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• PRESENTD BY :-
• PATIL PRANJAY SADASHIV.
• FIRST YEAR M.PHARM.
• DEPARTMENT OF QUALITY ASSURANCE.
H. R. Patel Institute of Pharmaceutical Education
and Research, Shirpur
TOTAL QUALITY MANAGEMENT:
TQM
TOTAL QUALITY MANAGEMENT:
TQM
Origins, Evolution & key elements
What is Quality?
Quality is “fitness for use”
(Joseph Juran)
Quality is “conformance to requirements”
(Philip B. Crosby)
Quality of a product or services is its ability to satisfy
the needs and expectations of the customer
Evolution of Quality Management
Inspection
Quality
Control
Quality
Assurance
TQM
Salvage, sorting, grading, blending, corrective
actions, identify sources of non-conformance
Develop quality manual, process performance
data, self-inspection, product testing, basic
quality planning, use of basic statistics,
paperwork control.
Quality systems development, advanced quality
planning, comprehensive quality manuals, use of
quality costs, involvement of non-production
operations, failure mode and effects analysis, SPC.
Policy deployment, involve supplier & customers,
involve all operations, process management,
performance measurement, teamwork, employee
involvement.
W. E. Deming and the 6 Era’s of Quality
1920’s : New statistical thinking and methods in
manufacturing
1930/40’s : Use of statistical thinking outside
manufacturing
1950/60’s : Systems of improvement
1970/80’s : The fourteen points
Late 80’s : The “New Climate”
1990’s : System of Profound Knowledge
Deming’s view of a production as a system
Consumer
Research
Design &
redesign
Receipt & test of
materials
Suppliers,
materials &
equipment
Production,
assembly,
inspection
Distribution Consumers
Test of processes, machines,
methods, cost
Improve Quality
Productivity improves
Provide jobs and
more jobs
Deming’s Chain Reaction
Cost decreases because
of less rework, fewer
mistakes, fewer delays,
snags, better use of
machine time and
materials
Stay in business
Capture the market with
better quality and lower price
PLAN
CHECK
DOACT
The Deming Cycle or PDCA Cycle
Plan a change to the process. Predict the
effect this change will have and plan how
the effects will be measured
Implement the change on
a small scale and measure
the effects
Adopt the change as a
permanent modification
to the process, or
abandon it.
Study the results to
learn what effect the
change had, if any.
W. Edwards Deming’s 14 Points
Create constancy of purpose towards improvement
of product and services.
Adopt the new philosophy. We can no longer live
with commonly accepted levels of delays, mistakes,
defective workmanship.
Cease dependence on mass inspection. Require,
instead, statistical evidence that quality is built in.
End the practice of awarding business on the basis of
price tag.
1)
2)
3)
4)
W. Edwards Deming’s 14 Points
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 that everyone may work effectively for
the company.
5)
6)
7)
8)
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 his right to pride of workmanship.
9)
10)
11)
12)
W. Edwards Deming’s 14 Points
Institute a vigorous programme of education and
retraining.
Create a structure in top management that will push
everyday on the above 13 points.
13)
14)
W. Edwards Deming’s 14 Points
Deming’s System of Profound Knowledge
Appreciation for
system
Knowledge
about variation
Theory about
knowledge
Knowledge of
psychology
Philip Crosby’s Four Absolutes
Definition : Conformance to
requirements
System of quality is
prevention
Performance Standard :
Zero Defects
Measurement : Price of non-
conformance (PON)
What is Quality?
What system is needed
to cause quality?
What performance
standard should be used?
What measurement
system is required?
Crosby’s Successful Company
Characteristics of the Eternally Successful
Organisation
People do things right routinely
Growth is profitable and steady
Customer needs are anticipated
Change is planned and managed
People are proud to work there
Philip B. Crosby’s 14 Points
Make it clear that management is committed to
quality.
Form quality improvement teams with
representatives from each department.
Determine where current and potential quality
problems lie.
Evaluate the cost of quality and explain its use as a
management tool.
1)
2)
3)
4)
Raise the quality awareness and personal concern of
all employees.
Take actions to correct problems identified through
previous steps.
Establish a committee for the zero defects
programme.
Train supervisors to actively carry out their part of
the quality improvement programme.
5)
6)
7)
8)
Philip B. Crosby’s 14 Points
Hold a ‘zero defects day’ to let all employees realise
that there has been a change.
Encourage all individuals to establish improvement
goals for themselves and their groups.
Encourage employees to communicate to
management the obstacles they face in attaining their
improvement goals.
Recognise and appreciate those who participate.
9)
10)
11)
12)
Philip B. Crosby’s 14 Points
Establish quality councils to communicate on a
regular basis.
Do it all over again to emphasise that the quality
improvement programme never ends.
13)
14)
Philip B. Crosby’s 14 Points
Joseph M. Juran’s Quality Trilogy
Quality Planning
Establish quality goals
Identify customer needs
Translate needs into our
language
Develop a product for
these needs
Optimise product
features for these needs
Quality Control
Prove the process can
produce under
operating conditions
Transfer process to
operation
Quality
Improvement
Seek to optimise the
process via tools of
diagnosis
Juran’s Trilogy Diagram
Quality Planning Quality control (during operations)
Original zone of
quality control
Quality
improve
-ment
New zone
of quality
control
Cost of
Poor
Quality
TIME
20
40
0
0
Lessons learned
1) Identify who are the customers
2) Determine the customer’s needs
3) Translate the needs into our language
4) Develop a product to meet those needs
5) Optimise a product so as to meets our needs
as well as the customer’s.
6) Develop a process which is able to produce the
product
7) Optimise the process
8) Prove the process can make the product
under operating conditions
Juran’s Quality Planning Road Map
Joseph M.Juran and the Cost Of Quality
2 types of costs:
Unavoidable Costs: preventing defects (inspection,
sampling, sorting, QC)
Avoidable Costs: defects and product failures
(scrapped materials, labour for re-work, complaint
processing, losses from unhappy customers
“Gold in the Mine”
Joseph M.Juran and the Cost Of Quality
100% defective Point of “Enough
quality”
Total
Costs
Unavoidable
costs
Avoidable
costs
Costs
Joseph M. Juran’s 10 Points
Build awareness of the need and opportunity for
improvement.
Set goals for improvement.
Organise to reach the goals (establish a quality
council, identify problems, select projects, appoint
teams, designate facilitators)
Provide training.
Carry out projects to solve problems
1)
2)
3)
4)
5)
Report progress.
Give recognition.
Communicate results.
Keep score.
Maintain momentum by making annual
improvement part of the regular systems and process
of the company.
6)
7)
8)
9)
10)
Joseph M. Juran’s 10 Points
What is TQM?
Constant drive
for continuous
improvement and
learning.
Concern for
employee
involvement and
development
Management
by Fact
Result Focus
Passion to deliver
customer value /
excellence
Organisation
response
ability
Actions not just
words
(implementation)
Process
Management
Partnership
perspective
(internal /
external)
Learning
LEARNING AND TQM
Process Improvement
Quality Improvement
Customer
Satisfaction
Shareholder
Satisfaction
Employee
Satisfaction
BASIC PRINCIPLES OF TQM
Approach Management Led
Scope Company Wide
Scale Everyone is responsible for Quality
Philosophy Prevention not Detection
Standard Right First Time
Control Cost of Quality
Theme On going Improvement
FOUR KEY PRINCIPLES
•Measure quality so you can affect it
•Focus on a moving customer
•Involve every employee
•Think long term - Act short term
THE CASE FOR QUALITY
1 Success of competitors who take quality seriously
2 Rising expectations of customers
3 Quality differentiates companies from the
competition
4 Narrowing of supplier bases by quality conscious
companies
.
5 Growing evidence that growth in market
share comes from sustained quality.
6 Cost advantages
7 High cost of catastrophic failure
8 Inspection poor substitute for right first time
THE CASE FOR QUALITY
SEVEN DEADLY SINS OF TQM
•Flight to nowhere
•One size fits all
•Substituting TQM for leadership
•Inside - Out indicators
•Mandatory religion
•Quality kept as a separate activity
•Teaching to the test
Booz-Allen & Hamilton
IS QUALITY A SOUND INVESTMENT?
Year Company Stock Growth (Oct 94)
1988 Motorola 373.0%
1988 Westinghouse (CNFD) - 49.6%
1989 Xerox (BPS) 75.9%
1990 General Motors 1.6%
1990 Federal Express 10.6%
1990 IBM (IBM Rochester) - 34.9%
1991 Selectron 526.9%
1992 AT&T (UCS) 32.2%
1992 AT&T (TSBU) 32.2%
1992 Texas Instruments (DS&E) 106.8%
1993 Zyta 8.4%
1994 Eastman Chemical 18.5%
Total Stock Value £23016 (91.8% growth)
Standard & Poor 500 Stock value £15911 (32.6% growth)
Source: US Dept. of Commerce Study 1995
THE NEW ISO 9000 2000
QUALITY STANDARD
REASONS FOR CHANGE
• ISO Technical
Committee (TC) argue
that:
The main reason for the year
2000 revision is to give users
the opportunity to add value to
activities and to improve their
performance continually by
focusing on the major processes
within the organisation
ISO 9000 2000 CHANGES
• CUSTOMER FOCUSED
ORGANISATION
• LEADERSHIP
• INVOLVEMENT OF PEOPLE
• PROCESS APPROACH
• SYSTEM APPROACH TO
MANAGEMENT
• CONTINUAL
IMPROVEMENT
• FACTUAL APPROACH TO
DECISION MAKING
• MUTUALLY BENEFICIAL
SUPPLIER RELATIONSHIPS
IMPLEMENTATION PRINCIPLES
• MANAGEMENT
RESPONSIBILITY
• RESOURCE
MANAGEMENT
• PRODUCT
REALIZATION
• MEASUREMENT,
ANALYSIS AND
IMPROVEMENT
More clearly defined requirements
• Continual improvement
• increased emphasis on the role of top
management
• establishment of measurable
objectives at relevant functions and
levels
• Monitoring of information of
customer satisfaction and/or
dissatisfaction as a measurement of
the system performance
• Increased attention to resource
availability; determination of
training effectiveness
• Measurement extending to the
system, process, and product
• Analysis of collected data on the
performance of the quality
management system
Quality is a Journey,
not a Destination

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Total quality management

  • 1. • PRESENTD BY :- • PATIL PRANJAY SADASHIV. • FIRST YEAR M.PHARM. • DEPARTMENT OF QUALITY ASSURANCE. H. R. Patel Institute of Pharmaceutical Education and Research, Shirpur TOTAL QUALITY MANAGEMENT: TQM
  • 2. TOTAL QUALITY MANAGEMENT: TQM Origins, Evolution & key elements
  • 3. What is Quality? Quality is “fitness for use” (Joseph Juran) Quality is “conformance to requirements” (Philip B. Crosby) Quality of a product or services is its ability to satisfy the needs and expectations of the customer
  • 4. Evolution of Quality Management Inspection Quality Control Quality Assurance TQM Salvage, sorting, grading, blending, corrective actions, identify sources of non-conformance Develop quality manual, process performance data, self-inspection, product testing, basic quality planning, use of basic statistics, paperwork control. Quality systems development, advanced quality planning, comprehensive quality manuals, use of quality costs, involvement of non-production operations, failure mode and effects analysis, SPC. Policy deployment, involve supplier & customers, involve all operations, process management, performance measurement, teamwork, employee involvement.
  • 5. W. E. Deming and the 6 Era’s of Quality 1920’s : New statistical thinking and methods in manufacturing 1930/40’s : Use of statistical thinking outside manufacturing 1950/60’s : Systems of improvement 1970/80’s : The fourteen points Late 80’s : The “New Climate” 1990’s : System of Profound Knowledge
  • 6. Deming’s view of a production as a system Consumer Research Design & redesign Receipt & test of materials Suppliers, materials & equipment Production, assembly, inspection Distribution Consumers Test of processes, machines, methods, cost
  • 7. Improve Quality Productivity improves Provide jobs and more jobs Deming’s Chain Reaction Cost decreases because of less rework, fewer mistakes, fewer delays, snags, better use of machine time and materials Stay in business Capture the market with better quality and lower price
  • 8. PLAN CHECK DOACT The Deming Cycle or PDCA Cycle Plan a change to the process. Predict the effect this change will have and plan how the effects will be measured Implement the change on a small scale and measure the effects Adopt the change as a permanent modification to the process, or abandon it. Study the results to learn what effect the change had, if any.
  • 9. W. Edwards Deming’s 14 Points Create constancy of purpose towards improvement of product and services. Adopt the new philosophy. We can no longer live with commonly accepted levels of delays, mistakes, defective workmanship. Cease dependence on mass inspection. Require, instead, statistical evidence that quality is built in. End the practice of awarding business on the basis of price tag. 1) 2) 3) 4)
  • 10. W. Edwards Deming’s 14 Points 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 that everyone may work effectively for the company. 5) 6) 7) 8)
  • 11. 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 his right to pride of workmanship. 9) 10) 11) 12) W. Edwards Deming’s 14 Points
  • 12. Institute a vigorous programme of education and retraining. Create a structure in top management that will push everyday on the above 13 points. 13) 14) W. Edwards Deming’s 14 Points
  • 13. Deming’s System of Profound Knowledge Appreciation for system Knowledge about variation Theory about knowledge Knowledge of psychology
  • 14. Philip Crosby’s Four Absolutes Definition : Conformance to requirements System of quality is prevention Performance Standard : Zero Defects Measurement : Price of non- conformance (PON) What is Quality? What system is needed to cause quality? What performance standard should be used? What measurement system is required?
  • 15. Crosby’s Successful Company Characteristics of the Eternally Successful Organisation People do things right routinely Growth is profitable and steady Customer needs are anticipated Change is planned and managed People are proud to work there
  • 16. Philip B. Crosby’s 14 Points Make it clear that management is committed to quality. Form quality improvement teams with representatives from each department. Determine where current and potential quality problems lie. Evaluate the cost of quality and explain its use as a management tool. 1) 2) 3) 4)
  • 17. Raise the quality awareness and personal concern of all employees. Take actions to correct problems identified through previous steps. Establish a committee for the zero defects programme. Train supervisors to actively carry out their part of the quality improvement programme. 5) 6) 7) 8) Philip B. Crosby’s 14 Points
  • 18. Hold a ‘zero defects day’ to let all employees realise that there has been a change. Encourage all individuals to establish improvement goals for themselves and their groups. Encourage employees to communicate to management the obstacles they face in attaining their improvement goals. Recognise and appreciate those who participate. 9) 10) 11) 12) Philip B. Crosby’s 14 Points
  • 19. Establish quality councils to communicate on a regular basis. Do it all over again to emphasise that the quality improvement programme never ends. 13) 14) Philip B. Crosby’s 14 Points
  • 20. Joseph M. Juran’s Quality Trilogy Quality Planning Establish quality goals Identify customer needs Translate needs into our language Develop a product for these needs Optimise product features for these needs Quality Control Prove the process can produce under operating conditions Transfer process to operation Quality Improvement Seek to optimise the process via tools of diagnosis
  • 21. Juran’s Trilogy Diagram Quality Planning Quality control (during operations) Original zone of quality control Quality improve -ment New zone of quality control Cost of Poor Quality TIME 20 40 0 0 Lessons learned
  • 22. 1) Identify who are the customers 2) Determine the customer’s needs 3) Translate the needs into our language 4) Develop a product to meet those needs 5) Optimise a product so as to meets our needs as well as the customer’s. 6) Develop a process which is able to produce the product 7) Optimise the process 8) Prove the process can make the product under operating conditions Juran’s Quality Planning Road Map
  • 23. Joseph M.Juran and the Cost Of Quality 2 types of costs: Unavoidable Costs: preventing defects (inspection, sampling, sorting, QC) Avoidable Costs: defects and product failures (scrapped materials, labour for re-work, complaint processing, losses from unhappy customers “Gold in the Mine”
  • 24. Joseph M.Juran and the Cost Of Quality 100% defective Point of “Enough quality” Total Costs Unavoidable costs Avoidable costs Costs
  • 25. Joseph M. Juran’s 10 Points Build awareness of the need and opportunity for improvement. Set goals for improvement. Organise to reach the goals (establish a quality council, identify problems, select projects, appoint teams, designate facilitators) Provide training. Carry out projects to solve problems 1) 2) 3) 4) 5)
  • 26. Report progress. Give recognition. Communicate results. Keep score. Maintain momentum by making annual improvement part of the regular systems and process of the company. 6) 7) 8) 9) 10) Joseph M. Juran’s 10 Points
  • 27. What is TQM? Constant drive for continuous improvement and learning. Concern for employee involvement and development Management by Fact Result Focus Passion to deliver customer value / excellence Organisation response ability Actions not just words (implementation) Process Management Partnership perspective (internal / external)
  • 28. Learning LEARNING AND TQM Process Improvement Quality Improvement Customer Satisfaction Shareholder Satisfaction Employee Satisfaction
  • 29. BASIC PRINCIPLES OF TQM Approach Management Led Scope Company Wide Scale Everyone is responsible for Quality Philosophy Prevention not Detection Standard Right First Time Control Cost of Quality Theme On going Improvement
  • 30. FOUR KEY PRINCIPLES •Measure quality so you can affect it •Focus on a moving customer •Involve every employee •Think long term - Act short term
  • 31. THE CASE FOR QUALITY 1 Success of competitors who take quality seriously 2 Rising expectations of customers 3 Quality differentiates companies from the competition 4 Narrowing of supplier bases by quality conscious companies .
  • 32. 5 Growing evidence that growth in market share comes from sustained quality. 6 Cost advantages 7 High cost of catastrophic failure 8 Inspection poor substitute for right first time THE CASE FOR QUALITY
  • 33. SEVEN DEADLY SINS OF TQM •Flight to nowhere •One size fits all •Substituting TQM for leadership •Inside - Out indicators •Mandatory religion •Quality kept as a separate activity •Teaching to the test Booz-Allen & Hamilton
  • 34. IS QUALITY A SOUND INVESTMENT? Year Company Stock Growth (Oct 94) 1988 Motorola 373.0% 1988 Westinghouse (CNFD) - 49.6% 1989 Xerox (BPS) 75.9% 1990 General Motors 1.6% 1990 Federal Express 10.6% 1990 IBM (IBM Rochester) - 34.9% 1991 Selectron 526.9% 1992 AT&T (UCS) 32.2% 1992 AT&T (TSBU) 32.2% 1992 Texas Instruments (DS&E) 106.8% 1993 Zyta 8.4% 1994 Eastman Chemical 18.5% Total Stock Value £23016 (91.8% growth) Standard & Poor 500 Stock value £15911 (32.6% growth) Source: US Dept. of Commerce Study 1995
  • 35. THE NEW ISO 9000 2000 QUALITY STANDARD
  • 36. REASONS FOR CHANGE • ISO Technical Committee (TC) argue that: The main reason for the year 2000 revision is to give users the opportunity to add value to activities and to improve their performance continually by focusing on the major processes within the organisation
  • 37. ISO 9000 2000 CHANGES • CUSTOMER FOCUSED ORGANISATION • LEADERSHIP • INVOLVEMENT OF PEOPLE • PROCESS APPROACH • SYSTEM APPROACH TO MANAGEMENT • CONTINUAL IMPROVEMENT • FACTUAL APPROACH TO DECISION MAKING • MUTUALLY BENEFICIAL SUPPLIER RELATIONSHIPS
  • 38. IMPLEMENTATION PRINCIPLES • MANAGEMENT RESPONSIBILITY • RESOURCE MANAGEMENT • PRODUCT REALIZATION • MEASUREMENT, ANALYSIS AND IMPROVEMENT
  • 39. More clearly defined requirements • Continual improvement • increased emphasis on the role of top management • establishment of measurable objectives at relevant functions and levels • Monitoring of information of customer satisfaction and/or dissatisfaction as a measurement of the system performance • Increased attention to resource availability; determination of training effectiveness • Measurement extending to the system, process, and product • Analysis of collected data on the performance of the quality management system
  • 40. Quality is a Journey, not a Destination