Using safety cases in industry and healthcare A pragmatic review of the use of safety cases in safety critical industries – lessons and prerequisites for their application in healthcare

This report presents the results of a study that reviewed the use of safety cases in six safety-critical industries, as well as the emerging use of safety cases in healthcare.

The aims of the study were to describe safety case use in other industries, to make pragmatic recommendations for the adoption of safety cases in healthcare and to outline possible healthcare application scenarios.

The core of a safety case is typically a risk-based argument and corresponding evidence to demonstrate that:

• all risks associated with a particular system have been identified
• appropriate risk controls have been put in place
• there are appropriate processes in place to monitor the effectiveness of the risk controls and the safety performance of the system on an ongoing basis.

The purpose of a safety case is to provide a structured argument, supported by a body of evidence, that provides a compelling, comprehensible and valid case that a system is acceptably safe for a given application in a given context

The use of safety cases is an accepted best practice in UK safety-critical industries and is adopted by companies as a means of providing rigour and structure to their safety management systems.

The Health Foundation is exploring the development of safety cases in healthcare through our Safer Clinical Systems programme. The learning from this work could have far-reaching implications, not just for how staff assure safety within their clinical settings, but also for how the regulators and commissioners of healthcare services monitor patient safety in the UK.