Damage Control

A nonconformity has occurred so you need to go into “damage control” (and I don’t mean spinning it to minimize any financial concerns). If you have product in the field that could compromise patient safety, you may need to initiate a recall or notify customers. If you have potentially non-conforming products in inventory that is waiting to be shipped, you may need to quarantine the inventory until you have assurance that the products are safe.

Containment Commensurate with Risk

Containment actions should be commensurate with the risk. Containment actions will be quite different if patient safety is involved as opposed to something not effecting form, fit, or function.