ANALISIS WAKTU VALIDASI BAHAN BAKU DOBUTAMIN HCL DENGAN METODE FAILURE MODE & EFFECT ANALYSIS (FMEA) DI INDUSTRI FARMASI

DARMAWAN, CHRISTIAN (2023) ANALISIS WAKTU VALIDASI BAHAN BAKU DOBUTAMIN HCL DENGAN METODE FAILURE MODE & EFFECT ANALYSIS (FMEA) DI INDUSTRI FARMASI. S1 thesis, Universitas Mercu Buana Bekasi.

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Abstract

Perusahaan PT NPL, yang bergerak di bidang farmasi, menghadapi masalah keterlambatan dalam proses validasi kadar bahan baku Dobutamin HCl di Departemen Quality Control. Salah satu masalah utama adalah terjadinya defect pada proses pengukuran sampel. Keadaan ini dapat menyebabkan kerugian bagi perusahaan. Tujuan dari penelitian ini adalah untuk mengidentifikasi faktor penyebab defect dan meminimalkan defect dengan melakukan analisis langsung menggunakan diagram pareto, diagram Fishbone, dan metode Failure Modes and Effect Analysis (FMEA) dengan menggunakan nilai Risk Priority Number (RPN). Berdasarkan pengolahan data, dapat disimpulkan bahwa potensial failure mode dalam proses validasi bahan baku adalah masalah yang sering terjadi pada alat instrumen dan ketidaksesuaian jadwal kalibrasi. Hasil penelitian menunjukkan bahwa faktor utama yang menyebabkan kegagalan dalam proses validasi adalah kondisi alat instrumen yang sering bermasalah, dengan nilai RPN tertinggi mencapai 252. Usulan perbaikan untuk mengurangi kegagalan dalam proses validasi kadar adalah mengatur waktu maintenance dan kalibrasi alat instrumen tanpa mengganggu jadwal validasi bahan baku. Kata Kunci: Keterlambatan, FMEA, RPN, Diagram Pareto, Fishbone PT NPL, a pharmaceutical company, faced a delay in the validation process of Dobutamine HCl raw material levels in the Quality Control Department. One of the main problems is the occurrence of defects in the sample measurement process. This situation can cause losses for the company. The purpose of this study is to identify the factors that cause defects and minimise defects by conducting direct analysis using Pareto diagrams, Fishbone diagrams, and the Failure Modes and Effect Analysis (FMEA) method using the Risk Priority Number (RPN) value. Based on data processing, it can be concluded that potential failure modes in the raw material validation process are frequent problems with instrument tools and calibration schedule mismatches. The results showed that the main factor causing failure in the validation process is the condition of the instrument that is often problematic, with the highest RPN value reaching 252. Proposed improvements to reduce failures in the grade validation process are managing the maintenance and calibration time of the instrument without disrupting the raw material validation schedule. Keywords: Delay, FMEA, RPN, Pareto Diagram, Fishbone

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