Which elements are typically included in a deviation report?

• A. Customer complaint log.
• B. Documentation of departure, investigation findings, and corrective actions.
• C. Equipment maintenance schedule.
• D. Only the departure event with no follow-up.

Answer: (B)

In deviation management, the record should capture what happened, why it happened, and how it will be prevented in the future. The best choice reflects that by including the departure (what deviation occurred), the investigation findings (why it happened and its impact), and the corrective actions (immediate steps, root-cause addressing actions, and plans to prevent recurrence). This creates a complete, auditable record that supports accountability and effective CAPA.

The other options don’t fit as well. A customer complaint log is a related record that can trigger a deviation, but it alone doesn’t constitute the full deviation report with the event description, investigation, and corrective actions. An equipment maintenance schedule is about ongoing upkeep and does not document a specific deviation. Recording only the departure event without follow-up fails to close the loop, since investigation and corrective actions are essential to prevent recurrence.