We had an outside company come in last year to perform our Internal Audit. They found 25 NC's which are all procedure related that have no effect on product. These NC's are mainly "you should have added this statement to adhere to the standard" or the need to add or clarify verbiage to procedures or the Quality Manual to meet the standard expectations. What process has been used to address these types of NC's? If we write a CAPA, how would we verify the effectiveness of adding a statement to a procedure to better align with the standard? Again, the findings were not apart of any procedures that had a direct impact on product. The NC's found have no risk to the performance of the device. We are currently in our recertification audit and received a major non-conformance for not formally addressing last year's 25 Internal Audit findings. We stated in this year's management review that we plan to close them out by Mid April.
Desperate for suggestions.....
Desperate for suggestions.....