Referencing to Supplier Outputs within our Document Control System

B

brbobo4

#1
Hello,

First time posting, I hope this is the correct group. Please let me know if it is not.

The company I current work for develops combination products which we package in standard cardboard cartons (non-sterile barrier). For much of our packaging development we rely on a third party who we work with to create the outputs (Drawings and specifications) based on our input requirements. We review and approve those outputs and then they get controlled in the vendors validated document control system. In our DHF we then point to the document at our vendor and we have quality agreements in place on access to those files during an audit.

As they manufacture against their approved output and changes to those outputs would require reapproval from us is there any need to re-control or duplicate the control of this output within our document control system? I’m always cautious about duplication of documentation.

Any standards or regulations you could reference to support your position would be greatly appreciated. Most of what I have found to date is very high level.
 
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somashekar

Staff member
Super Moderator
#2
Hello,

First time posting, I hope this is the correct group. Please let me know if it is not.

The company I current work for develops combination products which we package in standard cardboard cartons (non-sterile barrier). For much of our packaging development we rely on a third party who we work with to create the outputs (Drawings and specifications) based on our input requirements. We review and approve those outputs and then they get controlled in the vendors validated document control system. In our DHF we then point to the document at our vendor and we have quality agreements in place on access to those files during an audit.

As they manufacture against their approved output and changes to those outputs would require reapproval from us is there any need to re-control or duplicate the control of this output within our document control system? I’m always cautious about duplication of documentation.

Any standards or regulations you could reference to support your position would be greatly appreciated. Most of what I have found to date is very high level.
You are perfectly fine as long as you have the required competency to demonstrate for your approving status. The rest of it depends upon your controls you exercise initially and periodically on the process that is outsourced.
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And welcome to the COVE
 
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