Tips on Conducting Medical Device Audit Opening Meetings Based on Training 130,000+ Auditors
For a new auditor, the opening meeting is critical. The manner in which you conduct yourself, and how organized you are, establishes your credibility and sets the tone for the audit to follow. If you appear tentative and unorganized, your audit will probably not go smoothly. With that in mind, here are some tips on how to conduct your next opening meeting.
This is based on our experience training more than 130,000 auditors over the last 50 years.
Checklist to cover during your audit opening meeting
Shown below is a recommended checklist of items to cover if you are doing a formal external audit of a medical device manufacturer or supplier. If you are doing an internal audit in a smaller medical device company, that’s obviously a less formal situation so you may not need to cover all of the items noted below.
- 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.
- 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.
- 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.
- Discuss the role of each team member
Make sure everyone knows who is doing what, at what time and where they should be.
- 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.
- 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.
- Indicate the criteria upon which the audit is based
This seems obvious to you but may not be to others. Remind participants that you will be auditing against ISO 13485:2016, 21 CFR Part 820.30, procedure QAP101, etc.
- 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. Semantics matter.
- 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.
- 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.
- Review how audit findings will be documented
How you will use of NCs, Concerns, OFIs, etc. or the grading methodology. Also, make sure everyone understands how possible findings can be addressing during the audit and under what circumstances the audit would be terminated early.
- 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.
- Indicate that your team will try not to upset operations
You don’t want to create animosity by keeping someone 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 jobs as soon as possible.
- 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.
- 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 to display monitor 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 their assistant.
- 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.
- Note when the audit report will be forthcoming
Especially with external audits, your auditees will be apprehensive about this so be clear about when they can expect the final report. You can provide a short range “between December 13-15” but don’t say “sometime in the next few weeks.”
- Conclude the opening meeting
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. Also, don’t take a “15-minute bathroom break” after the opening meeting ends. Start the audit immediately to maintain momentum and convey a sense of urgency.
Some common open meeting pitfalls and how to handle them
Any experienced auditor will tell you that things do not often go as planned. Here are some common situations that arise during the opening meeting and how to handle them.
- Management does not attend the opening meeting
This happens quite often. Executives double book themselves or get trapped in meetings or conference calls that run long. If this occurs, make sure you capture this information in the audit report using the opening meeting attendance record. Also, follow up with them post-audit to give them a personal rundown on findings.
- The auditee tells you that the agreed upon schedule no longer works
Taking a hard line rarely works and sets a poor tone for the rest of the audit. In this case, work with the audit representative to adjust the schedule.
- The auditee tells you that critical documented information will not be available for review
This is indeed a problem. In this case you will need to find out why and confer with the audit manager to decide on whether to continue or delay the audit.
Take the next step in expanding your medical device auditing skills
If you enjoyed this article, we have a variety of auditing classes you may want to consider. Our ISO 13485:2016 lead auditor training class which is one of our most popular classes . If you are involved in MDSAP auditing, consider our MDSAP Auditor Training or if you are involved in EU Medical Device Regulation (2017/745) compliance, consider our EU MDR auditor training class. All three of these auditor training classes are available as in-person seminars or as virtual instructor-led training (VILT).