How should you document a deviation and corrective action?

• A. Record time, person, description of deviation, actions taken, disposition of product, verification steps, and sign-off.
• B. Ignore deviation and proceed
• C. Only record the time
• D. Delete records

Answer: (A)

Recording deviations and the corresponding corrective actions is about creating a complete, auditable trail that shows what happened, how the issue was controlled, and that the product is handled safely. When a CCP limit is breached or a process goes off spec, you document all the key details in a formal record: the exact time the deviation occurred and who reported it, a clear description of what happened and which limit was exceeded, the actions taken to contain the issue and prevent further impact, how the affected product was dispositioned (held, reworked, or discarded), the verification steps used to confirm that the corrective action was effective (retests, recalibrations, follow-up checks), and the sign-off by the responsible supervisor or QA. This level of detail builds a traceable history, supports root-cause investigation, and provides evidence for audits that proper controls were applied.

Missing essential information makes the record useless and undermines safety and compliance. Ignoring the deviation or recording only a fragment like the time, or deleting records, would remove accountability and prevent proper verification or traceability.