Setting the Context

At the outset of any scientifically-based study it is essential to state its context, objectives and assumptions. This frames the assessment and establishes the main aims, assumptions and constraints as well as other aspects like the intended audience. In systems assessment, we refer to this as the assessment context. Defining the context carefully is very important, as it is essential in communicating the scope of the work.

Quintessa’s experience of safety assessment is very valuable in defining the context. We bring knowledge of regulatory expectations, for example, and the best ways of dealing issues such as uncertainties. Our experience is also of great benefit in deciding what level of detail is fit for purpose, and how the safety assessment best uses the available information.

The assessment context is also the stage at which an assessment methodology is defined. A clear, logical and structured approach is very important, especially if the assessment is of interest to a wide range of people. Here, we bring knowledge of developing assessment approaches that is founded in our participation in international projects focused on improving safety assessment methods.