In design controls the verification step is very important. There is high risk factor if the device does not pass verification test. Though I have never personally encountered this kind of problem but, according to me the main issue that would occur is failure in software performance. So as a result there is a malfunction in a device that keeps humans safety at risk. And at the end this can call for recalls or removal of device. In this situation one option could be reevaluate and reexamine the whole device and process. Another option could be doing more tests of samples. After all this I would say that if it goes wrong do not go for major change you should understand the problem.
I've experienced a portion of the test and validation from my former co-op position, I wed to help to write the protocols and test cases for different systems and run it. I've run into a lot of testing that it didn't pass special being a part of innovation center which is not a final product and is a cost center, not a profitable group. We used to work on an immature solution. So a lot of time we have to work with PMs to adjust the testing cases or try to come up with a solution for the found issues. Also, sometime we would outsource other company for testing special if it needs certifications.
If the deviation happens, firstly we need to locate which one or multiple parts could possibly contribute to the failure of verification. This is very important and may be highly related to small decisions such as design dimensions, wrong analytical method, data collection mistake, and etc. In general, different corrections apply to different causes of failure. Normally, the typical solution will be more management meetings that gathers all team members in the project and talk about the parts that could be most be likely to go wrong. And then, quality control members do another verification after several corrections until they got the successful result.
Verification is an immensely important step in the medical device development life cycle. A deviation is essentially when a technician is forced (or mistakenly) deviates away from the test protocol which could be caused by anything from unexpected outcomes of the medical device all the way to human error. My most recent experience was during the final steps of verification where we sent parts for testing and 90% of the parts had failed. We did some more research to find out that it was a combination of the test method as well as manufacturing issues which led to the failing of our product. Since the test method was not ideal for this verification process, we had to deviate from it to enhance the verification process, thus leading to a deviation.
When a deviation occurs in a protocol due to a failure, it is often required to investigate the reason why the failure occurred. This investigation is often called a Root Cause Analysis. In a root cause analysis the failure is described, possible causes of the failure are suggested, and finally the root cause is identified. Once the root cause is identified, it can be corrected or mitigated in order to move forward with conforming product or samples. Deviations can cause major delays to a project, so it is important to prototype well so that there will be no surprises after design freeze while you are testing samples for design verification.
