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How disorderly a pile is your machinery technical file?

08 August 2013

For those that design and manufacture machinery, compiling the technical files for CE marking, as well as the documentation that their customers are required to produce by the Provision and Use of Work Equipment Regulations (PUWER), might seem a straightforward task.

However, both the procedural and documentation requirements for the Machinery Directive 2006 are still regularly overlooked, says Paul Laidler.

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 and any other applicable directives. An essential element of this is the production of a technical file which must conform to the provisions set out in the Machinery Directive. 

So what process should be followed to ensure that documentation is up to the required standard?

There is now even greater emphasis on performing and documenting risk assessments. As it is easier to design safety in than to engineer hazards out, this process must start at the product design phase. 

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”. 

Risk assessments are not only required by the Machinery Directive, they are also an essential ingredient in machinery end users meeting the PUWER requirements.

One challenge 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.

The risk assessment solution
There are software packages 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 document fully the risk assessment processes and, in the case of CE marking, to 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.

Paul Laidler is business director for machinery safety at TÜV SÜD Product Service




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