A systems engineering approach to equipment qualification in healthcare

Abstract

Equipment Qualification is a formal quality assurance process in manufacturing which establishes confidence that specified equipment is ‘ready for its intended use’. This thesis, in drawing parallels between requirements of manufacturing equipment and medical equipment, hypothesises that the protocols, practices and tools of Equipment Qualification can be adapted for application in healthcare.

In manufacturing, where the quality of output is of critical concern, the scope of Equipment Qualification is limited to building confidence that the equipment can produce product to specification. In healthcare, where patient safety is the critical concern, the identification and control of potential causes of adverse events is of central importance in establishing confidence that the equipment is ‘ready for its intended use’.

This thesis details the development of an Equipment Qualification framework for healthcare to guide healthcare practitioners in best practice tools, techniques and considerations for the identification and control of potential causes of adverse events. The Equipment Qualification framework presented in this thesis synthesises existing knowledge in the domains of risk management, quality, safety, reliability, maintenance, calibration, human factors engineering and lean methods with empirical findings of benchmarking case studies in manufacturing companies and requirements analysis case studies and questionnaire in healthcare.

A systems engineering approach is adopted to manage the complexity of the Equipment Qualification process. The framework, consisting of a model written in the systems engineering modelling language IDEFØ and supporting qualification template protocols, was verified and validated via a novel expert review process.