scholarly journals STUDY OF POSSIBILITIES OF JOINT APPLICATION OF PARETO ANALYSIS AND RISK ANALYSIS DURING CORRECTIVE ACTIONS

Author(s):  
Volodymyr Haievskyi

Continuous improvement in the quality management system is based on corrective action. Corrective actions require the identification of priority defects that require priority elimination of the causes of occurrence. The traditional method of prioritization can be considered a Pareto chart, built by the number of identified inconsistencies. This technique makes it possible to prioritize the most frequently detected defects. However, defects that are rare can significantly outweigh those that are often encountered in their consequences. The defect risk is a complex indicator that simultaneously takes into account both the number of detected defects and their impact. Failure Mode and Effects Analysis (FMEA) can be used to quantify risk. This technique allows to determine the risk priority number (RPN), taking into account the number of detected defects (O), the consequences of the appearance of a defect (S) and the possibility of timely detection of a defect or cause before the onset of undesirable consequences (D). The priority number of risks numerically characterizes the risks of a defect and can be used as a criterion for determining priority defects. Based on the values of the priority number of risks, a Pareto chart can be built and defects that form 80% of the risk area can be identified. These defects require urgent corrective action. According to the data taken from production, it is shown that the Pareto analysis by the priority number of risks gives results that differ from the analysis by the number of identified inconsistencies. Application of the proposed approach will allow introducing risk-oriented methods into the procedures for carrying out corrective actions. This will make it possible to direct the resources of the enterprise to eliminate the causes of defects that are actually detected and can have the most significant consequences for consumers of products

2014 ◽  
Vol 1006-1007 ◽  
pp. 381-385
Author(s):  
Wei Min Ye ◽  
Wo Ye Liu ◽  
De Yong Zhao ◽  
Cui Juan Gao ◽  
Yong Fen Xie ◽  
...  

To solve the drawbacks that the existing Pareto chart do not consider the fuzzy attribute of quality and imbalance of the improvement opportunities for quality defects, the nonconformity membership analysis method was introduced to lead a classification analysis on quality defects data, which increased the flexibility of data analysis, and Pareto priority index was introduced to assess improvement opportunities for quality defects, which increased the rationality during decision-making for quality defective items to improve. The two ways were both integrated to the analysis instance of equipment maintenance quality data based on fuzzy weighted Pareto chart, then weights and dynamic threshold were set to get different results of the Pareto analysis. The presented method can provide effective method support for organizations to scientifically analyze equipment maintenance quality data and accurately determine the direction of quality improvement.


Author(s):  
Nguyen Thuy Quynh Loan

A study objective is to identify key factors of QMS (Quality Management System) influencing the organizational performance in pharmaceutical factories getting GMP (Good Manufacturing Practices) certificate. The original research model consists of eight independent factors (leadership, process management, education and training, supplier management, customer focus, employee involvement, product design, and continuous improvement) and three dependent factors related to organizational performance (productivity, product quality and customer satisfaction). The study collects 265 suitable questionnaires filled by middle managers or the top managers of the pharmaceutical factories getting GMP in Vietnam. The results identify key factors of QMS as leadership, employee involvement towards customer focus, and continuous improvement towards product design have positively impact to organizational performance that is represented by productivity and product quality, customer satisfaction. The study thensuggests managerial implications to top management of pharmaceutical factories in improving performance through enhancing key factors of QMS implementation.


2017 ◽  
Vol 4 (2) ◽  
pp. 159
Author(s):  
Septarina Prita ◽  
Jean Suha Theresia Br. Aritonang ◽  
W. Wasito

Library is all about service, therefore UPT Perpustakaan Universitas Jember commited to always do a continuous improvement on their service by implying quality management systems ISO 9001:2008. Tools to evaluate the effectiveness of quality management systems is quality audit which is held by Badan Penjamin Mutu (BPM) and performed annually. Quality audit performed by interviewing respondents, ask the respondents to filling in the questionnaires, and the last method is observing the library activity, and analyzes if the reality meets the standards set by the UPT Perpustakaan itself. There are 3 types of finding resulted by quality audit avtivity, they are cathegorized as observative finding, minor finding and mayor finding. Minor findings have been found in Pembinaan Koleksi's sector and Gugus Penjamin Mutu's sector whilst the mayor findings coming from Sirkulasi's sector, Pengembangan dan Kerjasama's sector and Layanan Perujukan dan Koleksi Khusus's sector. Mayor findings means that management should give more attention to the implimentation of quality management system which is implied to these sectors because the findings can influence the conformity between the processes and the products offered so that those will affect the services's quality given by the library. Minor findings means that finding will not influences the quality of the services, and generally human error is the cause of that findings. But although it will not influences the quality of the services, the minor findings still needs to be documented and need a correction action to correct the findings so that in the future, the management can prevent similar findings to ever occured again.Keywords: ISO 9001:2008, Library, Quality Audit, Quality Management Systems


2018 ◽  
Vol 4 (1) ◽  
pp. 0035-0041
Author(s):  
Lílian Maria Moreira Lopes ◽  
Sarah De Oliveira Teixeira Cardoso ◽  
Adriana Ferreira De Faria

A busca pela sobrevivência vem fazendo com que as empresas adotem estratégias para se manterem competitivas no mercado, aliado a isso, obter qualidade em seus processos e produtos se torna um fator crucial para as organizações. Dessa forma, tendo ciência da importância da qualidade para a competitividade das instituições, o objetivo desse trabalho consiste em descrever o processo de implantação de um Sistema de Gestão da Qualidade (SGQ), de acordo com os requisitos normativos da ISO 9001:2015 em duas empresas prestadoras de serviços na região do Vale do Aço e evidenciar a importância da participação da alta direção nesse processo. A metodologia utilizada para implantação do SGQ consistiu na definição de seis metas físicas, sendo possível realizar todas as atividades necessárias. O SGQ foi implantado nas empresas, estando em fase inicial de operação e requer grande atenção da alta direção para que as deficiências sejam sanadas e o sistema apresente melhoria contínua.The search for survival has led companies to adopt strategies to remain competitive in the market, along with this, getting quality in your processes and products becomes a crucial factor for organizations. In this way, being aware of the importance of quality for the competitiveness of institutions, the purpose of this work is to describe the process of implementing a Quality Management System (QMS), according to the ISO 9001: 2015 standard requirements in two service companies in the Vale do Aço region and to highlight the importance of the participation of top management in this process. The methodology used for the implementation of the QMS consisted in the definition of six physical goals, being possible to carry out all the necessary activities. The QMS was implemented in the companies, being in the initial phase of operation and requires great attention of the top management so that the deficiencies are solved and the system presents continuous improvement.


Signos ◽  
2021 ◽  
Vol 13 (2) ◽  
Author(s):  
Javier Ramos Ramos ◽  
Alix Fernanda Cañaveral Rodríguez ◽  
Hernando Camacho Camacho

This research was aimed at creating a methodological guide for the implementation of the quality management system based on the NT ISO 13485: 2016 for medical devices manufacturers, which seeks to share with its readers the parameters necessary for implementing regulatory purposes and convey a perspective on how organizations should apply the standard requirements. The research considered the needs and expectations of organizations in Colombia producing medical devices, evaluated their ability to provide products and services that meet requirements and promote customer satisfaction through continuous improvement. The research starts from a theoretical base that analyzes the application of ISO 13485: 2016 and the requirement of good manufacturing practices in different countries, and the competitive advantages present by exploring the existing literature and the standard requirements. This article results have a mixed approach: quantitative, through the development of a self-diagnosis tool; and qualitative, through a methodological guide development. In each section of the standard, an exposition structure was adopted to facilitate content consultation and compression, thus fulfilling the purpose and applicability aiming to guide a clear and simple implementation.


Author(s):  
Gil Garteiz ◽  
Amir Zylberman

Abstract Tower successfully completed a product qualification of its 130nm copper process this year. The key to this achievement was finding and eliminating a dominant failure mechanism, which appeared during HTOL stress. This paper will cover the failure analysis, in-line problem identification, and corrective actions taken that eventually lead to successful product qualification.


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