Risk Assessment on Packaging Machine (EN ISO 12100)
Background
A leading food packaging company operates several high-speed automated packaging machines used for sealing and boxing products. To meet growing production demand, the company introduced a new vertical form-fill-seal machine.
As part of their CE/UKCA conformity obligations, a full EN ISO 12100 risk assessment was commissioned to identify hazards, evaluate risks, and implement risk reduction measures before the machine entered service.
Initial Risk Identification
The risk assessment team (engineers, safety specialists, and operators) conducted a systematic analysis of the machine’s life cycle—from installation to maintenance and decommissioning.
Key hazards identified included:
Guard Failure
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Movable guarding around the sealing jaws and cutting knives showed inadequate interlock redundancy.
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A single-point failure could allow access to hazardous moving parts during operation.
Control System Failure
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The emergency stop (E-stop) circuit lacked category 3 (PL d) performance level under EN ISO 13849-1, risking failure to stop the machine in the event of a fault.
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Control logic did not detect all sensor faults, increasing the likelihood of unexpected machine restart.
Energy Isolation (Lockout/Tagout)
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No dedicated isolation point for pneumatic and electrical energy during cleaning and maintenance.
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Risk of accidental energisation during blade replacement or jam clearance.
EN ISO 12100 Risk Assessment Process
Activity
Risk Identification
Analysed machine functions, tasks, and possible misuse
Outcome
Identified mechanical, electrical, and ergonomic hazards
Activity
Risk Estimation
Assessed severity, frequency, and possibility of avoidance
Outcome
Guard failure & control failure ranked as High
Activity
Risk Reduction
Applied the hierarchy of controls (inherent design, safeguarding, information)
Outcome
Developed corrective measures
Corrective Actions Implemented
Corrective Action
Guard failure
Installed dual-channel interlocks with safety-rated monitoring; introduced routine guard inspection schedule
Result
Guards remain functional even if one interlock fails
Corrective Action
Control system failure
Upgraded E-stop circuit to Category 3 (PL d); implemented fault detection logic
Result
Ensures reliable machine stop and fault detection
Corrective Action
Energy isolation
Added lockable main isolator and pneumatic dump valve with visual status indicator
Result
Safe maintenance and zero-energy verification
Residual Risk & Information for Use
After implementing engineering controls, residual risks were addressed by:
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Updating the Operator Manual with safe cleaning and maintenance procedures.
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Installing clear signage for emergency stop locations and energy isolation points.
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Conducting operator and maintenance training on lockout/tagout (LOTO).
Results & Benefits
The risk assessment and corrective actions delivered measurable safety and compliance improvements:
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✅ Compliance Achieved – Machine now conforms to EN ISO 12100 and relevant supporting standards (EN ISO 13849-1, EN ISO 14119).
✅ Reduced Accident Potential – Guard and control upgrades significantly lower the risk of entrapment or accidental energisation.
✅ Enhanced Maintenance Safety – Lockout points ensure technicians can verify zero energy before intervention.
✅ Improved Operator Confidence – Clear procedures and visible controls foster a safer working culture.
Conclusion
​Through a structured EN ISO 12100 risk assessment, the company identified critical hazards—including guard failure, control system faults, and inadequate energy isolation—and successfully implemented robust engineering controls.
This proactive approach not only ensured legal compliance but also safeguarded employees, minimised downtime, and strengthened the company’s reputation for safety and quality.
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