Typical misconceptions in companies

There is still often the assumption that risk assessments are only relevant for mechanical engineers - after all, that's how it has always been. Other sectors do not see themselves affected. Another argument often heard is that there is a lack of time and resources. The design department should develop products, not create documentation. Added to this is the conviction that their own product is safe anyway - so why go to the effort of a risk assessment that ultimately does not make the product any better?

Legal requirements apply to all products

Such assumptions misjudge the legal requirements. As a result, they lead to a non-compliant product as defined by EU directives and regulations - and this applies to all product types, not just machinery.

Consequences of a missing or inadequate risk assessment

In addition, a missing or inadequate risk assessment has further consequences. Almost every product requires user information that must comply with legal and normative requirements. However, this is not possible without a risk assessment, as its contents form an essential basis for the user information. As a result, this information is also incorrect - and another breach of the law is inevitable.

Two key objectives of a good risk assessment

A well-conducted risk assessment therefore achieves two goals at once:

• Proof that the product is safe - provided that the specifications from the risk assessment are also implemented.
• User information that deserves this name, as it contains all security-relevant content.

What information is relevant for technical editing

But what information is meant? The so-called residual risks are often mentioned, which later appear as warnings in the user information. However, this is only one part. A technical writer can and must take far more content from a risk assessment.

Standards as a valuable source of information

Even the list of applied standards that the design department has taken into account during product development can be a source for technical writing. Many product-related standards also contain specific requirements for user information. In the case of machine-related standards, this can often be found at the end of a standard (e.g. in chapter 6 or 7). In other product areas - such as electrical engineering - this information can be found elsewhere in the respective standard. In this case, the technical editors in the design department should specifically ask whether the relevant standards have been researched and are available. A central point of contact, such as a CE coordinator, is ideal.

The chapter "Limits of the product" provides crucial details

In addition, the chapter "Limits of the product or machine" in the risk assessment provides a great deal of information that is valuable for user information, for example:

• Intended use
• Reasonably foreseeable misuse
• Life phases, user group
• Spatial boundaries
• Technical limits
• Time limits
• Location and area of application

How information from the risk assessment can be transferred to the user information

The intended use should be described in such a way that it can be incorporated directly into the user information - i.e. more than just a simple note that the product is only to be used as intended.

The foreseeable misuse provides information that can be found in the "Inappropriate use" section of the user information. The section "Life phases, user group" helps with structuring and defining the qualifications of the users. Here, the risk assessment should consider the life phases after product handover - from transportation for simple products to commissioning for complex machines or systems.

The spatial limits include information on space requirements, connections and movement areas - crucial if the user is to install the device. The technical limits can be used as the basis for the Technical data section of the user information. The time limits relate to service life and maintenance intervals and form the basis for the "Maintenance" chapter. Information on the location and area of use - such as indoor use or climatic conditions - is also relevant for the user.

Derive residual dangers and warnings correctly

And finally, the residual hazards from which the warnings arise. These are documented in the evaluation tables or sections of the risk assessment. In practice, however, it often turns out that the information provided there is not very meaningful. In this case, the only option for the technical editorial team is to consult with the design department - a laborious, time-consuming and nerve-wracking process. To avoid such friction, both sides should agree on what the information in the risk assessment should look like.

Cooperation between design and technical editing

Another option is to introduce a standardized process for warnings, for example according to the SAFE method. This ensures that all relevant information is available in the required quality - for the benefit of the manufacturer and for the safe use of the product by the user.

Conclusion: A solid risk assessment for CE conformity

If all these points are taken into account in a risk assessment and implemented in the user information, a significant step towards CE conformity has already been taken.