QUALITY MANAGEMENT

Modul-1 : QUALITY MANAGEMENT

Modul-2 : MANAGEMENT FUNCTIONS

Modul-3 : GMP FOR PHARMACEUTICAL
PRODUCTS (CPOB)
Modul-4 : ICH Q10 PHARMACEUTICAL QUALITY
SYSTEM
Modul-5 : GOOD DISTRIBUTION PRACTICES
 Modul-1: QUALITY MANAGEMENT

Total Quality Management in Pharmacy

Wayan Redja

2017
 QUALITY MANAGEMENT

Quality Management?
Quality Management System?
Quality Assurance?
Total Quality Management?
Purpose of Quality Management
Why Quality Management?

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 Quality Management?
Y
A LI T
ce
What is Quality?
QU el l en
Ex Goo ge
d
a
er
Av oor
P QUALITY
Ability to fulfill requirements.
Closeness to the standard.
Degree to which a set of inherent
characteristics fulfills requirements.*
(ISO 9000:2005)

* Requirements
Need or expectation that is stated, generally
implied or obligatory.

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 Quality Management?

TIV
IWhat is Quality of Proces
TY
U C
OD Quality of Process is Productivity
PR

Effectiveness
Productivity = Efficiency

Effective, Efficient > Productive

Effectiveness, Efficiency > Productivity

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 Quality Management?

m EM
ENT What is Management
A G
N
MA
Management
Coordinated activities to direct and control
an organization. (

Management functions:
- Planning, Organizing, Actuating, Controlling
(POAC)
- Plan, Do, Check, Act (PDCA)

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 Quality Management?

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 Quality Management?

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 Quality Management?

t y nt
a li e What is Quality Managemen
Qu ge m
n a
a
M Quality Management
Management with regard to
quality.

Coverage
- Quality Management
System
- Quality Assurance
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 Quality Management System?

l i ty
u a e nt
Q em
a
g
n a te m What is System ?
M s
Sy

System (ISO 9000)

Set of interrelated and interrelating
elements.

Examples
- Education System
- Health System
- Cardiovascular System
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 Quality Management System?

l ity nt
u a What e is Quality Management Syst
Q ge m
n a em
Ma Syst
Quality Management System (QMS)
(ISO 9000)
System with regard to Quality
Management.

Coverage of QMS (Elements)

- Organization Structure
- Processes
- Procedures
- Resources
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 QUALITY MANAGEMENT SYSTEM ISO 9000
The Process Based QMS
CONTINUAL IMPROVEMENT
OF THE QMS

Management CUSTOMER
CUSTOMER (and other
Responsibility
(and other interested
interested parties)
Measurement,
parties) Resource Analysis, SATISFACTION
REQUIREMEN Management Improvement
TS
Product
Realization
INPUT PROCESSES PRODU
OUTPUT
5M
CT

Value-adding activities
Information flow WR11
 What is Quality Assurance?
Definition
alit Quality Assurance
Q u su
As Part of Quality Management focused on
providing confi-
dence that quality requirements to be fulfilled.
(ISO 9000:2005)

The activity of providing the evidence needed to

establish
confidence, among all concerned, that the
quality function
is being effectively performed. (J.M.Juran, 1988)

A wide ranging concept covering all matters that

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 What is Quality Assurance?

l i ty Principles
u a nce
Q raQA Principles
s su
A
Make quality people before making
quality product.
Build quality into the product.
Do it right from the first time.
Do what is written and write what is
done.
The 5 NOs : Dont make, deliver ,
accept, keep
and use defect product. WR04a
The next process is our customer
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 Total Quality Management

Definition
M
TQ Total Quality Management
Management based on the
participation of all
members of an organization in
improving
processes, products, services, and
the culture
they work in.

A management approach to long-

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term success
through customer satisfaction. WR14
 Total Quality Management
TQM Experts
M
J.M. Juran
TQ Trilogi Kualitas
1. Quality Planning - Customer Satisfaction Focus
Principles
2 . Quality Control - Quality Performance
Evaluation Principles
3. Quality Improvement - Continual Quality System
Improvement
Principles
1. Clear
goal
W.E.forDeming
quality improvement
2. Leadership for management changes
3.
Deming 14 Management Principles
No inspection, build quality into the product
4. Mutually beneficial supplier relationship
5. Continual quality improvement
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 Total Quality Management
TQM Experts
M
TQ J.M. Juran
Trilogi Kualitas
1. Quality Planning - Customer Satisfaction Focus
Principles
2 . Quality Control - Quality Performance
Evaluation Principles
3. Quality Improvement - Continual Quality System
Improvement
Principles

1. Clear goal for quality improvement

2.W.E. Deming
Establish and promote Human Resource
Deming 14 Management Principles
Development
3. Establish job training
4. Good leadership
5. Leadership for management changes WR04a
6. Change MBO to Leadership
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 Total Quality Management
M TQM Experts
TQ
W.E. Deming
Deming 14 Management Principles
7. (continuation)
Promote conducive working environment
8. Minimize pressures and slogans
9. Focus more to quality rather than quantity
10. Solid team work collaboration
11. Build quality into the product
12. Mutually beneficial supplier relationship
13. Continual quality improvement
14. Promote and motivate all members of the organizatio
to achieve the above-mentioned transformation.
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 Conventional
Total Qualityvs Modern Quality
Management
Management

Q M Perspectives Convention Modern

T al
Definition Narrow Broad (Anything)
7. Promote conducive(Product)
working environment
8. Minimize pressuresProduct
Orientation and slogans Customer/Busines
9. Focus more to quality rather than squantity
10. Focusteam
Solid of Product
work collaboration Process/System
Manajemen
11. Build quality into the product
12. Quality Koordinator
Mutually beneficial QC Managerrelationship
supplier CEO
13. Quality Assurance
Continual Inspection /QC
quality improvement Build Quality into
The
14. Promote and motivate all members of the organizatio
Product(TQC/TQA)
to achieve the above-mentioned transformation.
Supplier Short Term Long Term (Less
Relationship (More Suppliers) WR04a
Suppliers)
Decision Making Persuasive/Auth Factual, Process,WR18
 Purpose of Quality Management

i t y t
l
a me n
u
Q ge
a To fulfill customer requirements
n
Ma To satisfy customer and other stake-holders
To assure effectiveness, efficiency, and
productivity
To eliminate reprocesses
To assure quality
To be able to compete
To maintain sustainability

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 Why Quality Management?

l i ty nt
u a e
Q ge m
na Customer requirements should be
Ma
fulfilled.
Customer requirements are changing.
QA assists in enhancing customer
satisfaction.
QA provides confidence to its customers
and the
organization.
Competitive pressure
Advances in technology
QA provides the framework for continual
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improvement
 Reference
1. ISO 9000:2005 Quality Management System Fundamentals and Vocabulary.
2. Vincent Gaspersz. Total Quality Management. PT GramediaPustaka Utama: Jakarta,
2001 .
3. JM Juran and FM Gyrna. Editors. Quality Control Handbook. 4 th Ed. McGraw Hill, Inc.:
New York, 1988.

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