Kerangka Quality Risk Management pada Lini Pengemasan Granule Farmasi menggunakan FMECA Acceptance gate (Go/No-Go) dalam Konteks GMP/CPOB
DOI:
https://doi.org/10.58344/jii.v5i8.7991Keywords:
Acceptance gate Go/No-Go, FMECA, GMP/CPOB, Pengemasan Granule Farmasi, Quality Risk ManagementAbstract
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 granul meningkatkan risiko mix-up, kesalahan identitas-pelabelan, ketidaksesuaian material, kegagalan integritas kemasan, serta kelemahan dokumentasi-rekonsiliasi. Meskipun Quality Risk Management (QRM) telah diterapkan, analisis risiko pada praktiknya masih cenderung berhenti pada pemeringkatan risiko dan belum diterjemahkan secara sistematis 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 menggunakan pendekatan studi kasus deskriptif-analitis melalui pemetaan proses, identifikasi critical decision point dan failure mode, penilaian severity-occurrence-detection, perhitungan Risk Priority Number (RPN), analisis criticality, perancangan Acceptance Gate dan mitigasi risiko, serta evaluasi desain-validasi oleh lima ahli. Hasil penelitian menunjukkan risiko dominan berkaitan dengan identitas produk, status material, bobot isi, integritas kemasan, foreign matter, efektivitas deteksi, segregasi produk tidak sesuai, dan rekonsiliasi akhir. Kerangka ini menghasilkan delapan Acceptance Gate berkriteria Go, Go with Mitigation, dan No-Go, dilengkapi persyaratan evidence, otoritas keputusan, dan mekanisme eskalasi. Evaluasi desain menunjukkan penurunan estimasi RPN residual, pergeseran zona criticality, peningkatan kejelasan keputusan, serta penguatan traceability-auditability. Validasi ahli menghasilkan skor rata-rata 3,50 dari 4,00 (indeks 0,875), menempatkan kerangka pada kategori sangat layak. Kerangka QRM–FMECA–Acceptance Gate ini menyediakan mekanisme sistematis untuk menerjemahkan analisis risiko menjadi keputusan operasional yang lebih konsisten, terdokumentasi, dan selaras GMP/CPOB.
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