Three (3) compliance issues are discussed regarding management review meetings, including procedural requirements, forms and records, and attendance.
Has your company ever received an audit finding or FDA 483 observation for the failure to provide objective evidence of management with executive responsibility attending the management review?
This type of finding is typically followed by a sentence that begins with “Specifically,” and ends with a quotation from the company’s management review procedure. There are three reasons why this finding is so common:
- Procedural requirements for attending the management review meeting do not match the actual practice
- Forms and records used to document the management review meetings are inadequate
- One or more members of the management team just didn’t show up
There are no prescriptive requirements in ISO 13485 or 21 CFR 820 that specify who must attend a management review meeting. Therefore, let’s investigate each of the possible reasons for this finding.
One of the auditors I worked with for several years used to say, “You need to make sure your procedures give you ‘wiggle room.’” He knew from practical experience that managers are busy, and sometimes they can’t attend meetings. He also knew that sometimes job titles change, but your company’s organizational chart and procedures will lag behind these changes. In one of my previous blogs, I indicated that your management review procedure should allow some flexibility. The following are three probable events related to management review attendance:
- Management review requires rescheduling,
- Some of the management team is unable to attend
- Some of the management team can only participate by conference call
Rescheduling Management Review Meetings
Most companies document the requirement for when reviews must be conducted in the management review procedure. For example, “The management review shall be conducted during the first month of each quarter to review quality metrics from the previous quarter.” Instead, I recommend stating that at least two management reviews shall be conducted each year, and the date of the next management review shall be scheduled as part of the action items during each management review. Your procedure should also state that additional management reviews should be scheduled during periods of significant change to ensure the continued effectiveness of the quality system.
Even if you follow my advice for scheduling management reviews, you still need a mechanism for rescheduling the management review if an emergency comes up. I recommend allowing only the most senior manager on-site and the management representative to have the authority to reschedule the meeting. You can use Microsoft Outlook as a tool for communicating the rescheduled date to top management, but action items from the previous management review should reflect the change. Action items in your management review are quality system records, while printouts of your calendar are not. You should also consider placing a time limit on how far in the future, a management review can be rescheduled.
Delegating Attendance of Management Review Meetings & Conference Calls
To address #2 in the possible scenarios listed above, I recommend that your procedure allows for management to send a delegate in their place to a management review. I also recommend that your procedure allow managers to attend meetings remotely (i.e., via conference call, Webex, etc.) to address #3 listed above. However, management should be making every effort to attend the management review live, and everyone should be able to review the review inputs (i.e., Clause 5.6.2a-h) before the meeting.
Forms & Records of the Management Review Meetings
Management review meeting minutes are records that must indicate who was in attendance. If your procedure indicates that a specific job function should be represented at the Management Review, you need a form that is designed specifically to provide objective evidence that this person attended. Therefore, instead of listing job titles on the attendance sheet, or just using blanks for attendees to sign, you should have a form that lists the job titles. If a delegate is sent, they should indicate that they are the delegate authorized to sign for the absent member of top management.
Skipping the Management Review Meetings
Management review meetings are regulatory requirements and are intended to improve your quality system. If you can’t attend, you need to review the review inputs before the meeting and provide feedback. You should also assign a delegate who is supposed to take notes and represent the function of the manager that is not present. If you have been assigned the responsibility of preparing an input slide to the review, then you still need to provide this even if you are not present. If you are the management representative, and someone fails to provide slides for the management review, I recommend asking the assigned person to provide hard copies for each of the attendees. If the person doesn’t do this, indicate in the meeting minutes that inputs in one area were not available, and add an action item to the meeting conclusions regarding the need to address this gap.
If you are interested in a free management review webinar on this topic, please sign-up for our webinar. The webinar will also be available as a free recording for anyone that is registered. Registrants will also receive a copy of the webinar slide deck and a copy of the Medical Device Academy’s Management Review template.