From my experience with a CAPA usually an ER is filled out with the non-conformity which initiates the CAPA process. An example that occurred in my company was a minor one but there was a labeling issue due to a change in a requirement in the asian market. There were already products in stock out with distribution, so there were steps taken through the CAPA procedure to print new labels for that specific market. As well as, deciding on a way to identify any products that were getting shipped out to customers with the old label on them since they were already in inventory with distribution.