The European risk assessment process refers to the evaluation of a product’s compliance with the product’s legal requirements. The process of risk assessment has three phases consisting of 8 steps in total. The focus of this post will be on the eight stages. The essential steps of the risk assessment process are, as follows:
- Identifying the product: This step refers to determining the product, along with all the applicable legal requirements, including harmonised standards and other provisions giving presumption of conformity. However, given that the European legislation covers a broad array of products, hazard and impacts, sometimes an overlap can occur. In such case, and if not stated otherwise in the legislation, more than one pieces of the EU legislation may need to be considered for a product, and its risk assessment procedure should be carried out following all applicable legal requirements.
- Identifying relative hazards: many hazards may arise from a product, and their correct identification and relevance estimation are significantly dependent on the applicable CE directives and their requirements. If identified incorrectly, the specific product may endanger the health and safety of consumers. Hazards can arise from anything associated with the product, for instance: flammability, hygiene, electrical properties, design, construction, mechanical resistance, etc.
- Identifying the subject at risk: As a subject is seen anything of public interest covered by the respective EU harmonisation legislation. For instance, subjects could be people, property, domestic animals or even the environment.
- Providing a description of how all identified hazards could harm the subject: A harm scenario must be developed, and it should contain a detailed description of how the recognised hazards may affect the subject at risk. A thorough description of the primary components of the hazards, subject, product and circumstances need to be included as well. Of great importance is to add the shortest or critical path to harm in the harm scenario. The hazards may occur on a regular basis or to be accidental, and this also needs to be taken into account when preparing a harm scenario.
- Determining the eventual harm: The risk assessor needs to identify the target that is or could be harmed and the possible result.
- Defining the harm’s severity: An assessment of the foreseeable level of harm to the subject needs to be undertaken. To do that, one of the two possible approaches must be followed. The first approach refers to describing the degree of harm for each subject area. The other method is more flexible and eliminates the need for detailed descriptions. It relates to the use of abstract terms that can be applied to any subject.
- Determining the likelihood of harm occurrence: It is known as the most challenging part of the risk assessment and requires the preparation of a quantified figure of probability for each one of the harm scenario’s steps. In this regard, a preferred method is the utilisation of recognised and reliable probabilities. The estimation of the probability for each scenario’s step can enhance the quality and transparency of the risk assessment.
- Defining the risk degree by combining the harm’s severity and the probability of that harm happening in the harm scenario described: This is the final step of the risk assessment. Here, the risk assessors need to determine the degree of risk, which can be low, medium, high and serious.