Risk assessment of machinery
- In accordance with NEN-EN-ISO 12100 and the Machinery Directive.
- From hazard analysis to risk reduction measures
- Substantiated technical dossier for your CE process
What is a risk assessment of a machine?
A risk assessment of a machine is the systematic analysis by which you identify all the hazards of a machine, estimate the associated risks, and determine appropriate measures to reduce those risks. The risk assessment is the basis of machine safety: it determines which safety functions are needed and what level of reliability those functions must achieve. For new machinery, a risk assessment is mandatory under the Machinery Directive, and a new assessment is also required when an existing machine is substantially modified. Kwadrant IA carries out the risk assessment according to NEN-EN-ISO 12100, the international standard that prescribes the methodology.
Machine risk assessment and RI&E: the difference
The terms risk assessment and RI&E are often used interchangeably, but they address different levels. A machine risk assessment (machine RI&E) assesses the risks of one specific machine or plant and follows the Machinery Directive and NEN-EN-ISO 12100. It focuses on the design and safety functions of the machine itself.
In contrast, the Risk Inventory and Evaluation (RI&E) under the Occupational Health and Safety Act assesses the entire workplace: all work equipment, processes and conditions to which employees are exposed. The machine risk assessment provides input to this broader RI&E. Both are necessary and complement each other.
Risk assessment in five steps according to NEN-EN-ISO 12100
NEN-EN-ISO 12100 prescribes a fixed, repeatable sequence. We follow these five steps.
1.
Defining usage limits
Determine what the machine does, who operates it and in what environment and life stages (from commissioning to maintenance and disposal).
2.
Identifying hazards
Mapping of all hazards: mechanical, electrical, thermal, noise, vibration and radiation, in each phase of use.
3.
Assessing risk
For each hazard, determine how serious the potential harm is and how likely and frequent the exposure, for example, using the riskograph or the Fine & Kinney method.
4.
Evaluate risk
Assess whether the risk is acceptable or whether risk reduction is needed.
5.
Take risk-reducing measures
Apply measures in the established priority order: safe design first, then technical safeguards (such as guards, light curtains and safety circuits) and finally user information and instructions.
Methods of determining risk
There are several recognized methods for estimating a hazard. Which one is most appropriate depends on the machine and the type of hazard.
Riskographer
The riskograph determines risk through a decision tree based on severity of injury, frequency of exposure and ability to avoid the hazard. The method is consistent with the determination of the Performance Level according to EN-ISO 13849-1.
Fine & Kinney
The Fine & Kinney method calculates a risk number by multiplying probability, exposure and effect. The resulting number makes it possible to prioritize risks among themselves and substantiate the urgency of action.
HAZOP and FMEA
For complex or process plants, additional methods are used, such as HAZOP (structured deviation analysis) and FMEA (analysis of failure modes and their consequences). These reveal risks that a single estimate may miss.
Start your project with a technical consultation
We like to think with you from the initial design phase to realization and commissioning.
Risk assessment, Machinery Directive and technical file
Proper risk assessment is indispensable for the CE marking of a machine. The Machinery Directive 2006/42/EC (and from 2027 the new Machinery Regulation (EU) 2023/1230) requires the manufacturer to record the risk assessment in the technical file and to demonstrate the measures applied. Even for existing machines, assessment remains important: in case of a major modification or re-commissioning, the requirements for a new machine often apply again. Kwadrant IA provides a well-founded report that is directly usable for the CE process and is in line with the safety functions in the control system.
Kwadrant IA as a risk assessment partner
Kwadrant IA assesses machine safety from the practice of control. Because we control engineering, panel building and control software in-house, we translate the results of a risk assessment directly into concrete, technically feasible safety functions: not a report that disappears into a drawer, but measures that land in the design. Our working method is transparent with open calculation and a quotation within five working days, and is in line with your broader machine safety and CE trajectory.
We do not build standard solutions, but technically sound systems that match the complexity of modern mechanical engineering.
Years of experience in the field of industrial automation
Industrial automation with international standards
Industrial automation requires more than just a correctly constructed panel. We start with the architecture of the system and make conscious choices in component selection, standardization and scalability. By fully mastering engineering, panel construction and integration, we realize control systems that perform reliably in demanding industrial environments. From modular construction to international compliance, every detail is focused on quality, longevity and manageable Total Cost of Ownership.
We do not build standard solutions, but technically sound systems that match the complexity of modern mechanical engineering.
Frequently asked questions about risk assessment of machinery
When is a risk assessment of a machine mandatory?
A risk assessment is mandatory for any new machine placed on the market under the Machinery Directive, and for any major modification of an existing machine. Without a substantiated risk assessment, a manufacturer cannot apply a valid CE marking.
What is the difference between a risk assessment and an RI&E?
A risk assessment (machine RI&E) focuses on the risks of one specific machine according to the Machinery Directive and NEN-EN-ISO 12100. The RI&E from the Occupational Health and Safety Act assesses the entire workplace and all work equipment. The machine assessment provides input for the broader RI&E.
Which standard prescribes the methodology of risk assessment?
NEN-EN-ISO 12100 is the international standard that describes the methodology for risk assessment and risk reduction of machinery. The standard establishes the fixed sequence: determine limits of use, identify hazards, estimate and evaluate risks, and take measures.
How is the severity of a risk determined?
The severity of a risk is determined by weighing the potential harm against the probability and frequency of exposure. Methods such as the riskograph and Fine & Kinney make that weighing systematic and repeatable so that measures can be prioritized by urgency.
Does a risk assessment also apply to existing machinery?
Yes. Existing machinery must remain safe during operation and maintenance, and a major change often reverts to the requirements for a new machine. A renewed risk assessment determines what measures are needed.
