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ANALISIS METODE FAILURE MODE AND EFFECT ANALYSIS (FMEA) DALAM IMPLEMENTASI RISK-BASED THINKING ISO 9001:2015 DI INDUSTRI MANUFAKTUR
PT. XYZ mengalami peningkatan risiko tinggi dari 25% (2020) menjadi 40% (2024) dengan kerugian finansial meningkat dari Rp 847 juta menjadi Rp 1,89 miliar, menunjukkan kesenjangan antara persyaratan standar dengan implementasi praktis yang memerlukan metodologi analisis risiko yang lebih sistematis. Penelitian menggunakan metode campuran dengan desain studi kasus analitis melalui workshop FMEA, wawancara terstruktur dengan 3 responden kunci, dan observasi langsung. Implementasi FMEA berhasil mengidentifikasi 23 komponen kritis dari 145 proses bisnis dengan konsistensi 87%, 47 mode kegagalan spesifik, dan 156 mekanisme pengendalian. Akurasi penentuan prioritas risiko meningkat dari 60% menjadi 91% dengan waktu pengambilan keputusan dipercepat dari 2-3 hari menjadi 2-3 jam. Implementasi 35 tindakan perbaikan mencapai keberhasilan 100% dengan rata-rata pengurangan RPN 49,3%. Investasi Rp 425 juta menghasilkan penghematan tahunan Rp 850 juta dengan payback period 6 bulan, membuktikan efektivitas FMEA dalam mengoptimalkan manajemen risiko dan mendukung Risk-Based Thinking ISO 9001:2015. PT. XYZ experienced a high risk increase from 25% (2020) to 40% (2024) with financial losses increasing from IDR 847 million to IDR 1.89 billion, indicating a gap between standard requirements and practical implementation that requires a more systematic risk analysis methodology. The research employed a mixed-method approach with an analytical case study design through FMEA workshops, structured interviews with three key respondents, and direct observation. The implementation of FMEA successfully identified 23 critical components from 145 business processes with 87% consistency, 47 specific failure modes, and 156 control mechanisms. Risk priority determination accuracy improved from 60% to 91%, with decision-making time accelerated from 2-3 days to 2-3 hours. The implementation of 35 corrective actions achieved 100% success with an average RPN reduction of 49.3%. An investment of Rp 425 million resulted in annual savings of Rp 850 million with a payback period of 6 months, demonstrating the effectiveness of FMEA in optimizing risk management and supporting Risk-Based Thinking in accordance with ISO 9001:2015.
KODEPRODI61109#Manajemen Perkantoran_S2, Universitas Pendidikan Indonesia
ANALISIS METODE FAILURE MODE AND EFFECT ANALYSIS (FMEA) DALAM IMPLEMENTASI RISK-BASED THINKING ISO 9001:2015 DI INDUSTRI MANUFAKTUR (Text)
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HD28 Management. Industrial Management
L Education (General)