scholarly journals Design and Conduct of Clinical Studies by Integration of Quality by Design (QbD) into Quality Management System (QMS) - A Pragmatic Approach

2021 ◽  
Vol 7 (2) ◽  
Author(s):  
Choudhary V
Keyword(s):  
Quality Management ◽  
Drug Development ◽  
Safety Profile ◽  
Clinical Studies ◽  
Management System ◽  
Quality By Design ◽  
Quality Management System ◽  
Pragmatic Approach ◽  
Development Cycle ◽  
Smooth Design

Quality is a prerequisite during entire drug development cycle. Clinical studies are required to prove effectiveness of experiment drug and to evaluate its safety profile in humans. To have a smooth design and conduct of clinical studies; Quality-by-Design (QbD) approach can be integrated with Quality Management System (QMS) to ensure the end-to-end quality optimization. Quality by Design is not widely used currently in clinical research.

ANALYSIS THE IMPACT OF THE IMPLEMENTATION OF QUALITY MANAGEMENT SYSTEM (QMS) AND SAFETY AND HEALTHY AT WORK MANAGEMENT SYSTEM (SHWMS / SMK3) ON THE JOB PERFORMANCE OF EMPLOYEES

2018 ◽  
Vol 3 (01) ◽  
pp. 45
Author(s):  
Nur Hidayat ◽  
Indah Kusuma Hayati
Keyword(s):  
Quality Management ◽  
Job Performance ◽  
Latent Variables ◽  
Management System ◽  
Quality Management System ◽  
Partial Least Square ◽  
Least Square ◽  
Global Challenges ◽  
The Impact ◽  
Work Management

Recently, the evolvement of globalization era has been the global challenges that cannot be avoided either by private or government sectors, and they are requested to be survived encountering such the condition. The implementation of Quality Management System (QMS) in the operational company is the way how to guarantee the quality of products or services offered to the people. One of the purposes of QMS implementation is to provide a prime satisfaction to the customers. The impact of QMS implementation is expected to increase job performance of the employees. Besides the implementation of Quality Management System (QMS), the impact of global challenges has been increasing the competitive efforts to execute more effective production process. However, it has required manpower protection accordingly. This research aims to find out whether the implementation of quality management system and safety and healthy at work management system have impacted on the job performance of employees. Objects of this research are the employees in the production department at PT Guna Senaputra Sejahtera Plant 1 Bogor. Data analysis technique of this research has applied software Smart PLS (Partial Least Square). PLS has estimated a model of correlation among the latent variables and correlation between latent variables and its indicators. Result of data processing has indicated that the implementation of Quality Management System (QMS) and system of safety and healthy at work have positively and significantly impacted job performance of employees.Keywords : Quality Management System (QMS), Safety and Healthy at Work System ( SHWS / SMK3), and Job Performance of Employees

Development of a Quality Management System for Electric Power applied to Small Wind Turbines

2012 ◽  
pp. 1083-1088
Author(s):  
O.H. Ando Junior ◽  
M.O. Oliveira ◽  
J.M. Neto ◽  
A.D. Spacek ◽  
R.C.B. Leborgne ◽  
...  
Keyword(s):  
Quality Management ◽  
Electric Power ◽  
Wind Turbines ◽  
Management System ◽  
Quality Management System ◽  
Small Wind Turbines

ROLE OF RESPONSIBILITY IN THE QUALITY MANAGEMENT SYSTEM

2020 ◽  
Vol 14 (3) ◽  
pp. 805-816
Author(s):  
Zdravko Krivokapić ◽  
◽  
Miladin Stefanović
Keyword(s):  
Quality Management ◽  
Management System ◽  
Quality Management System

A Multi-Agent Hierarchical Fuzzy Signatures Approach To Optimize A Quality Management System

2010 ◽  
Vol 4 (4) ◽  
pp. 1-10
Author(s):  
Hajer Ben Mahmoud ◽  
Raouf Ketata ◽  
Taieb Ben Romdhane ◽  
Samir Ben Ahmed
Keyword(s):  
Quality Management ◽  
Management System ◽  
Quality Management System ◽  
Multi Agent

Competency management of laboratory personnel using LIMS

2020 ◽  
Vol 10 (6) ◽  
pp. 636-641
Author(s):  
Konstantin S. Varaksin ◽  
◽  
Artem S. Makarov ◽  
Alexander Y. Lyapin ◽  
◽  
...  
Keyword(s):  
Quality Management ◽  
Management System ◽  
Quality Management System ◽  
Information Management System ◽  
Test System ◽  
Test Methods ◽  
Laboratory Activities ◽  
Resource Requirements ◽  
Laboratory Workers ◽  
Competence Test

The updated edition of the ISO/IEC 17025 standard introduced significant changes to the structure, terminology, resource requirements, processes, quality management system of testing and calibration laboratories. New requirements were established for the organization of laboratory activities – a process approach and risk-based thinking, which provides for a reduction in part of the prescriptive requirements and the introduction of requirements based on the analysis of the performance of actions. In accordance with GOST ISO IEC 17025-2019, the laboratory must authorize personnel to perform specific laboratory activities, as well as guarantee their competence. This article discusses the organization of the competence management system for the personnel of the laboratories of the organizations of Transneft system using the laboratory information management system (LIMS). The model of the process implementation has been described. It has been established that the competence test system allows you to regularly monitor the skills and knowledge of laboratory workers both in terms of the elements of the Quality Management System and in the applied measurement (test) methods. The personnel responsibility matrix implemented in LIMS regulates the powers and functionality of employees, ensuring that employees are allowed to perform work in accordance with their competence. The functions implemented in LIMS made it possible to automate the management of the competence of laboratory workers in accordance with the requirements of GOST ISO/IEC 17025-2019 and other regulatory documents.

Gestión de riesgos empresariales: los necesarios cambios

Oikos ◽  
2016 ◽  
Vol 19 (39) ◽  
pp. 93 ◽  
Author(s):  
Ricardo Vega Bois
Keyword(s):  
Risk Management ◽  
Quality Management ◽  
Management System ◽  
Quality Management System ◽  
Iso 9000 ◽  
Management Control ◽  
System Requirements ◽  
Requirements Quality ◽  
Management Recommendations ◽  
Environmental Audits

RESUMENLa normas de la serie ISO 9000 – 2000, Sistema de Gestión de Calidad, Requisitos de un Sistema de Gestión de Calidad, Recomendaciones para la mejora de desempeño en base a un Sistema de Gestión de calidad y Directrices para la realización de auditorías medioambientales y de calidad, han sido base para la evaluación, implementación, aplicación y seguimiento de sistemas de Control de Gestión Empresarial, estando en la actualidad (2015) en un procesos de revisión y propuesta, lo que implicará algunos cambios de forma y otros de fondo interesantes de considerar.Palabras clave: gestión, riesgos, control de gestión, calidad, normas internacionales.Enterprise risk management: the necessary changesABSTRACTThe standards ISO 9000 - 2000 Quality Management System, System Requirements Quality Management Recommendations for improving performance based on a Quality Management System and Guidelines for conducting environmental audits and quality have been the basis for evaluation, implementation, enforcement and monitoring systems Control Management, being at present (2015) in a review and proposal processes, which involve some changes in form and other interesting background consider.Keywords: management, risk, management control, quality international standards.Gestão de riscos empresariais: as mudanças necessárias RESUMO As normas da série ISO 9000-2000, Sistema de Gestão da Qualidade, Requisitos de um Sistema de Gestão de Qualidade, Recomendações para a melhora do desempenho com base a um Sistema de Gestão da Qualidade e Diretrizes para a realização de auditorias meio ambientais e de qualidade, têm sido a base para a avaliação, implementação, aplicação e fiscalização de Sistemas de Controle de Gestão Empresarial, sendo na atualidade (2015) num processo de revisão e proposta, que implicará algumas mudanças na forma e outros de fundo interessante de considerar.Palavras-chave: gestão, risco, controle de gestão, qualidade, normas internacionais.

Effective service delivery through quality management system (QMS) in oil and gas servicing companies, a case study of selected firms, Port Harcourt

2019 ◽  
Author(s):  
Chem Int
Keyword(s):  
Quality Management ◽  
Service Delivery ◽  
Management System ◽  
Oil And Gas ◽  
Quality Management System ◽  
Local Content ◽  
Port Harcourt ◽  
Test Of Hypotheses ◽  
The Impact ◽  
Effective Service

This study investigated the impact of Quality Management System (QMS) on effective service delivery in Oil and Gas Servicing Companies in selected firms in Port Harcourt, Nigeria. The opinion of 50 respondents were sampled using questionnaires, interviews as well as observation from journals and texts used in this work to examine the Quality Management System (QMS) of the selected firms. Using simple percentages and the Chi-square (X2) test of hypotheses, it was hypothetically established that the implementation of QMS practices, has impacted the work process, procedure and improvement on quality over the years in the Oil and Gas Servicing companies in Port Harcourt Nigeria. The research identified an adopted use of Failure Mode and Effect Analysis (FMEA) tool as a continual quality improvement initiative developed in the local content oil and gas servicing operation for equipment handling, management and to drive sustained improved performance quality processes as a key driver of a progressive that will place local content companies as an options for producing companies and at par with multinational oil and gas companies.

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