Contract Manufacturer Question - Whether or not the reference to the ex-CMO

#1
Hi,

Until a few months ago, a company had contracted out their manufacturing to a CMO (contract manufacturer organization). Since then, they have been slowly bringing the manufacturing process in-house. However, all of their SOPs including their Quality Manual and forms heavily reference the CMO. For a few years, the CMO was heavily integrated into their Quality Management System.

My question is whether or not the reference to the ex-CMO in the company's procedures and Quality Manual will constitute a major finding. The audit is in a few weeks. The company has developed its own manufacturing SOPs in the last two months, but they have not edited out the reference to the ex-CMO in either the Quality Manual or their other procedures.

Any response is appreciated. Thank you! :)
 
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somashekar

Staff member
Super Moderator
#3
Hi,

Until a few months ago, a company had contracted out their manufacturing to a CMO (contract manufacturer organization). Since then, they have been slowly bringing the manufacturing process in-house. However, all of their SOPs including their Quality Manual and forms heavily reference the CMO. For a few years, the CMO was heavily integrated into their Quality Management System.

My question is whether or not the reference to the ex-CMO in the company's procedures and Quality Manual will constitute a major finding. The audit is in a few weeks. The company has developed its own manufacturing SOPs in the last two months, but they have not edited out the reference to the ex-CMO in either the Quality Manual or their other procedures.

Any response is appreciated. Thank you! :)
I see no issues as long as the actions are in line with the procedures and there is a good level of understanding. I hope any of the validations procedures an reports are not just a lift from the CMO document, and the people who own it now have a good hold over these activities. What you are stating could be just a matter of <control+F> find and replace / delete.
How can proper knowledge sharing ever be an adverse finding....
 

Ronen E

Problem Solver
Staff member
Moderator
#4
I see no issues as long as the actions are in line with the procedures

[...]

How can proper knowledge sharing ever be an adverse finding....
If they no longer work with that CMO but the procedures keep pointing to it then I don’t see how actions are in line with procedures in this case.
 

Golfman25

Trusted Information Resource
#5
If they no longer work with that CMO but the procedures keep pointing to it then I don’t see how actions are in line with procedures in this case.
It's the difference between substantive and technical. Sure, technically it's "wrong" because the CMO no longer exists. However, substantively you simply replace the CMO with the current organization. The world moves in real time and there may be little value added by updating all documents due to a name change. Some type of blanket statement should be adequate until time allows for the updates.
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#6
Since then, they have been slowly bringing the manufacturing process in-house. SNIP...
Any response is appreciated. Thank you! :)
To me, that's the critical part: from what you describe, you are in a state of flux, insourcing the manufacturing processes and, in my experience, that's where the disconnects happen and from a risk based thinking perspective, this "temporary context" is a mine field for quality continuity.

If I were an auditor performing a risk-based assessment, I would pay a lot of attention on the communication between the two organizations with clear definition of responsibilities for this "transitional" period as it creates a large number of potential problems. Don't ever underestimate the lack of attention to quality by a supplier that knows that is being eliminated.

If the documentation carries one name or the other is inconsequential as long as the processes are still effective and being followed.
 
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