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What is this phase about?
Hazard identification and characterisation aims at gaining insight in the product, any hazards relevant while using the product, any events that may occur and any possible outcomes of such events.
“Using” includes all intended and other foreseeable use of and interactions with the product, taking into account the variability in the population.
Hazard identification asks for an analysis of all hazards of the product (e.g. sharp edge, electric energy source, chemical substance), hazards of the environment in which it is used, the interaction of persons with it, and human factors (both physical and cognitive) of relevant populations as well as an analysis of possible incident types, e.g. fall, drowning, suffocation, cutting, inhalation, ingestion.
The first result of this phase will be a qualitative overview of what can go wrong and which factors are involved.
This overview can be presented in a list of scenario’s (descriptions of accidents) or represented in graphical form (for more information see examples). The “hazard characterisation” phase will address the severity of what can go wrong (see Note 1). The factors involved will be analysed in the “exposure assessment” phase to estimate the probability of occurrence.
Hazard characterisation aims at drawing conclusions about the severity of adverse effects. This phase builds on the result of the hazard identification. The identification results in specific possible incident mechanisms. In this characterisation phase, the possible adverse effects and their severity have to be evaluated. For example, hazard identification shows that a fall from a children’s high chair is possible. In the hazard characterisation phase it is then necessary to analyse the relation between the fall height and the effects, e.g. bruise, fracture, concussion. Furthermore, the severity of the effects has to be quantified in terms of reversibility, medical consumption etc. For chemical risks, this kind of analysis is better known as dose-response assessment. More details and instructions can be found under More information and tools.
The result of this phase together with hazard identification will be an overview of scenarios in which the relation between hazards, mechanisms, adverse effects and their severity is given.
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