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Total Quality Management

Total Quality Management

Quick Overview:

§  Objectives.
§  Introduction.
§  Concept.
§  Goal.
§  Management.
§  TQM working.
§  Benefits.
§  Barrier.

 Objectives:

·        To provide high quality drug product to patients or prescribers.
·        Process improvement.
·        Defect prevention.
·        Helping teams to make better decision.
·        Continuous improvements to processes systems, people, suppliers, partners, products and services.


  Quality: 

·         Conformance of standard or specification.
·        Fitness for use.
·        Meeting customer requirements or expectations.
·        ICH has defined Quality as “the totality features and characteristics of the product that satisfy consumer needs or intended purpose.”
     Quality management:
§  Identity
§  Strength
§  Safety
§  Purity

 The Eight Dimension Of Quality:

1.     Performance.
2.     Features.
3.     Reliability.
4.     Conformance.
5.     Durability.
6.     Serviceability.
7.     Aesthetics.
8.     Perceived quality.

 Concept of Total Quality Management:

·        Total Quality Management is a management approach that originated in the 1950's and has steadily become more popular since the early 1980's.
·        Total Quality is a description of the
ü Culture,
ü attitude and
ü organization of a company..
·        TQM is a method.
·        TQM implementation is the establishment of a quality management system.

 What’s the goal of TQM?
“Do the right things right the first time, every time.”
ü Concentrate on customer & be customer focused.
ü Communicate and educate.
ü Train the work force.
ü Measure and record.
ü Involvement of top management.
ü Introducing team work.
ü Organize by process not by function.

 Another way to put it:

TQM is all managers leading and facilitating all contributors in
 everyone’s two main objectives:
(1) Total client satisfaction through quality products and services.
(2) Continuous improvements to-
                                                      Processes,
                                                      Systems,
                                                      people,
                                                      Suppliers,
                                                      Partners,
                                                      Products and services.



  The building blocks of TQM:

ü Processes.
ü People.
ü Management systems and
ü Performance measurement.



 TQM Working:

·        Quality Laboratory Processes (QLP) Laboratory quality control is designed to detect, reduce, and correct deficiencies in a laboratory's internal analytical process prior to the release of patient results, in order to improve the quality of the results reported by the laboratory

·        Quality Control (QC) a system of maintaining standards in manufactured products by testing a sample of the output against the specification.

·        Quality Assessment (QA) refers to the broader monitoring of other dimensions or characteristics of quality.

·        Quality Improvement (QI) is aimed at determining the causes or sources of problems identified by QC and QA.

·        Quality Planning (QP) A method for measuring the achievement of the quality objectives.

·        Quality Goals ISO 9001 addresses quality goals through the use of the term 'quality objectives' but goes no further. The purpose of a quality system is to enable you to achieve, sustain and improve quality economically.

 Eight key elements:

To be successful implementing TQM,
an organization must concentrate on the –

·        Ethics.
·         Integrity.
·         Trust.
·         Training.
·         Teamwork.
·         Leadership. 
·         Communication.

 Productivity and TQM:

·        Traditional view:
     Quality cannot be improved without significant losses in productivity.

·        TQM view:
     Improved quality leads to improved productivity.

 Total Quality Management and Continuous  
 Improvement:

·        TQM is the management process used to make continuous improvements to all functions.
·        TQM represents an ongoing, continuous commitment to improvement.
·        The foundation of total quality is a management philosophy that supports meeting customer requirements through continuous improvement.

 Total Quality Management Benefits:

ü    Strengthened competitive position.
ü    Adaptability to changing or emerging market   
   conditions and to environmental and other  
   government regulations.
ü    Higher productivity.
ü    Enhanced market image.
ü    Elimination of defects and waste.
ü    Reduced costs and better cost management.
ü    Higher profitability.
ü    Improved customer focus and satisfaction.                                    
ü    Increased customer loyalty and retention.
ü    Increased job security.
ü    Enhanced shareholder and stakeholder value.
ü    Improved and innovative processes.
ü    The benefits of total quality management are       
   endless, helping your organization get results.

Barriers in Successful TQM:

·        Lack of understanding of the TQM concept.
·        Absence of visible support from senior and top management.
·        Many layers of existing organization structure.
·        Poor internal communication.
·        Heavy workloads.
·        Nature of organization.
·        Lack of adequate education and training.
·        Limited resources.
·        Irregularity of the meetings.
·        Delay in implementation of the recommendation of QIT’s.





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