Importance of risk management

Risk is the probability combined with the severity that a particular characteristic of a product will cause injury, either to the user or to others.

A product which has a significant probability of causing a serious injury will be considered a serious risk, which is the highest level in product risk assessment and requires urgent action.

Hazard is the risk of injury that arises from product characteristics – these characteristics are called hazards. Any feature of a product which has the potential to cause injury in certain circumstances is a hazard.

Different product types have different types of hazards – for example, what is considered a hazard for a toy, would not necessarily be a hazard for an electrical product. This is because different people use products in different ways.  Some features of a product (such as electricity) are hazards on their own if the product does not adequately protect against contact with it. Many hazards are obvious, but often there are hidden hazards that require a deeper consideration.

The European Commission has created the Risk Assessment Guidelines tool, also known as the RAG tool. The tool is based on the Commission Decision (EU) 2019/417, which sets out guidelines for the Safety Gate. These guidelines have an annex that describes the risk assessment method behind the RAG tool.

The tool is divided into two sections:

1) ‘General information and overview’ that covers the product name, product category and the description of the product.

2) Scenarios that focus attention on hazards, injury and user types.

The RAG tool supports the estimation of the risk level by assisting the user in selecting the appropriate injury severity level and estimating the probability. This takes place in the following stages:

1) the user identifies the product hazard, the type of injury that it can cause and the user type.

2)  the user must consider how the hazard will lead to the injury. This is described in an injury scenario. An injury scenario is a sequence of events that need to occur for the product to cause injury. This will usually consist of several steps.

3)  the user must estimate probabilities for each of the steps in the injury scenario.

When these steps have been accomplished, the RAG tool will calculate the risk level for the user.

The user is, however, advised to test the robustness of the risk assessment by making variations of the probabilities and the risk level to see how much the input parameters can change before the risk level is altered. This is called sensitivity analysis in the tool.

European product safety legislation seeks to limit risks by specifying essential safety requirements for many products. Product standards provide a way of identifying and quantifying product hazards.

Harmonised standards ensure that all product hazards have been addressed, which is why compliance with standards offers a presumption of safety.

The European Commission has created some very useful guidance for risk assessments:

• The RAPEX Guidelines (Commission implementing decision (EU) 2019/ 417) that describe how the European Safety Gate cooperation works. They include an annex with a detailed description of risk assessment guidelines for consumer products.
• The Risk Assessment Guidelines page on the European Commission’s website also includes a user manual with details about how to use the RAG tool.

Further examples of risk types and risk levels of dangerous products are available on the Safety Gate website. Type the product into the free text search box and select the relevant product category to view notified examples. A risk type and level present in a similar product with a similar defect can help when making risk assessment.