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Incident Report No.: IR/EHS/2025/049
Incident Raised By: (Name, Sign & Date)
Department: Production / Warehouse
Date of Incident: 29-Aug-2025
Time: 02:15 PM
Category: ☑ Quality Impacting Incidents ☐ Quality Non-Impacting Incidents
(SECTION I) Description of the Incident:
During dispensing of Lactose Monohydrate (excipient) for Batch No. TBL/2025/135 in the dispensing area, approximately 4.5 kg of material spilled on the floor due to rupture of a polyethylene bag while being lifted. Spillage was noticed by the dispensing operator.
(SECTION II) Immediate Action:
- Area was immediately cordoned off to avoid cross-contamination.
- Spilled material was collected as per SOP for material spillage and disposed of as pharmaceutical waste.
- The remaining material in the damaged bag was labeled as “Rejected” and kept in quarantine.
- Housekeeping team performed area cleaning and sanitization.
- Incident reported to QA and EHS for assessment.
Action Taken By: Production Officer (Name, Sign & Date)
Action Checked By: Production Head (Name, Sign & Date)
Preliminary Investigation (Root Cause for Incident):
- Material bag was not handled using recommended lifting equipment (trolley/hoist).
- Operator attempted manual lifting which caused stress and rupture of bag seam.
- Inadequate adherence to material handling SOP.
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:
- Spilled material disposed of as per waste disposal SOP.
- Damaged bag rejected and documented in material reconciliation.
Preventive Action:
- Enforce strict use of mechanical lifting aids (trolley/hoist) for bulk materials.
- Re-train warehouse and production staff on safe material handling procedures.
- Strengthen inspection of material bags on receipt to check seam strength.
- Conduct EHS refresher training on spill management.
Responsible Staff: Production Supervisor / Warehouse In-charge
Target Date for Completion: 08-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:
- No quality impact on other materials as spillage was contained and area was cleaned.
- Batch reconciliation to be updated.
- Incident categorized as minor loss with EHS risk, not impacting product quality.
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:
Estimated loss of 4.5 kg excipient (~₹2,000/-). No impact on production schedule.
Remarks: Incident Closed.
Head of Quality Assurance Department / VP Technical: (Sign, Date & Name)