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 A Case Study on Recall of used Scopes in the Endoscopy Department by using a Failure Mode & Effect Analysis (FMEA) Proactive Risk Management

2020 ◽  
pp. 13-24
Author(s):  
Zuber Mujeeb Shaikh
Keyword(s):  
Risk Management ◽  
Failure Mode ◽  
Failure Modes ◽  
Risk Priority Number ◽  
Effect Analysis ◽  
Mode Effect ◽  
Potential Failure ◽  
Failure Mode Effect Analysis

Failure Mode and Effects Analysis (FMEA) is the process of reviewing as many components, assemblies, and subsystems as possible to identify potential failure modes in a system and their causes and effects. The study revealed that the Risk Priority Number (RPN) was initially 450 and it has decreased to 90 after implementing all the actions in FMEA.

scholarly journals Identifikasi Potensi Modus Kegagalan Yang Dapat Menghambat Kelancaran Proses Pelayanan Rawat Jalan Menggunakan Failure Mode Effect Analysis (FMEA) Di Rumah Sakit BM Jakarta Barat

2020 ◽  
Vol 8 (2) ◽  
pp. 105-113
Author(s):  
Achmaddudin Sudiro
Keyword(s):  
Failure Mode ◽  
Failure Modes ◽  
Outpatient Service ◽  
Outpatient Services ◽  
Effect Analysis ◽  
Outpatient Unit ◽  
Mode Effect ◽  
Potential Failure ◽  
Fmea Method ◽  
Failure Mode Effect Analysis

Outpatient services hosted by the hospital have never been absent from public visits. In fact, every year an outpatient visitor is always increasing. This research intends to identify potential failure mode that can  inhibit of every flow of service in the outpatient care unit using the Failure Mode Effect Analysis (FMEA) method. Qualitative research plan using an observation survey approach and in-depth interviews with the outpatient service head Coordinator conducted in February 2020 on the hospital outpatient unit service process. The results of this study Indicate the potential failure mode that has the value of the RPN above the value of cut off point 180 as many as six out of ten failure modes. Firstly, the check is not on schedule (360), secondly, the patient lags a turn call order Check (270), third, Specific drug failure is not available (245), fourth, general patient protests with the price of the drug (224), fifth, the patient is void to poly (196), the sixth patient registrant online missed sequence number queue (180). Based on the results of the research, hospitals are expected to follow up with the results of this research by conducting a redesign of the process that occurs today using the FMEA to maintain service quality.

Use of failure mode effect analysis (FMEA) to improve medication management process

2017 ◽  
Vol 30 (2) ◽  
pp. 175-186 ◽  
Author(s):  
Khushboo Jain
Keyword(s):  
Failure Mode ◽  
Failure Modes ◽  
Medication Management ◽  
Management Process ◽  
Effect Analysis ◽  
Content Type ◽  
Complex Process ◽  
Mode Effect ◽  
Corrective Actions ◽  
Failure Mode Effect Analysis

Purpose Medication management is a complex process, at high risk of error with life threatening consequences. The focus should be on devising strategies to avoid errors and make the process self-reliable by ensuring prevention of errors and/or error detection at subsequent stages. The purpose of this paper is to use failure mode effect analysis (FMEA), a systematic proactive tool, to identify the likelihood and the causes for the process to fail at various steps and prioritise them to devise risk reduction strategies to improve patient safety. Design/methodology/approach The study was designed as an observational analytical study of medication management process in the inpatient area of a multi-speciality hospital in Gurgaon, Haryana, India. A team was made to study the complex process of medication management in the hospital. FMEA tool was used. Corrective actions were developed based on the prioritised failure modes which were implemented and monitored. Findings The percentage distribution of medication errors as per the observation made by the team was found to be maximum of transcription errors (37 per cent) followed by administration errors (29 per cent) indicating the need to identify the causes and effects of their occurrence. In all, 11 failure modes were identified out of which major five were prioritised based on the risk priority number (RPN). The process was repeated after corrective actions were taken which resulted in about 40 per cent (average) and around 60 per cent reduction in the RPN of prioritised failure modes. Research limitations/implications FMEA is a time consuming process and requires a multidisciplinary team which has good understanding of the process being analysed. FMEA only helps in identifying the possibilities of a process to fail, it does not eliminate them, additional efforts are required to develop action plans and implement them. Frank discussion and agreement among the team members is required not only for successfully conducing FMEA but also for implementing the corrective actions. Practical implications FMEA is an effective proactive risk-assessment tool and is a continuous process which can be continued in phases. The corrective actions taken resulted in reduction in RPN, subjected to further evaluation and usage by others depending on the facility type. Originality/value The application of the tool helped the hospital in identifying failures in medication management process, thereby prioritising and correcting them leading to improvement.

scholarly journals ANALISIS NONCONFORMING PART PADA WING STRUCTURE PESAWAT CN-235 DENGAN MENGGUNAKAN METODE FMEA (FAILURE MODE EFFECT ANALYSIS)

2018 ◽  
Vol 13 (2) ◽  
pp. 67
Author(s):  
Much. Djunaidi ◽  
Andrew Krishna Ryantaffy
Keyword(s):  
Failure Mode ◽  
Failure Modes ◽  
Air Transportation ◽  
Transport Systems ◽  
Transportation Mode ◽  
Effect Analysis ◽  
Mode Effect ◽  
Wing Structure ◽  
Alternative Solutions ◽  
Failure Mode Effect Analysis

AbstrakTransportasi udara menjadi moda trasportasi yang terus berkembang di Indonesia. Dukungan terhadap sistem transportasi udara yang aman sangat dibutuhkan. Oleh karena itu, proses pembuatan pesawat terbang yang dilakukan di PT. Dirgantara Indonesia perlu terus dijaga kualitasnya.  Artikel ini membahas masalah kecacatan komponen rib pada wing structure pesawat CN235 pada saat proses perakitan struktur sayap pesawat.  Data menunjukkan bahwa komponen yang banyak mengalami kegagalan adalah rib, dengan tingkat keparahan yang ditimbulkan masuk dalam kategori fatal. Dengan menggunakan pendekatan failure mode effect analysis, kasus terjadinya rib yang tidak sesuai menjadi bentuk modus kegagalan yang menjadi prioritas perbaikan dengan nilai RPN yang tertinggi dibandingkan dengan modus-modus kegagalan lainnya. Alternatif solusi untuk mengatasi masalah tersebut adalah dengan melakukan inspeksi yang lebih ketat terhadap komponen khusus, serta melakukan analisis untuk faktor-faktor yang lain. Abstract[Analysis of Non-conforming Part on Wing Structure Aircraft CN-235 Using FMEA (Failure Modes Effect Analysis) Method] Air transportation is becoming a growing transportation mode in Indonesia. Support for safe air transport systems is needed. Therefore, the process of making aircraft that is done in PT. Dirgantara Indonesia needs to keep its quality. This article discusses the problem of the components of the rib component in the wing structure of the CN235 aircraft during the assembly process of the aircraft wing structure. The data indicate that the components that many fail are rib, with the severity generated into the fatal category. By using the failure mode effect analysis approach, the case of incompatible rib becomes the form of failure mode that becomes the priority of improvement with the highest RPN value compared to other failure modes. Alternative solutions to overcome these problems is to conduct more rigorous inspections of specific components, as well as perform analysis for other factors.Keywords: FMEA; Wing structure; Rib component; Safety flight

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.  

scholarly journals Application of Failure Mode Effect Analysis (FMEA) to Improve Medication Safety in the Dispensing Process – A Study at A Teaching Hospital, Sri Lanka

2021 ◽  
Author(s):  
J.A.Lakshika Anjalee ◽  
Victoria Rutter ◽  
Nithushi Samaranayake
Keyword(s):  
Sri Lanka ◽  
Failure Mode ◽  
Teaching Hospital ◽  
Failure Modes ◽  
Tertiary Care ◽  
Care Hospital ◽  
Effect Analysis ◽  
Mode Effect ◽  
Risk Processes ◽  
Failure Mode Effect Analysis

Abstract Background: Failure Mode Effect Analysis (FMEA) is a prospective, team based, structured process used to identify system failures of high risk processes before they occur. Medication dispensing is a risky process that should be analysed for its inherent risks using FMEA. Objectives: The objective of this study was to identify possible failure modes, their effects and causes in the dispensing process of a selected tertiary care hospital using FMEA. Methods: Two independent teams (Team A and Team B) of pharmacists conducted the FMEA for two months in the Department of Pharmacy of a selected teaching hospital, Colombo, Sri Lanka. Each team had five meetings of two hours each, where the dispensing process and sub processes were mapped, and possible failure modes, their effects, and causes, were identified. A score for potential severity (S), frequency (F) and detectability (D) was assigned for each failure mode. Risk Priority Numbers (RPNs) were calculated (RPN=SxFxD) to prioritise identified failure modes. Results: Team A identified 48 failure modes while Team B identified 42. Among all 90 failure modes, 69 were common to both teams. Using the RPN, Team A prioritised one failure mode, while Team B prioritised three (having identical RPNs). Both teams identified overcrowded dispensing counters as a cause for 57 failure modes. Redesigning of, dispensing tables, dispensing labels, the dispensing and medication re-packing processes, and establishing a patient counseling unit were the major suggestions for correction.Conclusion: FMEA was successfully used to identify and prioritise possible failure modes of the dispensing process through active involvement of pharmacists.

Sign in / Sign up

Export Citation Format

Share Document