2021
DOI: 10.24198/mfarmasetika.v6i4.35053
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Kajian Metode Root Cause Analysis yang Digunakan dalam Manajemen Risiko di Industri Farmasi

Abstract: 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 … Show more

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Cited by 10 publications
(8 citation statements)
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“…Identify RCA methods often used include Fishbone Diagram, Pareto Analysis, 5Whys, Brainstorming, Failure Mode Effect Analysis (FMEA), and Six Sigma (Susendi et al, 2021). The first method is Fishbone Diagram.…”
Section: Resultsmentioning
confidence: 99%
“…Identify RCA methods often used include Fishbone Diagram, Pareto Analysis, 5Whys, Brainstorming, Failure Mode Effect Analysis (FMEA), and Six Sigma (Susendi et al, 2021). The first method is Fishbone Diagram.…”
Section: Resultsmentioning
confidence: 99%
“…The data taken is breakdown data at the NPK 3 unit within March-June 2019. Afterwards, the data analyzed using the Root Causes Analysis method with Fishbone Diagram and 5-Why Analysis, in order to identify the root cause [22].…”
Section: Methodsmentioning
confidence: 99%
“…It is calculated by dividing the operator's productive working time by the available working time. Productive working time is the time during which the operator works without rest, while the available working time is set by the company (Susendi et al, 2021). Generally, the recommended working time is 40 hours per week, and lost work time can occur due to employee absenteeism or damage to production machinery (Yani & Lina, 2015).…”
Section: Overall Labor Effectiveness (Ole)mentioning
confidence: 99%