scholarly journals ANALISIS PENINGKATAN KUALITAS PROSES PEMBANGUNAN GEDUNG 7 DENGAN PENDEKATAN QUALITY RISK MANAGEMENT (QRM) DAN FAILURE MODE EFFECTS AND CRITICALITY ANALYSIS (FMECA)

2020 ◽  
Vol 15 (2) ◽  
pp. 49-60
Author(s):  
Inggit Marodiyah ◽  
Indung Sudarso
Keyword(s):  
Risk Management ◽  
Failure Mode ◽  
Failure Modes ◽  
Quality Risk Management ◽  
Mode Effects ◽  
Safety Belt ◽  
Quality Risk ◽  
Criticality Analysis

Manajemen kualitas digunakan untuk mengevaluasi kualitas bangunan, sedangkan manajemen risiko digunakan untuk mengetahui risiko yang berpengaruh terhadap kualitas bangunan. Seperti sumber daya manusia yang tidak memakai alat pelindung diri (APD) saat melakukan pekerjaan dikarenakan dengan alasan pekerjaan semakin lama serta ribet dikerjakan. Sehingga dengan adanya beberapa proses yang belum terstandar, maka dapat berisiko mempengaruhi kualitas pembangunan yang tidak sesuai harapan. Tujuan dilakukan penelitian ini adalah untuk mengetahui tingkat risiko yang berpengaruh terhadap kualitas pembangunan dan menentukan mitigasi untuk peningkatan kualitas pembangunan. Metode yang di gunakan adalah Quality Risk Management (QRM) yang berfungsi mengevaluasi indikator yang mempengaruhi peningkatan kualitas dan Failure Modes Effects and Criticality Analysis (FMECA) untuk mengevaluasi dampak potensial dari setiap kegagalan dengan memberi skala prioritas demi mengetahui tingkat risiko. Hasil yang diperoleh dari pendekatan QRM dan FMECA yaitu pekerjaan rangka atap dengan RPN sebesar 42 dan plesteran dinding luar dengan RPN sebesar 28 yang tergolong risiko tinggi (Critical High ). Sehingga mitigasi risiko yang diberikan yaitu pemakaian APD seperti safety belt safety shoes, helmet serta konsentrasi agar dapat membantu mencegah atau mengatasi apabila risiko yang tidak di inginkan dapat mempengaruhi kualitas bangunan.  

Risk and DoE-Based Analytical Failure Mode Effect Analysis (AFMEA) to Simultaneous Estimation of Montelukast Sodium and Bilastine by HPTLC Method Using Enhanced AQbD Approach

2021 ◽  
Author(s):  
Pintu Prajapati ◽  
Jayesh Tamboli ◽  
Ashish Mishra
Keyword(s):  
Risk Management ◽  
Failure Mode ◽  
Failure Modes ◽  
Simultaneous Estimation ◽  
Effect Analysis ◽  
Quality Risk Management ◽  
Montelukast Sodium ◽  
Mode Effect ◽  
Quality Risk ◽  
Failure Mode Effect Analysis

Abstract The fixed-dose combination (FDC) of montelukast sodium (MLS) and bilastine (BIL) is used for monotherapy in the patient with seasonal allergic rhinoconjuctivitis and asthma. According to the upcoming ICH (International Council for Harmonization) Q14 guideline, the development of the analytical method by the implementation of the Analytical Quality by Design (AQbD) approach based on principles of Quality Risk Management (QRM) and design of experiments (DoE) would be a regulatory requirement for the registration of new drug substance and product in ICH countries. Hence, a robust high-performance thin layer chromatography method has been developed, which was not previously reported for simultaneous estimation of MLS and BIL using risk and DoE-based enhanced AQbD approach. The analytical failure mode effect analysis (AFMEA) was started with the identification of potential analytical failure modes followed by their effect analysis by RPN ranking and filtering method. The DoE-based AFMEA was applied for optimization of high-risk analytical failure modes by central composite design using Design-Expert software. The method operable design ranges and control strategy was set for quality risk management throughout the lifecycle of the developed method. The developed method was validated as per ICH Q2 (R1) guideline. The method was applied for the assay of FDC, and results were found in compliance with the labeled claim.

scholarly journals Risk Management in Magnetic Resonance: Failure Mode, Effects, and Criticality Analysis

2013 ◽  
Vol 2013 ◽  
pp. 1-5 ◽  
Author(s):  
Antonella Petrillo ◽  
Roberta Fusco ◽  
Vincenza Granata ◽  
Salvatore Filice ◽  
Nicola Raiano ◽  
...  
Keyword(s):  
Risk Management ◽  
Magnetic Resonance ◽  
Failure Mode ◽  
Risk Index ◽  
Magnetic Resonance Examination ◽  
Mode Effects ◽  
Management Procedure ◽  
Critical Phases ◽  
Criticality Analysis ◽  
Examination Process

The aim of the study was to perform a risk management procedure in “Magnetic Resonance Examination” process in order to identify the critical phases and sources of radiological errors and to identify potential improvement projects including procedures, tests, and checks to reduce the error occurrence risk. In this study we used the proactive analysis “Failure Mode Effects Criticality Analysis,” a qualitative and quantitative risk management procedure; has calculated Priority Risk Index (PRI) for each activity of the process; have identified, on the PRI basis, the most critical activities and, for them, have defined improvement projects; and have recalculated the PRI after implementation of improvement projects for each activity. Time stop and audits are performed in order to control the new procedures. The results showed that the most critical tasks of “Magnetic Resonance Examination” process were the reception of the patient, the patient schedule drafting, the closing examination, and the organization of activities. Four improvement projects have been defined and executed. PRI evaluation after improvement projects implementation has shown that the risk decreased significantly following the implementation of procedures and controls defined in improvement projects, resulting in a reduction of the PRI between 43% and 100%.

Design of a robust fault-tolerant control algorithm based on failure mode effects criticality analysis for a three-axis satellite

2017 ◽  
Vol 233 (1) ◽  
pp. 91-110
Author(s):  
Mohammad Reza Abedini ◽  
Mostafa Abedi
Keyword(s):  
Failure Mode ◽  
Control Algorithm ◽  
Failure Modes ◽  
Fault Tolerant ◽  
Equilibrium Points ◽  
Fault Tolerant Control ◽  
System Level ◽  
Fault Estimation ◽  
Mode Effects ◽  
Criticality Analysis

This paper proposes a robust fault-tolerant control algorithm for a three-axis satellite. In this regard, an adaptive sliding attitude control algorithm is suggested, which has the capability of fault estimation in the satellite actuators and correction of their effects. For this, the disturbances due to environmental effects and actuator failures and also the satellite unknown parameters are estimated by the adaptive updating law; the sliding mode algorithm compensates the errors due to estimation process. In the suggested design process, the sliding surface is selected so that the unwinding and singularity problems are solved, and also a compensator part is included to remove unstable equilibrium points. In this paper, the failure mode effects criticality analysis have been done to classify different failure modes of reaction wheel according to their severity and probability of occurrence. Accordingly, the critical failure modes and their effects at the control system level are derived. It is shown that the derived critical failures lead to small or severe variations in the generated torques of reaction wheels for which a supervision level will be proposed to correct their effects. Finally, different simulations are conducted to validate expected performance of the suggested algorithms.

Reliability Evaluation of Ship Driver Based on Failure Mode Effects and Criticality Analysis

2013 ◽  
Vol 655-657 ◽  
pp. 2409-2413
Author(s):  
Xiao Li Xu ◽  
Qing Liu ◽  
Bo Qiang Zhu
Keyword(s):  
Failure Mode ◽  
Traffic Safety ◽  
Human Error ◽  
Failure Modes ◽  
Safety Management ◽  
Mode Effects ◽  
Maritime Traffic ◽  
Major Mode ◽  
Human Failure ◽  
Criticality Analysis

Since human error accounts for more than 70% in the causes of maritime accidents, the analysis of human error mode will benefit the scientific analysis and evaluation of maritime traffic safety management, to get the nature security finally. With the application of Failure mode, effects, and criticality analysis （FMECA）, this paper sums up ten specific human failure modes. After the analysis of the modes based on materials from British Maritime Commission, it uses the Criticality Analysis （CA） to analyze the major mode of high hazard. The result has important guiding significance and value on refining the main hazards of maritime accidents, and the nature of maritime management.

Development of Reliable Condition Monitoring Technology for Maritime Using FMECA and Bayesian Network Modeling

2018 ◽  
Author(s):  
Shan Guan ◽  
Knut Erik Knutsen ◽  
Øystein Åsheim Alnes
Keyword(s):  
Bayesian Network ◽  
Failure Mode ◽  
Condition Monitoring ◽  
Failure Modes ◽  
Vibration Monitoring ◽  
Mode Effects ◽  
Monitoring Technique ◽  
Oil Monitoring ◽  
Criticality Analysis ◽  
Over Time

Condition monitoring technique has been widely applied in Maritime to ensure safe operation and minimise unscheduled downtime. However, in practice, ship operators need to assure that a failure mode is indeed monitored by the sensor intended for it, and the sensor has sufficient accuracy and precision for its purpose. Additionally, for a reliable condition monitoring technique, issues such as sensors degradation or drift that will reduce the data quality over time must be addressed. All these require that ship owners to select a monitoring system with the best suitable sensors technology while is economically viable. In this paper, tunnel thruster was used as a case study to demonstrate the basic approach to develop a reliable condition monitoring technique through Failure Mode, Effects and Criticality Analysis (FMECA). Based on failure modes, four types of condition monitoring techniques were identified including Vibration Monitoring, Acoustic Emission Monitoring, Wear Debris /Water in Oil Monitoring, and Thermal Monitoring, where vibration monitoring is discussed in detail as an example for defining the sensor specification. For a reliable condition monitoring technique, prediction of sensor reliability will be especially useful in the situation where sensors systems can degrade over time in service. Using temperature sensors as an example, a Bayesian network (BN) modeling approach has been carried out for assessing sensor reliability affected by aging.

Amalgamated Criticality Analysis Methodology

2013 ◽  
Vol 679 ◽  
pp. 101-106
Author(s):  
Ming Li Liao ◽  
Yung Tsan Jou ◽  
Cheng Shih Liaw
Keyword(s):  
Failure Mode ◽  
Failure Modes ◽  
Design Tool ◽  
Maximal Entropy ◽  
Mode Effects ◽  
Knowledge Based ◽  
Analysis Methodology ◽  
Safety And Reliability ◽  
Mathematical Difficulties ◽  
Criticality Analysis

Failure mode effects and criticality analysis (FMECA) is a widely useful design tool for enhancing product quality, safety and reliability. Most of the current FMECA procedure is in accordance with MIL-STD-1629A by which to conduct FMECA and criticality analysis, which is able to prioritize the failure modes and undertake limited corrective actions toward eliminating product risks. However, the criticality analysis calculation and its interpretation for a failure mode have some mathematical difficulties and erroneous omissions. To resolve these problems, this study proposes a new amalgamated criticality analysis methodology, which is knowledge-based to obtain the four different factor criteria and then using the maximal entropy ordered weighted geometric averaging (ME-OWGA) approach to compute the criticality numbers for a system. This study evaluates criticality analysis in the context of a communication system; the experimental results demonstrate that the proposed method is both accurate and provides discriminating analysis information that helps decision making in product design processes.

A STATE-OF-THE-ART REVIEW OF FMEA/FMECA

1994 ◽  
Vol 01 (04) ◽  
pp. 515-543 ◽  
Author(s):  
ABDELKADER BOUTI ◽  
DAOUD AIT KADI
Keyword(s):  
Failure Mode ◽  
Failure Modes ◽  
State Of The Art ◽  
Analysis Procedure ◽  
Basic Principles ◽  
Mode Effects ◽  
System Service ◽  
Computer Codes ◽  
Potential Failure ◽  
Criticality Analysis

The Failure Mode and Effects Analysis (FMEA) documents single failures of a system, by identifying the failure modes, and the causes and effects of each potential failure mode on system service and defining appropriate detection procedures and corrective actions. When extended by Criticality Analysis procedure (CA) for failure modes classification, it is known as Failure Mode Effects and Criticality Analysis (FMECA). The present paper presents a literature review of FME(C)A, covering the following aspects: description and review of the basic principles of FME(C)A, types, enhancement of the method, automation and available computer codes, combination with other techniques and specific applications. We conclude with a discussion of various issues raised as a result of the review.

scholarly journals A Novel Approach to Support Failure Mode, Effects, and Criticality Analysis Based on Complex Networks

Entropy ◽  
2019 ◽  
Vol 21 (12) ◽  
pp. 1230 ◽  
Author(s):  
Lixiang Wang ◽  
Wei Dai ◽  
Guixiu Luo ◽  
Yu Zhao
Keyword(s):  
Complex Networks ◽  
Failure Mode ◽  
Failure Modes ◽  
Weighted Graph ◽  
Complex Network Theory ◽  
Mode Effects ◽  
Novel Approach ◽  
Potential Failure ◽  
The Impact ◽  
Criticality Analysis

Failure Mode, Effects and Criticality Analysis (FMECA) is a method which involves quantitative failure analysis. It systematically examines potential failure modes in a system, as well as the components of the system, to determine the impact of a failure. In addition, it is one of the most powerful techniques used for risk assessment and maintenance management. However, various drawbacks are inherent to the classical FMECA method, especially in ranking failure modes. This paper proposes a novel approach that uses complex networks theory to support FMECA. Firstly, the failure modes and their causes and effects are defined as nodes, and according to the logical relationship between failure modes, and their causes and effects, a weighted graph is established. Secondly, we use complex network theory to analyze the weighted graph, and the entropy centrality approach is applied to identify influential nodes. Finally, a real-world case is presented to illustrate and verify the proposed method.

scholarly journals Resilience-based failure mode effects and criticality analysis for regional water supply system

2014 ◽  
Vol 17 (2) ◽  
pp. 193-210 ◽  
Author(s):  
Hwee Hwang ◽  
Kevin Lansey ◽  
Daniel R. Quintanar
Keyword(s):  
Water Supply ◽  
Failure Mode ◽  
Network Flow ◽  
Failure Modes ◽  
Flow Model ◽  
Assessment Method ◽  
Water Supply Systems ◽  
Mode Effects ◽  
Criticality Analysis ◽  
Regional Water

An alternative risk assessment method, known as failure mode effects and criticality analysis (FMECA), is demonstrated on the regional water supply systems (RWSS) in Tucson, AZ, USA that combines delivery of potable and reclaimed water and conveyance of wastewater to a developing area within the Tucson RWSS. The goal of FMECA is to examine the volumetric severity of a component failure on the overall system function by modeling the system under alternative failure modes. Within FMECA, the Risk Priority Number (RPN) is applied to compare the risk criticality between components' failures. To complete FMECA, the Tucson RWSS is represented in a network flow model that optimally allocates flows between sources and demand points to minimize operational costs. Potential failure mode consequences are evaluated from the flow model as the volume of water not delivered to users if the component is unavailable. The volumetric severity of the failure event is converted to an ordinal value using stakeholder judgment. Likelihood of each failure mode is similarly defined by stakeholders on a 1–10 scale. The RPN is then computed as the product of the severity and likelihood. RPN values for all failure modes are then ranked to assess the most critical elements. Alternative system configurations are examined to assess the value of redundancies on the Tucson RWSS resilience.

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