Waste and Rework from Labeling Errors and Inconsistent Placement

$100,000-$200,000 in audit labor and external consultant fees; $500,000+ regulatory fines for failed traceability; customer relationship risk from slow compliance response; potential product liability from missing serialization • $12,000-$28,000/month in first-piece scrap, reprinting costs, labor for rework, and slow ramp-up of new product lines • $15,000-$35,000/month in labor rework hours, material waste (mislabeled units scrapped), downtime costs, and expedited reprinting

Compliance Coordinator manually collects batch reports from production; calls operators to verify labeling parameters were followed; compiles PDF reports for external auditors; emails compliance memos to all departments with manual instruction reminders • Compliance Coordinator manually cross-references production logs with QA sample data; calls shift supervisors to verify labeling parameters for specific batches; creates ad-hoc Excel reconciliation of which serial numbers were applied correctly; sends compliance packages to customers via email with manual certifications • Compliance Coordinator receives escalations via email or phone; manually audits archived production batches; compares old label images against new requirements; circulates non-conformance memos to production via email with manual checklist reminders