Production & Process Incidents-Equipment breakdown or malfunction

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Incident Report No.: IR/PRD/2025/045
Incident Raised By: (Name, Sign & Date)
Department: Production
Date of Incident: 29-Aug-2025
Time: 11:20 AM

Category: ☐ Quality Impacting Incidents ☑ Quality Non-Impacting Incidents


(SECTION I) Description of the Incident:

During the compression process of Batch No. TBL/2025/089, the Tablet Compression Machine (Model: Cadmach CMD3-27 Station) suddenly stopped due to motor failure. Production was interrupted, and approximately 8 kg of granules remained uncompressed in the hopper.


(SECTION II) Immediate Action:

  • Machine was immediately stopped and isolated from power supply.
  • In-process material was collected in polybags and labeled as “On Hold – Pending QA Decision”.
  • Engineering department was informed for troubleshooting.
  • Incident was reported to QA.

Action Taken By: Production Officer (Name, Sign & Date)
Action Checked By: Production Head (Name, Sign & Date)


Preliminary Investigation (Root Cause for Incident):

  • Engineering inspection revealed motor overheating due to inadequate lubrication in the gear system.
  • Preventive maintenance schedule was not followed as per 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:

  • Replace faulty motor with new one.
  • Clean and lubricate gear assembly.

Preventive Action:

  • Revise preventive maintenance schedule for compression machine.
  • Engineering to maintain logbook for lubrication check every 15 days.
  • Retrain production and engineering staff on equipment handling and maintenance.

Responsible Staff: Engineering Officer (Name, Designation)
Target Date for Completion: 05-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 observed on processed batch material.
  • Material to be resumed after machine rectification and line clearance by QA.

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 observed; minor production delay of 4 hours.
Remarks: Incident Closed.

Head of Quality Assurance Department / VP Technical: (Sign, Date & Name)

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