Certificate of Conformance and/or Analysis - which to use
Hello, I am wondering if folks have insight around Certificates of Conformance - maybe specifically why a customer would need a CoC when a Certificate of Analysis (CoA) is already provided? I deal almost exclusively with CoAs at my organization but occasionally have requests to provide a CoC, usually in addition to the CoA already provided. The system we use can generate one or the other systematically so these occasional requests have to be addressed manually. My only experience with CoC is that they are more often requested for border crossing/maritime shipments so I don't know if this just happens to be country specific (the country(s) a product travels through not necessarily the end destination)?
4 Replies
I am not an expert but would like to keep my views.
While creating Quality Assurance plans and selecting Manufacturing record book requirements.
Generally, COC is kept. It's a kind of undertaking. It is having Quality Head Signatures. Purchase Orders also ask for COC as a must document.
Duke Okes
160 Posts
You might want to ask the customers who are asking for them.

My thoughts are that CoCs are CYA while CoAs are for when the organization wants to be able to track specific variables, and perhaps make process adjustments accordingly. Just because something is in spec/compliance doesn't mean it won't impact variability.
Hi Shelly,

That is correct, they are usually required for border crossing. A certificate of origin is also one that is generally required for border crossing. I have used the certificate of conformance as a supplement to the certificate of analysis, as one is only a signed statement and the other shows the result, specification, etc. It would be good if your system could print both at the same time, rather than requiring you to print one or the other. Hopefully that is something that can be fixed by IT.

Best of luck,
John Elwer
4 Posts
Depends on what you sell. We require our suppliers to provide a Certificate of Conformity that cover regulatory items. Example, product-contact plastic must comply with 21 CFR 177 for food additives. A COC from other suppliers specifies they are not sending us genetically modified materials. We ask for these to be updated every five years as part of supplier management.

For our company, the COA is lot/batch/shipment specific, while the COC is more broad that the company or site meets certain requirements that don't need spelled out on every single COA.

Hope that helps.