When discussing machine safety, the concepts of risk analysis and risk assessment often arise. They are sometimes used interchangeably, but within machine safety, they actually mean different things. Here, we clarify the difference and show how they are connected to CE marking, the machinery directive, and the upcoming machinery regulation.

What is a risk analysis?

A risk analysis is the first part of the risk management process for machinery. It includes:

  1. Determining the machine's limitations (intended use and foreseeable misuse)

  2. Identifying sources of risk and hazardous situations.

  3. Estimating the risk for each source and situation.

In other words, risk analysis is about understanding and describing the risks.

What is a risk assessment?

A risk assessment goes a step further than risk analysis. It includes the analysis (1-3 above) and additionally:

  1. Evaluating the risk and deciding on the need for risk reduction.

  2. Reducing the risk or eliminating the source with protective measures.

This means that a risk assessment is a comprehensive evaluation where sources of risk are identified, risks are evaluated, and risks are mitigated or reduced.

The connection to CE marking and the machinery directive

To CE mark a machine according to the Machinery Directive 2006/42/EC (and soon the Machinery Regulation 2023/1230), a documented risk assessment is required. It is a central part of the technical file that authorities may request.

Without a proper risk assessment, a machine is not legal to sell or operate in the EU market.

How Noex helps you

With Noex, companies get a digital platform for technical manufacturing documentation including risk assessments, checklists, inspection protocols, and other supports to facilitate CE marking of machines. The platform guides step by step and consolidates all documentation in one place. The result:

  • Structure and traceability

  • Reduced risk of errors

  • Faster process toward CE marking

FAQ - Frequently Asked Questions about Risk Analysis and Risk Assessment

What is the difference between risk analysis and risk assessment? 

Risk Analysis = identify and estimate risks. Risk Assessment = analysis + evaluation of the need for measures followed by actions to reduce or eliminate risk.

Is risk assessment mandatory for CE marking? 

Yes, according to the Machinery Directive and upcoming Machinery Regulation, all machines must have a documented risk assessment as part of the technical documentation. 

Why should risk assessments be done at an early stage?

If safety is not considered from the beginning, it can be costly and difficult to integrate retroactively. If it still needs to be addressed reactively, it often comes at the expense of both availability and usability.

What happens if we neglect risk assessments?

Without proper documentation, you risk (besides having an unsafe machine and a poorer work environment) downtime with significant costs as a consequence, fines/penalties, recalls, insurance issues, and in the worst case, personal liability.

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