that deviations are important to keep included in both validations and verification reports. Deviations can provide important information that ultimately can change the whole output or scope of the verification. There was a verification protocol/report that I was aiding with in which there was not enough test coupons to meet the requirements that were set forth in the protocol. The scope had to be narrowed to just include one of the materials that were to be tested rather than both. The deviation we put in was that an addendum would be drafted and attached to the protocol and be completed at a later time when there as enough material available.

In my company, there are 2 main categories for our testing deviations: deviating from a standard, or deviating from the protocol. For testing our implants we follow ASTM standards for our testing procedures, but there are certain tests where we always have to deviate from the standard by creating custom fixtures for testing. For testing our instruments, the verification tests are usually specific to each instrument, and are custom designed by the development and testing engineers. Since it is a new test that has not been executed before, it is common for them to have to deviate from the protocol in order to complete the test. I agree that it is not ideal to deviate from a test protocol, but in some cases the test cannot be completed without deviating, and as long as a justification is provided, I think it is acceptable to have deviations.

My colleagues above me make some great points. I agree that noticing any deviation earlier is better than after the validation. It would seem we also agree that verification should have as little deviations as possible. But I think srg36 makes a good point in that deviations are common in running new tests. I think this largely takes effect when there is a new member on the team. I started volunteering at a cardiac tissue lab and I was tasked with doing a "simple" DNA Assay. I was given the protocol and followed it meticulously, but undoubtedly I had to make some deviations. When the protocol asked for 0.01 mico liters, I was unsure how accurately I could get that quantity, and ultimately unsure how much that would affect my overall outcome. As it turns out the protocol given to me was quite old and certain changes were executed by those who have done it before, but never changed the document. This asks the question, is the DNA Assay I did valid? Was I right to stick to the original protocol, or should we adopt this new slightly deviated as our new standard? Does that change anything else? Had I known about the deviation earlier it could have saved time and money.
Anyway. I think that if our project that summer where to have been published, I would expect that there would be some mention of a deviation in the verification/validation section, as well as a deviation section to go list out the steps taken and the assumed impact it had.