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Journal : Dinasti International Journal of Economics, Finance

Implementation of Risk-Based Thinking ISO 9001:2015 Using FMEA in the Manufacturing Industry: A Case Study of PT XYZ Rahmawati, Dwitya Nur; Suryadi, Edi; Hadijah, Hady Siti; 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.
Adaptation of the 4D Model in Developing a Competency Documentation Framework for ISO 9001:2015 Implementation in the Manufacturing Industry Rahmayanti, Tiana Nur; Suryadi, Edi; Inayati, Tutik; 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.v6i5.5278

Abstract

Effective competency documentation remains a critical challenge in implementing ISO 9001:2015 Clause 7.2 across Indonesian manufacturing industries, primarily due to the absence of a structured methodological framework. This methodological gap hinders the systematic and effective management of employee competencies. This study proposes an integrated competency documentation system through the adaptation of the 4D model (Define, Design, Develop, Disseminate) for ISO 9001:2015-certified manufacturing organizations. The research employed a development method encompassing Define, Design, and Develop stages, with data triangulation from document analysis, stakeholder interviews, and expert validation conducted in an automotive component manufacturing company. Validation involved two experts with complementary expertise and testing with multi-department employees. The results produced four integrated Standard Operating Procedures: formulation of competency standards, development of a competency matrix, planning of competency development, and evaluation of effectiveness. Expert validation indicated a score of 79.5% (categorized as good) with an inter-rater reliability of r = 0.94, while user trials yielded high levels of satisfaction. The system effectively addressed gaps in standard setting, employee competency mapping, systematic evaluation, and integrated documentation. The adaptation of the 4D model proved to be an effective approach for balancing standard compliance with operational needs, providing a practical contribution to ISO 9001:2015 implementation within the Indonesian manufacturing sector.
Co-Authors -Okyireh, Theodore Oduro Abyannash, Mohammed Acheampong*, Kennedy Ade Sobandi, Ade Adhara, Yhora Listy Adman, Adman Agus Rahayu Ahmad, Agus Amir Machmud, Amir Angela, Sylvia Sysca Anggi Permatasari, Anggi Annisa, Rahimatul Askolani Askolani, Askolani Astiwardhani, Winny Aziz, Farouk Besar, Mohd. Hairul Azrin Haji Disman, Disman Disman, H Dwi Budi Santoso Eddy Haryanto Eeng Ahman, Eeng Elyusufi, Abdul Muhaimin F.A. Milawasri, F.A. Firman Firman Fitriani, Kulsum Gaya Tridinanti, Gaya H.O Munthe, Huriana Hady Siti Hadijah, Hady Siti Hasanah, Siti Fathimah Nurul Hendri Winata, Hendri Heriman, Heriman Hernawan, Yosep Heryana, Toni Isla, Janaria Putri Islamy, Fahmi Jahidah Jannah, Siti Roudlatul Khomairoh, Sheina Nabila Kurniawan, Fakhry Hafiyyan Kusumah, Echo Perdana Lustina, Lustina Lutina, Lutina M. Arief Ramdhany Mattin, Fadly Abdussyalam Maulana, Mahbub Afini Maya Sari Mega Rahmawati, Mega Milawasri, F A Miranda, Winda Muhklas, Muhklas Mukhlas Mukhlas Nasim, Arim Nugraha, Dini Nugraha, N Nur Istiqomah, Wahyu Nurbilady, Nadya Frizka Nurhasan, Rohimat Opoku, Ernest Purnomo, Budi Supriatono Puspo Dewi Dirgantari Rahmawati, Dwitya Nur Rahmayanti, Tiana Nur Rasto, Rasto Ratih Rahmawati Ratna Gumilang, Risa Rofi Rofaida Saady, Farma Ladia Samaya, Doni Sari, Sinta Nadia Sasmitha, Jonathan Lucky Selfina, Sirrila Dewi Sojannah, Jannah Sriastuti, Winda Nur ST, Agus Sulastri Sulastri Sundusiah, Sundusiah Suwatno Suwatno Syamsul Hadi Senen, Syamsul Hadi Triyanah, Tia Tutik Inayati Ukas, Maman Yangiboyev, Sirojjiddin Yudi Sekaryadi