Hello,
In my company, we are reviewing our QMS, and as part of it, I have been asked to review our Nonconformity and CAPA Process.
We work in compliance with ISO 13485 and the 21 CFR 820.
The habit in the company is to escalate every NC to CAPA with the result that we are unable to manage the amount of CAPA.
I have suggested the Quality Manager to design the Nonconformance and CAPA Process based on the risk and to take a decision based on the risk on whether or not an NC should be escalated to a CAPA, but he said that this is not in conformance with the ISO standard. I am confused in my previous company we certainly didn't raise a CAPA for each NC. Could you please share your experience?
Thanks for your help in advance
In my company, we are reviewing our QMS, and as part of it, I have been asked to review our Nonconformity and CAPA Process.
We work in compliance with ISO 13485 and the 21 CFR 820.
The habit in the company is to escalate every NC to CAPA with the result that we are unable to manage the amount of CAPA.
I have suggested the Quality Manager to design the Nonconformance and CAPA Process based on the risk and to take a decision based on the risk on whether or not an NC should be escalated to a CAPA, but he said that this is not in conformance with the ISO standard. I am confused in my previous company we certainly didn't raise a CAPA for each NC. Could you please share your experience?
Thanks for your help in advance