Non-conformance can occur at any point in the production process, and this does not always indicate the need for a CAPA. A non-conformance for a singular unit of the device can just indicate a minor human error from an operator. This non-conformance can be fixed through a rework unless the problem is too big to salvage the product, in which case it would have to be scrapped. CAPAs occur if there is something inherently wrong with the process itself and a CAPA could prevent future non-conformance. CAPAs kick off a series of changes in the QMS, starting with the problem itself and webbing out into many different procedures and work instructions and even specifications to fix the problem consistently throughout.