I worked on several projects for R&D which always got delayed due to disagreements with the quality department. One major product that we produce is an intra-aortic balloon which is a class two device. Based on a CAPA that the manufacturing department received, we had to test 300 samples of a particular IAB for a leak test. If one of the three hundred IABs failed then 1500 IABs would need to be tested. The quality and engineering departments disagreed on this issue for days because the engineers had a realistic approach while the quality department wanted to follow the methods documented from the FDA. The engineers had to abide by the standards that the quality department demanded. Luckily, none of the IABs failed and the CAPA was closed. This is one out of hundreds of instances when the quality department and engineers in R&D or manufacturing disagreed on how to approach an issue.