The author provides suggestions for improving the writing of your medical device management review, scheduling meetings and engaging top management.
If the US FDA is not allowed to see Management Review meeting minutes, why were there one-hundred and seven 483 inspection observations against the Management Review process in FY 2012?
The US FDA is also not allowed to view records for internal audits and supplier audits, but there are 483 observations for these processes too. The FDA will assess effectiveness of these processes by reviewing your procedures, by verifying that you have a schedule and you’re sticking to it, and the ultimate test is to look for CAPAs initiated from these processes.
To avoid a 483 inspection observation against your Management Review process, you need four things:
- Procedure for Management Reviews
- Schedule for your Management Reviews
- Template to prevent errors
- Top management team that is trained
Writing a Medical Device Management Review Procedure
There is no requirement for a Management Review procedure in ISO 13485, but 21 CFR 820.20c states that the quality system shall be reviewed “at defined intervals and with sufficient frequency according to established procedure.” This frequency may be documented in the Quality Manual, or in a Management Review procedure.
If you choose to write a procedure, keep it simple and reference a controlled template that includes each of the requirements listed above. Your procedure should also allow flexibility for each of the following probable events:
- Management Review requires rescheduling
- Some of the Management Team is unable to attend
- Some of the Management Team can only attend by conference call
- An action item from a previous review is left incomplete
- An action item is changed after the Management Review
- There is insufficient time available to review all the inputs during a single Review
Your Schedule for a Medical Device Management Review
The most common procedural requirements for the frequency of Management Reviews are:
- At least once per year
Most companies choose to require a schedule of “at least once per year,” but what’s the point of reviewing quality system data from last February in January?
“13485 Plus” is a guidance document for the implementation of ISO 13485. Section 5.6.1 of the guidance document states, “If changes are planned or being implemented, more frequent reviews are normally needed.” Some companies even include this statement in their Management Review procedure. Unfortunately, most companies do not remember to change their schedule when they plan significant changes to their quality management system—such as mergers, new product launches or an employee lay-off.
Every Management Review should include an action item scheduling the next Management Review. The timing of the next Management Review should reflect changes planned for the quality system and improvements needed to maintain effectiveness.
Conducting more than one Management Review also gives you the flexibility, assuming your procedure allows it, to review only some of the required inputs during a single Management Review. If you are short of time during your next management review, you could intentionally skip a required element. However, this approach also requires that you track which elements have been covered during your annual schedule and which elements were not. Any skipped elements must be covered at least once during the annual schedule for Management Reviews.
A Template for Medical Device Management Review
One of the most common nonconformities during an ISO audit is a finding that one of the required inputs or outputs was not included in the Management Review. The best way to ensure you don’t forget something is to use a template that is maintained by your document control process. This template should include the following:
- Eight Inputs (ISO 13485, Clause 5.6.2)
- Three Outputs (ISO 13485, Clause 5.6.3)
- Review of the Quality Policy (ISO 13485, Clause 5.3)
- Review of the Quality Objectives (ISO 13485, Clause 5.4.1)
- Review of the QMS effectiveness (ISO 13485, Clause 5.6.1)
The last item should be a conclusion in your management review meeting minutes. Often, the conclusions is worded in the following way, “The Quality Management System remains suitable, adequate and effective—with the exception of the areas that have been identified as requiring corrective actions in this management review.”
Engaging Top Management
Roles and responsibilities for the Management Review must be assigned. Some leaders choose to assign 100% of the Management Review to the Management Representative, and then the same executives complain that reviews are boring and take too long. In order to get the management team engaged, the responsibility for preparing reviews must be assigned to all members of the team. The Management Representative is responsible for “reporting to top management on the performance of the quality management system and any need for improvement,” but the ISO Standard does not imply that the representative cannot seek help from the rest of the team.
Each member of top management should be assigned responsibility for preparing and reporting on part of the Management Review. This approach will ensure that all members of the management team are involved and engaged in the process. Your team may be assigned to work in pairs or smaller teams. Your team’s responsibilities may also be rotated to ensure that each member of the team is cross-trained and understands the importance of each Management Review requirement.
Before you can expect your management team to accept responsibility for preparing and reporting on the performance of the quality management system and improvement needs, Top Management needs training to understand each of the requirements.
Free Webinar Training
Medical Device Academy also offers free webinar training on the Management Review process. If you are interested in training your top management team, please register for this management review webinar. It 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 Medical Device Academy’s Management Review template.