The Quality Unit

 

The Quality Unit at the Mycetoma Research Centre (MRC) plays a vital role as a specialised oversight body committed to upholding the highest standards of quality, reliability, compliance, and safety across all aspects of the Centre’s multifaceted operations. Its primary responsibility is to systematically monitor, evaluate, and improve the quality of scientific research, clinical services, diagnostic procedures, treatment protocols, educational programmes, training initiatives, and outreach activities conducted at the Centre.

To achieve these objectives, the Quality Unit implements rigorous quality assurance and quality control measures, ensuring that all activities align with nationally and internationally recognised standards. These standards include Good Clinical Practice (GCP), which governs the ethical and scientific quality of clinical trials; Good Laboratory Practice (GLP), which ensures the integrity and reproducibility of laboratory work; Good Financial Practice, which promotes transparency and accountability in financial management; and ethical research conduct, safeguarding the rights and well-being of research participants and ensuring compliance with ethical guidelines.

The Unit also emphasises the importance of safety protocols, establishing and enforcing comprehensive safety measures to protect staff, patients, researchers, and visitors. This encompasses risk assessments, safety training programmes, incident reporting, and continuous safety audits to minimise hazards and ensure a secure environment.

Additionally, the Quality Unit plays a crucial role in developing, reviewing, and updating Standard Operating Procedures (SOPs), policies, and protocols that govern the Centre’s activities. It facilitates staff training and capacity-building initiatives to promote a culture of quality and safety throughout the organisation.

Furthermore, the Unit conducts regular internal audits and inspections to verify adherence to established standards and to identify areas for improvement. It also coordinates with external accreditation bodies and regulatory agencies to maintain certifications and accreditations, demonstrating the Centre’s commitment to excellence.

Ultimately, the Quality Unit serves as the backbone of the MRC’s commitment to excellence, ensuring that all activities are conducted in a manner that is scientifically rigorous, ethically sound, and environmentally and socially responsible. Its efforts are central to fostering an environment of continuous quality improvement, innovation, and safety, which collectively underpin the Centre’s reputation as a leading institution in mycetoma research and related healthcare services.

 

The Unit Objectives

  • To establish and embed a comprehensive Quality Management System (QMS) across all departments of the Centre, ensuring consistent adherence to quality standards and operational excellence.
  • To ensure compliance with internationally recognised best practices by implementing targeted activities and initiatives that uphold the Centre’s commitment to quality, safety, and ethical standards.
  • To foster a culture that upholds the highest ethical standards and encourages continuous improvement through ongoing training, monitoring, and review processes.
  • To enhance the Centre’s readiness for international collaboration and increase funding eligibility by demonstrating compliance with global quality standards.

 

The Unit Core Activities

Development and Implementation of Policies & SOPs

  • Design and regularly update policies and SOPs for clinical care, laboratory diagnostics, scientific research, clinical trials, education and training and community-based research.
  • Ensure SOP adherence in all units.

Internal Audits and Inspections

  • Conduct routine internal quality audits of laboratories, data collection sites, and clinical services.
  • Identify non-conformities and support implementation of Corrective and Preventive Actions (CAPA).

Ethical and Regulatory Compliance

  • Ensure ethical approvals are in place for all research protocols.
  • Monitor compliance with national ethics regulations and international frameworks (e.g., Declaration of Helsinki).

Training and Capacity Building

Train researchers, clinicians, laboratory technicians, administration staff and community workers in:

  • GCP, GLP, GFP, others
  • Research ethics
  • Laboratory quality management
  • Biobanking and biosafety

 

 

Documentation and Data Quality Assurance

  • Oversee proper documentation and archiving of laboratory and imaging results, patient data, and research documents and files.
  • Ensure data traceability, accuracy, and compliance with FAIR (Findable, Accessible, Interoperable, Reusable) data principles.

Accreditation and Certification Support

  • Assist laboratories in achieving or maintaining quality certifications.
  • Support center-wide readiness for WHO Collaborating Center status or international audits.

Monitoring of Field and Community Activities

  • Standardise and audit outreach programmes (mobile clinics, field epidemiology) to ensure consistency and ethical conduct.
  • Support quality control in community education and engagement materials.

Quality Performance Indicators

  • Define and monitor key performance indicators (KPIs) (e.g., error rates, turnaround time, protocol deviations).
  • Conduct quarterly reviews and continuous improvement meetings.