I believe that the quality department, at the most successful and consistent companies, runs deep within the structure of the organization. By this I mean that although there is a designated quality department, there has to be a great emphasis on the integration of these employees and their procedures within each facet of the company. For example, within each R&D meeting, ideally, there is also an individual from the quality team present to identify potential compliance issues before they develop a faulty idea. By catching these potential errors early on in the development process, time, money, and intercompany relationships are put under less duress. This example of integration should also be applied to every other department within the company as well to ensure that marketing, manufacturing, etc. all are within FDA regulation and abide by the companies own compliance goals. If a procedure is not followed, I believe that it would be most effective for the quality department to not only point out the offending issue, but show the erroneous party how to fix the mistake. Ideally, this would be done in person to more effectively communicate the corrective actions and avoid most misunderstandings that could put unnecessary strain on the intercompany relationships.