A couple of weeks ago my company had to place product on hold and initiate a CAPA because of nonconforming product. At a high level, a custom component from a supplier was not made to specification and was used to make the final device. Thankfully, the bracketed product was not shipped to customers so we were able to quarantine all affected devices immediately. However, we had to assess the risk of the non-conforming component to the device performance and function as well as the risk to patient/user safety before taking the product off of hold. The CAPA investigation highlighted that the supplier polished the tool used in the validated process and this seemingly harmless activity, actually manifested into a huge problem for us.