What is a risk assessment?
According to Section 5 of the German occupational safety and health act (Arbeitsschutzgesetz, ArbSchG) and Section 4 BioStoffV, employers must have risks in the workplace assessed by qualified personnel before beginning with any activities. The assessment can be performed by employees who have been trained as biosafety officers, for example. A risk assessment determines the measures required for a safe working environment. Risks must be avoided or minimised. Existing risk assessments for the individual areas of a biobank can serve as the basis here for documentation of the risks. A responsible person must consider all of the activities and work processes foreseen at the biobank.
Should the activities change, the risk assessment must be updated accordingly. Even without any changes, a risk assessment must be performed at least every two years, updated as necessary and the identified measures implemented (Section 4 BioStoffV).
The Technical Rules for Biological Agents (TRBA) 400 offer support here and give practical examples. The ABAS has also published a step-by-step guide on its website featuring further examples. It has identified the following seven steps to perform and update a risk assessment:
- Define the work areas and activities
- Determine the risks
- Assess the risks
- Define specific, state-of-the-art occupational safety measures (technical, organisational, personal and behavioural) according to the S-T-O-P principle
- Implement the measures
- Review the effectiveness of the measures
- Update the risk assessment (specifically, adjust in case of changes to the operational conditions as per Section 3 ArbSchG).
In the following presentation, Bettina Meinung (QM Core Team, GBN) shares tips for preparing a risk assessment. She delivered this presentation during a GBN webinar on handling infectious samples held on 29 April 2020. See here for the full webinar documentation.