Risk Assessment Documentation & the new European Machinery Directive 2006/42/EC

J.B. Titus

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The European Machinery Directive 2006/42/EC clearly calls out the requirements for the “Technical File”. Per this new Directive companies should consider that the risk assessment is required compliance documentation. This requirement is specifically detailed in the General Principles section of Annex I. In the earlier Directive there was always a need to access the hazards, but now the complete assessment process in included. Additionally, Annex VII of the new Directive also requires the entire risk assessment as part of the “Technical File”. In my opinion, machine builders need to realize that compliance to the new Directive includes documenting their risk assessment procedure.

I bring this out because over the last ten years there have been plenty of discussions about the new risk assessment requirements as machine safety vaulted to the top of considerations around the world. Wasn’t it back in the late 1990’s when the robotics world here in the U.S. declared that all robots will be supplied with risk assessments as part of their documentation from 1999 going forward? Throughout the next ten years I can personally count over a dozen machine standards that have included normative requirements for risk assessments as they completed their 3 to 5 year update cycles. Many standards now require that the risk assessment be initiated during the design stage and that it’s a “living” document for the life cycle of the machine.

With all this said, it seems that there is still confusion on one hand as to what is really required by regulation and on the other hand as to what will actually be supplied in the documentation. Yes, a dichotomy seems to live on! What are the possible drivers for suppliers of engineering or machinery to possibly not fully embrace supplying the risk assessment details? Do they consider some of the details to be proprietary? Is it that they don’t fully understand the risk assessment process? Is it an added expense which impacts narrow profit margins? Maybe it’s because they’ve made this machine for several years and there’s never been a serious hazard based incident? Or do some feel that this information slightly opens the liability door openly acknowledging that their machine might include a hazard?

I believe that all of these considerations (and more) play a role in the dichotomy discussion and that most of these perspectives have some basis on the issue of residual risk. Daily if not weekly I’m reminded that the awareness of residual risk is not openly acknowledged by machine builders. The fact that residual risk for any hazard will never reach zero – is in itself an acknowledged intellectual fact. But, it’s like the word “safety” in the 1970’s and 80’s which was feared if it appeared in print. We’ve advanced too far today to still hang onto old behaviors. I suggest that we learn from history to actively and smartly embrace these new requirements and carve out new pathways for sustainability.

    Are you a laggard or have I updated your mind?

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Machine Safety & Residual Risk

Machine Safety and “reasonably foreseeable misuse”

Machinery Directive 2006/42/EC & EN ISO 13849-1; 2006 - with comments

Contact: www.jbtitus.com for “Solutions for Machine Safety”.