How to run a Management Review

Ed Panek

VP QA RA Small Med Dev Company FDA and ISO13485:16
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#11
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.
Obtain the data from the stakeholders in a manner that answers the questions required. Does it describe the activity? is it measurable? Specific? are the levers for improving it available in the data?
 

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