Kerangka Quality Risk Management Pada Lini Pengemasan Granule Farmasi Menggunakan FMECA Acceptance Gate (Go/No-Go) Dalam Konteks GMP/CPOB

Yuliarni, Dian (2026) Kerangka Quality Risk Management Pada Lini Pengemasan Granule Farmasi Menggunakan FMECA Acceptance Gate (Go/No-Go) Dalam Konteks GMP/CPOB. Masters thesis, Institut Teknologi Sepuluh Nopember.

Text 6032231188-Master_Thesis.pdf Download (13MB)

Abstract

Industri farmasi dituntut menjamin mutu produk dan kepatuhan terhadap Good Manufacturing Practice (GMP/CPOB), khususnya pada lini pengemasan sebagai tahap akhir sebelum produk dilepas ke pasar. Kompleksitas interaksi manusia, mesin, material, informasi, dan verifikasi berlapis pada lini pengemasan granule meningkatkan risiko mix-up, kesalahan identitas dan pelabelan, ketidaksesuaian material, kegagalan integritas kemasan, serta kelemahan dokumentasi dan rekonsiliasi. Meskipun Quality Risk Management (QRM) telah diterapkan, hasil analisis risiko pada praktiknya masih cenderung berhenti pada pemeringkatan risiko dan belum secara sistematis diterjemahkan menjadi aturan keputusan operasional yang eksplisit, konsisten, dan dapat diaudit. Penelitian ini bertujuan mengembangkan kerangka QRM yang mengintegrasikan Failure Mode, Effects, and Criticality Analysis (FMECA) dengan mekanisme Acceptance Gate sebagai dasar pengambilan keputusan berbasis risiko pada lini pengemasan granul farmasi. Penelitian ini menggunakan pendekatan studi kasus deskriptif-analitis melalui pemetaan proses, identifikasi critical decision point dan failure mode, penilaian severity, occurrence, dan detection, perhitungan Risk Priority Number (RPN), analisis criticality, perancangan Acceptance Gate dan mitigasi risiko, serta evaluasi desain dan validasi oleh lima ahli. Hasil penelitian menunjukkan bahwa risiko dominan berkaitan dengan identitas produk, status material, bobot isi, integritas kemasan, foreign matter, efektivitas deteksi, segregasi produk tidak sesuai, dan rekonsiliasi akhir. Kerangka yang dikembangkan menghasilkan delapan Acceptance Gate dengan kriteria keputusan Go, Go with Mitigation, dan No-Go, yang dilengkapi persyaratan evidence, otoritas keputusan, dan mekanisme eskalasi. Evaluasi desain menunjukkan penurunan estimasi RPN residual, pergeseran zona criticality, peningkatan kejelasan keputusan, serta penguatan traceability dan auditability. Validasi ahli menghasilkan skor rata-rata 3,50 dari 4,00 atau indeks 0,875 dan menempatkan kerangka dalam kategori sangat layak. Kerangka QRM–FMECA–Acceptance Gate yang dikembangkan menyediakan mekanisme sistematis untuk menerjemahkan analisis risiko menjadi keputusan operasional yang lebih konsisten, terdokumentasi, dan selaras dengan GMP/CPOB. ===================================================================================================================================
The pharmaceutical industry is required to ensure product quality and compliance with Good Manufacturing Practice (GMP/CPOB), particularly in the packaging line as the final stage before the product is released to the market. The complexity of interactions between humans, machines, materials, information, and layered verification on the granule packaging line increases the risk of mix-ups, identity and labelling errors, material discrepancies, packaging integrity failures, as well as weaknesses in documentation and reconciliation. Although Quality Risk Management (QRM) has been implemented, the results of risk analysis in practice still tend to stop at risk ranking and have not yet been systematically translated into explicit, consistent, and auditable operational decision rules. This research aims to develop a QRM framework that integrates Failure Mode, Effects, and Criticality Analysis (FMECA) with an Acceptance Gate mechanism as the basis for risk-based decision-making in the pharmaceutical granule packaging line. This research uses a descriptive-analytical case study approach thru process mapping, identification of critical decision points and failure modes, assessment of severity, occurrence, and detection, calculation of Risk Priority Number (RPN), criticality analysis, design of Acceptance Gate and risk mitigation, as well as design evaluation and validation by five experts. The research results show that the dominant risks are related to product identity, material status, net weight, packaging integrity, foreign matter, detection effectiveness, segregation of non-conforming products, and final reconciliation. The developed framework produces eight Acceptance Gates with decision criteria of Go, Go with Mitigation, and No-Go, supplemented by evidence requirements, decision authority, and escalation mechanisms. Design evaluation shows a decrease in estimated residual RPN, a shift in criticality zones, improved decision clarity, and strengthened traceability and auditability. Expert validation resulted in an average score of 3.50 out of 4.00 or an index of 0.875, placing the framework in the highly feasible category. The developed QRM–FMECA–Acceptance Gate framework provides a systematic mechanism for translating risk analysis into more consistent, documented, and GMP/CPOB-aligned operational decisions.

Item Type:	Thesis (Masters)
Uncontrolled Keywords:	Acceptance gate Go/No-Go, FMECA, GMP/CPOB, Pengemasan Granule Farmasi, Quality Risk Management.
Subjects:	T Technology > T Technology (General) > T174.5 Technology--Risk assessment.
Divisions:	Interdisciplinary School of Management and Technology (SIMT) > 61101-Master of Technology Management (MMT)
Depositing User:	Dian Yuliarni
Date Deposited:	24 Jul 2026 03:16
Last Modified:	24 Jul 2026 03:16
URI:	http://repository.its.ac.id/id/eprint/136676

Actions (login required)

View Item