Analisis Risiko pada Pengujian Alat Kesehatan dengan Metode Fault Tree Analysis dan Failure Mode and Effect Analysis

Abrari, Annisa (2024) Analisis Risiko pada Pengujian Alat Kesehatan dengan Metode Fault Tree Analysis dan Failure Mode and Effect Analysis. Other thesis, Institut Teknologi Sepuluh Nopember.

Text 5010201183_Undergraduate_Thesis.pdf - Accepted Version Restricted to Repository staff only until 1 October 2026. Download (7MB) | Request a copy

Abstract

Balai Pengamanan Alat dan Fasilitas Kesehatan (BPAFK) Surabaya merupakan salah satu institusi pengujian dan kalibrasi alat, sarana, dan prasarana kesehatan. BPAFK Surabaya memiliki 3 Laboratorium pengujian yaitu Laboratorium Pengujian Dosis Perorangan, Laboratorium Proteksi Radiasi & Uji Kesesuaian, dan Laboratorium Uji Produk. Hampir setiap aktivitas dalam proses pengujian alat kesehatan dapat menimbulkan risiko operasional yang dapat merugikan. Hal ini disebabkan karena adanya kesalahan yang terjadi selama proses pengujian sehingga diperlukan peran manajemen risiko. Oleh karena itu, penelitian ini bertujuan untuk mengidentifikasi, menganalisis, mengevaluasi, dan memberikan rekomendasi langkah penanganan risiko pada proses pengujian alat kesehatan. Metode yang digunakan dalam penelitian ini adalah Failure Mode and Effect Analysis (FMEA) dan Fault Tree Analysis (FTA). Identifikasi dan analisis risiko dilakukan pada 3 pengujian alat kesehatan dengan metode Failure Mode and Effect Analysis (FMEA). Risiko yang diidentifikasi merupakan risiko yang dianggap menyebabkan kerusakan pada alat, berdampak pada operator serta hambatan dalan proses pengujian. Setelah itu dilakukan penilaian 3 dimensi risiko yaitu severity, occurrence, dan detection. Penilaian occurrence dilakukan dengan metode Fault Tree Analysis (FTA), severity dan detection dinilai berdasarkan expert judgement. Kemudian dilakukan evaluasi risiko yang terdiri dari perhitungan Risk Priority Number (RPN), ketagorisasi 4 level risiko (extreme risk, high risk, medium risk, dan low risk), dan penentuan risiko prioritas. Tahap terakhir adalah menentukan rekomendasi langkah penanganan risiko prioritas. Berdasarkan hasil identifikasi risiko menggunakan metode Fault Tree Analysis, diperoleh 57 risiko dari 38 aktivitas besar pada proses pengujian alat kesehatan. Kemudian, dilakukan penilaian dan evaluasi risiko menggunakan metode Failure Mode and Effect Analysis. Berdasarkan hasil perhitungan RPN, diketahui bahwa terdapat 9% risiko merupakan extreme risk, 23% risiko merupakan high risk, 33% risiko merupakan medium risk, dan 35% risiko merupakan low risk. Setelah dilakukan penentuan level risiko, dilakukan penentuan prioritas risiko dengan menggunakan konsep pareto dan diperoleh bahwa terdapat 29 risiko yang termasuk ke dalam risiko prioritas dan 28 risiko yang termasuk ke dalam risiko non-prioritas. Risiko yang termasuk ke dalam risiko prioritas dan memiliki nilai severity minimal sebesar 9 akan dibuat rekomendasi upaya penanganan risiko.
======================================================================================================================================
Balai Pengamanan Alat dan Fasilitas Kesehatan (BPAFK) is one of the institutions for testing and calibrating health equipment, facilities and infrastructure. BPAFK Surabaya has 3 testing laboratories, namely the Individual Dose Testing Laboratory, the Radiation Protection & Conformity Test Laboratory, and the Product Testing Laboratory. Almost every activity in the medical device testing process can pose operational risks that can be detrimental. This is due to errors that occur during the testing process so that a risk management role is needed. Therefore, this research aims to identify, analyze, evaluate and provide recommendations for risk management steps in the medical device testing process. The methods used in this research are Failure Mode and Effect Analysis (FMEA) and Fault Tree Analysis (FTA). Risk identification and analysis was carried out on 3 medical device tests using the Failure Mode and Effect Analysis (FMEA) method. The risks identified are risks that are considered to cause damage to the equipment, impact on operators and obstacles in the testing process. After that, a 3-dimensional risk assessment is carried out, namely severity, occurrence and detection. Occurrence assessment is carried out using the Fault Tree Analysis (FTA) method, severity and detection are assessed based on expert judgment. Then a risk evaluation is carried out consisting of calculating the Risk Priority Number (RPN), categorizing 4 levels of risk (extreme risk, high risk, medium risk, and low risk), and determining priority risks. The final stage is to determine recommendations for priority risk management steps. Based on the results of risk identification using Fault tree Analysis Method, 57 risks were obtained from 38 major activities in the medical device testing process. Then, a risk assessment and evaluation is carried out using the Failure Mode and Effect Analysis method. Based on the results of the RPN calculation, it is known that 9% of the risks are extreme risks, 23% of the risks are high risks, 33% of the risks are medium risks, and 35% of the risks are prioritization was carried out using the Pareto concept and it was found that there were 29 risks included in the priority risks and 28 risks included in the non-priority risks. Risks that are included in priority risks and have a minimum severity value of 9 will be made recommendations for risk management efforts

Item Type:	Thesis (Other)
Uncontrolled Keywords:	Failure Mode and Effect Analysis, Fault Tree Analysis; Manajemen Risiko, Proses Pengujian Alat Kesehatan, Risiko ========================================================== Failure Mode and Effect Analysis, Fault Tree Analysis, Medical Devices Testing, Risk, Risk Management
Subjects:	T Technology > T Technology (General) T Technology > T Technology (General) > T174.5 Technology--Risk assessment.
Divisions:	Faculty of Industrial Technology and Systems Engineering (INDSYS) > Industrial Engineering > 26201-(S1) Undergraduate Thesis
Depositing User:	Annisa Abrari
Date Deposited:	28 Jul 2024 13:45
Last Modified:	28 Jul 2024 13:45
URI:	http://repository.its.ac.id/id/eprint/109137

Actions (login required)

View Item