Yazar Arşivi İçin: Regula Inspection

Sometimes the politics of auditee behavior can be quite amusing. Auditees telling you everything they think you want to hear can be humorous at times. Likewise auditees that absolutely refuse to cooperate can also seem strange.

The GMP audit starts with the opening meeting. During the opening meeting, the audit team is introduced, the audit planned is reviewed, and audit criteria is confirmed. At this time any logistical needs are also addressed such as auditor meeting room, computer access, directions to the site, and so forth. 

When conducting an audit, the auditor should first assess the company documentation against the related reference documents. Any findings would then be against company documentation or the quality management system. Then the auditor should match employee actions and records (performance) against what is stated in their own internal documentation. Any findings noted would be against performance of actions as required.