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Kajian Metode Root Cause Analysis yang Digunakan dalam Manajemen Risiko di Industri Farmasi
Abstrak
Untuk meningkatkan pengembangan produk, efisiensi proses produksi dan strategi pengendalian, Food and Drug Administration (FDA) mendorong penerapan Quality by Design (QBD) sebagai pendekatan ilmiah yang berbasis pada penerapan mutu risiko dalam pengembangan produk obat. Manajemen risiko bertujuan untuk menganalisis sebuah sistem terhadap potensi penyimpangan yang terjadi untuk mencegah masalah yang lebih serius. Artikel ini bertujuan untuk memberikan pengetahuan mengenai metode root cause analysis yang dapat digunakan dalam manajemen risiko mutu terhadap masalah yang terjadi di industri farmasi. Dalam mereview artikel ini jurnal yang didapat dari berbagai sumber secara daring melalui berbagai jurnal nasional dan internasional yang diakses dari situs Google scholar, Elsevier dan PubMed. Hasil dari review artikel metode analisis akar penyebab, seperti Pareto Analysis, Fishbone Diagram, 5Whys, Failure Mode and Effect Analysis, Brainstorming dan Six Sigma, dapat digunakan untuk menemukan akar penyebab suatu masalah dengan perbedaan masing-masing metode dari segi tahapan, analisis dan penilaian risiko. Dari review yang dibuat, dapat disimpulkan bahwa keenam metode root cause analysis yang diketahui memiliki perbedaan serta kelebihan dan kekurangan masing-masing metode, sehingga dalam penggunaannya dapat disesuaikan dengan kebutuhan suatu masalah yang terjadi di industri farmasi melalui kriteria kelebihan dan kekurangan metode tersebut.
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