A Proposal of Architecture Framework and Performance Indicator Derivation Model for Digitalization of Quality Management System

Manufacturers of pharmaceuticals and medical devices are accountable for the quality and stable supply of their health-related products. In order to guarantee the provision of products that meet quality requirements, they have established and are operating quality management systems. On the other hand, as the risk of unstable supply increases due to pandemics and outsourcing of supply chains, there is a need to strengthen the monitoring capabilities for early detection of quality problems and countermeasures. Recently, with the advancement of digital technology, IoT, automation and block chain technologies are expected to be used in the field of quality management. Alternatively, quality management systems must continuously maintain their performance in the process of change. However, no method has been established to systematically promote the digitalization of quality management systems and to evaluate the performance of the transition process. In this paper, we propose an architecture framework and a model for deriving performance indicators to promote the digitalization of quality management systems and to evaluate the performance of the transition process. Issues and future plans in this field are also discussed.