C
calimar75
Had our recertification audit a couple weeks ago and the auditor gave a Minor NC because he did not like the justification that was written in many of our complaints regarding our decision for not escalating the issue to a CAPA.
Has anyone ever experienced this before? I have worked at a number of medical device companies and used very similar verbiage and never had an issue.
The statement is in three parts. First it states that the issue has been investigated and root cause assigned (satisfying the fact that it's not an unknown failure). Then it states that the issue is a known failure and that this type of issue has been investigated in the past for the product family in question. Then last it states that trending is performed at our cross-functional complaint meeting on a monthly basis and that if trends are identified within product families that the need for escalation will be addressed then.
Anyone have any feedback or comments on my justification or any experience with responding to such a subjective NC?
Thanks Forum Members.
Has anyone ever experienced this before? I have worked at a number of medical device companies and used very similar verbiage and never had an issue.
The statement is in three parts. First it states that the issue has been investigated and root cause assigned (satisfying the fact that it's not an unknown failure). Then it states that the issue is a known failure and that this type of issue has been investigated in the past for the product family in question. Then last it states that trending is performed at our cross-functional complaint meeting on a monthly basis and that if trends are identified within product families that the need for escalation will be addressed then.
Anyone have any feedback or comments on my justification or any experience with responding to such a subjective NC?
Thanks Forum Members.