Quality management system at the Zanzibar Food & Drugs Agency (ZFDA) was conceptualized and developed taking into account previous efforts at ensuring quality performance in the implementation of the core mission activities of ZFDA.
Quality Management System (QMS) Unit functions as the Principal’s secretariat on quality assurance issues and its performance is guided by Quality Policy. The pivotal role of this unit is to determine quality standards set internally for measuring performance in all core operational areas of the Board if are constantly met and updated and that they measure up to the national, regional and international benchmarks.
The mission of QMS UNIT is to catalyze the attainment of the core ZFDA Mission by promoting the instillation of Quality Assurance and Quality Control culture in all ZFDB activities with a view to enhance quality and standard of delivery of regulatory services to its internal and external stakeholders.
Quality Management System (QMS) Unit functions as the Principal’s secretariat on quality assurance issues and its performance is guided by Quality Policy. The pivotal role of this unit is to determine quality standards set internally for measuring performance in all core operational areas of the Board if are constantly met and updated and that they measure up to the national, regional and international benchmarks. Specific functions of the QMS unit are as follows:
1. Advice ZFDA Management and departments on development, implement and maintain of Quality Management System that are appropriate and relevant to the Zanzibar Food & Drugs Board;
2. Coordinate internal and external QMS auditing of Zanzibar Food & Drugs Board and its regulatory services;
3. Establish and review Zanzibar Food & Drugs Agency quality policy;
4. Link with external actors, in particular with professional and regulatory bodies, employers, students, community and alumni to raise the profile of the Zanzibar Food & Drugs Agency;
5. Ensure existence and implementation of an acceptable and stout system of regulatory services delivery;
6. Coordinate strategies for staff training on quality assurance area established after conducting a needs survey.
7. Coordinate strategies for documents control in all departments in the Zanzibar Food & Drugs Agency.
ROLES AND RESPONSIBILITIES OF ZFDB DEPARTMENTS ON QUALITY MANAGEMENT SYSTEM
Each department at Zanzibar Food & Drugs Agency strives to ensure that core mission activities of ZFDA are delivered in acceptable quality standards. Hence, all ZFDA departments are therefore required to:
1. Implement their mandated roles effectively and in the most cost-effective manner so as to contribute to the effort to achieve the umbrella ZFDA goals and objectives;
2. Develop and periodically revise unit-specific performance standards, and striving to meet those standards in practice;
Prepare unit-specific quality assurance (QA) procedures, operational manuals and measurement instruments, and providing Quality Management System (QMS) Unit with
1. copies of such documents;
2. Conduct regular self-evaluations to determine the extent to which it meets the set performance standards in practice, and use the results of such evaluations to improve practice;
3. Provide the QMS Unit with self-assessment reports in readiness for university-level and external evaluations;
4. Implement the recommendations resulting from internal and external Auditing and providing the QMS Manager with timely reports on the status of such implementation; and
Keep staff and other stakeholders informed of the evaluation results and efforts being made to implement the recommended improvements.
ACTIVITIES CURRENTLY GOING ON IN QMS UNIT
Currently the Quality Management System (QMS) Unit is carrying out the following major activities:
1. Coordinating and implement East African Community (EAC) Medicines Regulatory Harmonization Project in harmonized and functioning Quality Management System (QMS) within the EAC National Medicines Regulatory Authorities (NMRAs) in accordance with national and internationally recognized standards.
2. Development of documents to be used in implementation of QMS within ZFDA.
Conducting sensitization workshops/training for staff on quality assurance issues;