Abstract

The paper presents a study of the potential for applying the Quality Function Deployment (QFD) method to the analysis of the framework for safety management contained in the Ionising Radiation (Medical Exposure) Regulations (IRMER) of 2000. The QFD method has been successfully applied to many industrial and manufacturing processes in order to ensure that quality is built into products at the outset rather than tested for after their production. In this context, the term quality is used to describe the degree to which the needs and requirements of the customer are fulfilled. More frequently, now, the QFD approach is being applied to health care in order to engineer clinical processes that can best fulfil the needs of the patient. In the case of diagnostic radiology, safety management must not only be concerned with radiation protection but, more importantly, with the accuracy and consistency of any diagnostic outcome. Both are important patient needs. A first stage analysis of IRMER 2000 is presented that assesses how patients' needs are expressed by the individual IRMER components of justification, optimisation, clinical audit, expert advice, equipment and training. The analysis involved a QFD assessment by four radiation protection experts with over 100 man-years of experience. A second stage analysis assesses how the individual IRMER components have been engineered into a safety management framework through specific requirements embodied in IRMER 2000. The results of this assessment are discussed in terms of clinical, human, operational management and equipment related aspects of the radiological process. This study highlights how the QFD approach may be applied to engineer specific aspects of radiological practice that play a key role in ensuring that patients' needs are fully met. As an example, clinical audit requirements are analysed by means of the QFD method to indicate the design requirements of information and knowledge based systems that can provide the necessary information for this type of key management activity.

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