SARI, WULAN (2008) PENERAPAN SISTEM MANAJEMEN MUTU DI LABORATORIUM PENGUJI BALAI PENGKAJIAN BIOTEKNOLOGI. S2 thesis, Universitas Mercu Buana Jakarta-Menteng.
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Abstract
Persaingan pasar yang semakin meningkat menuntut terjaminnya mutu suatu produk. Organisasi (dalam hal ini laboratorium) harus mampu memberikan jaminan mutu terhadap hasil pengujiannya serta mendapatkan pengakuan secara nasional dan internasional. Jaminan mutu dan akreditasi dapat dicapai bila organisasi menerapkan Good Laboratory Practice (GLP) dan Quality Management System (QMS) dalam setiap kegiatannya. Untuk GLP, dasar acuan yang dapat digunakan adalah ISO/IEC 17025 : 2005 dan ISO 15189 : 2007; sedangkan QMS adalah ISO 9001 : 2000. Karya Akhir ini bertujuan untuk mengetahui faktor yang mempengaruhi penerapan sistem manajemen mutu (SMM) di laboratorium penguji Balai Biotek berdasarkan proses yang ada. Karya Akhir ini tidak membahas setiap klausul yang ada hingga mengantar laboratorium penguji Balai Biotek memperoleh suatu akreditasi. Berdasarkan studi terhadap ketiga standar di atas serta hasil pengumpulan data, informasi dan pengamatan, disimpulkan bahwa terdapat 4 (empat) faktor penting yang mempengaruhi keakuratan data hasil pengujian yaitu SDM (kompetensi, job placement dan job description), peralatan (kalibrasi, perawatan dan lingkungan kerja), metode pengujian (kemuktahiran metode dan validasi) serta dokumentasi/rekaman (SDM, peralatan dan metode pengujian). Pengumpulan data, informasi, pengamatan dan wawancara dilakukan terhadap personil yang terlibat langsung pada proses pengujian serta pihak manajemen. Hal yang diamati adalah proses pengujian yang dilakukan di laboratorium penguji Balai Biotek. Berdasarkan hal tersebut teridentifikasi lima tahapan proses yang paling menentukan keakuratan data hasil pengujian. Tahapan tersebut yaitu penerimaan sampel, verifikasi sampel, persiapan pengujian, pengujian dan hasil. Kemudian dilakukan perbandingan antara 4 faktor utama dengan tahapan proses pengujian yang dilakukan laboratorium penguji Balai Biotek serta persyaratan teknis yang terdapat pada ISO 17025 : 2005. Dari perbandingan itu, disimpulkan bahwa secara keseluruhan laboratorium penguji Balai Biotek hampir memenuhi persyaratan teknis yang ada. Kata kunci : mutu, GLP, QMS/SMM, laboratorium penguji, ISO/IEC 17025:2005 Increasing of market competition requires quality assurance of products. Organization (in this case is laboratory) must be able to give quality assurance for analysis results and to get national and international accreditation. Quality Assurance and Accreditation can be achieved if an organization applies Good Laboratory Practice (GLP) and Quality Management System (QMS) in every activity. For GLP, reference can be used is ISO/IEC 17025:2005 and ISO 15189:2007, while QMS is ISO 9001:2000. This final paper is purposed to know factors influencing of QMS applications in Balai Biotek based on applied process. This final paper doesn't work through each aught clause until take in assay laboratory’s Balai Biotek gets an accreditation. Based on study of above three standards and data collected, information and observation can be concluded there are four important factors affecting of measurement data accuracy. Those are human resources (competence, job placement, and job description), equipment (calibration, maintenance, and work environment), testing method (updated method and validation), and then documentation/copy. Collecting of data, information, observation and interview is done to personnel and management directly involved in process of measurement. The things are measured in process of measurement applied in Balai Biotek. Base on above conditions identified five steps of processing are most important to decide of measurement data accuracy. The steps are sample acceptance, sample verification, examination preparation, examination and result. Then, the 4 (four) main factors will compare with step processes examination that done by assay laboratory’s Balai Biotek and technical requirements that exists on ISO 17025: 2005. For those compares, can be concluded that Balai Biotek can satisfy to available technical requirements. Key word: quality, GLP, QMS / SMM, assay laboratory ISO / IEC 17025:2005
| Item Type: | Thesis (S2) |
|---|---|
| Call Number CD: | CDT-551-08-015 |
| NIM/NIDN Creators: | 55105120068 |
| Uncontrolled Keywords: | quality, GLP, QMS / SMM, assay laboratory ISO / IEC 17025:2005, MPO, Manajemen oprasional |
| 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 |
| Divisions: | Pascasarjana > Magister Manajemen |
| Depositing User: | MELATI CAHYA FITRIANI |
| Date Deposited: | 23 May 2022 03:42 |
| Last Modified: | 15 Jul 2022 03:39 |
| URI: | http://repository.mercubuana.ac.id/id/eprint/61503 |
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