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All Journal Dinasti International Journal of Economics, Finance & Accounting (DIJEFA)
Hady Siti Hadijah
Universitas Pendidikan Indonesia, Bandung, Indonesia.
Economics, Econometrics & Finance

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Implementation of Risk-Based Thinking ISO 9001:2015 Using FMEA in the Manufacturing Industry: A Case Study of PT XYZ Dwitya Nur Rahmawati; Edi Suryadi; Hady Siti Hadijah; Rasto Rasto
Dinasti International Journal of Economics, Finance & Accounting Vol. 6 No. 5 (2025): Dinasti International Journal of Economics, Finance & Accounting (November - De
Publisher : Dinasti Publisher

Show Abstract | Download Original | Original Source | Check in Google Scholar | DOI: 10.38035/dijefa.v6i5.5272

Abstract

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.
Co-Authors Dwitya Nur Rahmawati Edi Suryadi Rasto Rasto