QUALITY MANAGEMENT SYSTEM

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QUALITY MANAGEMENT SYSTEM

• PRESENTATION TO BOTSWANA DRUG ADVISORY BOARD
  MEMBERS
• 13th 17th AUGUST 2007

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Outline

• What is QMS?
• What were the motives?
• What are the benefits?
• QMS at TFDA
• Implementation status
• Plans ahead
• Envisaged challenges

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What is QMS?

• A system that ensures consistent delivery of
  services to meet customer requirements and
  expectations
• Follows ISO 90012000 - 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.

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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

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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 ME system.

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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

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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

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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

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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 90012000 certification and
  coordinate all formalities with certification
  body.

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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

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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

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QMS Implementation status

• Roadmap document has been prepared - outlines
  implementation steps strategies
• Sensitization done
• Training on principles application of ISO
  90012000 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

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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 90012000
  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.

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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

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Plans ahead

• Internal auditing to identify opportunities for
  improvement
• External auditing for conformance audit
• Application for Certification

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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

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Thank you for your attentionGood Management
is Quality Management Together we shall
achieve - This is our quality motto