In my experience with nonconformance with one of our products, it was related to an issue that was identified through receiving feedback from our QC team. In addition, this finding matched with the findings discovered from our field technicians that provided technical support to our clients. Once this issue was discovered, we documented the number of complaints and began to initiate a CAPA with regulatory, QC, and R&D. We had to establish the severities of the problems and how to fix the problem and formulate a preventative action plan. This would trigger an SOP for QC to follow along with R&D to ensure the problem can be recreated and fixed. A rework would not be involved because the problem was related to only a few units since the device was being beta tested, this caused these units to return to fix the problem. Once again, this puts high emphasis on the importance of testing medical equipment prior to release. The problem here was related to a grounding issue that caused interferances to the results of the test that the device was intended to do.