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MODULE - 1
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Syllabus
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Principles and Practice : Definition, basic approach, gurus of TQM, TQM Framework, awareness, defining quality,
historical review, obstacles, benefits of TQM.
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Quality Management Systems : Introduction, benefits of ISO registration, ISO 9000 series of standards, ISO 9001
requirements.
Contents
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1.1 Principles and Practice . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 - 2
Jan.-15, 16, 17, July-15, 16, 17, Marks 14
1.2 Quality Management Standards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 - 9
July-16, Marks 8
1.3 ISO 9000 Quality System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 - 10
1.4 ISO 9000 Series of Standard . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 - 11
Jan.-15, 16, July-15, 16 Marks 10
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Total Quality Management
1-2
1.1 Principles and Practice
Principles and Practice and Quality Management Systems
6.
VTU : Jan.-15, 16, 17, July-15, 16, 17
ISO definition of TQM :
· "Management approach to an organization, centered
· TQM stands for "Total Quality Management". An
on quality, based on the participation of all its
organization uses TQM as a long term approach to
members and aiming at long-term success through
achieving customer satisfaction.
customer satisfaction and benefits to all members of
· Total Quality Management requires all employees of
the
organization
for
improving
the
the organization and to society."
products,
1.1.2 Basic Approach of TQM
processes and services. All employees, no matter
what role, are responsible for quality and quality
· Six concepts of Total Quality Management are :
assurance. When done correctly, the entire business
1.
culture is TQM.
· Management commitment to TQM principles and
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methods
1.1.1 Definitions of TQM
· Various definitions of TQM are :
1.
2.
3.
4.
5.
&
long
term
Quality
plans
for
the
Organization
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2.
Focus on the customer/client
· Customer/client requirements should be considered
Total Quality Management (TQM) is a
management framework based on the belief that
an organization can build long-term success by
having all its members, from low-level workers
to its highest ranking executives, focus on quality
improvement and, thus, delivering customer
satisfaction.
as the top priority, and it is important to always
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remember that it is the customer who defines what
quality is. Keep the customer satisfied at all times.
3.
Quality at all levels of the work force
· Involve all the employees in the organization in the
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quality process. It is very important to make your
"Total Quality Management (TQM) is an
approach to improving the effectiveness and
flexibility of business as a whole. It is essentially
a way of organising and involving the whole
organisation, every department every activity,
every single person at every level."-Oakland
employees understand how the quality process
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works, for they are the ones who will create/sustain
quality, and not you.
4.
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Continuously improve the quality process
· A very critical concept in TQM is to continuously
enhance and refine your quality process.
"Total Quality Management is a combination of
socio-technical process towards doing the right
things (externally), everything right (interally),
first time and all the time with economic viability
considered at each stage of each process."-Zaire
and Simintiras
5.
Treating suppliers as partners
· Have a close relationship with your suppliers, treat
them as if they were partners to your company, this
will better involve them in your quality process,
and they will start appreciating and respecting your
work on TQM, and they will work with you
"TQM is the systematic analysis, but the focus is
turning from a process driven by external
controls through procedure compliance and
enhancement
to
a
process
of
habitual
improvement where control is embedded within
and is driven by the culture of the organisation."
-Foster and Whittle
towards achieving your goals when it comes to
enhancing quality.
6.
Establish
processes
performance
measures
for
the
· Measure the performance of quality process. Use
tools to track your quality process and measure its
"TQM is a strategic approach to produce the best
product and service possible through constant
innovation." -Atkinson
®
Top level support for TQM
performance to see if there is any improvement
needed.
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Total Quality Management
1-3
1.1.3 Gurus of TQM
Principles and Practice and Quality Management Systems
ideas became fundamental to the Japanese, whose
· By definition, a guru is a good person, a wise
industries developed to lead the world. In the USA,
person and a teacher. A quality guru should be all
however, it was not until 1979 that Deming was
of these, plus have a concept and approach to
listened to, when he was working with the Nashua
quality within business that has made a major and
Corporation. Deming has been awarded one of
lasting impact.
Japan’s most distinguished honours, the second
· The implementation of TQM has been strongly
order of the sacred Treasure, for his contribution to
influenced by the writings of Deming (1986), Juran
Japanese quality. The Deming prize and Deming
(1993), Feigenbaum (1993), Ishikawa (1993) and
price for application are awarded by JUSE in
Crosby (1989) which helped us to understand
honour of his contribution to quality.
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· Deming has identified the customer as ‘the most
concept of TQM.
important part of the production line. It will not
1.1.3.1 W. Edwards Deming (1900-1993)
· Dr.
William
suffice to have customers that are merely satisfied
achieved
customers that are delighted with your products
world-class recognition for his contributions to
and services will return again and bring new
quality improvement. He was born in Iowa in
business with them’. It therefore follows that the
October 1900. He received his Ph.D. in mathematical
supplier should develop products and services
physics from Yale University, then joined the US
ahead of customer demands and not wait until the
Department
customer needs them because by then it will be too
physicist.
Edwards
of
Deming
Agriculture
Deming
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as
studied
has
a
under
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mathematical
the
eminent
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late and competitors will have stolen the market.
statistician R.A. Fisher in London, and he was also
· The
Deming
approach
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is
the
systematic
influenced by the originator of statistical process
improvement of quality. Improved quality leads to
control (SPC), Dr. Walter Shewhart.
reduced rework fewer delays and better utilization
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· During 1941 Deming lectured in Statistical Methods
of equipment. As productivity improves and the
to American industrialists, engineers and inspectors
company is able to market better quality at a lower
primarily
The
price, the company is in a good position to provide
programme had a dramatic effect on productivity
security of employment and consequently stay in
involved
in
the
war
effort.
and scrap reduction. When the war was over, these
advances
· Deming’s lectures in the 1950s drew upon his
attributed to failure to get the message through to
statistical background, where one of the central
management.
themes was variability of process. In each process
Japanese
not
sustained,
which
business.
Deming
· Following
were
a visit to Japan, connected with a
census.
Deming
was
invited
by
whether it be a manufacturing or service operation,
the
there are two contributions to variability - those
Japanese Union of Scientists and Engineers (JUSE)
attributable to individual machines or operations
to present a lecture course to Japanese research
(’special causes’), and those related to weakness of
workers, plant managers and engineers on quality
the management systems (’common causes’). It is to
control methods. Deming, learning from previous
the elimination of the common causes that Deming
experience, requested that he should also give a
addresses his ‘fourteen points’.
presentation to Japan’s Chief Executive Officers.
· Deming saw the ‘fourteen points’ as the basis for
During 1950 he spoke to 100 of the industrial
change.
leaders, in 1951 he presented to a further 400. In the
1)
years following, the widespread adoption of his
®
TM
Create
constancy
of
purpose
towards
improvement of product and service, with the
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Total Quality Management
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Principles and Practice and Quality Management Systems
aim to become competitive, to stay in business
and to provide jobs.
The responsibility of the supervisor must be
changed from sheer numbers to quality.
2)
Adopt the new philosophy. We are in a new
economic age, created by Japan, Transformation
of Western management style is necessary to halt
the continued decline of industry. We can no
longer live with commonly accepted levels of
delays, defective materials and workmanship.
b) Remove the barriers that rob people in
management and in engineering of their right to
pride of workmanship. This means, inter alia,
abolition of the annual or merit rating and of
management by objective.
3)
Cease dependence on inspection to achieve
quality. Eliminate the need for mass inspection
by building quality into the product in the first
place using statistical techniques.
4)
5)
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13) Institute a vigorous programme of education and
retraining. New skills are required for changes in
techniques, materials and service.
14) Put everybody in the company to work, to
accomplish the transformation. Define top
management’s commitment to improving quality
and productivity.
End the practice of awarding business on the
basis of price tag. Purchasing must be considered
with the design of product, manufacturing and
sales to work with the chosen supplies, the aim
is to minimize total cost not merely initial cost.
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· In addition to the fourteen points, Deming has
highlighted common obstacles to achieving quality.
These are the seven deadly diseases of which the
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Improve constantly and forever every activity in
the
company,
to
improve
quality
and
productivity and thus constantly decrease costs.
*
lack of constancy of purpose.
*
emphasis an short-term profits.
6)
Institute training and education on the job,
including management.
*
mobility of management.
7)
Institute supervision. the aim of supervision
should be to help people and machines to do a
better job. Supervision must react to adverse
conditions.
*
running a company on visible figures alone.
8)
9)
first four are :
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1.1.3.2 Philip B. Crosby (1926-2001)
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· Philip B. Crosby Snr has obtained world recognition
for
Drive out fear, through effective communication,
so that everyone may work effectively for the
company.
his
consultancy
and
improvement.
approach
to
quality
· After serving in the navy in the Korean War,
Corsby
Break down barriers between departments.
People in research, design sales and production
must work as a team to tackle anything that may
be encounted with the product or service.
become
quality
manager
on
the
first
Pershing Missile Programme. It was here that the
concept of zero defects was born. He worked his
way up through ITT and for fourteen years was
corporate
10) Eliminate slogans, and targets for the work force
asking for zero defects and new levels of
productivity without provision of the methods to
achieve this.
vice-president
with
worldwide
responsibilities for quality. Following, the success of
his book ‘Quality is Free’, published in 1979.
· Crosby advocates a top down approach, this is
11) Eliminate
work
standards
that
prescribe
numerical quotas for the day. Substitute aids and
helpful supervision, using the methods to be
described.
because, like other gurus, he believes that over 80%
12) a) Remove the barriers that rob the hourly
workers of the right to pride of workmanship.
under a Crosby programmes. They then cascade the
®
of problems are management caused and fewer than
20% are caused by workers. For this reason
executives and managers are the first to be educated
concepts to all employees in their organization. The
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Total Quality Management
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Principles and Practice and Quality Management Systems
work groups if possible, if they are complex or
long range they can be referred to a task team
specially established by management.
‘four absolutes’ are the cornerstones of the Crosby
philosophy. They are :
1.
2.
Quality
is
defined
as
conformance
to
requirements. Quality does not mean goodness or
excellence, we should all concentrate on
identifying requirements and improving them.
The system for causing quality is prevention, not
appraisal.
3.
The performance standard must be zero defects,
not ‘that’s close enough.
4.
The measurement of quality is the price of
non-conformance.
Crosby
estimates
that
manufacturing companies spend 25% of turnover
on doing things wrong or reworking and service
companies spend up to 40% on non-conformance.
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Crosby
has
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proposed
fourteen-step approach. This is as follows :
1)
3)
Quality measurement – The method is to display
current and potential non conformance problems
in a manner which can be readily understood
and evaluated. The objective is to evaluate
trends, identify problems and develop corrective
actions.
6)
Employee education – Training, particularly of
supervisors is essential if the ZD launch is to
succeed.
9)
ZD day – The ZD day is an event which ensures
all employees know there has been a change. It is
frequently accompanied by celebrations and
show business razzmatazz.
11) Error cause removal – Employee are encouraged
to submit problems. Management has to react to
these suggestions to maintain the momentum of
the programme.
Management commitment – To make it clear
where management stand on quality. A policy
statement should be agreed by operating
management and implemented.
Quality improvement team – The team is set up
to manage the quality improvement programme.
Members of the team should be drawn from
across the company.
5)
8)
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2)
4)
Zero defect planning – Zero defects (ZD) is a
central plank in the strategy and therefore
planning how to launch and how to gain
employee commitment to this phase is important.
10) Goal setting – Supervisors encourage their work
groups to set improvement goals eg. reduction in
defectives and publish results of improvements.
· The improve quality (and to reduce the price of
non-conformity)
7)
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12) Recognition – All individuals should receive
appreciation for their contribution, the most
effective recognition is not financial but peer
group oriented.
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13) Quality councils – Quality professionals should
meet on a regular basis to develop themes for
improvements.
14) Do it all over again – The quality improvement
programme of never-ending improvement.
1.1.3.3 Joseph M. Juran (1904-2008)
Cost of quality – To define and measure the cost
of quality. This is the sum of failure, appraisal
and prevention costs and according to Corsby it
should be less than 2.5% of sales turnover.
· Juran suggests an organizational approach which
Quality awareness – Quality awareness should
be a low key activity and comprise two activities,
regular management/employee communication
meetings and published information through
posters and house magazines.
second level consists of a breakdown of first level
Corrective action – As problems are identified by
previous steps they should be tackled to prevent
recurrence. Problems should be solved by local
the key aspects of the first quality level involve,
®
focuses on management of two levels. A first level,
oriented
towards
top
management,
emphasizes
quality as the fitness for use by consumers, while a
quality missions into missions oriented towards
departments in the firm. For these departments, it is
then
necessary
to
work
in
accordance
with
specifications designed to achieve the fitness for use,
according to Juran
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Total Quality Management
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Principles and Practice and Quality Management Systems
priorities are set up and relationships between
the firm and the quality strategy are drawn.
1) Product design
2) Conformance to specification
· Throughout these phases, Juran recommends that
3) Availability
training be given a top priority.
4) Reliability
Research
5) Maintainability and
Post
sales
6) Serviceability.
Maintenance
technique
· To achieve it, however, Juran recommends that we
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also follow an unending cycle which is given by
1) Market research
Prototype design
Equipments
2) Product development
3) Design
4) Manufacture and planning
5) Purchasing
6) Production process control
7) Inspection
8) Tests
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Specifications
Manufacturing
plan
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Fig. 1.1.1 Juran’s spiral of quality
1.1.3.4 Genichi Taguchi (1924-2012)
· Dr. Genichi Taguchi is executive director of the
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American Supplier Institute Inc, and also director of
the Japan Industrial Technology Institute. Born in
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9) Sales and finally feedback through market research.
1924, he graduated from Kiryu Technical College
· For Juran, top management is important as it is an
and received a doctorate in science from Kyushu
University in 1962.
essential actor in the everlasting process of market
· Taguchi
research to manufacture to sales. For the quality
joined
Laboratory
management process, Juran proposes three phases –
the
(ECL)
of
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Electrical
Nippon
Communications
and
Telegraph
The Control Sequence, which seeks to solve
sporadic problems. This is in essence the function
of quality control. Here statistical techniques as
well as tolerance fool proofing are used.
Company in 1949 and worked there until 1961 to
b) The Breakthrough sequence, which consists of
quality
improvement
by
solving
chronic
problems. To do so, Juran recommends that we
use the ‘Universal process’ for quality
improvement, consisting of study the symptoms,
Diagnose the causes and Apply remedies. In this
sequence, Juran advocates a project-by-project
improvement. At any time, many such projects
are ongoing simultaneously. The breakthrough
sequence requires a breakthrough in attitudes.
associate. He returned to Japan and was a Professor
a)
c)
improve the productivity of the ECL’s research and
development activities. He went to the USA in 1962
and visited Princeton University as a research
at Aoyama Gakuin University in Tokyo until 1982.
During which time he served as a consultant to
major Japanese corporations such as Toyota Motors,
Fuji Film and Nippondenso.
· His major contribution has involved combining
engineering and statistical methods to achieve rapid
improvements in costs and quality by optimizing
product design and manufacturing processes.
Institutionalization of the review process over the
quality management process. In such a program,
short and long-term goals are made explicit,
®
· Taguchi’s techniques aim to go a stage further than
the principles of eliminating causes of problems, by
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Total Quality Management
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· Dr.
allowing the user to design products or processes
that are insensitive to causes.
followed
other
quality
control
Deming the creator of Plan-Do-Check-Act model. As
a matter of fact he expanded that into a 6 step plan
· In 1960 Taguchi had shown that if the design intent
from a 4 :
1. Determine goals and targets
of the target value was the value at which the
design, whether product or process, functioned best,
then any deviation from that value meant an
deterioration
Ishikawa
believers as well. One of those was W. Edwards
Taguchi Loss Function
incremental
Principles and Practice and Quality Management Systems
of
performance
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and
incurred a loss. This loss was passed on to the next
customer, whether internal or external, so that
ultimately both the company and society would
experience that loss in some way.
to a point where the customer would find the
· It can be seen that any deviation from target value
of a critical characteristic may now be evaluated not
Implement the work
5.
Chuck the effects of implementation
6.
Take appropriate action.
2.
Histogram
3.
Flow chart
4.
Run chart
5.
Scatter diagram
6.
Pareto chart.
· TQM framework consists of important blocks.
Upper specification
limit
L = k(y–T)
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1.1.4 TQM Framework
only in dimensional terms but also in financial ones.
Loss
(`)
Engage in education and training
4.
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product no longer acceptable and go for sourcing
Lower specification
limit
3.
quality tools :
1. Control chart
loss increase parabolically as the deviation increases
elsewhere. This concept is shown in Fig. 1.1.2.
Determine methods of reaching those goals
· Dr. Ishikawa highly believed in the strength of six
· Close to the target value, the loss is minimal, but
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2.
2
Y = Measurement of
requirement
T
(Target value)
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1.
Gurus of quality : Shewhart, Deming, Juran
figenbaum, Ishikawa, Crosby and Taguchi.
2.
Principles and practices : Leadership, customer
satisfaction, employee involvement, supplier
partnership.
3.
Tools and techniques : Benchmarking, Quality
management
systems,
Quality
function
deployment quality by design. Management
tools, Failure mode and effect analysis. Statistical
process control.
4.
Product or service realization : Continuous
process improvement performance measures.
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· Fig. 1.1.3 shows a typical TQM framework.
Fig. 1.1.2 Loss function (Taguchi)
1.1.3.5 Kaoru Ishikawa (1915-1989)
TQM gurus
Tools and
techniques
Principles
and
practices
Product or
service
realization
· Kaoru Ishikawa is considered the Father of Japanese
Quality. He invented the Fishbone diagram (cause
and effect diagram) and CWQC - Company Wide
Quality Control. He also sponsored the concept of
"next operation (process step) as the client" to avoid
workplace politics.
®
Fig. 1.1.3 TQM framework
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Total Quality Management
1-8
1.1.5 Awareness of TQM
Principles and Practice and Quality Management Systems
1.
Garvin classified the definition of Quality into
five major groups. Those were transcendent,
product-based, user-based, manufacturing-based,
or value-based.
2.
Juran and Gryna, defined Quality as - Fitness for
purpose of use.
3.
Crosby defined Quality as - Conformance to
requirement.
4.
Gilmore defined Quality as - Conformance to
specification.
5.
Parasuraman defined Quality as - meeting and/or
exceeding customer's expectation.
6.
Besterfield defined Quality as - performance
over expectation
7.
Crosby defined Quality as - Zero defect products
or services
· An organisation will not begin the transformation to
TQM until it is aware that the quality of the
product or service must be improved.
· Awareness comes about when an organisation loses
market
share
or
realises
that
quality
and
productivity go hand-inhand.
· It also occurs if TQM is mandated by the customer
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or if management realises that TQM is a better way
to run a business and compete in domestic and
world market.
· Automation and other productivity enhancements
might not help a corporation if it is unable to
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market its product or service because the quality is
poor. The Japanese learned this fact from practical
experience.
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· Prior to World War II, they could sell their products
only at low prices, and even then it was difficult to
secure repeat sales. Until recent, corporations have
not recognised the importance of quality.
8.
Taguchi defined Quality as - Ability to perform
to its intended function without harmful effect.
9.
The totality of features and characteristics of a
product or service that bear on its ability to
satisfy stated or implied needs' - Quality
Vocabulary Part 1, International terms.
· However, a new attitude has emerged the quality
first among the equals of cost and service. Quality
and
productivity
are
not
mutually
increased productivity and other benefits.
improvement
conformance
of
the
is
not
product
limited
or
to
the
service
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10. The total composite product and service
characteristics
of
marketing,
engineering,
manufacture and maintenance through which the
product and service in use will meet the
expectation by the customer' - Feigenbaum
exclusive.
Improvements in quality can lead directly to
· Quality
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to
1.1.7 Barriers to TQM
specifications; it also involves the inherent quality in
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· There are several causes that creates barrier to TQM
the design of the system.
implementation. Some important obstacles are listed
· The prevention of the product, service, and process
below.
problems is a more desirable objective than taking
1.
Lack of understanding of the TQM concepts.
2.
Inadequate management support and resources
for TQM.
3.
Lack of employees commitment.
is no universally accepted definition of
4.
Inadequate planning for quality.
quality and seems to be no consensus definition
5.
Poor internal communication and co-ordination.
even though most of these definitions are correlated,
6.
Poor leadership style and ineffective motivation.
7.
Improper education and training to employees.
8.
Irregularities in conducting meetings.
corrective action after the product is manufactured
or a service rendered.
1.1.6 Definition of Quality
· There
but there exists similarities and common elements.
· Quality
can be defined in many ways, some
definitions are ®
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Total Quality Management
9.
1-9
Ineffective measurement techniques for objectives
and goals.
10. Delay in implementing recommendation
quality improvement team.
Principles and Practice and Quality Management Systems
10.Briefly explain
Management.
of
principles
of
Total
Quality
VTU : July-16, Marks 5
11. Briefly explain with suitable examples, 'The
Deming Philosophy'.
VTU : July-16, Marks 8
11. Not applying proper tools and techniques.
12. Define Total Quality Management and discuss
briefly the various dimensions of Quality.
1.1.8 Benefits of TQM
VTU : Jan.-17, Marks 10
· Following are some of the important benefits of the
13.With a neat block diagram, briefly explain TQM
frame work.
VTU : Jan.-17, Marks 6
TQM approach for the organization and as well as
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for employees :
1. Higher productivity
2.
Enhancing market image
3.
Increase customer loyalty
4.
High employee morale
5.
Reduce warranty
6.
Organizational development
7.
Solving lack of absenteeism
14.Define TQM. With the help of a block diagram
explain TQM framework. VTU : July-17, Marks 10
asy
15.What are different dimensions of quality ? With
an example of a CNC Lahte explain dimensions of
VTU : July-17, Marks 10
quality.
1.2 Quality Management Standards
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VTU : July-16
· ISO 9000 is a set of five world-wide standards that
8.
Growing profits
9.
Fiscal disciple through eliminating of unnecessary
expenditure
establish
requirements
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for
the
management
of
quality. Unlike product standards, these standards
are for quality management systems.
10. Repeat customers
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· The purpose is to ensure that a certified company
11. Increased job security
has a quality system in place that will enable it to
12. Cost reduction.
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meet its published quality standards.
· The ISO standards are generic in that they apply to
University Questions
all functions and all industries.
1. Define TQM. Explain six basic concepts of TQM.
VTU : Jan.-15, 16, July-15, 16, Marks 10
· The International Organization for Standardization
2. Explain briefly the contributions of any five
GURU's of TQM.
VTU : Jan.-15, Marks 10
(ISO) is the specialized international agency for
3. Explain Deming's 14 points.
national standards bodies of 91 countries.
standardization
and
at
present
comprises
the
VTU : Jan.-15, Marks 14
· The American National Standards Institute (ANSI)
4. Sketch TQM frame work.
VTU : July-15, Marks 5
is the member body representing the United States.
5. What are the obstacles
implementation of TQM?
associated
ISO is made up of approximately 180 technical
VTU : July-15, Marks 5
with
the
committees. Each technical committee is responsible
for one of many areas of specialization, ranging
6. What are the benefits of TQM ?
from asbestos to zinc.
VTU : July-15, Marks 4
· Quality
7. Explain contributions made by any two quality
VTU : Jan.-16, Marks 8
Gurus.
8. Explain benefits of TQM.
system is defined by ANSI as "the
collective plans, activities and events that are
provided to ensure that a product, process or
VTU : Jan.-16, Marks 8
service will satisfy the given needs".
9. Enumerate Deming's 14 principles and explain
VTU : Jan.-16, Marks 10
any two of them.
· Quality
system
is
defined
by
ISO
as
"the
organizational structure, responsibilities, procedures,
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Principles and Practice and Quality Management Systems
processes and resources for implementing quality
Therefore, engineering and construction firms and
management.
manufacturing companies who design, develop,
produce, install and service their products are
1.2.1 Need for ISO 9000
covered under this standard. The quality system
· ISO 9000 is necessary for an organization. It serves
requirements for ISO 9001 are listed in Table. 1.3.1.
following purposes.
1.
To
achieve
and
product/service.
maintain
2.
To improve quality of process
customer and stackholders need.
3.
To provide confidence to management and
employees about fulfillment of quality process.
4.
To provide confidence among consumers and
stack holders that they are using quality
services / products.
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University Question
quality
to
Quality System Requirements
of
meet
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Inspection, Measuring and
Text equipment
Quality System
Inspection and Test Status
Contract Review
Control of Nonconforming
Product
Design Control
Corrective Action
Document Control
Handling, Storage,
Packaging and Delivery
En
gi
1. What is ISO 9000 and its significance and why it
should be adopted ? List ISO 9000 family of
VTU : July-16, Marks 8
standards.
1.3 ISO 9000 Quality System
Management
Responsibility
Purchasing
Quality Records
Purchase Supplied Product
Internal Quality Audits
Product Identification and
Traceability
Training
Process Control
Servicing
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Inspection and Testing
· The purpose of ISO is to promote the development
Statistical Techniques
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et
Table 1.3.1 ISO 9001 Quality Systems
of standardization and related world activities in
· ISO 9002 specifices a model for quality assurance
order to facilitate the international exchange of
goods and services and to develop co-operation in
when only production and installation conformance
interllectual, scientific technological and economic
is required. This standard is particularly relevent to
activities.
process industries where specific requirements for
products are stated in terms of an established
· The results of ISO technical work are published as
design or specification under ISO 9002.
international standards and the ISO 9000 series is a
· ISO
result of this process.
· ISO 9000 is a series of five international quality
standards
developed
by
the
conformance
in
final
organization such as laboratories.
· ISO
basic definitions and is a road map to use the other
9004
contains
guidance
on
technical,
administrative and human factors affecting the
standards in the series.
quality of products and services. This standard
· The ISO 9001, 9002 and 9003 standards are for
provides
external quality assurance purposes for use in
ISO
9001
guidelines
for
developing
and
implementing a quality system.
ensures
1)
conformance to requirements during design and
development, production, installation and servicing.
®
only
the products they supply or divisions within an
Switzerland. The ISO 9000 standard provides some
situations.
requires
shops, equipment distributors that inspect and test
International
Organization for Standardization (ISO) in Geneva,
contractual
9003
inspection and testing. This standard concerns small
TM
ISO 9000 and ISO 9004 provide guidance to all
organizations
for
quality
management
purposes.
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2)
1 - 11
ISO 9001, ISO 9002 and ISO 9003 are used for
external quality assurance purposes in
contractual situations.
3)
Principles and Practice and Quality Management Systems
information system and can also sit comfortably
with production management systems of varying
complexity.
ANSI/ASQC Q90-Q94 are technically equivalent
to ISO 9000-ISO 9004 standards, respectively,
but use customary American language usage
and spelling.
· An
outstanding characteristic of ISO 9000 for
management
controls
to
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of
provides
production
and
VTU : Jan.-15, 16, July-15, 16
it mean to our company and what is involved ? The
· There are various models defined to meet different
short answer to the first is that virtually all
organizations. Three basic models are important.
manufactures, particularly those selling to public
asy
These are -
buyers or to multinationals, are expected to adopt
1.
ISO 9001
done so, so that this so called ‘voluntary’ standard
2.
ISO 9002
is, in fact, becoming mandatory for marketing
3.
ISO 9003
the standard and produce evidence that they have
En
gi
purposes. In the case of service companies now that
ISO 9001 Model - 1
the ISO 9000 services version is being taken up, the
advantage.
their
contents
of
customers
that
conformity
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to
specified
requirements is met throughout the whole cycle
· The answer to the second question of what is
detailed
nee
· ISO 9001 is for those companies that need to assure
adoption of the standard has become a marketing
the
automatically
1.4 ISO 9000 Series of Standard
any company interested in ISO 9000 are what does
in
it
quality
inefficiencies thereby increasing productivity.
· The two most basic questions which are asked by
is
that
delivery and reduces waste, downtime and labour
1.3.1 Scope of ISO 9000
involved
is
ensure
from
two
design to service. This applies particularly
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et
where there is a contract specifically requiring
overviews may be useful. The first is that there are
design and where product requirements are stated
two fundamental elements in adopting ISO 9000.
in performance terms (speed, capacity, integrity).
One is the acceptance and adoption of the ISO 9000
This is the fullest or most complete standard
philosophy and its installations as a standard, in
involving all the quality system elements detailed in
other words becoming an ISO 9000 standard
ISO 9004 at their most stringent.
company, the other element is obtaining the third
party approval or certification which allows a
ISO 9002 Model - 2
company to demonstrate its ISO 9000 status to
· If one has an established design or specification,
this is more appropriate. Here all one has to
buyers and prospectus.
demonstrate is one’s capabilities in production and
· The second overview is that ISO 9000 satisfies a
installation. It is also less stringent than ISO 9001.
number of significant and even critical strategic and
corporate requirements in a changing industrial and
ISO 9003 Model - 3
marketing environment. Chief amongest these are
· Sometimes one can demonstrate only capabilities for
marketing considerations, legal aspects, management
inspection and test, whether the product is supplied
and productivity and changing customer-supplier
from a manufacturer for those requirements. About
relationships.
half of the element of ISO 9004 are required here
· ISO 9000 is a ready-made system for providing the
and an even lower level of stringency than for
kind of integrated but flexible quality management
which
®
can
fit
into
an
overall
Model 2.
management
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Principles and Practice and Quality Management Systems
Element of the SO 9000 service
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SO
9001
Model for design
or development
or production
or installation
and servicing
SO
8402
Vocabulary
SO
9004
Quality management
quality system elements
SO
9000
Guidelines for selection
and use of the standards
SO
9002
asy
Model for
production
and
installation
1.4.1 Elements of the ISO 9000 Series
SO
9003
SO
9004
Model for
final
inspection
and test
The
service
standard
En
gi
Fig. 1.4.1
nee
Document
control
Document
control
Document
control
9002, ISO 9003) and its elements are given in the
Quality records
Quality records
Quality records
following table.
Training
Training
ISO 9001
Statistical
methods
Statistical
methods
· Quality system ISO 9000 models (ISO 9001, ISO
ISO 9002
ISO 9003
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Training
g.n
et
Management
responsibility
Management
responsibility
Management
responsibility
Purchaser
supplied product
Purchaser
supplied product
Quality systems
Quality systems
Quality systems
Corrective action
Correctice action
Product
identification
and traceability
Product
identification
and traceability
Product
idetnification
and traceability
Process control
Process control
Purchasing
Purchasing
Inspection and
testing
Inspection and
testing
Inspection and
testing
Control review
Contract review
Inspection,
measuring and
test equipment
Inspection,
measuring and
test equipment
Inspection,
measuring and
test equipment
Internal quality
audits
Internal quality
audits
Inspection and
test status
Inspection and
test status
Inspection and
test status
Control of
nonconforming
product
Control of
nonconforming
product
Control of
nonconforming
product
Handling,
storage,
packaging and
delivery
Handling,
storage,
packaging and
delivery
Handling,
storage,
packaging and
delivery
®
Statistical
methods
Design control
Servicing
Table 1.4.1 ISO 9000 models and elements
1.4.2 Implementation of Quality Management
System
· Implementation of ISO 900 QMS involves following
steps.
1.
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TOP management commitment
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2.
Appointment of management representative
3.
Create awareness
4.
Appoint an implementation team
5.
Training to team, supervisors
6.
Develop time schedule
7.
Selecting team head
8.
Reviewing present system
9.
Documentation
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referenced by it. The interaction between
processes making up the QMS is also described.
C] Control of documents : All of the documents in
your QMS must be legible, identified, reviewed,
authorized, up-to-date, issued, distributed, and
periodically updated. Obsolete documents have
to be identified and protected from unintended
use. Documents that come from outside the
organization also have to be identified and
controlled.
10. Install new system
D] Control of records : Certain records need to be
kept to demonstrate how the QMS is operating.
These records must be legible, and easy to
identify and retrieve. A written procedure must
describe how they are identified, stored,
protected, retrievable, and define their retention
and disposal times.
11. Internal audit
12. Management review
13. Preassessment
14. Registration
15. Award of ISO 9000 certificate
1.4.3 Requirements of QMS
1.
2.
asy
Principles and Practice and Quality Management Systems
En
gi
1.4.4 Documentation of ISO 9000
· The
General requirements : The Quality Management
System (QMS) is the collection of processes,
documents, resources, and monitoring systems
that direct the work of an organization regarding
product and service quality. The organization
needs to establish, document, carry out, and
maintain this system to meet the requirements
of ISO 9001:2000.
documentation
nee
is
pre-requisite
for
for all employees, management and other agencies
who are involved in implementing QMS.
rin
· Necessary documentation for QMS are :
Documentation requirements
A] General : The organization needs to document –
either electronically or on paper – the quality
policy, quality objectives, and quality manual.
Written procedure, plans, and operations need to
describe how product and service quality is
attained. Certain records, providing evidence of
activities that were carried out (i.e. purchase
orders, sales contracts, inspection records, design
review notes, etc.), have to be retained.
g.n
et
1.
Quality objectives
2.
Quality policy manual
3.
Quality system procedures
4.
Work instructions
5.
Records / formats / forms
· Documentation pyramid is shown in Fig. 1.4.2.
1.4.4.1 Advantages of Documentation
The quantity, detail, and form of the
documentation can differ from one organization
to another depending on size, type of activities,
or complexity of processes.
B] Quality manual : The quality manual describes
the extent of the QMS and may exclude certain
sections of the standard that don’t pertain to the
organization. All of the quality procedures are
either included in the quality manual or are
®
proper
implementing QMS. Documentation is the reference
TM
1.
Documentation provides a reference and
regularises the method of day-to-day activities.
2.
Documentation brings about clarity of objectives
and targets.
3.
Documentation brings consistency in operations.
4.
Documentation facilitates trouble shooting for
tracking processes.
5.
Documentation provides
employees and customers.
6.
Documentation provides basis for continuous
development.
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Total Quality Management
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Quality
manual
The quality manual is the core of the
quality system. It should address each area
of the ISO standard with a basic statement
claiming compliance and how to company
maintains compliance.
Procedures and instruction describe
how all the company's processes are
controlled. Procedures are higher level
documents, while work instruction are
very specific.
Procedures and
instructions
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Principles and Practice and Quality Management Systems
Records must be maintained to
show compliance of the quality
system, for feedback into the quality
system, and historical reasons.
Records
The ISO 9001
Documentation Pyramid
7.
asy
En
gi
Fig. 1.4.2
Documentation demonstrates the ISO quality system certification.
University Questions
nee
1. What are the necessary step to be followed in implementing ISO 9000 ?
2. List the steps in implementation of ISO - 9000.
VTU : Jan.-15, Marks 10
rin
VTU : July-15, Marks 6
g.n
et
VTU : Jan.-16, Marks 10
3. Write a note on documentation of ISO-9000 series.
4. What is ISO 9000 and its significance. Why it should be adopted ? List ISO 9000 family of standards.
VTU : July-16, Marks 8
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