Dear PM Advisor. July 1, 2013

Dear PM Advisor, I work for a Medical Device Company where Change Control is a common part of our lives. We need to use this whenever we make a change to our drawings, processes or even the early design of our products. Now that we are bringing in formal Project Management, we have been asked to add Project Change Control. Does Change Control exist within or outside the Quality System

Ch-ch-changes in Delaware.

Dear Changes,

Having formal Change Control within your company makes installing a formal Project Management methodology that much easier. Because you are already in the mode of not allowing unauthorized changes to occur within your facility. So the mindset is already there.

But keep Project Management out of your Quality System. You don't want the FDA snooping around your projects because there is too much being done there that doesn't follow exact procedures. Too much ad-libbing.

That being said, the FDA will still expect to see how your new product development projects work their way through your Design Control system. But please separate out Project Change Control from your Quality System's Change Control.

You can use the existing Quality Change Control form as a template but give it a different number and make sure that a different group of people reviews and authorizes Project Change Controls than your Management Review Board. You can also use the existing procedure as a starting point.

Your Project Change Control Review Board should be a subset of your Project Steering Committee. There needn't be a representative from Quality. This is all about managing changes to your projects, not the products that end up being overseen by the FDA.

Good luck,

PM Advisor

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