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How disorderly a pile is your machinery technical file?

How disorderly a pile is your machinery technical file? Paul Laidler of TÜV SÜD Produce Service looks at the process that should be followed to ensure that CE marking documentation is up to the required standard.

For machine builders, compiling the technical files needed for CE marking and the documentation required by the Provision and Use of Work Equipment Regulations, (PUWER), appears to be a straightforward task. However, there are recent legislative changes that have an impact on the required documentation, which means that legal requirements are often overlooked. So what process should be followed to ensure that the documentation is up to the required standard?

Before any item of machinery can be legally placed on the market in the EU, it must bear the CE marking. This cannot be applied unless the machine has been proven to meet the requirements of the Machinery Directive as well as any other applicable directives. An essential element in demonstrating that these requirements have been met is the production of a technical file which must conform to the provisions set out in the Machinery Directive.

However, even though the Machinery Directive was updated more than two years ago, it appears that many machinery manufacturers are still not aware of the changes, particularly those which impact on the content of the technical file. Annex VII of the Machinery Directive states, in paragraph 1(a), that the technical file must now include "documentation on risk assessment demonstrating the procedure followed, including:
i. a list of the essential health and safety requirements (EHSRs) which apply to the machinery,
ii. the description of the protective measures implemented to eliminate identified hazards or to reduce risks and, when appropriate, the indication of the residual risks associated with the machinery".

In addition, EHSR 1.1.2 states "machinery must be designed and constructed so that it is fitted for its function, taking into account foreseeable misuse" and "the aim of measures taken must be to eliminate any risk throughout the foreseeable lifetime of the machinery."

To summarise all of this, the process of meeting the requirements of the Machinery Directive, and hence being able to apply CE marking, now places even greater emphasis on performing and documenting risk assessments, as these are the only way to prove that the correct procedures have been followed. As it is easier to design safety in than to engineer hazards out, this process must start at the product design phase.

Risk assessments are not only required by the Machinery Directive, they are also an essential ingredient in meeting the PUWER requirements. This means that the questions that arise in the production of documentation for the Machinery directive are further amplified by those presented by PUWER. While carrying out one risk assessment is not a particularly onerous task, carrying out dozens, possibly involving more than one department or division of a company, presents rather more of a challenge.

One task is to successfully introduce the adoption of a company-wide standardised approach to risk assessment. Another is ensuring that nothing is missed when carrying out the risk assessments. Finally, ways must also be found to present the documentation in a convenient format, archive it securely so that it cannot be lost or damaged, and ensure that it can be retrieved easily as needed.

Removing the risk assessment headache
There are software solutions that have been specifically designed for machinery compliance risk management and take much of this headache away. Whatever software is chosen, it is essential that it is the latest version that reflects current legislation. It should also allow users to decide whether they work to ISO EN 13849-1 or EN 62061 for safety-related parts of the control system. As a minimum, the software should also cover the requirements of CE marking and PUWER 98.

The best packages will guide users through the steps necessary for compliance using a simple question-and-answer approach that ensures everything is properly completed and nothing is missed. It will then generate detailed reports in a uniform format, making it easy to fully document risk assessment processes and, in the case of CE marking, produce the essential technical files. If non-compliances are found, the software will create a 'to do' list that ranks items in order of risk. It will also make provision for storing reports electronically, so that back-up copies can be made.

However, machine safety is a complex area and even the best software cannot entirely eliminate the need for the advice and support from a human expert. It is therefore important to take this into account when choosing a software supplier, one that can demonstrate that it has the experience and expertise needed to provide this vital back-up. Make the right choice, however, and your technical files should never again be disorderly piles.
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