Does a process map satisfy 21 CFR 820.20(d) (Quality Plan)?

Mark Meer

Trusted Information Resource
#1
I've looked through the thread What is a Quality Plan? What Should be in a Quality Plan?, but it is dealing with ISO requirements.

As far as the FDA regulation goes, 21 CFR 820.20(d) states only:
"Each manufacturer shall establish a quality plan which defines the quality practices, resources, and activities relevant to devices that are designed and manufactured. The manufacturer shall establish how the requirements for quality will be met."

Is the expectation here that there be a specific "quality plan" documented (i.e. "here is our quality plan"). Or does the sum total of all established quality system procedures and controls implicitly make up the quality plan?

It seems like a process map (interaction of processes) would suffice as a "quality plan".

Thoughts?
 
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MIREGMGR

#2
Is the expectation here that there be a specific "quality plan" documented (i.e. "here is our quality plan"). Or does the sum total of all established quality system procedures and controls implicitly make up the quality plan?
My view is, the latter.

It seems like a process map (interaction of processes) would suffice as a "quality plan".
That's what my organization has.
 

ASteel

Starting to get Involved
#3
The company I work for just completed a contracted Internal Audit and our Interaction of Processes, nor the Quality Manual, sufficed for our Quality Plan. We did not state it to be as such, as the auditor wanted to see something separate.
 

hogheavenfarm

Quite Involved in Discussions
#4
If you search the post attachments under "quality plan" or "sample quality plan" or "quality plan template" you will find a number of samples.
 

Al Rosen

Holed-up in a Hotel in South Florida
Staff member
Super Moderator
#5
The company I work for just completed a contracted Internal Audit and our Interaction of Processes, nor the Quality Manual, sufficed for our Quality Plan. We did not state it to be as such, as the auditor wanted to see something separate.
Your Quality Manual and procedures would be your Quality Plan. A production router with instructions and/or reference to the procedures is a quality plan.
 
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