PHARMACEUTICAL QUALITY ASSURANCE

UNIT – I

TOTAL QUALITY MANAGEMENT (TQM)

Class: III – B. Pharm, VI - Semester

By:
Subject: Pharmaceutical Quality
Mrs. M. Sasikala,
Assurance
Associate Professor,
Theory Class: 03
Karpagam College of Pharmacy,
Session: II
Coimbatore – 641032.
Date: 17.04.2020
 ROLE OF TQM

• PRODUCTS • PRODUCTS • PRODUCTS

TOTAL QUALITY
QUALITY ASSURANCE
QUALITY CONTROL

MANAGEMENT
• PROCESSES • PROCESSES
• COMPANY
 DEFINITIONS ON TQM

A management approach to long-term

success through customer satisfaction.
In a TQM effort, all members of an
organization participate in improving
processes, products, services, and the
culture in which they work.

A continuous effort by the management as

well as employees of a particular
organization to ensure long term customer
loyalty and customer satisfaction.

An extensive and structured organization

management approach that focuses
on continuous quality improvement of
products and services by using continuous
feedback.
HISTORY OF TOTAL QUALITY MANAGEMENT (TQM)
FIVE PILLARS OF TOTAL QUALITY MANAGEMENT (TQM)

ORGANIZATIO
N

PROCESS LEADERSHIP

PRODUCT
TQM COMMITMENT
 EIGHT KEY ELEMENTS OF TQM

ETHICS INTEGRITY

TRUST TRAINING

TEAMWORK LEADERSHIP

RECOGNITION COMMUNICATION
 7 TOOLS OF TQM

Fishbone Control Strati- Pareto Histogra Scatter

Checklists
diagram chart fication chart m Diagram
SIX SIGMA (6σ; DMAIC) TOOLS OF TQM

DEFINE

MEASURE

ANALYZE

IMPROVE

CONTROL PROCESS
BASIC CONCEPTS OF TQM
 PRINCIPLES OF TQM

EVIDENCE – STRATEGIC
CUSTOMER ENGAGEMENT PROCESS IMPROVEMEN BASED RELATIONSHIP AND
LEADERSHIP
FOCUS OF PEOPLE APPROACH T DECISION MANAGEMENT SYSTEMATIC
MAKING APPROACH
 7 PHILOSOPHIES OF TQM

CONTINUOUS
CUSTOMER FOCUS
IMPROVEMENT

EMPLOYEE USE OF QUALITY

EMPOWERMENT TOOLS

PROCESS
PRODUCT DESIGN
MANAGEMENT

MANAGING SUPPLIER
QUALITY
 6 ‘C’s OF TQM

CONTINUOUS
CUSTOMER
CONTROL COMMITMENT CULTURE IMPROVEMEN COOPERATION
FOCUS
T
DEMING’S WHEEL/ PDCA CYCLE FOR TQM

ACT
PLAN
CHECK
DO
FUNDAMENTAL CHARACTERISTICS OF TQM

COMMITMENT

INVOLVEMENT

FUNDAMENTAL
KNOWLEDGE
THANK YOU
Forthcoming class: ICH GUIDELINES