Excessive Warranty Repair and Replacement Costs from Inadequate Analysis

$100,000-$300,000 in audit remediation costs, potential regulatory sanctions, delayed corrective actions that allow failure to persist across 10+ member hospitals, liability exposure • $100K-$500K annually from GPO-negotiated volume contracts • $200,000-$500,000 annually across member base in cumulative warranty costs that could be prevented by early design-flaw identification and product de-listing

Excel pivot tables on invoice data; phone calls to service techs for anecdotal failure reports; manual tracking of RMA counts per SKU; email threads with distributors • Manual audit worksheets in Word/Excel; phone calls to Regulatory Affairs to check manufacturer CAPA status; paper-based corrective action tracking; institutional memory of auditors • Member complaints trigger manual audit investigation; Auditor contacts individual hospitals for failure documentation; consolidates into PowerPoint for leadership; phone calls to manufacturer Quality department