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How to run a Management Review

QE1993

Involved In Discussions
#1
Hi all,

Looking for some tips and suggestions on how to run an efficient and meaningful management review meeting.

Thanks!
 
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Ed Panek

VP QA RA Small Med Dev Company FDA and ISO13485:16
Trusted
#2
There are certain elements that require discussion. There is no requirement about HOW MUCH discussion per item. Think of your audience. Cover everything required. Add extra coverage to the things your audience is most interested in but cover everything.

5.6 Management review
5.6.1 General
The organization shall document procedures for management review. Top management shall review
the organization’s quality management system at documented planned intervals to ensure its
continuing suitability, adequacy and effectiveness. The review shall include assessing opportunities for
improvement and the need for changes to the quality management system, including the quality policy
and quality objectives.
Records from management reviews shall be maintained (see 4.2.5).
5.6.2 Review input
The input to management review shall include, but is not limited to, information arising from:
a) feedback;​
b) complaint handling;​
c) reporting to regulatory authorities;​
d) audits;​
e) monitoring and measurement of processes;​
f) monitoring and measurement of product;​
g) corrective action;​
h) preventive action;​
i) follow-up actions from previous management reviews;​
j) changes that could affect the quality management system;​
k) recommendations for improvement;​
l) applicable new or revised regulatory requirements.​
5.6.3 Review output
The output from management review shall be recorded (see 4.2.5) and include the input reviewed and
any decisions and actions related to:
a) improvement needed to maintain the suitability, adequacy, and effectiveness of the quality​
management system and its processes;​
b) improvement of product related to customer requirements;​
c) changes needed to respond to applicable new or revised regulatory requirements;​
d) resource needs.​
 

QE1993

Involved In Discussions
#3
There are certain elements that require discussion. There is no requirement about HOW MUCH discussion per item. Think of your audience. Cover everything required. Add extra coverage to the things your audience is most interested in but cover everything.
Thanks. I guess I was looking for practical suggestions for running the actual meeting. Do you receive information from process owners prior to the meeting and report it at the meeting? Do you have each process owner present their information at the meeting?

I was recently promoted to Quality System Manager and improving Management Reviews is something that is near and dear to me. In the past, they have been conducted haphazardly (yet still taking HOURS to complete), we are always pencil whipping certain things because no one has clear direction on what kind of information they should come ready to provide and everyone leaves frustrated and annoyed by how much time was spent in proportion to how little was achieved. My goal is to make reviews more interactive, have value and take less time.
 
#5
I usually create a list of topics and hand outs. Our meeting is 4-6 people so it is easier to manage but I stay on list. I leave enough room to take notes on each list item so my 1 page list usually takes about 3 pages due to lots of white space for notes. I present the hand outs as I start each list item to stay on focus. Presenting the hand outs at the time I start to discuss is relatively new 'upgrade' as in the past I had people asking questions and bouncing around adding time and losing focus on what is being talked about.

The one big thing I try to keep down is 'off topic conversations'. It is going to happen, and a little bit is normally fine, I just don't want to waste 15 minutes talking about football.
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#6
I know this is NOT what the OP is looking for, but the PROPER setting and timing would be the (ISO 9001) "management review meeting" as a subset of a BUSINESS review meeting, where the organization's leadership discusses the critical and strategic aspects of the business, including financial results, business challenges, competitive pressures, etc....At an appropriate point, the meeting should discuss issues related to the big Q, including the topics that were listed already here. A "quality management system review meeting" should be a subset of a BUSINESS REVIEW event, hopefully offsite in a lavish resort....:naughty:
 

indubioush

Involved In Discussions
#7
Some suggestions:
Each individual process owner makes powerpoint slides for their data. These get compiled into a larger slide presentation. If you already have your KPIs/Metrics set for each process, give each one a grade (e.g., red, yellow, green). Send the presentation out to all meeting attendants prior to the management review meeting. Assign one person to take notes and list action items. If during the meeting an issue arises that is unable to be resolved, turn it into an action item (e.g., Jim and Bob to decide whether to disqualify Matel as Barbie provider). Each process owner presents their own slides. At the end of the meeting, the note taker reads all action items. Final report gets made and sent to the CEO and other tops for approval.
 

somashekar

Staff member
Super Moderator
#9
The first and foremost element is that the management must know what to review and why. :naughty:
What to review is guided by the standard and business dynamics
You do not need to have meetings. :gossip:
Management must know and freeze what MIS is needed, and base decisions and course to be taken further, and keep such a trail regularly.
Someone who is responsible to keep records of the review must be involved in all area reviews and effectively be able to link actions across processes per the process interactions, and have the management confidence. :agree:
.....easier said then done, but sadly management needs training about how to effectively review. :braincloud:
:2cents:
 

Ed Panek

VP QA RA Small Med Dev Company FDA and ISO13485:16
Trusted
#10
As with most other meetings, you need to create an agenda and stick to it. Someone needs to be in charge of keeping the meeting focused on the agenda and not allowing a lot of meandering and off-topic discussion.
This is key. Oftentimes meeting about delivering data turn into meeting investigating the data. I Find people have an aversion to uncertainty so they create logical playouts to explain data that they dont like. Thats bad and not the time/place. Stay on agenda. Items that seem to stir conversation assign to those responsible and table them as actions for the next meeting - Move on. Think of it as a report card - not a real conversation.
 
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