What is a Risk Assessment, according to the Machinery Directive?
The Risk Assessment is required by the European Machinery Directive. This stipulates that a manufacturer of machinery used in Europe must carry out a Risk Assessment before placing a machine on the market (i.e. actually selling it).
The term "Risk Assessment" is often used for the document in which the result of the Risk Assessment is documented in writing. But "Risk Assessment" is more specifically the process of systematically determining which risks exist for a machine, how serious these are, and what measures are taken to minimise the risk. It deals exclusively with safety and accident risks for people who work with or on the machine or who are within the machine's sphere of influence.
The main task of a Risk Assessment is therefore to make a machine safe enough so that no one is in danger during any stage of the machine's lifespan; from transport to dismantling.
Why do I need a Risk Assessment?
As previously mentioned, the EU Machinery Directive requires the Risk Assessment to be both carried out and documented in writing. In order to place a machine on the market in Europe, and to be in conformity with the law, it requires the CE mark. This mark – for machines – is not issued by an authority or a notified body, but the manufacturer may certify itself and issue the CE declaration by themselves. However, in order to be legally compliant, a Risk Assessment must be carried out, among other things.
In which cases is a Risk Assessment required?
A Risk Assessment is required for all products that fall under the EC Machinery Directive . These are (in basic terms) all products with at least one moving part that is driven by anything (except directly by human or animal) or intended to be driven by anything: so, for example, a machine tool, a cordless screwdriver or even a motorised garage door with a spring mechanism. There is also a list of other products that do not meet these characteristics, but still fall under the Machinery Directive. To determine whether a product falls within the scope of the Machinery Directive (and thus require a Risk Assessment), it's worth examining the scope of Article 1of the Directive.
The Machinery Directive also distinguishes between complete and partially completed machinery. Simply stated, partially completed machinery is a unit or an assembly that's intended to be incorporated into another machine (i.e. it can't be used on its own). However, this is irrelevant for the question of whether a Risk Assessment is required, because the Risk Assessment is required in both cases.
What happens if I put a machine on the market without a Risk Assessment?
First of all, nothing happens if a machine is sold for which no Risk Assessment has been carried out. After all, self-certification means that no authority checks whether all the requirements for CE marking have been met. However, this doesn't mean that it will never be noticed if proof of the Risk Assessment is missing. After all, if an accident were to occur, at the latest, the employers' liability insurance company would request the Risk Assessment from the manufacturer. In addition, there are government agencies, various market surveillance authorities, which proactively monitor compliance with CE requirements and may demand that machine manufacturers hand over the Risk Assessment at any time. These authorities are also supported by customs, which checks whether the CE marking has been affixed lawfully, especially for machines imported from outside the EU.
If an authority finds that the Risk Assessment is not available, it can impose fines of up to €100,000 (see also: http://www.gesetze-im-internet.de/prodsg_2021/__28.html in German only). In the event of an accident, it's also highly likely that the manufacturer will be liable for damages, as case law normally assumes that if a Risk Assessment had been carried out, the cause of the accident would have been identified and eliminated. In this case, there's even a risk that the responsible persons at the machine manufacturer will be held personally liable, due to gross negligence or intent.
Irrespective of the legal implications described above, more and more manufacturing firms are having the documentation of the Risk Assessment handed over to them when they purchase machines so that they, in turn, can provide complete assurance of safety. In many cases, therefore, it's not even possible to sell the machine without a Risk Assessment, due to these requirements.
How do I prepare a Risk Assessment?
The criteria to be checked as part of the Risk Assessment are set out in the International Standard DIN EN ISO 12100, which also specifies what content is required for the Risk Assessment documentation.
In principle, the standard requires the Risk Assessment to be carried out during the Design process. This is intended to ensure that the subject of safety is taken into account at a very early stage during the Design process. This is because it's usually much more time-consuming and cost-intensive to make changes, the later-on into the Design and Manufacturing processes you are.
Risk Assessment is an iterative process in which the first step is to identify the hazardous points. These can be, for example, hot surfaces, pinch points or the like. Identifying the hazards usually requires a little experience. There are also numerous standards that deal with the various types of hazards that can serve as a source of inspiration. The second step is then to assess the risk. This should take into account the severity of the potential harm, the probability of occurrence, the length of time spent in the hazardous area, and the possibility of avoiding the hazard.
A risk graph for risk assessment can help to carry out the assessment as objectively as possible.
Based on the assessment of the risk made in this manner, it can then be determined whether measures are required to minimise the risk. If this is the case, the third step is to determine one (or more) measures to reduce the risk. The following sequence must be followed:
- Design Measures
The best solution is to modify the design so that the risk is eliminated altogether. For example, the distance between two components could be increased so that a crushing hazard no longer exists.
- Protective Measures
The second-best solution is to provide a mechanical or electronic protection measure (e.g. a safety fence or a limit switch that stops the motor when a door is opened).
The worst solution is to create (i.e. write) a Warning with instructions for the people who handle the product. This Warning can be placed as a sticker near the point of danger or it can be included in the Operating Manual.
Now that the measures have been determined, the risk must be reassessed. If it's still not sufficiently minimised, further measures must be defined. Thus, steps 1 through 3 are gone through for each individual risk until the assessment determines that the risk has been reduced to an acceptable level.
Can standards help me with Risk Assessment?
Standards play an important role in risk assessment. Therefore, researching standards before beginning the Risk Assessment is absolutely essential.
As described, there is DIN EN ISO 120100, which not only describes the Risk Assessment procedure, but also contains a catalogue of hazards that usually occur. For many of these hazards and for protective devices, there are in turn other standards that contain detailed information.
There are also Type C Standards. These are standards which have been drawn up specifically for certain types of machinery and which specify concrete safety requirements for these machines. In principle, the authors of these Type C Standards have carried out a general Risk Assessment for the specific type of machine. This provides a good basis for the Risk Assessment of your own machine. However, the Type C Standard doesn't replace the Risk Assessment. This is because one's own design may contain hazards that couldn't be taken into account by the authors of the standard, because they can't possibly know the specific design.
The EU determines (at regular intervals) which standards lead to a so-called Presumption of Conformity. If these harmonised standards are complied with, the machine can be considered safe, with a high degree of probability. It's highly recommended to comply with these standards, since, conversely, a violation of these standards is an indication that the safety is not just to be assumed.
The list of harmonised standards is published periodically in the Official Journal of the EU here.
What does a Risk Assessment look like?
Neither the Machinery Directive nor does DIN EN ISO 12100 contain any formal requirement for the proof of the Risk Assessment. Accordingly, there are countless templates that can be used for a Risk Assessment. However, it's important that the following elements are included:
- A description of the product
- A list of the standards and regulations applied
- A list of the individual hazardous points with the risks, the evaluation, and the measures for risk reduction
- A list of the applicable and complied with health and safety requirements, according to the Machinery Directive
Who is allowed to prepare the Risk Assessment?
Every manufacturer is allowed to prepare the Risk Assessment on its own. Special training is (unfortunately) not required by the Machinery Directive or the market surveillance authorities. So, in principle, anyone can prepare a Risk Assessment. However, it's advisable to acquire a certain basic knowledge (e.g. through external training courses such as various kothes in-house training courses). In addition, it makes sense to have a certain amount of experience, because it's easy to become lost within the jungle of the many standards. A layperson is also more likely to overlook less obvious hazards that immediately catch the eye of a professional. Furthermore, it can happen that without the appropriate experience, one reaches for very complex (and thus, expensive) solutions that wouldn't be necessary at all.
At what point does a Risk Assessment have to be made available?
The Risk Assessment must be available at the same time as the obligation for CE marking takes effect. This is the case (at the latest) when the machine is handed over to the customer for use. In the case of series products (e.g. a jigsaw sold at DIY stores), this is the time when the machines leave the manufacturer's factory. In the case of complex systems, which are usually assembled on-site within the customer's production halls, this is the time of commissioning, when the machine or system is handed over to the customer.
What is the relationship between Technical Documentation and the Risk Assessment?
First of all, the Risk Assessment is part of the internal technical documentation that the machine manufacturer must prepare as part of the CE marking process, and that they must archive for at least 10 years. Incidentally, there's no obligation to hand over the Risk Assessment to the customer, even if this is often demanded, especially in plant engineering. In that case, however, it's a private contractual (and not a legal) requirement.
In contrast, the Operating Manual (also part of the technical documentation) must be handed over to the customer, together with the machine. The Operating Manual contains all possible information that the operators of the machine need in order to use and maintain it. The aim is also to ensure that this use is safe. To this end, the Operating Manual contains general information on the safe use of the machine, and specific safety information that warns of specific hazards. The Technical Editors, who are usually responsible for authoring the Operating Manual, find this safety-relevant information in the Risk Assessment. This is because the instructions are explicitly referred to here as the third stage of risk reduction. The Risk Assessment is therefore a prerequisite for the preparation of the Operating Manual.
In which language(s) must the Risk Assessment be available?
The Risk Assessment can be written in any official language of the EU. It doesn't necessarily have to be the official language of the country in which the machine builder is located. Of course, it's advantageous to select a language that's also spoken and understood by all persons involved in the Risk Assessment process. Thus, a German machine manufacturer can certainly write their Risk Assessment in English, for example. There's no obligation to translate the Risk Assessment into other languages.
When do I have to update the Risk Assessment?
As a general rule, the Risk Assessment describes the delivery condition of the machine. If the design changes, the Risk Assessment must change along with it, but it doesn't have to be changed retroactively for the machines that have already been delivered, because these machines retain their original condition and therefore match the archived version of the Risk Assessment.
An exception to this rule is when the delivered machines are modified (i.e. technically changed). It can then happen that the CE marking loses its validity. This is always the case if the modification constitutes a so-called substantial change. It's not so easy to determine whether a substantial change has been made. Generally speaking, a modification is substantial if the function of the machine is changed or expanded upon, or if the existing protective measures are no longer sufficient for a newly generated risk. In the case of a substantial change, the person who makes the change becomes the manufacturer of the machine. The same obligations then apply as for the CE marking of a new machine: Here, the currently valid regulations must also be complied with, regardless of how old the original design of the machine is. This can sometimes be a real challenge – especially if the conversion was not carried out by the original manufacturer. Because then, the person doing the rebuild is missing the original Risk Assessment, so they're forced to go through the entire Risk Assessment process all over again. This makes it understandable why many plant operators now also want to receive the Risk Assessment when the machine is delivered. This makes it much easier for them to prepare the Risk Assessment after a later rebuild, which they may even carry out themselves.
Anyone who places machinery on the market in the EU cannot avoid carrying out a Risk Assessment and documenting it accordingly. In doing so, it's essential to know and observe the relevant standards. This requires a good eye for recognising potential dangers and the knowledge of how these can be eliminated or "protected" as efficiently as possible.