CE-compliant technical documentation required? 

A risk assessment is required when, as a manuf­act­urer, you develop a machine and place it on the market or manufacture it for your own use. It is an essential part of the conformity assessment procedure and serves as proof that hazards have been identified, risks assessed and appropriate protective measures defined.

A new or updated risk assessment may also be required in the case of substantial modif­ic­at­ions to an existing machine. The same applies if the design, intended use or relevant legal and normative requir­em­ents change.

The risk assessment should ideally be produced during the design phase and updated through to completion. This allows the findings to be incorp­or­ated into the design early on. It can also be produced retr­osp­ect­ively; however, the necessary information often has to be gathered with greater effort in that case.

Yes. A missing or incomplete risk assessment can also be carried out or completed after the machine has been built. To do so, we consider the machine’s design, its intended use, any reasonably foreseeable misuse, existing protective measures and residual risks.

However, carrying out a retr­osp­ective risk assessment is often more complex than a design-accompanying risk assessment. Decisions and protective measures have to be traced back after the event. For this we need docum­ent­ation of the machine as well as the support of people who are familiar with its design and mode of operation.

If the risk assessment shows that risks have not been suff­ic­iently reduced, additional design-related or technical protective measures may be required. Remaining residual risks must be addressed in the operating instruct­ions.

As a rule, you do not have to autom­at­ic­ally hand over the complete risk assessment to the purchaser of your machine. It is part of the internal technical docum­ent­ation and serves as evidence that you have identified hazards, assessed risks and defined appropriate protective measures. You must be able to present this evidence to the relevant authorities upon request.

However, supplying the risk assessment to the customer can be agreed contract­ually. Larger companies, in particular, sometimes require it as part of their purchasing terms or spec­if­ic­at­ions. Therefore, before concluding a contract, it should be established which docum­ent­ation you are contract­ually obliged to provide.

Regardless of this, the residual risks and protective measures relevant for safe operation must be described in the operating instruct­ions. In this way, the operator receives the necessary safety information without autom­at­ic­ally gaining insight into the complete risk assessment.

Resp­ons­ib­ility for the conformity of the machine fund­am­ent­ally remains with the manuf­act­urer. It cannot be fully transferred by comm­iss­ioning an external service provider. kothes assumes resp­ons­ib­ility for the prof­ess­ional preparation of the risk assessment within the agreed scope of services.

For this we require complete and up-to-date information on the machine, its use and the intended protective measures. Your specialists check the technical assumptions and confirm that the documented information corresponds to the actual design.

If the design, operating conditions or functions are changed at a later stage, it must be checked whether the risk assessment needs to be adjusted. Clear coord­in­ation and final approval by the manuf­act­urer ensure that the risk assessment matches the actual status of the machine.

For a straightforward standalone machine, carrying out a risk assessment may take just a few project days, putting the cost in the low four-figure range. On average, our projects for individual machines usually range between 4,000 and 8,000 euros.

The specific price depends primarily on the complexity of the machine, the number of operating modes, the quality of the available docum­ent­ation and the level of coord­in­ation required. If technical information first has to be compiled or protective measures evaluated jointly, the effort increases.

For an entire product range, the initial investment may be higher. Here a modular approach can be worthwhile: Recurring hazards, protective measures and assessments are assessed once and then reused for additional machines and variants. As a result, the effort per risk assessment can decrease over time.

Before the start of the project, we review the available docum­ent­ation and define the scope of services together with you. On this basis, you receive a customised quote that also specifies the input required from you.