scholarly journals Implementing a quality management system using good clinical laboratory practice guidelines at KEMRI-CMR to support medical research

2018 ◽  
Vol 3 ◽  
pp. 137 ◽  
Author(s):  
Horace Gumba ◽  
Joseph Waichungo ◽  
Brett Lowe ◽  
Alfred Mwanzu ◽  
Robert Musyimi ◽  
...  
Keyword(s):  
Quality Management ◽  
Medical Research ◽  
Management System ◽  
Quality Management System ◽  
Clinical Laboratory ◽  
Research Programme ◽  
Good Clinical Practice ◽  
Laboratory Practice ◽  
Laboratory Personnel ◽  
Middle Income

Background: Good Clinical Laboratory Practice (GCLP) is a standard that helps ensure the quality and reliability of research data through principles of Good Laboratory Practice (GLP) and Good Clinical Practice (GCP). The implementation of GCLP includes careful documentation of procedures, competencies and safety measures. Implementation of GCLP is influenced by existing resources and quality systems, thus laboratories in low- and middle-income countries may face additional challenges. Methods: This paper describes implementation of Good Clinical Laboratory Practice (GCLP) at the Kenya Medical Research Institute-Center for Microbiology Research (KEMRI-CMR) as part of a quality system to support medical research. This study employed assessment, twinning (institutional mentorship) model, conducting relevant training workshops and Kaizen 5S approaches to implement an effective quality management system using GCLP standard. This was achieved through a collaboration between the KEMRI/Wellcome Trust Research Programme (KWTRP) and KEMRI-CMR. The aim was compliance and continuous monitoring to meet international GCLP standards in a way that could be replicated in other research organizations. Results: Following a baseline assessment in March 2017, training, mentorship and a cycle of quality audit and corrective action using a Kaizen 5S approach (sorting, setting in order, shining, standardizing and sustaining) was established. Laboratory personnel were trained in writing standard operating procedures and analytical plans, microbiological techniques, and good documentation practice. Mid-term and exit assessments demonstrated significant declines in non-conformances across all GCLP elements. KEMRI-CMR achieved GCLP accreditation in May 2018 by Qualogy Ltd (UK). Conclusions: Involving all the laboratory personnel in implementation of quality management system processes is critical to success. An institutional mentorship (twinning) approach shows potential for future collaborations between accredited and non-accredited organizations to accelerate the implementation of high-quality management systems and continuous improvement.

scholarly journals Implementing a quality management system using good clinical laboratory practice guidelines at KEMRI-CMR to support medical research

2019 ◽  
Vol 3 ◽  
pp. 137 ◽  
Author(s):  
Horace Gumba ◽  
Joseph Waichungo ◽  
Brett Lowe ◽  
Alfred Mwanzu ◽  
Robert Musyimi ◽  
...  
Keyword(s):  
Quality Management ◽  
Medical Research ◽  
Management System ◽  
Quality Management System ◽  
Clinical Laboratory ◽  
Research Programme ◽  
Good Clinical Practice ◽  
Laboratory Practice ◽  
Laboratory Personnel ◽  
Middle Income

Background: Good Clinical Laboratory Practice (GCLP) is a standard that helps ensure the quality and reliability of research data through principles of Good Laboratory Practice (GLP) and Good Clinical Practice (GCP). The implementation of GCLP includes careful documentation of procedures, competencies and safety measures. Implementation of GCLP is influenced by existing resources and quality systems, thus laboratories in low- and middle-income countries may face additional challenges. Methods: This paper describes implementation of GCLP at the Kenya Medical Research Institute-Center for Microbiology Research (KEMRI-CMR) as part of a quality system to support medical research. This study employed assessment, twinning (institutional mentorship) model, conducting relevant training workshops and Kaizen 5S approaches to implement an effective quality management system using GCLP standard. This was achieved through a collaboration between the KEMRI/Wellcome Trust Research Programme (KWTRP) and KEMRI-CMR. The aim was compliance and continuous monitoring to meet international GCLP standards in a way that could be replicated in other research organizations. Results: Following a baseline assessment in March 2017, training, mentorship and a cycle of quality audit and corrective action using a Kaizen 5S approach (sorting, setting in order, shining, standardizing and sustaining) was established. Laboratory personnel were trained in writing standard operating procedures and analytical plans, microbiological techniques, and good documentation practice. Mid-term and exit assessments demonstrated significant declines in non-conformances across all GCLP elements. KEMRI-CMR achieved GCLP accreditation in May 2018 by Qualogy Ltd (UK). Conclusions: Involving all the laboratory personnel in implementation of quality management system processes is critical to success. An institutional mentorship (twinning) approach shows potential for future collaborations between accredited and non-accredited organizations to accelerate the implementation of high-quality management systems and continuous improvement.

scholarly journals The experience of involvement of personnel of the medical research organization into management of its functioning

2019 ◽  
Vol 61 (1) ◽  
pp. 22-28
Author(s):  
G. V. Artamonova ◽  
Yana V. Danil’Chenko ◽  
D. V. Karas’ ◽  
T. S. Kostomarova ◽  
D. V. Kryuchkov ◽  
...  
Keyword(s):  
Quality Management ◽  
Medical Research ◽  
Management System ◽  
Quality Management System ◽  
Vascular Diseases ◽  
Iso 9001 ◽  
Active Involvement ◽  
Complex Problems ◽  
Cardio Vascular ◽  
Research Institute

The active involvement of personnel to management of functioning of organization at all levels has an economic usefulness and social value. The article presents experience of involvement of personnel into management as exemplified by medical research organization using international tool standard ISO 9001. Purpose ofstudy. To represent experience of involvement ofpersonnel to management of functioning research medical organization by force of implementation of quality management system corresponding to requirements of ISO 9001. The system ofmanagement ofmain types of functioning ofthe research institute of complex problems of cardio-vascular diseases was used as a study object. The worker of organization as a subject of management system was used as a unit of observation. Out of personnel of organization was organized a team of leaders trained to quality management. The model of quality management in the research institute of complex problems of cardio-vascular diseases was presented by such processes as research and curative diagnostic activities. The workers in a different way assess usefulness of implementation of quality management system for their professional work - positive responses gave 26% of junior medical personnel and up to 77% of administrators. This occurrence indicates to different purposes of involvement of personnel to management. The experience of implementation of quality management system in the research institute of complex problems of cardio-vascular diseases testifies that work ofpersonnel of any professional category in one way or another impact the achievement of targets of organization. At the expense of active involvement of personnel to process of management of activities the organization ameliorates its functioning on systemic level. To comprehend usefulness of quality management system by members of particular professional groups it is expedient to develop and implement innovative methods of personal interest in the results of work considering characteristics of particular team, its targets and aims in the area of quality.

scholarly journals Experiences with the accreditation of the Institute for Medical Research and Occupational Health, Zagreb, Croatia

2020 ◽  
Vol 71 (4) ◽  
pp. 312-319
Author(s):  
Zdenko Franić ◽  
Tomislav Bituh ◽  
Ranka Godec ◽  
Mirjana Čačković ◽  
Tomislav Meštrović ◽  
...  
Keyword(s):  
Quality Management ◽  
Occupational Health ◽  
Medical Research ◽  
Radiation Protection ◽  
Management System ◽  
Quality Management System ◽  
Ambient Air ◽  
Objective Evidence ◽  
Accreditation Agency ◽  
Calibration Laboratories

AbstractAccreditation in accordance with the international General Requirements for the Competence of Testing and Calibration Laboratories (HRN EN ISO/IEC 17025 standard) has become a widely accepted method of quality management and objective evidence of technical competence, knowledge, and skills of testing and calibration laboratories. In 2010, the Institute for Medical Research and Occupational Health (IMROH) had its management system accredited against the HRN EN ISO/IEC 17025 standard for the following scopes: determination of radioactivity, testing of ambient air quality, and testing in the scope of ionising radiation protection. This accreditation encompassed three laboratories: Radiation Protection Unit, Environmental Hygiene Unit, and the Radiation Dosimetry and Radiobiology Unit. In accordance with the rules of the Croatian Accreditation Agency, the second re-accreditation is due in 2020. This paper describes and discusses the quality management system at IMROH over the ten years of its implementation. We share our experiences about non-conformities discovered during regular work, internal audits, and external audits performed by the Croatian Accreditation Agency. The accredited management system significantly improved the performance of the accredited units, and the Institute increased its visibility and marketing advantage, consequently improving its market position.

Audits and inspections

2016 ◽  
Keyword(s):  
Clinical Trial ◽  
Quality Management ◽  
Clinical Research ◽  
Management System ◽  
Quality Management System ◽  
Detailed Comparison ◽  
Good Clinical Practice ◽  
Quality Data ◽  
Audit Process ◽  
Inspection Process

Audits and inspections are a vital and well recognised part of the clinical trial process. The requirement for quality data is recognised by everyone who works in clinical research. The ability to maintain accuracy and quality throughout a clinical trial is a dynamic process which involves both ongoing quality control (QC) steps and systematic and independent quality assurance (QA). This chapter starts by outlining the comparison between QC and QA and how these important processes form part of a Quality Management System (QMS) for an organisation. Additionally, we cannot begin to start discussing aspects of quality in clinical research without thinking about Good Clinical Practice (GCP) and this is frequently referenced throughout the chapter. Establishing a QA Unit, especially in the healthcare environment can be daunting. There always seems to be so many priorities and there are often pressures from within the organisation or from other teams for your help and support. It is important to allocate resources carefully to ensure the QA Unit is effective. By having an effective Quality Management System and a QA programme of effectual audits means that a range of possible risks may be prevented. Study-specific audits looking particularly at site audits are discussed as well as a systems based approach which is more common in larger QA Units. The audit process is reviewed in detail for both internal and external audits. Finally, inspection preparation, the inspection process and a detailed comparison of EMA, FDA and MHRA regulations used by inspectors is presented.

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