HAZENDA, TRIYANDI (2020) USULAN PERBAIKAN KUALITAS PRODUK STERIL DENGAN MENGGUNAKAN METODE DMAIC DAN FMEA DI PERUSAHAAN FARMASI. S1 thesis, Universitas Mercu Buana Bekasi.
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Abstract
ABSTRAK PT. NPL merupakan satu dari beberapa industri farmasi di daerah Gunung Putri, Bogor yang aktif memproduksi berbagai bentuk produk farmasi. Salah satu produk yang sering dikembangkan dan diproduksi di PT NPL adalah sediaan infus. Proses awal produksi pembuatan infus yaitu proses penimbangan bahan baku kemudian proses mixing dan filtrasi dan berlanjut berlanjut pada proses pengemasan primer dan sekunder. Salah satu permasalahan yang dijumpai di departemen Manufacture PT NPL terkait produksi sediaan Iohexol Infus yang sering terjadi adalah reject kemasan pada tahap proses filling. Produk Iohexol Infus yang memiliki jumlah cacat yang paling tinggi, yaitu sebanyak 980 pcs dari total cacat selama 3 periode yaitu bulan Desember 2019 – Februari 2020, perusahaan menetapkan minimal cacat yaitu sebanyak 222 dalam 3 periode. Maka dari itu perlu dilakukan perbaikan untuk mengurangi jumlah cacat yang dihasilkan. Perusahaan telah melakukan perhitungan sigma level dan diketahui nilai sigma untuk PT. NPL sebesar 3,53σ. Dari hasil analisa menggunakan pareto chart diketahui defect utamanya yang menjadi defect kritis yaitu Penutup luar (bagian atas) longgar/terbuka. Analisis untuk mengetahui akar permasalahan menggunakan metode Root Cause Analysis. Kemudian untuk menilai manakah penyebab dari cacat yang paling kritis maka digunakan metode Failure Mode And Effect Analysis (FMEA). Kemudian setiap penyebab permasalahan dicari usulan alternative solusi nya. Rekomendasi/usulan perbaikan kualitas produk Iohexol Infus dengan metode DMAIC dan FMEA terhadap perusahaan yaitu periksa kondisi kecepatan mesin dan setting sesuai standar supaya tidak menyebabkan reject pada kemasan dan apabila sudah dilakukan setting dan masih tejadi kerusakan maka lakukan perbaikan. Kata Kunci: Defect, Sigma Level, Pareto Chart, Root Cause Analysis, Failure Mode And Effect Analysis (FMEA) ABSTRACT PT. NPL is one of several pharmaceutical industries in Gunung Putri, Bogor that is active in producing various forms of pharmaceutical products. One product that is often developed and produced at PT NPL is an infusion preparation. The initial process of making infusion production is the process of weighing raw materials, then the process of mixing and filtration and continues on the primary and secondary packaging processes. One of the problems encountered in the PT NPL Manufacture department related to the production of Iohexol Infusion preparations which often occurs is reject packaging at the filling process stage. Iohexol Infusion products that have the highest number of defects, which are 980 pcs of total defects during the 3 periods namely December 2019 - February 2020, the company sets a minimum of defects that is 222 in 3 periods. Therefore it is necessary to make improvements to reduce the number of defects produced. The company has calculated the sigma level and known the sigma value for PT. NPL of 3.53σ. From the analysis using the Pareto chart, it is known that the main defect is the critical defect, ie the outer cover (top) is loose / open. Analysis to determine the root of the problem using the method of Root Cause Analysis. Then to assess which causes of the most critical defects, the Failure Mode And Effect Analysis (FMEA) method is used. Then every cause of the problem is sought for alternative solutions. Recommendations / suggestions for improving the quality of Iohexol Infusion products with the DMAIC and FMEA methods to the company, namely checking the condition of the engine speed and settings according to standards so as not to cause rejection on the packaging and if the settings have been done and there is still damage then do the repair. Keyword: Defect, Sigma Level, Pareto Chart, Root Cause Analysis, Failure Mode And Effect Analysis (FMEA)
| Item Type: | Thesis (S1) |
|---|---|
| Call Number CD: | FT/IND 20 025 |
| NIM/NIDN Creators: | 41616310015 |
| Uncontrolled Keywords: | Kata Kunci: Defect, Sigma Level, Pareto Chart, Root Cause Analysis, Failure Mode And Effect Analysis (FMEA) |
| Subjects: | 600 Technology/Teknologi > 650 Management, Public Relations, Business and Auxiliary Service/Manajemen, Hubungan Masyarakat, Bisnis dan Ilmu yang Berkaitan > 658 General Management/Manajemen Umum > 658.8 Marketing, Management of Distribution/Marketing, Manajemen Distribusi |
| Divisions: | Fakultas Teknik > Teknik Industri |
| Depositing User: | siti maisyaroh |
| Date Deposited: | 20 Apr 2022 06:01 |
| Last Modified: | 20 Apr 2022 06:01 |
| URI: | http://repository.mercubuana.ac.id/id/eprint/60237 |
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