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ROI CalculatorEscalation Workflow is the predefined process that ensures quality issues are routed to the right authority within defined time limits when risk, impact, or noncompliance thresholds are exceeded.
FDA CGMP expectations require that significant quality events, deviations, and complaints are reviewed by the Quality Unit and managed without delay. ISO 13485 and ISO 9001 require defined responsibilities, authorities, and internal communication for issues affecting product conformity and patient safety.
Why it matters: since delayed escalation increases patient risk, regulatory exposure, and overall recall impact.
