The Machinery Directive 2006/42 / EC of the European Union states that a risk assessment must be carried out for a machine.

The aim is that the machine can be designed and built in such a way that there is no great risk if someone uses this machine. Appendix I, in particular, which deals with the basic safety and health protection requirements for the design and construction of machines, provides very good guidelines and assistance here.

It is explained here that the risk assessment should be an iterative process. This means that you first have to determine the limits of the machine. – What is their intended use and what are misuse that can actually be foreseen without further ado.
Then it should be assessed which hazards this machine can pose.
It is expected that the risk for this will then be assessed. So a combination of the severity of an injury and the likelihood of it occurring. It is good practice if the previous evaluations are based on a system of indicating numbers. This makes it very clear when you need to take additional measures to reduce the risk or not.
If you have now carried out these steps so far, you may have to consider how to reduce the existing risk. Here, too, the guideline helps by specifying an order.
First of all, the risk should be eliminated or minimized by means of constructive measures.
Only if this does not have the desired effect should protective measures be taken and only then, as a further possible measure to reduce a risk, should the user be informed about residual risks.
It is therefore clear why the directive speaks of an iterative process. You have to define a countermeasure and then use this measure to evaluate the new risk that then arises. If this is still too big, you have to take further measures.

In practice, it happens now and then that the risk assessment to be carried out for a machine is only carried out after it has been successfully designed.
Sometimes the prevailing opinion is that you know all the risks of the machine to be developed, since you are ultimately active in this business field, and you may have already developed one or the other machine for this market.
Often this may also be the case. However, sometimes it is quite risky to go down this path. Should a risk arise after the successful construction of the machine, it can happen that one has to go back to the construction phase in order to eliminate this risk and thus the planned market launch is delayed, which can be associated with all kinds of business risks.

This is why this task should be integrated into the design process as early as possible when designing machines.

In addition, there are all sorts of different types of machines. Some can be used directly by someone. Other machines are assembled with additional components to form larger, higher-level machines.
Here in particular, it should be of great interest to those who build this higher-level machine to know the risk assessment of the machines that they are installing themselves. After all, a risk assessment must also be created for the higher-level machine itself. And of course all the risks of the sub-components go into this.

In this context, it should also be pointed out that a good knowledge of the risks emanating from one’s own machine is helpful when it comes to defining responsibilities in contracts. How far can you go to give your customers, who continue to build their own machine, commitments in connection with conformity? Is it possible that the customer creates new risks by installing his own machine, for which one should be contractually responsible?

So what is the point of the risk assessment?

• Well, first of all there is the not inconsiderable actual purpose to be mentioned.
  To achieve that users of machines can work with them as safely as possible.
• But this is of course also about liability to possible harmed persons. If you can now show that you have assessed and reduced risks to the best of your knowledge and belief, then this is certainly another advantage of the risk assessment.
• The Machinery Directive also helps with the creation of operating instructions.
  On the one hand, the Machinery Directive clearly communicates which points must at least be included in an operating manual.
  On the other hand, it helps because the analysis itself first identifies important points about residual risks worth mentioning.
• In addition, it is of course an advantage if you can enter the sales phase as quickly as possible, without delays due to having to go back to the drawing board to eliminate risks that you only recognized after you had already finished. Therefore start the analysis iteratively and proactively in the design phase.
• Finally, it should be pointed out again to the contract negotiations. A good knowledge of the interrelationships through the risk assessment gives a certain advantage in contract negotiations when it comes to precisely these issues.

I would be happy to help you prepare this.