MODULE – 5

QUALITY

QUALITY IN DAILY LIFE

Quality has been an age-old concern. The discerning customer in shops and market places has applied
―quality techniques,‖ prodding and turning fruits and vegetables testing for firmness, freshness and fitness
for the purpose of consumption. If the products were not adequate, the purchase would not take place.
In the hustle and bustle of cattle markets farmers argued and bartered over the fitness of animals for breeding,
dairy farming or consumption, providing evidence for their case by inspection against criteria learned from
their forefathers. Those shoppers and farmers passed on their knowledge to their children and similarly it was
passed on to their children‘s children.
I too learned the principles of inspection and learning from my mother as she scrutinized clothes and
footwear, fruits and vegetables in our town market. Eager market traders would get short shrift from her if
clothes had weak stitching, zips got stuck when zipping, fruits were marked and bruised or vegetables
appeared old and unpalatable.
The issue of quality of goods and services is not new. Throughout history, society has demanded that
providers of goods and services should meet their obligations. As long ago as 1700 BC King Hammurabi of
Babylon introduced the concept of product quality and liability into the building industry of the time by
declaring:
If a building falls into pieces and the owner is killed then the builder shall be put to death. If the owner‘s
children are killed then the builders‘ children shall be put to death.
A BROADER VIEW OF “WHAT IS QUALITY”

Ask people this question and we get a diverse range of answers. A good answer given in a seminar on quality
was ―Quality‖ is a perception. Quality could be all things to all people. Quality like beauty lies in the eyes of
the beholder. Quality like any other concept begins in the mind. Quality is found in great abundance in our
daily life. We live in a quality age, in a quality home, fully of quality furniture. We buy quality goods and
drive a quality car and demand quality service from others.

In our industry, this is the most commonly used word in day-to-day work. Infact we see a lot of posters
espousing the cause of quality but posters by themselves cannot help unless everyone is educated about the
meaning of quality. Without a clear understanding of the term quality, it is difficult to achieve it. Lack of
understanding gives rise to the ambiguous use of the word ―quality‖ and leads to variation in priorities,
decisions, actions and attitude.

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The oxford dictionary defines quality as ―degree of excellence, relative nature or kind or character. General
Excellence.

Other meanings associated with the word quality are as follows:

 A good product
 Sturdy
 Durable
 Made of best materials
 Easy to operate
 Nice in appearance and touch
 Produced with care

These when translated into a broader sense mean as follows:

 Description of consumer wishes

 Observance of terms of delivery
 Has good documentation
 Is available at a reasonable price
 A product meeting laid down specifications

Thus, the definition of quality should:

 Take into account customer requirement and needs

 Be customer oriented
 Be aware of customer specifications

For example, when we buy a T.V., we look at the following parameters:

 Brand
 Sales talk/Sales brochure
 Picture and sound quality
 Size/dimensions
 Appearances
 Weight
 Terms of payment
 Maintenance cost
 Terms of delivery
 Installation
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  Servicing/skills

For example, when we go to a restaurant, we look at the following parameters:

 Courtesy of staff
 Layout of table/comfort
 Lighting/Ambience/Atmosphere
 Correct order taking
 Services of the waiters
 Neatness/Clean linen
 Reasonably Quick service
 Tasty food
 Courteous serving

Quality Definitions by “QUALITY GURUS”

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For better clarity of “Quality” term, we must learn and understand the concept/ meaning of the following
topics:

Quality Assurance

QA contains all those planned and systematic actions necessary to supply adequate confidence that a product
or service will satisfy/fulfill given requirements for Quality.

QA includes QC, but it emphasizes quality in the design of products and processes.

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Quality Control

QC is the process through which we measure the actual quality performance and compare it with the set
standards.

And if there is a deviation then we take corrective actions.

The typically quality control program is based on the periodic inspection, followed by feedback of the results
and change or adjustment whenever required.

Quality System

A Quality System is the company-wide and plant-wide operating work structure, responsibilities, procedures,
and processes for guiding the coordinated actions of the workforce, the machines, and the information of the
organization in the best and most practical ways to assure customer satisfaction. Quality
Assurance and Quality Control both are part of the quality system.

Total Quality Management – TQM

It basically aims to involve every person from every function or department of an organization working
together to eliminate defects/errors and prevent 3M Waste from the manufacturing process.

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What is Cost of Quality (COQ)
Cost of Quality is a methodology used to define and measure where and what amount of an organization’s
resources are being used for prevention activities and maintaining product quality as opposed to the costs
resulting from internal and external failures. The Cost of Quality can be represented by the sum of two
factors. The Cost of Good Quality and the Cost of Poor Quality equals the Cost of Quality, as represented in
the basic equation below:
CoQ = CoGQ + CoPQ
The Cost of Quality equation looks simple but in reality it is more complex. The Cost of Quality includes all
costs associated with the quality of a product from preventive costs intended to reduce or eliminate failures,
cost of process controls to maintain quality levels and the costs related to failures both internal and external.

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The Cost of Good Quality (CoGQ)
1. Prevention Costs – costs incurred from activities intended to keep failures to a minimum. These can
include, but are not limited to, the following:
o Establishing Product Specifications
o Quality Planning
o New Product Development and Testing
o Development of a Quality Management System (QMS)
o Proper Employee Training
2. Appraisal Costs – costs incurred to maintain acceptable product quality levels. Appraisal costs can
include, but are not limited to, the following:
o Incoming Material Inspections
o Process Controls
o Check Fixtures
o Quality Audits
o Supplier Assessments

The Cost of Poor Quality (CoPQ)

3. Internal Failures – costs associated with defects found before the product or service reaches the
customer. Internal Failures may include, but are not limited to, the following examples:
o Excessive Scrap
o Product Re-work
o Waste due to poorly designed processes
o Machine breakdown due to improper maintenance
o Costs associated with failure analysis
4. External Failures – costs associated with defects found after the customer receives the product or
service. External Failures may include, but are not limited to, the following examples:
o Service and Repair Costs
o Warranty Claims
o Customer Complaints
o Product or Material Returns
o Incorrect Sales Orders
o Incomplete BOMs

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 o Shipping Damage due to Inadequate Packaging

QUALITY GURUS AND THEIR KEY CONTRIBUTION TO QUALITY MANAGEMENT

Who is a quality guru?
A guru, by definition, is a good person, a wise person and a teacher. A quality guru should be all of these, plus have a
concept and approach to quality within business that has made a major and lasting impact. The gurus mentioned in this
section have done, and continue to do, that, in some cases, even after their death.
The gurus There have been three groups of gurus since the 1940’s:
The gurus
There have been three groups of gurus since the 1940’s:
Early 1950’s Americans who took the messages of quality to Japan

Late 1950’s Japanese who developed new concepts in response to the Americans

1970’s-1980’s Western gurus who followed the Japanese industrial success

It is beyond the scope of this site to go into great detail on each of the gurus, their philosophies, teachings and tools;
however, a brief overview of their contribution to the quality journey is given, supported by several references.
Early 1950’s Americans who took the messages of quality to Japan Late 1950’s Japanese who developed new concepts
in response to the Americans 1970’s-1980’s Western gurus who followed the Japanese industrial success It is beyond
the scope of this site to go into great detail on each of the gurus, their philosophies, teachings and tools; however, a
brief overview of their contribution to the quality journey is given, supported by several references.
The Americans who went to Japan:
Dr. W. Edwards Deming: Probably the most known quality guru—for a reason. Developed a complete description
and guide to quality management (14 points and 7 deadly diseases). The American management consultant convinced
the world about the power of simple tools like the Plan-Do-Check-Act-circle (PDCA) and Statistical Process Control
(SPC).
W Edwards Deming placed great importance and responsibility on management, at both the individual and company
level, believing management to be responsible for 94% of quality problems.
His fourteen point plan is a complete philosophy of management, that can be applied to small or large organisations in
the public, private or service sectors:
• Create constancy of purpose towards improvement of product and service
• Adopt the new philosophy. We can no longer live with commonly accepted levels of delay, mistakes and defective
workmanship

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• Cease dependence on mass inspection. Instead, require statistical evidence that quality is built in
• End the practice of awarding business on the basis of price
• Find problems. It is management’s job to work continually on the system
• Institute modern methods of training on the job
• Institute modern methods of supervision of production workers, The responsibility of foremen must be changed from
numbers to quality
• Drive out fear, so that everyone may work effectively for the company • Break down barriers between departments
• Eliminate numerical goals, posters and slogans for the workforce asking for new levels of productivity without
providing methods
• Eliminate work standards that prescribe numerical quotas
• Remove barriers that stand between the hourly worker and their right to pride of workmanship • Institute a vigorous
programme of education and retraining
• Create a structure in top management that will push on the above points every day
He believed that adoption of, and action on, the fourteen points was a signal that management intended to stay in
business. Deming also encouraged a systematic approach to problem solving and promoted the widely known Plan, Do,
Check, Act (PDCA) cycle. The PDCA cycle is also known as the Deming cycle, although it was developed by a
colleague of Deming, Dr Shewhart. It is a universal improvement methodology, the idea being to constantly improve,
and thereby reduce the difference between the requirements of the customers and the performance of the process. The
cycle is about learning and ongoing improvement, learning what works and what does not in a systematic way; and the
cycle repeats; after one cycle is complete, another is started

Dr Joseph M Juran developed the quality trilogy – quality planning, quality control and quality improvement. Good
quality management requires quality actions to be planned out, improved and controlled. The process achieves control
at one level of quality performance, then plans are made to improve the performance on a project by project basis,
using tools and techniques such as Pareto analysis. This activity eventually achieves breakthrough to an improved level,
which is again controlled, to prevent any deterioration

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Juran believed quality is associated with customer satisfaction and dissatisfaction with the product, and emphasised the
necessity for ongoing quality improvement through a succession of small improvement projects carried out throughout
the organisation. His ten steps to quality improvement are:

• Build awareness of the need and opportunity for improvement

• Set goals for improvement

• Organise to reach the goals

• Provide training

• Carry out projects to solve problems

• Report progress

• Give recognition

• Communicate results

• Keep score of improvements achieved

• Maintain momentum

He concentrated not just on the end customer, but on other external and internal customers. Each person along the
chain, from product designer to final user, is a supplier and a customer. In addition, the person will be a process,
carrying out some transformation or activity.

Dr Kaoru Ishikawa made many contributions to quality, the most noteworthy being his total quality viewpoint,
company wide quality control, his emphasis on the human side of quality, the Ishikawa diagram and the assembly and
use of the “ seven basic tools of quality”:

• Pareto analysis which are the big problems?

• Cause and effect diagrams what causes the problems?

• Stratification how is the data made up?

• Check sheets how often it occurs or is done?

• Histograms what do overall variations look like?

• Scatter charts what are the relationships between factors?

• Process control charts which variations to control and how?

He believed these seven tools should be known widely, if not by everyone, in an organisation and used to analyse
problems and develop improvements. Used together they form a powerful kit.

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One of the most widely known of these is the Ishikawa (or fishbone or cause and effect) diagram.

CAUSES CAUSES PROBLEM

or EFFECT

Like other tools, it assists groups in quality improvements. The diagram systematically represents and analyses the real
causes behind a problem or effect. It organises the major and minor contributing causes leading to one effect (or
problem), defines the problem, identifies possible and probable causes by narrowing down the possible ones. It also
helps groups to be systematic in the generation of ideas and to check that it has stated the direction of causation
correctly. The diagrammatic format helps when presenting results to others.

Dr Genichi Taguchi believed it is preferable to design

product that is robust or insensitive to variation in the Robust product

manufacturing process, rather than attempt to control

design Parameter design
all the many variations during actual [Link] put this • P esign
idea into practice, he took the already established knowledge on a • Tolerance design
Statistical process control
experimental design and made it more usable and practical for r
quality professionals. His message was concerned with the a
routine optimisation of product and process prior to m
manufacture rather than quality through inspection. Quality and e
reliability are pushed back to the design stage where they really t
belong, and he broke down off-line quality into three stages: e
r
• System design
d

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 Level of
quality Quality control procedure
and stage of evolution

“Taguchi methodology” is fundamentally a prototyping method that enables the designer to identify the
optimal settings to produce a robust product that can survive manufacturing time after time, piece after piece,
and provide what the customer wants. Today, companies see a close link between Taguchi methods, which
can be viewed along a continuum, and quality function deployment (QFD).

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Philip B Crosby is known for the concepts of “ Quality is Free ” and “Zero Defects”, and his quality
improvement process is based on his four absolutes of quality:

• Quality is conformance to requirements

• The system of quality is prevention

• The performance standard is zero defect

• The measurement of quality is the price of non-conformance

His fourteen steps to quality improvement are:

• Management is committed to a formalized quality policy

• Form a management level quality improvement team (QIT) with responsibility for quality
improvement process planning and administration

• Determine where current and potential quality problems lie

• Evaluate the cost of quality and explain its use as a management tool to measure waste

• Raise quality awareness and personal concern for quality amongst all employees

• Take corrective actions, using established formal systems to remove the root causes of
problems

• Establish a zero defects committee and programme

• Train all employees in quality improvement

• Hold a Zero Defects Day to broadcast the change and as a management recommitment and
employee commitment

• Encourage individuals and groups to set improvement goals

• Encourage employees to communicate to management any obstacles they face in attaining

their improvement goals

• Give formal recognition to all participants

• Establish quality councils for quality management information sharing

• Do it all over again – form a new quality improvement team

CONTROL CHART: A KEY TOOL FOR ENSURING QUALITY AND MINIMIZING

VARIATION

Invented by Walter A. Shewhart while he was working for Bell Labs in the ’20s, control charts
have been used in a variety of industries as part of a process improvement methodology.
Shewhart understood that, no matter how well a process was designed, there will always be
variation within that process—and the effect can become negative if the variation keeps you from
meeting deadlines or quotas.
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Statistical process control (SPC) :

 Application of statistical techniques to determine whether a process is delivering what the

customer wants. Or confirms to specification,

 Tools : control charts

 Acceptance sampling: Application of statistical techniques to determine whether a

quantity of material should be accepted or rejected based on inspection or test of sample.

 Variation of the output is due to ;

 Common causes :Purely random , unidentifiable sources of variation that are unavoidable
with the existing process and the process in control.

 Assignable causes ; Any variation causing factors that can be identified and eliminated.

 Performance measurements : Abnormal variations in a process output can be measured by

performance variables.

 Variables : Product characteristics which can be measured on continuous scale.

 Attributes : Product characteristics that can be counted for acceptable performance.

Advantages of Statistical Quality Control

1. Cost reduction: In this method, only a fragmentary output is inspected to ensure the
quality of product, therefore probe cost would be reduced greatly.

2. Huge efficiency: Inspection of a fractional portion requires lesser time and tedium in
comparison to holistic investigation leading to huge escalation in efficiency and
production.

3. Easier to use: Pitching SQC not only reduces process variability but also makes the
process of production-in-control. Even, it is much to apply by an individual without
having such extensive specialized guidance.

4. Authentic anticipation: SQC is the most preeminent approach that can accurately predict
future production. To ensure the degree of perfection and product performance, SQC
provides a great predictability.

5. Prior fault detection: Any deviation from standard control limits depicts signs of danger
in the underlying production process that invites necessary corrective measurement to be
taken earlier. SQC is helpful in early detection of faults.

1.1. Control Chart

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A control chart is an important aid or statistical device used for the study and control of the
repetitive processes. It was developed by A. Shewhart and it is based upon the fact that variability
does exist in all the repetitive process.

A control chart is a graphical representation of the collected information. The information may
pertain to measured quality characteristics of samples.

Control Chart patterns

The Control Chart patterns can be classified into two categories

1. Chance pattern of variation (or) Common cause of variation

2. Assignable cause pattern of variation

1. Chance Pattern of Variation

A control chart having a chance pattern of variation will have the following three characteristics:

(i) Most of the points will lie near the central line.

(ii) Very few points will be near the control limits.

(iii) None of the points (except 3 in a thousand) fall outside the control limits.

Figure: Control Chart for Chance Pattern of Variation

2. Assignable Cause Pattern of Variation

The most important types of assignable cause patterns of variations are:

(i) Extreme Variation

(ii) Indication of Trend

(iii) Shifts

(iv) Erratic Fluctuations

(i) Extreme Variation

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Extreme variation is recognised by the points falling outside the upper and lower control limits.
Thus, when the sample points outside these limits on X chart, p chart or both it means some
assignable causes of error are present and corrective action is necessary to produce the products
within the specified limits.

(a) Error in measurement and calculations

(b) Samples chosen at a peak position of temperature, pressure and such other factors.

(c) Wrong setting of machine, tools, etc.

(d) Samples chosen at the commencement or end of an operation.

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Figure: Control Chart for Extreme Variation

(ii) Indication of Trend

If the consecutive points on X or R chart tend to move steadily either towards LCL or UCL, it can
be assumed that process is indicating a Trend, that is change is taking place slowly and through
all the points are lying with in control limits, after some time it is likely that the process may go
out of control if proper case or corrective action is not taken.

Causes of Trend

(i) Tool wear

(ii) Wear of threads on clamping device

(iii) Effects of temperature and humidity

(iv) Accumulation of dirt and clogging of fixtures and holes

Figure: Control Chart for Indication of Trend

(iii) Shift

When a series of consecutive points fall above or below the central line on either X or R

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chart, it can be assumed that shift in the process has taken place indicating presence of some
assignable cause.

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It is generally assumed that when seven consecutive points lie above or below the central line, the
shift has occurred.

Causes of Shift

(i) Change in material

(ii) Change in operator, inspector, inspection equipment

(iii) Change in machine setting

(iv) New operator, carelessness of the operator

(v) Loose fixture etc.

Figure: Control Chart for Shift

(iv) Erratic Fluctuations

Erratic fluctuation is characterised by ups and downs as shown in Figure is given below. This
may be due to single causes or a group of causes affecting the process level and spread. The
causes of erratic fluctuations are rather difficult to identify. It may be due to different causes
acting at different times on the process.

Causes of Fluctuations

(i) Frequent adjustment of machine

(ii) Different types of material being processed

(iii) Change in operator, machine, test equipment etc.

Figure: Control Chart for Erratic Fluctuations

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Brief History of Statistical Quality Control

1924: W. A. Shewhart introduces the control chart concept in a Bell Laboratories Technical
Memorandum.

1928: Acceptance sampling method is developed and redefined by H. F. Dodge and

H. G. Roming at Bell Laboratories.

1944: Industrial quality control (a journal) beings publications.

1946: The American Society for Quality Control (ASQC) is formed as a merger of varies quality
societies.

1957: Turan and Gragna: Published first time Quality Control Handbook.

1959: Technometrics (a journal of statistical for the physical, chemical engineering sureness) is
established J. Stuart Hunder is the founding editor.

1969: Industrial Quality Control replaced by Quality Progress (Journal of Quality Technology).

1989: The journal Quality Engineering appears. 1989: Motorola‟s six sigma initiative begins.

1990: ISO 9000 certification activities increase in U. S. Industry and soon.

Basic Principles of Control Chart

A typical control chart is graphical display of a quality characteristic that has been measured or
computed from a sample statistic versus the sample number or time. The chart contains center
line that represents the average value of the quality characteristic corresponding to the in-control
state. Two other horizontal lines called Upper Control Limit (UCL) and Lower Control Limit
(LCL). These control limits are chosen so that if the process is in control, nearly all of the sample
points will fall between them. As long as the points plot within the control limits, the process is
assumed to be in control and no action necessary. If a point that plots outside of the control limits
is interpreted as the process is out of control.

Even if all the points plot inside the control limits, if they behave in a systematic or non-random
manner, then this could be an indication that the process is out of control. If the process is in
control, all the plotted points should have an essentially random pattern. Usually, there is a
reason why a particular non-random pattern appears on a control chart and if it can be found and
eliminated process performance can be improved.
Figure: A typical control chart

Uses of Control Charts

The most important use of a control chart is to improve the process. We have found that,
generally,

1. Most processes do not operate in a state of statistical control.

2. Consequently, the routine and attentive use of control charts will identify assignable
causes. If these caused can be eliminated from the process, variability will be reduced
and the process will be improved.

3. The control chart will only detect assignable causes. Managements, operator and
engineering action will usually be necessary to eliminate the assignable causes.

Reasons for the Control Charts are popular in Industries

1. Control charts are a proven technique for improving productivity.

2. Control charts are effective in defect prevention

3. Control charts prevent unnecessary process adjustment

4. Control charts provide diagnostic information

5. Control charts provide information about process capability.

Warning Limits on Control Charts

Some analysts suggest using two sets of limits control charts. The outer limits say, at three sigma
are the usual action limits, that is, when a point plots outside of this limit, a search for an
assignable cause is made and corrective action is taken if necessary. The inner limits, usually at
two sigma are called warning limits.
If one or more points fall between the warning limits and the control limits or very close to the
warning limit, we should be suspicious that the process may not be operating properly.

The use of warning limits can increase the sensitivity of the control chart. One of their
disadvantage is that they may be confusing to operating personnel.

Types of Control Charts

Basically control charts are classified into two types.

1. Variable Control Charts

2. Attribute Control Charts

1.2. Variable Control Chart

Variable control chart mainly consist of three charts namely

1. Mean (Average) control chart ( X )

2. Range control chart (R)

3. Standard deviation control chart (σ)

Attribute Control Chart

Attribute control chart mainly consist of three charts which are

1. Fraction defective chart (p)

2. Chart for defects (c)

3. Chart of number of defectives (np or d)

Assignable Causes of Variation

The assignable causes occurs different situations. They are

1. Points fall outside the control limits

2. A sequence of 7 or more points

3. Points form a trend

 4. Points fall very close to central line.

Due to these causes or the presence of assignable causes, the process is considered as out of
control.

Constant Cause System or Common Causes

Suppose all the points fall within the control limits but do not form a trend or any sequence of
points then it is called constant cause system and the process is in control.

Steps in developing the control charts :

 Preparation :

 Choose a variable or attributes

 Determine the basis , size, frequency of sampling .

 Set up the control chart.

 Data collection:

 Record the data

 Calculate the relevant statistics , average, proportions.

 Plot the statistics on chart.

 Determine the control limits :

 Draw the central line that is process average .

 Compute UCL and LCL

 Analysis and interpretation :

 Investigate the client for the lack of control.

 Eliminate the out of control points.

 Recompute limits if required.

 Use as a problem solving tool.

 Use control chart data for determining the process capability.

CONTROL CHART FORMULA
CONTROL CHART CONSTANT TABLE

TOTAL QUALITY MANAGEMENT (TQM)

Total – Made up of whole

Quality – Degree of excellence provided by a product or service.

Management – Act, art, or manner of handling, controlling, directing, etc.

Total quality management, or TQM, is a management approach designed to help companies

create an environment of continuous improvement, consistently delivering high-quality work that
delights customers.
“TQM is the 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.”

TQM FRAMEWORK

The figure shows the framework of TQM system. It begins with the knowledge provided by
gurus of quality: Shewhart, Deming, Juran, Figenbaum, Ishikawa, Crosby, and Taguchi. As the
figure shows, they contributed to the development of principles and practices and/or the tools
and techniques. Some of these tools and techniques are used in the product and/or service
realization activity. Feedback from internal/external customers or interested parties information
to continually improve the organization‟s system, product and/or service

TQM FRAMEWORK
THE EIGHT PRINCIPLES OF TQM
1. Customer focus: Every action comes from a drive to deliver more value to the customer.

2. Total employee involvement: Include all staff, not just managers, in ideation and
decision-making. After all, executives don’t have a monopoly on good ideas.

3. Process-centered: Standardizing workflows into processes reduces the chance of human

error. It also boosts efficiency and helps teams deliver products faster.

4. Integrated system: Create an infrastructure that encourages company-wide collaboration

with a strong, shared corporate mission, values, and culture.

5. Strategic and systematic approach: The primary tenet of TQM is to make strategic
choices to improve your company as a whole rather than only specific issues. For example, don’t
just replace underperforming employees, explore why they underperformed in the first place to
better understand if there is room for improvement in hiring, onboarding, or training practices
instead.
6. Continual improvement: Rather than going for a single big project, focus on
implementing small changes. Improving customer satisfaction or core processes is a long-term
game.

7. Fact-based decision-making: A culture of data and analysis means fewer emotion-fueled

mistakes. Set KPIs and invest in tracking and analytics to monitor them. Intuition will always
have a place in business, but you should back it up with data.

8. Clear communication: Everyone in your company should be on the same page. You need
to standardize your vision, processes, and plans. To make things easier, use a reliable platform
for all communication.

WHAT ARE THE BUILDING BLOCKS OF TOTAL QUALITY MANAGEMENT?

The main building blocks of TQM are culture, analytics, a systemic approach, and long-term
investment. You can’t implement any of the TQM principles without mastering these business
areas:

• Culture: The idea that every employee is responsible for driving change in the company
requires an organizational culture that supports it at all levels. Without all staff on board, any
quality improvement will be temporary.

• Measurement and analytics: If you don’t have the data, you can never know if you
improved or not. That’s why you must adopt a mindset of tracking everything efficiently and
consistently.

• Systemic outlook: Don’t treat just the symptoms, seek out the root of issues and address
those.

• Long-term investment: Investment decisions should be made with long-term

achievements in mind. While overhauling your hiring and training process might seem daunting,
such changes will pay for themselves in the future.

QUALITY FUNCTION DEPLOYMENT

Dr. Mizuno, professor emeritus of the Tokyo Institute of Technology, is credited with initiating
the Quality Function Deployment (QFD) system. The first application of QFD was at Mitsubishi
Heavy Industries Ltd. in the Kobe Shipyard, Japan, in 1972. After four years of case study
development, refinement and training, QFD was successfully implemented in the production of
mini vans by Toyota. Using 1977 as a base, a 20% reduction in startup costs was reported in the
launch of a new van in October 1979, a 38% reduction by November 1982 and a cumulative 61%
reduction by April 1984. Quality function deployment was first introduced in the United States
in 1984 by Dr. Clausing of Xerox. QFD can be applied to practically any manufacturing or
service industry. It has become a standard practice by most of the leading organizations who also
require it for their suppliers. Quality function deployment 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. An organization that correctly implements QFD
can improve engineering knowledge, productivity and quality, and reduce costs, product
development time and engineering changes. 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, into directions and actions, in terms of
engineering or technical characteristics.

Quality function development is a team-based management tool in which customer expectations

are used to drive the product development process. Conflicting characteristics or requirements
are identified early in the QFD process and can be resolved before production

QFD TEAM:

There are two types of teams namely

1. Team for designing a new product

2. Team for improving an existing product

BENEFITS OF QFD:
1. Improves Customer satisfaction

 Creates focus on customer requirements

 Uses competitive information effectively

Prioritizes resources

 Identifies items that can be acted upon

2. Reduces Implementation Time

 Decreases midstream design changes

 Limits post introduction problems

 Avoids future development redundancies Promotes Team Work

 Based on consensus

 Creates communication

 Identifies actions

3. Provides Documentation

 Documents rationale for design

 Adds structure to the information

 Adapts to changes (a living document)

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 into 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 the primary chart in quality planning

The structure of QFD can be thought of as a framework of a house, as shown in figure. The parts
of the house of quality are described as follows:

The exterior walls of the house are the customer requirements. On the left side is a listing of the
voice of the customer or what the customer expects in the product. On the right side are the
prioritized customer requirements or planning matrix. Listed items include customer
benchmarking, customer importance rating, target value, scale-up factor and sales point. The
ceiling, or second floor, of the house contains the technical descriptors. Consistency of the
product is provided through engineering characteristics, design constrains and parameters. The
interior walls of the house are the relationships between customer requirements and technical
descriptors. Customer expectations (customer requirements) are translated into engineering
characteristics (technical descriptors). The roof of the house is the interrelationship between
technical descriptors. Trade offs between similar and/or conflicting technical descriptors are
identified. The foundation of the house is the prioritized technical descriptors. Items such as the
technical benchmarking, degree of technical difficulty and target value are listed. This is the
basic structure for the house of quality. Once this format is understood, any other QFD matrices
are fairly straightforward and easy to understand The structure of QFD can be thought of as a
framework of a house, as shown in figure 23.3. The parts of the house of quality are described as
follows:

The exterior walls of the house are the customer requirements. On the left side is a listing of the
voice of the customer or what the customer expects in the product. On the right side are the
prioritized customer requirements or planning matrix. Listed items include customer
benchmarking, customer importance rating, target value, scale-up factor and sales point. The
ceiling, or second floor, of the house contains the technical descriptors. Consistency of the
product is provided through engineering characteristics, design constrains and parameters. The
interior walls of the house are the relationships between customer requirements and technical
descriptors. Customer expectations customer requirements) are translated into engineering
characteristics (technical descriptors).

The roof of the house is the interrelationship between technical descriptors. Trade offs between
similar and/or conflicting technical descriptors are identified. The foundation of the house is the
prioritized technical descriptors. Items such as the technical benchmarking, degree of technical
difficulty and target value are listed. This is the basic structure for the house of quality. Once this
format is understood, any other QFD matrices are fairly straightforward and easy to understand

The general purpose of QFD model includes the components addressed in below Figure
Customers requirements (CR) - Also known as "Voice of Customer" or VoC, they are the
"whats" the customers want from the product to be developed. They contain customers‟ wishes,
expectations and requirements for the product. Customer importance ratings - Once these
"whats" are in place, the customer needs to provide numerical ratings to these "whats" items in
terms of their importance to the customer. A numerical rating of 1 to 5 is often used, in which
the number 5 represents the most important and1 the least. Customer market competitive
evaluations - In this block, a comparison is made between a company's product/service and
similar competitive products/services on the market by the customer. The comparison results will
help the developer position the product on the market as well as find out how the customer is
satisfied now. For each product, the customer gives 1 to 5 ratings against each CR, 5 being best
satisfied and 1 the worst. Technical specifications – They are the technical specifications that are
to be built into a product with the intention to satisfy the CR. They are sometimes referred as
"hows" because they are the answers to CR: how can the requirements be addressed or satisfied.
They are the engineers' understanding in technical terms what customers really want. The
technical specifications must be quantifiable or measurable so that they can be used for design.
Relationship matrix - Relationship matrix is used to maintain the relationship between CR and
design requirements. In other words, the matrix corresponds to the "whats" vs. "hows". It is the
center part of HoQ and must be completed by technical team. A weight of 1-3-9 or 1-3-5 is often
used for internal representation of relationship, 1 being the weak and the biggest number being
the strong relationship. Correlation matrix - It is the triangular part in the HoQ (the "roof"). The
correlation matrix is used to identify which "hows" items support one another and which are in
conflict. Positive correlation help identify "hows" items that are closely related and avoid
duplication of efforts. Negative correlation represents conditions that will probably require trade-
offs. The positive and negative ratings are usually quantified using 2, 1, -1, and -2 ratings, with 2
being the two "hows" items are strongly supportive to each other and -2 being the conflicting.
Sometimes only 1 and -1 are used. Target goals - Completed by technical team, these are the
"how muchs" of the technical "hows" items. They provide designers with specific technical
guidance for what have to be achieved as well as objectively measuring the progress. The goals
have to be quantified in order to be specific and measurable. Technical difficulty assessment -
Technical team conducts the assessment. It helps to establish the feasibility and realizability of
each "hows" item. A 1 to 5 ratings are used to quantify technical difficulty with 5 being the most
difficult and 1 being the easiest. Technical competitive evaluation - It is used for comparing the
new product with competitor's products to find out if these technical requirements are better or
worse than competitors. Again, 1 to 5 ratings are used with 5 being the fully realized each
particular "hows" item and 1 being the worst realized. Overall importance ratings - This is the
final step of finishing HoQ for phase 1. For each column, sum all the row numbers each of which
is equal to the production of relationship rating and customer's important rating. The results help

identify critical product requirements and assist in the trade-off decision making process.
PHASES OF QFD

PRODUCT PLANNING

 Translating what customer wants or needs into set of prioritized design requirements.

 Prioritized design requirements describe looks/design of product.

Involves benchmarking – comparing product’s performance with competitor’s products.

 Setting targets for improvements and for achieving competitive edge.

PART PLANNING

 Translating product requirement specifications into part of characteristics.

 For example, if requirement is that product should be portable, then characteristics could
be light-weight, small size, compact, etc.

PROCESS PLANNING

 Translating part characteristics into an effective and efficient process.

 The ability to deliver six sigma quality should be maximized.

PRODUCTION PLANNING

 Translating process into manufacturing or service delivery methods.

 In this step too, ability to deliver six sigma quality should be improved

BENEFITS OF QFD

QUALITY CIRCLES
Quality circle may be defined as a small group of workers (5 to 10) who do the same work
voluntarily meeting together regularly during their normal working time usually under the
leadership of their own supervisor to identify, analyze and solve work related problems.

This group presents the solution to the management and wherever possible implement the
solution themselves. The QC concept was first originated in Japan in 1960. The basic cycle of a
quality circle starts from identification of problem.

Philosophical basis of QC

1. A belief that people will take pride and interest in their work if they get autonomy and take
part in decision making.

2. It develops a sense of belongingness in the employees towards a particular organization.

3. A belief that each employee desires to participate in making the organization a better place.

4. It is a mean/method for the development of human resources through the process of training,
work experience and participation in problem solving

5.A willingness to allow people to volunteer their time and effort for improvement of
performance of organization.

6. The importance of each member’s role in meeting organizational goal.

CONDITIONS FOR SUCCESS OF QUALITY CIRCLES

 Quality circles must be staffed entirely by volunteers.

 Each participant should be representative of a different functional activity.

 The problem to be addressed by the QC should be chosen by the circle, not by

management, and the choice honored even if it does not visibly lead to a management
goal.

 Quality circles must be staffed entirely by volunteers.

 Each participant should be representative of a different functional activity.

  The problem to be addressed by the QC should be chosen by the circle, not by
management, and the choice honored even if it does not visibly lead to a management
goal.

 Management must be supportive of the circle and fund it appropriately

 Management must be supportive of the circle and fund it appropriately

1. Non member

Help in implementing the ideas of members.

2. Members

Contributing views in problem identification , problem solving by attending meeting.

3. Leader

Conduct meeting, create enthusiasm, Keep track of meeting, training members.

4. Facilitator
a) Link between leader and steering committee

b) give training to member and leader

c) provide feedback to Steering committee about the results of QC.

d) Help in preparing presentations

e) Evaluate QC Program.

[Link]

Even though there is no special department for QC an committee is formed among the
employees to:-

1) Prepare agenda for meeting

2) Maintaining report on QC operations

3) Coordinating training program and arranging seminar etc.

6. Steering committee

The role of Steering committee

a) Provide budget for Quality Circle

b) Make QC as part of Organisation goal

c) Supplying resources to Quality

[Link] Management

CEO, MD, GM, Chairman are in this level without their support QC cannot be successful.

BENEFITS OF QUALITY CIRCLES

 It infuses team spirit among the workers.

 It improves decision making ability.
  It improves employee communication at all levels of the organization.
 It improves problem solving ability.
 It improves leadership skill.
 It builds confidence / trust.
 It incorporates a sense of belonging to their organization.
 It creates a sense of corporate loyalty and corporate pride.
KAIZEN - THE DEFINITION

Kaizen (Ky ‘ zen) is a Japanese term that means continuous improvement, taken from words
'Kai', which means continuous and 'zen' which means improvement. Some translate 'Kai' to mean
change and 'zen' to mean good, or for the better

Kaizen is one of the most commonly used words in Japan. It is used, not only in the workplace,
but in popular culture as well. Kaizen is a foundation on which companies are built. Kaizen is
such a natural way for people in Japan to think that managers and workers often do not make a
conscious effort to think “Kaizen.” They just think the way they think – and that way happens to
be Kaizen.

Kaizen means improvement, continuous improvement involving everyone in the organization

from top management, to managers then to supervisors, and to workers. In Japan, the concept of
Kaizen is so deeply engrained in the minds of both managers and workers that they often do not
even realize they are thinking Kaizen as a customer-driven strategy for improvement This
philosophy assumes according Imai that ‘’our way of life – be it our working life, our social life
or our home life – deserves to be constantly improved’’

WHAT KAIZEN WILL DO TO BUSINESS?

 Continual Improvement for Your Product & Services

 Delivers a Competitive Advantage
 Encourages Grassroots Thinking
 A Culture of Continual Improvement
 Avoids Information Silos
 Boosts Workplace Productivity
 Enhances Creativity
  Improves Team working
KAIZEN UMBRELLA

As presented by Imai, Kaizen is an umbrella concept that embraces different continuous

improvement. The Kaizen umbrella is a set of methods and approaches that describe this
philosophy: Customer orientation - fulfilling the customer’s needs is our main objective. Total
Quality Control - statistical process control and other statistical tools are necessary to understand
the process

activities on an organization

The continuous cycle of kaizen activity has six phases:

1. Identify a problem or opportunity
2. Analyze the process
3. Develop an optimal solution
4. Implement the solution
5. Study the results and adjust
6. Standardize the solution

KAIZEN ADVANTAGES
Kaizen's focus on gradual improvement can create a gentler approach to change in contrast to big
efforts that may be abandoned due to their tendency to provoke change resistance and pushback.

 Kaizen encourages scrutiny of processes so that mistakes and waste are reduced.
 With fewer errors, oversight and inspection needs are minimized.
 Employee morale improves because Kaizen encourages a sense of value and purpose.
 Teamwork increases as employees think beyond the specific issues of their department.
 Client focus expands as employees become more aware of customer requirements.
 Systems are in place to ensure improvements are encouraged both in the short and long
terms.
KAIZEN DISADVANTAGES

 Companies with cultures of territorialism and closed communication may first need to
focus on cultural changes to create a receptive environment.
 Short-term Kaizen events may create a burst of excitement that is shallow and short-lived
and, therefore, is not sustained.
EXAMPLES OF KAIZEN

Toyota is arguably the most famous for its use of Kaizen, but other companies have successfully
used the approach. Here are the examples:

Lockheed Martin. The aerospace company is a well-known proponent of Kaizen. It has used the
method to successfully reduce manufacturing costs, inventory and delivery time.

Ford Motor Company. When lean devotee Alan Mulally became CEO of Ford in 2006, the
automaker was on the brink of bankruptcy. Mulally used Kaizen to execute one of the most
famous corporate turnarounds in history.

POKA-YOKE
Poka-yoke is a Japanese term that means "mistake-proofing" or "inadvertent error prevention".
A poka-yoke is any mechanism in a process that helps an equipment operator avoid mistakes and

defects by preventing, correcting, or drawing attention to human errors as they occur.

(Pronounced PO-ka yo-KAY)

Poka yoke has 2 status and 3 functions

Status:

 The error will happen

 The error has happened
Functions:

 Stop
 Check
 Alarm
WHEN TO USE MISTAKE PROOFING

When a process step has been identified where human error can cause mistakes or defects to
occur, especially in processes that rely on the worker’s attention, skill, or experience In a service
process, where the customer can make an error which affects the output At a hand-off step in a
process, when output (or for service processes, the customer) is transferred to another worker
When a minor error early in the process causes major problems later in the process When the
consequences of an error are expensive or dangerous
HOW TO IMPLEMENT? (STEPS)

BENEFITS OF POKA YOKE

While the obvious reason for applying Poka Yoke principle is the quality of what is produced,
there are other benefits.

 Workers will need less training, because the process they are now following will
automatically correct any deviation from what is required.
 Increased safety where work is done with hazardous materials or in risky conditions, such
as working with electricity or petrochemicals.
 quality checks by sampling and inspection can be reduced, because the elimination of
mistakes is built into the process, either b prediction or by detection
 the work will be less repetitive and boring because of the removal of some of the
inspection that was needed before
 Quality-based work and continuous improvement become a way of life.
 No defective items, or very few, are produced, thus reducing waste and costs
 Confidence levels in the product(s) are improved, because stakeholders know that the
production process eliminates or radically reduces defects being produced
 QUALITY SYSTEMS

QUALITY MANAGEMENT SYSTEM (QMS) : (QMS) is a system that documents the policies,
business processes, and procedures necessary for an organization to create and deliver its
products or services to its customers, and therefore increase customer satisfaction through high
product quality. In short, a QMS helps a company meet its regulatory requirements and customer
requirements, and make continuous improvements to its operations.

ISO (International Organization of Standardization)

The International Organization of Standardization (ISO) was founded in 1946 in Geneva,

Switzerland. The development of International Standards is to facilitate the exchange of goods
and services worldwide. ISO consists of more than 90 country members. The ISO Technical
Committee (TC) developed a series of International Standards for Quality Systems, which were
first published in 1987. The standards (ISO 9000,9001, and 9004) were intended to be advisory
and developed for use in two-party contractual situations and internal auditing. These
standards were adopted by European Community and have been accepted worldwide with
emphasis on quality and economic competitiveness. The fourth edition of ISO 9001 was released
in the year 2008 and it replaces the third edition (ISO9001 : 2000), which have been amended to
clarify the points in the text and also to enhance the compatibility with ISO 14001 : 2004. Most
countries have adopted ISO 9000 series as their national standards.

WHAT IS THE INTERNATIONAL ORGANIZATION FOR STANDARDIZATION

(ISO)?

The International Organization for Standardization (ISO) is an international nongovernmental

organization made up of national standards bodies; it develops and publishes a wide range of
proprietary, industrial, and commercial standards and is comprised of representatives from
various national standards organizations.

The organization's abbreviated name—ISO—is not an acronym; it derives from the ancient
Greek word ísos, meaning equal or equivalent. Because the organization would have different
acronyms in different languages, the founders of the organization decided to call it by the short
form ISO

Understanding the International Organization for Standardization (ISO)

The International Organization for Standardization was founded in 1947 and is headquartered in
Geneva, Switzerland. The organization began in the 1920s as the International Federation of the
National Standardizing Associations (ISA). After being suspended during World War II, the
United Nations Standards Coordinating Committee (UNSCC) proposed a new global standards
body and the International Organization for Standardization was formed. The ISO works in 165
countries. Members of the organization are the foremost standards organizations in their
countries; there is only one member per country. While individuals and companies cannot
become members of ISO, there are various ways that industry experts can collaborate with the
ISO.

Members of ISO meet annually at a General Assembly to discuss the strategic objectives of the
organization. In addition, there is a 20-person council with rotating membership that provides
guidance and governance for the organization. ISO develops and publishes standards for a vast
range of products, materials, and processes. The organization's standards catalog is divided into
approximately 97 fields, which include healthcare technology, railway engineering, jewelry,
clothing, metallurgy, weapons, paint, civil engineering, agriculture, and aircraft. In addition to
producing standards, ISO also publishes technical reports, technical specifications, publicly
available specifications, technical corrigenda, and guides.

The ISO plays an important role in facilitating world trade by providing common standards
among different countries. These standards are intended to ensure that products and services are
safe, reliable, and of good quality. For the end-user and consumer, these standards ensure that
certified products conform to the minimum standards set internationally. The ISO has been
credited with setting more than twenty thousand standards, ranging from manufactured products
and technology to food safety, agriculture, and healthcare standards.

In some cases, "ISO" is used to describe the product that conforms to an ISO standard as a result
of the ubiquity of these standards. For example, the speed of film, or the sensitivity of a
photographic film to light, is referred to by its ISO number (ISO 6, ISO 2240, and ISO 5800).
SOME STATISTICS

Members

 148 national standards bodies

 97 member bodies
 36 correspondent members
 15 subscriber members

Technical Committee structure

 2981 technical bodies

 188 technical committees
 546 subcommittees
 2224 working groups and
 23 ad hoc study groups

n Staff
Technical secretariats

 37 member bodies provide the administrative and technical services for the secretariats of
technical committees (TC) and subcommittees (SC) These services equal a full-time staff
of 500 persons

Central Secretariat
Geneva

 151 full-time staff from 24 countries coordinate

 140 million CHF per year is estimated as the operational expenditure for the ISO work

How are ISO standards developed?

The International Organization for Standardization has a six-stage process for developing
standards. The stages include the following:
  Proposal stage. The first step in developing a new standard starts when industry
associations or consumer groups make a request. The relevant ISO committee determines
whether a new standard is indeed required.

 Preparatory stage. A working group is set up to prepare a working draft of the new
standard. The working group is composed of subject matter experts and industry
stakeholders; when the draft is deemed satisfactory, the working group's parent
committee decides which stage occurs next.

 Committee stage. This is an optional stage during which members of the parent
committee review and comment on the draft standard. When the committee reaches
consensus on the technical content of the draft, it can move to the next stage.

 Enquiry stage. The draft standard at this stage is called a Draft International Standard
(DIS). It is distributed to ISO members for comments and, ultimately, a vote. If the DIS is
approved at this stage without any technical changes, ISO publishes it as a standard. If
not, it moves to the approval stage.

 Approval stage. The draft standard is submitted as a Final Draft International Standard
(FDIS) to ISO members. They vote to approve the new standard.

 Publication stage. If ISO members approve the new standard, the FDIS is published as
an official international standard.

ISO participating members vote on standards approvals. A standard must receive affirmative
votes from at least two-thirds of participating members and negative votes from no more than
one fourth of participating members.

What is ISO certification?

As it relates to ISO standards, certification is a certifying body's assurance that a service, product
or system meets the requirements of the standard. While ISO develops the standards, third-party
certification bodies certify conformity with those standards.

According to the ISO, the phrase "ISO certification" should never be used to indicate that a
product or system has been certified by a certification body as conforming to an ISO standard.
Instead, ISO suggests referring to certified products or systems using the full identification of the
ISO standard.

For example, instead of "ISO certified", ISO recommends using the phrase "ISO 9001:2015
certified." This fully identifies the standard being certified, including the version -- in this case,
the version of ISO 9001 released in 2015.

While ISO does not do certifications, its Committee on Conformity Assessment works on
standards related to the certification process.

How do businesses become ISO certified?

The process of getting certified for an ISO standard can be expensive, time-consuming and
potentially disruptive to the business. Before taking any steps to get certified, determining the
need for certification can be the most important step.

The first step in becoming certified is determining whether certification is worth the costs. Some
reasons that organizations pursue certifications include the following:

 Regulatory requirements. Some businesses and products require certification that they
meet common standards.

 Commercial standards. When certification is not a regulatory requirement, products and

services that are certified to meet minimum standards are a necessity for some industries.

 Customer requirements. Even where there is an industry standard or regulatory

requirement for certification, some customers such as government agencies, may prefer
or require certification.

 Improved consistency. Certification can help large organizations deliver

consistent quality assurance across business units as well as across international borders.

 Customer satisfaction. Enterprise customers that use a product or service in different

contexts and countries appreciate consistent performance. Compliance with standards can
also help the certified organization resolve customer issues.
The certification process for ISO standards varies, depending on the standard and the certifying
body. For popular standards, organizations may need to first review and select a suitable
certification body.

ISO 9000 SERIES OF STANDARDS.

ISO 9000: 2005 - Quality Management Systems (QMS) – Fundamentals and Vocabulary
discusses the fundamental concepts related to QMS and provides the terminology used in the
other two standards
ISO 9001 : 2008 – Quality Management Systems (QMS) – Requirements is the standards
used registration by demonstrating conformity of the QMS to customers, regulatory and
organization‟s own requirements.
ISO 9004 : 2000- Quality Management Systems (QMS) – GUIDELINES FOR
PERFORMANCE IMPROVEMENT provides guidelines that an organization can use to
establish a QMS focused on improving performance.
ISO 9001
Design, Development, Production, Installation & Servicing
ISO 9002
Production, Installation & Servicing
ISO 9003
Inspection & Testing
ISO 9004
Provides guidelines on the technical, administrative and human factors affecting the product or
services.
WHAT ISO DOES?

 ISO does not carry out ISO 9001 or ISO 14001 certification.
 ISO does not issue certificates.
 ISO does not accredit, approve or control the certification bodies.
 ISO develops standards and guides to encourage good practice in accreditation and
certification.
  ISO 9001 and ISO 14001 are among ISO's most well known standards ever.
 They are implemented by more than a million organizations in some 175 countries.
 ISO 9001 helps organizations to implement quality management.
 ISO 14001 helps organizations to implement environmental management.
 Both ISO 9001 and ISO 14001 concern the way an organization goes about its work.
 They are not product standards.
 They are not service standards.
 They are process standards.
 They can be used by product manufacturers and service providers.

CLAUSES (ELEMENTS) OF ISO 9000 (During the year 2000)

1. Scope

2. Normative Reference

3. Terms and Definitions

4. Quality Management System (QMS)

4.1 General Requirements

4.2 Documentation

5. Management Responsibility

5.1 Management Commitment

5.2 Customer Focus

5.3 Quality Policy

5.4 Planning

5.5 Responsibility, Authority and Communication

5.6 Management Review

6. Resource Management
6.1 Provision of Resources

6.2 Human Resources

6.3 Infrastructure

6.4 Work Environment

7. Product Realization

7.1 Planning of Product Realization

7.2 Customer related processes

7.3 Design and Development

7.4 Purchasing

7.5 Production and Service Provision

7.6 Control of Monitoring and Measuring devices

8. Monitoring and Measurement

8.1 General

8.2 Monitoring and Measurement

8.3 Control of Non-Conforming Product

8.4 Analysis of Data

8.5 Improvement
STRUCTURE OF ISO 9000

BENEFITS

For businesses

 suppliers can base the development of their products and services on specifications that
have wide acceptance in their sectors
 free to compete on many more markets around the world

For customers

 worldwide compatibility of technology

 wide choice of offers & competitor prices

For governments

 health, safety and environmental legislation

For trade officials

 level playing field for all competitors

 technical barriers to trade

For developing countries

 international consensus of technological know-how

  right decisions in investing their scarce resources

For consumers

 provides assurance about their quality, safety and reliability

For everyone

 quality of life in general

For the planet

 International Standards on air, water and soil quality, and on emissions of gases and
radiation

ISO 14000: Environmental Standards

ISO 14000

Concepts of ISO 14001:2004 Standards

ISO 14001:2004 is standards is the heart of all the environmental standards. This standard
provides organizations with the elements of for an environmental systems, which can be
integrated into other management systems to help achieve environmental and economic goals.
This standard provide guidelines for registration and/or self-declaration of the organization’s
environmental management systems. This standard is written in a manner that it can be
applicable to all types and sizes of organizations. This standard is also capable to accommodate
diverse geographical, cultural, and social conditions. The demonstration of successful
implementation of the system can be used to assure other parties that an appropriate EMS is in
place.

ISO 14001:2004 works as follows:

 ISO14000 is generic in nature. It does not intend to specify the level of environmental
performance of an organization. If that had been the case, ISO would have written it according to
the specific activity of each business.
 However, ISO has developed many other environmental standards that deal with specific
environmental standards. These standards are beyond the scope of ISO14001:2004 standards at
the moment.
 ISO14001:2004 provide a framework to the organizations so that they could communicate
about EMS matters with the other stakeholders including customers, environmental regulators,
the public and so forth.
 It also provides framework to the organizations-irrespective of their current level of
environmental maturity-to remain committed for environmental management and its continual
improvement as well.
ISO 14000, the Environmental Management Systems (EMS).
The overall aim of the Environmental Management systems is to provide protection to the
environment and to prevent pollution.
 The success of ISO 9000 along with increased emphasis on Environmental issues were
instrumental in ISO‟s decision to develop Environmental Management Standards.
 In 1991, ISO formed the Strategic Advisory Group on the Environment (SAGE) which led to
the formation of Technical Committee (TC) 207 in 1992. Mission of TC207 is to develop
standards for an Environmental Management System (EMS) which was identified as ISO 14000.

 TC 207 has Established six sub-committees

1. Environmental Management System (EMS)

2. Environmental Auditing (EA)
3. Environmental labeling (EL)
4. Environmental Performance Evaluation (EPE)
5. Life-Cycle Assessment (LCA)
6. Terms & Definitions
Environmental Management System (EMS) :
EMS has two Evaluation Standards. They are
1. Organization Evaluation Standards
2. Product Evaluation Standards
REQUIREMENT OF ISO 14001
1. GENERAL REQUIREMENTS
 EMS should include policy, planning implementation & operation, checking & corrective
action, management review.
2. ENVIRONMENTAL POLICY (Should be based on mission)
 The policy must be relevant to the organization‟s nature.
 Management‟s Commitment (for continual improvement & preventing pollution).
 Should be a framework (for Environmental objectives & Targets).
 Must be Documented, Implemented, & Maintained.
3. PLANNING
 Environmental Aspects
 Legal & other Requirements
 Objectives & Targets
 Environmental Management Programs
4. IMPLEMENTATION & OPERATION
 Structure & Responsibility
 Training, Awareness & Competency
 Communication
 EMS Documentation
 Document Control
Operational Control
 Emergency Preparedness & Response
5. CHECKING & CORRECTIVE ACTION
 Monitoring & Measuring
 Nonconformance & Corrective & Preventive action
 Records
 EMS Audit
6. MANAGENMENT REVIEW
 Review of objectives & targets
 Review of Environmental performance against legal & other requirement
 Effectiveness of EMS elements
 Evaluation of the continuation of the policy
BENEFITS OF ENVIRONMENTAL MANAGEMENT SYSTEM:

GLOBAL BENEFITS

 Facilitate trade & remove trade barrier

 Improve environmental performance of planet earth
 Build consensus that there is a need for environmental management and a common
terminology for EMS
ORGANIZATIONAL BENEFITS

 Assuring customers of a commitment to environmental management

 Meeting customer requirement
 Improve public relation
 Increase investor satisfaction
 Market share increase
 Conserving input material & energy
 Better industry/government relation
 Low cost insurance, easy attainment of permits & authorization
WHAT IS ISO 21001?

ISO 21001 is a quality management system that aims to standardise education management to
ensure it meets learners’ needs. It’s intended to help schools, colleges, training providers and
other educational organisations implement best practice. It is based on the widely followed ISO
9001 quality management systems.
Around the world, education quality varies significantly. This means that in some cases, learners
are not receiving the best level of education available. As an Educational Organisation
Management System (EOMS), ISO 21001 attempts to address this problem. To do so, it
emphasizes several concepts related to education management best practice:

 Education quality depends on trained facilitators/teachers

 A learner-centric approach is valued

  Good resources and facilities are provided

 Curriculum and material is relevant to learners

 Family and societal support is offered

 Gender-sensitive design is incorporated

 A safe and conducive learning environment

The standard aims to help educational establishments improve quality by incorporating these
concepts and objectives into their teaching and training methods. ISO 21001 also recognises that
technology is revolutionising every facet of the education system, from streamlining homework
assignments and marking to giving special needs students more personalised support.

WHY IS ISO 21001 CERTIFICATION IMPORTANT?

ISO 21001 certification is intended to ensure that education providers are offering the highest
quality instruction available to learners. In the coming years, ISO 21001 will be increasingly
recognised as an independent measure of an education provider’s quality. Therefore, any
organisation that offers teaching and training will benefit from having their education

management assessed against the standard.

BENEFITS OF THE ISO 21001 EOMS INCLUDE:

 ISO 21001 certification empowers you to deliver more effective and efficient educational
services, offering a customised experience to every learner, while supporting people with
special educational needs.

 ISO 21001 helps educational organisations to ensure that learners receive the desired
quality of education, while improving the learner’s productivity, safety and wellbeing.

 Enhance competitiveness and credibility – by implementing an effective EOMS, which

complements a learner-centric approach.
  Sustainable growth – a powerful EOMS addresses the education sector’s key challenges,
leaving you better positioned to appraise and realise new opportunities.

 Enhance brand reputation – an internationally recognised certificate from TÜV SÜD

promotes your brand image and improves company morale

WHAT IS SIX SIGMA?

Six Sigma is a quality management methodology used to help businesses improve current
processes, products or services by discovering and eliminating defects. The goal is to streamline
quality control in manufacturing or business processes so there is little to no variance throughout

Six Sigma is a data-based methodology to improve performance by reducing variability. It

requires thorough understanding of product and process knowledge and is completely driven by
customer expectations.

EVOLUTION OF SIX SIGMA

The need for process improvements and a continuous improvement methodology like Six Sigma
came into existence only due to

 Rising customer expectations in terms of quality, delivery and cost,

 Global competition - Japanese and Chinese threats,

 Proven technique for quantum jumps in business results.

Six Sigma was trademarked by Motorola in 1993, but it references the Greek letter sigma, which
is a statistical symbol that represents a standard deviation. Motorola used the term because a Six
Sigma process is expected to be defect-free 99.99966 percent of the time — allowing for 3.4
defective features for every million opportunities. Motorola initially set this goal for its own
manufacturing operations, but it quickly became a buzzword and widely adopted standard.

Six Sigma is specifically designed to help large organizations with quality management. In 1998,
Jack Welch, CEO of GE, helped thrust Six Sigma into the limelight by donating upwards of $1
million as a thank you to the company, recognizing how Six Sigma positively impacted GE’s
operations and promoting the process for large organizations. After that, Fortune 500 companies
followed suit and Six Sigma has been popular with large organizations ever since.

GOALS OF SIX SIGMA

 To reduce variation
 To reduce defects /rework
 To improve yield /productivity
 To enhance customer satisfaction
 To improve the bottom-line
 To improve top-line
 Shortening cycle-time

WHAT IS SIGMA AND WHY IS IT SIX SIGMA?

Mean is the arithmetic average of a process data set.
Central tendency is the tendency of data to be around this mean.
Standard Deviation (also known as Sigma or σ) determines the spread around this
mean/central tendency.

The more number of standard deviations between process average and acceptable process limits
fits, the less likely that the process performs beyond the acceptable process limits, and it causes a
defect. This is the reason why a 6σ (Six Sigma) process performs better than 1σ, 2σ, 3σ, 4σ, 5σ
processes.

Obviously 7 or more σ processes are even better than a 6σ (Six Sigma) process, and yet
throughout the evaluation and history of Six Sigma process, the practitioners gained the belief
that a 6σ process is good enough to be reliable in almost all major situations except some
systems whose defects can cause unrepairable consequences.

LSL and USL stand for “Lower Specification Limit” and “Upper Specification Limit”
respectively. Specification Limits are derived from the customer requirements, and they specify
the minimum and maximum acceptable limits of a process.
For instance in a car manufacturing system the desired average length (Mean length) of car door
can be 1.37185 meter. In order to smoothly assemble the door into the car, LSL can be 1.37179
meter, and USL can be 1.37191 meter. To reach a 6σ quality level in such a process, the standard
deviation of car door length must be at most 0.00001 meter around the mean length.

Sigma is also the capability of the process to produce defect free work. Higher the capability,
lower the defects.

In the above figure, the red curve indicates a 2σ level of performance where we observe that its
peak is very low (fewer outputs are around the desired average) and the variation is from extreme
left to extreme right of the figure. If the process improves from 2σ to 3σ (green curve), you will
observe that the process variation reduces and the process has a larger peak (more outputs are
around the desired average, but a different average than red curve). As the process performance
increases from 3σ to 6σ (blue curve), the process becomes centered between the upper and lower
specification limits and does not have much variation. Here with blue curve the majority of
process outputs are around the desired average. This is why it is good and it causes less defects
beyond the lower and upper specification limits.

DIFFERENT SIGMA LEVELS AND DEFECTS

Sigma Level Defects/Million Percentage Defects

1 691462 69%
 2 308538 31%

3 66807 6.7%

4 6210 0.62%

5 233 0.023%

6 3.4 0.00034%

7 0.019 0.0000019%

In the above table, you will observe that as the Sigma level increase the Defects decrease. For
example, for a 2σ process the Defects are as high as 308,538 in one million opportunities.
Similarly, for a 6σ process the Defects is as low as 3.4 in one million opportunities. The 2σ
performance level will have more defects than a system in 6σ performance level as the standard
deviation for a 2σ process is much larger than the standard deviation for a 6σ process.

SIX SIGMA IMPLIMENTATION METHODOLOGIES

DMAIC (Define, Measure, Analyze, Improve, Control) is used to correct a process that already
exists.
DMADV (Define, Measure, Analyze, Design, Validate) is used to create a new process.

Define Define the problem.

Define the customer(s) and the requirements.
Define the current capability.
Define the key processes that will have the greatest impact on
customer.

Measure Identify the statistical measures to monitor the key process.

Set up the data collection plan.
Measure the process

Analyse Determine the analysis tools and methods to be used.

Summarize the data measured.
Run the analysis and determine the root causes, effects, etc.
Improve Improve and Implement.
Focus on developing process/technology to improve the root
cause.
Test the method on sample process and validate the
improvement.

Control Standardize and document the process and implement the plan.
Monitor the process and feedback the results back to the process
for continuous improvement.
LEVELS OF EXPERTISE IN SIX SIGMA

The belts in martial arts were adapted to recognize the different levels of expertise in six sigma.
The belts in order of expertise are:

WHITE BELT

 White belt training introduces to the basic six sigma concepts including quality and
process thinking.
 White belt training is knowledge-based training.
 An introductory overview of six sigma is given in white belt training.
 White belt training motivates interest and understanding in six sigma.
YELLOW BELT

 In yellow belt training, DMAIC methodology is introduced.

  The simple process and quality tools used are taught. For example, the concept of
variation, voice-of-customer aanalysis, process mapping, and brainstorming for root
cause analysis.

 Yellow belts are trained to lead and facilitate improvement sessions using these tools.

 They also serve as team members on a green belt DMAIC project

GREEN BELT

 Green belt training takes participants through each phase of DMAIC.

 In addition to process and quality tools, data analysis through statistics is taught.

 Green belt participants come into training with the DMAIC project already assigned to
them.

 They will apply what they learn to their projects in training sessions.

 Green belt participants are trained to lead and carry out DMAIC projects on a part-time
basis

BLACK BELT

 Black belts are full time six sigma specialists.

 They lead and carry out complex projects assigned to them by senior management.

 They are given training in advanced quality and statistical tools which are used in six
sigma.

 For example, process capability, inferential statistics, and design of experiment(DOE)

MASTER BLACK BELT

 Master black belt receives additional training like advanced statistical analysis, process
simulation, project management, and change management.

 They serve as six sigma trainers and coaches to the rest of the organization.

SIX SIGMA BENEFITS

 Reducing Waste
 Improving Time Management
 Increase Customer Loyalty
 Boost Employee Motivation
 Higher Revenues and Lower Costs
QUALITY AUDIT

Definition

Quality audit is a process of examination and verification of procedures, records, and activities of
a quality system that is carried out by an audit team or an internal or external quality auditor.
Quality audit is considered an integral part of the quality management system and is considered
as a critical component in the ISO quality system standard ISO 9001

Meaning

Quality audit is described as a documented examination that is independently conducted at

periodic intervals. Any failure in proper implementation can be published publicly and result in
the dismissal of quality certification.

Quality audit is a standard monitoring process that ensures proper assessment of a system,
adequate implementation of processes, elimination of problem areas, and boosting the efficiency
of the methods.

TYPES OF QUALITY AUDIT

The various types of quality audits are as follows-

1. Internal quality system audit – As the name suggests, an internal quality system audit is
a tool to measure quality. It evaluates EQMS or Electronic Quality Management System
in an organization to ensure maximum outcomes and highest efficiency levels. The
software manual in this quality audit type is audited so that all the key employees can
access the document and the work instructions are audited so that quality processes can
meet set targets
2. Production Team Audit – In a production team audit, the quality auditors have to
evaluate past activity for escapes, evidence of training and changes to processes. An
organization carries out a production team audit when it needs re-qualifications related to
skill management. It is also conducted when a Certified Operator program or Operator
Acceptance programs are in place.
3. Supplier Audit – This type of quality audit helps an organisation to join forces with its
suppliers directly in real-time. When you conduct a quality audit in the supply chain, it
becomes easier to establish accountability if there is a chance of poor performance. The
company can control the quality of the suppliers and even the sub-tier suppliers by
implementing supplier audits in its system. There is a higher level of transparency
because of quality audit, and this encourages the identification of the areas that needs
improvement via KPIs or Key Performance Indicators. The supplier audit can easily view
purchase order activities like receipts to take the necessary corrective actions.
4. Safety Audits- Safety policies in an organization are a necessity because it can prevent
accidents from happening. If someone is injured, it can mean loss of life or any other
serious issue that can be damaging to the company. A successful safety policy improves
the overall well-being of an employee. Safety audits are aimed at protecting the safety of
the employees in an organization by viewing the plans and designs. It also examines
organizational procedures and reviews equipment operation to ensure routine safety in
the company.
5. Environmental Audit – The environmental audit helps to create a safe environment by
identifying workplace risks. It also ensures that all the employees are using personal
protective equipment and taking the necessary measures in the workplace
6. Facilities Audit – A facilities audit reviews building systems, technology, and
manufacturing equipment to ensure safety. It also helps to identify the improvements that
can encourage quality outcomes
7. Risk Assessment Audit – As the name suggests risk assessment audit helps to create and
implement an effective strategy for risk mitigation. It prioritizes preventive measures and
makes sure that they are implemented as per the need of the hour
8. Regulatory Audit – This type of audits helps to verify compliance with set standards and
regulations. It reviews the data collection method and quality practices to identify the
areas of non-conformance.
9. Design Control Audit – The design control audit helps to review the design plan, output,
and input for proper acceptance. It ensures the recognition of formalized processes in the
workplace so that it can meet acceptable safety and quality standards and perform risk
analysis.
10. Method Validation Audit – The method validation audit ensures standardization of
analytical test methods that are used during the manufacturing process for accuracy and
consistency in case of products