Incident Report Format | Incident Report Template | Incident Report Format For Production & Process Incidents | Incident Report For Power Failure / Sudden Line Stoppage |
Incident Report No.: IR/PRD/2025/046
Incident Raised By: (Name, Sign & Date)
Department: Production
Date of Incident: 29-Aug-2025
Time: 03:05 PM
Category: ☑ Quality Impacting Incidents ☐ Quality Non-Impacting Incidents
(SECTION I) Description of the Incident:
During the coating operation of Batch No. CTD/2025/112, the coating pan (Gansons GAC-350) suddenly stopped due to a power failure in the production block. Power outage lasted for approximately 18 minutes, leading to interruption of the coating process. The batch was partially coated, and tablets inside the pan remained exposed during stoppage.
(SECTION II) Immediate Action:
- Coating process was stopped and the pan load was maintained under controlled temperature & humidity.
- Partially coated tablets were transferred to stainless steel containers and labeled as “On Hold – Pending QA Decision”.
- Engineering department and electrical maintenance team were informed immediately.
- Incident was reported to QA for evaluation.
Action Taken By: Production Officer (Name, Sign & Date)
Action Checked By: Production Head (Name, Sign & Date)
Preliminary Investigation (Root Cause for Incident):
- Electrical team confirmed power failure was caused by tripping of the main distribution panel due to overload in the utility block.
- Emergency backup generator took longer than expected to auto-start due to delay in fuel supply valve opening.
Department Head: (Sign, Date & Name)
(SECTION III) Classification of Errors / Events responsible for Incident:
☐ Breakdown of an Equipment / Instrument / Utility Machine
☐ Malfunctioning of an Equipment / Instrument / Utility Machine
☑ Power Failure
☐ Documentation Error
☐ Human Error
☐ Others
(SECTION IV) Suggested Corrective Action & Preventive Action To Be Taken:
Corrective Action:
- Restarted coating process after line clearance from QA.
- Electrical team reset the main panel and restored power.
Preventive Action:
- Preventive maintenance of backup generator to ensure auto-start function.
- Maintain adequate diesel level and check valve mechanism weekly.
- Install Uninterrupted Power Supply (UPS) for critical coating machine controls.
- Train utility staff on faster power restoration protocol.
Responsible Staff: Electrical Engineer (Name, Designation)
Target Date for Completion: 07-Sep-2025
Suggested By: Department Head (Sign, Date & Name)
Reviewed By: Plant Head (Sign, Date & Name)
(SECTION V) Evaluation and Recommendation by QA / VP Technical:
- Batch quality impact assessed: risk of non-uniform coating on portion of tablets.
- Batch to undergo additional uniformity and dissolution testing before release.
- If results comply, batch may be released; otherwise, batch to be rejected.
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:
Potential reprocessing / rejection risk. Estimated loss of 1.5 hours production time and additional testing cost.
Remarks: Incident Closed.
Head of Quality Assurance Department / VP Technical: (Sign, Date & Name)