COA (Certificate of Analysis) issued from supplier - His name or mine?

T

tracyw - 2011

#1
I can't find anything on this topic.
My contract manufacturer issues the COA upon completion of their work and testing ... signing as "
Conformance of this lot/batch is certified by:" with their name/title/company
then I get it and sign the "
[FONT=&quot]Release of this Product for Distribution is authorized by:" name/title/company

The document itself currently has my logo and address on it, but some folks want to change it to the contract manufacturer. I think that I should keep my info on there because I am the spec holder/owner, even though my contractual agreement with them indicates they house the original batch records - I have web access to and print hard copies periodically.
I think this is jeopardizing our brand integrity. I know there are contracts and patents in place to prevent any of my customers to have my supplier make product directly for them. Did I mention we do NOT private label??? And that all of my artwork reads "manufactured for ... " my company.

What are other small companies doing about this? We don't want to advertise for the supplier and give them so much business that they can't support us anymore, but want to maintain a harmonious relationship!
Thanks,
Tracy, CQA (ASQ), RAC (RAPS):confused:
Quality Manager

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S

sixsigmais

#2
Re: COA issued from supplier - his name or mine?

In this case, i wouldnt do any changing, just use your name as current practice. Now you are the people who dealing with this supplier, mean you are the customer. So, this is nothing wrong for you to sign the contract as a customer
 
G

gar4guv

#3
Re: COA issued from supplier - his name or mine?

I also think you should leave your logo and address on the COA. Since you are the spec developer and the device is listed in your name, you are responsible for collecting any inquiries or complaints from the end user. Even if your info is somewhere else on the product, having different addresses may cause confusion.

As a contract manufacturer, when asked, we have put another company's logo and contact info on certs that we created. This keeps our customer happy, and we don't have to field any technical questions that our customer's customers might have.

Here is a link to the FDA guidance doc for general labeling requirements (the COA is considered labeling since it's literature that accompanies the product). I didn't see anything stating that the contract manufacturer's info has to be anywhere on the product.

http://www.fda.gov/MedicalDevices/D...GeneralDeviceLabelingRequirements/default.htm

This is all assuming that your device is not subject to any product tracking requirements.
 
T

tracyw - 2011

#5
Re: COA issued from supplier - his name or mine?

My management. Of course the contract manufacturer was eager to get his logo back on there. My current resolution is "I don't agree with it, but I'll do it." I've repeated said my experience, as that of my regulatory/quality consultant friends, is NOT to disclose any contract manufacturer. Big boss said his previous company did it all the time.
 

Jim Wynne

Staff member
Admin
#8
Another angle for discussion, is the form a controlled document within your QMS?
Which form? There's no reason for a supplier's form to be controlled in a customer's system, although the requirements for the information provided might be.

As to the original question, there's nothing wrong with reproducing the data on your own form and retaining the supplier's original. There's also nothing wrong with a desire to keep supplier information confidential if your customers allow it. You just have to be careful to reproduce the information exactly as it appears in the supplier's document, and not represent your company as having originally produced the data. Note that if something bad happens, you might wind up having to divulge anyway.
 
P

prototyper

#9
Which form? There's no reason for a supplier's form to be controlled in a customer's system, although the requirements for the information provided might be.

As to the original question, there's nothing wrong with reproducing the data on your own form and retaining the supplier's original. There's also nothing wrong with a desire to keep supplier information confidential if your customers allow it. You just have to be careful to reproduce the information exactly as it appears in the supplier's document, and not represent your company as having originally produced the data. Note that if something bad happens, you might wind up having to divulge anyway.
I was suggesting that if the document ownership is with the OP's company and the requirement is for the supplier to complete this document, then why change the logo!
 

Jim Wynne

Staff member
Admin
#10
I was suggesting that if the document ownership is with the OP's company and the requirement is for the supplier to complete this document, then why change the logo!
In reading the OP I see that it's a good question because it wasn't made clear. It appears that the present document belongs to the OP's company and the supplier is filling it in and signing with his company information.
 
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