PUTRI, VIRNA CYNTHIA (2020) ANALISIS PERBAIKAN PROSES QUALITY CONTROL GUNA MENGURANGI KETERLAMBATAN RELEASE PRODUK DENGAN METODE SIX SIGMA (Studi Kasus di Industri Farmasi). S1 thesis, Universitas Mercu Buana Jakarta.
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Abstract
PT. HL is a company engaged in pharmaceuticals, one of the departments at PT. HL, namely the Quality Control Department having delay problems in the product release process with an average percentage defect in the number of samples that were late in 2019 is 50% and the sigma value before improvement was 2.47 and DPMO 165792. Therefore an analysis using the Six Sigma method with the DMAIC (Define, Measure, Analyze, Improve, Control) which aim for reducing the number of defects by providing recommendations for improvement. By applying the Six Sigma method, it is known that the most dominant type of defect is damage to the HPLC column, the most potential cause of problems is that there is no standard of maintenance, the characteristics of the contents of the columns vary, and the columns are used for various mobile phases and product. Proposed improvement such as make SOP handling of columns and buy columns as needed and specifications of the column to the supplier and group the columns based on the product or mobile phase. After implementing the proposed improvements and controls, from the calculation of DPMO after the improvement of the process obtained a value of 100000 which is equivalent to the 2.78 sigma level. This value indicates that the company’s sigma increased by 0.31 (2.78 – 2.47) meaning it still needs to be increased again. Keyword : Release product, Six Sigma, DMAIC, Defect. PT. HL merupakan perusahaan yang bergerak dibidang farmasi, pada salah satu departemen di PT. HL yaitu Departemen Quality Control mengalami permasalahan keterlambatan proses release produk dengan rata-rata presentase defect jumlah sampel yang terlambat tahun 2019 yaitu 50% dan nilai sigma sebelum perbaikan adalah 2,47 dan DPMO 165792. Oleh karena itu dilakukan analisis mengunakan metode Six Sigma dengan tahap DMAIC (Define, Measure, Analyze, Improve, Control) yang bertujuan mengurangi jumlah defect dengan memberikan rekomendasi usulan perbaikan. Dengan mengaplikasikan metode Six Sigmadiketahui jenis defect paling dominan yaitu kerusakan kolom HPLC, faktor penyebab permasalahan yang paling potensial yaitu tidak ada standar perawatan, karakteristik isi kolom beragam, dan kolom digunakan untuk berbagai fase gerak dan produk. Usulan perbaikan yang diberikan yaitu membuat SOP penanganan kolom dan membeli kolom sesuai kebutuhan dan spesifikasi kolom pada supplier dan mengelompokkan kolom berdasarkan produk atau fase gerak. Setelah menerapkan usulan perbaikan dan control yang ada, dari perhitungan DPMO setelah perbaikan proses diperoleh nilai 100000 yang setara dengan tingkat sigma 2,78. Nilai tersebut menandakan bahwa sigma perusahaan meningkat sebesar 0.31 (2.78 - 2.47) berarti masih perlu ditingkatkan lagi. Kata Kunci : Release produk, Six Sigma, DMAIC, Defect.
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