How do you produce a risk assessment for a machine?
In six steps: determine the limits of the machine, identify hazards, estimate risks, evaluate risks, derive measures following the three-step method and repeat the cycle until all risks are adequately reduced. The risk assessment starts in the concept phase, not at the end of the design work.
Which steps make up a risk assessment?
What is the three-step method?
| Step | Measure | Example |
|---|---|---|
| 1. Inherently safe design | Eliminate or reduce the hazard by design | Avoid a crushing point through sufficient clearance, limit forces, remove sharp edges |
| 2. Technical safeguards | Shield the hazard with protective equipment | Fixed or interlocking guard, light curtain, two-hand control, safe stop |
| 3. Information for use | Point out the remaining residual risks | Warnings on the machine, statements in the instructions for use, specified personal protective equipment |
The order is binding. A warning must not replace a measure that would have been possible by design or by technical means.
When does the risk assessment begin?
In the concept phase, alongside the design work. That is not a formality but the only point at which step 1 of the three-step method can still have any effect.
Anyone who starts the risk assessment only after the design is finished has already built in the design decisions and is left with safeguards and warnings. That is more expensive, worse and, in case of doubt, not in line with the standards.
In practice this means: the first version is created with the concept, is updated with every design change and is complete at release. It is a working document, not a final report.
What has to be documented?
- The limits determined for the machine, including foreseeable misuse.
- All hazards, hazardous situations and hazardous events identified.
- The risk estimation before and after the measure, so that its effectiveness is traceable.
- The protective measures taken, each assigned to its hazard.
- The standards applied, with their editions.
- The remaining residual risks; they then have to appear in the instructions for use.
Which mistakes happen most often?
- Only normal operation is considered. Yet maintenance, fault clearance and cleaning are the phases with the most accidents.
- Foreseeable misuse is missing, although it is expressly part of determining the limits.
- The three-step method is skipped and everything is solved with a warning.
- Residual risks appear in the risk assessment but not in the instructions for use.
- The risk assessment is not updated after its first version, although the design has changed.
- Protective measures are named, but the performance level achieved is not demonstrated.
Sources and standards
- EN ISO 12100: safety of machinery, risk assessment and risk reduction
- Machinery Regulation (EU) 2023/1230, Annex III, essential health and safety requirements
- EN ISO 13849-1: safety-related parts of control systems
- German Ordinance on Industrial Safety and Health (BetrSichV), Section 3
Editions of standards and their harmonised status change continuously. Check standard numbers and editions against the current list in the Official Journal of the EU before applying them. This article is a technical classification and does not replace legal advice.
Frequently asked questions
Who may produce a risk assessment?
The standard prescribes no formal qualification. The manufacturer is responsible. In practice it takes knowledge of the machine, the standards and the evaluation method, usually a team of design, control engineering and a safety specialist.
What is the difference from the workplace risk assessment?
The risk assessment is done by the manufacturer for the product before placing it on the market. The workplace risk assessment is done by the operating company for the specific workplace under national occupational safety law. Both are mandatory and neither replaces the other.
Do I have to supply the risk assessment to the customer?
No. It is part of the technical documentation and has to be submitted to the market surveillance authority upon reasoned request. The customer receives the residual risks derived from it through the instructions for use.
How long do I have to keep it?
As part of the technical documentation, at least ten years after the machine was placed on the market.
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This article was produced with AI assistance and reviewed for technical accuracy before publication. Editorial responsibility within the meaning of Art. 50(4) of the AI Act (EU) 2024/1689 lies with Heinrich Knutas.
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