Consulting, Compliance and Validation

The instruction manual as a safety factor

The instruction manual as a safety factor

We talked about the history of the instruction manual, the rules that govern it and the procedures that we at Spai follow for its drafting. In this article we want to explain that the instruction manual should not be seen as a list of instructions on how to move, use and maintain a machine, but as a safety factor.

With the instructions for use we must consider all the interactions between the technical good and the recipients who, it is expected, will interact with it (transport, installation, use, maintenance …). The instruction manual must contain all the information necessary to ensure that the recipient is not exposed to risks and dangers during these phase.

Machine or partly completed machine? What documentation to prepare?

The Machinery Directive identifies two macro product families: machines and partly completed machines. Simply speaking, we can say that machines are those capable of completing a specific production process. Partly completed machines, on the other hand, are the various elements that make up the machines; in practice, partly completed machines guarantee a specific operation or application but are destined to be assembled with others to make up the machines.

Depending on the type (machine or partly completed machine) a series of documents are required by law to be prepared before it is put on the market.

  • The Technical Construction File (FTC). The technical file must demonstrate that the machine complies with the requirements of the Machinery Directive. The technical file contains information on the design, manufacture and operation of the machine. The technical file, which must not be given to the customer but must be kept in the manufacturer’s files, must contain the risk analysis.
  • The EC declaration of conformity. It is mandatory for all machines sold within the European Union. The EC declaration of conformity attests that the product complies with the health and safety requirements of the Community directives.
  • The instruction manual. As we have already written, the instruction manual is an integral part of the machine. It must be delivered to the customer and it is the tool through which the manufacturer illustrates to the customer all the characteristics of the product that he considers important for safe use.

What attention should be given to safety in the Instruction Manual?

As we wrote in the article “How to write the instruction manual” it is important that there is a professional to write this document: the technical editor. The technical editor, unlike the engineer or worker who assembled the machine, has specific skills in terms of manuals and vocabulary, knowledge of the law and, not least, is able to predict or better imagine any criticality or misuse of the machine.

In fact, the law states that the instruction manual must also contain these safety issues:

  • Reasonably foreseeable misuse. It must be ensured that the machine can be used in a manner different from that indicated in the instructions for use. Possible misconduct must be anticipated: haste, carelessness, forgetfulness…
  • Residual risk. It is the risk that it remains even after taking the protective measures indicated in the manual.

“In our opinion, it is essential where the safety instructions are located in the instruction manual – explains Fabio Farneti, Sole Administrator of Spai Srl -. The legislation says that the instructions for installation, transport, use and maintenance must be present in the instruction manual. However, these instructions are often a single chapter, located separately, not infrequently at the end of the manual. Our approach is different, driven by the idea that the important thing is not only to be in compliance with the law, but to give concrete useful information to those who will use the machine. Let’s assume we are in the chapter of the instruction manual where we explain how to disassemble a panel of the machine for maintenance. It is in that same chapter that, in our opinion, the safety information relating to that passage should be inserted, such as, for example, taking care not to forget a tool inside the machine. They seem small things, but they are the ones that make the difference: many people limit themselves to the minimum necessary to comply with the regulations, we try to go further.”


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