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TOTAL QUALITY
MANAGEMENT

SUBMITTED TO-DR. FARHAN J AHMED

SUBMITTED BY-ANJALI

M PHARM IST SEM

DEPTT OF PHARMACEUTICS

JAMIA HAMDARD

 

Introduction
To the better understanding the meaning of

the total quality management we should firstly
understand the meaning of the “Quality”.

“Quality is customer satisfaction” ,“Quality is
Fitness for Use.”

Loss of quality means loss of customer
satisfaction , public health and loss of
organization resource

 

Definition
Total quality management (TQM) is a modern approach to the management of the

whole organization that emphasizes the role of quality in meeting the needs and
expectations of its customers.

TQM stresses the need for the whole company to manage quality at every stage of
production and interaction with the customer

FOCUS ON
THE

CUSTOMER

INVOLVE CONTINOUS
EMPLOYES IMPROVEMENT

TQM

MEASURE QUALITY
ACCURATELY IMPROVEMENT

 

WHAT IS QUALITY

ISO 9000:2000 DEFINATION OF QUALITY-

It is the degree to which a set of inherent
characteristics fulfills requirements.

“Fitness for use”
Quality is excellence that is better than

a minimum standard.
“Conformance to requirements”
The ability of your product or service to

satisfy

 

WHAT IS TOTAL QUALITY MANAGEMENT?

TOTAL-MADE UP OF THE WHOLE

QUALITY-DEGREE OF EXCELLENCE A PRODUCT OR A SERVICE PROVIDES

MANAGEMENT-ACT,MANNER OF HANDLING(or)ART

 

TQM can also be defined as
1. Total : Every employ of the organization is involved.
2. Quality : Customer requirements are continuously satisfied.

The quality here focuses in 3 perspectives:
Quality of the products and services aligned with customer

specifications
Quality or amount of returns to satisfy the stakeholder needs Quality of
working conditions internal to the organization.

3. Management : Senior management is fully committed toward the
goals of total quality (customer satisfaction, effective employee
participation, doing things right first time, eliminating the wastes and
defects, increasing the efficiency and effectiveness of the work)
TQM ensures that the management adopts a strategic overview of the
quality & focuses on prevention rather than inspection.

 

Importance of TQM

Quality culture means prevention and elimination of errors, waste,
reworks. So, the concept of TQM has been developed from inspection of
quality control and quality assurence.

TQM is extremely important to business because it keeps a company
competitive and productive.

It not only focuses on quality but also on the continuous improvement of
process capabilities.

 

TQM framework
It covers all aspects of an

organization and the way it
operates.

Performance is achieved
by planning the
involvement of people in CULTURE COMMUNICATION
improving the processes.

All this can be
implemented by an PLANNING
effective leadership,
communication and
commitment.

PERFORMANCE
EXCELLENCE
PERFORMANCE OF TQM

PEOPLE COMMITMENT PROCESS

 

TOTAL TEAM

EMPL WORK AND

OYEE QUALITY

COM CHAIN
CUSTOMER

MITM
SATISFATON

ANT

SYSTEMA
TIC

APPROA
CH PROCESS

TQM
THINKING

INTEGRATE
D SYSTEM

TRAINING

CONYINOU
S

EFFECTIE
IMPROVEME

COMMUNICATION
NT

 

KEY PRINCIPLES OF TQM

 There are number of key principles that can be identified and associated
with the definition of the TQM, including:

CONTINOUS
IMPROVEME

NT

QUALITY SATISFY THE
ORIENTED TQM PRINCIPES

CUSTOMER
MANAGEMENT

SATIFY THE
SUPPLIER

 

Quality oriented management
Vignan Pharmacy College, Vadlamudi.
10

Management should inspire and motivate the
entire workforce

Communication strategy, method and timeliness
must be well defined to be followed by the entire
workforce.

The mission and vision should balance the needs of
the company and customers.

Top management should act as the main driver for
TQM and create an environment that ensures its
success.

 

Satisfy the customer

Satisfaction is basically physiological state,
Satisfaction is a function of total experience with

organization.
The research gives ten domains of satisfaction
includes:
Quality, value, timeliness, efficiency, ease of access,
environment, inter-departmental team work,
commitment to the customer and innovation.

 

Satisfy the supplier
External suppliers: A company must look to satisfy

their external suppliers by providing them with clear
instructions and requirements and then paying them
fairly on time.

Internal suppliers: A supervisor must try to keep his
or her workers happy and productive by providing
good task instructions, the tools they need to do their
job and good working conditions. The supervisor must
also reward the workers with praise and good pay.

 

Continuous improvement
It’s a never-ending improvement.
Continuous improvement, called kaizen by the

Japanese, requires that the company continually
strive to be better through learning and problem
solving.

Now let’s look at two approaches that can help
companies with continuous improvement: the plan–
do–study–act (PDSA) cycle and benchmarking

 

Continuous improvement

The Plan–Do–Study–Act Cycle The plan–do–study–
act (PDSA) cycle describes the activities a company PLAN
needs to perform in order to incorporate continuous
improvement in its operation.

CONTIOU
S

DO ACT
IMPROVE

MENT

STUDY

 

Specific steps in the cycle
1. PLAN:

Managers must evaluate the current process and make plans
based on any problems they find

They need to document all current procedures, collect data,
and identify problems.
2. DO (implementing the plan) :

During the implementation process managers should document
all changes made and collect data for evaluation

3. STUDY: The data are evaluated to see whether
the plan is achieving the goals established in the
plan phase.
4. ACT: The best way is to communicate the results

to other members in the company and then
implement the new procedure if it has been
successful. Note that this is a cycle; the next step is
to plan again, we need to continue evaluating the
process, planning, and repeating the cycle again

 

Stone work of TQM
will focus on explaining the main steps (stages) that help in paving the way for the
organizational transition to TQM…

BUILDING A
QUALITY

EVALUATIN FRAMEWORK
G AND

BUILDING A
CONTROLLI

QPD
NG

TQM

LAUNCHING
THE COMMUNICATING

CHANGES THE QUALITY
STRATEGY

MEASURING AND
ANALAYSING THE

PERFORMNCE

 

Benefits of TQM
Customer’s confidence.
Improvement of organization’s reputations.
Increase in productivity.
Reduction in product cost.
Increase in profits.
Employ motivation.
Team spirit.
Improvement in attitude.

 

WHAT DOES TQM
MEAN?
A philosophy that involves everyone in an
organization in a continual effort to improve
quality and achieve customer satisfaction.

 

WHAT’S THE GOAL OF TQM?

DO THE RIGHT THINGS RIGHT THE FIRST TIME EVERY TIME

 

TOTAL QUALITY MANAGEMENT..

Total Quality Management (or TQM) is a supervision concept coined by W.
Edwards Deming

“Total quality management is an approach that
seeks to improve quality and performance which
will meet or exceed customer expectations.”

 

MANAGEMENT PROGRAM

1. Top management commitment and involvement.
2. Customer involvement & designing products for
quality.
3. Designing and controlling production processes.
4. Developing supplier partnerships.
5. Customer service, distribution, installation.
6. Building teams of empowered employees.
7. Benchmarking and continuous improvement

 

TQM IN PHARMACEUTICAL INDUSTRY

SYSTEMS FOR DEVELOPMANT OF TOTAL QUALITY MANAGEMANT

GMP

BRC

HACCP

ISO

 

 

TQM is the integration of all functions and
processes within an organization in order
to achieve continuous improvement of
the quality of goods and services. The
goal is customer satisfaction.

 

OBJECTIVES OF TQM

Process improvement
Defect prevention
Measuring system capacity
Developing improvement checklist
Helping teams make better decisions
Developing operational definitions
Observing behavior changes over a period of time.

 

PRINCIPLES OF TQM

CUSTO
CONTIN MER LEADER

UAL FOCUS SHIP
IMPROV
EMENT

8 QM PROCES
PRINCI APPROACH

PLES

SYSTEM
APPOACH

 

QUALITY MANAGEMANT

SUM OF ALL ACTIVITIES PERFORMED IN AN ORGANIATION TO PRODUCE AND
MAINTAIN A PRODUCT WITH DESIRED QUALITY LEVEL AGAINT A MINIMUM
COST

QUALITY MANAGEMENT FUNCTIONS-

DESIGN

CONTROL

IMPROVEMENT

ASSURANCE

 

PRINCIPLES OF TQM

 

QA IN PHARMA INDUSTRY
(INTER RELATIONSHIP)

 

GOOD MANUFACTURING PRACTICES

“Good manufacturing practice is that part of quality assurance
which ensures that products are consistently produced and
controlled to the quality standards appropriate to their intended use
and as required by the marketing authorization or product
specification”.

What is good manufacturing practice (GMP) ?………
GMP is a part of quality assurence, which ensure that
product are consistently produced and controlled to
the quality standards.

Every product should be manufactured pure, safe,
effective…

FDAis also having this responsibility and one of the
FDI work and inspect, food , drug manufactured by
the factories and other health care organizations.

These controls & practices established in
government regulations called GMP.

 

Principles of GMP
Vignan Pharmacy College, Vadlamudi.
21
1. Writing step by step operating procedures and work instructions.
2. Following written procedures and instructions.
3. Properly and accurately documenting our work.
4. Validating our work.
5. Designing & constructing facilities and equipment
6. Maintaining facilities and equipment.

7. Clearly defining, developing and demonstrating
job competence.
8. Protecting our products against contamination.
9. Building the quality in to the product by system
quality controlling components and product related
process. Such as manufacturing, packing, labeling,
testing, distribution, marketing.
10. Conducting planed and periodic audits.

 

why are GMP’s requirement?
Government requirement.
Ensure quality products.
Reduced rejects and recalls.
Satisfied customers.
Maintain manufacturing consistency.
Company image and reputation

 

Importance of GMP
In the United States the Center for Drug Evaluation

and Research (CDER) promotes and protects public
health by assuring that safe and effective drugs.

There exits different types of risk with medicines..
one of which is a preventable adverse event,

which can be caused by different reasons.
One of the reasons for this event can be a product

quality defect.
This risk can be avoided by effective

implementation of GMP.

 

why good manufacturing practices (GMPs)
established?…

GMP regulations were originally established over time
after three tragedies. They are as follows:
1. Elixir sulfanilamide disaster.
2. Sulfathiazole calamity. 3. Thalidomide disaster.

 

DEFINATION

Good manufacturing practice guidelines
provide guidance for manufacturing,
testing, and quality assurance in order to
ensure that a food product is safe for
human consumption

 

GENERAL GUIDELINES FOR GMP

PLANT MAINTAIANCE WATER

STORAGE WINDOWS

WORK SURFACE LIGHTING

SUPERVISION CLEANING AND SANITATION

WALLS PERSONAL HYGIENE

TRAINING CEILING

DOORS STAFF HYGIENE

AIR QUALITY AND VENTILATION FLOORS

PLANT CONSTRUCTION AND DESIGN

 

GOOD LABORATORY PRACTICES

GLP IS A SET OF PRINCIPLES THAT AVOIDS A FRAMEWORK WITHIN WHICH A LAB
STUDIES ARE PLANNED, PERFORMED, MONITORED, RECORDED, REPORTED AND
ACHIEVED.

“A QUALITY SYSTEM CONCERNED WITH THE ORGANISATIONAL PROCESS AND THE
CONDITIONS UNDER WHICH NON CLINICAL HEALTH AND ENVIRONMENTAL SAFETY
STUDIES ARE PLANNED, PERFORMED, MONITORED, RECORDED, ACHIEVED AND
REPORTED.”

GLP FOLLOWLED IN LABS TO AVOID ACCIDENTS WHILE HANDLING REAGENTS.
GLP HAS FOLLOWED BY EVERY LAB PERSONNEL.

 

PRACTICES FOLLOWED IN LAB

1. All personnel working In lab must wear uniform/
aprons to perform in the lab practices.

2. Wearing of mask, hats, covers, gloves, shoes, etc.
should be hygienically recommended under GLP.

3. Safety glasses, protective eye glasses are
essential to carry hazardous operations.

4. Ill person should not allow to work.
5. Avoid poor illumination, obnoxious flavors and

noise in lab
6. Provisions of exhaust fans in lab.

 

SANITARY & HYGIENIC PRACTICES

lighting and ventilation
Location of premises
Floors and walls
Ceilings
Insects
Doors and windows
Potable water supply
equipment design

 

GOOD HYGIENIC PRACTICES

It refers to the set of practices associated
with the preservation of health and healthy
living.

Include all practices regarding the
conditions and measures necessary to
ensure quality

 

Areas examined under GHP

1. Primary production
2. Establishment: design and facilities
3. Control of operation
4. Establishment: maintenance and sanitation
5. Establishment: personal hygiene

6. Transportation
7. Product information and consumer awareness
8. Training

 

Good Manufacturing Practices are the basis of the production
and preparation of safe food

Good Hygienic Practices deal with safety and suitability
requirements to be followed world-wide

Each food operation should adapt existing codes to their
specific set of conditions

Food operations should also decide which practices are
critical for the safety of a product and thus have to be included
in the HACCP plan.