Incident Report Format | Incident Report Template | Incident Report Format For Quality Control Department Incidents | Incident Report HPLC Instrument Malfunction |
Incident Report No.: IR/QC/2025/054
Incident Raised By: (Name, Sign & Date)
Department: Quality Control
Date of Incident: 29-Aug-2025
Time: 03:40 PM
Category: ☑ Quality Impacting Incidents ☐ Quality Non-Impacting Incidents
(SECTION I) Description of the Incident:
During assay and related substances analysis of Batch No. TBL/2025/165 (Metformin Tablets 500 mg) on HPLC system (Waters Alliance e2695 with PDA Detector), the chromatogram showed unstable baseline drift and noisy peaks, making the test results invalid. The same issue persisted even after reinjection with fresh mobile phase.
(SECTION II) Immediate Action:
- Ongoing analysis was stopped.
- QC Head was informed immediately.
- System was shut down and labeled as “Under Maintenance – Do Not Use”.
- Batch placed on “Hold” until resolution of the incident.
Action Taken By: QC Analyst (Name, Sign & Date)
Action Checked By: QC Supervisor (Name, Sign & Date)
Preliminary Investigation (Root Cause for Incident):
- Engineering service team inspected the instrument and found leakage in pump seal and blockage in column inlet frit, leading to pressure fluctuations and unstable baseline.
- Preventive maintenance not performed as per schedule.
Department Head: (Sign, Date & Name)
(SECTION III) Classification of Errors / Events responsible for Incident:
☑ Malfunctioning of Equipment / Instrument
☐ Breakdown of Equipment / Instrument
☐ Power Failure
☐ Documentation Error
☐ Human Error
☐ Others
(SECTION IV) Suggested Corrective Action & Preventive Action To Be Taken:
Corrective Action:
- Pump seal replaced and column cleaned / replaced.
- System suitability test re-run to confirm instrument performance.
- Affected batch reanalyzed using another HPLC system.
Preventive Action:
- Revise preventive maintenance schedule for HPLC (monthly checks of seals, tubing, and pump).
- Maintain instrument health logbook with daily pressure and baseline records.
- Conduct refresher training for QC staff on instrument monitoring & early troubleshooting.
Responsible Staff: QC Engineer / Supervisor (Name, Designation)
Target Date for Completion: 12-Sep-2025
Suggested By: QC Head (Sign, Date & Name)
Reviewed By: Plant Head (Sign, Date & Name)
(SECTION V) Evaluation and Recommendation by QA / VP Technical:
- QA recommended using results only from validated and compliant HPLC system.
- Incident categorized as instrument malfunction with potential impact on regulatory compliance.
- No impact on product quality since test was repeated on another system.
Q.A. Head / VP Technical: (Sign, Date & Name)
(SECTION VI) Compliance of the Recommendations and Closure:
Verification Done By:
- Department Head (Sign, Date & Name)
- QA Head / VP Technical (Sign, Date & Name)
Final Conclusion with Estimated Commercial Loss:
Approx. ₹15,000/- for spare parts and service cost; ~6 hours delay in batch release.
Remarks: Incident Closed.
Head of Quality Assurance Department / VP Technical: (Sign, Date & Name)