Management Review

Management review is another requirement of quality system for medical device manufacturer. A procedure for management review should be written to handle management review. This procedure is to provide a system and instruction, to assign responsibilities for scheduling, conducting and recording management reviews for the company’s quality management review. The blog for management review shall talk about 1. Frequency and scheduling 2. Attendance 3. Agenda 4. Review Input 5. Quality Policy and Quality Objectives 6. Review Output and 7. Record of management review.

1.     Frequency and Scheduling

Executive management should review the quality performance and quality management of the whole organization at least once a year. Specific dates like June and December should be stated if the management review decided to review twice a year. Executive management when responding to changing and special conditions and events like consent decree and warning letter can call for any unscheduled and extraordinary reviews. Nothing is carved in stone.

 2.     Attendance

Management reviews should be chaired by top executive like CEO and attended by managers representing Quality Assurance, Marketing and Sales, Design Engineering, Regulatory Affairs, Manufacturing, Quality Control, Purchasing and Human Resources. Managers who cannot be present can send representative and he or she after receiving the meeting minutes, may submit their input and comments to the CEO and/or quality assurance.

 3.     Agenda

QA should setup the agenda for management review a week or more prior to the meeting and distributed to all participating managers. This will give respective managers some time to prepare for the meeting and raise some quality issue during the management review.

 4.     Management Review Input

The following are some of the quality issues which can be discussed in the quality review: action Items from last meeting, process performance and product conformity, internal quality audits, external quality audits, corrective and preventive action (CAPA), post-production feedback, customer complaints, product recall, customer recall, training, continual improvement, new or revised regulatory requirements and its ramification, medical device reporting (MDR), safety and effectiveness, application status and any changes that could affect the company’s quality system.

 5.     Quality Policy and Quality Objectives

Quality policy and quality objectives are two keys issues to be discussed during management review. During management review, the progress of quality policy and quality objectives must be discussed.  Quality objectives must be systematically evaluated to access the progress during management review. If the quality objective of certain issue is closed, the resource can be moved to deal with another quality objective.

 If any quality objective is not achieved on time, the review can investigate and determine the causes of the failure to achieve the deadline. Management can decide what to do with the failed quality objective. They can drop the objective, reduce the scope, reassign responsibility, allocate additional resources or extend the deadline.

 During the management review, new objectives are established when necessary to improve quality performance during the management review. These new objectives should be documented in the Quality Objective Record.

 The quality policy of the organization shall be discussed to access its suitability to the whole organization in the middle of new regulatory, addition of new product, product changes and the like. For example, if a medical device company begins to manufacture Class III device, its quality policy and quality system may need to be updated.

 6.     Management Review Output

Resources needed for the implementations of the improvements are identified as review output. This includes the assignment of responsibility, time-frame, and allocation of human like more personnel and the employment of consultants, equipment and know-how. Management review output is documented in review meeting’s minutes. Action items are highlighted.

 7.     Record

Management review output during the meeting should be prepared by Quality Assurance and distributed to the attending managers and absent managers as well. All the management review record shall be stored in a known location both virtually and hard-copy. These record can only be disposed according to the time-frame stated in control of record’s policy.

21 CFR 820.20(c)	Does management with executive responsibility review the suitability and effectiveness of the quality system at defined intervals and with sufficient frequency according to established procedures to ensure that the quality system satisfies the requirements of this part and the company’s established quality policy and objectives?
21 CFR 820.20(c)	Are the dates and results of quality system reviews documented?

Disclaimer: Although the author had exhaustively researched all sources to ensure the accuracy and completeness of the information contained in this blog, but no warranty and fitness is implied. I assumed no responsibility and implied warranty of any kind for errors, inaccuracies, omission, or any inconsistency herein. No liability is assumed for incidental or consequential damages in connection with the use of the information contained herein. Readers should always use their own judgment and review all related regulatory guidelines. Guidelines can change over time.