At my company most non-conforming issues usually stem from either operator mistakes or product not conforming to QC testing.

When non-conforming issue occurs due to operator error an investigation is initiated. The investigation report usually entails a 6M (Man, Method, Material, Measurement, Mother Nature (Environment), and Machine). The operator usually makes a mistake with documentation, forgetting a step in the batch record, or conducting a step in correctly. After the investigation is complete an update to an SOP or a batch record is done. The investigation concludes it was Man as the root cause. This doesn’t require a CAPA.

When something fails QC testing such as a device failing dimension specification an investigation is also initiated. If, for the example, the conclusion of the investigation states its Machine related, then a CAPA is usually opened to initiate a change to the machine. At my company we had some devices failing QC dimension specification as the product was falling out of specification after the product was “cut”. Therefore, a CAPA was opened to replace the blades that were cutting the product to new blades.