Is there a requirement for an Approved Equipment List?

P

Philipp

#1
Hello,

I am looking for a requirement that you must have an overview of which products are made with which equipment. Or which equipment is approved for which product?
Does this requirement exists somewhere in the ISO or the Quality System Regulation?

Thanks
Philipp
 
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somashekar

Staff member
Super Moderator
#2
Something close to this is asked for in the "Validation of processes for production and service provision " In the ISO13485, while in the FDA 21CFR820., at sec 820.75 process validation is addresed.

Dear Philipp...
If you are more specific about your requirement, answers here can be that much more precise.
 
#3
Sec. 820.181 Device master record (DMR) states, in part "...(b) Production process specifications including the appropriate equipment specifications..."
Sec. 820.184 Device history record (DHR) requires, in part"...to demonstrate that the device is manufactured in accordance with the DMR..."

So, the DMR has to include equipment specifications, and the DHR has to show the DMR was followed. I think this answers your question as far as which piece of equipment is approved (and used) for the product.
 

yodon

Staff member
Super Moderator
#4
And just to add on a bit to db's reply...

The manufacturing process is validated and part of the validation includes the equipment used. If you validate on one line, you cannot just add another line. You either need to validate on the new line or justify why validation was not necessary (which to completely waive would be, IMO, difficult to defend).
 

LUV-d-4UM

Quite Involved in Discussions
#5
See clause 6.3 Identification of equipment and 7.5.1c. List the critical process equipment that supports the process and put them in a Maintenance Plan.
 
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