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Hello,
I have a question that I can not find the answer to here on Cove or anywhere else. We are a medical device manufacturing company with a class 2 device. We adhere to CMDR, ISO 13485:2003 FDA 820. I am the internal auditor and was auditing when I seen a form with production performing a functional check an the final QC then signing the final QC acceptance( the same person) then QA having final release. From previous auditor I was told that production can not sign off on their own work. I spoke to my QA Directory and QA Manger and we started digging into the standards to see if we could find a clause in the standards that said anything of this. The Directory thought it was against the Cgmp's but again I could not find any objective evidence of this. Can production perform a functional check then sign off on it and accept it with QA having the final release?
Thank you for any help
I have a question that I can not find the answer to here on Cove or anywhere else. We are a medical device manufacturing company with a class 2 device. We adhere to CMDR, ISO 13485:2003 FDA 820. I am the internal auditor and was auditing when I seen a form with production performing a functional check an the final QC then signing the final QC acceptance( the same person) then QA having final release. From previous auditor I was told that production can not sign off on their own work. I spoke to my QA Directory and QA Manger and we started digging into the standards to see if we could find a clause in the standards that said anything of this. The Directory thought it was against the Cgmp's but again I could not find any objective evidence of this. Can production perform a functional check then sign off on it and accept it with QA having the final release?
Thank you for any help

