These elements serve different purposes and should not be blended together. A correction addresses the specific observed condition; an interim control protects operations while the investigation continues; root-cause analysis explains why the issue occurred; CAPA changes the system to prevent recurrence; and retrospective review determines whether the same weakness affected prior records, batches, products, or decisions. A credible remediation plan links these elements in sequence and shows who owns each action, what evidence will demonstrate completion, and how the organization will determine whether the action was effective.
FAQ
