Quality Systems, Quality Control and Testing

2018 ◽  
pp. 317-360
Author(s):  
Evan W. Duggan ◽  
Richard Gibson

The growing attendance at seminars and conferences dedicated to quality programs attests to the increasing recognition of the continued importance of quality. Unfortunately, in many organizations, this intensified quality focus has not been effectively applied to information systems — a surprising outcome given the many demonstrations of a direct relationship between information systems delivery process and information systems quality and success. In this chapter, we analyze process-centered contributions and solutions to the increasing challenges of producing high-quality systems. We provide a balanced overview of evidence that has emerged from practical, real-world experiences and empirical research studies, an overview that incorporates the positions of both proponents and opponents of process-centricity. We then provide an assessment of the contexts in which software process improvements and quality- enhancing initiatives can thrive.


1994 ◽  
Vol 77 (3) ◽  
pp. 785-789
Author(s):  
Miguel Valcárcel ◽  
Angel Ríos

Abstract After a brief introduction to the generic aspects of automation in analytical laboratories, the different approaches to quality in analytical chemistry are presented and discussed to establish the following different facets emerging from the combination of quality and automation: automated analytical control of quality of products and systems; quality control of automated chemical analysis; and improvement of capital (accuracy and representativeness), basic (sensitivity, precision, and selectivity), and complementary (rapidity, cost, and personnel factors) analytical features. Several examples are presented to demonstrate the importance of this marriage of convenience in present and future analytical chemistry.


2012 ◽  
Vol 2 (1) ◽  
pp. 51-64
Author(s):  
Aikaterini-Lampro N. Salvara ◽  
Sofia D. Kordolaimi ◽  
Maria E. Lyra

1998 ◽  
Vol 11 (2) ◽  
pp. 65-70 ◽  
Author(s):  
J.D. van der Bij ◽  
T. Vollmar ◽  
M.C.D.P. Weggeman

Many views on quality management in professional service firms derived from ideas of industrial quality management. It seems that in the area of professional services these ideas are taken over without much criticism. For instance, the ideas on quality control and quality assurance generally are heavily based on the ISO 9000 standards. In The Netherlands the PACE‐standards have been deduced from the ISO 9000 standards for application in hospitals. In this paper it has been argued that in many cases a more situational approach will be preferable. A global framework for a quality system in a professional service firm has been presented.This framework has been compared with the restrictions for quality systems in hospitals, following from the PACE‐standards.


2020 ◽  
Vol 66 (1) ◽  
pp. 91-101
Author(s):  
Mirela Ilikj ◽  
Irena Brchina ◽  
Liljana Ugrinova ◽  
Vasil Karcev ◽  
Aleksandra Grozdanova

In 2015, in Republic of North Macedonia, a new law for narcotics has been adopted, where the changes include legal cultivation of cannabis for medicinal use as well as legal production of cannabis extracts for medicinal use. In order to gain high quality of cannabis and cannabis products for medicinal use and to meet some quality standards that will guarantee consistency, traceability and continuous quality of the product, it is necessary to implement Quality Systems. Good quality system is ISO standard system but for cannabis for medicinal use, GACP, GMP and GLC standards are used more often. Production of cannabis for medicinal use consists of: process of cultivation where GACP standards are applicable, primary processing where GMP standards are the most important and quality control of final product regulated with GLP standard. In this review, explanation of these standards as well as overview of modes of their implementation has been made. Keywords: GxP, GMP, GACP, GLP


1991 ◽  
Vol 74 (5) ◽  
pp. 863-868
Author(s):  
Mary G Schultz ◽  
William L Brown

Abstract An effective quality management system in the analytical laboratory must be designed to satisfy customers' needs and expectations while serving the laboratory's interests. An understanding of total quality and its components Is essential for the development of a quality management system In the analytical laboratory. Quality systems are founded on quality laboratory practices; they have a strong quality control component, and, more recently, monitoring through quality assurance. Development of a quality Improvement component with more emphasis on quality planning Is also needed to provide the necessary system for quality management


2021 ◽  
pp. bmjqs-2020-012751
Author(s):  
Morgane Clarke ◽  
Chiara Pittalis ◽  
Eric Borgstein ◽  
Leon Bijlmakers ◽  
Mweene Cheelo ◽  
...  

BackgroundIn low-income and middle-income countries, an estimated one in three clinical adverse events happens in non-complex situations and 83% are preventable. Poor quality of care also leads to inefficient use of human, material and financial resources for health. Improving outcomes and mitigating the risk of adverse events require effective monitoring and quality control systems.AimTo assess the state of surgical monitoring and quality control systems at district hospitals (DHs) in Malawi, Tanzania and Zambia.MethodsA mixed-methods cross-sectional study of 75 DHs: Malawi (22), Tanzania (30) and Zambia (23). This included a questionnaire, interviews and visual inspection of operating theatre (OT) registers. Data were collected on monitoring and quality systems for surgical activity, processes and outcomes, as well as perceived barriers.Results53% (n=40/75) of DHs use more than one OT register to record surgical operations. With the exception of standardised printed OT registers in Zambia, the register format (often handwritten books) and type of data collected varied between DHs. Monthly reports were seldom analysed by surgical teams. Less than 30% of all surveyed DHs used surgical safety checklists (n=22/75), and <15% (n=11/75) performed surgical audits. 73% (n=22/30) of DHs in Tanzania and less than half of DHs in Malawi (n=11/22) and Zambia (n=10/23) conducted surgical case reviews. Reports of surgical morbidity and mortality were compiled in 65% (n=15/23) of Zambian DHs, and in less than one-third of DHs in Tanzania (n=9/30) and Malawi (n=4/22). Reported barriers to monitoring and quality systems included an absence of formalised guidelines, continuous training opportunities as well as inadequate accountability mechanisms.ConclusionsSurgical monitoring and quality control systems were not standard among sampled DHs. Improvements are needed in standardisation of quality measures used; and in ensuring data completeness, analysis and utilisation for improving patient outcomes.


1997 ◽  
Vol 43 (5) ◽  
pp. 893-896 ◽  
Author(s):  
David L Phillips

Abstract Unit-use testing or single-test-system analysis has existed for many years. Quality-control and quality-assurance procedures have generally used conventional methods and lyophilized or aqueous control materials. Because these materials were readily available and generally accepted, they became part of the quality-assurance program for many early unit-use test systems such as the DuPont aca®. Over the years, these control products became standard and are now required as part of good laboratory practice. Technically speaking, however, conventional quality-control methods and materials cannot completely control the test system when used in a unit-use or single-test-system device. When conventional control material is run on a unit-use single-test system, only that testing unit is checked. One cannot test every unit with control material because by definition these are single-test systems: Once the control has been run, the patient’s sample cannot be run. Conventional quality-assurance and quality-control methods do not, of themselves, assure quality. A one-size-fits-all, or “two levels per day of use” as outlined in the CLIA ’88 regulations, is not appropriate. The divergence between HCFA-approved practices and those of the deemed agencies, coupled with the financial aspects of this quality-control method, led to the formation of the Subcommittee on Unit Use Testing of the National Committee on Clinical Laboratory Standards to develop guidelines for manufacturers, users, and regulators to use in developing new quality systems.


Sign in / Sign up

Export Citation Format

Share Document