Machine Risk Assessment Checklist ISO 12100

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7 critical items still open - these are the highest-risk gaps.

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1. Machine limits

Intended use and reasonably foreseeable misuse are written downCRITICALOperating modes defined (automatic, manual, setup, maintenance, cleaning)Space limits recorded (range of movement, clearances, access)Time limits recorded (lifespan, service intervals)Operator, maintenance and other user groups and skill levels listedEnvironmental limits recorded (temperature, dust, washdown, explosive atmosphere)Interfaces with other machines and utilities listed

2. Hazard identification

Mechanical hazards identified (crushing, shearing, entanglement, ejection)CRITICALElectrical hazards identified (contact, stored energy, arc)Thermal hazards identified (hot or cold surfaces)Noise and vibration hazards identifiedHazards from materials and substances identified (dust, fumes, fluids)Radiation and laser hazards identified where relevantErgonomic hazards identified (posture, lifting, controls layout)Hazards during all life phases considered: transport, installation, commissioning, use, decommissioningHazardous situations and events listed for each hazard

3. Risk estimation and evaluation

Method for severity, exposure and avoidance defined and applied consistentlyCRITICALRisk estimated for each hazard before measuresRequired performance level (PLr) or SIL set for each safety functionCRITICALRisk evaluated against acceptance criteriaAssessment covers all users and all operating modes

4. Risk reduction

Inherently safe design measures applied firstCRITICALSafeguarding (guards, interlocks, light curtains) applied for remaining riskInformation for use (manual, signs, training) used only for residual riskSafety functions designed and verified to required PL or SILCRITICALEmergency stop function provided and checkedLockout and energy isolation points providedNew hazards introduced by each measure checkedRisk re-estimated after measures

5. Validation and documentation

Safety functions validated by test and recordedCRITICALStandards applied and editions recordedRisk assessment retained in the technical fileResidual risks communicated in the instructionsAssessment reviewed after any modification or incidentAssessor names, roles and dates recorded

Tick each item you can evidence. Any unticked critical item means the assessment is not ready to support CE marking or release. This checklist follows the structure of ISO 12100 but is not a replacement for the standard or for qualified safety assessment.

Technical file in your ERP

Optional: a review of how risk assessments and test records could be tied to machine serial numbers.

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How to use the checklist

Run it with the design lead, a controls engineer and someone from service or operations. Tick what you can evidence by document, drawing or test record, not what you believe is true. Keep the filled checklist with the risk assessment file and repeat it on each major change. A short checklist run at design freeze catches more than a long audit at delivery.

Include service and operator voices
Keep evidence links, not only ticks
Review at design freeze and before shipment
Re-run after any modification

The three step method

ISO 12100 asks you to reduce risk in a fixed order: first by inherently safe design, then by safeguarding and complementary protective measures, then by information for use. Warning signs and training are the last resort, not a substitute for a guard. Group four of this checklist follows that order, and auditors check it.

Worked example

On a pallet wrapper, crushing at the turntable is identified in group two. Severity is serious, exposure is frequent, avoidance is possible only with a slow table speed. Design reduces speed and removes pinch gaps, a perimeter guard with an interlock covers the rest, and the interlock function gets a required PL d. The result is recorded and validated by test.

Common mistakes

Assessing only normal operation and forgetting setup, jam clearing and cleaning, where most injuries happen. Others set risk scores to justify the existing design instead of the reverse. Also frequent: no re-assessment after a customer modification, and no link between hazards and the safety functions that control them.

Frequently Asked Questions

Is a risk assessment legally required for CE marking?

Yes. Under the EU Machinery Directive and the Machinery Regulation, the manufacturer must carry out a risk assessment and document it in the technical file. ISO 12100 is the standard method most often used.

How often must it be updated?

Whenever the design, intended use or operating conditions change, and after relevant incidents or new findings. There is no fixed calendar interval, but a review at each design release is good practice.

Who should perform it?

A cross functional team with knowledge of the design, operation, maintenance and safety standards. The manufacturer remains responsible even if consultants support it.

Does this replace a third party review?

No. Some machines listed in Annex IV of the Directive need a notified body or specific procedures. This checklist helps you prepare but does not replace formal assessment where required.

If you want the risk assessment, safety function register and technical file linked to each machine serial number in your ERP, we can help scope it.

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Machine Risk Assessment Checklist Based on ISO 12100