Landmarks

Performing an audit usually has several identifiable landmarks that are useful for the audit program manager to gauge the progression of an audit.

• Audit Agenda
• Opening Meeting
• Audit Activities (Sampling, Inspection, Etc.)
• Closing Meeting
• Issueing the Final Report

The audit agenda will outline the processes to be inspected and the dates and times for the audit to occur. It will also include confirmation of auditee information as well as scope, criteria, and identifying audit team members. This should be issued prior to beginning the audit itself. As a consulting agency, Medical Device Academy aims to issue an agenda 1-2 weeks before the first day of an audit.

The Opening meeting is the very first activity of day 1. of the audit. It explains the process, introduces the audit team to the auditee and re-confirms scope, criteria, etc as well as gives the auditee a chance to ask any questions they have prior to the audit itself.

After the opening meeting, the audit activities will begin. Technically the agenda and opening meeting are considered audit activities as well but this landmark is the actual inspection and review of records, conducting interviews, observing processes, etc., portion of the audit.

The closing meeting is the final activity of and should be at the very end of the audits duration. It is where the audit team will discuss the findings of the audit and gives the auditee a chance to ask any additional questions that they may have.

The issuance of the Final Audit Report occurs some time after the closing meeting. This is because the closing meeting is an input into the audit report and because the audit team needs a chance to finalize their notes and proofread the report before issuance.