Total Quality Management

Module : Quality Management

Dr Appaso M Gadade
Assistant Professor, MED
Email: appaso.gadade@thapar.edu
 Syllabus
1. Meaning and significance of ‘Quality’
2. Fitness levels of quality:
3. Characteristic features and limitations of each type;
4. Essential components of Quality;
5. Product Features; Freedom from Deficiencies;
6. Characteristics and attributes under each for products and services;
7. Phases or elements of building quality in a product: Quality of design, Quality of conformance, Quality of
performance, History of quality; Evolution of the concepts of quality;
8. Big Q Vs Small Q: changing scope of quality activities;
9. Ishikawa’s seven quality tools;
10. Quality circles;
11. TQM meaning and TQM culture.
 References
1. Juran, J.M. and Gryna, F.M., Quality Planning & Analysis, 3rd Edition, McGraw Hill (2001).
2. Grant, E.L., Statistical Quality Control, 3rd Edition, McGraw Hill (2014).
3. Beckwith, T.G., Marangoni, R.D., and Lienhard, J.H., Mechanical Measurements, 6th Edition, Pearson
Education (2006).
 Meaning and Significance of Quality

• The concept and vocabulary of quality are elusive.

• Different people interpret quality differently.
• Few can define quality in measurable terms that can be proved operationalized.
• When asked what differentiates their product or service;
 The banker will answer” service”
 The healthcare worker will answer “quality health care”
 The hotel employee will answer “customer satisfaction
 The manufacturer will simply answer “quality product”
 Five Approaches of Defining Quality

• Harvard professor David Garvin, in his book Managing Quality summarized

five principal approaches to define quality.

 Transcendent
 Product based
 User based
 Manufacturing based
 Value based
 Transcendental view
• Those who hold the transcendental view would say “I can’t define it, but I know it when I
see it”
• Advertisers are fond of promoting products in these terms.
 “ Where shopping is a pleasure” (supermarket). “We love to fly and it shows"
(airline).
 Television and print media are awash with such indefinable claims and therein lies the
problem:
• Quality is difficult to define or to operationalize. It thus becomes elusive when using the
approach as basis for competitive advantage. Moreover, the functions of design,
production and service may find it difficult to use the definition as a basis for quality
management.
 Product Based
• Quality is viewed as a quantifiable or measurable characteristic or attribute. For example

durability or reliability can be measured and the engineer can design to that benchmark.

• Quality is determined objectively.

• Although this approach has many benefits, it has limitation as well. Where quality is

based on individual taste or preference, the benchmark for measurement may be

misleading.
 User Based
• It is based on idea that quality is an individual matter and products that best satisfy their
preferences are those with the highest quality. This is rational approach but leads to two
problems;
• Consumer preference vary widely and it is difficult to aggregate these preferences into
products with wide appeal. This leads to the choice between a niche strategy or a market
aggregation approach which tries to identify those product attributes that meet the needs of
the largest number of consumers.
• Another problem concerns the answer to the question “Are quality and customer
satisfaction the same?” the answer is probably not. One may admit that a Lincoln
continental has many quality attribute, but satisfaction may be better achieved with an
Escort.
 Manufacturing Based
• Manufacturing-based definitions are concerned primarily with engineering and
manufacturing practices and use the universal definition of “conformance to requirements”.
Requirements or specifications are established by design and any deviation implies a
reduction in quality. The concept applies to services as well as product. Excellence in
quality is not necessarily in the eye of the beholder but rather in the standards set by the
organization.
• This approach has the serious weakness. The consumer’s perception of quality is equated
with conformance and hence is internally focused.
 Value Based
• It is defined in term of costs and prices as well as number of other attributes. Thus, the

consumer’s purchased decision is based on quality at an acceptable price.

• This approach is reflected in the popular Consumer Reports magazine which ranks

products and services based on two criteria: Quality and Value.

• The highest quality is not usually the best value.

• That designation is assigned to the “best- buy” product or service.

 TQM
What is TQM?
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.

“ No doubt , humans are always deficient”

(Al-Quran)
 System

MANAGEMENT OF
PROCESS
QUALITY
CUSTOMER
FOCUS
Driver HUMAN RESOURCE AND
DEVELOPMENT AND SATISFACTION
MANAGEMENT
SENIOR
EXECUTIVE
LEADERSHIP
STRATEGIC
QUALITY QUALITY
PLANNING AND
OPERATIONAL
RESULTS
INFORMATION
AND ANALYSIS

System Approach for TQM

 Quality Levels
• At organizational level, we need to ask following questions:
 Which products and services meet your expectations?
 Which products and services you need that you are not currently receiving?
• At process level, we need to ask:
 What products and services are most important to the external customer?
 What processes produce those products and services?
 What are the key inputs to those processes?
 Which processes have most significant effects on the organization’s performance
standards?
 That designation is assigned to the “best- buy” product or service.
 Quality in Services
• Technical Quality versus Functional Quality
 Technical quality—the core element of the good or service.
 Functional quality—customer perception of how the good functions or the service is
delivered.
• Expectations and Perceptions
 Customers’ prior expectations (generalized and specific service experiences) and their
perception of service performance affect their satisfaction with a service.
 Satisfaction = (Perception of Performance) – (Expectation)
 The Quality Gurus
• Quality Gurus
- Individuals who have been identified as making a significant contribution to improving
the quality of goods and services.
 Walter A. Shewhart
 W. Edwards Deming
 Joseph M. Juran
 Armand Feigenbaum
 Philip Crosby
 Genichi Taguchi
 Kaoru Ishikawa
 Three of the Quality Gurus Compared

Source: Modified from John S. Oakland, Total Quality Management (London: Heinemann Professional Publishing Ltd., 1989), pp. 291–92.
Three of the Quality Gurus Compared (Contd..)

Source: Modified from John S. Oakland, Total Quality Management (London: Heinemann Professional Publishing Ltd., 1989), pp. 291–92.
Three of the Quality Gurus Compared (Contd..)

Source: Modified from John S. Oakland, Total Quality Management (London: Heinemann Professional Publishing Ltd., 1989), pp. 291–92.
 The Quality Gurus (Contd..)
• Walter A. Shewhart
- Statistician at Bell Laboratories
 Developed statistical control process
methods to distinguish between random and
nonrandom variation in industrial processes
to keep processes under control.
 Developed the “plan-do-check-act” (PDCA)
cycle that emphasizes the need for 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.
continuous improvement.
 Strongly influenced Deming and Juran.
 The Quality Gurus (Contd..)
 W. Edwards Deming
- Advocated Statistical Process Control (SPC)
 Methods which signal shifts in a process that will likely lead to products and/or services
not meeting customer requirements.
 Emphasized an overall organizational approach to managing quality.
 Demonstrated that quality products are less costly than poor quality products.
 Identified 14 points critical for improving quality.
 The Deming Prize
 Highest award for industrial excellence in Japan.
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.
Source: “14 Point System” from Deming Management at
13. Institute a vigorous program of education and retraining. Work by Mary Walton, copyright © 1990 by Mary Walton.
Used by permission of G. P. Putnam’s Sons, a division of
14. Take action to accomplish the program. Penguin Putnam, Inc.
 Deming’s Phylosophy
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 alone.
5. Improve constantly and forever the system of production and service.
 Deming’s Phylosophy
6. Institute training
7. Teach and institute leadership.
8. Drive out fear. Create an environment of innovation.
9. Optimize the team efforts towards the aims and purposes of the company.
10. Eliminate exhortations for the workforce.
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.
 Deming’s Philosophy
 “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.
 Deming’s 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!
 The Quality Gurus (Contd..)
 Joseph M. Juran
⁻ Emphasized the importance of producing quality products through an approach focused
on quality planning, control, and improvement.
⁻ Defined product quality as “fitness for use” as viewed by the customer in:
• Quality of design • Quality of conformance
• Availability • Safety • Field use
 Categorized the cost of quality as:
 Cost of prevention
 Cost of detection/appraisal
 Cost of failure
 Juran’s Philosophy
 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.
 Quality should be talked about in a language senior management understands: money (cost
of poor quality).
 At operational level, focus should be on conformance to specifications through elimination
of defects- use of statistical methods.
 Juran’s 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.
 The Quality Gurus (Contd..)
 Armand Feigenbaum
⁻ Proposed the concept of “total quality control,” making quality everyone’s
responsibility.
 Stressed interdepartmental communication.
 Emphasized careful measurement and report of quality costs
 Philip Crosby
⁻ Preached that “quality is free.”
⁻ Believed that an organization can reduce overall costs by improving the overall quality
of its processes.
 The Crosby Philosophy
Absolute’s of Management
• Quality means conformance to requirements not elegance.
• There is no such thing as quality problem.
• There is no such thing as economics of quality: it is always cheaper to do the job right the
first time.
• The only performance measurement is the cost of quality: the cost of non-conformance.
Basic Elements of Improvement
• Determination (commitment by the top management)
• Education (of the employees towards Zero Defects (ZD))
• Implementation (of the organizational processes towards ZD)
 The Quality Gurus (Contd..)
 Genichi Taguchi
⁻ Emphasized the minimization of variation.
• Concerned with the cost of quality to society.
• Extended Juran’s concept of external failure.
 Kaoru Ishikawa
⁻ Developed problem-solving tools such as the cause-and-effect (fishbone) diagram.
⁻ Called the father of quality circles.
 Defining the Dimensions of Quality
 Quality in Goods  Quality in Services
⁻ Performance ⁻ Reliability
⁻ Features ⁻ Tangibles
⁻ Reliability ⁻ Responsiveness
⁻ Durability ⁻ Assurance
⁻ Conformance ⁻ Empathy (the ability to imagine
⁻ Serviceability how another person is feeling and

⁻ Aesthetics so understand his/her mood).

⁻ Perceived quality
 Characteristics of TQM Leader
 Visible, Committed and Knowledgeable
 A Missionary Zeal
 Aggressive Targets
 Strong Drivers
 Communication of Values
 Organization
 Customers Contact
 Total Quality Operations: HRM
Five Principles are:
 Quality Work
 Focus on the Customer
 Strategic Holistic Approach to Improvement
 Continuous Integration as a Way of Life
 Mutual Respect and Teamwork
 Customer Satisfaction
Three Part System

Customer Expectations

Company Operations Customer Satisfaction

(Processes)
 Cost of Quality:
Three Views of quality Costs
Higher quality means higher cost.
 Quality attributes such as performance and features cost more in terms of labor, material,
design and other costly resources.
 The additional benefits from improved quality do not compensate for additional expense.
The cost of improving quality is less than the resulting savings.
 The saving result from less rework, scrap and other direct expenses related defects.
 This is said to account for the focus on continuous improvement of processes in Japanese
firms.
 Cost of Quality:
Three Views of quality Costs
Quality costs are those incurred in excess of those that would have been incurred if the
product were built or the service performed exactly right the first time.
 This view is held by adherents of TQM philosophy.
 Costs include not only those that are direct, but also those resulting from lost customers,
lost market share and the many hidden costs and foregone opportunities not identified by
modern cost accounting systems.
 Elements of TQM
 Leadership
⁻ Top management vision, planning and support
 Employee involvement
⁻ All employees assume responsibility for inspecting the quality of their work.
 Product/Process Excellence
⁻ Involves product design quality and monitoring the process for continuous
improvement.
⁻ Poka-yokes are devices that prevent defects from being produced.
 Elements of TQM (Contd…)
 Continuous Improvement
⁻ A concept that recognizes that quality improvement is a journey with no end and that
there is a need for continually looking for new approaches for improving quality.
 Customer Focus (on “Fitness for Use”)
⁻ Design quality
• Specific characteristics of a product that determine its value in the marketplace.
⁻ Conformance quality
• The degree to which a product meets its design specifications.
 Importance of TQM in Pharma Industry
Handling:
 Containers should be opened carefully and subsequently resealed in an approved
manner.
 Highly sensitising material such as penicillins and cephalosporins should be handled in
separate production areas.
 Highly active or toxic API (Active Pharmaceutical Ingredients) (e.g. certain steroids,
cytostatic substances) should be manufactured in a dedicated area and using dedicated
equipment.
 Pure and final API should be handled in an environment giving adequate protection
against contamination.
 Importance of TQM in Pharma Industry
Storage:
 Secure storage facilities should be designated for use to prevent damage or deterioration
of materials.
 These should be kept cleanand tidy and subject to appropriate pest control measures.
 Environmental conditions should be recorded.
 The condition of stored material should be assessed at appropriate intervals.
 Storage conditions for APIshould be based upon stability studies taking into account
time, temperature, humidity
 Containers should be opened carefully and subsequently resealed in an approved
 Importance of TQM in Pharma Industry
Packaging:
 Labelling and packaging processes should be defined and controlled to ensure that
correct packaging materials are used correctly and other specified requirements are met.
 Printed labels should be securely stored to avoid mix-ups arising.
 Marking and labelling should be legible and durable, provide sufficient information, for
accurate identification and indicate, if appropriate, required storage conditions, retest
and/or expiry date.
 Importance of TQM in Pharma Industry
Facilities and Equipment:
 The location, design, and construction of buildings should be suitable for the type and
stage of manufacture involved, protecting the product from contamination (including
cross-contamination) and protecting operators and the environment from the product.
 Equipment surfaces in contact with materials used in API manufacture should be non-
reactive.
 Importance of TQM in Pharma Industry
Sterile Area:
 Personnel suffering from an infectious disease or having open lesions on the exposed
surface of the body should avoid activities which could compromise the quality of API.
 Smoking, eating, drinking, chewing and storage of food should be restricted to
designated areas separated from production or control areas.
 Importance of TQM in Pharma Industry
Labelling:
 Each container should be identified by an appropriate label, showing at least the product
identification and the assigned batch code, or any other easily understandable
combination of both.
 Containers for external distribution may require additional labels.
 Importance of TQM in Pharma Industry
Computerized System:
 Computer systems should be designed and operated to prevent unauthorised entries or
changes to the programme.
 In the case of manual entry of quality critical data there should be a second independent
check to verify accuracy of the initial entry.
 A back-up system should be provided of all quality critical data.
 Quality Characteristics
 One or more elements that defines intended quality level of product or service is called
as Quality Characteristics
 Categories of Quality Characteristics:
 Structural Characteristics: Length, weight, strength, viscosity of fluid, and so on
 Sensory Characteristics: Test of good food, Smell of sweet fragrance, beauty of
model, and so on
 Time-oriented Characteristics: Time to process a purchase order, warranty, reliability,
and maintainability associated with a product; and ethical characteristics include
honesty, courtesy, friendliness, and so on
 Variables and Attributes
 Quality characteristics fall into two broad classes: variables and attributes
 Characteristics that are measurable and are expressed on a numerical scale are called
variables
 Example: The waiting time in a bank before being served, expressed in minutes, density
of a liquid in grams per cubic centimeter and the processing speed of a computer.
 A quality characteristic is said to be an attribute if it is classified as either conforming or
nonconforming to a stipulated specification
 A nonconforming unit has one or more nonconformities such that the unit is unable to
meet the intended standards and is unable to function as required
 Example : A CI pipe whose ID and weight both fail to satisfy specifications, thereby
making the unit dysfunctional
 Defects
 A defect is associated with a quality characteristic that does not meet certain standards
 The severity of one of more defects in a product or service may cause it to be
unacceptable (or defective)
 The modern term for defect is nonconformity, and the term for defective is
nonconforming item
 The American National Standards Institute, the International Organization for
Standardization, and the American Society for Quality provide a definition of a defect in
ANSI/ISO/ASQ Standard A8402(ASQ1994).
 Standards or Specifications
 A standard, or a specification, refers to a precise statement that formalizes the
requirements of the customer; it may relate to a product, a process, or a service.
 Specification: a set of conditions and requirements, of specific and limited application,
that provide a detailed description of the procedure, process, material, product, or service
for use primarily in procurement and manufacturing.
 Standards may be referenced or included in a specification.
 Standard: a prescribed set of conditions and requirements, of general or broad
application, established by authority or agreement, to be satisfied by a material, product,
process, procedure, convention, test method; and/or the physical, functional,
performance, or conformance characteristic thereof.
Source: National Bureau of Standards(NBS,2005)
 Quality of Design
 Quality = Quality of Design + Quality of Conformance + Quality of performance
 Quality of design deals with the stringent conditions that a product or service must
minimally possess to satisfy the requirements of the customer
 It implies that the product or service must be designed to meet at least minimally the
needs of the consumer
 Influencing factors: type of product, cost,
profit policy of the firm, demand for product,
availability of parts and materials, and
product safety
 Example: Design of steel cable- yield
strength- factor of safety
 Quality of Conformance
 Quality of conformance implies that a manufactured product or a service rendered must
meet the standards selected in the design phase
 Manufacturing Sector: defect prevention, defect
finding, and defect analysis and rectification
 As shown in Figure, The quality of design has an
impact on the quality of conformance
 The quality of design has an impact on the quality
of conformance
 One must be able to produce what was designed
 Quality of Performance
 Quality of performance is concerned with how well a product functions or service
performs when put to use
 It measures the degree to which the product or service satisfies the customer
 This is a function of both the quality of design and the quality of conformance.
 If a product does not function well enough to meet these expectations, or if a service
does not live up to customer standards, adjustments need to be made in the design or
conformance phase
 Feedback from the performance to the design phase, may prompt a change in the design
because the current design does not produce a product that performs adequately
 Big Q Vs Small Q
 Quality Management has seen a major shift from “quality of specific areas” to “quality
of overall operations”
 Relevance of big Q (“quality of overall operations”) is increasing and is more
appropriate measure than the Little Q since 1980s
 Adoption of Big Q grew during the 1980s, and the trend is probably irreversible
 Those most willing to accept the concept of Big Q have been the quality managers and
the upper managers
 Those most reluctant have been managers in the technological areas and in certain staff
functions
 Big Q was adopted to replace Little Q
Evolution from Big Q Vs Small Q
 What is Big Q?
 Big Q concepts were identified many years ago by Joseph M Juran
 A recognition that the quality of our procedures and products depends on the up-front
(early life cycle) design processes being lowest possible errors
 Big Q is defined as strategically managing quality in all business processes, products and
services as they relate to all relevant interested parties
 Achieve Big Q requires:
 A holistic systems approach by each program and functional group to seek out problems
 Analyze causes and take effective corrective and preventive actions throughout the entire
contract life cycle Predicting the defects in the upcoming phases and taking necessary
preventive actions
What is Big Q?
 Big Q Vs Small Q
Products: Industries:
 Contents of Little Q:  Contents of Little Q:
 Manufacturing products  Manufacturing

 Contents of Big Q:  Contents of Big Q:

 All products and Services whether for  All Industries  Services
sale or not  Manufacturing  Government

Processes: Quality is viewed as:

 Contents of Little Q:  Contents of Little Q:
 Process is directly related to the products  Technological problem

 Contents of Big Q:  Contents of Big Q:

 All process across the enterprise  Business Problem
 Big Q Vs Small Q
Customer: Quality Goals are included:
 Contents of Little Q:  Contents of Little Q:
 Customer who buy the products  Among production goals

 Contents of Big Q:  Contents of Big Q:

 All who are effected, external and internal  Company business Goals

How to think about Quality: Improvement is directed at:

 Contents of Little Q:  Contents of Little Q:
 Based on cultural of functional departments  Departmental Performance

 Contents of Big Q:  Contents of Big Q:

 Based on universal trilogy (Planning,  Company performance
Improvement and Control)
 Big Q Vs Small Q
Training:
 Contents of Little Q:
 Focus in quality department
 Contents of Big Q:
 Enterprise wide Quality
Responsibility:
 Contents of Little Q:
 The Quality manager
 Contents of Big Q:
 Senior management is also responsible
Big Q Vs Small Q
Big Q Vs Small Q
Big Q Vs Small Q
 Big Q Vs Small Q: Final Comments
 Little Q has to do with the problems of production and the tactical tools that lead to
control and improvement
 Big Q was Juran’s way of describing quality in a management setting: more strategic,
more comprehensive and system wide - in other words, quality management.
 Little Q and Big Q, are complementary. You need both to make quality real, to make
quality stick.
 What Can You Do?:
 Continue on the “Journey”: Continuous improvement in quality & cost
 Take time to strategically plan to achieve competitive advantage in your Deliverables/Solution
 Adopt “Big Q” Thinking
 Big Q was adopted to replace Little Q
Quality Culture
Quality Culture
 Dr Appaso M Gadade
Assistant Professor, MED
Email: appaso.gadade@thapar.edu