Planning a Clinical Risk Management Project

Abstract

A safety assessment cannot be tackled in an ad hoc manner. Even when a sound clinical risk management system is in place its application needs to be planned and orchestrated. This is achieved through the development of the clinical risk management plan, a deliverable which consolidates the project scope and intended assurance activities. The safety assessment will result in the production of a hazard register and safety case – material which forms the argument and evidence to justify and articulate the assessed clinical risk. This chapter looks at how a safety assessment should be shaped, the need for it to be integrated into the software development lifecycle and the deliverables which will be produced during the project.