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

研究成果: Conference contribution

2 被引用数 (Scopus)

抄録

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.

本文言語English
ホスト出版物のタイトルInnovation in Medicine and Healthcare - Proceedings of 9th KES-InMed 2021
編集者Yen-Wei Chen, Yen-Wei Chen, Satoshi Tanaka, Robert J. Howlett, Robert J. Howlett, Robert J. Howlett, Lakhmi C. Jain, Lakhmi C. Jain
出版社Springer Science and Business Media Deutschland GmbH
ページ129-139
ページ数11
ISBN(印刷版)9789811630125
DOI
出版ステータスPublished - 2021
イベント9th KES International Conference on Innovation in Medicine and Healthcare, KES-InMed 2021 - Virtual, Online
継続期間: 2021 6月 142021 6月 16

出版物シリーズ

名前Smart Innovation, Systems and Technologies
242
ISSN(印刷版)2190-3018
ISSN(電子版)2190-3026

Conference

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

ASJC Scopus subject areas

  • 決定科学一般
  • コンピュータサイエンス一般

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