Importance of risk management

Making an effective risk assessment

Products may have multiple hazards, and it is the responsibility of the manufacturer to manage these. The types of hazards that may be present and could cause injury will depend on the individual product and the people who are likely to use it. It is, therefore, essential for manufacturers to undertake an effective risk assessment for each product they make.

RAG tool

Carrying out a risk assessment using the publicly available RAG tool requires that the risk assessor develops an injury scenario describing how the product hazard can cause injury. Next, the risk assessor has to estimate the probability that the series of events described in the injury scenario can happen.

Developing injury scenarios

The RAG tool has a library of risk assessment templates each of which includes a number of injury scenarios. The templates within the library can be accessed from the main screen in the RAG tool (see picture) and be loaded into the tool.

The injury scenarios from the risk assessment templates can often be applied directly to the product, or they can serve as valuable inspiration for creating specific injury scenarios for the product that is subject to a specific case.

Estimation of probabilities

Confidence in probability estimation is essential to confidence in risk management and actions taken. The European Commission’s RAG tool can be used to assist with this confidence.

It is possible to develop a number of good practices for risk assessment:

Injury scenarios should be the shortest sequence of events in which a product hazard can cause injury or harm.
The risk assessment should consider the range of possible outcomes (injuries and probabilities) to provide a confident range of resulting risk levels.
Involving as many people as possible in the risk assessment will refine any assumptions or estimations made.
Risk assessment and probability estimations are skills that can only be developed by practice.
Uncertainties and assumptions must be clearly and explicitly stated to increase transparency and facilitate a qualified discussion of the results.
A sensitivity analysis should always be carried out to demonstrate how the risk level reacts to the input of lower or higher values (taken from Decision 2019/417).

Often estimates of probabilities are based on accident statistics or other types of records of events. This provides a minimum probability of that particular injury event. The only direction in which any uncertainty can go is in the direction of increasing probability.

Guidance material

The European Commission has created some very useful guidance in risk assessment:

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.

Screenshot of the RAG tool

Learn more about risk assessment for Safety Gate/RAPEX

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.

You can learn more about this subject in the case studies section.