Review by Exception

Definition

Review by exception is a batch review methodology where Quality Assurance reviewers focus their attention specifically on flagged deviations, out-of-specification results, or other exceptions within a batch record, rather than manually reviewing every single data point line by line. It relies on the EBR system automatically flagging anomalies as they occur.

Benefits

Review by exception can dramatically reduce batch review time compared to a full manual review, since reviewers spend their effort on the small subset of records that actually require judgment, while records that completed entirely within specification move through review more quickly.

Use Case

A QA reviewer opens a completed batch record in the EBR system and sees that 98% of entries are automatically confirmed as within specification, with two flagged exceptions requiring direct review, allowing the reviewer to focus attention there rather than checking every one of the hundreds of data points in the full record.

Frequently Asked Questions (FAQ)

Related Terms

• Batch Release
• Exception/Deviation Handling
• Batch Production Record (BPR)