1. www.tfda.or.tz 1 QUALITY MANAGEMENT SYSTEM PRESENTATION TO BOTSWANA DRUG ADVISORY BOARD MEMBERS 13 th – 17 th AUGUST 2007

2. www.tfda.or.tz 2 Outline What is QMS? What were the motives? What are the benefits? QMS at TFDA Implementation status Plans ahead Envisaged challenges

3. www.tfda.or.tz 3 What is QMS? A system that ensures consistent delivery of services to meet customer requirements and expectations Follows ISO 9001:2000 - a set of standardized requirements for quality, which guide organizations towards improved performance. The standard specifies requirements, which ensures consistent delivery of quality services that meet customer needs & expectations.

4. www.tfda.or.tz 4 What were the motives? Lack of defined processes & procedures for providing regulatory services Inadequate communication & feedback system btn Directorates, Zone offices, POEs & LGAs Records of activities undertaken were not well documented making archiving, retrieval & traceability of information difficult Weakness in performance measurement Weekly, monthly, quarterly & annual progress reports were prepared but not adequately evaluated

5. www.tfda.or.tz 5 What are the benefits? Systematic mapping, identification & documentation of processes & procedures Establishment of a well defined & documented communication system between Sections, Directorates, PoEs, Zonal offices, LGAs & customers. Improved documentation, recording & archiving of records or correspondences to ensure their quick retrieval & traceability. Continual improvement of overall performance thru establishment of M&E system.

6. www.tfda.or.tz 6 Benefits….. QMS focuses on customer satisfaction - It influences attitude among employees towards satisfying customers & reducing complaints. QMS allows for systematic internal quality auditing which also provides an avenue for corrective actions to be taken in case of non-conformities encountered. Fair evaluation of staff performance & rewarding, improvement in staff motivation & consequently organizational performance. Certification/accreditation brings about national & international recognition

7. www.tfda.or.tz 7 QMS at TFDA Structure: QMS Steering Committee (QMS SC) – TFDA Management Team QMS Coordination Committee (QMS CC) – TFDA Directorate representatives QMS Working Groups (QMS WGs) – Staff representing TFDA Sections Internal Quality Audit Team

8. www.tfda.or.tz 8 QMS SC Responsibilities –To approve and review quality policy, quality objectives & quality manual –To determine, provide and maintain necessary infrastructure including resources for QMS implementation –To conduct management review meetings –To provide updates on implementation status –To approve certification body –To oversee QMS CC & QMS WGs

9. www.tfda.or.tz 9 QMS CC - Responsibilities To develop quality policy, quality objectives & quality manual, including 6 compulsory procedures. To define documentation structure for TFDA. To oversee timely documentation of processes & procedures. To identify resource requirements for QMS implementation and propose to QMS SC. To organize for sensitization & training of staff on QMS To prepare quarterly progress reports on QMS implementation. To oversee implementation of corrective actions. To prepare for ISO 9001:2000 certification and coordinate all formalities with certification body.

10. www.tfda.or.tz 10 QMS WGs To identify key processes which need to be documented. To map identified processes using flow charts. To develop and document procedures and work instructions To prepare quarterly progress reports To maintain records of QMS implementation

11. www.tfda.or.tz 11 Internal Quality Audit Team Responsibilities: –To conduct internal quality audits according to audit plan, schedule & SOPs. –To prepare and present audit reports to QMS SC –To propose corrective & preventive actions to be taken to QMS SC

12. www.tfda.or.tz 12 QMS Implementation status Roadmap document has been prepared - outlines implementation steps & strategies Sensitization done Training on principles & application of ISO 9001:2000 & QMS have been done to top managers, heads of sections & other staff Internal auditors have been appointed & some trained on QMS auditing Processes have been identified & documented

13. www.tfda.or.tz 13 Implementation status….. Quality Policy statement is in place: Tanzania Food and Drugs Authority (TFDA) is committed to provide quality services in response to customer needs and expectations. We shall strive to balance the interests of our stakeholders without compromising quality, safety and/or effectiveness of food, drugs, cosmetics and medical devices by managing the Authority with utmost professionalism. We commit ourselves to comply with requirements of ISO 9001:2000 standard and continually improve the effectiveness of Quality Management System. We shall manage and provide resources for continuous improvement of our services to ensure customer satisfaction.

14. www.tfda.or.tz 14 Plans ahead Finalization of Quality Manual Finalization of documented (mandatory) & other procedures More sensitization to staff Training of other internal auditors Service delivery survey – gap analysis & performance measurement

15. www.tfda.or.tz 15 Plans ahead…… Internal auditing to identify opportunities for improvement External auditing for conformance audit Application for Certification

16. www.tfda.or.tz 16 Envisaged challenges Resources Resistance to change among TFDA staff Lack of sector specific examples (i.e. Regulatory Authorities) for benchmarking at national & regional levels Balance btn regulation & meeting customer demands Ad hoc activities & priority setting

17. www.tfda.or.tz 17 Thank you for your attention “Good Management is Quality Management – Together we shall achieve” - This is our quality motto