Is there an ideal time of year for conducting Management Review? Does it make sense for this to be part of the year-end activities? Or will cramming it into December lose meaning and purpose?
My opinion is that having a Management Review towards the end of the year makes good sense–especially in helping the management team plan and prepare for the next year. My vote would be to have one sometime around Christmas. In my experience, things are usually less hectic for medical device companies during then.
I will be helping three clients conduct Management Reviews in December. Each of these clients has a different take and point of view with respect to Management Review. Let me summarize:
- Client A – The December Management Review will be the 3rd one for 2012. They are very good about having at least one Management Review annually. However, sometimes the concept of Management Review is used too frequently. In my opinion, the time between Management Reviews is just too short. There are limited resources and their ability to make significant progress on QS and related issues between reviews is difficult. Plus, the team already meets weekly in a change review board to discuss complaints, CAPAs, ECOs, etc. I think this client uses Management Review too frequently. Twice year should be more than sufficient for them.
- Client B – Currently addressing deficiencies identified in a FDA Warning Letter. They’ve been in business since the late 1970s. I venture to guess that they’ve never had a Management Review. And as we’ve worked through the deficiencies, I’m not sure they see the vision and benefit of this or any other QMS related activity. We are having a Management Review because we have to.
- Client C – Hired CQ as a proactive measure, realizing their practices might not be in complete alignment with QS regulations. They want to be better and have asked me to provide guidance and direction to help them with compliance related initiatives. While they too have never held a Management Review, they realize the purpose of this and want to begin this practice this year.
Okay, three different “flavors” and approaches to conducting Management Review. And my advice to you is to incorporate Management Review as part of normal business. Just doing it to check it off the list really defeats the purpose.