Medical Device Regulatory Affairs

QUALITY MANAGEMENT AND STRATEGY

Hello and
Welcome
I currently work as a Quality Manager and also as an Associate Lecturer at SETU.

I teach on various streams in the part time courses. Current modules I teach on include Regulatory,
Innovation, Science and Management modules for the SETU, Carlow including EDI.

Previously worked in consulting for start-up enterprises and have a mixed background in management in
Food and Pharmaceutical Sector.

Qualifications:
• MBA with focus on Sustainability, Innovation and EDI
• MSc in Industrial Pharmaceutical Science
• Post Grad Certificate in Certificate in Quality Analytics for Biopharma
• BSc in Bioscience with Biopharmaceutical

You can contact me at Email: [email protected]

Typically get back to emails in less than 48 hours.

I travel for work and can be a bit longer, so I do appreciate your patience.

Looking forward to our journey over the next 12 weeks.

Housekeeping in the Classroom

Support and
Active Engage during
learn
Listening sessions
from each other

• Breaks included

• Please mute mobile devices and phone when

• Avoid ‘Googling’ when working in breakout room or tasks try engage your own mind – I want
your opinion not someone on the internets!

• Slides and further reading available via Blackboard each week

• Please be on time to avoid interrupting the class and to get the most from the lecture

• Fire Exits, Toilets, Situational Awareness

Open minds lead to better leaders
u We all come from a range of diverse backgrounds, experiences, cultures,
religions, orientations, abilities and educations. We all have something
valuable to bring to the table and something meaningful to learn from each
other. I want to encourage you to share your opinions along the way and lets
all try listen to each other with respect and an open mind. Please only share
what you feel comfortable to do so as the lectures will be recorded.
u Better Leadership and management comes from practising better active
listening to each other and that starts with kindness and open discussions
where no one is judged.
Additional Resources
If any student requires additional resources or requirements
to support their learning due to a disability, medical condition
or any other reason please in confidence email me or talk to
me at the end of class to arrange any additional support
where possible and within reason. I will do my best to
accommodate and also point you in the right direction for
supports at SETU. I want to make sure everyone in the room
has equal access to this module.
Structure of Learning

u I typically try to have use a range of learning tools utilising

lectures presentations, mixed media such as videos and
podcasts, and interactive materials.

u Wednesday will be lecture slide presentations

u Independent learning is expected for 214 hours of the course.

u Lecturers - 12 Classes in total – 36 Hours

WELCOME
1. Duration
• 15th of January to 9th April 2024
• 12 Weeks

2. Wednesdays 19:00 – 22:00 Room L117

3. Course materials: blackboard

 AI Statement
u You can use these tools ethically to help you learn. For
example, you could use them to help you to draw up a
study plan, to summarise information, to help narrow
down a topic or to generate flashcards or practice
questions.

u You should NOT use them unethically to create

some or all of your assignments for this module.

u See resources posted on blackboard on AI.

- Do not use for assessments - Study Note Notes

- Translation
- Do not put the lecturers slides - Study Plan
into any AI software - Summarise Information
Course Content
u The module is broken into 8 key learning outcomes
Assignments
u This module is 100% Continuous Assessment
u There will be a total of 2 Assignments TBC

u Assignment 1 (40%) SOP

u Due Due 23:59pm 16th February 2025
u Expected feedback by 2nd March 2025

u Assignment 2 (60%) Group

u Submitted File Due 23:59pm Due 6th April 2025
u Expected feedback by 20th April 2025
CA01

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CA02

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COURSE MODULE CONTENT

u LECTURE 1: History of Quality and Quality Gurus

u LECTURE 2: Introduction to CFR 820 and ISO 13485
u LECTURE 3: ISO 13485: Quality Management System
u LECTURE 4: ISO 13485: Management Responsibility
u LECTURE 5: ISO 13485: Resource Management
u LECTURE 6: ISO 13485: Product Realization
u LECTURE 7: ISO 13485: Measurement, Analysis and Improvement
u LECTURE 8: CFR 820: A-D
u LECTURE 9: CFR 820: E-H
u LECTURE 10: CFR 820: I-K
u LECTURE 11: CFR 820: L-O
u LECTURE 12: Auditing and Recalls
Quality
Management
What is Quality?

How would you define it?

15
Quality
Although there is no universally accepted definition of
quality, enough similarity does exist among the
definitions that common elements can be extracted:

• Quality involves meeting or exceeding customer

expectations.
Quality applies to products, services, people,
processes, and environments.

• Quality is an ever-changing state (i.e., what is

considered quality today may not be good enough
to be considered quality tomorrow

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u What is quality?
Dictionary has many definitions: “Essential
characteristic,” “Superior,” etc.

u Some definitions that are accepted in

various organizations:
u “Quality is customer satisfaction,”
u “Quality is Fitness for Use.”
 WHAT IS QUALITY?
Quality can be defined in a number of different ways and can
be objective to the person or organisation :

Fred Smith former CEO of FedEx defines quality as

"performance to the standard expected by the customer."

The U.S. Department of Defence (DOD) defines quality as "doing the

right thing right the first time always striving for improvement, and
always satisfying the customer.”

Boeing defines quality as "providing our customers with

products and services that consistently meet their
needs and expectations.”

Patient health and safety are foundational to everything we do. We achieve our
high standards in product quality and safety through proactive and transparent
systems and processes, and clear communications to our patients, providers and
stakeholders about the benefits and risks of our products. We hold ourselves
accountable to one another and strive to create a workforce that embodies
Pfizer’s core values and the principles of quality and integrity.
 Concepts
u What is a customer?
Anyone who is impacted by the product or process delivered by an
organization.
External customer: The end user as well as intermediate processors.
Other external customers may not be purchasers but may have
some connection with the product.
Internal customer: Other divisions of the company that receive the
processed product.

u What is a product?
The output of the process carried out by the organization. It may be
goods (e.g. automobiles, missile), software (e.g. a computer code,
a report) or service (e.g. banking, insurance)

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Concepts
u How is customer satisfaction achieved?
Two dimensions: Product features and Freedom from deficiencies.

u Product features – Refers to quality of design.

Examples in manufacturing industry: Performance, Reliability, Durability,

Ease of use, Esthetics etc.
Examples in service industry: Accuracy, Timeliness, Friendliness and
courtesy, Knowledge of server etc.

u Freedom from deficiencies – Refers to quality of conformance.

Higher conformance means fewer complaints and increased customer
satisfaction. (This is related to free from defects.)

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Why Quality?
Reasons for quality becoming a cardinal priority for
most organizations:
u Competition – Today’s market demand high quality
products at low cost. Having `high quality’
reputation is not enough! Internal cost of
maintaining the reputation should be less.
u Changing customer – The new customer is not only
commanding priority based on volume but is more
demanding about the “quality system.”
u Changing product mix – The shift from low volume,
high price to high volume, low price have resulted
in a need to reduce the internal cost of poor quality.

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Why Quality?

u Product complexity – As systems have become

more complex, the reliability requirements for
suppliers of components have become more
stringent.
u Higher levels of customer satisfaction – Higher
customers expectations are getting spawned by
increasing competition.

Relatively simpler approaches to quality product

inspection for quality control and incorporation of
internal cost of poor quality into the selling price,
might not work for today’s complex market
environment.
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 QUALITY, VALUE AND
ORGANIZATIONAL EXCELLENCE
• It is important for quality professionals to understand how
quality fits into the bigger picture of providing superior
value to customers.

• Organizations survive and thrive in a globally competitive

marketplace by providing superior value to customers.

• Achieving organizational excellence is about developing

the ability to consistently provide superior value to
customers over the long term.

• Superior value has three basic elements: superior quality,

superior cost, and superior service.
Quality perspectives
Everyone defines Quality based on their own
perspective of it. Typical responses about the
definition of quality would include:

1. Perfection
2. Consistency
3. Eliminating waste
4. Speed of delivery
5. Compliance with policies and procedures
6. Doing it right the first time
7. Delighting or pleasing customers
8. Total customer satisfaction and service
Quality levels

At organizational level, we need to ask following questions:

u Which products and services meet your expectations?
u Which products and services you need that you are not
currently receiving?

At process level, we need to ask:

u What products and services are most important to the
external customer?
u What processes produce those products and services?
u What are the key inputs to those processes?
u Which processes have most significant effects on the
organization’s performance standards?
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Additional Views of Quality in
Services

u Technical Quality versus Functional Quality

uTechnical quality—the core element of the good or service.
uFunctional quality—customer perception of how the good
functions or the service is delivered.
u Expectations and Perceptions
uCustomers’ prior expectations (generalized and specific
service experiences) and their perception of service
performance affect their satisfaction with a service.
uSatisfaction =
u (Perception of Performance) -(Expectation)
What is Total Quality
Management (TQM)

uAny ideas?

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Total Quality Approach

Just as there are different definitions of quality, there are

different definitions of total quality. For example, the DOD
defines the total quality approach as follows:

• Total quality consists of the continual improvement of

people, processes, products (including services), and
environments

• With total quality anything and everything that affects

quality is a target for continual improvement. When the
total quality concept is effectively applied, the end results
can include organizational excellence, superior value,
and global competitiveness.
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Three Legged Stool of Quality
u An easy way to remember the concept of TQM is the 3
legs of a stool

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30
FDA CFR Defines Quality as:

Quality means the totality of features and

characteristics that bear on the ability of a
device to satisfy fitness-for-use, including safety
and performance.

ISO 8402 defines quality as:

The totality of features and characteristics of a

product or service that bear on its ability to
satisfy stated or implied needs.
Historical Philosophies of Quality

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 HISTORY AND DEVELOPMENT
OF TOTAL QUALITY
• The total quality movement had its roots in the time and motion
studies conducted by Frederick Taylor in the 1920s

• On the next slide the timeline shows some of the major events in the
evolution of the total quality movement since the days of Taylor. Taylor
is now known as "the father of scientific management.”

• The most fundamental aspect of scientific management is the

separation of planning and execution

• Taylor's scientific management strategy meant making planning the

job of management and production the job of labour.

• World War II had an impact on quality that is still being felt. In general,
the effect was negative for the United States and positive for Japan.
 HISTORY AND DEVELOPMENT
OF TOTAL QUALITY
u Because of the urgency to meet production schedules
during the war, U.S. companies focused more on
meeting delivery dates than on quality. This approach
became a habit that carried over even after the war.

u Japanese companies, on the other hand, were forced to

learn to compete with the rest of the world in the
production of non-military goods. At first, their attempts
were unsuccessful, and "Made in Japan" remained
synonymous with poor quality, as it had been before
World War II.

u Around 1950, however, Japan decided to get serious

about quality and establishing ways to produce quality
products.
The Quality Gurus

u Quality Gurus
uIndividuals who have been identified as making a
significant contribution to improving the quality of
goods and services.
uWalter A. Shewhart
uW. Edwards Deming
uJoseph M. Juran
uArmand Feigenbaum
uPhilip Crosby
uGenichi Taguchi
uKaoru Ishikawa
36
37
38
Three of the Quality Gurus Compared

Modified from John S. Oakland, Total Quality

Management (London: Heinemann
Professional Publishing Ltd., 1989), pp. 291–
92.
Three of the Quality Gurus Compared (cont’d)

Modified from John S. Oakland, Total Quality

Management (London: Heinemann
Professional Publishing Ltd., 1989), pp. 291–
92.
Three of the Quality Gurus Compared (cont’d)

Modified from John S. Oakland, Total Quality

Management (London: Heinemann
Professional Publishing Ltd., 1989), pp. 291–
92.
The Quality Gurus (cont’d)

uWalter A. Shewhart
uStatistician at Bell Laboratories
u Developed statistical control process methods to
distinguish between random and nonrandom
variation in industrial processes to keep processes
under control.
u Developed the “plan-do-check-act” (PDCA) cycle
that emphasizes the need for continuous
improvement.
u Strongly influenced Deming and Juran.
 Shewhart’s Plan-Do-Check-Act
(PDCA) Cycle

Source: “The PDCA Cycle” from Deming Management at Work by Mary Walton, copyright © 1990
by Mary Walton. Used by permission of G. P. Putnam’s Sons, a division of Penguin Putnam, Inc.
W. EDWARDS DEMING
u Of the various quality pioneers in the United States,
the best known is W. Edwards Deming

u The Deming Cycle summarized as follows:

• 1. Conduct consumer research and use it in planning
the product (plan).
• 2. Produce the product (do).
• 3. Check the product to make sure it was produced in
accordance with the plan (check).
• 4. Market the product (act).
• 5. Analyze how the product is received in the
marketplace in terms of quality, cost, and other criteria
(analyze).
W. EDWARDS DEMING
uAdvocated Statistical Process Control (SPC)
uMethods which signal shifts in a process that will
likely lead to products and/or services not
meeting customer requirements.
uEmphasized an overall organizational approach
to managing quality.
uDemonstrated that quality products are less
costly than poor quality products.
uIdentified 14 points critical for improving quality.

uThe Deming Prize

uHighest award for industrial excellence in Japan.
46
Deming’s 14-Point Program for Improving
Quality
1. Create constancy of purpose for improvement of product and service.
2. Adopt the new philosophy.
3. Cease dependence on mass inspection.
4. End the practice of awarding business on the price tag alone.
5. Improve constantly and forever the system of production and training.
6. Institute training.
7. Institute leadership.
8. Drive out fear.
9. Break down barriers between staff areas.
10. Eliminate slogans, exhortations, and targets for the workforce.
11. Eliminate numerical quotas.
12. Remove barriers to pride in workmanship.
13. Institute a vigorous program of education and retraining.
14. Take action to accomplish the program.

“14 Point System” from Deming Management at

Work by Mary Walton, copyright © 1990 by Mary
Walton. Used by permission of G. P. Putnam’s
Sons, a division of Penguin Putnam, Inc.
The Deming philosophy
14 points for management:
1. Create and publish to all employees a statement
of the aims and purposes of the company. The
management must demonstrate their commitment
to this statement.
2. Learn the new philosophy.
3. Understand the purpose of inspection – to reduce
the cost and improve the processes.
4. End the practice of awarding business on the
basis of price tag. Instead, minimize total cost.
Build a long-term relationship of loyalty and trust
with suppliers.
5. Improve constantly and forever the system of
production and service. 48
The Deming philosophy
6. Institute training on the job.
7. Teach and institute leadership.
8. Drive out fear. Create an environment of
innovation.
9. Optimize the team efforts and break down
barriers between departments.
10. Eliminate slogans, target, exhortations form the
workplace.
11. Eliminate numerical quotas for production.
12. Remove the barriers that rob pride of
workmanship.
13. Encourage learning and self-improvement.
14. Take action to accomplish the transformation.

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The Deming philosophy

u “A System of Profound Knowledge”

1. Appreciation for a system - A system is a set
of functions or activities within an
organization that work together to achieve
organizational goals. Management’s job is to
optimize the system. (not parts of system,
but the whole!). System requires co-
operation.
2. Psychology – The designers and
implementers of decisions are people.
Hence understanding their psychology is
important.

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The Deming philosophy

3. Understanding process variation – A

production process contains many sources
of variation. Reduction in variation improves
quality. Two types of variations- common
causes and special causes. Focus on the
special causes. Common causes can be
reduced only by change of technology.
4. Theory of knowledge – Management
decisions should be driven by facts, data
and justifiable theories. Don’t follow the
managements fads!

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The Seven Deadly Diseases
Interestingly, in addition to providing management with his useful
14 principles, Deming also identified what he labelled as the
"Seven Deadly Diseases".
Deming's seven deadly diseases of Management describe the
most serious barriers that management faces to improving
effectiveness and continual improvement.

1. Lack of constancy of purpose

2. Emphasis on short-term profits
3. Evaluation by performance, merit rating, or annual review of
performance
4. Mobility of management
5. Running a company on visible figures alone
6. Excessive medical costs
7. Excessive costs of warranty, fuelled by lawyers who work for
contingency fees
 Joseph M. Juran

u Joseph Moses Juran was a Romanian-born

u American engineer and management
consultant. He is principally remembered as an
evangelist for quality and quality management
having written several influential books on
those subjects.
u Juran believed quality is associated with
customer satisfaction and dissatisfaction with
the product, and emphasised the necessity for
ongoing quality improvement through a
succession of small improvement projects
carried out throughout the organisation
Joseph M. Juran
u Emphasized the importance of producing quality products
through an approach focused on quality planning, control, and
improvement.

u Defined
product quality as “fitness for use” as viewed by the
customer in:
u Quality of design
u Quality of conformance
u Availability
u Safety
u Field use

u Categorized the cost of quality as:

u Cost of prevention
u Cost of detection/appraisal
u Cost of failure
The Juran philosophy
u Pursue quality on two levels:
1. The mission of the firm as a whole is to
achieve high product quality.
2. The mission of each individual department is
to achieve high production quality.

u Quality should be talked about in a language

senior management understands: money
(cost of poor quality).

u At operational level, focus should be on

conformance to specifications through
elimination of defects- use of statistical
methods.
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The Juran philosophy
Quality Trilogy –
1. Quality planning: Process of preparing to meet
quality goals. Involves understanding customer
needs and developing product features.

2. Quality control: Process of meeting quality goals

during operations. Control parameters.
Measuring the deviation and taking action.

3. Quality improvement: Process for breaking

through to unprecedented levels of performance.
Identify areas of improvement and get the right
people to bring about the change.
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Quality Planning - Juran
u Quality Planning: Quality planning involves
developing the products, systems, and
processes needed to meet or exceed
customer expectations.

u The following steps are required:

• 1. Determine who the customers are.
• 2. Identify customers' needs.
• 3. Develop products with features that respond
to customer needs.
• 4. Develop systems and processes that allow
the organization to produce these features.
• 5. Deploy the plans to operational levels
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 Quality Control - Juran

• Quality Control: The control of quality

involves the following processes:

• 1. Assess actual quality performance.

• 2. Compare performance with goals.

• 3. Act on differences between performance

and goals.
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Quality Improvement - Juran
Quality Improvement: The improvement of quality should be
ongoing and continual:

1. Develop the infrastructure necessary to make annual quality

improvements.

2. Identify specific areas in need of improvement, and

implement improvement projects.

3. Establish a project team with responsibility for completing

each improvement project.

4. Provide teams with what they need to be able to diagnose

problems to determine root causes, develop solutions, and
establish controls that will maintain gains made.

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Juran's Three Basic Steps to Progress

1. Achieve structured improvements on a continual basis

combined with dedication and a sense of urgency

2. Establish an extensive training program.

3. Establish commitment and leadership on the part of

higher management.
Juran’s 10 Steps to Quality improvement
1. Build awareness of both the need for improvement and opportunities for
improvement.

2. Set goals for improvement.

3. Organize to meet the goals that have been set.

4. Provide training.

5. Implement projects aimed at solving problems.

6. Report progress

7. Give recognition.

8. Communicate results.

9. Keep score.

10. Maintain momentum by building improvement into the company's

regular systems.
The Quality Gurus (cont’d)

u Armand Feigenbaum
u Proposed the concept of “total quality control,”
making quality everyone’s responsibility.
u Stressed interdepartmental communication.
u Emphasized careful measurement and report of
quality costs

u PhilipCrosby
u Preached that “quality is free.”
u Believed that an organization can reduce overall
costs by improving the overall quality of its
processes.
 Philip Crosby

u Philip Bayard "Phil" Crosby, (June 18, 1926-

August 18, 2001) was a businessman and
author who contributed to management theory
and quality management practices.

u •Crosby initiated the Zero Defects program at

the Martin Company Orlando, Florida plant. As
the quality control manager of the Pershing
missile program, Crosby was credited with a
25 percent reduction in the overall rejection
rate and a 30 percent reduction in scrap costs.
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The Crosby philosophy

Absolute’s of Management
u Quality means conformance to requirements not
elegance.
u There is no such thing as quality problem.
u There is no such thing as economics of quality: it is
always cheaper to do the job right the first time.
u The only performance measurement is the cost of
quality: the cost of non-conformance.

Basic Elements of Improvement

u Determination (commitment by the top management)
u Education (of the employees towards Zero Defects
(ZD))
u Implementation (of the organizational processes
towards ZD)
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Crosby’s 14 Steps to Quality Improvement

1. Make it clear that management is committed to quality for the long term.
2. Form cross-departmental quality teams.
3. Identify where current and potential problems exist.
4. Assess the cost of quality and explain how it is used as a management fool.
5. Increase the quality awareness and personal commitment of all employees.
6. Take immediate action to correct problems identified.
7. Establish a zero defects program.
8. Train supervisors to carry out their responsibilities in the quality program.
9. Hold a Zero Defects Day to ensure all employees are aware there is a new direction.
10. Encourage individuals and teams to establish both personal and team improvement goals.
11. Encourage employees to tell management about obstacles they face in trying to meet quality
12. Recognize employees who participate.
13. Implement quality councils to promote continual communication.
14. Repeat everything to illustrate that quality improvement is a never-ending process,
History of quality management
u Next 20 odd years, when top managers in USA focused on
marketing, production quantity and financial performance,
Japanese managers improved quality at an unprecedented
rate.
u Market started preferring Japanese products and American
companies suffered immensely.
u America woke up to the quality revolution in early 1980s.
Ford Motor Company consulted Dr. Deming to help
transform its operations.
(By then, 80-year-old Deming was virtually unknown in USA.
Whereas Japanese government had instituted The Deming
Prize for Quality in 1950.)
u Managers started to realize that “quality of management” is
more important than “management of quality.” Birth of the
term Total Quality Management (TQM).
u TQM – Integration of quality principles into organization’s
management systems. 66
The Quality Gurus (cont’d)

u Genichi Taguchi
uEmphasized the minimization of variation.
uConcerned with the cost of quality to society.
uExtended Juran’s concept of external failure.

u Kaoru Ishikawa
uDeveloped problem-solving tools such as the
cause-and-effect (fishbone) diagram.
uCalled the father of quality circles.
Defining the Dimensions of
Quality
uQuality in Goods uQuality in Services
uPerformance uReliability

uFeatures uTangibles

uReliability uResponsiveness

uDurability uAssurance

uConformance uEmpathy

uServiceability

uAesthetics

uPerceived quality
TOTAL QUALITY CHARACTERISTICS
v A total commitment to continually increasing value for customers,
investors, and employees
v A firm understanding that market driven means that quality is defined by
customers, not the company
v A commitment to leading people with a bias for continuous improvement
and communication
v A recognition that sustained growth requires the simultaneous
achievement of four objectives continually forever:
v (a) customer satisfaction,
v (b) cost leadership,
v (c) effective human resources
v (d) integration with the supplier base
v A commitment to fundamental improvement through knowledge, skills,
problem solving, and teamwork
v A commitment to fast-paced, constant learning, and an ability to respond
quickly to changes in the competitive environment
v A commitment to achieving end-to-end collaboration using web-based, on-
demand tools that are fully integrated throughout the supply chain
v A commitment to maintaining an environment in which creativity, critical
thinking, and innovation are not just encouraged and supported, but
demanded
Future of Quality

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The Future of Quality
u There are several trends that will shape the future
of quality management. These trends are as
follows:

u Increasing global competition: More and better

competition from emerging industrialized nations
will be an ongoing part of life for organizations.

u Increasing customer expectations: Today's global

customer is interested in not just the quality of a
product provided but also the quality of the
organization that backs it up. Customers want an
excellent product or service from an organization
that also provides accurate billing, reliable
delivery, after-purchase support, and social
responsibility.
The Future of Quality

u Opposing economic pressures: The global

marketplace exerts enormous, unrelenting
pressure on organizations to continually
improve quality while simultaneously
reducing the prices they charge for goods
and services. The key to achieving higher
quality and lower prices for customers is
the reduction of the expenses associated
with satisfying unhappy customers—
expenses that amount to as much as 25%
of the cost of sales in many companies
The Future of Quality

u New approaches to management:

u Companies that succeed in the global
marketplace have learned that you
manage budgets, but lead people. The old
approach of providing an occasional
seminar or motivational speech for
employees without making any
fundamental changes in the way the
organization operates will no longer work
Competitivness

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Quality and Global
Competitiveness
u One of the results of World War II combined with
subsequent technological advances was the creation of
the global marketplace.
u Following the war, industrialized countries began looking
for markets outside their own borders. Although the war
gave the world a boost in this regard, it was advances in
technology that really made the global marketplace
possible.
u Advances in communications technology have made
people from all over the world electronic neighbours and
electronic customers.
u Advances in transportation technology allow raw
materials produced in one country to be used in the
manufacture of products in a second country that are in
David L. Goetsch and Stanley
turn, sold to end users in a third country Davis,Seventh Edition (2013) - Quality
Management for Organizational
Excellence:Introduction to Total
Quality
The Cost of Poor Quality
u Few things affect an organization's ability to compete in
the global marketplace more than the costs associated
with poor quality.
u When an organization does what is necessary to improve
its performance by reducing deficiencies in key areas
cycle time, warranty costs, scrap and rework, on-time
delivery, billing, etc.), it can reduce overall costs without
eliminating essential services, functions, product
features, ana personnel.
u Reducing the costs associated with poor quality is
mandatory for companies that hope to compete in the
global marketplace.
u Reducing such costs is one of the principal drivers
behind the total quality concept of continual
improvement.
David L. Goetsch and Stanley
Davis,Seventh Edition (2013) - Quality
Management for Organizational
Excellence:Introduction to Total
Quality
The Characteristics of World
Class Organisations

u It is often said that only "world-class" organizations can

compete in the global marketplace. But what is a world-
class organization?

u Question: What would you say constitutes

a ‘world class’ organisation?