How to Conduct an Internal Audit Opening Meeting: Tips from Training 130,000+ Medical Device Auditors

Shown below is a recommended checklist of items to cover if you are performing a formal external audit of a medical device manufacturer or supplier. If you are performing an internal audit in a smaller medical device company in a less formal situation, you may not need to cover all of the items noted below.

1. Introduce yourself and the team members, as needed
   Take care to note each person’s responsibilities during the audit and ask your auditees to do the same. At this time, all participants should identify “communication links” between the two teams and clarify all lines of communication and what type of communication should be used based on time of day, urgency, etc.

2. Record names of all participants
   It is best to use a pre-printed attendance form. Have everyone print their name, title, and sign the form. Your opening meeting should not include all potential auditees. Rather, you should only invite the auditee management, and where appropriate, those responsible for the functions or processes to be audited.

3. Confirm purpose and scope of the audit
   The lead auditor and auditee should revisit the scope and objective of the audit, even if it has not changed. Discuss and solve differences and areas of conflict as they arise during the meeting.

4. Discuss the role of each team member
   Make sure everyone knows who is doing what, at what time and where they should be.

5. Confirm the auditee’s working hours
   Find out when your auditees end their day and when they wish to take a lunch break. Confirm that the appropriate subject matter experts will be available at the time indicated on the audit plan. This is important because you need flexibility to change the schedule on the fly if needed.

6. Get the names of guides and contacts for the areas being audited
   Assigned guides should be available immediately after the opening meeting so the audit can begin on time.

7. Indicate the criteria upon which the audit is based
   This seems obvious to you but may not be to others. Remind participants what you will be auditing against, e.g., ISO 13485:2016, 21 CFR Part 820.30, procedure QAP101, etc.

8. Emphasize the audit objectives and take a positive approach
   It’s important that you set a tone of positivity and indicate that you are not trying to uncover nonconformities but instead are searching for evidence of compliance.

9. Present and confirm the audit plan
   Ensure that the sequence, times and appropriate people are available as scheduled. However, be prepared to change the sequence of audit activities.
   
   
10. Discuss how the audit will be conducted
    The lead auditor should provide a summary of methods and procedures to be used to conduct the audit, confirm the audit plan and remind that auditee that the schedule may change as needed.

11. Review how audit findings will be documented
    Indicate how you will use NCs, Concerns, OFIs, etc. or the grading methodology. Also, make sure everyone understands how possible findings can be addressed during the audit and under what circumstances the audit would be terminated early.

12. Discuss the responsibilities of auditee management
    This applies if nonconformities, opportunities for improvement or concerns are found. Note that even if there are no nonconformities, an audit is only a sampling and may not uncover all issues.

13. Indicate that your team will try not to upset operations
    You don’t want to keep someone away from doing their job longer than necessary. Be sensitive to the fact that while you are interviewing people, their normal workload does not disappear. Reassure people that you will try to be as efficient as possible so they can get back to their responsibilities as soon as possible.

14. Confirm the timing of daily debriefings
    Try to be as punctual as possible but also notify everyone that they should be somewhat flexible on start and end times.

15. Confirm the logistics for the audit as needed
    If auditing in an unfamiliar location, confirm the area assigned for you to work, availability of printers/copiers, the guest wireless password, how to access display monitors in the debriefing meeting room, meeting times, how to contact auditee counterparts during the day. Texting is the most immediate and effective method followed by phone, email or contact via assigned assistants.

16. Confirm the time and day of the closing meeting
    During multiday audits, the lead auditor and auditee should have daily debriefings to discuss progress and nonconformities to date. These are good opportunities to discuss and resolve situations not anticipated by either group.

17. Note when the audit report will be forthcoming
    Especially with external audits, your auditees will be apprehensive about receiving the final audit report. Be clear about when they can expect the final report. You can provide a short range “between December 13-15” but don’t leave the audit report timeline open-ended e.g., “sometime in the next few weeks”.

18. Conclude the opening meeting and proceed immediately into the audit
    Discuss and resolve any issues of the audit plan and make sure there are no lingering uncertainties. Be polite and thank all participants in advance for their cooperation. Do not take a “break” after the opening meeting ends. Start the audit immediately to maintain momentum and convey a sense of urgency.