Failure Mode Critical Effect Analysis and Design of Experiment-Based Robust Chromatographic Method for Simultaneous Estimation Lornoxicam and Eperisone Hydrochloride

2020 ◽  
Vol 58 (10) ◽  
pp. 929-939
Author(s):  
Pintu Prajapati ◽  
Vipul Radadiya ◽  
Shailesh Shah
Keyword(s):  
Failure Mode ◽  
Design Of Experiment ◽  
Failure Modes ◽  
Risk Control ◽  
Quadratic Model ◽  
Simultaneous Estimation ◽  
Effect Analysis ◽  
Analysis And Design ◽  
Critical Effect ◽  
Hptlc Method

Abstract Failure mode critical effect analysis and design of experiment-based high performance thin layer chromatography (HPTLC) method has been developed for simultaneous estimation of lornoxicam (LOC) and eperisone hydrochloride (EPR). Failure modes were identified on the basis of prior knowledge and experimental data with the help of Ishikawa diagram for the development of method. The criticality of failure mode was assessed by giving risk priority number and criticality rank on the basis of preliminary experimental trials. The identified critical failure modes were analyzed for their effect by design of experiment (DoE)-based Plackett–Burman screening design. From 11 critical factors, the volume of methanol and modifier in mobile phase composition were found as critical failure modes. Critical failure mode was further analyzed by DoE based on central composite design for study of their relationship with resolution of both drugs. Quadratic model suggested by design was further used for failure mode risk control and navigation of design space for a resolution of both drugs more than 1.5. Failure mode risk control strategy was set for robust HPTLC method for simultaneous estimation of both drugs in laboratory mixture. Developed and validated HPTLC method was applied for assay of LOC and EPR in their laboratory mixture and assay values were found in good agreement with a spiked amount of drugs.

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.

Failure mode and effect analysis (FMEA) to improve collaborative project-based learning: Case study of a Study and Research Path in mechanical engineering

2021 ◽  
pp. 030641902199904
Author(s):  
Elena Bartolomé ◽  
Paula Benítez
Keyword(s):  
Active Learning ◽  
Failure Mode ◽  
Mechanical Engineering ◽  
Failure Modes ◽  
Collaborative Study ◽  
Project Based Learning ◽  
Educational Process ◽  
Effect Analysis ◽  
Questions And Answers

Failure Mode and Effect Analysis (FMEA) is a powerful quality tool, widely used in industry, for the identification of failure modes, their effects and causes. In this work, we investigated the utility of FMEA in the education field to improve active learning processes. In our case study, the FMEA principles were adapted to assess the risk of failures in a Mechanical Engineering course on “Theory of Machines and Mechanisms” conducted through a project-based, collaborative “Study and Research Path (SRP)” methodology. The SRP is an active learning instruction format which is initiated by a generating question that leads to a sequence of derived questions and answers, and combines moments of study and inquiry. By applying the FMEA, the teaching team was able to identify the most critical failures of the process, and implement corrective actions to improve the SRP in the subsequent year. Thus, our work shows that FMEA represents a simple tool of risk assesment which can serve to identify criticality in educational process, and improve the quality of active learning.

Fuzzy risk assessment for electro-optical target tracker

2016 ◽  
Vol 33 (6) ◽  
pp. 830-851 ◽  
Author(s):  
Soumen Kumar Roy ◽  
A K Sarkar ◽  
Biswajit Mahanty
Keyword(s):  
Failure Mode ◽  
Failure Modes ◽  
Linear Equations ◽  
Mode Analysis ◽  
Failure Behavior ◽  
Membership Functions ◽  
Design And Development ◽  
Effect Analysis ◽  
Content Type ◽  
Criticality Analysis

Purpose – The purpose of this paper is to evolve a guideline for scientists and development engineers to the failure behavior of electro-optical target tracker system (EOTTS) using fuzzy methodology leading to success of short-range homing guided missile (SRHGM) in which this critical subsystems is exploited. Design/methodology/approach – Technology index (TI) and fuzzy failure mode effect analysis (FMEA) are used to build an integrated framework to facilitate the system technology assessment and failure modes. Failure mode analysis is carried out for the system using data gathered from technical experts involved in design and realization of the EOTTS. In order to circumvent the limitations of the traditional failure mode effects and criticality analysis (FMECA), fuzzy FMCEA is adopted for the prioritization of the risks. FMEA parameters – severity, occurrence and detection are fuzzifed with suitable membership functions. These membership functions are used to define failure modes. Open source linear programming solver is used to solve linear equations. Findings – It is found that EOTTS has the highest TI among the major technologies used in the SRHGM. Fuzzy risk priority numbers (FRPN) for all important failure modes of the EOTTS are calculated and the failure modes are ranked to arrive at important monitoring points during design and development of the weapon system. Originality/value – This paper integrates the use of TI, fuzzy logic and experts’ database with FMEA toward assisting the scientists and engineers while conducting failure mode and effect analysis to prioritize failures toward taking corrective measure during the design and development of EOTTS.

Risk Evaluation Approach in Failure Mode and Effect Analysis of Automotive Headlamp Assembly

2014 ◽  
Vol 564 ◽  
pp. 72-76
Author(s):  
Shukriah Abdullah ◽  
Aziz Abdul Faieza
Keyword(s):  
Failure Mode ◽  
Failure Modes ◽  
Assessment Tool ◽  
Action Plan ◽  
Technical Problem ◽  
Assembly Process ◽  
Preventive Action ◽  
Effect Analysis ◽  
Evaluation Approach ◽  
Process Failure

Headlamp assembly entailed a complex assembly process and error in assembled can result in technical problem and higher reject rate at the end of the assembly process. A study has been conducted, in one of the automotive headlamp assembly in Malaysia, where there are numerous defect detected during the assembly process, such as metal spacing missing, wrong model housing, wrong sticker affix, wrong orientation with a total of 80% defects detected. Currently the headlamps are assembled with no dimensional control, results in high physical nonconformity product. The main objective of this project is to identify potential failure in headlamp assembly process. The approach used was risk assessment tool which is Process Failure Mode and Effect. This work also developed the corrective action plan for accurate ranking of Failure Modes by Risk Priority Number-based method and implement it to the process assembly. The result showed that there was increased of 5% in preventive action and 4% increment of the detection action

Failure Mode and Effect Analysis (FMEA) for Enhancing Reliability of Water Tube Boiler in Thermal Power Plant

2016 ◽  
Vol 8 (02) ◽  
pp. 79-86
Author(s):  
Kapil Dev Sharma ◽  
Shobhit Srivastava
Keyword(s):  
Power Plant ◽  
Failure Mode ◽  
Thermal Power Plant ◽  
Failure Modes ◽  
Thermal Power ◽  
Effect Analysis ◽  
Water Tube ◽  
Potential Failure ◽  
Fmea Method ◽  
Continuous Power

Failure mode and effect analysis is one of the QS-9000 quality system requirement supplements, with a wide applicability in all industrial fields. FMEA is the inductive failure analysis instruments which can be defined as a methodical group of activities intended to recognize and evaluate the potential failure modes of a product/ process and its effects with an aim to identify actions which could eliminate or reduce the chance of the potential failure before the problem occur. The purpose of this paper is to evaluate the FMEA research and application in the Thermal Power Plant Industry. The research will highlight the application of FMEA method to water tubes (WT) in boilers with an aim to find-out all the major and primary causes of boiler failure and reduce the breakdown for continuous power generation in the plant. Failure Mode and Effect Analysis technique is applied on most critical or serious parts (components) of the plant which having highest Risk Priority Number (RPN). Comparison is made between the quantitative results of FMEA and reliability field data from real tube systems. These results are discussed to establish relationships which are useful for future water tube designs.

Cost consequence of failure in failure mode and effect analysis

2017 ◽  
Vol 34 (8) ◽  
pp. 1318-1342 ◽  
Author(s):  
Jeff Guinot ◽  
John W. Sinn ◽  
M. Affan Badar ◽  
Jeffrey M. Ulmer
Keyword(s):  
Failure Mode ◽  
Failure Modes ◽  
Cost Data ◽  
Ordinal Scale ◽  
Automotive Application ◽  
Manufacturing Cost ◽  
Potential Cost ◽  
Effect Analysis ◽  
Content Type ◽  
Cost Consequence

Purpose The purpose of this paper is to investigate the possibility of including the cost consequence of failure in the a priori risk assessment methodology known as failure mode and effect analysis (FMEA). Design/methodology/approach A model of the standard costs that are incurred when an electronic control module in an automotive application fails in service was developed. These costs were related to the Design FMEA ranking of the level of severity of the failure mode and the probability of its occurrence. Monte Carlo simulations were conducted to establish the average costs expected for each level of severity at each level of occurrence. The results were aggregated using fuzzy utility sets into a nine-point ordinal scale of cost consequence. The criterion validity of this scale was assessed with warranty cost data derived from a case study. Findings It was found that the model slightly underestimated the warranty costs that accrued, but the fit could be improved with adjustments dictated by actual usage conditions. Research limitations/implications Cost data used in the simulations were derived from government and academic surveys, analyses, and estimates of the manufacturing cost structure; and nominal costs for various quality issues experienced by Tier 2 automotive electronics supplier. Specificity is lacking. The sample size and the type of the failure modes used to validate the model are constrained by the number and type of products which have had demonstrable performance concerns over the past three years, with cost data available to the authors. The power of the validation is limited. The validation is considered a screening assessment. Practical implications This work relates the characterization of risk with its potential cost and develops a scaling instrument to allow the incorporation of cost consequence into an FMEA. Originality/value A ranking scale was developed that related severity and occurrence rank scores to a cost consequence rank that keys to a cost of quality figure (given as percent of sales) that would accompany a realization of the failure mode.

scholarly journals Aplikasi Six Sigma dan Design of Experiment untuk Peningkatan Mutu Proses Kain Cotton Tetoron (Studi Kasus Perusahaan Tekstil)

Jurnal IPTEK ◽  
2020 ◽  
Vol 4 (2) ◽  
Author(s):  
Ni Made Sudri ◽  
Yenny Widianty ◽  
Anissa Fernanda
Keyword(s):  
Failure Mode ◽  
Design Of Experiment ◽  
Six Sigma ◽  
Effect Analysis ◽  
Mode Effect ◽  
Failure Mode Effect Analysis

Perbaikan Desain sistem Industri Tekstil dengan Six Sigma dan FMEA untuk peningkatan mutu proses. Six Sigma merupakan metoda peningkatan kualitas secara terus menerus ,dengan cara meminimalkan jumlah cacat. FMEA (Failure Mode Effect Analysis) alat dipergunakan untuk bantu penentuan tindakan yang sesuai , penghilangan mode kegagalan secara prioritas. Selanjutnya tahapan improve untuk penentuan faktor paling berpengaruh terhadap terjadinya cacat warna, supaya pengaruh dari factor gangguan jadi minimum. Apabila fungsi kontrol dilakukan dan factor penyebab cacat tidak muncul lagi akan terjadi peningkatan nilai sigma. Hasil analisa FMEA diperoleh factor temperature mesin dan material yang paling berpengaruh terhadap terjadinya cacat warna, dengan nilai RPN masing –masing 210 dan 120, Hasil perhitungan Six Sigma terjadi peningkatan nilai sigma darikondisi awal sebesar 3,78 sigma menjadi 4,93 sigma, atau terjadipeningkatan kemampuan proses 1,15 sigma. Usulan perbaikan menggunakan DOE (design of experiment) agar cacat warna tidak muncul disarankan dengan seting alat control suhu mesin thermosol dan pencampuran bahan kimia NaCl dioptimalkan. Kata Kunci : Six Sigma, FMEA, DOE

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.

scholarly journals Analisa defect produk sheet area corrugator 301 menggunakan metode SPC dan FMEA di PT Indah Kiat

2020 ◽  
Vol 12 (3) ◽  
pp. 332
Author(s):  
Evan Mandala Putra ◽  
Sri Mukti Wirawati ◽  
Pugy Gautama
Keyword(s):  
Process Control ◽  
Production Process ◽  
Statistical Process Control ◽  
Failure Mode ◽  
Failure Modes ◽  
Uneven Surface ◽  
Statistical Process ◽  
Effect Analysis ◽  
Product Defect ◽  
Fmea Method

This study aims to analyze defects in the sheet production process in the 301 Corrugator area by analyzing the total number of sheets produced and the number of sheets that have been damaged over a certain period of time using the Statistical Process Control (SPC) method and Failure Modes and Effect Analysis (FMEA). Based on the research results, there are 6 defects, namely untidy cuts, wrinkled sheets, uneven surface, curved sheets, uneven sides, loose sheet layers. The most dominant defect is uneven surface, which is 185.141 Kg or 60%. Based on the value of the RPN table, the product defect that has the highest value is the loose sheet layer with an RPN value of 245 from the calculation stage of the RPN value, a suggestion is made to reduce defects resulting from the loose sheet layer. From the stage of making improvements, the company should prioritize and focus on the types of disabilities and types of disabilities that have the highest RPN ranking when using the Failure Mode and Effect Analysis (FMEA) method.

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