Quality Control Analysis Using the Failure Mode and Effect Analysis Method Analisis Pengendalian Kualitas Menggunakan Metode Failure Mode and Effect Analysis
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Published:
Feb 21, 2024
Keywords:
Epodion, rh-Erythropoietin Alfa, syringes, FMEA, quality control
Main Article Content
Abstract
This study aims to identify critical factors contributing to defects in Epodion rh-Erythropoietin Alfa syringes and propose strategies to minimize production flaws. Through Failure Modes and Effect Analysis (FMEA), the research identified cracking as the predominant defect, accounting for 43 out of 62 observed syringe flaws in a production batch of 162,332 units. The Risk Priority Number (RPN) calculation yielded a score of 162, indicating material-related issues as the primary concern. Consequently, the study recommends stringent quality testing of raw materials to enhance material strength and diminish product defects, thereby bolstering overall manufacturing quality.
Highlights :
- The study aimed to investigate factors contributing to defective Epodion® rh-Erythropoietin Alfa syringes, with a focus on reducing cracks during manufacturing.
- A Failure Mode and Effect Analysis (FMEA) approach was used to identify the primary causes of failure, revealing cracking as the predominant issue affecting 43% of defective units.
- Enhanced quality control measures for raw materials prior to their utilization within the production process were recommended to minimize product defects.
Keywords: Epodion, rh-Erythropoietin Alfa, syringes, FMEA, quality control.
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How to Cite
[1]
M. L. Hakim and A. S. Cahyana, “Quality Control Analysis Using the Failure Mode and Effect Analysis Method”, PELS, vol. 7, pp. 37-42, Feb. 2024.
Section
Industrial Engineering
This work is licensed under a Creative Commons Attribution 4.0 International License.
References
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[5] Krisnaningsih, Erni, Pugy Gautama, and Muhammad Fatih Kholqy Syams. "Usulan Perbaikan Kualitas Dengan Menggunakan Metode FTA dan FMEA." Jurnal Intent: Jurnal Industri Dan Teknologi Terpadu 4.1 (2021): 41-54.
[6] Gaspersz, V. Integrated Performance management system the Balanced Scorecard with the Six Sigma for business and Government Organizations. Jakarta: Gramedia Pustaka Utama. 2005.
[7] Wirawati, Sri Mukti. "Analisis pengendalian kualitas kemasan botol plastik dengan metode Statistical Process Control (SPC) di PT. Sinar Sosro KPB Pandeglang." Jurnal Intent: Jurnal Industri dan Teknologi Terpadu 2.1 (2019): 94-102
[8] Assauri, Sofyan. "Manajemen Pemasaran. dasar-Dasar, Konsep, Strategi, Penerbit CV." (1998).
[9] E. M. Ratri, E. B. G, and M. Singgih, “Peningkatan Kualitas Produk Roti Manis pada PT Indoroti Prima Cemerlang Jember Berdasarkan Metode Statistical Process Control (SPC) dan Failure Mode and Effect Analysis (FMEA),” e-Journal Ekon. Bisnis dan Akunt., vol. 5, no. 2, p. 200, 2018.
[10] Stamatis, D. H. “Failure Mode and Effect Analysis: FMEA from Theory to Execution”. Penerbit: ASQC Quality Press, Milwaukee. 1995.
[11] Chrysler LLC. Potential Failure Mode And Effects Analysis. Ford Motor Company, General Motors Corporation. 2008.
[12] McDermott., E, Robin. The Basic of FMEA. Edisi 2. USA : CRC Press. 2009.
[13] B. R. Kani, R. J. M. Mandagi, J. P. Rantung, and G. Y. Malingkas, “Keselamatan Dan Kesehatan Kerja Pada Pelaksanaan Proyek Konstruksi (Studi Kasus: Proyek Pt. Trakindo Utama),” J. Sipil Statik, 2013.
[14] L. N. Huda, “Analisis Kualitas Produk Minuman Guna Meningkatkan Performansi Jumlah Produksi Dengan Metode Fmea (Failure Mode And Effects Analysis),” Talent. Conf. Ser. Sci. Technol., 2018.
[15] D. F. Mayangsari, Hari Adianto, and Yoanita Yuniati, “Usulan Pengendalian Kualitas Produk Isolator Dengan Metode Failure Mode and Effect Analysis (Fmea) Dan Fault Tree Analysis (Fta),” Tek. Ind. Nas. Bandung, vol. 3, no. 2, pp. 81–91, 2015.
[16] Herawati, Herlin, and Dewi Mulyani. "Pengaruh kualitas bahan baku dan proses produksi terhadap kualitas produk pada UD. Tahu Rosydi Puspan Maron Probolinggo." UNEJ e-Proceeding (2016): 463-482.
[17] Napitupulu, Monica Elisa, and Shinta Wahyu Hati. "Analisis pengendalian kualitas produk garment pada project in line inspector dengan metode six sigma di bagian sewing produksi pada pt bintan bersatu apparel batam." Journal of Applied Business Administration 2.1 (2018): 29-45.