I'm continually asked by our customers about what they need as a manufacturer or operator of machines.
My answer is: "A Risk Assessment, an Operating Manual and your additional technical documentation. Once you have all this, there's nothing to stop you from affixing the CE mark to your machine without hesitation. But be aware that the Risk Assessment can contain valuable information for your design, because safety problems can often be solved best by good design. It's therefore advisable to start the Risk Assessment at an early stage, especially for new developments. This can save costly expenditures for avoidable safety-based solutions".
"OK, but we as manufacturers don't have the time or the capacity to familiarise ourselves with this subject. Can you support us on this?"
"Of course we can!"
Product Safety in three Steps
Step 1: Risk Assessment and, if the ATEX Directive applies, prepare an Ignition Source Analysis
For the Risk Assessment and the Ignition Source Analysis, we arrange a research meeting with your technical contact person, and we research all the hazards that the machine poses to people – throughout each phase of the machine's life.
Once back at home, we use a professional software tool to carry out a Risk Assessment, in accordance with the Machinery Directive 2006/42/EC and DIN EN ISO 12100 and, if required, we can also carry out an Ignition Source Analysis – in accordance with the ATEX Directive 2014/34/EU.
The Risk Assessment includes the description of the machine, with the assessment of the respective risks, using a Risk Graph and the listing of the appropriate measures for risk reduction. The following types of risk reduction are available: design solutions, mechanical and control engineering protective measures and warnings. The warnings include not only safety instructions but also personnel qualification, machinery safety and warning signs, and personal protective equipment.
After the Risk Assessment has been validated, in accordance with the "four eyes principle" and then proofread, you will receive a test copy. This can be used to clarify comments and open questions. Your comments are incorporated, you receive the final copy, and you then provide us with your approval. The Risk Assessment is then complete.
Step 2: Performance Level Calculation
The Risk Assessment results in so-called "Required Performance Levels" (PLr; r for required) for the control engineering protective measures. <em/> <em/> The Performance Level indicates the reliability of a safety function that is used to reduce a risk. When calculating the performance level, the safety function is reproduced in software and calculated on the basis of the parameters of the components used. Of course, the calculated Performance Level must be at least as high as the required Performance Level (PL ≥ PLr). In order to avoid unnecessary costs, we can support you as early as the Design Phase, in selecting appropriate components.
Step 3: Operating Manual
The Operating Manual represents an additional building block for a safe product. The Risk Assessment is relevant when authoring the Operating Manual, insofar as the information originating from the "Warning" risk reduction type must be listed in the Operating Manual. This is of course not the end of the story, as the requirements for a standards-compliant and target audience-oriented Operating Manual are numerous and should not be the subject of this article. You'll find detailed information on this on our website and within the kothes smart space.
As the manufacturer of a machine, your Designers have to keep so many things in view that subjects such as Risk Assessments, Ignition Source Analyses and Performance Level Calculations are only disruptive factors during their day-to-day business. So it's nice to know that there are service providers who can do this work for you; so your Designers can remain devoted to their core competencies. Another advantage: You receive all documents from just one source.
If you have any questions about CE marking, please feel free to contact me!