How are exceptions to an SOP handled?

• A. Automatically approved if impact is low
• B. Documented as deviations with risk assessment, approval by authority, and CAPA if needed
• C. Filed for deletion after 30 days
• D. Reported only in quarterly audit

Answer: (B)

Handling exceptions to an SOP means treating them as formal deviations that require documentation, risk assessment, explicit approval, and corrective action to prevent recurrence. When an exception occurs, you record what happened, why the SOP couldn’t be followed, and the potential impact on safety, quality, and compliance. Then you perform a risk assessment to determine severity and likelihood, decide whether the deviation needs authorization from the designated authority, and obtain that approval before proceeding. If the assessment reveals root causes or systemic risk, you implement a CAPA (Corrective and Preventive Actions) plan and verify its effectiveness. This approach preserves traceability, accountability, and regulatory readiness, and ensures deviations are managed consistently rather than ignored or delayed.

Automatic approval for low impact isn’t appropriate because even minor deviations can have unintended consequences and should go through proper governance. Deleting records after 30 days would remove essential audit trails and violate record-keeping requirements. Reporting only in quarterly audits delays detection and correction of issues and undermines timely risk management.