820.50 (A) (2)Define the Type and Extent of Control to be exercised over Vendor

R

RobertP45

I am creating a new process to cover “extent of control to be exercised over the product, services, suppliers, contractors, and consultants, based on the evaluation results”, which is from FDA CFR 820.50-Purchasing Controls. The last FDA visit we were asked how do you define and use Tightened Controls over a supplier or contracted vendor. I am trying to locate a definition of “extent of control” or “tightened controls” either on guidance documents from the FDA site or by Googling the terms. We have processes in place, but an FDA acceptable definition of these for the FDA, needs to be more comprehensive than what I presently have. Thank you!
:bonk:

 

sagai

Quite Involved in Discussions
Do not kill me ...
You have the process that is compliant with the corresponding QSR, but it not as long/comprehensive as the FDA inspector expects, and you have a non compliance based on that?
Or am I mistaken?
There is no f@<k1@ guidance as such as far as I know ...
Well, you may know QSIT, but thats all I guess (could be from GHTF too, not sure).
Many thanks.
 
R

RobertP45

Sagai,
Thanks for the response. The concern they had was they wanted a better explanation of how we would apply this control to or over the vendor. At a high level my procedure includes audits and acceptance of how issues are identified, but I was hoping to find an FDA definition and use that in my procedure to appease them.
 
J

Joanb

Audits are certainly needed. You probably want to create your own company standard definition and document the basis for it. :bigwave:
 
J

Joanb

I believe the issue would be if you created your own in-house standards and were not ensuring that your company is enforcing them. In other words, not following through with what you say you are going to do and why you are doing it.
 
Top Bottom