Commissioning technical documentation: scope, process, your input

The Machinery Directive 2006/42/EC requires two things of the manufacturer. First, a technical file under Annex VII: it demonstrates that the machine meets the requirements, stays in house and is presented only when a market surveillance authority makes a reasoned request. Second, instructions under Annex I section 1.7.4: they go to the user with every machine.

The technical file does not have to exist permanently as a finished folder. It must, however, be capable of being assembled within a reasonable time – by the person named for that purpose in the declaration of conformity. It has to be kept for at least ten years from the date of manufacture; for series production, from the date the last unit was made.

An instruction manual written without a risk assessment warns of whatever occurs to the author. That is rarely what needs warning about. A risk assessment to EN ISO 12100 proceeds systematically: determine the limits of the machine, identify hazards, estimate and evaluate risks, take measures – first by design, then by safeguarding and only last by information for use.

What remains after the first two steps are the residual risks. Exactly these belong in the manual, together with the measure the user has to take. A serious commission therefore starts with the question whether a risk assessment exists and whether it matches the machine as built. Where it is missing, it is worked out first – together with the design department, because decisions on protective measures are the manufacturer’s.

The sequence is the same for a one-off machine and for a series; only the depth differs. What matters is the order: the structure of the manual follows from the risk assessment and the intended use, not the other way round.

A service provider can write, structure, illustrate and know the standards. What it cannot know is how the machine was actually built and how it behaves in operation. The more complete the input, the less is guessed – and the shorter the technical review at the end.

The first sign is unspectacular: the manual describes the machine that was delivered – with its options, its control panel, its guards. A manual that describes three variants at once and leaves the choice to the reader misses its purpose.

The second: it is organised by tasks, not by assemblies. The operator looks for “changing the tool”, not for “assembly 4”. The third: every warning can be traced back to a line of the risk assessment, names the hazard, the consequence and the remedy – and stands where the action is described. The fourth: the manual carries a revision that belongs to the machine. Check these four points on a draft and after half an hour you know what you have in front of you.

Not every product receives a declaration of conformity. Partly completed machinery – for instance a unit that is built into a plant only at the customer’s site – is supplied with a declaration of incorporation and assembly instructions; its technical documentation follows Annex VII part B.

Where several machines are linked into an assembly that functions as an integral whole, whoever puts the assembly together is the manufacturer of that assembly – with a risk assessment of its own for the interfaces and documentation of its own. And anyone who modifies an existing machine so that new hazards arise or risks increase has to examine whether this amounts to a substantial modification. These three cases should be settled before commissioning, because they determine the scope.

From 20 January 2027 the Machinery Regulation (EU) 2023/1230 applies and replaces the Machinery Directive. The basic logic stays: risk assessment, technical documentation, instructions, declaration of conformity. Among the changes, instructions may be provided digitally under certain conditions, and substantial modification is expressly regulated.

For documents produced now this means they should be built so that the transition is a revision and not a rewrite. Which regime applies to a specific machine depends on when it is placed on the market.