Don Fardie
Registered
Newbie here and trying to determine the correct inputs for some of topics within the 2015 standards. With Risk Assessment being a big part of the new 2015 release, is that to help in eliminating the need for a CAPA form? I assume if you are practicing RA to its fullest, you would avoid the need of a CAPA, because you caught it before it happened. I have an issue where I want to change a product material to meet a higher overall performance and is related to a failed product, but the customer admitted exceeding our guidelines. So the question is what category this would fall under...CAPA or RA
Thanks in advance!
Thanks in advance!