The Seven Steps to a CE Mark: Step 4, Performing the Risk Assessment

The manufacturer is obliged to carry out a risk analysis to determine all the hazards associated with his machine. The result of this analysis must then be considered in the design and construction of that machine. The contents and scope of a hazard analysis are not specified in any directive, but EN ISO 12100 describes the general procedure.

All relevant hazards must be identified, based on the intended use – taking into consideration all the lifecycles once the machine is first made available on the market. All the various groups who come into contact with the machine, such as operating, cleaning or maintenance staff for example, are also considered.

The risk is assessed and evaluated for each hazard. Risk-reducing measures are established in accordance with the state of the art and in compliance with the standards. The residual risk is assessed at the same time: If it is too high, additional measures are required. This iterative process is continued until the necessary safety is achieved.

SIL Calculations

The combined consideration of hardware, fault tolerance, category, DC, PFHD and SFF provides the following SIL assignment. All conditions must always be met. If one single condition is not met, the SIL has not been achieved.

Compare the required SIL from the risk assessment with the achieved SIL. If the achieved SIL is greater than or equal to the required SIL, the requirement for the implementation is considered to have been met.

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Whatever the reason for undertaking a formal risk assessment on machinery or work equipment, Pilz consultants can provide an impartial service. Risk assessments are encountered in almost every walk of life, even for crossing the road. But when it comes to machinery, a formal risk assessment needs certain requirements to be fulfilled, and the person performing the risk assessment must be competent to do so.

While some companies have personnel who are competent to perform formal risk assessments on machinery, others appreciate that they lack the competence and therefore need support from consultants. There are also occasions when companies are busy and do not have the resources available when required, or they may choose to use an independent service provider for this critical task.

For any of these scenarios, the consultancy division of Pilz Automation Safety L.P. can undertake risk assessments on machines or machine designs in accordance with the requirements of relevant standards. Each assessment identifies the hazards present, estimates and evaluates the risks, and determines and outlines the measures that may be applied to reduce the risks to acceptable levels.

As part of the risk assessment, the consultants identify applicable standards, regulations and best industry practices, prepare a statement of the machine’s limits, and examine all hazards throughout the relevant machine lifecycle phases.

Because Pilz consultants have decades of experience of machine safety, their advice related to risk-reduction measures is particularly useful. This is in contrast to some other consultants that can highlight problems but are unable to advise on pragmatic, cost-effective risk-reduction measures.

Furthermore, if the client requires ongoing support, Pilz can provide engineering services to take the safety concept forward, and even supply products to implement a safety-related control and monitoring system. Alternatively, the client can take the consultants’ risk assessment report and carry out the necessary work in-house or work with a third-party supplier or system integrator of their choice.

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Can I demand a copy of a risk assessment from the machine builder?

Certain social partners including European trade unions lobbied for a requirement that Risk Assessments be supplied with machinery to create more transparency and to compensate for such variations in assessment. However, it is not mandatory for machine builders to provide a risk assessment.

Is it correct that there is a new requirement relating to Risk Assessment?

In the existing directive:' The manufacturer is under an obligation to assess the hazards in order to identify all of those which apply to his machine; he must then design and construct it taking account of his assessment." The term Risk Assessment was not directly used in the directive but was referred to in harmonized standards EN1050 and more recently EN ISO 14121.

The iterative process of risk assessment is now enshrined unambiguously in the directive
The manufacturer of machinery or his authorized representative must ensure that a risk assessment is carried out in order to determine the health and safety requirements which apply to the machinery. The machinery must then be designed and constructed taking into account the results of the risk assessment...
...By the iterative process of risk assessment and risk reduction referred to above, the manufacturer or his authorized representative shall: eliminate the hazards or reduce the risk associated with these hazards by application of protective measures, in order of priority established..."