Quality Assurance Unit
Facility Lead: Mr S. M. Ariful Islam Chowdhury, M Pharm., MPH
Mr S M Ariful Islam Chowdhury is a Quality Management System (QMS) specialist with 21 years of experience in leadership roles within complex operations, supervision, and compliance of managing the challenging programmes in pharmaceutical industries and icddr,b. He started his career as a pharmacist in the top leading internationally benchmarked industry, Square Pharmaceuticals Ltd, Dhaka Unit since its inception. At Square, he experienced the valuable supervision and guidance of project experts from renowned pharmaceutical consultant, Bovis Lend Lease Pharmaceuticals, UK. His high level of adaptability and flexibility supported him in changing his career to the new arena of Medical Laboratory Quality Assurance and he joined icddr,b’s Laboratory Quality Assurance unit in 2009 with a highly charged, critical mission of Laboratory Accreditation. He is one of the pioneers in the country in this area and has proven his capacity for international regulations, compliance, and accreditation programmes for laboratories. Mr Chowdhury has also completed his Master of Public Health. He plays a major role on behalf of icddr,b, providing consultancy on QMS for government and other organisations in the health sector.
The major functions of the Quality Assurance programme include designing the Quality Management System according to ISO 15189, ISO 15190 and ISO 17025 requirements, and the organisational policies; preparing and approving the Quality Management Procedures and allied documents to constitute the Quality Manual; reviewing the technical procedures and associated documents, approving them to constitute the Technical Manuals; implementing Quality Assurance Systems in the laboratories according to the procedures outlined in Quality Manual and requirements of the Technical Manual; implementing and maintaining Document Control System (review, approve, issue, obsolete, retain, and destroy); ensuring process evaluation and document review; and organising Laboratory Management Committee meetings with regular follow-ups and update.
An integral part of the programme Quality Assurance Office is to prepare training plans, carry out training needs assessment in different laboratories, and conduct training every year on QMS, ISO requirements, QSEs, and related issues. The Office follows up and investigates the Occurrence Report, Corrective/ Preventive Action, Complaints and Suggestions, and Risk Management Report, and log them for trend analysis. The Quality Assurance Office prepares the Internal QMS Audit Plan, forms and conducts trainings for the QMS Audit Team, prepares Audit Checklist, organises QMS Audit for the laboratories, and follow the audit observations and corrective actions. The Office also strives to ensure Proficiency Testing of laboratory services, implementing and measuring the indicators for continuous improvement. The Office is monitoring Good Laboratory Practices; resolving the discrepancies, and taking improvement actions. The ultimate goal of this programme is to implement and sustain QMS in LSSD laboratories and ensure ISO 15189 and ISO 15190 accreditation status of diagnostic laboratory services, and acquire ISO 17025 accreditation for other testing laboratory services. Additionally, the Office offers its essential quality assurance services to all the icddr,b facilities as needed to the extent feasible.