Management Review for FDA ????



Those of you in the medical device industry are aware that management reviews are required by FDA regulation, specifically in the Quality System Regulation, 21 CFR Part 820.  

The specific regulation is Part 820.20 (c) which states “Management with executive responsibility shall 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 manufacturer's established quality policy and objectives. The dates and results of quality system reviews shall be documented.”

So, we perform Management Reviews because FDA regulations require it? (Hence the question mark after the title of this article.) In fact, if you are performing management reviews only to satisfy FDA, you may be complying but you are probably wasting your time. Effective management reviews should have tangible value to the senior executives performing the review. In this post, we will review how to perform effective management reviews, that will assist in the effective management of the company.

In the mid 90’s I was selected to be the Vice President of Regulatory Affairs and Quality Assurance for a major manufacturer of cardiovascular devices. The Management Review QSR requirement was relatively new, and I took on the responsibility of the Management Representative (as defined in the QSR) and established a Management Review procedure. I first met with the CEO and explained to him that the he would chair the Management Review meetings, and I wanted to make sure he received the information he considered valuable. He remarked that he would see the value of the effort if it allowed him to better manage the company. I proceeded to work with his staff to establish measurable quality indicators for each of their functions. Once that was accomplished, I took on the responsibility of collating the indicators and preparing presentation in graphical format.

We began having quarterly management reviews, per the approved procedure, and documented. The number of quality indicators was kept to less than 20, and the meetings served the purpose of identifying potential quality issues early and directing follow up.

At the end of my first year as the VP or RA/QA at my annual performance evaluation, I received the greatest compliment of any review I had experienced. My boss, the CEO said to me “Larry I see you more than just the VP or RA/QA, I see you as a business partner. The reviews you set up have made me a better leader, and I thank you for that.”  I certainly got clear picture of the value of the management reviews, but also accomplished something that that I think all VP’s of RA/QA should strive for, specifically to be seen as a member of the business team, and a valuable contributor to the success the business.

This brevity of this post does not allow for a detailed explanation of how to set up and accomplish effective management reviews. It is important for your company to understand FDA expectations for management review, and I stand ready to assist you establishing or fine tuning your management reviews, and providing clear value to your company.

Contact me at  or 314-499-5148