16/04/2014

Dr LeMANAGEMENT
Thai Phong
QUALITY
Foreign Trade University
T:
0975.055.299
AND
PRODUCTIVITY
E:lethaiphong@gmail.com

QUALITY MANAGEMENT:
Dr L Thi Phong

Chapter 1: Quality Management:

Vice Dean
Faculty of Business Administration
Foundation
T: 0975.055.299
E: lethaiphong@gmail.com

Chapter 2:
Quality: Models and
frameworks
Dr Le Thai Phong
Foreign Trade University
T: 0975.055.299
E:lethaiphong@gmail.com

QUALITY MANAGEMENT:
Dr L Thi Phong

Chapter 1: Quality Management:

Vice Dean
Faculty of Business Administration
Foundation
T: 0975.055.299
E: lethaiphong@gmail.com

Contents

1. Early quality management framework

2. Deming Prize
3. Malcolm Badridge
4. Eupean Union Prize
Cost of quality
2. Waste
3. Q Base system
4. GMP
5. HACCP
Others

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Early quality management framework

Early quality management framework

1 Create constancy of purpose towards
improvement of product and service.
2 Adopt the new philosophy. We can no longer
live with commonly accepted levels of delays,
mistakes, defective workmanship.
3 Cease dependence on mass inspection. Require
instead statistical evidence that quality is built in.
4 End the practice of awarding business on the
basis of price tag.
5 Find problems. It is managements job to work
continually on the system.

Early quality management framework

6 Institute modern methods of training on the job.
7 Institute modern methods of supervision of production workers.
The responsibility of foremen must be changed from numbers to
quality.
8 Drive out fear, so that everyone may work effectively for the
company.
9 Break down barriers between departments.
10 Eliminate numerical goals, posters, and slogans for the
workforce asking for new levels of productivity without providing
methods.
11 Eliminate work standards that prescribe numerical quotas.
12 Remove barriers that stand between the hourly worker and his
right to pride of workmanship.
13 Institute a vigorous program of education and retraining.
14 Create a structure in top management that will push every day
on the above 13 points.

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Early quality management framework

Juran
1904-2008

Early quality management framework

1 Build awareness of the need and opportunity for improvement.
2 Set goals for improvement.
3 Organize to reach the goals (establish a quality council, identify
problems, select projects, appoint teams, designate facilitators).
4 Provide training.
5 Carry out projects to solve problems.
6 Report progress.
7 Give recognition.
8 Communicate results.
9 Keep score.
10 Maintain momentum by making annual improvement part of the
regular systems and processes of the company.

Early quality management framework

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Early quality management framework

Four absolutes:
Definition conformance to requirements.
System prevention.
Performance standard zero defects.
Measurement price of non-conformance

Early quality management framework

1 Make it clear that management is committed to
quality.
2 Form quality improvement teams with
representatives from each department.
3 Determine where current and potential quality
problems lie.
4 Evaluate the cost of quality and explain its use as a
management tool.
5 Raise the quality awareness and personal concern of
all employees.
6 Take actions to correct problems identified through
previous steps.

Early quality management framework

7 Establish a committee for the zero defects program.

8 Train supervisors to actively carry out their part of the quality
improvement program.
9 Hold a zero defects day to let all employees realize that there has
been a change.
10 Encourage individuals to establish improvement goals for themselves and their groups.
11 Encourage employees to communicate to management the
obstacles they face in attaining their improvement goals.
12 Recognize and appreciate those who participate.
13 Establish quality councils to communicate on a regular basis.
14 Do it all over again to emphasize that the quality improvement
program never ends.

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Quality award models: Deming Prize

1950: the Union of Japanese Scientists and
Engineers (JUSE) instituted the prize for
contributions to quality and dependability of
product.

Quality award models: Deming prize

Quality award models: Deming prize

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Quality award models: Deming prize

Quality award models: Deming prize

Quality award models: the Malcolm

Baldrige National Quality Award
1980s in USA, aiming at:
Help improve organizational performance
practices, capabilities and results;
Facilitate communication and sharing of best
practices information;
Serve as a working tool for understanding and
managing performance and for guiding,
planning and opportunities for learning

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Quality award models: the Malcolm

Baldrige National Quality Award

Quality award models: European

Early 1990s: the launch of the European
Quality Award by the European Foundation
for Quality Management (EFQM)

Quality Award Models: European

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Quality Award Models: European

Quality model: 4Ps + 3Cs

Quality model: 4Ps + 3Cs

Planning the development and deployment of
policies and strategies; setting up appropriate
partnerships and resources; and designing in
quality.
Performance establishing a performance
measure framework a balanced scorecard for
the organization; carrying out self-assessment,
audits, reviews and benchmarking.
Processes understanding, management, design
and redesign; quality management systems;
continuous improvement.

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Quality model: 4Ps + 3Cs

These four Ps: hard management necessities
Three Cs of Culture, Communication, and
Commitment: soft outcomes of the model

Cost of quality
Cost of quality = cost of control (cost of
conformance) + cost of failure of control (cost
of non-conformance)

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Cost of quality

Cost of quality

Failure cost

5R
Reject
Rework
Recall
Return
Regret

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Waste
Wasting:

PDCA cycle
It is 4 step methodology for business process
improvement
Plan
Do

Establish objectives and how they will be achieve

Put the plan into effect

Check
Action

Verify that the process achieved the desired results

Analyse any differences and their causes
Take action to improve things

It is an iterative process so repeat to continue

achieving improvement

PDCA cycle

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Planning stage
Set up

Planning stage
Set up

Document
system
(Procedure,
regulations)

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Q-Base system
For SME with lack of resources to implement
fully ISO 9001, Telarc Q-Base provides an
excellent alternative.
Q-Base Code is based upon the ISO 9001.
It enables you to implement basic
management disciplines to assure quality of
products and services.

Q-Base system
< 10 employees
Rarely employ staff who are quality
management professionals.
Are managed by the owner who has a strong
hands-on role and spends after-hours on
paperwork.
Work on low profit margins
Rarely have a documented system and
procedures manual.

Q-Base system: clauses

1.
2.
3.
4.
5.
6.
7.
8.

Management of the quality system

Control of documents and records
Customers' needs
Purchasing
Training and work instructions
Inspecting and control of substandard work
Continual Improvements
Association, Industry or other criteria

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GMP:
Good Manufacturing Practice
GMP ensures that quality is built into the
organization & processes involved in
manufacture
GMP covers all aspects of manufacture including
collection, transportation, processing, storage,
QC & delivery of the finished product

GMP
Part of QA which ensures
that products are
consistently produced &
controlled to the quality
standards appropriate to
their use.
GMP is an integral part of
QA.

GMP

GMP in solid dosage forms

GMP in semisolid dosage forms
GMP in Liquid orals
GMP in Parenterals Production
GMP in Ayurvedic medicines
GMP in Biotechnological products
GMP in Nutraceuticals & cosmeceuticals
GMP in Homeopathic medicines

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GMP

Good Manufacturing Practice

Good Management Practice
Get More Profit
Give more Production
GMP Training with out tears

Ten Principles of GMP

1.
2.
3.
4.
5.
6.

Design & construct the facilities & equipments properly

Follow written procedures & Instructions
Document work
Validate work
Monitor facilities & equipment
Write step by step operating procedures & work on
instructions
7. Design, develop & demonstrate job competence
8. Protect against contamination
9. Control components & product related processes
10. Conduct planned & periodic audits

Beyond GMP
Reduce pollution - Zero discharge
Adaptation of environment friendly methods
Consideration for better & healthier life
tomorrow
Consideration of ethics in life
One should begin with end in mind otherwise it
will be the beginning of the end

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PERSONNEL
Adequate staff with relevant knowledge,
experience and capabilities in assigned task
a. Production and QC are headed by different
persons, neither of whom shall be responsible to
the other
b. Responsibilities and authority of key
personnel are clearly defined
c. Training on the understanding of procedures,
work instruction, GMP principles, etc.

3 Key Personnel
The head of production
The head of QC
The head of QM (QA)

The head of QM (QA)

The head of QM (QA) should be a qualified
pharmacist, have adequate training & practical
experiences which enable him/her to perform
him/her function personally.
The head of QM (QA) should given full authority &
responsibility in all quality system/assurance duties.

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PREMISES
Specify the requirements of location, design , constructions and
maintenance of manufacturing premises with respect to
the following:
a. prevention of contamination from surrounding
environment and pests
b. prevention of mix up of materials and products
c. facilities such as toilet, changing rooms, sampling areas
and QC lab
d. defined areas for certain activities
e. wall, ceiling, drains , air intake and exhaust, lighting and
ventilation, pipe work and light fitting
f. storage areas

PREMISES
Suitable location, design , constructions and
maintenance for manufacturing premises :
defined areas for certain activities (e.g material
sampling & dispensing)
wall, ceiling, drains , air intake and exhaust,
lighting and ventilation, pipe work and light fitting
storage areas of adequate space
Physical separation of toilets and QC lab from
production

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Building & facilities

1.
2.
3.
4.
5.
6.
7.
8.

Design and construction features.

Lighting.
Ventilation, air filtration, air heating and cooling.
Plumbing.
Sewage and refuse.
Washing and toilet facilities.
Sanitation.
Maintenance.

Paint Finish
Not only building
paintwork must be
considered but also
equipment

Building Finishes
Not Acceptable

Acceptable

PVA Paint

Epoxy or Enamel paint

Window sills

Flush glazed windows

Exposed pipes

Smooth surfaces

Horizontal pipes & services

Concealed services

Open floor drains

Floor cracks, flaking floor
surfaces
Ceiling cracks & joints

Hygienic drains
Homogonous sealed floors
epoxy finish or welded vinyl
Smooth sealed ceilings

Exposed, open light fittings

Flush light fittings

S/Steel or Melamine
furniture

Wooden furniture

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Poor & Good Windows

HACCP
In the early 1960s, food scientists at Pillsbury, in
collaboration with NASA scientists realized that
traditional food safety methods testing and analysis
- would be inadequate to guarantee food quality in
space.
Taking strategy from munitions makers, they were
asked to identify certain critical failure areas and
eliminate them from the system.

What is HACCP?
NASA had already mandated the use of Critical
Control Points in their engineering management, so
Pillsbury adopted it for food.
In 1971 and 1972 there were numerous incidents of
botulism poisoning from commercially canned foods
in the US.
The US Government asked Pillsbury to train its inspectors
and help with a new food safety program based on
Pillsburys NASA experience, which eventually became
HACCP.

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What is HACCP?
Hazard Analysis and Critical Control Points.
This program is often cited as a very successful
collaboration between industry and
government.

The initial HACCP system was based on three

principles:
1. Conduct a hazard analysis.
2. Determine critical control points.
3. Establish monitoring procedures.

Based on its experience, Pillsbury quickly

adopted two additional principles:
Establish corrective actions to take when
deviations occur at a CCP.
Establish critical limits to be enforced at CCPs.

The first HACCP foods

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HACCP Today
1.
2.
3.
4.
5.

Conduct a hazard analysis.

Determine the CCPs.
Establish critical limit(s).
Establish a system to monitor control of the CCPs.
Establish the corrective action to be taken when
monitoring indicates that a particular CCP is not under
control.
6. Establish procedures for verification to confirm that the
HACCP system is working effectively.
7. Establish documentation concerning all procedures and
records appropriate to these principles and their
application.

HACCP Today
Used in all types of manufacturing, not simply food or
beverages.
Adopted by brewers in the early 1990s.

Other models

6 sigma
JIT Just in Time
Benchmarking
SA 8000
TQM

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6 sigma

6 sigma

6 sigma
68.26% of the population within 1 standard
deviation around the mean
95.46% of the population within 2 standard
deviations around the mean
99.74% of the population within 3 standard
deviations around the mean

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6 sigma in different industries

DPMO

1000000

Restaurant bills

(defectsper 100000
million
opportunities) 10000

Airlines baggagecheck in

1000
100

Egypt Air (5,8)

Air India(5,8)
Lufthansa (6,6)

10
1

Best-in-class

0,1

Quantas, SAS

0,01

Source: Motorola, Air Safety Online

6 sigma in different industries

DPMO

1000000

Restaurant bills

(defectsper 100000
million
opportunities) 10000

Airlines baggagecheck in

1000
100

Egypt Air (5,8)

Air India(5,8)
Lufthansa (6,6)

10
1

Best-in-class

0,1

Quantas, SAS

0,01

Source: Motorola, Air Safety Online

The quality mantra

Quality can not be tested into

products; it has to be built in by
design

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