One thing that’s certain about regulations: they’re bound to change. Europe is making significant alterations to one of the primary ruling documents for production equipment, adding requirement that should improve safety while putting more focus on risk assessment.

The European Union’s Machinery Directive (2006/42/EC) goes into effect Dec. 29, replacing the longstanding Machinery Directive (98/37/EC). “This is a major rewrite, the last one that was this broad was more than 10 years ago," says Udo Heinz, Division Manager Industrial Machinery for TUV Rheinland of North America Inc., based in Carlsbad, Calif.

He predicts that many suppliers will be caught unprepared when the regulators begin enforcing the new rules that let them impound equipment that doesn’t meet requirements. “Come January, I’m sure there will be a lot of frantic calls when people find out their products are hung up at customs or at a plant where they’re being blocked from starting up,” Heinz says.

That likelihood will be increased because the new regulations call for each signing country to beef up its enforcement for compliance. The enforcement staffs will be looking for documentation, making sure it meets the new requirements. As with many regulations, the paperwork will take some getting used to. The new Directive requires serial numbers on each Declaration of Compliance. That’s not as onerous as it sounds. Companies can use a range of numbers so they don’t have to change them for each unit in a shipment.

This documentation will of course be associated with a number of new technical requirements. One of the biggest changes comes in safety, where equipment makers must account for foreseeable misuse. “It’s no longer good enough to say ‘don’t do this.’ If people are going to do something, you need to look at it and design to prevent them from doing it," Heinz says.

He cites a cleaning scenario in which a cleaning staff comes in to wash down a machine, taping its safety interlock switches so that doors remain open and the machine could run in an unsafe state with the safety features defeated. That tape often stays in place when equipment is run to dry it, creating a safety hazard and also presents a hazard to the staff cleaning and the equipment.

“Under the new regulations, you’ve got to do something like locate the safety switch somewhere where people can’t tape over it,” Heinz says.

Another technical change is that when panels are attached to protect operators, they must be held on using captive screws, ensuring that they won’t be lost when the shield is removed. This could reduce the number of times that protective structures aren’t replaced, which should reduce injuries. Though altering the screw mounts isn’t a huge challenge, the repercussions can be sizeable.

“If you know about these small things, you can do something about them. But it gets blown out of proportion if an official says the machine can’t be turned on when the customer is hoping to ramp up production. Something that costs a couple dollars and a few minutes of design time could cost 100 times as much if you have to retrofit a machine in the field," Heinz says.

European regulators have also strengthened their focus on risk assessment. This analysis has played a growing role in a number of other European standards in recent years. For example, risk assessment is a mainstay in both the ISO 13849 and IEC 62061 standards that recently took effect in European Union countries.

Machinery Directive (2006/42/EC) also requires that risk assessment and safety design be integrated into product design instead of being bolted on when the equipment is nearing its move from design into production. Incorporating safety from the beginning should reduce injuries and make it more difficult for personnel to cut corners in dangerous ways. “There are significant benefits if you do the assessment in the front part of design so that the safety solution is logically integrated into the machine,” Heinz says.

Like many new regulations, the directive has some areas that leave room for interpretation. Heinz says one of these is a section that requires that operators be able to see any area that holds the potential for compromised safety. That may become difficult in large work areas like a robotic cell.

“If the operator can’t see the back side of a robot cell, designers need to reposition the operator or put controls on something like a pendant so the operator can move around,” Heinz says. “The pendant is a good idea, but ...