Looking at 21 CFR 820.20 which calls out in section (d) for Quality Planning

RCW

Quite Involved in Discussions
#1
I know this subject has probably been beaten to death in the ISO 9000 forum BUT......

I'm looking at 21 CFR 820.20 which calls out in section (d) for Quality Planning.

Could somebody give me some input on what they use to satisfy this requirement?

Does this refer to just the manufacture of the product (steps for manufacture, test and inspection)?

Is it more involved to include purchasing, shipping and other levels of the quality system?

I'm assuming it's product specific and a general/generic flow chart to show the processes involved doesn't fulfill the requirement.

I would like to use a flow chart to simplify things.

All practical comments will be taken into consideration.

Thanks!
 
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E

elbee

#2
Our Quality Plans are product specific. Each itemized section says "Controlled per section x.x of the Quality Systems Manual". Where specific requirements are actually needed, they are noted in a subheading in that section.
Example:
-----------------------------------
Inspection and Measuring Equipment: Controlled per section x of the Quality Manual.

Product Specific Requirements: None

------------------------------------
Inspection and Test Status: Controlled per section x of the Quality Manual.

Product Specific Requirements: Final release of product lots for sterilization per Quality Procedure x.
Final release of product lots for shipment to customer per Quality Procedure x.
-----------------------------------

Pretty simple, but it's made it through 2 FDA inspections and several ISO/MDD audits.
 
A

Alf Gulford

#3
The design project folder (assuming that's part of the process) may form part of this, also.

During the design reviews we bring in people from Manufacturing, Purchasing, Receiving Inspection, etc. This is where we start to document what we may need for additional expertise, assembly and inspection/test equipment, material handling equipment and so on.

Our Quality Manual points to the project folders as an important source of quality planning information.

Alf
 
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