Risk assessment

The risk assessment is just one of the documents required for CE-compliant machines that a machine manufacturer must create during the course of development. The creation of the risk assessment is an iterative process that can take a long time. This should result in a qualitative improvement of the machine and an increase in the basic health and safety requirements. Easier said than done! Because the question often arises; where do we start? What information is relevant? Have we done enough for health and safety? What residual risks are acceptable? The many questions at the start of a project can lead to uncertainty or neglect. We would therefore like to provide a brief introduction to the topic of risk assessment.

Legal regulations

The first point of contact for machine manufacturers in Germany is the

It contains all the legally relevant information for placing machinery on the market. It quickly becomes apparent that there is always talk of the

The following must be observed

The Machinery Directive is an EU directive. This means that it applies to EU member states (with some special rules) and not to individual machine manufacturers. Each country is given a few years to transpose the contents of the Machinery Directive into national laws.
As the process of passing laws can take a very long time in Germany, very general and basic formulations are used there. This means that the laws do not have to be adapted over several years in the event of minor changes to the directives. German laws therefore contain the ‘what’. In the case of mechanical engineers, this includes the Product Safety Act.
Regulations are then derived from the laws, which are much more specific because small changes can be implemented more quickly. That's where you find the ‘how’. The 9th Ordinance to the Product Safety Act is thus derived from the Product Safety Act.

This results in the following legal hierarchy

  • Machinery Directive 2006/42/EC (applies to EU countries)
  • Product Safety Act (applies to machine manufacturers; the ‘what’)
  • 9th ProdSV (applies to machine manufacturers; the ‘how’)

Section 3 (2) of the 9th ProdSV therefore contains requirements that refer to annexes of the Machinery Directive. The annex is therefore legally relevant for the machine manufacturer. Of interest is Annex VII, i.e. the list of technical documents to be provided. In the context of the topic of this page, not the entire list is shown, but only the part for the risk assessment. Here is an extract from the Machinery Directive:

⎯ the risk assessment documentation showing the procedure followed, including
(i) a list of the essential health and safety requirements that apply to the machinery
(ii) a description of the protective measures taken to eliminate identified hazards or minimise risks and, where appropriate, an indication of the residual risks presented by the machinery,
⎯ the standards and other technical specifications applied, indicating the essential health and safety requirements covered by those standards,...

At this point, it is only stated that a risk assessment must be carried out. However, it is not specified in more detail. Fortunately, Section 3 (5) of the 9th ProdSV goes on to state that harmonised standards can be used. This means that machine manufacturers do not have to reinvent the wheel at this point, but have the option of building their machines in accordance with harmonised standards, which fulfils the essential health and safety requirements from the perspective of the law. The following standard was drafted for this purpose

  • DIN EN ISO 12100 - Safety of machinery
    - General principles for design General principles for design -Risk assessment and risk minimisation

This standard therefore serves as a guideline for the preparation of the risk assessment.

If you need advice or help with the creation, please contact us.

 

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