Exception/Deviation Handling

Definition

Exception or deviation handling is the structured process for documenting, investigating, and resolving any departure from the Master Batch Record's approved procedures or specifications during batch execution. In an EBR system, deviations are typically flagged automatically when a recorded value or action falls outside predefined parameters.

Benefits

Automated deviation flagging within an EBR removes reliance on operators or reviewers manually catching an out-of-range entry, and creates a consistent, documented starting point for every investigation, supporting the review-by-exception model that speeds up batch release.

Use Case

An operator records an in-process temperature reading outside the validated range. The EBR system immediately flags the entry, prevents the batch from silently proceeding without acknowledgment, and routes the deviation into the quality team's investigation queue.

Frequently Asked Questions (FAQ)

Related Terms

• Non-Conformance (NC)
• CAPA (Corrective and Preventive Action)
• Review by Exception