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

Kasei Miura, Nobuyuki Kobayashi, Tetsuro Miyake, Seiko Shirasaka, Yoshimasa Masuda

Research output: Chapter in Book/Report/Conference proceedingConference contribution

Abstract

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.

Original languageEnglish
Title of host publicationInnovation in Medicine and Healthcare - Proceedings of 9th KES-InMed 2021
EditorsYen-Wei Chen, Yen-Wei Chen, Satoshi Tanaka, Robert J. Howlett, Robert J. Howlett, Robert J. Howlett, Lakhmi C. Jain, Lakhmi C. Jain
PublisherSpringer Science and Business Media Deutschland GmbH
Pages129-139
Number of pages11
ISBN (Print)9789811630125
DOIs
Publication statusPublished - 2021
Event9th KES International Conference on Innovation in Medicine and Healthcare, KES-InMed 2021 - Virtual, Online
Duration: 2021 Jun 142021 Jun 16

Publication series

NameSmart Innovation, Systems and Technologies
Volume242
ISSN (Print)2190-3018
ISSN (Electronic)2190-3026

Conference

Conference9th KES International Conference on Innovation in Medicine and Healthcare, KES-InMed 2021
CityVirtual, Online
Period21/6/1421/6/16

Keywords

  • Architecture framework
  • Digitalization
  • Performance measurement
  • Quality management system

ASJC Scopus subject areas

  • Decision Sciences(all)
  • Computer Science(all)

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