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Quality Management
Systems
By
Dr M.Valliammal
Professor
AMET Business School , AMET University
Objectives of QA
• Managing good manufacturing practices(GMP)
including:
• Managing Good laboratory practices(GLP)
• Managing safety programme
• Assuring quality of raw materials
• Assuring quality and traceability of finished products
• Evaluating plant environment.
Total Quality
Management
Managing for Quality& High
performance
Elements of TQM
(as Per Norman Gaither)
2
1
 Top management commitment and involvement
Customer involvement ,Design products for
quality,Design production processes for quality
 Control production processes for
quality,Develop supplier partnerships
 Customer service, distribution, and installation
 Teams of empowered employees
 Benchmarking and continuous improvement
Elements of TQM
(as Per Norman Gaither)
2
2
 Customer involvement
 Design products for Quality
 Design product process for quality
 Customer service ,distribution and
installations
How Do Quality Circles Work?
2
8
All members of a Circle need to receive training
•Members need to be empowered
•Members need to have the support of Senior
Management
•How Can They be Used in an Organization?
•Increase Productivity
•Improve Quality
•Boost Employee Morale
Activating teamwork in Quality Circles
Team Exercise
Break down into teams of 6-8 people,Establish a
leader and rules for your Circle
• Have a brainstorming and problem-solving session to
resolve the issue on the next slide
Team Exercise
A Collegiate class on Statistical Analysis has a total
enrollment of 45 people.Average attendance is 18 students
The class consists mainly of lectures
• How can the professor of this class improve the quality
of
Activating teamwork in Quality Circles
Team Exercise
Break down into teams of 6-8 people,Establish a
leader and rules for your Circle
• Have a brainstorming and problem-solving session to
resolve the issue on the next slide
Team Exercise
A Collegiate class on Statistical Analysis has a total
enrollment of 45 people.Average attendance is 18 students
The class consists mainly of lectures
• How can the professor of this class improve the quality
of
Models for Achieving TQM
and set realistic, competitive long-term objectives,
The Need for a Model in TQM
At the century close, the creation of the global
market, international orientation of management that
sweeps national boundaries, introduction of new
technologies, and shift towards customer focused
strategies, make the competition stronger than ever.
The criteria for success in this global,
internationally oriented market have been changing
rapidly.
In order to expand business, enter new markets,
Models for Achieving TQM
excellence became an imperative. Management's
effort has been directed towards discovering what
makes a company excellent.
To achieve excellence, companies must develop a
corporate culture of treating people as their most
important asset and provide a consistent level of high
quality products.
services in every market in which they operate.
Such an environment has supported the wide
acceptance of Total Quality Management (TQM)
which emerged recently as a new, challenging,
marketable philosophy.
Models for Achieving TQM
It involves three spheres of changes in an
organization -- people, technology and structure.
There is also a need for a systematic approach so
that each element of TQMEX can be bonded
together smoothly.
Oakland [1989] originated the idea of a 3-
cornerstone model. The proposed 4-pillar model
(Figure 3.1) brings the customer's requirement into
the system.
An Integrated Model of TQM (Sohal,
Tay,Wirth-1989)
TQM Mission
Quality Improvement
team
Systematic problem
Solving Focus
Statistical
Quality Control Total participation
Customer Focus
Building Block of TQM (Zaire
Model)
•Quality planning Leadership
•Vision for world class competitiveness
SPC
SQC
User
Supplier
Chain
Process
Flexibility
eWorkpla
c
Design
Management
Control
system
•Continuous Improvement
•Added value management Activity
•Employee involvement
Level 1 Foundation
Level 2
Pillars
Level 3
The top
Malcolm Baldrige National Quality Award
In 1987, jumpstarting a small, slowly growing
U.S. quality movement, Congress established the
Malcolm Baldrige National Quality Award to
promote quality awareness, to recognize quality and
business achievements of U.S. organizations, and to
publicize these organizations’ successful
performance strategies.
Now America’s highest honor for performance
excellence, the Baldrige Award is presented annually
to U.S. organizations by the President of the United
States.
Malcolm Baldrige National Quality Award
Awards are given in manufacturing, service, small
business, education, and health care. In October
2004, President Bush signed into law legislation that
authorizes NIST to expand the Baldrige award
program to include non-profit organizations.
In 2007, non-profit organizations will be eligible
to apply for the award. In conjunction with the
private sector, the National Institute of Standards
and Technology designed and manages the award
and the Baldrige National Quality Program.
Malcolm Baldrige National Quality Award
Program impact
Since the first awards were presented in 1988, the
Baldrige National Quality Program has grown in
stature and impact.
Today, the Baldrige program, the award’s
criteria for performance excellence, and the
Baldrige award recipients are imitated and admired
worldwide.
In particular, the Baldrige criteria for
performance excellence have played a valuable role
in helping U.S. organizCahtaipotern4s improve.
Malcolm Baldrige National Quality Award
The criteria are designed to help organizations
improve their performance by focusing on two
goals: delivering ever improving value to customers
and improving the organization’s overall
performance.
Several million copies of the criteria have been
distributed since 1988, and wide-scale reproduction
by organizations and electronic access add to that
number significantly.

Malcolm Baldrige National Quality Award
Gordon Black, chairman and chief executive
officer of Harris/Black International Ltd., said the
publication containing the Baldrige criteria for
influential document in the modern history of
Following are some of the program’s highlights:
•State and local quality programs, most modeled
after the Baldrige program, have grown from fewer
than 10 in 1991 to 44 programs in 41 states.
Malcolm Baldrige National Quality Award
Internationally, nearly 80 quality programs are
operating. Most are modeled after the Baldrige
program, including one established in Japan in 1996.
Since 1988, 1,149 applications have been
submitted for the Baldrige Award from a wide
variety of types and sizes of organizations.
Malcolm Baldrige National Quality Award
Winners
2006 MESA Products, Inc.Tulsa, Okla. (small
Malcolm Baldrige National Quality Award
2005
Sunny Fresh Foods, Inc.
Monticello, Minn. (manufacturing)
DynMcDermott Petroleum Operations
New Orleans, La. (service)
Park Place Lexus
Plano, Texas (small business)
Richland College,,Dallas, Texas (education)
Jenks Public Schools
Jenks, Okla. (education)
Bronson Methodist Hospital
Malcolm Baldrige National Quality Award
Criteria for performance
The current award criteria are stated to have three
important roles in strengthening US
competitiveness:
•To help improve organizational performance
practices, capabilities and results
•To facilitate communication and sharing of the best
practice information among US organizations of all
types
•To serve as a working tool for understanding and
managing performance and for guiding planning and
Malcolm Baldrige National Quality Award
Criteria for performance
The criteria are designed to help organizations use
an aligned approach to organizational performance
management that results in:
•Delivery of ever-improving value to customers,
contributing to market success
•Improvement in overall organizational
effectiveness and capabilities
•Organizational and personal learning
Malcolm Baldrige National Quality Award
Criteria for performance
The seven categories of the criteria are:
1. Leadership
2. Strategic Planning
3. Customer & Market Focus
4. Measurement, Analysis and Knowledge
Management
5. Workforce Focus
6. Process Management
7. Results
Total Quality management for excellence
(TQMEX Model)
Total Quality management for excellence
(TQMEX Model)
The Logic of TQMEX
In order to have a systematic approach to TQM, it
is necessary to develop a conceptual model.
Generally, a model is a sequence of steps arranged
logically to serve as a guideline for implementation
of a process in order to achieve the ultimate goal.
The model should be simple, logical and yet
comprehensive enough for TQM implementation. It
also has to sustain the changes in business
environment of the new era.
Total Quality management for excellence
(TQMEX Model)
The Model also reflects teachings of the
contemporary quality gurus. The idea was to
develop a universally applicable step-by-step
guideline by including recognized practices in
TQM:
•Japanese 5-S Practice (5-S)
•Business Process Re-engineering (BPR)
•Quality Control Circles (QCCs)
•ISO 9001/2 Quality Management System (ISO)
Total Quality management for excellence
(TQMEX Model)
Total Productive Maintenance (TPM)
As Osada pointed out, 5-S is the key to total quality
environment.
Therefore, it should be the first step. BPR is
concerned with re-defining and designing your business
process in order to meet the needs of your customers
effectively.
It is more concerned with the business objectives
and systems, and should follow as Step 2. QCCs are
concerned with encouraging the employees to
participate in continuous improvement and guide them
through.
Total Quality management for excellence
(TQMEX Model)
They improve human resources capability to
achieve the business objectives. Therefore, this
should be Step 3. ISO 9000 is to develop a quality
management system based on the good practices in
the previous three steps.
TPM is a result of applying 5-S to equipment
based on a sound quality management system. In
fact ISO 9001 requires procedures for process
control and inspection and testing equipment which
are part of TPM. Therefore TPM should be
Total Quality management for excellence
(TQMEX Model)
TQMEX is a sequential model which is easy to
remember and simple to implement. This is in line
with the quality principle of Keep It Short and
Simple (KISS), although it is not simple to make a
model simple!
Companies starting to implement TQM should
follow TQMEX step-by-step. Companies which
have already gone through some degree of
improvement using some of the steps should review
what have not been done and do it as their next step
of improvement.
Models for Achieving TQM
The Four Pillars of TQM
Models for Achieving TQM
The Four C’s of TQM
Commitment
Competence
Communication
Continuous Improvement
Total Quality Management Kite marks
What are TQM kite marks?
Going to five steps of TQMEX model makes an
organization to have been built on a strong basis
and a proactive environment for the final stage-
TQM.There are clear business objectives &
process involved.
TQM kite marks are nationally or internationally
recognized quality standards.that provide
discipline,external assessment.The best known
TQM kite marks are ISO 9004,Japans Deming
prize,Malcolm BaldrigeCNhapatert4ionalQualityaward.

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Quality management systems

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  • 13. Objectives of QA • Managing good manufacturing practices(GMP) including: • Managing Good laboratory practices(GLP) • Managing safety programme • Assuring quality of raw materials • Assuring quality and traceability of finished products • Evaluating plant environment.
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  • 20. Total Quality Management Managing for Quality& High performance
  • 21. Elements of TQM (as Per Norman Gaither) 2 1  Top management commitment and involvement Customer involvement ,Design products for quality,Design production processes for quality  Control production processes for quality,Develop supplier partnerships  Customer service, distribution, and installation  Teams of empowered employees  Benchmarking and continuous improvement
  • 22. Elements of TQM (as Per Norman Gaither) 2 2  Customer involvement  Design products for Quality  Design product process for quality  Customer service ,distribution and installations
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  • 28. How Do Quality Circles Work? 2 8 All members of a Circle need to receive training •Members need to be empowered •Members need to have the support of Senior Management •How Can They be Used in an Organization? •Increase Productivity •Improve Quality •Boost Employee Morale
  • 29. Activating teamwork in Quality Circles Team Exercise Break down into teams of 6-8 people,Establish a leader and rules for your Circle • Have a brainstorming and problem-solving session to resolve the issue on the next slide Team Exercise A Collegiate class on Statistical Analysis has a total enrollment of 45 people.Average attendance is 18 students The class consists mainly of lectures • How can the professor of this class improve the quality of
  • 30. Activating teamwork in Quality Circles Team Exercise Break down into teams of 6-8 people,Establish a leader and rules for your Circle • Have a brainstorming and problem-solving session to resolve the issue on the next slide Team Exercise A Collegiate class on Statistical Analysis has a total enrollment of 45 people.Average attendance is 18 students The class consists mainly of lectures • How can the professor of this class improve the quality of
  • 31. Models for Achieving TQM and set realistic, competitive long-term objectives, The Need for a Model in TQM At the century close, the creation of the global market, international orientation of management that sweeps national boundaries, introduction of new technologies, and shift towards customer focused strategies, make the competition stronger than ever. The criteria for success in this global, internationally oriented market have been changing rapidly. In order to expand business, enter new markets,
  • 32. Models for Achieving TQM excellence became an imperative. Management's effort has been directed towards discovering what makes a company excellent. To achieve excellence, companies must develop a corporate culture of treating people as their most important asset and provide a consistent level of high quality products. services in every market in which they operate. Such an environment has supported the wide acceptance of Total Quality Management (TQM) which emerged recently as a new, challenging, marketable philosophy.
  • 33. Models for Achieving TQM It involves three spheres of changes in an organization -- people, technology and structure. There is also a need for a systematic approach so that each element of TQMEX can be bonded together smoothly. Oakland [1989] originated the idea of a 3- cornerstone model. The proposed 4-pillar model (Figure 3.1) brings the customer's requirement into the system.
  • 34. An Integrated Model of TQM (Sohal, Tay,Wirth-1989) TQM Mission Quality Improvement team Systematic problem Solving Focus Statistical Quality Control Total participation Customer Focus
  • 35. Building Block of TQM (Zaire Model) •Quality planning Leadership •Vision for world class competitiveness SPC SQC User Supplier Chain Process Flexibility eWorkpla c Design Management Control system •Continuous Improvement •Added value management Activity •Employee involvement Level 1 Foundation Level 2 Pillars Level 3 The top
  • 36. Malcolm Baldrige National Quality Award In 1987, jumpstarting a small, slowly growing U.S. quality movement, Congress established the Malcolm Baldrige National Quality Award to promote quality awareness, to recognize quality and business achievements of U.S. organizations, and to publicize these organizations’ successful performance strategies. Now America’s highest honor for performance excellence, the Baldrige Award is presented annually to U.S. organizations by the President of the United States.
  • 37. Malcolm Baldrige National Quality Award Awards are given in manufacturing, service, small business, education, and health care. In October 2004, President Bush signed into law legislation that authorizes NIST to expand the Baldrige award program to include non-profit organizations. In 2007, non-profit organizations will be eligible to apply for the award. In conjunction with the private sector, the National Institute of Standards and Technology designed and manages the award and the Baldrige National Quality Program.
  • 38. Malcolm Baldrige National Quality Award Program impact Since the first awards were presented in 1988, the Baldrige National Quality Program has grown in stature and impact. Today, the Baldrige program, the award’s criteria for performance excellence, and the Baldrige award recipients are imitated and admired worldwide. In particular, the Baldrige criteria for performance excellence have played a valuable role in helping U.S. organizCahtaipotern4s improve.
  • 39. Malcolm Baldrige National Quality Award The criteria are designed to help organizations improve their performance by focusing on two goals: delivering ever improving value to customers and improving the organization’s overall performance. Several million copies of the criteria have been distributed since 1988, and wide-scale reproduction by organizations and electronic access add to that number significantly. 
  • 40. Malcolm Baldrige National Quality Award Gordon Black, chairman and chief executive officer of Harris/Black International Ltd., said the publication containing the Baldrige criteria for influential document in the modern history of Following are some of the program’s highlights: •State and local quality programs, most modeled after the Baldrige program, have grown from fewer than 10 in 1991 to 44 programs in 41 states.
  • 41. Malcolm Baldrige National Quality Award Internationally, nearly 80 quality programs are operating. Most are modeled after the Baldrige program, including one established in Japan in 1996. Since 1988, 1,149 applications have been submitted for the Baldrige Award from a wide variety of types and sizes of organizations. Malcolm Baldrige National Quality Award Winners 2006 MESA Products, Inc.Tulsa, Okla. (small
  • 42. Malcolm Baldrige National Quality Award 2005 Sunny Fresh Foods, Inc. Monticello, Minn. (manufacturing) DynMcDermott Petroleum Operations New Orleans, La. (service) Park Place Lexus Plano, Texas (small business) Richland College,,Dallas, Texas (education) Jenks Public Schools Jenks, Okla. (education) Bronson Methodist Hospital
  • 43. Malcolm Baldrige National Quality Award Criteria for performance The current award criteria are stated to have three important roles in strengthening US competitiveness: •To help improve organizational performance practices, capabilities and results •To facilitate communication and sharing of the best practice information among US organizations of all types •To serve as a working tool for understanding and managing performance and for guiding planning and
  • 44. Malcolm Baldrige National Quality Award Criteria for performance The criteria are designed to help organizations use an aligned approach to organizational performance management that results in: •Delivery of ever-improving value to customers, contributing to market success •Improvement in overall organizational effectiveness and capabilities •Organizational and personal learning
  • 45. Malcolm Baldrige National Quality Award Criteria for performance The seven categories of the criteria are: 1. Leadership 2. Strategic Planning 3. Customer & Market Focus 4. Measurement, Analysis and Knowledge Management 5. Workforce Focus 6. Process Management 7. Results
  • 46. Total Quality management for excellence (TQMEX Model)
  • 47. Total Quality management for excellence (TQMEX Model) The Logic of TQMEX In order to have a systematic approach to TQM, it is necessary to develop a conceptual model. Generally, a model is a sequence of steps arranged logically to serve as a guideline for implementation of a process in order to achieve the ultimate goal. The model should be simple, logical and yet comprehensive enough for TQM implementation. It also has to sustain the changes in business environment of the new era.
  • 48. Total Quality management for excellence (TQMEX Model) The Model also reflects teachings of the contemporary quality gurus. The idea was to develop a universally applicable step-by-step guideline by including recognized practices in TQM: •Japanese 5-S Practice (5-S) •Business Process Re-engineering (BPR) •Quality Control Circles (QCCs) •ISO 9001/2 Quality Management System (ISO)
  • 49. Total Quality management for excellence (TQMEX Model) Total Productive Maintenance (TPM) As Osada pointed out, 5-S is the key to total quality environment. Therefore, it should be the first step. BPR is concerned with re-defining and designing your business process in order to meet the needs of your customers effectively. It is more concerned with the business objectives and systems, and should follow as Step 2. QCCs are concerned with encouraging the employees to participate in continuous improvement and guide them through.
  • 50. Total Quality management for excellence (TQMEX Model) They improve human resources capability to achieve the business objectives. Therefore, this should be Step 3. ISO 9000 is to develop a quality management system based on the good practices in the previous three steps. TPM is a result of applying 5-S to equipment based on a sound quality management system. In fact ISO 9001 requires procedures for process control and inspection and testing equipment which are part of TPM. Therefore TPM should be
  • 51. Total Quality management for excellence (TQMEX Model) TQMEX is a sequential model which is easy to remember and simple to implement. This is in line with the quality principle of Keep It Short and Simple (KISS), although it is not simple to make a model simple! Companies starting to implement TQM should follow TQMEX step-by-step. Companies which have already gone through some degree of improvement using some of the steps should review what have not been done and do it as their next step of improvement.
  • 52. Models for Achieving TQM The Four Pillars of TQM
  • 53. Models for Achieving TQM The Four C’s of TQM Commitment Competence Communication Continuous Improvement
  • 54. Total Quality Management Kite marks What are TQM kite marks? Going to five steps of TQMEX model makes an organization to have been built on a strong basis and a proactive environment for the final stage- TQM.There are clear business objectives & process involved. TQM kite marks are nationally or internationally recognized quality standards.that provide discipline,external assessment.The best known TQM kite marks are ISO 9004,Japans Deming prize,Malcolm BaldrigeCNhapatert4ionalQualityaward.