In my one experience with audits, the quality department must all be actively involved. The quality manager creates a detailed plan and assigns a designated role for each member in order to have a seamless system. There were no violations that arose. There are of course minor delays in finding the exact documents to answer the auditor’s question. There were personnel from other departments that were brought in as experts on certain subjects. Leading up to the audit, there was a meeting to brief everyone involved as well as a practice run to understand how the process would work.