Chapter … 2
TOTAL QUALITY MANAGEMENT
Objectives:
Upon completion of this section, the student should be able to
• Explain the major stages in the quality movement.
• Define ‘Total Quality Management’ (TQM).
• List and explain the key elements of TQM.
• List the philosophies and tools of TQM.
• Explain the concept of quality in the pharmaceutical industry.
Introduction
Quality is a term that is widely used when talking about how good or poor a product or
service is. However, defining this term is not so easy. In most cases, it refers to how well the
product is able to match the specifications and meet the customer’s expectations. ISO
defines quality as “The degree to which a set of inherent characteristics fulfills the
requirements.”
2.1 EVOLUTION OF QUALITY MANAGEMENT
In the early 1900s, businesses were looking for ways to reduce the number of faulty
products being produced. In 1911, Frederick W. Taylor published a book titled “The Principles
of Scientific Management” which focused on how organizations must use people effectively.
He proposed the concept of ‘clearly defined tasks’ and ‘standard conditions’ and proposed
people be assigned for the purpose of ‘inspection’ of goods. This led to the birth of the
“Inspection Department” and its focus was on preventing defects which in turn, developed
into the concept of Quality Control.
During the 1930s, Dr. W. Shewhart developed methods for statistical analysis of
production proceses. Through use of a ‘control chart’ he showed how variations in
manufacturing processes lead to variations in quality of the product. His theory of Statistical
Quality Control highlighted the detection and control of problems in quality by testing
several samples at different stages of the production process.
During the 1940s, Japanese industry leaders wanted to change the quality of their
products which were largely seen as cheap imitations. At their invitation, western quality
experts such as W. Edwards Deming, Joseph M. Juran and Armand V. Feigenbaum visited
Japan to guide these industries with their quality needs.
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Pharmaceutical Quality Assurance Total Quality Management
Deming taught the Japanese the concepts of statistical analysis and using it for quality
control. Juran’s teachings focused on the idea of getting managers involved with the quality
process. In the early 60s, the Japanese firms came up with ‘quality circles’ that comprised a
voluntary group of workers who met to discuss about improving some aspect of their work
and then presented their thoughts to the management. This led to employees feeling more
motivated to contribute to the workplace. Gradually, the discussions began to center around
improvements that could be made in all organizational areas and not merely the quality of
products. This is how the idea of ‘Total Quality’ originated.
In 1969, Feigenbaum presented a paper at the first international conference on quality
control in Tokyo. In it, he used the term ‘Total Quality’ for the first time. Around the same
time, Ishikawa in Japan also came up with the concept of ‘Total Quality Control’ which
differed from the western theory of total quality.
By observing the great strides made by Japan in dealing with quality issues, industry
leaders in the West began their own set of quality initiatives in the 1980s and 1990s. These
ideas covered a large spectrum of techniques and strategies, and it was all covered by the
term ‘Total Quality Management’ or “TQM.”
2.2 DEFINITION OF TQM
Today, TQM has evolved greatly from those initial days, and every day, there is some or
the other innovation being added to the term. TQM is defined in several ways, such as:
‘TQM is a management system and philosophy that strives towards constant organizational
improvement in order to achieve excellence and ensure customer satisfaction and loyalty.’
‘TQM is the continued process of detecting/reducing/eliminating errors in manufacturing,
streamlining the process of supply chain management, improving customer experience, and
ensuring employees are well-trained.’
‘TQM is a structured approach to organizational management with a process focused on
improving the quality of outputs of an organization, including services and goods, by the
constant improvement of its internal practices.’
‘TQM is an organizational management philosophy seeking to continuously improve the
quality of processes and products.’
Using a set of management and quality tools, TQM approach seeks to increase business
even as it reduces loss due to improper practices. Being a highly adaptable concept, it has
been widely applied in several industries in the production and service sectors.
The main components of TQM include:
• Focus on consumer
• Analysis of process
• Work in quality teams
• Systematic analysis of problems
• Implement planned changes and evaluate results
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Pharmaceutical Quality Assurance Total Quality Management
• Use data to identify problems and solutions
• Implement changes
TQM focuses on continuous improvement at all levels right from planning up to
execution on the shop floor. The main concern is to avoid mistakes and thus, prevent defects
in the products. By regular improvement of personnel, equipment, processes and capabilities,
it seeks to ensure quality that is consistent. TQM is also based on the main principle that
mistakes are often a result of faulty processes and systems and not of individuals per se. By
identifying the causes of such mistakes, it is possible to eliminate them through three
mechanisms:
• Prevent errors from occurring.
• Where prevention is not possible, early detection to prevent the mistake causing
damage down the chain.
• Immediate correction of process if mistakes recur.
2.3 KEY ELEMENTS OF TQM
There are eight key elements on which an organization must focus to implement TQM
with success:
(a) Ethics
(b) Integrity
(c) Trust
(d) Training
(e) Teamwork
(f) Leadership
(g) Recognition
(h) Communication
These eight elements are further clubbed into four groups as follows, based on their
function:
(a) Group I – Foundation – Ethics, Integrity and Trust
(b) Group II – Building Bricks – Training, Teamwork and Leadership
(c) Group III – Binding Mortar – Communication
(d) Group IV – Roof - Recognition
1. Foundation:
A foundation of ethics, integrity and trust helps to create an open and fair environment
that fosters involvement by everyone in the organization. Ethics deals with what is good and
bad in a given situation, both at the individual and the organizational levels. Integrity refers
to the honesty with which one adheres to facts. When ethics are followed with integrity, it
leads to development of trust, the third element of the ‘foundation’, which creates an
environment of cooperativeness.
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Pharmaceutical Quality Assurance Total Quality Management
2. Building Bricks:
Employees need to be trained in performing their duties right and in problem solving.
They must also be trained in interacting with others, to do their job better through teamwork.
Any team is only as good as its leader, though, and so, there has to be inspirational
leadership by someone who understands TQM and is committed to it in daily practice.
3. Binding Mortar:
The link which binds all elements of TQM is communication which refers to a common
understanding of the message by both the sender and receiver. Openness in communication
between members of an organization, and with vendors, and customers is key to the success
of TQM.
4. Roof:
Recognizing the contributions of people in an organization, whether for teams or for
individuals, is the final element in TQM. When employees receive recognition, it brings about
a leap in their self-esteem and such employees are more motivated which ultimately leads to
better productivity and quality of work they do.
2.4 PHILOSOPHIES OF TQM
Several quality experts have given their viewpoints on how to achieve quality. Some of
the most important concepts have been summed up in the table below:
Walter A. Shewhart Understanding variability, concept of statistical control charts
W. Edwards Deming Management’s responsibility for quality, 14 points for quality
improvement
Joseph M. Juran Concept of quality cost, quality trilogy (quality planning, quality
control, quality improvement)
Armand E. Feigenbaum Total quality control
Philip B. Crosby Concept of zero defects, do it right the first time
Kaoru Ishikawa Concept of internal customer, quality circles
Genichi Taguchi Concept of product design quality, developed Taguchi loss
function
Advantages of TQM:
• Innovation in processes
• Greater productivity
• Reduced defects in product
• Increased customer satisfaction
• Higher profitability and reduced costs
• Higher employee morale
• Better adaptability to changing market conditions
• Increased competitiveness
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Pharmaceutical Quality Assurance Total Quality Management
Tools used in TQM
Tool Purpose
Cause and effect diagram/Fishbone diagram Identify and analyze causes of a problem
Checklists Gathering of data
Flowcharts Document detailed steps of a process
Scatter diagrams Relation between two variables
Control charts Identify variations in process
Histograms Graphical display of frequency distribution
of data
Pareto analysis Degree of importance of each element
2.5 TQM IN DRUG INDUSTRY
Pharmaceutical literature does not offer any common definition for the term ‘quality’. The
idea implied in most definitions is the idea that the drug product has to meet customer
needs. Customers cannot really assess the quality of their drugs and this is the reason why
governments have to step in with rules and regulations to ensure the quality of medicines.
A study of the history of drug regulations reveals that most laws were enacted in
response to tragedies that occurred when patients received drugs that were contaminated or
not properly processed or incorrectly labeled. This led to a focus by drug makers on Quality
Control – the process of testing the quality of products manufactured in their facilities.
As time evolved, and pharmaceutical processes grew more complex, it gradually came to
be realized that no process is perfect all the time, and there are drifts from the normal
functioning. The best of testing methods may miss detecting a problem because the
destructive nature of the testing means only few samples drawn at random can be tested.
Thus, there was a realization that relying on mere testing of products at the end of the
manufacturing process is an ineffective (and costly) way of trying to ensure quality.
According to regulatory bodies across the world, high quality drug products are those
that can be relied upon to deliver the desired clinical effects with consistency. Consumers of
medicines need to know for sure that the drug product they are consuming are of good
quality, safe for consumption, and will be effective in relieving them of their ailment. This
quality can be guaranteed only if the products have it built into them right from the very first
stage of design of the product and process. Realization of this basic principle led to the
International Conference on Harmonization (ICH) in 2002, introducing a hitherto unheard of
term in the drug processing field – the concept of ‘Quality by Design’ or QbD.
2.5.1 Quality by Design
The ICH guideline Q8 (R2) Pharmaceutical Development defines QbD as, “A systematic
approach to development that begins with predefined objectives, emphasizes product,
process understanding and process control, based on sound science and quality risk
management.”
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Pharmaceutical Quality Assurance Total Quality Management
To achieve the objective of QbD, it is important to understand product characteristics
and study process characteristics using a combination of prior knowledge and experimental
studies. From this data generated during product development, it becomes possible to
decide which quality parameters in starting materials are the most important, and which
critical processing factors need to be controlled to achieve a product with all the desired
quality attributes.
The ICH Q10 guideline says that a Pharmaceutical Quality System is one that “assures
that the desired product quality is routinely met, suitable process performance is achieved,
the set of controls are appropriate, improvement opportunities are identified and evaluated,
and the body of knowledge is continually expanded.”
ICH
Pharmaceutical Development
Q8
+
ICH
Quality Risk Management QbD
Q9
+
ICH
Quality Management Q10 Quality By Design
Fig. 2.1: Quality by Design
In other words, a robust pharmaceutical quality system is the key to supplying customers
with high quality drugs. Such a system has the following characteristics:
• Aligned with requirements of current Good Manufacturing Practices (cGMP)
• Science-based and risk-based
• Comprehensive
• Proactive and accountable
Developing such pharmaceutical quality systems is the key to meeting patient
requirements in an efficient manner. Because they deliver consistent quality, these systems
also serve to increase the confidence of regulatory bodies about the organization’s
commitment to quality.
REVIEW QUESTIONS
1. Name the key thinkers of the quality movement and write about their concepts of
quality.
2. Define TQM and discuss its advantages.
3. List the key elements of TQM and the tools it uses.
4. Explain how TQM principles are applied in the pharmaceutical industry.
5. Write a brief note about the concept of Quality by Design (QbD) in pharma industry.
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2.6
