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Practical considerations for laboratories: Implementing a holistic quality management system

A laboratory quality management system (LQMS) is an essential element for the effective operation of research, clinical, testing, or production/manufacturing laboratories. As technology continues to rapidly advance and new challenges arise, laboratories worldwide have responded with innovation and p...

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Autores principales: Pillai, Segaran, Calvert, Jennifer, Fox, Elizabeth
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Frontiers Media S.A. 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9670165/
https://www.ncbi.nlm.nih.gov/pubmed/36406233
http://dx.doi.org/10.3389/fbioe.2022.1040103
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author Pillai, Segaran
Calvert, Jennifer
Fox, Elizabeth
author_facet Pillai, Segaran
Calvert, Jennifer
Fox, Elizabeth
author_sort Pillai, Segaran
collection PubMed
description A laboratory quality management system (LQMS) is an essential element for the effective operation of research, clinical, testing, or production/manufacturing laboratories. As technology continues to rapidly advance and new challenges arise, laboratories worldwide have responded with innovation and process changes to meet the continued demand. It is critical for laboratories to maintain a robust LQMS that accommodates laboratory activities (e.g., basic and applied research; regulatory, clinical, or proficiency testing), records management, and a path for continuous improvement to ensure that results and data are reliable, accurate, timely, and reproducible. A robust, suitable LQMS provides a framework to address gaps and risks throughout the laboratory path of workflow that could potentially lead to a critical error, thus compromising the integrity and credibility of the institution. While there are many LQMS frameworks (e.g., a model such as a consensus standard, guideline, or regulation) that may apply, ensuring that the appropriate framework is adopted based on the type of work performed and that key implementation steps are taken is important for the long-term success of the LQMS and for the advancement of science. Ultimately, it ensures accurate results, efficient operations, and increased credibility, enabling protection of public health and safety. Herein, we explore LQMS framework options for each identified laboratory category and discuss prerequisite considerations for implementation. An analysis of frameworks’ principles and conformity requirements demonstrates the extent to which they address basic components of effective laboratory operations and guides optimal implementation to yield a holistic, sustainable framework that addresses the laboratory’s needs and the type of work being performed.
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spelling pubmed-96701652022-11-18 Practical considerations for laboratories: Implementing a holistic quality management system Pillai, Segaran Calvert, Jennifer Fox, Elizabeth Front Bioeng Biotechnol Bioengineering and Biotechnology A laboratory quality management system (LQMS) is an essential element for the effective operation of research, clinical, testing, or production/manufacturing laboratories. As technology continues to rapidly advance and new challenges arise, laboratories worldwide have responded with innovation and process changes to meet the continued demand. It is critical for laboratories to maintain a robust LQMS that accommodates laboratory activities (e.g., basic and applied research; regulatory, clinical, or proficiency testing), records management, and a path for continuous improvement to ensure that results and data are reliable, accurate, timely, and reproducible. A robust, suitable LQMS provides a framework to address gaps and risks throughout the laboratory path of workflow that could potentially lead to a critical error, thus compromising the integrity and credibility of the institution. While there are many LQMS frameworks (e.g., a model such as a consensus standard, guideline, or regulation) that may apply, ensuring that the appropriate framework is adopted based on the type of work performed and that key implementation steps are taken is important for the long-term success of the LQMS and for the advancement of science. Ultimately, it ensures accurate results, efficient operations, and increased credibility, enabling protection of public health and safety. Herein, we explore LQMS framework options for each identified laboratory category and discuss prerequisite considerations for implementation. An analysis of frameworks’ principles and conformity requirements demonstrates the extent to which they address basic components of effective laboratory operations and guides optimal implementation to yield a holistic, sustainable framework that addresses the laboratory’s needs and the type of work being performed. Frontiers Media S.A. 2022-11-03 /pmc/articles/PMC9670165/ /pubmed/36406233 http://dx.doi.org/10.3389/fbioe.2022.1040103 Text en Copyright © 2022 Pillai, Calvert and Fox. https://creativecommons.org/licenses/by/4.0/This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
spellingShingle Bioengineering and Biotechnology
Pillai, Segaran
Calvert, Jennifer
Fox, Elizabeth
Practical considerations for laboratories: Implementing a holistic quality management system
title Practical considerations for laboratories: Implementing a holistic quality management system
title_full Practical considerations for laboratories: Implementing a holistic quality management system
title_fullStr Practical considerations for laboratories: Implementing a holistic quality management system
title_full_unstemmed Practical considerations for laboratories: Implementing a holistic quality management system
title_short Practical considerations for laboratories: Implementing a holistic quality management system
title_sort practical considerations for laboratories: implementing a holistic quality management system
topic Bioengineering and Biotechnology
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9670165/
https://www.ncbi.nlm.nih.gov/pubmed/36406233
http://dx.doi.org/10.3389/fbioe.2022.1040103
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