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A METHOD TO EXPLORE PRODUCT RISK IN PRODUCT LIFECYCLE MANAGEMENT OF CONFIGURED PRODUCTS

Part of: Design Organisation and Management

Published online by Cambridge University Press:  11 June 2020

R. Riascos Castaneda ,
E. Ostrosi ,
T. Majić ,
J. Stjepandić  and
J.-C. Sagot
R. Riascos Castaneda*
Affiliation:
Roche Diabetes Care, Germany
E. Ostrosi
Affiliation:
Université Bourgogne Franche-Comté, France
T. Majić
Affiliation:
Croatian Academy of Sciences and Arts in Diaspora and Homeland, Switzerland
J. Stjepandić
Affiliation:
PROSTEP AG, Germany
J.-C. Sagot
Affiliation:
Université Bourgogne Franche-Comté, France
*
*roberto.riascos@gmail.com

Abstract

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Today high quality and low product development turnaround time are company-wide priorities. Quality supporting processes such as an effective risk management system shall support continuous business running and meeting the goals of an organization. In this paper, an approach is presented on how to integrate the product risk management in Product Lifecycle Management for configured products by definition of an additional software module and its implementation.

Keywords

risk managementconfiguration managementconfigured productproduct lifecycle management (PLM)

Information

Type
Article
Information
Proceedings of the Design Society: DESIGN Conference , Volume 1 , May 2020 , pp. 687 - 696
Creative Commons
Creative Common License - CCCreative Common License - BYCreative Common License - NCCreative Common License - ND
This is an Open Access article, distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivatives licence (http://creativecommons.org/licenses/by-nc-nd/4.0/), which permits non-commercial re-use, distribution, and reproduction in any medium, provided the original work is unaltered and is properly cited. The written permission of Cambridge University Press must be obtained for commercial re-use or in order to create a derivative work.
Copyright
The Author(s), 2020. Published by Cambridge University Press

References

Aven, T. (2012), “Foundational Issues in Risk Assessment and Risk Management”, Risk Analysis, Vol. 32 No. 10, pp. 1647–1656. https://doi.org/10.1111/j.1539-6924.2012.01798.xCrossRefGoogle ScholarPubMed
Aven, T. and Zio, E. (2014), “Foundational Issues in Risk Assessment and Risk Management”, Risk Analysis, Vol. 34 No. 7, pp. 1164–1172. https://doi.org/10.1111/risa.12132CrossRefGoogle ScholarPubMed
Baylis, K., Zhang, G. and McAdams, D.A. (2018), “Product family platform selection using a Pareto front of maximum commonality and strategic modularity”, Research in Engineering Design, Vol. 29, pp. 547–563. https://doi.org/10.1007/s00163-018-0288-5CrossRefGoogle Scholar
Beckett, R.C. and Vachhrajani, H. (2017), “Transdisciplinary Innovation: Connecting Ideas from Professional and User Networks”, Journal of Industrial Integration and Management, Vol. 2 No. 4, p. 1750016. https://doi.org/10.1142/S2424862217500166CrossRefGoogle Scholar
Bruun, H.P.L. et al. (2015), “PLM system support for modular product development”, Computers in Industry, Vol. 67, pp. 97–111. https://doi.org/10.1016/j.compind.2014.10.010CrossRefGoogle Scholar
Custódio, D.T. et al. (2018), “Variant product configuration of industrial air handling units in a MTO environment”, International Journal of Advanced Manufacturing Technology, Vol. 95, pp. 1025–1037. https://doi.org/10.1007/s00170-017-1171-7CrossRefGoogle Scholar
Flood, D. et al. (2015), “A roadmap to ISO 14971 implementation”, Journal of Software: Evolution and Process, Vol. 25 No. 5, pp. 319–336. https://doi.org/10.1002/smr.1711Google Scholar
Hatcliff, J. et al. (2018), “Challenges of distributed risk management for medical application platforms”, 2018 IEEE Symposium on Product Compliance Engineering (ISPCE), 14-16 May 2018, https://doi.org/10.1109/ISPCE.2018.8379270CrossRefGoogle Scholar
ISO (2003), ISO 10007 (2003), Quality management systems — Guidelines for configuration management, International Organization for Standardization, Geneva.Google Scholar
ISO (2012), ISO 14971 (2012), Medical devices. Application of risk management to medical devices (Standard for the application of risk management to medical devices), International Organization for Standardization, Geneva.Google Scholar
ISO (2018), ISO 31000 (2018), 05 Risk management - Guidelines, International Organization for Standardization, Geneva.Google Scholar
Kirkire, M.S., Rane, S.B. and Jadhav, J.R. (2015), “Risk management in medical product development process using traditional FMEA and fuzzy linguistic approach: a case study”, Journal of Industrial Engineering International, Vol. 11, pp. 595–611. https://doi.org/10.1007/s40092-015-0113-yCrossRefGoogle Scholar
Lämmer, L. et al. (2015), “Product Lifecycle Management”, In: Stjepandić, J. (Ed.), Concurrent Engineering in the 21st Century: Foundations, Developments and Challenges, Springer International Publishing, Cham, pp. 389–420, https://doi.org/10.1007/978-3-319-13776-6_16Google Scholar
Leimeister, M. and Kolios, A. (2018), “A review of reliability-based methods for risk analysis and their application in the offshore wind industry”, Renewable and Sustainable Energy Reviews, Vol. 91, pp. 1065–1076. https://doi.org/10.1016/j.rser.2018.04.004CrossRefGoogle Scholar
Manz, S. (2019), Medical Device Quality Management Systems. Strategy and Techniques for Improving Efficiency and Effectiveness, Academic Press, London. https://doi.org/10.1016/c2017-0-01146-1Google Scholar
Mathiasen, J.B. and Mathiasen, R.M. (2017), “Practicing Transdisciplinary Engineering in a Global Development Context: The Transferring, Translating and Transforming Approaches”, Journal of Industrial Integration and Management, Vol. 2 No. 4, p. 1750017. https://doi.org/10.1142/S2424862217500178CrossRefGoogle Scholar
Ostrom, L.T. and Wilhelmsen, C.A. (2019), Risk Assessment. Tools, Techniques, and Their Applications, Second Edition, John Wiley & Sons, Inc., Hoboken. https://doi.org/10.1002/9781119483342CrossRefGoogle Scholar
Ostrosi, E. et al. (2014), “Modularity: New trends for product platform strategy support in concurrent engineering”, Advances in Transdisciplinary Engineering, Vol. 1, pp. 414–423, https://doi.org/10.3233/978-1-61499-440-4-414.Google Scholar
Pfouga, A. and Stjepandić, J. (2018), “Leveraging 3D geometric knowledge in the product lifecycle based on industrial standards”, Journal of Computational Design and Engineering, Vol. 5 No. 1, pp. 54–67. https://doi.org/10.1016/j.jcde.2017.11.002CrossRefGoogle Scholar
Pongrac, B. and Majić, T. (2015), “Business Risk Management”, Technical Journal, Vol. 9 No. 1, pp. 94–98.Google Scholar
Raudberget, D. et al. (2019), “Developing agile platform assets – exploring ways to reach beyond modularisation at five product development companies”, Int. Journal of Agile Systems and Management, Vol. 12 No. 4, pp. 311–331. https://doi.org/10.1504/IJASM.2019.104588CrossRefGoogle Scholar
Riascos, R. et al. (2015), “Digital Mock-up”, In: Stjepandić, J. (Ed.), Concurrent Engineering in the 21st Century: Foundations, Developments and Challenges, Springer International Publishing, Cham, pp. 355–388. https://doi.org/10.1007/978-3-319-13776-6_13Google Scholar
Rusu, M. (2019), “The configuration management requirements for aviation, space and defense organizations”, INCAS Bulletin, Vol. 11 No. 1, pp. 239–253, https://doi.org/10.13111/2066-8201.2019.11.1.19.CrossRefGoogle Scholar
Stark, J. (2016), Product Lifecycle Management (Volume 2): The Devil is in the Details, 3rd edition, Springer International Publishing AG. https://doi.org/10.1007/978-3-319-24436-5CrossRefGoogle Scholar
Stark, J. (2019), Product Lifecycle Management (Volume 4): The Case Studies, Springer Nature, AG, Switzerland. https://doi.org/10.1007/978-3-030-16134-7CrossRefGoogle Scholar
Stjepandić, J., Wognum, N. and Verhagen, W.J.C. (2020), Systems Engineering in Research and Industrial Practice. Foundations, Developments and Challenges, Springer Nature, AG, Switzerland. https://doi.org/10.1007/978-3-030-33312-6Google Scholar
Sun, J. et al. (2017), “Modularization of Product Service System Based on Functional Requirement”, Procedia CIRP, pp. 301–305. https://doi.org/10.1016/j.procir.2017.03.038CrossRefGoogle Scholar
Teferra, M.N. (2017), “ISO 14971 - Medical Device Risk Management Standard”, International Journal of Latest Research in Engineering and Technology (IJLRET), Vol. 3 No. 3, pp. 83–87.Google Scholar
Wallis, R. et al. (2014), “Intelligent utilization of digital manufacturing data in modern product emergence processes”, Advances in Transdisciplinary Engineering, Vol. 1, pp. 261–270. https://doi.org/10.3233/978-1-61499-440-4-261Google Scholar
Wognum, N. et al. (2019), “Transdisciplinary systems engineering: implications, challenges and research agenda”, International Journal of Agile Systems and Management, Vol. 12 No. 1, pp. 58–89. https://doi.org/10.1504/ijasm.2019.10019955CrossRefGoogle Scholar
Zhao, X. and Bai, X. (2010), “The Application of FMEA method in the risk management of medical device during the lifecycle”, 2nd International Conference on E-business and Information System Security, 22-23 May 2010, pp. 455–458. https://doi.org/10.1109/EBISS.2010.5473713CrossRefGoogle Scholar