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Minimising machine safety risk

Author : Paul Taylor, TÜV SÜD

01 July 2021

It is a common assumption in industry that if machinery has the CE marking, no further action on the purchaser’s part is required. However, it is vital that machinery owners understand both their responsibilities and those of their machine’s manufacturer.

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Now that the United Kingdom has left the EU, machinery end-users in the UK will slowly start to see a UKCA mark appearing on compliant products, rather than the EU’s CE marking. As EU Directives are transposed into National Law, the UK already has a legal system in place that applies. EU harmonised standards have therefore been carried across as UK designated standards, in order to maintain a single model.

In the UK, the Supply of Machinery (Safety) Regulations implement the EU’s Machinery Directive (2006/42/EC2) and contain detailed requirements for the manufacture of safe new machinery for both the UK and European markets.

All machines supplied in the European Economic Area (EEA) from 1 January 1995, must comply with the Machinery Directive (2006/42/EC) and be safe. The Essential Health and Safety Requirements (EHSR) lay down the minimum compliance criteria. While the use of standards is not mandatory, if a standard is applied correctly conformance with the relevant EHSRs of a directive may be presumed. They therefore represent the surest way to compliance. However, the end-user, must still ensure that the equipment complies with the Directive and is in fact safe.

Machinery must be able to satisfy the EHSRs for any corresponding hazard which may apply to it. The EHSR requirements are wide ranging, taking into account potential dangers to operators and other persons who may be at risk. A typical example of an EHSR is the requirement to provide adequate warning labels where there are moving parts that might trap parts of the body of personnel using the machine. Another would be the requirement to provide safety guards to machine tools.

However, taking into account the state of art, it may not be possible to meet all the objectives set by EHSRs, as technologies often move more quickly than the standards trying to catch up with them. With this in mind, the machinery must be designed and constructed with the purpose of approaching these objectives.

The preferred way to comply with EHSRs is by risk assessment and the application of harmonised EN standards. Risk assessment is therefore a vital step in ensuring compliance and a fundamental starting point for designers of machinery under the Machinery (Safety) Regulations. Some useful references include the standard EN ISO 12100 “Safety of Machinery – Risk Assessment”, which defines risk assessment as “a series of logical steps to enable, in a systematic way, the analysis and evaluation of the risks associated with machinery.”

EN ISO 12100 goes on: “Risk assessment is followed, whenever necessary, by risk reduction. Iteration of this process can be necessary to eliminate hazards as far as practicable and to adequately reduce risks by the implementation of protective measures.”

A risk assessment must therefore be carried out to examine any potential hazards associated with the machinery. This provides information for a risk evaluation, in which a decision is made on the safety of that machinery, so that risks can be reduced where necessary.

EN ISO 12100 outlines the hazard analysis/risk assessment procedure as follows:

- Determination of the limits of the machinery

- Hazard identification

- Risk estimation and risk evaluation

EN ISO 12100 also provides guidance on the safety of machinery and the type of documentation required in verifying a risk assessment. The first step in the risk assessment process 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:

- crushing due to moving elements

- electrical shock or electrocution due to faulty parts which become live

- permanent hearing loss due to prolonged exposure to noise caused by stamping of parts

A risk assessment would normally be carried out for each hazard identified. Control measures can then be applied to mitigate the risk. Once these 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.

The technical file for a machine will prove due diligence and provide the evidence of compliance. However, it does not have to include detailed information such as the sub-assemblies of the machine, unless a knowledge of them is essential for verification and compliance with the EHSRs.

The technical file must remain available for inspection by a competent national authority, such as the HSE, for a period of ten years. One of the items that a technical file must contain is the risk assessment documentation demonstrating the procedure followed. This must include a list of the EHSRs which apply to the machinery, and a description of the protective measures implemented to eliminate identified hazards, or to reduce risks, and an indication of any residual risks. The technical file can be a traditional paper file, or stored electronically, with hyperlinks to documents, and it must be updated as the product is adapted.

Machinery owners

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 Supply of Machinery (Safety) Regulations or the Provision and Use of Work Equipment Regulations 1998 (PUWER).

Section 6 of PUWER requires that inspections must be repeated ‘at suitable intervals’ if machines are exposed to conditions that may lead to deterioration. This means that risk assessments must therefore be conducted at appropriate intervals as every machine will experience some form of deterioration.

Paul Taylor, TÜV SÜD
Paul Taylor, TÜV SÜD

Although, risk assessments must therefore be conducted conscientiously and at appropriate intervals, we still visit sites that simply forget and have not taken any action for five years or more. An internal process must therefore be set up, which is overseen by an individual who is capable to ensure that risk assessments are carried out as required. Taking this simple approach ensures that risk assessment is swiftly integrated into the everyday working practices of an organisation, and it is never neglected.

The person who decides what the assessments cover and how they are done, must of course be competent to do this. While the exact definition of a competent person is not currently regulated, the Health & Safety Executive (HSE) definition is: “Someone who has sufficient training and experience or knowledge and other qualities that allow them to assist you properly. The level of competence required will depend on the complexity of the situation and the particular help you need.”

The machinery risk assessment process can be complex and once completed, may result in significant changes to the workplace environment. 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.

About the author:

Paul Taylor is the Business Development Director for Industrial Services at TÜV SÜD, a global product testing and certification organisation. TÜV SÜD’s Machinery Safety Division is the official partner of the Process and Packaging Machinery Association on regulatory affairs.


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