I think the best QC can do is keep double checking everything occasionally make "tests" to assess the project. This can be in many forms, like just some questions that express our concerns about the product, or asking about a thing that you do not understanding why they are doing so. Theses can all be signs that the procedure/product needs verification. I think it works bests if a QC follows the production in a timeline manner and do the "quality control" work by ticking boxes for each stage: investigating each stage of the production carefully and make sure that it is going in the right direction for every step.
I learned a lot about QC from my current COOP, essentially everything needs to be documented as soon as material arrives it is noted off, and its batch number is taken down. It is quite important in the medical field to note down where everything is coming from and what its batch number because if there are issues it can be tracked down, the entire idea is to ensure that people are able to locate what the exact problem is and what material caused it. When I was helping to pack up a small batch of parts it was required that we submit an easy to track method that was connected to the parts. The most important part is definitely to be organized because that ensures that you can track the steps that were taken and that means knowing what each person is doing and that comes from a very through task list where it is clear who is assigned to what task. Furthermore, each step that is taken is carefully decided and not simply performed because it was the easiest option.
I do not have much experience with the industry and medical devices for quality control, but I do have experience with our quality control department at a laboratory with how they maintain accurate results, as well as team management and organization. It may be different to how QC ensures the quality of a product, but I think the concept and how they work are pretty similar. In our laboratory, we focus on performing and analyzing results based on PCR amplification. After we analyze the results correctly on the clinical side, we would send those results to QC. QC then uses that paper to check on their computer of the correct test performed, PCR sheet number, which machine it ran on, passing sets of controls, and if the samples are positive or negative. They first have to confirm that all of that information is correct and that the results are analyzed correctly. Within our QC department, we have roughly 4 people per shift. Work is divided amongst everyone. One person would be in charge of discrepancies, while the abundance of PCR sheets is divided amongst everyone else. With the PCR sheets, each QC person would go to clinical and collect their stack of papers to do their work and go collect more once they have finished. For the confirmation of the sheets, they have a set guideline for results to be in the acceptance criteria in order for them to enter those results and send it out to doctors and clinics. For example, with New York samples, the controls, High, Medium, and Low, have to be within the CT score range in order for it to pass and be in the criteria. If it is not in range, it gets rejected and has to run again. When that happens, that paper gets sent back to clinical for it to be reprocessed and troubleshooted. They have these set guidelines to follow and to make sure the results are accurate to show if the patient has that disease or not. If it was not verified and sent out, then it poses a risk to patients if they have the disease and they do not get treated, or if they do not have it and are given medication they do not need.
The work is pretty straightforward with how detailed the guidelines are. The proper test analysis and SOP outlines all of these within our laboratory. If there are any samples that have questionable results, then they would send it up to perform additional testing to confirm that the sample is actually positive or negative. Everything needs to be within standard or it does not pass the criteria and will be rejected. We have had a couple of issues in the past, I heard, of QC not verifying the test results that clinical analyzed and sent that through. I believe the QC tech and the lab technician that were at fault were reprimanded and had to sign documentation and underwent additional training to avoid these types of issues in the future. Everybody makes mistakes and QC is there to stop any of those issues from continuing on from their side. With discrepancies, they check that is the correct sample, patient information, and testing that needs to be cancelled. The organization is all there with each person being responsible for what they are assigned for the day. If they finish their assignment, they are to help others and double check everything to ensure proper analysis for doctors and clinics.