The most common mistake in risk analysis for a GPSR file is ticking off a checklist instead of genuinely thinking through how a product will be used in practice. The analysis then looks at the product as it appears in the photograph, whereas the regulation requires considering what happens when it ends up in a consumer's hands: misuse, use by children, use in combination with other products, or use that deviates from the instructions for use.
The consequence of this mistake is not that something immediately goes wrong. In fact, usually nobody notices anything, for years on end. The mistake only comes to light when a complaint arrives, a competent authority requests the file, or something happens with the product. Then it turns out that the risk analysis is just a list with ticks next to 'risk of cuts: no' and 'fire hazard: no', without any indication of why it was assessed that way.
A checklist is not a risk analysis
A risk analysis that only ticks off categories misses the element that the regulation requires: a substantiation per situation. A toy trigger with small parts is something different for an eight-year-old child than for a two-year-old. An extension cord used indoors carries different risks than the same cord outdoors, in the rain. Those nuances disappear when an analysis is completed as a form rather than as a thinking exercise. Competent authorities and, in the event of an incident, also your own insurance company or lawyer, specifically look at that substantiation: is there a line of reasoning, or is there only a conclusion.
Why this mistake occurs so often
This mistake usually does not arise from carelessness, but from time pressure and unfamiliarity with what exactly is being asked. A product file feels like administrative burden, and filling in a list is simply faster than thinking through use situations per product. In addition, suppliers often already provide a declaration of conformity or test report, which makes it seem as though the risk analysis is thus already done. This is a misunderstanding: a test report says something about the product at the moment of testing, not about how the product reaches the consumer in practice and is used. If you are unsure about your own role in that supply chain, and therefore about who should actually conduct this analysis, you can see in a few questions what applies to you.
What is actually needed: thinking per use situation
A useful risk analysis describes per relevant hazard why it is or is not applicable, and on what basis that assessment was made. This can be based on a test report, on the instructions for use, on comparable products, or on the composition of the material. What matters is that the reasoning is traceable for someone who does not know the product: a competent authority, a successor in the organization, or yourself three years from now. That is also precisely why gpsria.eu structures the risk analysis per article, with the questions that apply to that type of product. We do not provide our own judgment: the analysis is completed and substantiated by you, we ensure that nothing is overlooked.
Who assesses whether the analysis is sufficient
Whether a risk analysis is adequate is not determined by gpsria.eu and cannot be determined by a generic tool either. That assessment lies with the competent authority, and in case of doubt about a specific product, with an expert or lawyer who knows the situation. What can be structured is the process surrounding it: that every relevant question is asked, that the substantiation is recorded, and that the file is complete at the moment it is requested. In the knowledge base organised by topic it is explained which documents belong to it and how they relate to the technical documentation.
Keep for six years, even if nothing happens
A well-structured hazard analysis has value over the long term. Documentation must be retained for an extended period, and an analysis consisting only of checkmarks cannot be reconstructed after a few years: nobody will then remember why a particular hazard was assessed as not relevant at the time. A substantiated analysis remains legible and useful, even when the person who prepared it no longer works for the company. How that process works in practice, and where the information in the system comes from, is explained on the page on how it works.
Would you like to know whether this is relevant for your products, and what role applies to you? The free role check provides an initial indication in a few questions, and the subscription structure shows what else is involved if you actually want to build out the file.