MURNI, YOSSY PUTRI ASTA (2018) PENERAPAN METODA DMAIC SEBAGAI UPAYA PENGENDALIAN KUALITAS PADA TABLET XYZ DI PT. ABC. S1 thesis, Universitas Mercu Buana Jakarta.
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Abstract
The production process of tablet drug preparations is a multi-steps process, to determine the process has been carried out properly tested on certain test parameters, in this study conducted on critical test parameters namely tablet weight uniformity, tablet hardness, tablet fragility, tablet disintegration time, dissolution, and uniformity of the content of active tablets. Each production process is influenced by natural variation and assignable variation which causes the production process to be out of control and influences the consistency and achievement of output quality specifications. This study aims to analyze the stage of the tablet manufacturing process and how the DMAIC method in the quality control of tablet drugs in PT. ABC, during the January 2017 period until December 2016 quantitative data were collected from the measurement results of tablet quality characteristics, namely on the test parameters of tablet weight uniformity, tablet hardness, tablet fragility, tablet disintegration time, dissolution, and uniformity of the active substance content of the tablet, to be analyzed using the method DMAIC with control chart tools, Process Capability, and FMEA. The results showed that at the process stage the tablet weight uniformity, tablet hardness, tablet fragility, and statistically disintegrated tablet time included in-control, whereas dissolution and uniformity of the active ingredient content of the tabet including out-of-control were then performed where the results of the process capability were obtained. is Cp = 0.423 and content uniformity obtained results of Cp = 0.605, where if Cp <1.00 means Low Process Capability, it is necessary to take active efforts to improve the quality towards the desired target. After that, the analysis is done using FMEA, based on the results of the analysis with FMEA shows that the main cause of variations in results is the granulation process and mixing process, in the process heater and Rotation Speed which are part of the tools that greatly affect the results. Therefore improvements are made to minimize variations in the results that occur in the heater and rotation speed that is carried out is to make a maintenance schedule, making SOP (standard operating procedure) for maintenance hetaer and rotation speed, the SOP contains procedures for carrying out maintenance on the heater and rotation speed and making work instructions if improvements are made, then control is done by providing recording forms for maintenance purposes. Keywords: Drug Quality, DMAIC, Tablet Test Parameters. Proses produksi sediaan obat tablet merupakan multi-steps process, untuk mengetahui proses telah berjalan dengan baik dilakukan pengujian pada parameter ujitertentu, pada penelitian ini dilakukan terhadap parameter uji kritis yaitu keseragaman bobot tablet,kekerasan tablet, kerapuhan tablet, waktu hancur tablet,dissolusi, dan keseragaman kandungan zat aktif tablet. Setiap proses produksi dipengaruhi oleh variasi alamiah (natural variation) dan variasi buatan (assignable variation) yang menyebabkan proses produksi tidak terkendali (out-of control) serta berpengaruh terhadap konsistensi dan tercapainya spesifikasi kualitas output. Penelitian ini bertujuan untuk menganalisis tahap proses pembuatan tablet dan bagaimana penerapan metoda DMAIC dalam pengendalian kualitas obat tablet di PT. ABC, selama periode januari 2017 sampai desember 2016 dilakukan pengumpulan data kuantitatif hasil pengukuran karakteristik kualitas tablet yaitu pada parameter uji keseragaman bobot tablet,kekerasan tablet, kerapuhan tablet, waktu hancur tablet,dissolusi, dan keseragaman kandungan zat aktif tablet, untuk kemudian dianalisis menggunakan metode DMAIC dengan alat bagan kendali (control chart), Capability Proses, dan FMEA. Hasil penelitian menunjukkan bahwa pada tahap proses keseragaman bobot tablet,kekerasan tablet, kerapuhan tablet, dan waktu hancur tablet secara statistic termasuk in-control, sedangkan disolusi dan keseragaman kandungan zat aktif tabet termasuk out-of control kemudian dilakukan dimana didapat hasil perhitugan capability Process Disousi adalah Cp = 0.423 dan keseragaman kandungan didapat hasil Cp = 0.605, dimana jika Cp < 1.00 Berarti Kapabilitas Proses Rendah maka perlu upaya-upaya giat untuk peningkatan kualitas menuju target yang diinginkan. Setelah itu dilakukan analisa menggunakan FMEA, berdasarkan hasil dari analisis dengan FMEA didapatkan hasil bahwa penyebab utama dari variasi hasil adalah pada proses granulasi dan proses mixing, dalam proses tersebut heater dan Rotation Speed yang merupakan komponen bagian dari alat yang sangat mempengaruhi hasil. Maka dari itu dilakukan Perbaikan untuk meminimalisasi variasi hasil yang terjadi pada heater dan rotation Speed yang dilakukan adalah membuat jadwal maintenance, Pembuatan SOP (standard operasional procedure) untuk maintenance hetaer dan rotation Speed, SOP berisikan tentang prosedur pelaksanaan maintenance pada heater dan rotation Speed dan mebuat instruksi kerja jika dilakukan perbaikan, kemudian dilakukan control dengan menyediakan form-form pencatatan untuk keperluan maintenance. Kata Kunci: Kualitas Obat, DMAIC, Parameter uji Tablet.
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