Label Reconciliation
ProductionAlso known as: Label accountability, Label count reconciliation, Packaging reconciliation
The process of accounting for all labels issued vs used vs destroyed during a production run, required under Part 111.
What It Means
Label reconciliation is the process of accounting for the quantity of labels issued for a production run versus the number applied to finished product, with any discrepancy investigated. Under 21 CFR Part 111 Subpart G, label reconciliation is required unless the operation uses 100% electronic or electromechanical label examination for cut or rolled labels. The purpose is to prevent obsolete, incorrect, or excess labels from entering the production environment and being applied to wrong products. Label reconciliation is closely linked to changeover control: production line changeovers (switching from Product A to Product B) are where mislabeling errors most commonly occur. SQF and BRCGS audits also evaluate label reconciliation practices.
What It Is Not
Label reconciliation is NOT simply counting labels. It requires investigating discrepancies (more or fewer labels than expected), destroying excess labels, and maintaining records. It is also not optional under Part 111 unless the facility has 100% electronic label verification. The exception exists because electronic systems catch mislabeling in real-time, making reconciliation redundant.
Evidence and References
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