MAYANTI, MALINDA (2025) ANALISIS PENINGKATAN EFISIENSI DAN KUALITAS PADA PROSES PENGUJIAN BAHAN BAKU GLYCERINE MELALUI PENERAPAN DIGITAL LEAN SIX SIGMA BERDASARKAN CGMP. S2 thesis, Universitas Mercu Buana Jakarta.
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Abstract
The pharmaceutical industry must comply with Current Good Manufacturing Practice (cGMP) to ensure product safety and quality. BPOM emphasizes the obligation to test for Ethylene Glycol (EG) and Diethylene Glycol (DEG) contamination in raw materials such as glycerine, which has the highest testing percentage in the industry. The average lead time for glycerin testing in 2023 reached 415.3 hours, exceeding the target of 336 hours, indicating inefficiency. This study aims to identify waste and defect-causing factors, evaluate process efficiency, and design Lean Six Sigma-based improvements in accordance with cGMP. Methods include Process Activity Mapping (PAM), Value Stream Mapping (VSM), Process Cycle Efficiency (PCE), Four Block Diagram, Fishbone Diagram, FMEA, and Design of Experiment. Results showed the largest defects in the EG & DEG Identification Test process (44%) and the Concentration Test process (36%), with an initial PCE of 80.2% and a sigma value of 3.72 (Quadrant A). Improvements reduced lead time to 305.6 hours, increased PCE to 91.2%, and improved the sigma value to 4.63 (Quadrant D). The application of Digital Lean Six Sigma was proven effective in enhancing efficiency, quality, and cGMP compliance in glycerine raw material testing. Keywords: Digital Lean Six Sigma, Four Block Diagram, DOE, Laboratory, Glycerine Industri farmasi wajib mematuhi Current Good Manufacturing Practice (cGMP) untuk menjamin keamanan dan kualitas produk. BPOM menegaskan kewajiban pengujian cemaran Ethylene Glycon (EG) dan Diethylene Glycol (DEG) pada bahan baku seperti glycerine, yang memiliki persentase pengujian tertinggi di industri. Rata – rata lead time pengujian glycerine tahun 2023 mencapai 415.3 jam, melebihi target 336 jam, menunjukkan adanya ketidakefisienan. Penelitian ini bertujuan mengidentifikasi pemborosan dan faktor penyebab defect, mengevaluasi efisiensi proses, serta merancang perbaikan berbasis Lean Six Sigma sesuai cGMP. Metode mencakup Process Activity Mapping (PAM), Value Stream Mapping (VSM), Process Cycle Efficiency (PCE), Four Block Diagram, Fishbone Diagram, FMEA, dan Design of Experiment. Hasil menunjukkan defect terbesar dari proses uji Identifikasi EG & DEG (44%) dan proses uji Kadar (36%), dengan PCE awal 80.2% dan nilai sigma 3.72 (kuadran A). Perbaikan menurunkan lead time menjadi 305.6 jam, meningkatkan PCE menjadi 91.2%, dan nilai sigma menjadi 4.63 (kuadran D). Penerapan Digital Lean Six Sigma terbukti efektif meningkatkan efisiensi, kualitas, dan kepatuhan cGMP pada pengujian bahan baku glycerine. Kata kunci: Digital Lean Six Sigma, Four Block Diagram, DOE, Laboratorium, Glycerine
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