CAPA vs. Risk Assessment - Changing a product material for better performance

#1
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!
 

Brizilla

Quite Involved in Discussions
#2
Technically EVERYTHING is RA now. CAPA is an acronym for Corrective Action/Preventive Action. Risk assessment has replaced the formal Preventive Action process in the Standard. Corrective Action will always be needed. It is up to your company on how you do the RA process. If you feel that in some cases the formal Preventive action process is useful to you then by all means use it.
 
#3
Thanks for the feedback. Because it was not a failure due to something we did, it doesn't mean I should overlook an opportunity to improve something Especially if it has minimal risk to the business and the process in doing so. I guess I pretty much answered it right there!!!. I'll save the CA for when it's a Must Correct!! Thanks for your help....Great Forum!
 

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