How should deviations from an SOP be documented and escalated?

• A. Record the deviation, assess impact, notify supervisor, initiate CAPA if needed, and communicate resolution.
• B. Record deviation only.
• C. Notify supervisor only.
• D. Initiate CAPA without recording.

Answer: (A)

Handling deviations from an SOP requires a complete, auditable process: record the deviation, assess its impact, notify the supervisor, initiate CAPA if needed, and communicate the resolution. Recording creates a traceable record of what happened, which is essential for accountability and future reference. Assessing impact helps determine the level of risk to quality, safety, or regulatory compliance and guides the next steps. Notifying the supervisor ensures proper oversight and approval, so actions align with organizational responsibilities. Initiating CAPA when needed addresses root causes and prevents recurrence, turning a one-time issue into a structured improvement. Finally, communicating the resolution closes the loop, documenting what was done and the final outcome so everyone understands the status and any follow-up actions. Incomplete options fall short because they omit one or more of these crucial steps, leaving records incomplete, risks unmanaged, or responsibilities unclear.