Engineering / Maintenance Audit Checklist

1. Facility & Premises

• Preventive maintenance schedule for building, HVAC, and utilities.

• Cleanliness and upkeep of engineering areas (workshops, utility rooms).

• Access control to engineering/maintenance areas.

• Adequate lighting, ventilation, and safety signage in utility areas.

• Calibration and qualification records for critical utilities (AHUs, chillers, boilers).

2. Equipment Qualification & Maintenance

• Equipment qualification status (IQ, OQ, PQ) maintained.

• Preventive maintenance (PM) plan available and updated.

• Maintenance records/logbooks complete and signed.

• Breakdown maintenance handled with documented reports.

• Spare parts inventory management system in place.

• Calibration schedule for instruments followed.

3. HVAC & Environmental Systems

• HVAC qualification/validation records available.

• HEPA filter integrity test (DOP/PAO) records.

• Differential pressure, temperature, and humidity monitoring.

• Preventive maintenance of AHUs documented.

• Environmental monitoring aligned with cleanroom classification.

4. Water & Utility Systems

• Water system qualification (PW/WFI) records maintained.

• Routine microbiological and chemical testing records.

• Sanitation records of water systems.

• Preventive maintenance of pumps, tanks, pipelines.

• Calibration records for temperature/pressure sensors.

• Compressed air/nitrogen/steam system monitoring records.

5. Calibration

• Master calibration schedule available and approved.

• Critical instruments identified and calibrated on time.

• Calibration certificates traceable to national/international standards.

• Out-of-calibration impact assessment documented.

• Records of calibration stickers/labels on instruments.

6. Safety & Compliance

• Fire safety equipment inspected and records available.

• Electrical panels, earthing, and emergency power systems maintained.

• Safety interlocks on critical equipment functional.

• Lockout/Tagout (LOTO) procedure implemented.

• Personal protective equipment (PPE) provided and monitored.

7. Documentation & Records

• SOPs for engineering/maintenance activities available and followed.

• PM/BM (Preventive & Breakdown Maintenance) logbooks updated.

• Equipment history cards maintained.

• Deviations, breakdown reports, and CAPAs documented.

• Change control records for engineering modifications.

8. Vendor & Contract Management

• Qualification of third-party maintenance service providers.

• Service agreements and AMC contracts in place.

• Records of external calibration/validation agencies.

• Spare part and consumable vendor approval documented.

9. Training & Competency

• Training records of engineering/maintenance staff available.

• Competency assessment for handling critical systems (HVAC, water).

• Safety and GMP training conducted regularly.

• Health check-ups for engineering staff as per policy.

10. Regulatory & GMP Compliance

• Engineering practices aligned with cGMP and regulatory expectations (FDA, EMA, WHO).

• Engineering documents controlled under QMS.

• Preparedness for regulatory inspections.

• Previous audit findings and CAPA implementation reviewed.

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