This is a great question. Prior to FDA or BSI audit, the quality department of the company prepares for the audit in gathering few DHRs (Device History Records). From the auditor’s perspective, he/she ensures that the company meets its own Quality System. The auditor assesses the company’s quality system and compares with the few lots recently manufactured. Some auditors are really challenging as to their mindset is that they must issue an observation or a finding before leaving the plant. However, from the quality perspective, this should help the company in improving their quality system. Overall, audits are means to identify how well the company performs to their QMS and to prevent any significant product failure.