Kajian Risiko pada Proses Penyimpanan dan Pendistribusian Bahan Baku di Gudang Industri Farmasi dengan Pendekatan Metode Failure Mode and Effect Analysis

Hanif Azhar Musyaffa; Mas Rahman Roestan; Evi Sylvia Nurrasjid; Iwa Kustiyawan

doi:10.55606/jig.v2i3.3149

Authors

Hanif Azhar Musyaffa Universitas Padjadjaran
Mas Rahman Roestan Universitas Padjadjaran
Evi Sylvia Nurrasjid Universitas Padjadjaran
Iwa Kustiyawan PT Bio Farma (Persero)

DOI:

https://doi.org/10.55606/jig.v2i3.3149

Keywords:

Risk Assessment, Pharmaceutical Industry, Inventory Warehouse

Abstract

Quality risk management is one of the important things in quality control in a pharmaceutical industry. One of the risky activities in the pharmaceutical industry is in storage and distribution. Every activity carried out in the inventory warehouse can potentially cause risks that affect quality including the flow of the storage and distribution process of goods. Based on this, a study was conducted in the form of a risk assessment on the flow of the storage and distribution process of release goods in the inventory warehouse of a pharmaceutical industry in Bandung which aims to determine the level of risk that has the potential for failure. The FMEA (Failure Modes and Effects Analysis) method is a method that can be used to assess the risks that can occur in the flow of the storage and delivery process of goods in the warehouse. This risk assessment is carried out with the stages of risk identification, risk analysis, and risk evaluation using categorization based on the Risk Priority Number (RPN). In this study, 15 risks were obtained with details of 1 low category risk, 7 medium category risks, 6 high category risks, and 1 very high category risk. Therefore, the pharmaceutical industry can immediately determine mitigation steps and take control measures against risks in the high and very high categories to reduce the risk of failure with the hope that the quality, safety and efficacy of the product can be maintained properly

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References

Akmal, M., & Kurnia, G. (2023). Analisis risiko operasional gudang menggunakan failure mode and effect analysis (Studi kasus: Gudang konsolidasi ekspor PT XYZ). Jurnal Rekayasa Sistem Industri, 8(2), 28–38.

Buffa, E. S. (2003). Modern Production: Operation Management (7th ed.). New York: John Wiley and Sons.

Cardoso, P., Flávia, M., & Kelen, S. (2018). Risk analysis evaluation of piroxicam 20mg capsules manufacture process by FMEA technique. International Journal of Drug Regulatory Affairs, 6(1), 19–25.

Damayanti, C., & Hasanah, A. N. (2023). Penilaian risiko kontaminasi silang pada area produksi pada salah satu industri farmasi di DKI Jakarta. Majalah Farmasetika, 8(5), 424.

Delivery, D., & Mv, L. (2022). Quality risk management (QRM): A review. International Journal of Biology, Pharmacy, and Allied Sciences, 11(10), 149–154.

Ismael, O. A., & Ahmed, M. I. (2020). Using quality risk management in pharmaceutical industries: A case study. Quality - Access to Success, 21(178), 106–113.

Lotllikar, M. (2013). Quality risk management (QRM): A review. Journal of Drug Delivery and Therapeutics, 3.

Mandhare, T., Khuspe, P., Nangare, P., & Vyavhare, R. (2018). Quality risk management: A review. American Journal of PharmTech Research, 8, 56–86.

Mascia, A., Cirafici, A. M., Bongiovanni, A., Colotti, G., Lacerra, G., Di Carlo, M., et al. (2020). A failure mode and effect analysis (FMEA)-based approach for risk assessment of scientific processes in non-regulated research laboratories. Accreditation and Quality Assurance, 25(5–6), 311–321. https://doi.org/10.1007/s00769-020-01441-9

Pangestuti, D. C., Nastiti, H., & Husniaty, R. (2021). Failure mode and effect analysis (FMEA) for mitigation of operational risk. Inovasi, 17(3), 593–602.

Purnawati, Y. N., Dahlan, & Nurpajriani. (2019). Kajian risiko pengoperasian gudang materiil. Jurnal Manajemen Bisnis Transportasi dan Logistik, 5(3), 409–418.

Ramli, S. (2011). Pedoman praktis manajemen risiko dalam perspektif K3, OHS risk management. Jakarta: Dian Rakyat.

Vijayakumar Reddy, V., Vishal Gupta, N., Raghunandan, H. V., & Nitin Kashyap, U. (2014). Quality risk management in pharmaceutical industry: A review. International Journal of PharmTech Research, 6(3), 908–914.

Wahyuni, A. E., & Rais, A. (2019). Analisis metode FMEA pada proses operasional shipping dalam pendistribusian part Toyota pada perusahaan PT XYZ. Bina Teknika, 15(1), 61.

World Health Organization (WHO). (2013). Annex 2 - WHO guidelines on quality risk management. WHO Expert Committee on Specifications for Pharmaceutical Preparations, 47(9), 61–92.

World Health Organization (WHO). (2013). Annex 2 - WHO guidelines on quality risk management. WHO Expert Committee on Specifications for Pharmaceutical Preparations.

World Health Organization (WHO). (2013). Deviation handling and quality risk management. Retrieved from http://www.who.int/immunization_standards/vaccine_quality/risk_july_2013.pdf

Wu, J., Tian, J., & Zhao, T. (2014). Failure mode prioritization by improved RPN calculation method. Proceedings - Annual Reliability and Maintainability Symposium.

Wu, X., & Wu, J. (2021). The risk priority number evaluation of FMEA analysis based on random uncertainty and fuzzy uncertainty. Complexity, 2021.

Zandieh, M. (2020). Risk assessment of clean room used in pharmaceutical industries in design, manufacturing, equipping and operating phases by FMEA based on some chemical engineering concepts. Archives of Pharmacy Practice, 11, 39–45.