Event management systems need to have an escalation mechanism to ensure critical events are quickly elevated to a senior level to ensure organization-wide timely reactions.
There are many reasons for a fast escalation.
- Events that trigger reporting to Regulatory Agencies (e.g. Serious Breach, Urgent Safety Measures (UK), Field Alerts, Biological Product Deviation, Medical Device Report)
- Events that require immediate action to prevent additional harm from across the organization
- Events that require marshalling resources from large parts of the organization
|
GMP |
GCP |
GPVP |
GLP |
Research |
IT |
|
• Impact to data integrity • Impact to product quality/supply |
• Impact to data integrity • Data/privacy breach |
• Event impacting on-time compliance rates (not isolated/steady state) |
• Impact to data integrity |
• Impact to data integrity |
• Reference GxP area for Impact resulting from/linked to system error/failure |
|
• Product Quality/ CMC events in accordance with MRB criteria (or other events of similar scope of impact) |
• Impact to study integrity • Impact to subject’s safety, rights or welfare |
• Gaps in reporting/ collection of potential AEs |
• Impact to study integrity |
• Impact to study integrity |
• System design, testing, deployment, upgrade, etc. event impacting GxP data integrity or regulatory compliance |
|
• Recurring event with broad scope of impact |
• Recurring event with broad scope of impact |
• Recurring event with broad scope of impact |
• Recurring event with broad scope of impact |
• Recurring event with broad scope of impact |
• Recurring event with broad scope of impact |
|
• Impact to program milestones & corporate goals |
• Impact to program milestones & corporate goals |
• Impact to program milestones & corporate goals |
• Impact to program milestones & corporate goals |
• Impact to program milestones & corporate goals |
|
|
• Potential Falsified or Counterfeit Product |
• Potential Fraud or Misconduct |
• Potential Fraud or Misconduct |
|||
|
• Credible Risk of Product Shortage |
• Quality event with patient safety risk/gap |
• GxP Data Breach |
|||
|
• Potential Product Recall |
• Significant Quality Event Notified to Regulatory Authority |
• System error or failure with significant GxP compliance impact |
|||
|
· Potential Critical Finding Resulting from Regulatory Authority Inspection or Audit by External Body/Third Party · Quality Event/Observation Classified as Critical (Event or Internal Audit) Notification from Regulatory Authority or other External Authority of Findings of Significant/Critical Quality Deficiency (inspection or other than through inspection) o e.g.; Refusal to File, Notification of Inadequate Response to Inspection Findings (e.g.; Other Action Indicated (FDA classification), Warning Letter |
|||||
You can drill down to a lower, more practical level, like this
|
Escalation Criteria |
Examples of Quality Events for Escalation |
|
Potential to adversely affect quality, safety, efficacy, performance or compliance of product (commercial or clinical) |
• Contamination (product, raw material, equipment, micro; environmental) • Product defect/deviation from process parameters or specification (on file with agencies) • Significant GMP deviations • Incorrect/deficient labeling • Product complaints (significant PC, trends in PCs) • OOS/OOT (e.g., stability) |
|
Product counterfeiting, tampering, theft |
• Product counterfeiting, tampering, theft reportable to Health Authority (HA) • Lost/stolen IMP • Fraud or misconduct associated with counterfeiting, tampering, theft • Potential to impact product supply (e.g., removal, correction, recall) |
|
Product shortage likely to disrupt patient care and/or reportable to HA |
• Disruption of product supply due to product quality events, natural disasters (business continuity disruption), OOS impact, capacity constraints |
|
Potential to cause patient harm associated with a product quality event |
• Urgent Safety Measure, Serious Breach, Significant Product Compliant, Safety Signal that are determined associated with a product quality event |
|
Significant GMP non-compliance/event |
• Non-compliance or non-conformance event with potential to impact product performance meeting specification, safety efficacy or regulatory requirements |
|
Regulatory Compliance Event |
• Significant (critical, repeat) regulatory inspection findings, lack of commitment adherence • Notification of directed/for cause inspection • Notification of HA correspondence indicating potential regulatory action |
An updated and expanded version of this is found here.
5 thoughts on “Escalation of Critical Events”