Manufacturer of machines and plants, as well as manufacturers of electrical devices must determine, which hazards and risks are associated with their products. This legal requirement can be found in different EU directives, such as:
It´s often assumed that performing a risk assessment is voluntary. The Machinery Directive 2006/42/EC and the Machinery Regulation (EU) 2023/1230 clarify in Annex I and Annex III respectively that the risk assessment is a mandatory requirement:
The manufacturer of machinery (…) must ensure that a risk assessment is carried out in order to determine the health and safety requirements which apply to the machinery. (2006/42/EC, Annex I)
The manufacturer of machinery or a related product shall ensure that a risk assessment is carried out in order to determine the essential health and safety requirements which apply to the machinery or related product. (2023/1230, Annex III)
The new Low Voltage Directive 2014/35/EU (LVD) also makes manufacturers fully responsible:
The manufacturer shall establish the technical documentation. (…) and shall include an adequate analysis and assessment of the risk(s).
The guidelines of the so-called New Legislative Framework require the implementation of an appropriate risk analysis and assessment.
Different terms such as risk analysis, risk evaluation or risk estimation are used in connection with risk assessments. These terms represent different steps in the process of risk assessment.
The process of risk assessment for machines and systems is described in the international standard EN ISO 12100:
Risk Analysis*
Risk Reduction
*The process steps Risk Analysis and Risk Evaluation together forms the Risk Assessment.
The risk reduction methods has to be fulfilled by designers in a fixed order. This legally prescribed sequence can be found in the Machinery Directive and Machinery Regulation as well as in EN ISO 12100. CENELEC Guide 32 offers corresponding information for products according to the Low Voltage Directive. The different documents only differ in terminology:
The legally required integration of safety into design / construction processes is not observed. Risk assessments are carried out too late or not at all!
Risk assessments are carried out by one (1) person after the machine has been built, if at all. This procedure does not meet the legal requirements, but usually costs a lot of money! Every person involved in the product development process is obliged to participate in the risk assessment as part of their activities. Hazards are identified early on and suitable measures are defined immediately. Eliminating hazards at the time of commissioning or in operation can be very expensive!
All persons involved in the development processes rely on a CE representative or CE coordinator who is not provided for by law. These people can coordinate, organize or support, but are not responsible for the operational implementation of risk assessments in projects!
The cost-saving inherently safe designs are not used. Instead, expensive protective devices are installed that would not be necessary in this form for the identified hazards and the assessed risk. A qualitative risk assessment can help to avoid unnecessary and cost intense safety measures!
Notes on residual hazards in the operating instructions are chosen instead of technical solutions. Numerous judgments show that compliance with the order required by law is particularly important in order to avoid liability cases.
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