Quality in healthcare

QUALITY IN
HEALTHCARE
DR. P. M. BHUJANG
Medical Director
Sir H N Hospital & RC

QUALITY

• We know ….. Yet we cannot explain

• Latin - Qualis: - such as Thing really
is

DIFFERENT CONNOTATIONS

• Peculiar and essential character
• A distinguishing attribute
• Fitness for purpose - use (Juran)
• Quality must be worked and anxiously
achieved
• Quality is a means to an end
• The end is continued viability

WHY INTEREST IN QUALITY?

• Increasing financial investment
• Emphasis on accountability
• Cost effectiveness
• Public scrutiny and customer forums
• High level of disapproval eroding client
confidence
• Quality creates loyal customers.

DEFINITION
British Standard - or ISO 8402

The totality of features and characteristics
of an entity (product or service) that bear
on its ability to satisfy stated and implied
needs.

PRODUCTS OR SERVICES
MUST MEET THE FOLLOWING
REQUIREMENTS
• Satisfy a well defined specifications
• Meet customer‟s expectations
• Comply with applicable regulations and
standards.
• All this at a price which will yield profit for
the supplier and considered reasonable
by customer.

DR. EDWARD DEMING
Good quality does not necessarily
mean high quality. It means a
predictable degree of uniformity and
dependability at low cost with a
quality suited to the market.

QUALITY (MANAGEMENT)
DEMANDS ATTENTION TO
• Quality and suitability of inputs
• The manner in which inputs are delivered,
stored, and transformed into product or
service.
• The manner in which the product or
service is delivered to the customer, used
and installed.
Quality : Doing right things the right
way the first time.

CHARACTERISTICS OF
QUALITY
• Measurable Attributes
- Dimensions
- Composition
- Specification
- Purity etc.
• Non Measurable Attributes
- Taste
- Appearance
- Customer Appeal
- Service
- Sales support etc.

DIMENSIONS OF QUALITY

• Accessibility • Performance
• Assurance • Reliability
• Competence • Responsiveness
• Conformity • Security
• Courtesy • Tangibles
• Deficiency
• Durability
• Empathy
• Humanness

ELEMENTS

• Customer focus
• System view
• Data driven analyses
• Implement involvement
• Multiple causation
• Solution identification
• Process optimization
• Continuing improvement
• Organizational learning

EVOLUTION OF QUALITY AND
ITS STANDARDS
• Developments
• Means for meeting the needs.
• The processes of managing for quality have
undergone extensive and continuing change.

• Ancient Principles were –
- Product inspection by consumers (Still used
in small markets)
- The craftsmanship concept in which buyers
rely on the skill and reputation of craftsman.

EVOLUTION OF QUALITY AND ITS
STANDARDS (contd)
• Industrial revolution - Factory system
• Craftsman – became factory workers
• Industrial Revolution introduced.
i. Written specifications for materials
finished goods and inspection criteria.
ii. Measurement and associated
instruments.

STANDARDS (contd)
- Inspection was confined to bring a post
production activity.
- Inspection of - Incoming goods
- Manufactured components
- Assemblies at appropriate points in the
manufacturing process.
• Non conforming products - Scrapped
• It was more a screening process than a
preventive process.

STANDARDS (contd)
• Late Nineteenth century
USA - Taylor‟s System of Scientific Management
(separation of planning from execution)
• Central Inspection Dept.
(e.g. Hawthorn‟s Electric Comp. - Out of 40,000
workers 5200 Inspection personnel)
• Bell Telephone company –
- After 2nd world war Defence Purchases
- American Society for Quality Control (ASQC)
• Concept of Statistical Control Process
• Quality Control
• Quality Assurance

EVOLUTION OF SOME
STANDARDS.
Year Stds Country
1942-45 MIL STDS USA
1959 MIL-Q-9858 USA
1963 MIL-Q-9858-A USA
1968 AQAP-1/4/9 NATO
1970 DTT/STD 05-8 UK
1979 BS 5750 UK
1987 ISO 9000 - ISO
SERIES
1994 ISO-9000-SERIES ISO
2000

ERA OF QUALITY

1920's - Germany dominated the
manufacturing industry

1950's- America captures the world market

1980's - Japanese rule the roost riding the
quality wave.

PARADIGM SHIFT

Sr. No. Old Belief New Paradigm
1. Managing a job Managing is through leadership and is a way of life
(It requires one to reduce the size of one’s ego and
to increase the importance of all others in one’s
mind).
2.
Concept of external customer alone Concept of external and internal customers.
3.
Marketing assignment is to sell what is Organizations must accurately assess the
being produced customer’s needs and then go about satisfying
them.
4. The potential in each human being is enormous and
Workers are just hand and feet. They is just waiting to be used. The feelings and brains
have to be told what to do. of each person are more important and not his hand
and feet.
5. People don’t like to work or produce People enjoy working and produce good quality if
good quality, and will always do as little they are trained properly, are given responsibility
as possible unless they have strong and authority to make change at their work place
supervision or incentives. and are treated with respect (Concept of TEI)

6. Quality is headache of Quality Control. Quality of everybody’s responsibility and
principally of producers (Concept of TQC).

PARADIGM SHIFT (Contd)
Sr. No. Old Belief New Paradigm
7. Good house-keeping is nice but not Top quality cannot be produced without
important excellent house-keeping (Concept of 5S)
8. A reasonable inventory of raw The lower the sustainable level of inventory
materials and in-process materials is the more efficient is the production process-
essential to avoid production the target of inventory being zero (Concept
stoppages. of JIT).
9. Economic batch quality quantity is Target is batch size of one. Set up time is to
calculated from set up time and be made insignificant.
inventory carrying cost. Generally
speaking, production is best served
by large batch size.
10. Supplier’s are necessary evils and Choose a supplier and build a long term trust
should never be trusted. relationship.
11. Once sold, the product is forgotten. Service manuals, spare parts, service
No attention is paid to after sales technology are all managed systematically.
service.
12. Crisis management. Problems are PDCA wheel is conscientiously rotated.
dealt with as they crop up with no People are not afraid to reveal weaknesses
understanding of why they do so. and take responsibility for their work.

COMPONENTS
1. Quality Policy and communication - Decided –
documented – communicated to every one in
the organization in the language easily
understood.

2. Team work and participation

3. Problem solving tools and techniques
e.g. - quality circles
- Cross Functional Teams
- One common approach

COMPONENTS (contd)
DEMING’S CYCLE (PDCA)
Act – Appraise Plan – approach
Award and Appreciate Data to get
(Change Process – then go to I) Act Plan experiments to run

Check results Do the plan –
Check Do Gather data
Analyse data
Evaluate Run experiment
Experiment Demonstrating
doing and counseling Deploying

A problem is a gap between the actual state of affairs and
goals or way things should be.

COMPONENTS (contd)
4. Standardization:
It is a management tool for encouraging and securing
optimum utilization of resources and maximum efficiency
of operations through formal establishment of the most
suitable, pre- determined solutions and answers to
recurring problems and needs.
5. Design and implementation of Quality System e.g. ISO
6. Quality costs and measurements. Poor quality is very
expensive
7. Process control - Emphasis on prevention of any quality
deficiencies
8. Customer – supplier Integration
To achieve Zero Defect.

COMPONENTS (contd)
9. Education and training
An important component

10.Quality Audit and Review
- Product oriented
- Process oriented
- System oriented

SOME TERMS

• Quality System: Organizational structure, procedures,
processes and resources needed to implement quality
management.
• Quality Policy: The overall intentions and direction of an
organization with regard to quality, as formally expressed by
top management.
• Quality Planning: Activities that establish the objectives
and requirements for quality and for the application of quality
system elements.
• Quality Management: All activities of the overall
management function that determine the quality policy,
objectives and responsibilities and implement them by means
such as quality planning, quality control, quality assurance
and quality improvement within quality system.

SOME TERMS (contd)
• Quality Assurance: All the planned and systematic
activities implemented within the quality system and
demonstrated as needed, to provide adequate
confidence that an entity will fulfil requirements for
quality.
• Quality Assurance aim is thus to achieve objectives,
through development of people by promoting family
feeling in a group.
• Quality Assurance program will succeed where people
are respected and are involved in decisions concerning
their work life.
• For its success QA program has to become an
organization culture.

SOME TERMS (contd)
• Quality paradigm should percolate top down wards.
• Concept of Quality Assurance contained all those
planned and systematic actions required to provide
adequate confidence that a product or service would
satisfy given requirements for quality.
• Based on “Process compliance” 7 M‟s
• Men Milieu (Environment)
• Material Measurement (Monitoring)
• Machine Money (Resource)
• Method
• The era of “Quality Assurance” also made use of
Statistical Process Control (SPC) and Reliability
Engineering.
•

SOME TERMS (contd)
• Japanese applied the QA on company wide basis
which came to be known as “Company-Wide Quality
Control (CWQC)
• Era of CWQC is also known as Total Quality Control
(TQC)

• Total Quality Management (TQM)
• Came into being in 80‟s because of intense competition
• Technology - Establishes strong link with
HRD function
• Quality Engineering - Customer focused
- Employee oriented

TOTAL QUALITY MANAGEMENT
• Definition (TQM) :
Management approach of an organization centered on
quality, based on the participation of all its members and
aiming at long term success through customer
satisfaction and benefits to all members of the
organization and to society.

• Definition from People (Employee)
We are engaged in an ongoing journey of continuous
measurable improvements, championed by empowered
individuals a all levels of the organization, our
leadership philosophy inspire teamwork, trust, and belief
in people which results in an enjoyable and productive
work place, dedicated o the highest possible level of
customer satisfaction.

(contd)
• Some other Definitions of TQM

• A cooperative form of doing business that relies on the
talents and capabilities of both labour and management
to continually improve quality and productivity using
teams
--------------Jablansk
• A structured system for creating organization wide
participation in planning and implementation, a
continuous improvement process to meet and exceed
customer needs.
-------------- Bressard

(contd)
• Application of quantitative methods and human
resources to improve the material and services supplied
to an organization all the processes within an
organization and the degree to which the needs of the
customer are met now and in the future
-------------- Mossard

• Integration of all functions and processes within an
organization in order to achieve continues improvement
of the quality of goods and services. the goal is
-----------Ross

(contd)

• Systematic approach to implement lasting changes in
an organization through the use of
- Teamwork and participation
- Statistical methods and analyses
- Management leadership
- Problem solving and process management
---------Blaunt Memorial Hospital

(contd)
Road towards TQM

Decide

Prepare

Start

Expand

Integrate

TQM

(contd)

TQM - Processes (The Juran Tirology)

Quality Planning
(Design for Quality)
Quality control

Quality improvement

- TQM is an approach for continuously improving the
quality goods and services, delivered through the
participation of all levels and functions of the
organization.

• Customer‟s Focus

• Executive Leadership

• strategic quality Management

• Education and Training

• Measurement

• Measurement and Information

• Total organization Involvement

• Customer – Supplier Partnership

• Quality System

• Quality Improvement

• Quality Control

• Quality Planning (Designing for Quality)

• Lower Cost

• Higher Revenue

• Empowered Employees

• Delighted Customers

LEVELS IN THE EVOLUTION OF
QUALITY MANAGEMENT

• Total Quality Management
- Continuous improvement
- Customer orientation
- Empowered employees

• Total Quality Control
- Corrective and preventive actions
- Company wide QA
- Extensive use of QA tools

LEVELS IN THE EVOLUTION OF
QUALITY MANAGEMENT (contd)

• Quality Assurance
- Corrective actions
- Statistical Process control
- Process compliance in manufacturing

- Corrections
- Grading salvage
- Post production exercise

CQI - CONTINUOUS QUALITY
IMPROVEMENT
• CQI is a global approach to business development, that
establishes an integrated programme through, which a
company can achieve continuously incremented
improvements in its chosen key performance measures
by focusing on the better leadership of people and the
improved management of business processes.

• Transformation of an organization's culture to emphasize
on quality of service and product as perceived by the
organization's customer or those whom it serves.
----------------Mustafakhan

IMPROVEMENT (contd)
• The principal challenges are –
- Shorter Product cycles
- Generic Products
- Increased competition for fixed or diminishing
markets
- Higher Customer Expectations
- Higher Staff Expectation

IMPROVEMENT (contd)
• The reasons for failure of quality programmes include –
i. They are imposed from above
ii. They lack ownership by the staff
iii. There are no clearly communicated objectives
iv. They are frightening and threatening to the status
quo
v. There is resistance to change
vi. They are seen as expensive
vii. CQI is the key to business survival.

• TQM Mainly - Applied to industry
• CQI Mainly - Applied to Services

ELEMENTS

• Customer focus
• System view
• Data driven analyses
• Implement involvement
• Multiple causation
• Personally devastating review systems
• Mobility of management, job hopping from one company
to another.
• Use of visible figures only for a management with little
or no consideration of figures that are unknown or
unknowable.

IMPROVEMENT (contd)

CQI uses quality management practices to obtain
top quality performance management techniques
are allied to a process- designed to make sure the
company does not stand in the way of the staff
delivering a top performance.

IMPROVEMENT (contd)
• The core of the programme is the business survival
strategy.
• Determine the functions that need to be done.
• Ensure the right processes are used in the right
functions.
• Get the right people to do the right jobs.
• Have the products, services, processes and procedures
that are customer focused for both external and internal
customers.
• When implementing the programme, one should
remember that processes are rational with predictable
outcomes, whereas people are so complex that their
responses can be non-rational and cannot be accurately
predicted).

IMPROVEMENT (contd)

QUALITY GURUS
• Edward Deming - Father of Japanese Quality
revolution
• Born in 1900
• Doctorate in Mathematical Physics
• Worked in US Govt. - Statistical Sampling
Techniques. Sent to Japan as an advisor
• Attempted to make major changes in the style of
Western management. (win:win situation)

QUALITY GURUS (contd)
DEMING’S CHAIN
• Deming has a reputation as the man who transformed
Japanese industry after the Second World War.
• Deming‟s definition of quality – three areas that are
crucial for the overall quality of a product, quality of
design, quality of conformance, quality of the sales and
service functions.

• Improve Quality

• Improve Productivity

• Decrease costs


• Decrease prices

• Increase Market

• Stay in Business

• Provide jobs – more jobs

• Increase Return on investment

• Deming’s Philosophy based on three basic
precepts.
1. Customer orientation
2. Continuous improvement
3. Quality is determined by the system.

• Deming's Absolutes of Quality
1. Do it right first time
2. Defects prevention is the only acceptable approach
3. Zero defects is the only performance standards
4. Cost of quality is the only measure of quality

Deming's Five Deadly Sins of Western
Management
• Lack of constancy of purpose to plan product
and services that will have a market, keep the
company in business and provide jobs'

• Emphasis on short term profit, short term
thinking fed by fear of turnover push from
bankers

Deming’s Fourteen points.
1. Create constancy of purpose for improvement of product
and service.
Allocate resources for long range needs rather than
short term profitability.
2. Adopt the new Philosophy
No longer to live with commonly accepted levels of
delays, mistakes, defective materials and defective
workmanship.
3. Cease Dependence upon mass inspection.
4. End “Lowest Tender” contracts (single reliable supplier)
5. Improve every process

6. Institute training on the Job
7. Adopt and institute leadership
8. Drive out fear
Encourage effective two way communication and other
means to drive out fear throughout the organization.
9. Break Down Barriers
Between staff areas and departments
10. Eliminate slogans, exhortations and targets to the work
force.
Demanding zero defects and new levels of productivity
without providing method

11.Eliminate Arbitrary Numerical Targets

12. Permit pride of workmanship

13. Encourage education
Vigorous programme of education
Encourage self improvement for everyone

14. Take action to accomplish the transformation.
Top management‟s commitment for that.

Joseph Juran
• Born in 904
• Trained as an Engineer
• Juran was invited to Japan in 1950‟s
• He defines quality as Fitness forum
• Stresses the need to reduce the cost of quality.
TQM
• It is a collection of all the things, that we must do to have
quality
• Senior Managers must take personal charge of leading
the change
• Training of Management Hierarchy
• Institution‟s commitment to achieve perpetuate, and
institutionalize total quality.

Ten steps to quality Improvement.
1. Build awareness of the need and opportunity for
improvement .
2. Set goals for improvement
3. Organize to reach the goals
(Establish a quality council, Identify problems, Select
projects, Appoint teams, Designate facilitators)
4. Provide Training
5. Carry out projects to solve problems
6. Report Progress
7. Give Recognition
8. Communicate results
9. Keep score
10. Maintain momentum by making annual improvement part
of the regular systems and processes of the company.

He advocated –

i. Quality circles – because they improve communications
between management and labour

ii. Use of statistical process control.

Dr. Philip Crosby:
• Crosby – did not (unlike other two) recognize the merit of
the Japanese Quality Model.
• Dr. Crosby has also come out with a 14 step prescriptions
for quality management.
1. Management Commitment
2. The Quality Improvement Team
3. Quality Measurement
• To display current and potential non-conformance
problems to permit objective evaluation and corrective
action.

4. The cost of Quality
To define the ingredients of the cost of quality and
explain its use as a management tool.
5. Quality Awareness
By all persons
6. Corrective action
Systemic method of resolving the problems.
7. Zero Defects Planning (not close to)
8. Supervisor Training
9. Realization of Change
By all the employees
10. Goal setting
To establish improvement goals by all individuals.


11. Error – Cause removal
Problems Faced by the employees
12. Recognition
To appreciate those who participate.
13. Quality councils
To bring together the professional quality people for
planned communication on regular basis.
14. Do it over again
To emphasize that the quality improvement
programme never ends.

According to Crosby –
• Quality does not come from a system. It comes from
the understanding and application of management
concepts and education.
• Quality is conformance to requirements not goodness.
• The system he advocates is prevention - not appraisal
• Zero defect - not close enough
Crosby's absolutes of Quality
• Quality means conformance 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 (and all
the time)
• The only performance measure is the cost of quality
• The only performance standard is zero defect.


Ishikawa

• Quality must be company wide
• The next step of a process is its customer ,as preceding
step is its supplier.
• Promote feedback and create channels of
communication with both the above
• Quality circles to emphasize, participative team work
• Emphasis on education and training.
• Quality audits
• Rigorous use of statistics
• Just in time process


Tuguchi

• He is the major name in the field of statistical process
control, and the name Tuguchi methods of experimental
and quality analysis.
• Use of statistical techniques
• Evaluation of quality from both an end user and process
approach
• Loss is directly related to variability from target
• It variability is reduced the quality level will go up and
cost will come down

Feigenbaum

• Total quality control : Quality development
• Maintenance
• Improvement
• Cuts across all activities in the organization and involve
all systems phases
• Both customers and suppliers are drawn to the total
quality concept.
• The goal of quality is to meet satisfactorily whatever
customers believe to be their requirements for the
service or the product.

QUALITY IMPROVEMENT TOOLS
• Quality Improvement and Measurement Tools are used to
help.

i. Identify Issues
Problems of improvement
Sources

ii Represent the Solution - to a problem
Or to show the plan to be used
To tackle the problem.

QUALITY IMPROVEMENT TOOLS
(contd)
Flow Chart
• It is a pictorial representation of the steps and activities
that constitute a process. They are often used to show
the structure of an organization or used to show the flow
of computer programmes.

• Different shaped boxes represent different types of
issue such as –
• Document
• Decision
• Termination or choices

QUALITY IMPROVEMENT TOOLS (contd)
• Symbols for Flow Charts

- Start or stop

- Document

- Decision

- Delay

• Flow lines are inserted between the boxes to show the
direction of the flow.

Cause and Effect Diagram:
(Fish bone diagram or Ischikawa Diagram)

• This quality improvement tool is a great help in
brainstorming session, because it helps to display the
possible causes of a specific problem or condition.

• Put the goal or idea at the head of the fish.
• Divide the contributing factors to the achievement of the
goal into categories such as
Man
Materials
Machines
Methods

• Other factors Maintenance
Measurement
Markets
Money


• The problem solving team can analyze and fill in all the
contributing factors

• Cause and effect diagrams are useful to show the
relationship between one issue or contributing factor
and another.

• They do not tell as about priorities, which are best
tackled using other quality representation and
measurement tools.


G Natt Chart ( ? Bar Chart)

• It can be used as an aid to planning of work
• Primarily it shows the relationship of activities against
time and highlights areas, where the time planning has
gone erroneous.
• Further a G Natt Chart shows where activities need to
be started and finished in relation to other activities.
• A G Natt is a time based chart showing the start and
end points of various time based tasks.


Wk 1 2 3 4
• Actively
1
2
3
4

• A G Natt Chart helps to do things in the right order.
• Time overruns for individual activities and tasks could
be estimated and monitored using these charts.

Histograms

• They are used to display and identify the type of
distribution of data by drawing graphs for the number of
units in each class of the data.

• Histograms show different shape and can indicate a
probable cause for the deviation from most frequent
shape (normal shape).

• Different shapes of histogram, provide an insight into
the value of the data.

The Pareto Principle:
• The Pareto principle was invented by Ishikawa and is
used to divide the”vital few” from the “Important many”.
• It is particularly useful, where it is necessary to decide
on priorities.
e.g. Critical Quality Costs.
• Quality problems, which are small and have low impact
are accorded lower priority whereas topmost priority is
given to those quality problems, which are likely to have
a very great impact on the organization.
• The Pareto principle is used to catch the big fish and to
leave the little fish in the pond, for attention at some
future time.

• It is a method of showing the causes or defects which
are most important.

100 –
80 –
60 –
Sales 40 –
20 –

0 20 40 60 80 100
This representation of the data is yet another method of
“viewing a picture” of the data and can help in predicting
the effectiveness of improvements and enable an
understanding of problems and seriousness at a glance.


Some of the conclusions drawn based on the Pareto
Principle are –

• 80% of the quality costs came from 20% of the
problems
• 80% of the sales go to 20% of the customers
• 80% of the performance of the people comes from 20%
of their activities
• 85% of the problems are caused by management and
15% are caused by subordinates.

Scatter Diagram:
• They show the relationship between two variables and
each point on the diagram represents a poor of
variables.

Variable
Y

Variable X
0Scaller diagram may explain the variations in the
relationship among the two variables under consideration.
The exact nature of problems and the possible reasons


The Control Charts

• The main tools is the control chart
• There are different types of control charts depending on
different ways assessing the quality of a product.
• Many characteristics of co-product a measurable and
they are continuous variables.
• For controlling such variables two types of charts are
plotted, one for mean of the measurements (X chart)
and another for the range of the measurements (R
chart).

Activity Analysis:

• Functional Analysis and Failure Mode and Effect
Analysis are two of the many types of activity analysis
through which the paper work jobs can be analyzed as a
process just as one would analyze a manufacturing
process.

• Functional Analysis is a process for identifying quality
improvement opportunities within a department or
organization and is particularly suitable for
administrative operations.

• Functional Analysis helps to find out –

- Who the customers and suppliers dare ?
- The expectations of the consumers
- The expectations, the suppliers must meet.
- The tasks needed to achieve the required output
- The necessary measurements
- Where expectations are not being met
- The improvements, which are possible.

Statistical Process control (SPC)
• SPC IS a quality tool. It is also quality improvement
strategy, that is essential part of quality management.

• Basic element of SPC is
- Collection of data in an objective manner
- It is analysis in graphical form to provide the input to
a series of improvement processes.

• SPC is a term for analyzing how the business are
performing using members, diagrams and pictures.
• SPC can be used to understand the workings of any
activity from which numbers can be derived by
measurement.

• SPC helps to

i. Evaluate long term process variables
ii. Start short term actions on out of control situations.

• It is one of the quality tools, used to quantify the
progress of improvement of TQM process as a whole

• As its simplest level SPC is illustrated as average The
average can be used construct charts.


Nominal Group Techniques: (Brain Storming)

• It is for stimulating ideas, points issues or solutions
among a group.

• The group consists of 4-10 people. After the brain
storming a vote about the ideas with the highest priority
in the opinion of the group.

Steps:
• Participants silently write their individual list of ideas.
• They offer in rotation one idea each for recording on a
flipchart until all ideas are written down
• The ideas are then discussed and similar ones are
grouped together as one idea, with ideas which capture
the idea.
• The listed ideas from which the grouped idea came are
then deleted in order to avoid duplication.
• Each participant votes on the idea.
• Add up the individual votes to priorities the list
• With the Nominal Group Techniques, silly or impractical
ideas cannot be forced down the throats because they
simply get voted out.

JAPANESE MANAGEMENT
• Disciplined workers
• Give maximum importance to their jobs and take their
jobs very seriously
• Sense of responsibility (the next worker need not check
the machines because he is certain that previous worker
has done it)
• Experts in
planning
Scheduling
Conducting in time
• After 2nd World War they learnt lessons of quality rather
painfully which they still continue to practise
• Passion for excellence

JAPANESE MANAGEMENT (contd)
• Work harder and longer on their own
• Life time employment
• Good industrial relations
• Synergy in whole system
• Concepts of Total Quality Management imbibed in entire
system
• Concepts like JIT
• Integrated Supplier-Customer relationship
• Statistical analysis
• Full support from the management for quality programs
• Actively practice Kai Zen – continuous improvement
• Continuously educate and train the employees (at least
22 days in a year)

• Excellent management
- Facilities
- Responsible employees
- Little or no inventories
- Absence of work stoppages
- Almost no rejected products
• Absence of Crisis management and excellent
maintenance of equipments
• Technological advantages because of insistence on
building their process in house
• Skilled employees trained in-house
• Effective integration of operations policy and
manufacturing strategy

• They focus on long-term objectives and not on short cuts
and small gains.
• Workers belong to company unions rather than craft
unions.
• Practice the concept of consensus decision-making
• Collective responsibility and team rewards.
• Socialization of Japanese Firm to inculcate the culture of
the organization in the employees by such rituals as
- Singing company songs
- After hours group activities
- Company sponsored vacations
- Develop and sustain long term commitment and
loyalty to organization

• Directors are from Company (not form outside) they rise
in the company
• Dividends on the share values (not on market value)
• A large part of profit is pumped back into the company to
improve the techniques management etc.

Quality Circle
• Concept originated from Japan
• Dr. Ishikawa presented in April 1962

Original Definition:
Quality circle is a small group to perform voluntarily
quality control activities within the same workshop. This
small group carried on continuously as a part of company
wide quality control activities self development and
mutual development and improvement within the
workshop utilizing control techniques with all member
participating.

Revised:
• QC is a small group in which people, who work in the first
line work place, continually improve and maintain the
quality of products, services job and so on.
• This small group promotes the activity in such a way as
to autonomously administer it, utilize the QC concept and
technique and others display creativity land make self
development and mutual development.
• There are a number of basic factors in quality circles and
their development.
• Quality circles enable workers to participate in the
improvement of their products and their jobs, so building
pride in their product and a sense of participation in, and
belonging to the organization.

• Quality circles recognize and use the intellectuals and
practical potential of all employees of an organization and
provide a safe framework within which such contributions
can be made.
• Quality circles provide training and structured
opportunities for staff to become involved in the inter
personal processes within the organization that lead to
joint problem solving. The circles are employee owned
and allow for personal development and growth, together
with allowing a sense of achievement at work.
• Quality circles flourish best in, and promote, a democratic
participative and person oriented management style that
values two way communication and values the
contribution of all employees to the functioning of the
organization.


QC activity intends to –
• Develop their capacity
• Perform the self actualization for members
• Make its workplace full of brightness and vitality
• To improve customer satisfaction by high quality product
at lower cost free from defects, timely delivery and
prompt service.

Introduction of QC in an organization
• First requisite is the firm commitment of the top
management in the Quality Programmes.
• Following methods adopted before QC is introduced :
i. Conduct a survey of the organizations
ii. Discuss the findings with the top management
iii. Conduct special programmes to executives
iv. Select executives from various departments for
special intensive training programme.
v. Training has to be done with best faculty members
available on the subject.
vi. Form Quality Improvement Team, Section wise
vii. Conduct awareness programme to all workers and
train them in Q.C. programme.

• Ideal Size – 8-10 member but not more than 15
• There should be a co-ordinator, Joining QC should be
voluntary.
• Usually from the same shift and department.
• But workers from other shifts or departments working
similar jobs may be included.
• It is the responsibility of the management to provide
some space, organize meetings and promote QC
activities.
• Quality circles meet regularly and periodically. The
periodic meeting is normally once a week for one hour.
Facilitator or co-ordinator need not be present all the
time. But he should be in touch with the members,
particularly with the leader before and after the meeting.

Problem Solving: A list of problems using brain storming
techniques. They prioritize and classify the problems.

A. Category Problems: - Minimum involvement of other
departments.
B. Category problems- Involvement of other departments is
a necessity
C. Category problems – Management section and support
may be needed in implementing the solution.

It is advisable to start with A type of problems and then
more on to B and C

Once the problem is recognized, the following steps are
taken.
• Define the problem.
• Analyze the problem by collecting data
• Identify the causes
• Find out the root causes by data collection and analysis
• Identify solutions
• Select the appropriate solution
• Foresee the probable resistance for its implementation.
• Implement the solution on trial basis and check
performance
• Regular implementation
• Follow up / Review

Need to take some specialist advice/suggestion on some
occasions
Management Presentation - Periodically.
Benefits:
• Members - Improve their knowledge
- Learn to work together
- Learn to Interact
- Learn to present before management
- Improve their morale and confidence
- Learn to work systematically
- Learn to plan their activities
- Learn the techniques of problem
solving
- Help preventing the problems

• Organization - Quality improves
- Morale enhanced
- Cost effectiveness
- Attitudinal changes and better
teamwork.

• Two pillars:
1. JIT
2. Jidoka

JIDOKA (Automation with a human touch)
• E.g. A machine will detect a problem and stop the
production automatically rather than continue to run and
produce bad output.
• Jidoka is often labeled as „Stop and respond to any
abnormality‟
Four steps involved:
• Detect the abnormality
• Stop Can be easily
• adopted
• Fix or correct the immediate condition
• Investigate the root cause and install a Human
counter measure interference required

Some methodologies are:
• Kanben: In this system, each sub-unit of the plant tailors
the production precisely to the needs of the upstream
unit.
• Anden: Visual indication of the trouble giving instructions
to stop the work / line operation
E.g. Fire alarm in an office, Machine breakdown signal
system
• Poka-Yoke: Work process is so designed to eliminate the
human mistakes
• Visual Control: A System of visual control basically
means sharing information.

JUST – IN – TIME
• A structural approach in manufacturing organization
focuses on improving

1. Timeliness
2. Quality
3. Productivity
4. Flexibility


Utilizing various methods of
• Work Simplification
• Waste reduction

JIT is viewed as a level of perfection achieved through
continuous elimination of the wasteful use of resources.
• Non stock
• Zero inventory


JIT methods are:
• Elimination of waste
• Good Housekeeping
• Jidoka (Automation)
• Anden (Visual indication of trouble)
• Poka-Yoke (Not allowing mistakes to occur)
• Visual control
• Kanben (Demand pull)
• Scheduling
• Set-up reduction
• JIT materials management

KAIZEN
Kai -- To break apart
-- To modify
-- To change

zen -- Think about
-- Make good
-- Make better

Kaizen ----- Continuous Improvement
--- Change for the better
-- To brake apart and put back together better than
before


--Kaizen is used by the Japanese for any kind of
improvement.
(Both in the private and in the working life)
-- It is the most important Japanese management concept.
--Kaizen means
“Not only product improvement but improvement of all
the procedures till completion of the product up to
marketing and customer care including the constant
advancement of working humans”
--- Kaizen is the philosophy of the eternal change and
flexibility to react over to the changes of the environment.

Basic principles of Kaizen
• Kaizen is a process for identifying waste….
And reducing or eliminating it.
• Kaizen is process for identifying and implementing
standard work.
5 S --
-- Start ( organization ) Clearly distinguish needed from
unneeded items and eliminate the latter.
-- Set in order (Orderliness) Keep needed items in the
correct place for easy and immediate retrieval.
-- Shine – (Cleanliness) __ Keep the workplace swept and
thoroughly clean.
-- Standardize
-- Sustain __ (Discipline)


Kaizen

• Stresses above all humans and its potential for problem
solution – Human capital.
• The investments are directed less on technologies
although these may not be neglected.
• The workers of an enterprise are regarded as resources
and /or property
• Expenditures for personnel in particular for further
training

Kaizen – some features
• Speed - small steps
• Time frame - continuously and rising
• Participants - each employee
• Proceedings - collective spirit, group work
• Methodology - conventional know how
• Investment - small
• Success - human
• Effect - on a long term basis and
continuously
• Evaluation - achievement and for better results
• Advantages - outstanding suitable for slowly
rising economy.

• Learn to work systematically
• Learn to plan their activities
• Learn the techniques of problem solving
• Help preventing the problems

Organization

• Quality improves
• Morale enhanced
• Cost effectiveness
• Attitudinal changes and better team work.

SIX SIGMA PROCESS

• Six Sigma is a system of practices originally developed
by Motorola to systematically improve processes by
eliminating defects.
• Defects are defined as units that are not members of the
intended population.

The term Six Sigma
• Sigma (the lower-case Greek letter σ) is used to
represent standard deviation (a measure of variation) of a
population (lower-case „s‟, is an estimate, based on a
sample.

SIX SIGMA PROCESS (contd)

Definition:
One that produces 3.4 defective parts per million
opportunities (DPMO).

• A process that is normally distributed will have 3.4
parts per million beyond a point that is 4.5 standard
deviations above or below the mean (one-sided
Capability Study). This implies that 3.4 DPMO
corresponds to 4.5 sigmas, not six as the process
name would imply.

Key Concepts of Six Sigma:
At its core, Six Sigma revolves around a few key concepts.
• Critical to Quality: Attributes most important to the
customer
• Defect: Failing to deliver what the customer wants
• Process Capability: What your process can deliver
• Variation: What the customer sees and feels
• Stable Operations: Ensuring consistent, predictable
processes to improve what the customer sees and feels
• Design for Six Sigma: Designing to meet customer
needs and process capability

Methodology:
Six Sigma has two key methodologies: DMAIC and DMADV

DMAIC is used to improve an existing business process.

DMADV is used to create new product designs or process
designs in such a way that it results in a more predictable,
mature and defect free performance.

DMAIC
Basic Methodology consists of the following five steps:
• Define the process improvement goals that are consistent
with customer demands and enterprise strategy.
• Measure the current process and collect relevant data for
future comparison.
• Analyze to verify relationship and causality of factors.
Determine what the relationship is, and attempt to ensure that
all factors have been considered.
• Improve or optimize the process based upon the analysis
using techniques like Design of Experiments.
• Control to ensure that any variances are corrected before they
result in defects. Set up pilot runs to establish process
capability, transition to production and thereafter continuously
measure the process and institute control mechanisms.

DMADV
Basic methodology consists of the following five steps:
• Define the goals of the design activity that are consistent
with customer demands and enterprise strategy.
• Measure and identify CTQs (critical to qualities), product
capabilities, production process capability, and risk
assessments.
• Analyze to develop and design alternatives, create high-
level design and evaluate design capability to select the
best design.
• Design details, optimize the design, and plan for design
verification. This phase may require simulations.
• Verify the design, set up pilot runs, implement production
process and handover to process owners.

Roles required for implementation

Six Sigma identifies five key roles for its successful
Implementation.
1. Executive Leadership
2. Champions
3. Master Black Belts
4. Experts
5. Black Belts
6. Green Belts

Lean
• Introduced by Toyota in the 1960‟s as a systematic
approach to identifying and eliminating waste or non-
value-add activities in an organization through
continuous Improvement with the goal of creating value.

• Lean is therefore a strategy or system for remaining
competitive through identifying and eliminating wasteful
steps in products, services, or processes.

• The key principles of Lean are based on identifying
waste from the customer perspective, and determining
how to eliminate it.

Lean (contd)

The 7 Wastes
1. Waiting - eg. Employee or equipment idle time
2. Transportation - eg. Any movement that does not add
value
3. Processing itself - eg. Doing more work than necessary
4. Motion - eg. Wasted walking or movement
5. Poor “Quality” - eg. Errors or rework
6. Inventory - eg. Storing excess inventory/ materials
7. Overproduction – eg. Servicing more, sooner, faster
than required by the next step in the
process

Lean (contd)

The term “Lean” is used because a Lean organization:

• Optimizes human effort
• Uses less space
• Reduces the need for capital investment
• Decreases the amount of raw materials/supplies bought
and consumed
• Uses less time to produce and deliver products and
services

Lean (contd)

A more general interpretation of Lean Healthcare is:

The relentless elimination of waste in every area of
operations with the aim of reducing inventory, cycle
times and costs – so that delivering higher quality
patient services can be provided in the most efficient,
effective and responsive manner possible, while
maintaining the economic viability of the organization.

Medical (Clinical) Audit
• Clinical Audit is a quality improvement process that
seeks to improve patient care and outcomes through
systemic review care against explicit criteria and the
implementation of change.

• Aspects of structure, processes and outcomes of care
are selected and systematically evaluated against
explicit criteria

• Where indicated, changes are implemented at an
individual, team or service level and further monitoring
is used to confirm improvement in health care
delivery.

Medical (Clinical) Audit (contd)

Stages of clinical audit

Stage I Preparing audit By creating the right
environment
Stage II Selecting criteria

Stage III Measuring performance By using the correct
methods.
Stage IV Making improvements

Stage V Sustaining improvements

I. Preparing for Audit:
• Clinical audit is conducted with effective leadership
participation by all staff . Emphasis on team working and
support. This enables everyone to be responsible for
reporting analyzing and improving process.

• Service uses are also to be involved in the clinical audit
process. The priorities of those receiving care can differ
quite markedly from those of clinicians.
Usual sources for this purpose are –
- Letters containing comments or complaints
- Critical incident reports
- Individual patient‟s stories or feed back
- Direct observation of care
- Direct conversations

• Good documentation of clinical care
• Timely
• Truthful
• Comprehensive
• Legible
• Topic selection Specific
• Random
• Defining the purpose of the audit To improve
• To enhance
• To ensure
• To change

• Providing the necessary structures
• A. structured audit programme (committee structure,
feedback mechanisms, regular audit meetings).
• A team of well qualified staff.

• Identifying the skills and people needed to carry out
the audit.

• Training the staff and encouraging them to participate.
• Audit methods
• Change management
• Data collection and data analysis skills
• Felicitation skills

II. Selecting Criteria

• Criteria are used to assess the quality of care provided
by an individual, a team or an organization.
• These criteria –
1. Are explicit statements that define, what is being
measured.
2. Represent elements of care that can be measured
objectively.

Different professional groups use different criteria or
standards

Criteria can be classified as –

1. Structure (what you need)
• Staff
• Skills
• Space
• Equipment

2. Process (what you need)
• They include communication assessment, education,
investigations, prescribing surgical and other therapeutic
interventions.


Process:

• Identify key elements
• Carry out focussed systematic literature reviews
• Prioritize the criteria into “must do” and “should do”
• Present the criteria in a protocol.
• Include data collection forms instructions etc.
• Submit the protocol to external pre review


III. Measure Level of Performance:
• Patient registers are used to identify patients care
must be taken to identify the incomplete records.
• To make sure that the data collected are precise and
that only essential data are collected, certain details
about what is to be audited must be established from
the outset.
• Sampling:
• How many of the users (study population) to be
selected?
• How to choose a representative sample?
Should be decided in advance.


• Electronic information systems can contribute to audit
in many ways like improving access to research
evidence identifying users, collecting data, prompting
change through record templates, and enabling
revised systems of care to be introduced.

• In this exercise care should be taken to maintain
confidentiality of the patients.

IV Making improvements
A systematic approach to implementation is more
Effective. Approach should include -
• Identification of local barriers to change.
• Investigation of potential barriers to change assists in
the development of implementation plans.
• The support of teamwork
• Train the people to effect changes after taking them
into confidence.
• Use of a variety of specific methods
Use of multifaceted interventions chosen to suit the
particular circumstances is more likely to be effective in
changing performance than the use of single
intervention alone.

V. Sustaining Improvements - Very Important

• Monitor and evaluate change
• Collecting data for a second time, after changes have
been introduced in central to both assessing and
maintaining the improvements made during clinical
audit. The same procedures of sample selection,
information collection and analysis.

• If performance, targets have not been reached during
implementation, modifications to the plan or additional
interventions will be needed.

• Maintaining and reinforcing improvement.


• It is a complex process
• It includes
- Reinforcing or motivating factors built in by the
management to support the continual cycle of quality
improvement.
- Integration of audit into the organization‟s wider
quality systems.


Factors that promote the success of clinical audit –
• Sound leadership
• A conducive / supportive organizational environment
• Structures and systems to support audit including
mechanisms to make data collection easier.
• A well managed audit programme.
• Giving adequate attention to all stage of audit .
• Addressing a range of issues important to the trust
and individual clinicians.
• Top management commitment and participation of
every member of the organization.

BENCH-MARKING
Definition:
• Bench Marking is the process of identifying
understanding and adapting outstanding practices from
within the same organization or from other business to
help improve performance.
• This involves a process of company practices and
procedures to those of the best to identify ways in which
an organization can make improvements. Thus new
standards and goals can be set, which in turn will help
better satisfy the customer‟s requirements for quality
cost, product and service.
• In this way, organizations can add value to their
customers and distinguish themselves from their
competitors.

BENCH-MARKING (contd)
Bench marking:
• “A perfect legal way of copying the smartest business
practices”
• “How to steal the best ideas around”
What to bench mark?
• Vital few
• Key successful factors
• Key performance indicators
Bench marking is probably the single must important thing a
company can do when beginning the quality improvement
process.
It is a continuous learning and improvement process, which
ensures that best practices are uncovered, analyzed,
adapted and implemented where appropriate.

What bench marking can achieve?
• Incremental improvements to existing performance
standards.
• Quantum leaps by instigating new practices and ways of
working.
• The road to excellence creating the learning organization.
Success of bench marking:
• Baldridge award winners
• Deming prize winners
• ISO 9000 certificate holders
• Organization with other accreditation
• Documentation of best practices
• Benchmarking consortia

Bench marking protocol
• Keep it legal
• Be willing to give what you get
• Keep information internal
• Don‟t refer without permission
• Use benchmarking contacts
• Be prepared from the start
• Understand expectations
• Act in accordance with expectations
• Be honest
• Follow through with commitment.


What benchmarking is NOT:

• Stealing
• Copying
• Sleeping with the enemy
• Industrial tourism
• Recreational TQM.

Types of Bench Marking
• Internal
• Competitive - Organisation
• Non competitive - Organisation
• Best Practice/world class.

• Benefits of Benchmarking
• It sets performance goals
• It helps accelerate and manage change
• It improves processes
• It allows individuals to see the “outside the box”
• It generates an understanding of world class
performance.

Pit falls:
• Lack of focus and priority
• Lack of strategic relevance
• Lack of leadership
• Lack of perseverance
• Lack of planning
- Management not burying into the idea
- No clear owner of the programme
- Failure to consider customer requirements
- Change of sponsor before completion of the
programme
- Not involving “right staff” in the programme
- Team not measuring issues it agreed to addresses
- Programme causing too much of disruption of work
- Conflicting objectives of the organisation.

EDUCATION AND TRAINING
"If I am asked to cut a tree in eight hours I spend six hours
in sharpening the knife"
Fortune:
• If you want to build a high tech performance flexible
organization then you have to train your workers.
• Japanese Excellence in quality is due to training.

Training:
• Should be to everybody
• Mandatory
• Regular
• No gaps in knowledge and skill at any level
• Must include technical and behavioral aspects.

EDUCATION AND TRAINING (contd)

Determining training needs:
• Detailed study.
• Do not rush in designing the programme
• Not just general training
• Individualization
• Grouping
• Duration
• Content To be specified
• Methodology
• Timing

Training by whom?

• Internal Advantages and
• External Disadvantages
• Facilitator
• Coordinator

How much and when
• 4-6% of the total working hours
• 92-120 hours i.e. 12-15 days/year.
• During working hours
• At intervals
• Timing choice to worker (preferably)

Must become conversant with
• Absolute quality
• Problem solving
• Statistical process control
• Reducing waste
• Process simplification
• Team work
• Meeting customer‟s expectations

Every employee must be aware that
• His performance has an effect in the end service
• His high motivation should deliver constant good quality
product/service

• Benefits/impact
• Evaluation
- Hours of training of every employee
- Results
- Feedback from participants
- Cost-benefit analysis

• Review:
- Periodic review
- Reassessment of needs methodology
- Decide the future programme
- Continuous process

LEADERSHIP

• Leadership is the process of influencing group activities,
towards the accomplishment of goals in a given situation.

• Leadership is responsible for promoting commitment in
an institution.

• Commitment is the foundation of an effective total quality
programme.

• Leadership which promote such quality programme is
known as Total Quality Leadership.

LEADERSHIP (contd)
Role of Leaders:

• To develop team work
• Creating cordial relationships
• Act as counselor
• Time management
• Motivator
• Source of inspiration
• Power and authority for constructive purposes
• Proper delegation
• Managing and leading the group.

LEADERSHIP (contd)
Qualities of a Quality Leader:
• Mentor
• Facilitator
• Innovator
• Co-ordinator
• Monitor
• Coach
• Teacher
• Director

Manager DO THINGS RIGHT; Leaders DO RIGHT THINGS

LEADERSHIP (contd)
Ten commandments of leadership:

• Search for challenging opportunities to change, grow,
innovate and improve.
• Experiment, take risk, and learn from mistakes.
• Have a great vision for people.
• Make others participate in the vision by convincing them.
• Bring about collaboration by building trust among
members.
• Strengthen others by sharing all relevant information and
delegate authority.

LEADERSHIP (contd)

• Set an example for others by behaving in ways that are
suited to your personality.
• Plan for small successes that can promote constant
progress and bring about commitment.
• Recognize individual contributions to the success of
every project.
• Celebrate team accomplishments and success regularly.

LEADERSHIP (contd)
Managing resistance to change:
• To address the facts which lead to resistance.
• Usually they are:
- People look for stability and security
- Since change requires additional skills and
knowledge they are reluctant to acquire them.
- Leadership should understand these factors and
adopt strategies to convince and bring about
attitudinal changes
• Once that is done, to motivate, train, guide the people.
• Successful leaders are those who succeed in challenging
the present method of doing things and make things
happen.

LEADERSHIP (contd)
Leadership to ensure quality:
• Set personal example of practicing what you preach
about quality.
• Establish a quality vision and translate it into mission
statements
• Institutionalize the initiative and not individualize.
• Instill in every employee a sense of pride in the work
he/she does.
• Empower employees
• Document every process to create a manual for
conformance
• Devise systems that can function even if the individuals
change

LEADERSHIP (contd)
• Use external quality audits to benchmark efficacy of the
systems.
• Customers‟ complaints to be monitored, analyzed and
attended to immediately.
• To measure customer satisfaction levels to generate
ideas
• Delegate specified decision making powers down the line
• Improve communication at all levels
• Provide transparency in information
• Focus on preventive rather than curative maintenance
• Develop quality culture in the organization.

LEADERSHIP (contd)
Best Practices for Quality Leadership:
• Set a personal example or practicing what you preach
about quality.
• Establish a quality vision and translate it into mission
statements
• Institutionalize the initiative, don‟t individualize it.
• Instill in every employee a sense of pride in the work that
he must do.
• Invest in training people at all levels in quality theory and
practices.
• Empower employees to go to any length to satisfy the
customer.

LEADERSHIP (contd)

• Do not dogmatically stick to any; one TQM model.
• Calculate the savings from every TQM project.
• Document every process to create a manual for
conformance.
changes.
• Keep the processes fixed but the organizational structure
flexible.
• Use external quality audits to benchmark efficacy of
systems.

LEADERSHIP (contd)

Best Practices for Quality Customer Care:

• Measure customer satisfaction levels to generate ideas.
• Log, monitor, and analyse customer complaints every
day.
• Depend on market research to fine tune customer
communication strategy.
• Listen to the customer continuously and not at discrete
intervals.
• Use feedback to identify new segments and customer
expectations.

LEADERSHIP (contd)
• Design varying customer listening devices for different
needs.
• Convert every point of customer interaction into a
listening post.
• Use feedback data to update, monitor, and correct
complaints.
• Eliminate non-value-adding activities from every process.
• Reduce paperwork to make it easier for customers.
• Reduce the time customers spend waiting in offices.

LEADERSHIP (contd)

Best Practices for Institutionalizing Quality:

• Delegate specified decision making powers down the
line.
• Use technology to speed up communications and cut
cycle time.
• Identify steps that can be merged or eliminated
altogether.
• Provide transparency in information exchange and
reduce transaction times.
• Recruit inexperienced people to eliminate detraining.

LEADERSHIP (contd)

change.
• Launch TQM with a pilot project which is small but
important.
• Issue constant reminders on cost of poor quality.
• Focus on preventive rather than curative maintenance.
• Modify technology to match local conditions and
customer needs.
• Technology should be serviceable from within the
organization to a large extent.

STRATEGIES

• Mission, values, quality policy organizational goals.
• Organization for quality programmes
• Education and training
• Customers and their requirements
• Improvement opportunity identification
• Every activity standard
Assessed
• Integrating quality programmes with existing ones
• Organizational culture towards quality consciousness
• Communication
• Recognition and reward.

COST OF QUALITY
• Cost of quality is described as the measure of how much
it costs the institution to provide quality in everything the
institution does whether it manufactures products or
provides services.
• Other terms used are –
1. Cost of nonconformance (to specifications)
2. Price of quality.
• Quality is often associated with expense.
• Japanese proved that quality goods and services cost
less to produce, not more though-
1. Reduced waste
2. Greater productivity
3. Increased sales.
• All these three factors are interactive.

COST OF QUALITY (contd)
Cost of quality has following elements.

A. Cost of Errors or Cost of Rework

• Rework Necessary:
When product is redesigned, especially
in creative work

Unnecessary:
Information - Material mistake or
Process – Equipment Fault

Internal: Within the Institution
• Rework
External: Outside the Institution

Direct
• Rework
Indirect: e.g. Inspection, Replacing,
Repairing

• Costs associated with errors and defects are significant
in non-manufacturing and service sector.
• Deming says that 85 % of the quality problems are
created by people who never touch the product.

B. Cost of Inspection

• These costs include:
- Cost of enforcing quality control
- Cost of calibrating and measuring instruments and
gauges
- Cost of tooling

Cost of Inspection is high, especially in administrative areas.
Inspection does not bring quality. Prevention and doing it
right the first time are the keys.

The Cost of Quality is easy to measure in the production
areas and difficult in the service areas.
• The cost sometimes can exceed 25% of the sales
revenue, which may be surprising. This is because, 90 %
of the non-conformance costs are invisible.
• When the company is perfect, total costs of quality might
drop to only 7 % of the sales value. This needs
continuous hard work.

Purpose of measuring Cost of Quality:
• To set priorities
• Provide an Incentive

Measuring the cost of quality helps to
• Save Money
• Makes the organization more competitive
• Provides greater job security for the staff
Cost of implementing quality programs is far less than the
costs of not implementing it.
• Cost of implementing quality management programs is
recouped by greater productivity and lower total product
and service costs.
• The cost of producing high quality products and services
is zero, while the cost of producing low quality products in
services is equal to the cost of putting things right and
dealing with disgruntled customers.

• Singular pursuit of productivity through a focus on
efficiency is self-defeating
• Merril Lynch and Company estimated that the cost of
correcting mistakes and placating dissatisfied customers
was costing them more than $ 200 million a year.
• Hewlett Packard company discovered that rework and
dealing with customer complaints cost the company 20 %
revenues and involved time and effort of 25 % of
company employees.
• Cost of not doing things right the first time for a typical
service organization is equal to around 40 % of the total
operating costs.
• For the whole decade of the 1980‟s about 1/3rd of all the
work performed by all American Companies was actually
rework because of quality problems.

CERTIFYING BODIES
ISO
ISO is the abbreviation for International Organization for
Standardization. It is a Worldwide Federation of standards
bodies from more than 100 countries. The mission of ISO is
to promote the development of standardization and related
activities in the world with a view to facilitating exchange of
goods and services and to developing co-operation in the
spheres of intellectual, scientific technological economic
activity.
• ISO is a non-governmental organization with members
from different countries.
• ISO standards are voluntary and ISO has no authority to
enforce their implementation.

CERTIFYING BODIES (contd)
• ISO has developed several International standards
covering almost all technical fields.
• ISO does not carry out conformity assessment activities,
although it develops guidelines for those, which establish
the foundations for good practice.
• ISO standards are market driven. They are developed on
the basis of international consensus among experts from
the sector which has expressed a requirement for a
particular standard.
• ISO – 9000 certification – is obtained by interested
organization.
• ISO series came into being in 1987, which were later
revised in 1994 and recently in 2000.

QMS ISO 9001 – 200 (E)

4. Quality Management System
4.1General Requirements

• The organization shall establish, document implement
and maintain a quality, management system and
continually improve its effectiveness in accordance with
the requirements of this International Standard.


4.2 Documentation Requirement:
4.2.1 Documented statements of a quality policy and
quality objectives.
• Quality Manual
• Documented procedures required by this
International Standard.
• Documents needed by the organization to ensure
the effective planning, operation and control of its
process.
• Records required by this International Standard.

4.2.2 Quality Manual:
The organization shall establishes and maintain a
quality manual that includes:
• The scope of the quality management system, including
details of and justification for any exclusions.
• The documented procedures established for the quality
management system or reference to them.
• A description of the interaction between the process of
the quality management system.

4.2.3 Control of Documents:
• The documental procedures shall be established to
define the controls needed.


4.2.4 Records shall be maintained to provide evidence
of uniformity to requirements and of the effective operation
of the quality management system. Records shall remain
legible, readily identifiable and retrievable.

5. Management responsibility:
5.1 Management commitment
• Top management shall provide evidence of its
commitment to the development and implementation of
the quality management system and continually
improving its effectiveness by :

a) Communicating to the organization the importance of
meeting customers as well as statutory and regulating
requirements.
b) Establishing the quality policy.
c) Ensuring that quality objectives are established.
d) Conducting management reviews.
e) Ensuring the availability of resources .

5.2 Customer Focus:
• Top management shall ensure that customer requirements
are determined and are met with the aim of enhancing
5.3 Quality Policy:
Top management shall ensure that the quality policy :
1. Is appropriate to the purpose of the organization.
2. Includes a commitment to comply with requirements and
continually improve the effectiveness of the quality
management system.
3. Provides a framework for establishing and reviewing quality
objectives.
4. Is communicated and understood, within the organization
and,
5. Is reviewed for continuing suitability.

5.4 Planning:
5.4.1 Quality Objectives:

• Top management shall ensure that quality objectives
including those needed to meet requirements for product,
are established at relevant function and levels within
organization.

• The quality objectives shall be measurable and
consistent with the quality policy.

• 5.4.2 Quality Management System Planning

5.5 Responsibility, authority and communication
5.5.1 Management Representative:

• Top management shall appoint a member of
management, who irrespective of other responsibilities
shall have responsibility and authority that includes:
• Ensuring that processes needed for the quality
management system are established, implemented and
maintained.
• Reporting to top management on the performance of the
quality management system and any need for
improvement and.
• Ensuring the promotion of awareness of customer
requirements throughout the organization.


5.5.2 Internal Communication
Appropriate - regarding the quality management system.

5.6 Management Review :
• Review - QMS - at planned intervals to ensure
suitability, adequacy and effectiveness.
• Records - of review maintained.


5.6.1 Review in put shall include
• Results of audits
• Customer feed back
• Process performance and product conformity
• Status of preventive and corrective actions
• Follow up actions from previous management reviews
• Changes that could affect the quality management
system
• Recommendations for improvement

5.6.2 Review Output
The output from the management review shall include any
decisions and actions related to :
• Improvement of the effectiveness of the quality
management system and its processes.
• Improvement of product related to customer requirements
• Reserve needs.

6.1 Provision of Resources:
• To meet the customer‟s requirements

6.2 Human Resources
6.2.2 Competence, awareness and training

6.3 Infrastructure
6.4 Work Environment
7. Product realization
7.1 Planning of product realization
• Establish processes, documents
• Required verification, validation, monitoring inspection
and test activities
• Records needed to provide evidence that realization.

Support processes:
• Training /competence of people
• Marketing inputs
• Management of data/information

7.2 Customer related process

7.2.1 - Review of requirements related to product

7.2.2 - Customer communication

Systems in relation to -
• Product Information
• Schedule, contract, amendments (if any)
• Feedback .complacent from customer

7.3 Design and Development Planning
• Stages
• Review verification, validation
• Resources required along with their responsibility and
authority

7.3.1 Design Development Inputs
• Products requirements
• Statutory and regulatory requirements
• Results of contract review
• Competence requirements for people performing design
and development
• Feed back information from past experience

7.4 Purchasing
The organization shall establish
• Effective and effective purchasing process
• Criteria, based on which suppliers are selected and
evaluated.
They should include following –
• Evaluation of past experience with supplier
• Criteria for evaluating suppliers
• Audit of supplier management systems.

7.4.1 Purchasing Information

7.4.2 Verification of purchased product


7.5 Production and service provision in respect to-

• Choosing appropriate and competent Men
• Having documented (where required) Method
• Selecting appropriate – Machine
• Use of appropriate grade – Materials
• Monitoring and observing process at vital points through
Measurement.

7.5.1 Validation of Processes for production and
service provision

7.5.2 Identification and Traceability for the purpose of –

• Contractual requirement
• Organizations own requirements to take corrective
actions
• Legal/statuary requirement

7.5.3 Customer property
• Control of verification storage, maintenance of customer
supplied properly.

7.5.4 Preservation of Product

7.6 Control of Monitoring land measure device.

8. Measurement, Analysis and Improvement
Shall plan monitor, analyze and improve processes for –

• Production Evaluation
• Process Evaluation
• Customer Satisfaction
• Quality objectives

8.1 Monitoring and Measurement


8.2 Customer Satisfaction – include

• Customer and surveys
• Feed back on product
• Customer complaints
• Contract information
• Market needs
• Information relating to competition

8.2.1 Internal Audit (Quality)
8.2.2 Monitoring and Measurement Product


8.3 Control of non conforming product by –

• Rework to meet specified requirements
• Accepted as its under concession
• Regarded for alternative application
• Rejected or scrapped.

8.4 Analysis of Data
To achieve information for –
• Customer satisfaction
• Product characteristics
• Process capability/validation
• Suppliers

Results of such analysis can be useful to determine –
• Trends
• Effectiveness and efficiency processes
• Customer satisfaction
• Bench marking of its performances

8.5 Improvement

8.5.1 Continual Improvement

8.5.2 Corrective Action
To prevent re-occurrence of non conformities documented
procedures for -
• Identifying
• Analyzing &
• Taking corrective actions including those arising from
customer complaints


8.5.3 Preventive Action
• Action taken to prevent occurrence of potential non-
conformity

Some measures are –

• Institute reward system
• Cross functional, quality improvement teams
• Quality circles
• Kaizen Clubs

Route Certification
• Pre-Certification Requirement
Organizations interested

Should establish Quality Management System
Commitment from the top

Quality Manuals
Quantity Plans
Documents
Executive procedures
Work Instructions

• Quotation from different ISO certifying bodies
• Choice – based on - Market Target
• Preliminary Information - Sought by organization
• Application - in the prescribed form with fees.
• Pre-Assessment process:
- Detailed examination of the application to ensure
compliance.
- Correction – Amendments suggested
- Preliminary visit

After compliance
• Assessment Process
After intimating the dates and composition of the team is
advance

a) Introductory / opening meeting
b) Brief tour
c) Assessment execution
• Each member – accompanied by local guide
• Record Compliance
Non conformance
• Closing meeting and Report


Post Assessment Process
• Corrective Action - Minor noncompliance

• Certification
- Indicating conformance to specified standards
Valid for 3 years

Surveillance
Post certification surveillance visits
(Generally in once in six months) to verify maintenance of
QMS and continued requirements.

• Modification to scope of certification
• Suspension of Registration - for minor nonconformance
• Withdrawal of Registration
• For major nonconformance
• Appeals
• Renewal of Registration
- To apply 3 months before the expiry
- Fees
- Reassessment

Benefits of Q.M.S. Certification
A. To organizations
• Clearly indicates compliance with QMS standards
• Improves credibility and enhances customer confidence
• Reduces the need for multiple assessments
• Provides opportunity for continuous improvement through
regular audits
• Provides more avenues for trade in the global market
through bilateral agreements on mutual recognition of
certification.
B. To customers
• Assure continued capability of organization to meet the
requirements through regular surveillance
• Reduces the need for assessment of organizations
• Simplifies purchase procedures and decisions.

MALCOLM BALDRIDGE NATIONAL QUALITY AWARD
• Malcolm Baldridge National Quality Award was established
by U.S. Congress in 1987 to recognize U.S. companies for
their achievements in quality and business performance
and to raise awareness about the importance of quality and
performance excellence as competitive edge.
• The awards are not given to any specific products or
services.
• Three awards are given in the following categories.
- Manufacturing
- Service
- Small business
- Education
- Health care since 1999

Baldridge Criteria:
They are a frame work that any organization can use to
improve overall performance. Seven categories make up
the award criteria.
• Leadership
• Strategic Planning
Strategic Directions
Key Action Plans
• Customer and Market Focus
• Information and analysis
Management
Effective use of Data and Information
Analysis


• Human Resources Focus
• Process Management
• Business results:
In Key areas like Customer satisfaction
Financial
Market Place
Human Resources
Supplier - Partner
Operational

• Company‟s Performance in relation to competitors.

Selection

• Applications for the award are evaluated by an
independent Board of Examiners composed of primarily
private sector experts in quality and business.
Examiners look for achievements and improvements in
all seven categories.

• Each applicant receives a written summary of strengths
and areas for improvement in each area addressed by
the criteria.

Seven Criteria:

1. Leadership - 9%
2. Information Analysis - 8%
3. Strategic Quality Planning - 6%
4. HRD & HRM - 15%
5. Management of Process Quality - 14%
6. Quality and Operational Results - 18%
7. Customer Focus and Satisfaction - 30%
----------
Total 100%
======

INDIAN STANDARD ON QUALITY SYSTEMS
Bureau of Indian Standards
Indian Standards Manual was published

• IS 10201 (1982):
This descries the basic set of quality elements by which
the quality management systems could be developed
and implemented.
• IS 13999 (1990):
This defines the basic and fundamental terms relating to
the quality concepts, as they apply to the products and
services for the preparation and the use of quality
standards and to facilitate mutual understanding in
international communication.

• IS 14000 (1990):
Provides guidelines for the selection and the use of
series of Indian standards on quality systems that can be
used for internal quality management (IS 14004) as well
as external quality assurance purposes (IS 14001)
(IS 14002) and (IS 14003).

• IS 14004 (1990)
This standard together with IS 14000 provides guidance
to all organizations on quality management.
The standard helps in developing and implementing a
quality system as also determining the extent to which
each quality element is applicable

• IS 14001 (1990)
This standard is applicable when conformance to the
specified needs is to be assured by the supplier
throughout the whole cycle. From design through to
servicing.

• IS 14002 (1990)
This standard is for use when the specified requirements
for the products are stated in terms of an already
established design or specification. Only the suppliers‟
capabilities in production and installation are to be
demonstrated

Benefits:
• Industry would reap cost benefits by bringing down / elimination
failure at different stages.
• This would lead to customer satisfaction and better image of their
products.
• Purchasing parties require multiplicity of assessments. However,
with the introduction of a standard quality whose transparency
can be identified with reduction in the number of such
assessments. An assessment carried out by one of the
organizations is likely to be acceptable to several organizations,
when a standard is made use of for the purpose.
• Besides experts following a quality assurance system in line with
the International Standards would also be benefited.
• Satisfaction of the discerning customer in regard to both cost and
quality is the single most important criterion for the growth and the
long-term success of any organization and IS 14000 would have
a lions share of contribution in this direction.

Others
Deming’s Prize:
• Established in 1950
• Awarded by Juse - Japan Union of Scientists and Engineers
Includes 10 points called Deming Prize Check:
1. Policy
2. Organization and operation
3. Education and training
4. Collecting and using information
5. Analysis
6. Standardization
7. Control
8. Quality assurance
9. Effect
10. Planning for the factors


European Quality Award:

• Launched in Paris by EFQM - European Foundation for
Quality Management.

• Its aim is to recognize organizations who are paying
exceptional attention to quality management land to
encourage others to follow their example


9 Points Frame Work:

Enabling Factors Result Factors
1. Leadership - 8%
1. People Satisfaction - 9%
2. Policy and Strategy - 9%
2. Customer Satisfaction -20%
3. People Management - 9%
3. Impact on Society - 6%
4. Resources - 14%
4. Results - 15%
5. Process - 14%
-------
--------
Total 50%
Total 50%
=====
=====

The Process:

• The applicant has to address all criteria in the report.
• The assessors give scoring by detailed comments.
• The top surer after the first round are subject to site visit.
• There is a detailed code of conduct for the assessors.
• Actual situation compared and report is submitted to the
jury.

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