The development and validation of a traceability assessment model

Abstract

Regulation normally requires critical systems to be certified before entering service. This involves submission of a safety case-a reasoned argument and supporting evidence that stringent requirements have been met and that the system is acceptably safe. A good safety case encompasses an effective risk mitigation process which is highly dependent on requirements traceability. However despite its many benefits and regulatory requirements, most existing software systems lack explicit traceability links between artefacts. Reasons for the lack of traceability include cost, complexity and lack of guidance on how to implement traceability. To assist medical device organisations in addressing the lack of guidance on how to implement effective traceability, this paper aims to present the development and validation of a traceability process assessment model and the actions to be taken as a result of the validation. The process assessment model will allow organisations to identify strengths and weaknesses in their existing traceability process and pinpoint areas for improvement.