TY - GEN
T1 - A Proposal of Architecture Framework and Performance Indicator Derivation Model for Digitalization of Quality Management System
AU - Miura, Kasei
AU - Kobayashi, Nobuyuki
AU - Miyake, Tetsuro
AU - Shirasaka, Seiko
AU - Masuda, Yoshimasa
N1 - Publisher Copyright:
© 2021, The Author(s), under exclusive license to Springer Nature Singapore Pte Ltd.
PY - 2021
Y1 - 2021
N2 - 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.
AB - 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.
KW - Architecture framework
KW - Digitalization
KW - Performance measurement
KW - Quality management system
UR - http://www.scopus.com/inward/record.url?scp=85111134078&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85111134078&partnerID=8YFLogxK
U2 - 10.1007/978-981-16-3013-2_11
DO - 10.1007/978-981-16-3013-2_11
M3 - Conference contribution
AN - SCOPUS:85111134078
SN - 9789811630125
T3 - Smart Innovation, Systems and Technologies
SP - 129
EP - 139
BT - Innovation in Medicine and Healthcare - Proceedings of 9th KES-InMed 2021
A2 - Chen, Yen-Wei
A2 - Chen, Yen-Wei
A2 - Tanaka, Satoshi
A2 - Howlett, Robert J.
A2 - Howlett, Robert J.
A2 - Howlett, Robert J.
A2 - Jain, Lakhmi C.
A2 - Jain, Lakhmi C.
PB - Springer Science and Business Media Deutschland GmbH
T2 - 9th KES International Conference on Innovation in Medicine and Healthcare, KES-InMed 2021
Y2 - 14 June 2021 through 16 June 2021
ER -