Incident Report Format | Incident Report Template | Incident Report Format For Quality & GMP Incidents | Incident Report For Deviation from Approved SOPs |
Incident Report No.: IR/PRD/2025/047
Incident Raised By: (Name, Sign & Date)
Department: Production
Date of Incident: 29-Aug-2025
Time: 10:45 AM
Category: ☑ Quality Impacting Incidents ☐ Quality Non-Impacting Incidents
(SECTION I) Description of the Incident:
During granulation of Batch No. GRN/2025/075, it was observed that the sieving of wet mass was carried out using 8 mesh screen instead of the approved 10 mesh screen as per SOP No. PRD/GRN/014. Operator selected the wrong mesh size due to oversight. Deviation was identified during in-process check by Production Executive.
(SECTION II) Immediate Action:
- Granulation process was immediately stopped.
- Material already sieved was kept in poly-lined container with status label “On Hold – Pending QA Decision”.
- Correct mesh (10 mesh) was installed and further sieving was carried out as per SOP.
- Incident was reported to QA for assessment.
Action Taken By: Production Officer (Name, Sign & Date)
Action Checked By: Production Head (Name, Sign & Date)
Preliminary Investigation (Root Cause for Incident):
- Root cause identified as operator error due to lack of attention and inadequate cross-verification.
- Line clearance and checklist review were not performed as per SOP prior to starting sieving.
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:
- Hold material sieved with wrong mesh for QA decision.
- Continue sieving with correct mesh size as per SOP.
Preventive Action:
- Re-train production staff on critical steps in SOP compliance.
- Revise SOP to include second-person verification before selecting sieve mesh.
- Introduce a pre-operation checklist with mandatory QA/production sign-off.
Responsible Staff: Production Officer (Name, Designation)
Target Date for Completion: 10-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:
- QA to sample and test sieved granules for particle size distribution and flow properties.
- If results comply with specifications, batch may be continued for further processing.
- If results deviate, material to be discarded and re-granulation planned.
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 5 kg of wet mass (if rejected) and production delay of 2 hours.
Remarks: Incident Closed.
Head of Quality Assurance Department / VP Technical: (Sign, Date & Name)