Machine Risk Assessment: Requirements and Step-by-Step Guide

The manufacturer must determine which health and safety requirements apply and design and construct the machinery with the risk assessment results in mind. This is an iterative design process, not a form completed only after construction.

EN ISO 12100 provides a widely accepted method for machinery risk assessment and risk reduction. Other type A, B and C standards may provide additional methods or specific measures. Always verify the current status and product-specific standards for your machine.

Describe intended use, reasonably foreseeable misuse, user groups, environmental conditions and the complete lifecycle. Include transport, assembly, setting, cleaning, fault finding, maintenance and decommissioning as well as normal production.

Record assumptions explicitly. An unclear scope leads to missed hazards and conflicting instructions later.

For every lifecycle phase, identify who could be exposed and how. Consider mechanical movement, electrical energy, temperatures, noise, vibration, radiation, ergonomics, materials, control-system failures and unexpected start-up.

Describe the hazard, the hazardous situation and the event that could lead to harm. This makes it easier to select a measure that actually changes the cause or exposure.

For each scenario, estimate the possible severity of harm and the probability that it occurs. Apply the chosen method consistently and with enough detail to set priorities and compare measures.

A score is a decision aid, not evidence by itself. Substantiate the inputs, involve users and competent specialists, and decide whether further risk reduction is reasonably practicable.

Start with inherently safe design: remove the hazard or reduce energy and exposure through design changes. Then use guards, protective devices and complementary protective measures. Only after that, address residual risks through warnings, instructions and, where needed, personal protective equipment.

Warnings must not replace a feasible design or safeguarding measure. After each measure, verify that risk is adequately reduced and that no new hazards have been introduced.

For each risk, record the scenario, initial estimate, selected measures, supporting evidence and residual risk. Carry residual risk consistently into the instructions and other user information.

Review the assessment after design changes, new applications, incidents or relevant new knowledge. Record what was reassessed and why existing or additional measures are appropriate.

The legislation questionnaire in DME-CE helps identify risks and topics that require attention. Relevant answers feed into the risk assessment, allowing the team to build a structured assessment for each product or project while the design is still being developed.

Teams record hazards, hazardous situations and events across the complete lifecycle. Each scenario receives a visual risk assessment before measures are applied. This makes priorities and the assumptions behind the estimate immediately visible.

Measures are then documented according to the three-step method: inherently safe design first, followed by guards and complementary protective measures, and only then information for use. DME-CE also shows the residual risk after each measure, making its effect and the need for further reduction visible.

Residual-risk warnings can be carried into the instructions. Supporting evidence remains connected to the assessment, while teams can submit sections for review and maintain a traceable record of changes and revisions.

DME-CE supports the method and documentation, but does not independently decide whether a risk is acceptable and does not replace assessment by competent designers and safety specialists. The manufacturer remains responsible for the decisions and final risk reduction.