Comprehensive Steam Boiler Safety
Inspection Checklist
For Pharmaceutical Manufacturing Facility
(Aligned with ISO 9001:2015, ISO 45001:2018, ISO 14001:2015, and cGMP requirements)
1. General Documentation & Compliance
Checklist Item Status (✓/✗) Remarks
Boiler operating licenses
and certifications are
current and displayed.
Preventive maintenance
program documented as per
QMS (ISO 9001:2015).
Calibration records for
pressure gauges, safety
valves, flow meters, and
alarms are updated.
SOPs for boiler operation,
inspection, and emergency
shutdown are approved and
accessible.
Training records for boiler
operators available and
current (competency and
refresher training per ISO
45001:2018).
cGMP documentation
controls in place (logbooks,
batch records, deviation
reports).
Environmental permits and
compliance with emissions
standards (ISO
14001:2015).
2. Safety Devices & Controls
Checklist Item Status (✓/✗) Remarks
Pressure relief valves
inspected, tested, and
sealed (tamper-proof).
Water level indicators
(gauge glass, alarms,
automatic cut-off)
functional and calibrated.
Emergency shutdown
systems operational and
tested.
Flame safeguard controls
tested (flame failure
protection).
Safety interlocks for fuel
system operational.
Audible and visual alarms
functional (low water, high
pressure, flame failure, gas
leak).
Lockout/Tagout (LOTO)
procedures implemented.
3. Structural & Mechanical Integrity
Checklist Item Status (✓/✗) Remarks
Boiler shell, drums, and
tubes free of cracks,
corrosion, or leaks.
Refractory lining intact
without signs of erosion.
Doors, manholes, and access
hatches properly sealed.
Insulation intact and free of
asbestos or hazardous
materials (ISO 14001).
Piping and joints inspected
for leaks, corrosion,
vibration, and support
integrity.
Blower and fan systems
operational with vibration
monitoring.
4. Water Quality & Treatment (cGMP Critical Area)
Checklist Item Status (✓/✗) Remarks
Feedwater quality tested as
per pharmacopeia
standards (USP/EP/JP).
Water
softener/deaerator/RO
system functioning and
maintained.
Chemical dosing (e.g., anti-
scaling, oxygen scavenger)
controlled, documented,
and compliant with GMP
(no cross-contamination
risk).
Blowdown system
functional and recorded in
logbook.
Condensate return system
inspected for contamination
risks (important for sterile
manufacturing).
5. Fuel System & Combustion Controls
Checklist Item Status (✓/✗) Remarks
Fuel storage tanks secure,
leak-free, and compliant
with environmental
regulations.
Gas and oil pipelines leak-
tested (ISO 45001:2018 risk
control).
Burners inspected for
proper combustion, flame
stability, and efficiency.
Fuel-air ratio controls
calibrated.
Stack emissions (NOx, SOx,
CO2, CO, particulate matter)
monitored and compliant
with ISO 14001 and local
regulations.
Waste heat recovery
systems inspected.
6. Instrumentation & Monitoring Systems
Checklist Item Status (✓/✗) Remarks
Pressure gauges,
temperature sensors, and
flow meters calibrated.
Control panels clean, free of
dust/moisture, and labeled.
SCADA/DCS systems (if
applicable) validated and
compliant with GMP data
integrity requirements
(ALCOA+: attributable,
legible, contemporaneous,
original, accurate).
Event log records available
and reviewed for
deviations.
7. Occupational Health & Safety (ISO 45001 Integration)
Checklist Item Status (✓/✗) Remarks
Access platforms, ladders,
and walkways secure with
guardrails.
Adequate lighting and
ventilation in boiler room.
PPE (gloves, goggles,
hearing protection, heat-
resistant clothing) available
and used.
Fire extinguishers,
hydrants, and suppression
systems inspected and
accessible.
Emergency evacuation
routes clearly marked and
unobstructed.
Risk assessment
(HIRA/JSA) updated for
boiler operations.
8. Environmental Considerations (ISO 14001 Integration)
Checklist Item Status (✓/✗) Remarks
Boiler blowdown and
wastewater discharged
through approved
treatment system.
Emission records
maintained and reviewed
for compliance.
Fuel handling procedures
prevent spills and
contamination.
Energy efficiency measures
documented (condensate
recovery, economizers,
insulation).
Noise levels monitored and
controlled within
permissible limits.
Hazardous waste (sludge,
chemicals) managed and
disposed per environmental
regulations.
9. GMP-Specific Considerations for Pharma Facilities
Checklist Item Status (✓/✗) Remarks
Steam quality validated for
direct/indirect contact
applications (clean steam
vs. plant steam).
Steam traps functional and
validated (no contamination
risk to sterile areas).
Condensate free of
particulates, oil, or other
contaminants.
Preventive maintenance
conducted without
introducing foreign matter
into GMP areas.
Change control applied for
modifications in boiler
system or critical utilities.
Deviations,
nonconformances, and
CAPAs documented and
closed.
10. Emergency Preparedness & Response
Checklist Item Status (✓/✗) Remarks
Emergency response plan
available, covering boiler
explosion, fire, fuel leak, and
steam release.
Mock drills conducted and
documented.
Communication systems
tested (alarms, intercoms,
radios).
Coordination with local fire
department and regulatory
authorities documented.
11. Audit & Continuous Improvement
Checklist Item Status (✓/✗) Remarks
Internal audits conducted
as per ISO 9001 & ISO
45001 requirements.
Management review
includes boiler safety,
compliance, and
environmental
performance.
Non-conformities tracked,
CAPAs implemented, and
effectiveness verified.
Continuous improvement
initiatives documented
(energy efficiency, waste
reduction, risk mitigation).
