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ROI CalculatorA Notice of Event (NOE) captures resources & efforts related to an event, anomaly, or minor deviation from normal operations. It can also serve as an early notification of problems by documenting issues that require documentation but do not pose a direct threat to product safety and regulatory compliance.
Triage vs. Investigation: An NOE is not as comprehensive as a major deviation or nonconformance where there is likely some degree of concern with regards to the impact of the deviation or nonconformance and therefore must prepare an extensive investigation — but merely documents some unacceptable issue with no potential impact on product quality or patient safety or regulation submissions.
Streamlining Operations: With an NOE, the Quality Assurance (QA) group can quickly document these minor anomalies and not initiate lengthy, resource consuming Corrective and Preventive Action (CAPA) or Quality Assurance Report (QAR) investigations.
Risk Tracking: An NOE can also assist in monitoring minor repeatable anomalies to ensure that they don't lead to systemic, larger risks over a period of time.
An effective NOE often captures the following details:
Event Description: A brief, particular account of precisely what transpired.
Date and Location: The precise time the occurrence was acknowledged and the facility, batch, or system where it happened.
Impact Assessment: It provides documentation to support why this event doesn't impact product quality nor would require a major deviation report.
Immediate Corrections: Any quick fixes applied to return the process to normal state.
Deviation vs. NOE: A deviation creates either an actual or likely impact on product quality or GMP systems and therefore requires complete investigation (QAR). An NOE is an event that does not impact quality and is merely documented for traceability.
Notice of Escape (NOE): A Notice of Escape (NOE) notifies management that a defective product was manufactured at your location and placed in product distribution before it was contained and recalled.
CAPA: An NOE does not require a Corrective Action and Preventive Action (CAPA) as it is a non-transformational and is a documentation of a minor issue that has already been resolved or determined to not pose a danger.
Organizations that are responsible for NOEs should include them in their electronic Quality Management System (eQMS). Using an electronic repository ensures minor events are consistently recorded, are fully searchable for use during either internal or external audits, and can be reviewed periodically as part of the quality management process to evaluate the reliability of their processes.
