Implementation of Risk-Based Thinking ISO 9001:2015 Using FMEA in the Manufacturing Industry: A Case Study of PT XYZ
DOI:
https://doi.org/10.38035/dijefa.v6i5.5272Keywords:
Risk-Based Thinking, ISO 9001:2015, FMEA, Quality Management System, Manufacturing Industry, Risk ManagementAbstract
Risk-Based Thinking (RBT) is a foundational principle in ISO 9001:2015; however, many manufacturing companies continue to face challenges in translating this abstract concept into concrete, measurable operational actions. This study aims to develop and validate a practical framework for implementing RBT through Failure Mode and Effect Analysis (FMEA) within the quality management system of a manufacturing environment. A mixed-method case study was conducted at PT XYZ, a manufacturing company in Indonesia. The FMEA implementation included identifying failure modes, assessing severity-occurrence-detection, and calculating Risk Priority Numbers (RPN). Data collection encompassed stakeholder interviews, document analysis, and performance monitoring over a 24-month period. The FMEA process successfully identified 23 significant risks, categorized as critical (5 risks), high (8 risks), medium (7 risks), and low (3 risks). Post-implementation analysis revealed an average RPN reduction of 58%, from a range of 392–504 to 113–168, an increase in ISO 9001:2015 compliance from 83.8% to 96%, and notable improvements in operational performance. FMEA proves to be an effective pathway for operationalizing RBT within the ISO 9001:2015 framework in manufacturing contexts. The validated framework offers a practical guideline for the systematic implementation of risk management, contributing to enhanced quality management effectiveness and organizational competitiveness.
References
Acebes, F., González-Varona, J. M., López-Paredes, A., & Pajares, J. (2024). Beyond probability-impact matrices in project risk management: A quantitative methodology for risk prioritisation. Humanities and Social Sciences Communications, 11(1), 1–13. https://doi.org/10.1057/s41599-024-03180-5
Ahmed, S., Bossenberger, T., Nalichowski, A., Bredfeldt, J. S., Bartlett, S., Bertone, K., Dominello, M., Dziemianowicz, M., Komajda, M., Makrigiorgos, G. M., Marcus, K. J., Ng, A., Thomas, M., & Burmeister, J. (2021). A bi-institutional multi-disciplinary failure mode and effects analysis (FMEA) for a Co-60 based total body irradiation technique. Radiation Oncology, 16(1), 1–17. https://doi.org/10.1186/s13014-021-01894-3
Alruqi, M., Baumers, M., Branson, D. T., & Girma, S. (2022). The Challenge of Deploying Failure Modes and Effects Analysis in Complex System Applications—Quantification and Analysis. Sustainability (Switzerland), 14(3). https://doi.org/10.3390/su14031397
Andres-Jimenez, J., Medina-Merodio, J. A., Fernandez-Sanz, L., Martinez-Herraiz, J. J., & Ruiz-Pardo, E. (2020). An intelligent framework for the evaluation of compliance with the requirements of ISO 9001:2015. Sustainability (Switzerland), 12(13). https://doi.org/10.3390/su12135471
Anjalee, J. A. L., Rutter, V., & Samaranayake, N. R. (2021). Application of failure mode and effects analysis (FMEA) to improve medication safety in the dispensing process – a study at a teaching hospital, Sri Lanka. BMC Public Health, 21(1), 1–13. https://doi.org/10.1186/s12889-021-11369-5
Burkhart, D., & Bode, C. (2024). On supplier resilience: How supplier performance, disruption frequency, and disruption duration are interrelated. Journal of Purchasing and Supply Management, 30(3), 100921. https://doi.org/10.1016/j.pursup.2024.100921
Camango, C., & Cândido, C. J. F. (2023). ISO 9001 maintenance, decertification and recertification: a systematic literature review. Total Quality Management and Business Excellence, 34(13–14), 1764–1796. https://doi.org/10.1080/14783363.2023.2203379
Carro, A., Chacartegui, R., Tejada, C., Gravanis, G., Eusha, M., Spyridon, V., Simira, P., & Ortiz, C. (2021). Fmea and risks assessment for thermochemical energy storage systems based on carbonates. Energies, 14(19), 1–20. https://doi.org/10.3390/en14196013
Cunha, F., Dinis-Carvalho, J., & Sousa, R. M. (2023). Performance Measurement Systems in Continuous Improvement Environments: Obstacles to Their Effectiveness. Sustainability (Switzerland), 15(1). https://doi.org/10.3390/su15010867
Ćwiklicki, M., Pawełek, B., & Pilch, K. (2021). Organisational Resource Capacity and ISO 9001 QMS Implementation in the Local Government. Evidence from Poland. Public Organization Review, 21(2), 205–219. https://doi.org/10.1007/s11115-020-00485-2
Dimitrantzou, C., Psomas, E., Bouranta, N., & Kafetzopoulos, D. (2022). The role of organisational culture in total quality management adoption and cost of quality. Total Quality Management and Business Excellence, 33(15–16), 1718–1736. https://doi.org/10.1080/14783363.2021.1997143
Gourbier, L., Iacuzzi, S., Padovani, E., & Saliterer, I. (2025). Risk Management in the Public Sector: A Comparative Analysis of Central Government Settings in France, Germany, and Italy. Financial Accountability and Management, 41(2), 293–307. https://doi.org/10.1111/faam.12416
Hardy, C., Maguire, S., Power, M., & Tsoukas, H. (2020). Organizing risk: organization and management theory for the risk society.
Hashem, G., & Aboelmaged, M. (2023). Leagile manufacturing system adoption in an emerging economy: an examination of technological, organizational and environmental drivers. Benchmarking, 30(10), 4569–4600. https://doi.org/10.1108/BIJ-03-2022-0199
Ispas, L., Mironeasa, C., & Silvestri, A. (2023). Risk-Based Approach in the Implementation of Integrated Management Systems: A Systematic Literature Review. Sustainability (Switzerland), 15(13), 1–22. https://doi.org/10.3390/su151310251
Kabiesz, P. (2024). Safety Culture in SMEs of the Food Industry: A Case Study and Best Practices. Sustainability (Switzerland), 16(24). https://doi.org/10.3390/su162411185
Karasan, A., & Erdogan, M. (2021). Creating proactive behavior for the risk assessment by considering expert evaluation: a case of textile manufacturing plant. Complex and Intelligent Systems, 7(2), 941–959. https://doi.org/10.1007/s40747-020-00246-0
La Russa, R., Fazio, V., Ferrara, M., Di Fazio, N., Viola, R. V., Piras, G., Ciano, G., Micheletta, F., & Frati, P. (2022). Proactive Risk Assessment Through Failure Mode and Effect Analysis (FMEA) for Haemodialysis Facilities: A Pilot Project. Frontiers in Public Health, 10(March), 1–7. https://doi.org/10.3389/fpubh.2022.823680
Liao, Y., & Thomas, D. C. (2025). The Emergence of Collective Cultural Intelligence in Teams in Multicultural Contexts: A Dynamic Perspective. In Group and Organization Management (Vol. 50, Issue 2). https://doi.org/10.1177/10596011251314099
Liu, Y., & Tang, Y. (2022). Managing uncertainty of expert’s assessment in FMEA with the belief divergence measure. Scientific Reports, 12(1), 1–12. https://doi.org/10.1038/s41598-022-10828-2
Lois, P., Drogalas, G., Nerantzidis, M., Georgiou, I., & Gkampeta, E. (2020). Risk-based internal audit: factors related to its implementation. Corporate Governance (Bingley), 21(4), 645–662. https://doi.org/10.1108/CG-08-2020-0316
Markulik, Š., Šolc, M., & Blaško, P. (2024). Use of Risk Management to Support Business Sustainability in the Automotive Industry. Sustainability (Switzerland) , 16(10), 1–24. https://doi.org/10.3390/su16104308
Mittal, A., Gupta, P., Kumar, V., Antony, J., Cudney, E. A., & Furterer, S. L. (2023). TQM practices and their impact on organisational performance: the case of India’s deming-award industries. Total Quality Management and Business Excellence, 34(11–12), 1410–1437. https://doi.org/10.1080/14783363.2023.2177148
Moczydłowska, J., Sadkowska, J., Żelazko, B., Ciocoiu, C. N., & Stawicka, E. (2023). Understanding Risk Culture in the Context of a Sustainable Project: A Preliminary Study. Sustainability (Switzerland) , 15(6), 1–16. https://doi.org/10.3390/su15065302
Neyarapally, G. A., Millikan, E. D., & Manzo, C. (2023). Implementation and Integration of Risk Evaluation and Mitigation Strategies into the Health Care System. Applied Clinical Informatics, 14(2), 354–355. https://doi.org/10.1055/s-0043-1767683
Ogunmakinde, O. E., Egbelakin, T., Sher, W., Omotayo, T., & Ogunnusi, M. (2024). Establishing the limitations of sustainable construction in developing countries: a systematic literature review using PRISMA. Smart and Sustainable Built Environment, 13(3), 609–624. https://doi.org/10.1108/SASBE-10-2022-0223
Peres, R. S., Jia, X., Lee, J., Sun, K., Colombo, A. W., & Barata, J. (2020). Industrial Artificial Intelligence in Industry 4.0 - Systematic Review, Challenges and Outlook. IEEE Access, 8, 220121–220139. https://doi.org/10.1109/ACCESS.2020.3042874
Shabani, S., Bachwenkizi, J., Mamuya, S. H., & Moen, B. E. (2024). The prevalence of occupational injuries and associated risk factors among workers in iron and steel industries: a systematic review and meta-analysis. BMC Public Health, 24(1). https://doi.org/10.1186/s12889-024-20111-w
Smeulders, D., Dekker, H. C., & Van den Abbeele, A. (2023). Post-acquisition integration: Managing cultural differences and employee resistance using integration controls. Accounting, Organizations and Society, 107, 101427. https://doi.org/10.1016/j.aos.2022.101427
Soehardjojo, J., Delbridge, R., & Meardi, G. (2023). The hidden layers of resistance to dominant HRM transfer: Evidence from Japanese management practice adoption in Indonesia. Economic and Industrial Democracy, 44(3), 679–702. https://doi.org/10.1177/0143831X221086019
Teklay, B., & Bobe, B. J. (2024). Quality management adoption and management accounting change in a sub-Saharan African firm. Accounting, Auditing and Accountability Journal, 37(3), 713–742. https://doi.org/10.1108/AAAJ-03-2021-5212
Testorelli, R., Tiso, A., & Verbano, C. (2024). Value Creation with Project Risk Management: A Holistic Framework. Sustainability (Switzerland), 16(2). https://doi.org/10.3390/su16020753
Weitzel, J., Pappa, H., Banik, G. M., Barker, A. R., Bladen, E., Chirmule, N., DeFeo, J., Devine, J., Emrick, S., Hout, T. K., Levy, M. S., Mahlangu, G. N., Rellahan, B., Venema, J., & Workman, W. (2021). Understanding Quality Paradigm Shifts in the Evolving Pharmaceutical Landscape: Perspectives from the USP Quality Advisory Group. AAPS Journal, 23(6), 1–8. https://doi.org/10.1208/s12248-021-00634-5
Wen Zhang, Xiaoshuang Zeng, Huigang Liang, Yajiong Xue, & Xuanze Cao. (2023). Understanding how organizational culture affects innovation performance: A management context perspective. Sustainability (Switzerland), 15(8), 1–18.
Yucesan, M., Gul, M., & Celik, E. (2021). A holistic FMEA approach by fuzzy-based Bayesian network and best–worst method. Complex and Intelligent Systems, 7(3), 1547–1564. https://doi.org/10.1007/s40747-021-00279-z
Zimmerman, M. (2024). The value and limitations of self-administered questionnaires in clinical practice and epidemiological studies. World Psychiatry, 23(2), 210–212. https://doi.org/10.1002/wps.21191
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