Incident Report Format | Incident Report Template | Incident Report Format For Regulatory & Compliance Incidents | Incident Report For Non-compliance observed during self-inspection or regulatory audits |
Incident Report No.: IR/QA/2025/051
Incident Raised By: (Name, Sign & Date)
Department: Quality Assurance
Date of Incident: 29-Aug-2025
Time: 12:30 PM
Category: ☑ Quality Impacting Incidents ☐ Quality Non-Impacting Incidents
(SECTION I) Description of the Incident:
During internal self-inspection on 28-Aug-2025, it was observed that in the granulation area, the equipment cleaning logbook was not updated for the last two cleaning activities (dated 25-Aug-2025 and 26-Aug-2025). The deviation was noted by QA inspector and categorized as a documentation non-compliance.
Additionally, a similar observation was highlighted by a regulatory auditor during a previous audit, where the inspector stressed on real-time documentation practices.
(SECTION II) Immediate Action:
- QA instructed production staff to immediately update the cleaning record with proper details.
- Granulation equipment was verified physically to be in clean condition by QA.
- Area was allowed to continue operation only after compliance verification.
Action Taken By: QA Officer (Name, Sign & Date)
Action Checked By: QA Head (Name, Sign & Date)
Preliminary Investigation (Root Cause for Incident):
- Operator failed to record cleaning activity in real time due to workload and shift change.
- Inadequate awareness of importance of contemporaneous documentation.
- Lack of supervisory check on logbook entries.
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:
- Missing entries completed with proper annotation (“Late Entry”) along with justification and signatures.
- QA verified physical status of equipment before approving continuation of batch.
Preventive Action:
- Retrain all production staff on GMP principles and ALCOA+ (Attributable, Legible, Contemporaneous, Original, Accurate) documentation practices.
- Implement checklist-based supervisory review of logbooks at the end of each shift.
- Evaluate feasibility of electronic logbook system (ERP integration) to minimize manual errors.
Responsible Staff: QA Officer & Production Supervisor
Target Date for Completion: 20-Sep-2025
Suggested By: QA Head (Sign, Date & Name)
Reviewed By: Plant Head (Sign, Date & Name)
(SECTION V) Evaluation and Recommendation by QA / VP Technical:
- Observation categorized as regulatory risk, as repeated lapses may attract critical audit finding.
- Recommend periodic internal audits with stricter follow-ups on CAPA implementation.
- This case to be used as training example for all staff on importance of contemporaneous documentation.
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 direct material loss; however, risk of regulatory action in case of repeat non-compliance.
Remarks: Incident Closed after CAPA implementation.
Head of Quality Assurance Department / VP Technical: (Sign, Date & Name)