What is the Relationship Between Quality, Quality Assurance and the Section III Design Specification

2014 ◽  
Author(s):  
Richard W. Barnes
Keyword(s):  
Quality Assurance ◽  
Management System ◽  
Quality Management System ◽  
Quality Assurance Program ◽  
System Quality ◽  
Design Specification ◽  
Quality Product ◽  
Definition Of ◽  
First Time ◽  
The Relationship

This paper explores the relationship between the Design Specification required for each Section III component and the terms Quality, Quality Assurance, Quality Product, and Management System (Quality Management System). The author’s experience indicates that the relationship between Quality and Quality Assurance is poorly understood and that the resistance experienced to the implementation of a Quality Assurance Program is often due to the person’s lack of understanding that a Quality Assurance Program really does help people do their work “right the first time”. This lack of understanding often results in poorly defined requirements in the purchasing documents, inadequate definition of scope and a product that does not meet requirements. Even more importantly it can lead to the development of poor relationships between the purchaser and the supplier and particularly in the nuclear field, poor relationships with Regulators. The economic impact is also significant, delays in schedule, delays in product acceptance and payment results in costs that are eventually passed on to the consumer. Once the above relationships are properly understood and appreciated resistance can turn into positive acceptance. The Section III concept of providing a Design Specification as a complete basis for construction also takes on new meaning.

scholarly journals Employee engagement and improvement as important principles of TQM in public health institutes

2020 ◽  
Vol 8 (1) ◽  
pp. 189-201
Author(s):  
Ana-Marija Vrtodušić Hrgović ◽  
Kristina Črnjar ◽  
Ivana Škarica
Keyword(s):  
Public Health ◽  
Quality Assurance ◽  
Quality Management ◽  
Employee Engagement ◽  
Management System ◽  
Quality Management System ◽  
Customer Focus ◽  
Internal Customer ◽  
The Relationship

Quality assurance in public health presents one of the key factors in the quality of health service. Accordingly, there is increasing awareness of the need to integrate quality systems and their principles into the healthcare system. Their role is important in the context of quality assurance in accordance with patient requirements as well as in the process of improving the quality of health care service. They are essential for the successful implementation of a quality management system and refer to customer focus, leadership, engagement of people, process approach, improvement, evidence–based decision making, and relationship management. This paper presents the results of a study among Croatian Institutes of Public Health with regard to the level of implementation of quality principles related to employee engagement, improvement and internal customer focus. Analysis focused on the relationship between focus on internal customer (employees) and improvements as well as the employee engagement and improvement respectively. Results show there is a strong positive relationship between employee engagement and improvements, while between internal customer focus and improvement the relationship has not been verified. In the context of standardization of quality of public health services, the paper aims to expand theoretical knowledge about TQM principles, with the emphasis on the employee engagement, internal customer focus (employees) and process improvement. The results can serve as a basis for improving the existing practice of quality management system implementation in the public health sector, with emphasis on employees.

scholarly journals New Challenges for Biobanks: Accreditation to the New ISO 20387:2018 Standard Specific for Biobanks

BioTech ◽  
2021 ◽  
Vol 10 (3) ◽  
pp. 13
Author(s):  
Pasquale De Blasio ◽  
Ida Biunno
Keyword(s):  
Performance Monitoring ◽  
Quality Management System ◽  
Internal Audit ◽  
Accreditation Body ◽  
Accreditation Process ◽  
Testing Facility ◽  
Collection Data ◽  
Definition Of ◽  
First Time ◽  
Operational Aspects

Background: The emergence of “multi-omics” and “multi-parametric” types of analysis based on a high number of biospecimens enforces the use of a great number of high-quality “Biological Materials and Associated Data” (BMaD). To meet the demands of biomedical research, several Biological Resource Centers (BRCs) or Biobanks world-wide have implemented a specific Quality Management System (QMS) certified ISO 9001:2015 or accredited by CAP9 ISO 20387:2018. For the first time, ISO, with the support of several Biobanking experts, issued the ISO 20387:2018 which is the first ISO norm specific for Biobanks. The fundamental difference with present certification/accreditation standards is that the ISO 20387:2018 focuses not only on the operational aspects of the Biobank, but also on the “competence of the Biobank to carry our specific Biobanking tasks”. Methods: The accreditation process for ISO 20387:2018 required the definition of: (1) objectives, goals and organizational structure of the Biobank, including procedures for governance, confidentiality and impartiality policies; (2) standard operating procedures (SOPs) of all activities performed, including acquisition, analysis, collection, data management, distribution, preparation, preservation, testing facility and equipment maintenance, calibration, and monitoring; (3) procedures for control of documents and records, the identification of risks and opportunities, improvements, corrective actions, nonconforming records and evaluation of external providers (4) an internal audit and management reviews, verification of QMS performance, monitoring of quality objectives and personnel qualification and competency in carrying out specific Biobanking tasks. Results: The accreditation process is performed by an independent authorized organization which certifies that all processes are performed according to the QMS, and that the infrastructure is engineered and managed according to the GDP and/or GMP guidelines. Conclusion: Accreditation is given by an accreditation body, which recognizes formally that the Biobank is “competent to carry out specific Biobanking tasks”.

scholarly journals Profitability and leverage in eco-efficiency and quality management system for increasing the firms’ performance

2020 ◽  
Vol 22 (3) ◽  
Author(s):  
Budiman Sutrisno ◽  
Wendy Wendy
Keyword(s):  
Quality Management ◽  
Management System ◽  
Quality Management System ◽  
Stock Exchange ◽  
Multiple Linear Regression Model ◽  
Moderating Effect ◽  
Management Systems ◽  
Moderating Effects ◽  
Quality Management Systems ◽  
The Relationship

This research aims to analyze the moderating effects of profitability and leverage on the relationship between the quality management system and eco-efficiency toward the firm’s performance. The research sample consists of 75 firms listed on the Indonesia Stock Exchange as of 2017. Data concerning eco-efficiency and the quality management system are collected from the firm's annual report. This research utilizes a multiple linear regression model. The result shows that eco-efficiency and quality management system do not affect the firm’s performance. Profitability has a negative and significant moderating effect on the relationship between eco-efficiency toward the firm’s performance. Further, the moderating variable also positively and significantly moderates the relationship between the quality management system and the firm's performance. Leverage, on the other hand, is found to have no moderating effect on the relationship between eco-efficiency and quality management systems toward the firm's performance.  This study contributes and extends previous research by exploring eco-efficiency and quality management systems toward the firm’s performance simultaneously. Besides, it also examines the moderating relation of profitability and leverage in relationship with eco-efficiency and quality management system toward a firm's performance by using the sample from all firms which are listed on the Indonesia Stock Exchange and have implemented the system.

Development of the organization’s personnel management process

2020 ◽  
pp. 40-46
Author(s):  
A.M. Rodomanova
Keyword(s):  
Quality Management ◽  
Management System ◽  
Human Factor ◽  
Quality Management System ◽  
Management Process ◽  
Human Resource Management System ◽  
Resource Management System ◽  
Tools And Techniques ◽  
The Relationship

Modern trends in the human resource management system in order to improve the efficiency of the company and increase the productivity of personnel contain different tools and techniques. The study of the quality management system of enterprises revealed the relationship between the concept and strategy of the company’s development and personnel policy and identified the theses that contribute to positive changes in the field of employee management. The article analyzes the internal determination of the appropriate methodology, taking into account the characteristics of employees and the human factor.

A Quality Assurance System in a Pervasive Computing Environment

2010 ◽  
pp. 61-76
Author(s):  
Amitava Mitra
Keyword(s):  
Decision Making ◽  
Quality Assurance ◽  
Quality Management ◽  
Customer Satisfaction ◽  
Management System ◽  
Quality Management System ◽  
Quality Assurance System ◽  
Management Objectives ◽  
Product Service

As the competition for products and services continues to grow, with customer satisfaction playing an integral part in this process, organizations are faced with the task of ensuring quality in all of their activities. Since many organizations do not necessarily produce the entire product or deliver the service by themselves, they are dependent on other vital sources, for example, suppliers, that impact quality of the finished product/service. This necessitates development and implementation of a quality management system which can integrate information from the various entities to facilitate decision making in a timely manner. Additionally, it is desirable for such a quality management system to be responsive to the existing quality environment at the various sources that contribute to the manufacture of the product or delivery of the service. This chapter provides a foundation for accomplishing such quality management objectives.

Quality and Managerial Issues

2013 ◽  
pp. 591-614
Author(s):  
Gavin P Spickett
Keyword(s):  
Quality Control ◽  
Quality Assurance ◽  
Quality Management ◽  
Management System ◽  
Regulatory Authority ◽  
Quality Management System ◽  
Clinical Pathology ◽  
Eqa Schemes

Introduction Structure of the NHS and the NHS plan Clinical Pathology Accreditation (CPA) Medicines and Healthcare Products Regulatory Authority (MHRA) Quality management system (QMS) Concepts of quality assurance in the laboratory Quality control (internal) Quality control (external) 1: EQA schemes Quality control (external) 2: benchmarking and CE marking...

scholarly journals The Importance of the Laboratory Quality Management System in the Academic Curriculum in Developing Appropriate Student Competences for Our Current Societal Needs

Proceedings ◽  
2020 ◽  
Vol 55 (1) ◽  
pp. 7
Author(s):  
Cecilia Arsene ◽  
Simona Maria Cucu Man ◽  
Romeo Iulian Olariu
Keyword(s):  
Quality Assurance ◽  
Quality Management ◽  
Chemical Analysis ◽  
Management System ◽  
Quality Management System ◽  
Analytical Quality ◽  
Analytical Quality Assurance ◽  
Academic Curriculum ◽  
Societal Needs ◽  
Analysis Laboratory

Laboratory quality management system is a concept of utmost importance for industry and other economic sectors. Nowadays, even for university laboratories it is possible to have accredited tests according to standard ISO/IEC 17025. This paper demonstrates a way of evaluating the potential of academic experts to integrate successfully the quality management systems of a chemical analysis laboratory in the teaching process. However, designing an appropriate academic curriculum responding to our current societal needs is still very challenging. In teaching and developing practical competences in analytical quality assurance, training offered to students in aspects related to the validation of an analytical method including performance characteristics such as selectivity and specificity, linear range, sensitivity, limit of detection, limit of quantification, ruggedness, accuracy, precision, etc., are primary steps in the process of a complete understanding of quality management system topics. This contribution presents a compilation of the most important current developments in a university chemical analysis laboratory with good results in developing theoretical and practical skills in analytical quality assurance for students, graduates and postgraduates alike. Teaching students with an interdisciplinary approach allows them to gain knowledge in making connections between disciplines and theories, between practical problems and accumulated knowledge, and between society’s assumptions, expectations, and needs.

scholarly journals Total Quality Management System and Organisation Performance: Mediating Effect of Organisational Learning in Nepali Service Sector

2019 ◽  
Vol 4 (1) ◽  
pp. 39-60
Author(s):  
Tina Rawal Saud
Keyword(s):  
Quality Management ◽  
Total Quality Management ◽  
Management System ◽  
Service Sector ◽  
Quality Management System ◽  
Mediating Effect ◽  
Significant Positive Effect ◽  
Total Quality ◽  
The Relationship ◽  
Positive Effect

The main objective of this study was to examine the effect of total quality management system (TQM) on organisation performance along with the mediating effect of organisation learning in Nepali Service sector. The relationship between the TQM system, organisation learning and organisation performance was examined using Pearson correlation coefficient and regression analysis was conducted to test the hypotheses. Data was collected from 240 respondents (i.e., 118 from the ISO certified and 122 from non-ISO certified organisations). The findings of this study suggested that total quality management system had a significant positive effect on organisation performance and organisation learning mediated the relationship between total quality management system and organisation performance. Out of the seven dimensions of the TQM system only top management support, workforce management, customer relations, supplier quality management and process flow management had a significant positive effect on organisation performance. The results of the independent sample t-test further confirmed the high level of organisation performance in ISO certified organisations.

scholarly journals Development and Implementation of the Quality Management System as Applied to the Production of Medical Immunobiological Preparations at the Russian Research Anti-Plague Institute Microbe

2012 ◽  
pp. 96-98
Author(s):  
O. A. Lobovikova ◽  
I. V. Shul'gina ◽  
A. K. Nikiforov
Keyword(s):  
Quality Control ◽  
Quality Assurance ◽  
Quality Management ◽  
Russian Federation ◽  
Management System ◽  
Quality Management System ◽  
Iso 9001 ◽  
Design And Implementation ◽  
Factors Influencing ◽  
Russian Research

Developed are the methodical approaches for design and implementation of quality management system(QMS) in the production of preventive and diagnostic medical immunobiological preparations manufactured at the Russian Research Anti-Plague Institute Microbe. Analyzed and generalized is the current legislative-normative framework of Russian Federation in the sphere of quality control and quality assurance. Factors influencing the quality management system are revealed. QMS is certified in conformity with the requirements of international standard ISO 9001.

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