ANALISA MODE KEGAGALAN PADA TAHAPAN PENGEMBANGAN PRODUK ALAT KESEHATAN NON ELEKTROMEDIK STERIL DENGAN PENDEKATAN FMEA (STUDI KASUS DI PT.XYZ)

ISYANTO, VICKY (2020) ANALISA MODE KEGAGALAN PADA TAHAPAN PENGEMBANGAN PRODUK ALAT KESEHATAN NON ELEKTROMEDIK STERIL DENGAN PENDEKATAN FMEA (STUDI KASUS DI PT.XYZ). S1-Sarjana thesis, Universitas Mercu Buana Jatisampurna.

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01. HALAMAN JUDUL.pdf

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02. ABSTRAK.pdf

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03. SURAT PERNYATAAN.pdf

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04. LEMBAR PENGESAHAN.pdf

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05. KATA PENGANTAR.pdf

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06. DAFTAR ISI.pdf

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07. DAFTAR TABEL.pdf

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08. DAFTAR GAMBAR.pdf

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09. DAFTAR GRAFIK.pdf

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10. DAFTAR LAMPIRAN.pdf

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Abstract

ABSTRAK PT.XYZ merupakan perusahaan yang bergerak dibidang industri alat kesehatan. Diharapkan produk alat kesehatan yang diproduksi mampu memenuhi standar yang telah ditetapkan. Untuk dapat memenuhi standar tersebut maka perusahaan dalam melakukan pengembangan produk harus mengambil langkah yang tepat agar produk yang dikembangkan dapat sesuai dengan standar. Tools yang digunakan dalam penelitian ini adalah Failure Mode and Effect Analysis (FMEA) untuk mengidentifikasi dan menganalisa kegagalan pada pelaksanaan pengembangan produk pdan KAIZEN dengan prinsip PDCA. Tujuan penelitian ini adalah mengetahui jenis-jenis kegagalan dan penyebab kegagalan serta memberikan usulan perbaikan dan juga usulan pencegahan untuk mengurangi dan menghilangkan potensi kegagalan pada pelaksanaan pengembangan produk. Hasil akhir berupa nilai Risk Priority Number (RPN) diperoleh dengan menentukan dan mengalikan tingkat keparahan, kejadian, dan deteksi kegagalan. Berdasarkan hasil penelitian, Nilai RPN terbesar yang berpotensi memiliki resiko potensi kegagalan terbesar adalah Produk tidak sesuai dengan permintaan customer yaitu sebesar 200. Kata kunci : Alat kesehatan, Pengembangan produk, Failure Mode and Effect Analysis (FMEA), PDCA, Risk Priority Number (RPN). ABSTRACT PT.XYZ is a company which engage in the medical device industry. It is expected that medical device produced by PT.XYZ will be able to fulfill the standard which has been applied. To be able in fulfilling that standard, the company has to take the appropriate steps in implementing the product development in order to accordance with that standard. The tools used in this research is Failure Mode and Effect Analysis (FMEA) to identify and analyze the failure in implementing product development and KAIZEN with PDCA principle. The purpose of This research is to find out failure types and its causes. This research also gives suggestion of improvement and suggestion to reduce and eliminate the failure potential in the implementing product development. The final result is in the form of Risk Priority Number (RPN) which has been obtained by determining and multiplying the level of severity, incident, and failure detection. Based on the final result, the biggest RPN value which potentially has the biggest potential risk is the product that is not accordance with the customer demand in the amount of 200. Key words : Medical Device, Product Development, Failure Mode and Effect Analysis (FMEA),PDCA, Risk Priority Number (RPN)

Item Type: Thesis (S1-Sarjana)
Call Number CD: FT/IND 19 017
NIM: 41615320006
Uncontrolled Keywords: Alat kesehatan, Pengembangan produk, Failure Mode and Effect Analysis (FMEA), PDCA, Risk Priority Number (RPN).
Subjects: 600 Technology/Teknologi > 670 Manufacturing/Manufaktur, Pabrik-pabrik
600 Technology/Teknologi > 680 Manufacture For Specific Uses/Industri Pembuatan produk untuk penggunaan tertentu
Divisions: Fakultas Teknik > Teknik Industri
Depositing User: Nasruddin Mansyur S.Hum
Date Deposited: 05 Oct 2020 05:09
Last Modified: 05 Oct 2020 05:09
URI: http://repository.mercubuana.ac.id/id/eprint/57476

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