TQM PDF
TQM PDF
TQM PDF
UNIT-1 INTRODUCTION
Till 300 years ago, people used the power of their own muscles, animals or the force of wind and
flowing water to do all works. With the invention of the ‘steam engine’ they got a powerful method of
running their machines. This provided a tremendous boost to Industry. Goods started getting produced
in larger quantities using machines. This led to the beginning of the factory system. The significant
change from hand-made goods to machine-made goods, which began in Britain in 18th century, is known
as the Industrial Revolution. Why it was called Revolution? Because of the large scale changes it brought
about our economy, society and culture. IR soon spread to other nation like Germany, France, and
Portugal. As these countries became industrialized, they needed two things:
1. Raw materials for manufacturing and
2. New markets to sell the goods they made.
They found both raw materials as well as new markets to sell their goods in the non- industrialised
countries of Asia and Africa. So they started annexing to meet the needs of their new factories. Soon they
became jealous of each other, and wanted their own empires to grow. They started fighting among
themselves. This finally led to a great war in which several nations of the world were involved. It came
to be known as World War- I (August 1914-1918). Millions of soldiers and other people were killed or
wounded. Cities were destroyed and there was shortage of food and everything else. In 1939, there was
another war, called World War II. It lasted for 6 years and ended in 1945 after USA dropped atomic
bombs over two Japanese cities – Hiroshima and Nagasaki. After world war – II, most Japanese
companies had to start literally from Scratch. Everyday brought new challenges to managers and workers
alike, and everyday meant progress. They observed hard working ability and bringing new-new
technologies are not enough need a culture change towards “TOTAL COMMITMENT and TOTAL
IMPROVEMENT”. They also felled that human resource of Japan is highest important and precious but
they need more training for continuous development. Fortunately Japan called / invited American Experts
like Edward Deming, Joseph M.Juran and others in 1950s and early 1960s. In quality movement world
wide the Globalization took an important role in 2000. Due to transmission to open economy, a domestic
and international competition starts. Gradually TQM considered as the ultimatum for continuous
improvement and sustainable growth in present day business.
However, in 21 st century, high growth of economy- the new millennium brought about
increased emphasis on worldwide quality and the Internet. Japanese and other world’s business
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SK
SK
organization started not only for quality product and services for External customer satisfaction but
started satisfying them by trying to achieve the highest business excellence model – Deming Award,
Malcolm Baldrige National Quality Award, CII – EXIM Award and TPM Award and others. Thanks –
QUALITY
EVOLUTION OF QUALITY
1920s
Some of the first seeds of quality management were planted as the principles of scientific
management swept through U.S. industry.
Businesses clearly separated the processes of planning and carrying out the plan, and union
opposition arose as workers were deprived of a voice in the conditions and functions of their work.
The Hawthorne experiments in the late 1920s showed how worker productivity could be impacted
by participation.
1930s
Walter Shewhart developed the methods for statistical analysis and control of quality.
1950s
W. Edwards Deming taught methods for statistical analysis and control of quality to Japanese
engineers and executives.
Joseph M. Juran taught the concepts of controlling quality and managerial breakthrough.
Armand V. Feigenbaum’s book Total Quality Control, a forerunner for the present understanding
of TQM, was published.
Philip B. Crosby’s promotion of zero defects paved the way for quality improvement in many
companies.
1968
The Japanese named their approach to total quality companywide quality control.
Kaoru Ishikawa’s synthesis of the philosophy contributed to Japan’s ascendancy as a quality
leader.
Today
TQM is the name for the philosophy of a broad and systemic approach to managing organizational
quality.
Quality standards such as the ISO 9000 series and quality award programs such as the Deming
Prize and the Malcolm Baldrige National Quality Award specify principles and processes that
comprise TQM.
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DEFINITION OF QUALITY
If Q is greater than 1.0, then the customer has a good feeling about the product or service.
Performance
Features
Conformance
Reliability
Durability
Service
Response
Aesthetics
Reputation
All these nine dimensions can be clearly explained with the example of LCD projector.
These dimensions are somewhat independent therefore a product can be excellent in one
dimension and average or poor in another.
Therefore quality products can be determined by using a few of the dimensions of the quality.
Marketing has the responsibility of identifying the relative importance of each dimension of
quality.
These dimensions are then translated into the requirements for the development of a new product
or the improvement of an existing one.
DEFINITION OF TQM
Meaning
Total-Made up of the whole
Quality- Degree of excellence a product or service provides.
Management-Act, art or manner of handling, controlling, directing.
TQM FRAMEWORK
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It consist of
Gurus
Shewhart
Deming
Juran
Figenbaum
Ishikawa
Crosby
Taguchi
Customer Satisfaction
Employee Involvement
Supplier Partnership
Approach
Continuous Process Improvement
Measure
Performance measures
CONTRIBUTION OF DEMING
It should be clearly understood that mass inspection is for managing failure and defect
prevention is for managing success.
Stop Awarding Business Based on Price Alone:
The organization must stop awarding business based on the low bid because price has no
meaning without quality.
The goal is to have single suppliers for each item and to develop a long term relationship
of trust and loyalty, thereby providing improved products and services.
They must follow the materials throughout the life cycle in order to examine how
customer expectations are affected and provide feedback to the supplier regarding the
quality.
Improve Constantly and Forever the System:
Management must take more responsibility in actively finding and correcting problems,
so that quality and productivity are continually and permanently improved and costs are
reduced.
The focus is on preventing problems before they happen.
Responsibilities are assigned to the teams to remove the causes of the problems and
continually improve the process.
Institute Training:
Each employee must be oriented to the organizations philosophy of never ending
improvements.
Management must allocate resources to train their employees to perform their jobs in the
better manner.
Teach and Institute Leadership:
Improving Supervision in the organization is the management’s responsibility.
Management must appoint supervisors with training, so that the new philosophy can be
implemented.
Supervisors should create a positive and supportive work environment instead of
focusing on negative and fault finding atmosphere.
All communication must be clear from top management to supervisors to operators.
Drive out Fear, Create trust and Create a Climate for Innovation:
Management must encourage open, effective communication and team work.
Fear is caused because of lack of job security, possible physical harm, performance
appraisals, and ignorance of organization goals, poor supervision and not knowing the
job.
Driving out fear will lead to success, for this management must concentrate on workers
with adequate training, good supervision, and proper tools to do the job as well removing
physical dangers.
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When people are treated with dignity fear can be eliminated and they will work for the
general well being of the organization.
Optimize the efforts of teams, groups and staff areas:
Management must optimize the efforts of teams, groups and staff areas to achieve the
aims and purposes of the organization.
Internally the barriers exist among levels of management, among departments, within
departments and among shifts.
Externally it exists between the organization and its customers and suppliers.
The barriers exist because of poor communication, ignorance of organization mission and
it can be overcome by multifunctional team.
Eliminate Exhortations for the Workforce:
Exhortations that ask for increased productivity without providing specific improvement
methods can handicap an organization.
They do not produce better product or service because the workers are limited by the
system.
Improvements in the process cannot be made unless the tools and methods are available.
a. Eliminate Numerical Quotas for the Workforce:
Quotas and work standards focus on quantity rather than quality.
Instead of quotas, management must concentrate on methods of improvement.
They encourage poor workmanship in order to meet their quotas.
b. Eliminate Management by Objective:
Instead of management by objective, management must learn the capabilities of the
processes and how to improve them.
Management by numerical goal is an attempt to manage without knowledge of what to
do.
Remove Barriers that Rob People of Pride of Workmanship:
Loss of pride in workmanship exists throughout the organization because
Workers do not know how to relate to organizations mission
They are being blamed for system problems.
Poor designs lead to the production of junk.
Inadequate training is provided.
Punitive supervision exists.
Inadequate or ineffective equipment is provided for performing the required work.
Encourage Education and Self Improvement for Everyone:
When an organization needs is people who are improving with education, a long term
commitment to continuously train and educate people must be made by management.
Take Action to Accomplish the Transformation:
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Management has to accept the primary responsibility for the never ending improvement
of the process.
A cultural change is required from the previous “business as usual” attitude.
Management must be committed, involved and accessible if the organization is to
succeed in implementing the new philosophy.
CROSBY'S CONTRIBUTIONS
Philip Crosby, author of Quality is Free. Crosby emphasized meeting customer requirements by
focusing on prevention rather than correction.
14 Principles
1. Management commitment, that is, top level management must be convinced and committed and
communicated to the entire company.
2. Quality improvement team composed of department heads to oversee improvements.
3. Quality measurement is established for every activity.
4. Cost of quality is estimated to identify areas of improvement.
5. Quality awareness is raised among all employees.
6. Corrective action is taken.
7. Zero defects are planned for.
8. Supervisor training in quality implementation.
9. Zero defects day is scheduled.
10. Goal setting for individuals.
11. Error causes are removed by having employees informed management of problems.
12. Recognition is given, but it is non-financial, to those who meet quality goals.
13. Quality councils meet regularly.
14. Do it all over again (i.e., repeat steps one through thirteen).
CONTRIBUTION OF JURAN
Juran’s Triology
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Quality Planning
Quality Control
Quality Improvement
Quality Planning:
The planning component begins with external customers.
Once the quality goals are established, marketing determines the external customers and all
organizational personnel (managers, members of multifunctional teams or work groups)
determine the internal customer.
Once the customers are determined, their needs are discovered.
Customer needs has to be stated in their own words, however real needs may differ from stated
needs.
Internal customers may not wish to voice real needs out of fear of the consequences.
The customer needs which are stated in their view point should be translated to requirements
that are understandable to the organization and its suppliers.
The next step is to develop the product/service features that respond to customer needs, meet the
needs of organization and its suppliers.
The fourth step is to develop the processes able to produce the product or service features.
Transferring plans to operations is the final step of the planning process.
Quality Control:
Control is used by operating forces to help meet the product, process and service requirements.
Steps:
Determine items/subjects to be controlled and their units of measure.
Set goals for control and determine what sensors need to be put in place to measure the product,
process or service.
Measure actual performance.
Compare actual performance to goals.
Act on the difference.
Quality Improvement:
Aim is to attain the levels of performance that are significantly higher than current levels.
Process improvements begin with the establishment of quality council.
Two duties of quality council
Identify the improvement projects
Establish the project teams with a project owner.
Quality council needs to provide the teams with resources to determine the causes, create
solutions and establish controls to hold the gains.
In the figure juran provides a distinction between sporadic waste and chronic waste
Sporadic waste can be identified and corrected through quality control.
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Improvement Strategies:
Repair
Refinement
Renovation
Reinvention
Repair:
This strategy is simple; if anything is broken it must be fixed so that it functions as designed.
If a customer receives a damaged product, a quick fix is required.
The second level is to identify and eliminate the root causes of the problem and effects a
permanent solution.
Repair strategy does not make the process better than the original design.
Refinement:
Improvements to processes, products and services are accomplished on an incremental basis.
Refinement improves efficiency and effectiveness.
The change may be so gradual that there is no appearance of change.
The primary benefit of gradual change is that it produces little resistance from employees.
Renovation:
This strategy results in major or breakthrough improvements.
Innovation and technological advancements are key factors in this approach.
Eg: Rechargeable batteries
Reinvention:
Renovation is the most demanding improvement strategy.
It is preceded by the feeling that the current approach will never satisfy customer requirements.
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A new product, service, process or activity is developed using teams based on a complete
understanding of the customer requirements and expectations.
Types of Problems:
Compliance
Unstructured
Efficiency
Process design
Product design
BARRIERS TO TQM
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UNIT-II
TQM PRINCIPLES
LEADERSHIP
Definition:
Leadership has been described as the “process of social influence in which one person can enlist the aid and
support of others in the accomplishment of a common task”.
Alan Keith: "Leadership is ultimately about creating a way for people to contribute to making something
extraordinary happen."
Ken "SKC" Ogbonnia: "effective leadership is the ability to successfully integrate and maximize available
resources within the internal and external environment for the attainment of organizational or societal goals."
Ann Marie E. McSwain: “leadership is about capacity: the capacity of leaders to listen and observe, to use their
expertise as a starting point to encourage dialogue between all levels of decision-making, to establish processes
and transparency in decision-making, to articulate their own values and visions clearly but not impose them.
Leadership is about setting and not just reacting to agendas, identifying problems, and initiating change that makes
for substantial improvement rather than managing change.”
These three definitions talk about certain common things. They are resources, utilization of resources, managing
constraints and getting extraordinary results. These definitions also talk about motivating people to work in
unison to create results.
Concepts of Leadership
1. Be Proactive: Proactive people think beforehand and are ready to face a situation. Reactive people react as per
the situation and react on whims and emotions. A proactive person can plan beforehand for an eventuality. If you
are well prepared then you can face a situation or solve a problem more efficiently.
2. Begin with the end in Mind: “If you don’t know where to go then you will reach nowhere” goes an old saying.
Start a task with set goals. Goals are important as they tell you where to go. They help in focusing your approach
as well. Remember the famous incident from Mahabharata where Guru Dronacharya asks his disciple about what
they could see during target practice. Arjuna gives the most perfect answer as he was focusing on the target.
Because of his focused approach Arjuna became one of the best archers of his time.
3. Put First Things First: Because of multitude of tasks and assignments one needs to prioritize. This helps in
giving more attention to more important things at hand.
4. Think win-win: Think about mutual benefits rather than your own benefit alone. Everybody wants to have an
upper hand in life and in business dealings. But this is practically not possible. So best way is to find is the middle
of the road.
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5. Seek first to understand, then to be understood: First give other people ample time to express themselves.
This will help on many fronts. The other person gets enough opportunity to say what he wants to say. You get an
opportunity to understand other’s perspective. You get enough time to strategize accordingly.
6. Synergy: The best example of team work can be learnt from a pleasant orchestra or ‘jugalbandi’ in Indian
classical music. Especially in Indian classical music you will observe how maestros bury their egos and come out
with astounding performances.
7. Sharpen the Saw: Skill building or practice is very important. Nobody is perfect and perfection is a thing
which can never be achieved in one’s lifetime. Moreover, it always pays to practice as much as you can.
1. Customer needs: The first step is to discover the future needs of the customers. Who will they be? Will your
customer base change? What will they want? How will the organization meet and exceed expectations?
2. Customer positioning: Next, the planners determine where the organization wants to be in relation to the
customers. Do they want to retain, reduce, or expand the customer base? Products or services with poor quality
performance should be targeted for breakthrough or eliminated. The organization needs to concentrate its efforts
on areas of excellence. No two individual is same, so every type of customer should be treated as per his/her
profile. You cannot sell a premium product to a price conscious customer.
3. Predict the future: Next, the planners must look in to their crystal balls to predict future conditions that will
affect their product or service. Demographics, economic forecasts and technical assessments or projections are
tools that help predict the future.More than one organizations poduct or service has become obsolete because it
failed to foresee the changing technology. If the top management can foresee the future then it helps enable the
organization to prepare for future changes. Let us take example of SONY. With rapid change in technology SONY
has changed its product portfolio, so it is now MP3 player instead of Walkman which we get from SONY.
4. Gap analysis: Gap analysis is about the difference between what needs to be done and what are we currently
doing. It can give a clue about whether the organization should increase or decrease capacity for a particular
product.
5. Closing the gap: If there are gaps then long term plans should be about how to fill that gap.
6. Alignment (with vision and mission): Whatever quality goals an organization is chalking out it should not
lose focus from the long term vision and mission of the organization.
7. Implementation: Once every plan about goals is ready then the next step should be to plan about the
methodologies of implementation.
QUALITY STATEMENTS
The quality statements include the
1. Vision statement
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2. Mission statement and
3. Quality policy statement.
Once developed, they are only occasionally reviewed and updated.
They are the part of the strategic planning process.
The utilization of the three statements varies considerably from organization to organization.
Vision Statement
- The vision is a short declaration of what an organization aspires to be tomorrow.
- It is the ideal state that might never be reached but which we continually strive to achieve.
- Successful visions are timeless, inspirational and become deeply shared within the organization.
- Successful vision provides a guide line for decision making.
- It is important that the leader articulate and act upon the vision and those employees understand
the vision and can connect their work with the well-being of the organization.
Mission Statement
- The mission statement answers the following questions: who we are, who are the customers, what
we do, and how we do it.
- This statement is usually one paragraph or less in length, is easy to understand and describes the
function of the organization.
- It provides a clear statement of purpose for employees, customers and suppliers.
Quality Policy Statement
- The quality policy is a guide for everyone in the organization as to how they should provide
products and services to the customers.
- It should be written by the CEO with feedback from the workforce and be approved by the quality
council.
- Common Characteristics are
Quality is first among equals
Meet the needs of the internal and external customers
Equal or exceed the competition
Continually improve the quality
Include business and production practices
Utilize the entire workforce
CUSTOMER SATISFACTION
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Customers are important asset to the organization, satisfied customers will buy more, and buy
more frequently, and pay their bill promptly.
In a manufacturing and service organization, customer satisfaction is considered as a measure of
quality.TQM implies an organizational drive with meeting or exceeding customer needs.
Understanding the customer's needs and expectations is essential to winning new business.
To attain this level, the organization should examine their quality system to respond to their ever
changing customer's needs.
Types of customers.
1. Internal customers - each of them receives a product or service and in exchange, providers a product or
service.
2. External customers - one who uses the product or service, the one who purchase the product, or the who
influences the sale of the product.
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3.Service
4. Warranty
5. Price
6. Reputation.
CUSTOMER COMPLAINTS
Unlike the customer's feedback the customer complaints are reactive, and they are important in gaining
data on customer perceptions.
A dissatisfied customer can easily become a lost customer because of their frustrations. This customer
dissatisfaction becomes a measure for organizational process improvement measures.
Every single complaint should be accepted, analyzed, and acted upon to again win over customer's
confidence. Since more than 50% of the dissatisfied customers will buy again if they are complaint has
been heard and resolved.
By adopting a positive approach the complaints can be seen as an opportunity to obtain information and
provide a positive service to the customer.
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Handling the customer complaints
1. Investigate customer's experiences by actively receiving the customer feedback and then acting
promptly.
2. Develop procedures for complaint resolution that include empowering front-line employee.
3. Analyze complaints; try to put them in a category for speedy response.
4. Work to identify process and material variations and then eliminate the root cause.'more inspection' is
not a corrective action.
5. After receiving the response, a senior manager should contact the customer and strive top resolve the
concern
6. Establish customer satisfaction measures and constantly monitor them
7. Communicate complaint information, as well as the results of all inquiries and solutions, to all people
in the organization.
8. Provide a monthly complaint report to the quality council for their evaluation and if needed, the
assignment of process improvement teams.
9. Identify customer's expectations in advance rather than afterward through complaint analysis.
CUSTOMER RETENTION
Customer retention represents the activities that produce the necessary customer satisfaction which in
turn creates the customer loyalty.
Customer retention moves customer satisfaction to the next level by determining what is truly important
to the customers and making sure that the customer satisfaction system focuses valuable resources on
things that are important to the customer.
Customer retention is the connection between customer satisfaction and the bottom line.
World-class companies know that continuous improvement and customer satisfaction should go hand-
in-hand.
Improved service to the customer is a costlier affair, so an organization must determine its return on the
service investment. For this the important service elements that significantly improve revenues and
market share should be determined.
One survey indicates, it requires five times of effort to win a new customer than retaining a present
customer. In this context customer retention is important for organizational success.
EMPLOYEE INVOLVEMENT
Japanese management emphasizes the need to consider employee as a valuable resources rather than
treating them as a mere tools for production.
Employee involvement is one approach to improve quality and productivity.
It is not an replacement for management nor is it the final word in quality improvement, it aims at better
meeting of organizational goals at all levels.
1.MOTIVATION
Knowledge of motivation helps us to understand the utilization of employee involvement to achieve process
improvement.
Theories of Motivation
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He explained the motivation in terms of a hierarchy of needs and that there were five levels.
These are survival, security, social, esteem, and self-actualization.
It is important to note that as employees move up the hierarchy, they will immediately revert back to the
previous level if they feel threatened.
Hertzberg extends the Maslow's theory by using empirical research oin employee motivation.
He found that people were motivated by the motivators (intrinsic factors) like recognition,
responsibility, achievement, advancement and the work itself.
In addition he found that bad feelings were associated with preventable dissatisfiers or hygiene factors
(extrinsic factors) like low salary, minimal fringe benefits, poor working conditions, ill-defined
organizational policies and mediocre (ordinary) supervision.
He also explained that the presence of extrinsic factors (for example good working condition) does not
produce any motivation but their absence will create dissatisfaction among employees.
In a same manner the absence of intrinsic factors (for example advancement) does not produce any
dissatisfaction but their presence will provide strong level of motivation.
2.EMPOWERMENT
The dictionary meaning of the term empowerment is to invest people with authority. Its purpose is to tap the
enormous potential that lies within every worker.
Empowerment is nothing unusual; people generally want to be more in charge of their own jobs and carriers.
After all, they do that successfully in their personal lives every day. Most people appreciate and value the trust
and responsibility. This empowerment helps greatly in eliminating resistance to changes.
Empowerment is different from delegation or job enrichment, which means distributing or entrusting work to
others. In empowerment employee is held responsible for accomplishing a whole task.i.e. Employee becomes
process owner, thus not only responsible but also accountable.
3. TEAMS
Teams are very effective in solving all quality and productivity problems.
Team is defined as a group of people working together to achieve common objectives or goals.
Teamwork is the cumulative actions of the team during which each member of the team subordinates his
interests and opinions to fulfill the objectives or goals of the group.
Many heads are better than one, especially in meeting ever-changing customer needs.
Each member of the team have special ability that can be used for the problem. Many processes are so
complex that one person cannot able solve completely.
Based on the synergic effect, whole is greater than sum of its parts. Team work is better than sum of its
member contribution.
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Team builds a rapport with each other that allows everyone to do a better job.
Teams provide the vehicle for improved communication.
Types of teams
· Process improvement teams
· Cross-functional teams
· Natural work teams
· Self-directed/ self managed teams
Recognition Includes
Pictures on the bulletin board
Articles in newsletters or newspapers
Letters to families
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Making a presentation to management
Passing along compliments from others
Personal phone calls or notes
Placing positive notes in folders
Increased responsibility
Rewards
Individual Rewards
Better parking space
Dinner out
Gift certificates
Gift to charity in the name of the recipient
Washing an employee’s car during lunch hour
Trips
Event tickets
Group Rewards
Includes an outing such as a ball game, bowling and movies
Group lunch or dinner
“Cash awards are also effective motivators for individual and team awards.”
5. PERFORMANCE APPRAISAL
The purpose of performance appraisal is to let employees know how they are doing and provide a basis
for promotions, salary increases, counseling and other purposes related to an employee’s future.
There should be a good relationship between the employee and the appraiser.
Employees should be made aware of the appraisal process, what is evaluated and how often.
Employees should be told how they are doing on a continuous basis and not just at appraisal time.
The appraisal should point out strengths and weaknesses as well as how performance can be improved.
Appraisal nourish short term performance and destroy
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Everyone in the organization is involved in a systematic, long term endeavor to constantly improve
quality by developing processes that are customer oriented, flexible and responsible.
5S PRINCIPLE
SEIRI - Tidiness
SEITON - Orderliness
SEISO - Cleanliness
SEIKETSU-Standardization
SHITSUKE - Sustaining the discipline or self-discipline
KAIZEN
Value added and non-value added work activities.
Muda: which refers to seven classes of waste-overproduction, delay, transportation, processing,
inventory, wasted motion and defective parts
Principles of motion study and the use of cell technology.
Documentation of standard operating procedures.
The five S’s for workplace organization.
Visual management by means of virtual displays that everyone in the plant can use for better
communication.
Just in time principles to produce only the units in the right quantities at the right time and with the right
resources.
POKA-YOKE to prevent or detect errors.
Team dynamics, which includes problem solving, communication skills and conflict resolution.
SUPPLIER PARTNERSHIP
Partnering is a long term commitment between two or more organizations for the purpose of achieving
specific business goals and objectives by maximizing the effectiveness of each participant’s resources.
Sourcing
Sole
Multiple
Single
Supplier Rating
It is based on
Quality
On time delivery
Service
Internal Structure
Review reports
Customer satisfaction
Example: General Motors uses the traffic light to rate their suppliers
Red- Problem
Yellow- Potential Problem
Green - Ok
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Relationship Development
The previous topics contribute to the establishment of the relationship and inspection, training, teams,
recognition and reward contribute to the maintainability and growth of the relationship
1. Inspection
The goal of inspection is to eliminate, substantially reduce or automate the inspection activity.
4 phases of inspection
100% inspection
Sampling
Audit
Identity check
2. Training
3. Team approach
4. Recognition
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UNIT III
TQM TOOLS AND TECHNIQUES
THE SEVEN TRADITIOAL TOOLS OF QUALITY
OR
STATISTICAL PROCESS CONTROL
Statistical process control (SPC) is the application of statistical methods to the monitoring and control of a process
to ensure that it operates at its full potential to produce conforming product. Under SPC, a process behaves
predictably to produce as much conforming product as possible with the least possible waste.
Seven Tools:
Pareto Diagram
Process Flow Diagram
Cause and Effect diagram
Check sheets
Histogram
Scatter diagram
Control charts
1. PARETO DIAGRAM:
The Pareto diagram is a graphical overview of the process problems, in ranking order of the most
frequent, down to the least frequent, in descending order from left to right.
Thus, the Pareto diagram illustrates the frequency of fault types.
Using a Pareto, you can decide which fault is the most serious or most frequent offender.
The basic underlying rule behind Pareto's law is that in almost every case, 80% of the total
problems incurred are caused by 20% of the problem cause types; such as people, machines, parts,
processes, and other factors related to the production of the product.
Therefore, by concentrating on the major problems first, you can eliminate the majority of your
problems.
The few items that have the largest amount of occurrence is your more frequent problem, than are
the many items that only happen once in a while. This is called the "vital few over the trivial
many" rule.
Quite often, once you cure several of the "big hitters" you also eliminate some of the smaller
problems at the same time.
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4. CHECK SHEETS:
The check sheet is a simple document that is used for collecting data in real-time and at the location
where the data is generated.
The document is typically a blank form that is designed for the quick, easy, and efficient recording of
the desired information, which can be either quantitative or qualitative. When the information is
quantitative, the check sheet is sometimes called a tally sheet.
A defining characteristic of a check sheet is that data is recorded by making marks ("checks") on it.
A typical check sheet is divided into regions, and marks made in different regions have different
significance.
Data is read by
observing the location and
number of marks on the sheet.
5.HISTOGRAM:
A graphical representation, similar to a bar chart in structure, that organizes a group of data points into
user-specified ranges.
The histogram condenses a data series into an easily interpreted visual by taking many data points and
grouping them into logical ranges or bins.
Histograms are commonly used in statistics to demonstrate how many of a certain type of variable
occurs within a specific range. For example, a census focused on the demography of a country may use a
histogram of how many people there are between the ages of 0 and 10, 11 and 20, 21 and 30, 31 and 40,
41 and 50 etc.
6. SCATTER DIAGRAM:
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A scatter diagram is a tool for analyzing relationships between two variables.
One variable is plotted on the horizontal axis and the other is plotted on the vertical axis.
The pattern of their intersecting points can graphically show relationship patterns.
Most often a scatter diagram is used to prove or disprove cause-and-effect relationships.
7) CONTROL CHART:
A statistical tool to determine if a process is in control.
Control charts that factor in the quality attributes of a process to determine if the process is performing in
or out of control.
Types:
• P chart
• C Chart
• U Chart
P Chart: a chart of the percent defective in each sample set.
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C chart: a chart of the number of defects per unit in each sample set.
U chart: a chart of the average number of defects in each sample set.
Reasons for using Control Charts:
• Improve productivity
• Make defects visible
• Determine what process adjustments need to be made
• Determine if process is “in” or “out of control
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2. Interrelationship Digraph:
This tool displays all the interrelated cause-and-effect relationships and a factor involved in a complex
problem and describes desired outcomes.
The process of creating an interrelationship digraph helps a group analyze the natural links between
different aspects of a complex situation.
The interrelationship diagraph clarifies the interrelationship of many factors of a complex situation.
It allows the team to classify the cause and effect relationships among all the factors so that the key
drivers and outcomes can be used to solve the problem.
A relationship diagram allows a team to identify root causes from subjective data , systematically
explores cause and effect relationship, encourages member to think multi directionally and develops
team harmony and effectiveness
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A concern with a high number of output arrows is a driver or key cause. A key cause affects a large number of
other items. The above diagram shows the following key causes:
Poor scheduling practices’ (6 outgoing arrows),
Late order from customer’ (5 outgoing arrows), and
Equipment breakdown (3 outgoing arrows).
A concern with a large number of input arrows is affected by a large number of other concerns. Thus, it could
be a source of a quality or performance metric. ‘Poor scheduling of the trucker’ has 4 input arrows.
3. Tree Diagram:
This tool is used to break down broad categories into finer and finer levels of detail
This tool is used to reduce any broad objective in to increasing levels of detail in order to achieve the
objective.
The procedure is to first choose an action oriented objective statement from the interrelationship
diagraph, affinity diagram, and brainstorming.
Second using brainstorming chooses the major headings.
The third step is to generate the next level by analyzing the major headings.
Ask “What needs to be addressed to achieve the objective? Repeat this question at each level.
Three levels below the objective are usually sufficient to complete the diagram and make appropriate
assignments.
The diagram should be reviewed to determine if these actions will give the results anticipated or if
something has been missed.
The tree diagram encourages team members to think creatively, makes large projects manageable and
generates a problem solving atmosphere.
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4.Matrix Diagram:
The matrix diagram allows individuals or teams to identify, analyze and rate the relationship among two
or more variables.
QFD is the best example of the use of matrix diagram.
There are 5 standard formats
L-Shaped(2 Variables)
T-Shaped(3Variables)
Y-Shaped(3Variables)
C-Shaped(3 Variables)
X-Shaped(4 Variables)
The procedure for the diagram is to first select the factors affecting a successful plan.
Select the appropriate format Eg: L-Shaped
Next step is to determine the relationship symbols
Any symbols can be adopted provided the diagram contains a legend.
Numerical values are sometimes associated with the symbol as we have seen in QFD.
The last step is to complete the matrix by analyzing each cell and inserting the appropriate symbol.
The matrix diagram clearly shows the relationship of the two variables.
It encourages the team to think in terms of relationships, their strength and any patterns.
5. Prioritization Matrices:
This tool is used to prioritize items and describe them in terms of weighted criteria.
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It uses a combination of tree and matrix diagramming techniques to do a pair-wise evaluation of items
and to narrow down options to the most desired or most effective.
This tool prioritizes issues, tasks and characteristics based on weighted criteria.
Once prioritized effective decisions can be made.
Use AV person
Have substitute Use time
keeper
Have back-
7. Activity Network Diagram:
up
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A project network is a graph (flow chart) depicting the sequence in which a project's terminal
elements are to be completed by showing terminal elements and their dependencies.
The work breakdown structure or the product breakdown structure show the "part-whole" relations. In
contrast, the project network shows the "before-after" relations.
The most popular form of project network is activity on node, the other one is activity on arrow.
The condition for a valid project network is that it doesn't contain any circular references.
Project dependencies can also be depicted by a predecessor table. Although such a form is very
inconvenient for human analysis, project management software often offers such a view for data entry.
An alternative way of showing and analyzing the sequence of project work is the design structure
matrix.
SIX SIGMA
Six Sigma is a business management strategy originally developed by Motorola, USA in 1986. Six Sigma
seeks to improve the quality of process outputs by identifying and removing the causes of defects (errors)
and minimizing variability in manufacturing and business processes.
It uses a set of quality management methods, including statistical methods, and creates a special
infrastructure of people within the organization ("Black Belts", "Green Belts", etc.) who are experts in
these methods.
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Each Six Sigma project carried out within an organization follows a defined sequence of steps and has
quantified financial targets (cost reduction and/or profit increase). A six sigma process is one in which
99.99966% of the products manufactured are statistically expected to be free of defects (3.4 defects per
million).
SIX SIGMA IS SEVERAL THINGS
• A statistical basis of measurement: 3.4 defects per million opportunities
• A philosophy and a goal: as perfect as practically possible
• A methodology
• A symbol of quality
SIGMA VALUES
Six Sigma projects follow two project methodologies inspired by Deming's Plan-Do-Check-Act Cycle.
These methodologies, composed of five phases each, bear the acronyms DMAIC and DMADV.
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Define the problem, the voice of the customer, and the project goals, specifically.
Measure key aspects of the current process and collect relevant data.
Analyze the data to investigate and verify cause-and-effect relationships. Determine what the relationships
are, and attempt to ensure that all factors have been considered. Seek out root cause of the defect under
investigation.
Improve or optimize the current process based upon data analysis using techniques such as design of
experiments, poka yoke or mistake proofing, and standard work to create a new, future state process. Set up
pilot runs to establish process capability.
Control the future state process to ensure that any deviations from target are corrected before they result in
defects. Implement control systems such as statistical process control, production boards, visual workplaces,
and continuously monitor the process.
DMADV or DFSS
The DMADV project methodology, also known as DFSS ("Design For Six Sigma"), features five phases:
Define design goals that are consistent with customer demands and the enterprise strategy.
Measure and identify CTQs (characteristics that are Critical to Quality), product capabilities, production
process capability, and risks.
Analyze to develop and design alternatives, create a 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 the production process and hand it over to the process
owner(s).
IMPLEMENTATION:
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Six Sigma identifies several key roles for its successful implementation.
Executive Leadership includes the CEO and other members of top management. They are responsible for
setting up a vision for Six Sigma implementation. They also empower the other role holders with the
freedom and resources to explore new ideas for breakthrough improvements.
Champions take responsibility for Six Sigma implementation across the organization in an integrated
manner. The Executive Leadership draws them from upper management. Champions also act as mentors to
Black Belts.
Master Black Belts, identified by champions, act as in-house coaches on Six Sigma. They devote 100% of
their time to Six Sigma. They assist champions and guide Black Belts and Green Belts. Apart from
statistical tasks, they spend their time on ensuring consistent application of Six Sigma across various
functions and departments.
Black Belts operate under Master Black Belts to apply Six Sigma methodology to specific projects. They
devote 100% of their time to Six Sigma. They primarily focus on Six Sigma project execution, whereas
Champions and Master Black Belts focus on identifying projects/functions for Six Sigma.
Green Belts are the employees who take up Six Sigma implementation along with their other job
responsibilities, operating under the guidance of Black Belts.
Some organizations use additional belt colors, such as Yellow Belts, for employees that have basic training in
Six Sigma tools and generally participate in projects and 'white belts' for those locally trained in the concepts
but do not participate in the project team.
BENCHMARKING
Benchmarking is a systematic method by which organization can measure themselves against the best
industry practices.
It provides superior performance by providing an organized framework through which organizations
learn how the “best in class” do things, understand how these best practices differ from their own and
implement change to close the gap.
The essence of benchmarking is the process of borrowing ideas and adapting them to gain competitive
advantage.
It is a tool for continuous improvement.
Definition:
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Reasons to benchmark:
To achieve business and competitive objectives.
To develop organization strengths and reduce weaknesses.
To inspire mangers to compete
It allows goals to be set objectively based on external information
Benchmarking is time and cost efficient because the process involves imitation and adaptation rather
than pure invention.
It provides a working model of an improved process which reduces some of the planning, testing and
prototyping efforts.
Process:
Six steps:
Decide what to benchmark
Understand current performance
Plan
Study others
Learn from the data
Use the findings
Step 1: Decide what to benchmark
Most organizations have a strategy that defines how the firm wants to position itself and compete in the
market place.
This strategy is usually expressed in terms of mission and vision statement.
Supporting these statements is a set of critical activities which the organization must do successfully to
realize its vision.
They are often referred as “critical success factors”
Broad and shallow:
What is done?
Broad and shallow studies are useful in developing strategies, setting goals and reorganizing
functions to be more effective.
Narrow and Deep:
How it is done?
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It is useful in changing how people perform their jobs.
Step 2: Understanding Current Performance
To compare outside practices, it is necessary to thoroughly understand and document the current
process.
Attention must be paid to inputs and outputs.
The benchmarking team should be comprised of those who won or work in the process to ensure
suggested changes are actually implemented.
When documenting the process it is important to quantify it.
Units of measure must be determined.
These are the key metrics that will be compared during the benchmarking investigation.
Common examples are unit costs, hourly rates, asset measures and quality measures.
Step 3: Planning
Once internal processes are understood and documented it is possible to make decisions about how to
conduct the study.
Benchmark planning is a learning process.
The first is to use the information that are available in the public domain to focus the inquiry and to find
appropriate benchmark partners.
3 types of benchmarking
Internal
Competitive
Process
Internal-internal comparisons have several advantages, data are easy to obtain because problems of
confidentiality does not exist.
Competitive-product competitors are an obvious choice to benchmark. An organizations survival
depends on its performance relative to the competition.
Process-process benchmarking is sometimes known as functional or generic benchmarking.
Step 4: Studying others
Benchmarking studies look for two types of information: descriptions of how best in class processes are
practiced and the measurable results of these practices.
In seeking this information bench markers can use internal sources , data in the public domain, original
research or most likely a combination of sources.
When most people of benchmarking they generally think of conducting original research through site
visits and interviews.
This is not always necessary and some organizations find industrial tourism a waste of time.
Three techniques for conducting original research are questionnaires, site visits and focus groups.
Step 5: Learning from the data
Is there a gap between the organizations performance and the performance of the best in class
organizations?
What is the gap? How much is it?
Why is there a gap? What does the best in class do differently that is better?
If the best in class practices were adopted what would be the resulting improvement?
Benchmarking studies can reveal three different outcomes
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External processes may be significantly better than internal processes( a negative gap)
Process performance may be approximately equal(parity)
The internal process may be better than that found in external organizations(positive gap)
Negative gap calls for a major improvement effort
Parity requires further investigation to determine if improvement opportunities exist.
Positive gap should result in recognition for the internal process.
When best in class processes have been described and quantified, additional analysis is necessary to
determine the root causes of the gaps.
Step 6: Use the findings
When a benchmark study reveals a negative gap in performance, the objective is to change the process
to close the gap.
Benchmarking is a waste of time if change does not occur as a result.
FAILURE MODE AND EFFECT ANALYSIS (FMEA)
FMEA is an analytical technique that combines the technology and experience of people in identifying
foreseeable failure modes of a product or process and planning for its elimination.
FMEA is a “before the event” action requiring a team effort to easily and inexpensively alleviate
changes in design and production.
Types:
Design FMEA
Process FMEA
Reliability:
Reliability is one of the most important characteristics of any product, no matter what its application.
It is also an important aspect when dealing with customer satisfaction, whether the customer is internal
or external.
Customers want a product that will have a relatively long service life, with long times between failures.
Reliability may be defined as the probability of the product to perform as expected for a certain period
of time, under the given operating conditions and at a given set of product performance characteristics.
Types of failures:
i. Debug
ii. Chance
iii. Wear out
Debug- includes a high failure rate at the initial stages because of inappropriate use or flaws in the design or
manufacturing.
Chance-is the failure of the product due to accidents, poor maintenance or limitations on the design.
Wear out-covers failure after the product or process has performed as expected for at-least the time given by
the manufacturer as the product or process life. A successful design or product should ideally fail only in this
last method.
Intent of FMEA:
When acquiring new machines, creating a new product or even modifying an existing product, it is
always necessary to determine the product or process.
One of the most powerful methods available for measuring the reliability of the process or product is
FMEA.
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FMEA can be implemented both in design and process areas as it basically involves the identification of
the potential failure modes and the effect of those on both the internal and external customers.
FMEA attempts to detect the potential product related failure modes.
The technique is used to anticipate the causes of failure and prevent them from happening.
In order to make FMEA as successful, it is extremely important to treat the FMEA as a living document,
continually changing as new problems are found and being updated to ensure that the most critical
problems are identified and addressed quickly.
One purpose of FMEA is to compare the design characteristics relative to the planned manufacturing or
assembly methods to make certain that the product meets the customer requirements.
Corrective action should begin as soon as failure mode is identified.
Consumers today are far more particular than they have been in the past, demanding products of the
highest quality for the lowest possible cost.
FMEA also allows the engineer to keep a record of all thoughts and actions taken to ensure a safe and
reliable product.
FMEA Team:
The FMEA methodology is a team effort where the possible engineer involves assembly, manufacturing,
materials, quality, service, supplier and the customer.
The team leader has certain responsibilities, which include determining the meeting time and place,
communicating with the rest of the team, coordinating with the rest of the team, coordinating corrective
action assignment and follow-up, keeping files and records of FMEA forms, leading the team through
completion of the forms, keeping the process moving and finally drawing everyone in to participation.
There also should be a recorder who records the results on the form and distributes to participants in a
timely manner.
Stages of FMEA:
There are four stages of FMEA
Specifying Possibilities
Functions
Possible Failure Modes
Root Causes
Effects
Detection/Prevention
Quantifying Risk:
Probability of Cause
Severity of Effect
Effectiveness of Control to Prevent cause
Risk Priority Number
Correcting High Risk causes
Prioritizing Work
Detailing Action
Assigning Action Responsibility
Check Points on completion
Re-evaluation of Risk:
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Recalculation of Risk Priority Number
FMEA DOCUMENTATION
The Design FMEA document
The top section in the form is used mainly for document tracking and organization.
1. FMEA Number: On the top left corner of the document is the FMEA number, which is only needed for
tracking
2. Item: The item space is used only to clarify which exact component or process is being analyzed.
3. Design Responsibility: The team in charge of the design or process should be included. The name and
company of the person or group responsible for preparing the document should be included.
4. Prepared By: The name, telephone number and address should be included.
5. Model number/Year: Both the name and identification number of the system, sub-system or component
should be included to avoid confusion between similar components.
6. Key Date: The date the initial FMEA is due should be placed.
7. FMEA date: The date the original FMEA was complied and the latest revision date should be placed in the
FMEA date space.
8. Core Team: The names of the responsible individuals and departments that have authority to perform tasks
should be listed.
9. Item/Function: The name and number of the item being analyzed is recorded here. This information should
be as precise as possible to avoid confusion involving similar items. Next the function of the item is to be
entered here.
10. Potential failure Mode: It may be the method in which the item being analyzed may fail to meet the design
criteria.
11. Potential Effects of Failure: It is the effect of failure as perceived by the customer. The effects of failure
must be described in terms of what the customer will notice or experience in the product.
12. Severity: Severity is the assessment of the seriousness of the effect of the potential failure mode to the next
component, subsystem, system or customer if it occurs.
13. Classification: This column is used to classify any special product characteristics for components,
subsystems or systems that may require additional process controls.
14. Potential Causes/ Mechanisms of Failure: The failure modes may have more than one cause or
mechanism of failure, each of these must be examined and listed separately. Then each of these causes must be
reviewed with equal weight.
15. Occurrence: Occurrence is the chance that one of the specific cause/mechanism will occur.
16. Current Design Controls: It consist of prevention measures, design validation and design verification.
17. Detection: It is a relative measure of the assessment of the ability of the design control to detect either a
potential cause/mechanism before the component, subsystem or system is completed for production.
18. Risk Priority Number (RPN): RPN= (S) * (O) * (D)
19. Recommended Actions: After every concern has been examined and given a risk priority number, the team
should begin to examine the corrective actions that may be employed, beginning with the greatest RPN and
moving to descending RPN number
20. Responsibility and Target Completion dates: Here the individual or group responsible for the
recommended actions and the target completion date should be entered.
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21. Actions Taken: After an action has been implemented, a brief description of the actual action and its
effective date should be entered.
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UNIT-IV
Introduction:
Quality Function Deployment (QFD) is a planning tool used to fulfill customer expectations.
It is a disciplined approach to product design, engineering and production and provides in-depth
evaluation of a product.
QFD focuses on customer expectations or requirements often referred to as the voice of the customer.
It is employed to translate customer expectations in terms of specific requirements, in two directions and
actions, in terms of engineering or technical characteristics that can be deployed through
Product planning
Part development
Process Planning
Production Planning
Service Industries
QFD Team:
When an organization decides to implement QFD, the project manager and team members need to be
able to commit a significant amount of time to it, especially in the early stages.
Teams compose of members from marketing, design, quality, finance and production.
One of the most important tools in the QFD process is communication.
Team meetings are very important in the QFD process.
The team leader needs to ensure that the meetings run in the most efficient manner and that the members
are kept informed.
The meeting format should have some way of measuring how well the QFD process is working at each
meeting and should be flexible depending on certain situations.
Words used by the customer to describe their expectations are often referred to as the voice of the
customer.
Customer satisfaction like quality is defined as meeting or exceeding customer expectations.
QFD begins with marketing to determine what exactly the customer desires from a product.
During the collection of information, the QFD team must continually ask and answer numerous
questions such as
a) What does the customer really want?
b) What are the customers’ expectations?
c) Are the customers’ expectations used to drive the design process?
d) What can the design team to do achieve customer satisfaction?
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Organization of Information
House of Quality:
The primary planning tool used in QFD is the house of quality. The house of quality translates the voice
of the customer in to design requirements that meet specific target values and matches those against how
an organization will meet those requirements.
Many managers and engineers consider the house of quality to be primary chart in quality planning.
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The goal of the house of quality is to design or change the design of a product in away that meets or
exceeds the customer expectations.
Here the customer needs and expectations are expressed in terms of customer requirements; it is the duty
of the QFD team to convert these requirements in to engineering characteristics or technical descriptors.
Implementation of the customer requirements is difficult until they are translated in to counterpart
characteristics.
Counterpart characteristics are an expression of the voice of the customer in technical language.
The list of technical descriptors is divided in two primary, secondary and tertiary technical descriptors.
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The inside of the house of quality is called as the relationship matrix and it is usually filled by the QFD
team.
It is common to use symbols to represent the relationship between the customer requirements and
descriptors.
Example:
An empty column indicates that a particular technical descriptor does not affect any of the customer
requirements and after careful scrutiny may be removed from the house of quality.
The roof of the house of the quality called the correlation matrix is used to identify any interrelationships between
each of the technical descriptors.
Symbols:
The competitive assessments are a pair of weighted tables that depict item for item how competitive
products are compared with current organization products.
The competitive assessment tables are separated in to two categories customer assessment and technical
assessment.
The numbers 1 through 5 are listed in the competitive evaluation column to indicate a rating of 1 for
worst and 5 for best.
The customer competitive assessment is a good way to determine is the customer requirements has been
met and identifies areas to concentrate in on the next design.
Customer requirements and technical descriptors that are strongly related should also exhibit a strong
relationship in their competitive assessments.
If an organization technical assessment shows its products to be superior to the competition, then the
customer assessment should show a superior assessment.
If the customer disagrees, then a mistake in engineering judgement has occurred and should be
corrected.
Importance to customer
Target value
Scale-up factor
Sales point
An absolute weight
Meaning:
Total- All encompassing by maintenance and production individuals working together.
Productive-Production of goods and services that meet or exceed customers expectations
Maintenance-Keeping equipment and plant in as good as or better than the original condition at all times.
Steps:
Management learns the new philosophy
Management promotes the new philosophy
Training is funded and developed for everyone in the organization
Areas of needed improvement are identified
Performance goals are formulated
An implementation plan is developed
Autonomous work groups are established.
3. Training:
Teach the new philosophy to mangers at all levels.
Begin with senior management and work down to first line supervisors.
Don’t teach the HOW also teach the WHY
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Senior management must spend time learning about and understanding the ramifications of this
philosophy to their organization.
Some managers are needed to be replaced because they don’t accept change and also identify managers
who readily respond to new philosophy.
First line supervisors need to learn their role in what most likely will be a new environment.
There needs to be some instruction in the areas of jobs that maintenance people do and jobs that
production people do.
A great benefit of TPM is the cross-pollination of ideas between maintenance technicians and
production operators.
4. Improvement Needs:
There are usually some machines that seem to be on the verge of breaking down or require an excessive
amount of maintenance.
Employees who work with the equipment on a daily basis are better able to identify those conditions
than anyone else in the organization.
A good first step is to let the operators and maintenance technicians tell management which machines
and systems need the most attention.
An implementation team of operators and technicians to coordinate this process is essential.
Six Losses:
Downtime Losses:
Planned
Start ups
Shift Changes
Coffee and lunch breaks
Unplanned:
Equipment breakdown
Change over’s
Lack of material
Idling and minor stoppages
Slow downs and poor quality losses
Process nonconformities
Scrap
5. Goal:
Goal should be set after the improvement needs are identified.
The first goal is to establish the time frame for fixing the prioritized problem.
Technicians and operators will probably want it done faster than management because it causes them
more problems on a daily basis.
Identifying needs and setting goals begins the process of getting the organization to work as a team.
6. Developing Plans:
First, develop and implement an overall plan of action for training all employees.
Plans for developing the autonomous work groups should take place during the training phase.
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Plan to use, team of maintenance technicians and operators to work on particularly troublesome
problems.
Priorities can be set and management can make a commitment with resources to correct some of the
basic problems.
COST OF QUALITY
Quality costs are defined are those costs associated with the non-achievement of product or service quality as
defined by the requirements established by the organization and its contracts with customers and society.
Simply stated, quality cost is the cost of poor products or services.
3. Purchasing:
Costs are incurred to assure conformance requirements of supplier parts, materials or processes and to minimize
the impact of supplier non conformance on the quality of delivered products or services.
2. Returned Goods:
Costs incurred in evaluating, repairing and replacing goods.
4. Warranty Claims
Warranty costs include the total costs of claims paid to the customer or user after acceptance to cover expenses,
including repair costs, such as removing defective hardware from a system, or cleaning costs, due to food or
chemical service accident.
5. Liability Costs
Liability costs are organization-paid costs due to liability claims, including the cost of product or service liability
insurance.
6. Penalties
Penalty costs are those costs incurred because less than full product or service performance is achieved as required
by contracts with customers or by government rules and regulations.
8. Lost Sales
Lost sales comprise the value of the contribution to profit that is lost due to sales reduction because of quality
problems.
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1. Scope
2. Normative References
3. Definitions
Documentation
Quality Manual
Control of documents
Control of records
5. Management Responsibility
Management Commitment
Customer Focus
Quality policy
Planning
Responsibility, authority and communication
Management review
6. Resource Management
Human resources
Infrastructure
Work Environment
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This team should be drawn from all levels and areas of the organization so that it is representative.
It is important to keep the project visible for all employees.
Training:
The implementation team, supervisor and internal audit team should be trained.
This activity can be accomplished by sending team leaders for training and make them to train the
rest of the members by one or two day seminar.
Time Schedule:
A time schedule has to be framed for the implementation and registration of the system.
This time frame will vary depending on the size and type of organization and the extent of its
existing quality system.
Most organizations can complete this entire process in less than 1.5 years.
Select Element Owners:
The implementation team should select owners for each of the system elements.
Many of these owners will be the members of the implementation team.
Owners may be assigned more than one element.
The more people involved, the more effective the system.
Review the present system:
The present system has to be reviewed.
Copies of all the quality manuals, procedures, work instructions and forms which are used
presently are obtained.
These documents are sorted in to system elements to determine what is available and what is
needed to complete the system.
This is called as gap analysis.
Write the document:
Prepare written quality policy and procedure manuals, they can be combined in to one document.
Write appropriate work instructions to maintain the quality of specific function.
This process should involve every employee, because the best person to work with instruction is
the one who performs the job on a regular basis.
Install the new system:
Integrate the policies, procedures and work instructions in to the day today workings of the
organization and document what is being done.
Be sure all people are trained.
Internal Audit:
Conduct an internal audit of the quality system.
This step is necessary to ensure that the system is working effectively.
Minor corrections to the system are made as they occur.
A cross section of the trained people should be used for the audit team.
Management Review:
A management review is conducted.
The management review is used to determine the effectiveness in achieving the stated quality
goals.
Pre assessment:
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Documents to be prepared:
Records
Work Instructions
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Quality policy manual is the first level of documentation. This is the document that defines ‘what will be
done ‘and ‘why’.
It should be short and simple definition of the organizations quality intentions.
The remainder of the policy manual addresses what will be done to comply with the standard being used.
The policy manual communicates the quality policy and objectives of an organization.
This manual is a living document. Because it reflects the current system being followed in the
organization.
The second level of documentation is the quality procedures. These procedures describe the methods that
will be used to implement and perform the stated policies.
These procedures define who should perform specific tasks, when the task should be done and where the
documentation will be made.
These documents collectively define the organizations operations from receiving an enquiry to delivering
a completed product or service.
These procedures are confidential documents of the organization and therefore need not to be revealed to
others.
3. Work Instructions:
The third level of documentation is generally company specific. It gives details of how individual work
processes (e.g.: welding, casting) are carried out with in a company.
Work instructions should also specify how the work should be done, who should undertake the work and
what records are to be maintained.
The work instructions may be in the form of a detailed drawing, recipe, routing sheet, specific job function,
photograph, video or simply a sample for comparison of conformity.
The work instructions should be written by the employee who performs the task.
4. Records:
These provide evidence of activity having been performed in compliance with quality system procedure.
Records may be forms that are filled out, a stamp of approval on a product or a signature and date on some
type of document.
QUALITY AUDITING
Quality auditing should be carried out in order to verify whether a quality system is effective and suitable.
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Definition:
To determine the conformity or non-conformity of the quality system elements with regard to specified
requirements.
To determine the effectiveness of the implemented quality system in meeting specified quality objectives.
To meet regulatory requirements, if applicable.
To permit the listing of the audited organizations quality system in a register for third party certification.
To evaluate an organizations own quality system against a quality system standard.
Types of Audits:
Stages of an Audit:
1. Audit Planning
2. Audit Performance
3. Audit reporting
4. Audit follow-up
i. Audit schedules: It is a matrix of the timings, which details when each audit element is to be checked
throughout the year.
ii. Audit personnel: It refers to the appointment of an auditor.
iii. Notification to the auditee: This is the formal and timely request by audit to auditee for making available
all quality system documents relevant to the audit.
iv. Preparation of checklist: This lists all specific questions to be asked during audit.
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i. Opening/entry meetings: Opening meeting is organized to initially brief the auditee about the scope of
audit.
ii. Audit process: Audit is done according to the schedule and should cover entire scope, as planned. Regular
liaison meetings should be held.
iii. Audit deficiencies: During auditing, clear and precise discrepancy reports are raised. All discrepancies
should be based on sound and objective evidence.
i. Audit reporting deals with the recording of any non conformity and summarizing the audit findings.
ii. The audit report may contain:
Identification of the reference documents against which audit is conducted (ie quality system
standard), company’s quality manual.
Observation of non conformities
Corrective action requests
i. The auditor is only responsible for identifying the non conformity. But the auditee is responsible for
determining and initiating corrective action needed to correct a non conformity.
ii. Corrective action and subsequent follow up should be completed within a time period.
These 4 stages complete the ISO 9000 quality system audit
ISO 14001
What is ISO 14001?
• It is an Environmental Management System (EMS) that uses a continual improvement approach in
achieving and demonstrating sound environmental performance.
• The goal is for organizations to control the impacts that their activities, products and services have on
the environment.
• ISO 14000 is the standard, and ISO 14001 is the document containing the requirements.
Overview of the Requirements of the ISO 14001 Standard
• The organization must develop an effective system that meets the requirements of the Standard.
• Document, implement and maintain the system.
• The EMS documents need to be controlled.
Follow a Plan-Do-Check-Act approach.
– Plan - Establish the objectives and processes needed to deliver the results (in line with the EMS).
– Do - Implement the needed processes of the EMS.
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– Check - Check the processes against the policy, objectives, targets, regulations, and report on the
results. (Auditing)
– Act - Take actions that will continually improve the EMS.
Requirements (Plan): Management
• Top Management must be committed to and involved in the design and implementation of the EMS.
• They will write the Environmental Policy and be responsible for making sure it is communicated and
implemented.
• Many specific responsibilities are assigned to Top Management to ensure their input and participation.
• After implementation Management will conduct management review to ensure continued effectiveness
of the system.
• Requirements (Plan): Resources
• The EMS must clarify what resources, human and physical are required to create safe products and
operations.
• During development of the system you will determine how to ensure competent personnel, identify
training that is required, and identify the infrastructure and work environment required
• Requirements (Plan): Form EMS
• Your organization will need to plan all of the processes that go into making your product to ensure safe
conditions.
• You will need to state of scope of the EMS and clearly identify the products and define the locations or
sites that are part of the EMS.
Requirements (Do): Environmental Review
• An initial environmental review will be needed.
• An assessment of environmental aspects and their Impacts will have to be performed.
• Regulatory, legal and other requirements will need to be identified.
• Environmental programs with targets and objectives will need to be established, implemented and
evaluated on an ongoing basis.
• Emergency preparedness procedures will be required to address potential accidents and emergencies.
• Measuring and monitoring of product and process characteristics that can have an impact on the
environment will be required.
- Measuring and monitoring equipment will need to be controlled and calibrated.
- A process will be needed for the Environmental Safety Team to evaluate compliance to legal
and other requirements.
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