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Improvement Projects and Quality Plan (Examples and Advice needed)

Y

Yano4ka

#1
Dear colleagues!
I have started some months ago in the Quality role in a medical device company. All improvements that were made so far within the CAPA process. Now I plan for major change in the companies Document Control systems. As far as I understood, I will need to create a quality plan: integrating all aspects in one.
Can anyone help with an example (template to document my activities) or advice where to start from? Shall this processes be part of Risk Management?
Thanks in advance!
Y
 

yodon

Staff member
Super Moderator
#3
Not exactly sure I follow what you're doing / what you're asking.

You say you're overhauling the Document Control system. That's part of a Quality System and so you'd follow any change procedures for managing the Quality System. You mention you think you need a Quality Plan for this change. What's the basis for that? 13485 calls for general quality planning; i.e., how will the company plan on ensuring quality but it's not for a specific change.

Do you mean you're implementing a Quality System (quite broader than just a document control system) and you want to do a Quality Manual (the part about integrating all aspects)? If that's the case, then yes, companies generally have a top-level Quality Manual outlining how the standard (13485, for example) will be met, lower level procedures giving more detail, and then detailed procedures (Work Instructions) describing how things are done.

ISO 13485 does expect the company to implement Risk Management and ISO 14971 is the related standard.

If this is what you're asking then I'm sure if you do a search on "Quality Manual" you will get a lot of good information. If I'm off base, maybe clarify what you're needing to do and why you feel you need to do it.
 
Y

Yano4ka

#4
You say you're overhauling the Document Control system. That's part of a Quality System and so you'd follow any change procedures for managing the Quality System. You mention you think you need a Quality Plan for this change. What's the basis for that? 13485 calls for general quality planning; i.e., how will the company plan on ensuring quality but it's not for a specific change.
To be more specific, this is what I want to do: is to change the doc control system and to make sure that I do not loose the quality status of things that I have now and show that I have improved.
As I see from the reply I would need to have a procedure for managing changes, this is what is missing in my QMS... Can you sugget something?
Thanks!
 

yodon

Staff member
Super Moderator
#5
Change management is a broad topic and would be difficult to boil down to a simple post that would give you adequate insight into the process. I'll touch on a few points.

Pretty much all standards / regulations expect that you review and approve changes before they are released. They also expect that the same people (roles) that approved the previous revision approve the new revision. Revisions need to be clearly identifiable and those who use the changed procedures need to understand how to apply the changes (potential training opportunity) and when to begin applying the changes (effective date).

There are a ton of subtleties that can only be understood through experience and that are particular to a company's culture.

Be sure to involve stakeholders in the change process. Get their buy-in before rolling the changes out!

I hope that helps a little. I expect additional searches on change management would yield some good fruit.
 
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gogogomoveit

#7
FDA's very own Medical device Quality Systems Manual: A small entity's guide is probably the best place to start on the requirements on how to build an effective document and change control system. Just do a quick google search on the above keywords.
 
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