Incident Report Format | Incident Report Template | Incident Report Format For Warehouse & Logistics Incidents | Incident Report For Wrong material issuance (mix-up in API/excipient/packing material) |
Incident Report No.: IR/WH/2025/050
Incident Raised By: (Name, Sign & Date)
Department: Warehouse / Production
Date of Incident: 29-Aug-2025
Time: 09:40 AM
Category: ☑ Quality Impacting Incidents ☐ Quality Non-Impacting Incidents
(SECTION I) Description of the Incident:
During dispensing for Batch No. TBL/2025/141, it was observed that Microcrystalline Cellulose (MCC) was issued instead of Lactose Monohydrate. The error was identified during material cross-verification in the dispensing area by Production Executive before addition into the mixer. Wrong material label was detected, and the material was immediately segregated.
(SECTION II) Immediate Action:
- Issuance and dispensing process was immediately stopped.
- Wrongly issued container was quarantined and labeled as “Rejected – Wrong Issuance”.
- Correct material (Lactose Monohydrate) was re-issued from warehouse after QA verification.
- Incident reported to QA and Warehouse Head for assessment.
Action Taken By: Warehouse Officer (Name, Sign & Date)
Action Checked By: Warehouse Head (Name, Sign & Date)
Preliminary Investigation (Root Cause for Incident):
- Warehouse operator picked wrong container from adjacent location due to similar packaging of excipients.
- Secondary verification (by another warehouse staff) was not done before issuance.
- Material storage racks lacked clear visual differentiation / segregation of similar-looking excipients.
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:
- Quarantine and reconcile wrongly issued material.
- Issue correct material as per BMR requirements after QA confirmation.
Preventive Action:
- Enforce two-level verification system during material issuance (Warehouse + QA).
- Introduce barcode / ERP scanning system for issuance to avoid manual errors.
- Rearrange warehouse storage with color coding & segregation of APIs and excipients.
- Train warehouse staff on importance of correct material issuance and reconciliation.
Responsible Staff: Warehouse Supervisor (Name, Designation)
Target Date for Completion: 15-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:
- Since error was identified before material was added into the batch, there was no impact on product quality.
- Incident considered as near-miss with high risk potential.
- Emphasis on preventive measures and strict adherence to SOP for issuance.
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:
No commercial loss, only time delay of ~1 hour in batch dispensing.
Remarks: Incident Closed.
Head of Quality Assurance Department / VP Technical: (Sign, Date & Name)