Machinery items on the EU market must bear a CE marking, but this does not exempt you from all risk, explains Neil Dyson.
Before any item of machinery can be legally placed on the market in the EU, it must bear the CE marking. When manufacturers apply the CE marking to products and provide the associated Declaration of Conformity, they are confirming that the products meet the requirements of all relevant EU Directives and UK Regulations.
In our experience, many machinery owners assume that if their equipment has the CE marking that no further action is required. However, CE marking is not proof of a machine’s safety. Therefore, the Work Equipment Directive, which is implemented in the UK by the Provision and Use of Work Equipment Regulations 1998 (PUWER), applies to all work equipment regardless of its age, including equipment that carries the CE marking.
PUWER describes what an employer needs to do to protect employees in the workplace. It is therefore their responsibility to ensure that all machinery meets the requirements of the Machinery Directive and PUWER, of which risk assessments are an essential ingredient.
Machinery updates
To immediately identify any issues, a thorough and correct risk assessment should be completed before any new machinery goes into operation. Problems can then be rectified with the manufacturer, so that they or the machinery owner no longer run the risk of a prosecution under the Machinery Directive or PUWER.
A new risk assessment will also be required for any existing machinery that is modified. The Health & Safety Executive (HSE) states that if changes to machinery “are very substantial (e.g. significant new hazards and risks are introduced or new methods of control of the machine replace those previously provided, such as computer control of a previous manual machine) it may amount to being considered a “new” machine (or new assembly), for which you must undertake conformity assessment”.
The HSE goes on to state that even if changes to machinery are not substantial, such as refurbishment, the owner must still ensure that it continues to meet the requirements of PUWER, as well as any other requirements which may also apply to the product.
Assessment method
Risk assessments are an essential ingredient in meeting the requirements of PUWER, as well as the Machinery Directive. Annex VII of the Machinery Directive states that the technical file must now include “documentation on risk assessment demonstrating the procedure followed”.
The first step in the procedure is to identify anything that has the potential to cause harm. Secondly, an assessment must be made of the likelihood of a person coming into contact with these hazards and how much damage it would cause.
Examples of hazards that have the potential to do harm include:
- A manipulating robot
- A moving conveyor
- A pallet wrapper
A risk assessment would normally be carried out for each hazard identified. The Preliminary Hazard Analysis (PHA) method uses a Hazard Rating Number system. Referencing a table, the most appropriate phrase that applies to the hazard is chosen, the corresponding score results in a hazard rating number (HRN), which corresponds to the level of risk.
The PHA takes into consideration:
- The likelihood of a person or persons coming into contact with a hazard
- The degree of possible harm that could be caused
- The frequency of exposure
- The number of people at risk at the same time
Control measures can then be applied to mitigate the risk:
- Design the hazard out.
- Remove the need for man-machine interface.
- Design-in safeguards.
- Reduce the possibility of occurrence.
- Reduce the degree of harm.
- Warn and inform machine operators (but only if you can achieve adequate safety).
Once the control measures have been implemented, a re-assessment must then be actioned to ensure that they provide an adequate level of safety. The process is repeated until an adequate level of safety is achieved.
Ongoing compliance
Section 6 of PUWER requires that inspections must be repeated ‘at suitable intervals’ if machines are exposed to conditions that may lead to deterioration. In reality, every machine is exposed to conditions that may lead to deterioration, so the requirement effectively means that they must all be regularly inspected.
The solution is to set up an internal process, overseen by an individual or an inspection body, who ensures risk assessments are carried out according to an agreed schedule. It’s not something that is stuck on a shelf and forgotten.
PUWER requires that the persons who determine the nature of the assessments, and carry them out should be competent to do so. However, the failures we see on site are often due to a lack of appropriate internal expertise and physical resource to do an in-depth and correct assessment of all machinery. A decision to ‘make do’ or not invest in the appropriate expertise could result in expensive fines, or worse still prove fatal to machinery users.
Neil Dyson, is business line manager for Machinery Safety at TÜV SÜD Product Service, a global product testing, inspection and certification organisation.
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