TOTAL Quality

Management

Ehab A. Kader
Introduction

 Welcoming to TQM course

 Sharing our identity (Name, field, designation,
organization)
 Why you are here and what is your expectations?
Course Objectives

At the end of the course, you will:

 Understand principal and concepts of TQM
 Gain basic understanding and working knowledge of TQM
 Be aware of main quality tools and methods of implementation
 Explain ISO 9000 deployment and identify general road of
execution.
 Define different Quality awards and benefits from them.
Course Road Map

 Number of sessions: six (one/week)

 Session Duration: 4 hours
 Evaluation: 15% Attendance, 35% Midterm, 50% Final
assessment
Concepts

 What is quality?
Dictionary has many definitions: “Essential characteristic,”
“Superior,” etc.

 Some definitions that are accepted in various organizations:

 “Quality is customer satisfaction,”
 “Quality is Fitness for Use.”

 What is TQM?
A comprehensive, organization-wide effort to improve the
quality of products and services, applicable to all
organizations.
Concepts
 What is a customer?
Anyone who is impacted by the product or process
delivered by an organization.
External customer: The end user as well as
intermediate processors. Other external customers
may not be purchasers but may have some
connection with the product.
Internal customer: Other divisions of the company
that receive the processed product.

 What is a product?
The output of the process carried out by the
organization. It may be goods (e.g. automobiles,
missile), software (e.g. a computer code, a report)
or service (e.g. banking, insurance)
Concepts

 How is customer satisfaction achieved?

Two dimensions: Product features and Freedom from
deficiencies.
 Product features – Refers to quality of design.
Examples in manufacturing industry: Performance, Reliability,
Durability, Ease of use, Esthetics etc.
Examples in service industry: Accuracy, Timeliness,
Friendliness and courtesy, Knowledge of server etc.
 Freedom from deficiencies – Refers to quality of
conformance.
Higher conformance means fewer complaints and increased
customer satisfaction.
Why Quality?

Reasons for quality becoming a cardinal priority for

most organizations:
 Competition – Today’s market demand high quality
products at low cost. Having `high quality’ reputation
is not enough! Internal cost of maintaining the
reputation should be less.
 Changing customer – The new customer is not only
commanding priority based on volume but is more
demanding about the “quality system.”
 Changing product mix – The shift from low volume,
high price to high volume, low price have resulted in
a need to reduce the internal cost of poor quality.
Why Quality?

 Product complexity – As systems have become more

complex, the reliability requirements for suppliers of
components have become more stringent.
 Higher levels of customer satisfaction – Higher
customers expectations are getting spawned by
increasing competition.

Relatively simpler approaches to quality a product

inspection for quality control and incorporation of
internal cost of poor quality into the selling price,
might not work for today’s complex market
environment.
Quality perspectives

Everyone defines Quality based on their own perspective

of it. Typical responses about the definition of
quality would include:
1. Perfection
2. Consistency
3. Eliminating waste
4. Speed of delivery
5. Compliance with policies and procedures
6. Doing it right the first time
7. Delighting or pleasing customers
8. Total customer satisfaction and service
Quality levels

At organizational level, we need to ask following

questions:
 Which products and services meet your expectations?
 Which products and services you need that you are
not currently receiving?

At process level, we need to ask:

 What products and services are most important to the
external customer?
 What processes produce those products and services?
 What are the key inputs to those processes?
 Which processes have most significant effects on the
organization’s performance standards?
Additional Views of Quality in
Services

Technical Quality versus Functional Quality

Technical quality—the core element of the
good or service.
Functional quality—customer perception of
how the good functions or the service is
delivered.
Expectations and Perceptions
Customers’ prior expectations (generalized
and specific service experiences) and their
perception of service performance affect their
satisfaction with a service.
Quality Characteristics

Any feature or characteristic of a product or service

which is needed to satisfy customer needs or
achieve fitness for use is a quality characteristic.
Product Quality Characteristics
Accessibility Disposability Odour Size

Availability Admittance Operability Susceptibility

Appearance Flammability Portability storability

Adaptability Flexibility Producibility Taste

Cleanliness Functionality Reliability Testability

Consumption Interchangeabilit Safety Traceability

y
Durability Maintainability Security Toxicity

Transportability Vulnerability Weight

Service Quality Characteristics

Accessibility Credibility Honesty

Accuracy Dependability Promtness

Courtesy Efficiency Responsivevess

Comfort Effectiveness Reliability

competence Flexibility security

Quality Control
and
Quality Assurance
Quality Control

 With quality control there will be some development

from the basic inspection activity in terms of
sophistication of methods and systems, self-inspection
by approved operators, use of information and the
tools' and techniques which arc employed.

 What is Detection ?
It is about getting rid of the bad things after they have
taken place.
Quality Assurance

 A lasting and continuous improvement in quality can

only be achieved by directing organizational efforts
towards planning and preventing problems from
occurring at source.
 What is prevention ?
It stops non-conforming product being produced or non-
conforming services being delivered in the first place
Quality
Management
System
 Management

Quality Manual

The Quality
Manager
Goodwill Enthusiasm
and Motivation

The Staff

 It is the organizational structure of responsibilities,

activities, resources and events that together provide
procedures and methods of implementation to ensure
the capability of an organization to meet quality
requirements.
 Quality Quality
Quality
Management Control
Assurance
System

Quality Manual

Quality processes

Quality procedures Work Instructions

Quality Plans
(optional)

 The following documents shown comprise the QMS

and describe the organization‘s capability for
supplying products that will comply with laid down
quality standards.
Historical Philosophies of
Quality
History of quality
management
 Next 20 odd years, when top managers in USA focused on marketing,
production quantity and financial performance, Japanese managers
improved quality at an unprecedented rate.
 Market started preferring Japanese products and American companies
suffered immensely.
 America woke up to the quality revolution in early 1980s. Ford Motor
Company consulted Dr. Deming to help transform its operations.
(By then, 80-year-old Deming was virtually unknown in USA. Whereas
Japanese government had instituted The Deming Prize for Quality in
1950.)
 Managers started to realize that “quality of management” is more
important than “management of quality.” Birth of the term Total Quality
Management (TQM).
 TQM – Integration of quality principles into organization’s management
systems.
The Quality Gurus

Quality Gurus
Individuals who have been identified as making a
significant contribution to improving the quality of
goods and services.
Walter A. Shewhart
W. Edwards Deming
Joseph M. Juran
Armand Feigenbaum
Philip Crosby
Genichi Taguchi
Kaoru Ishikawa
Three of the Quality Gurus Compared

Source: Modified from John S. Oakland, Total Quality Management (London: Heinemann Professional Publishing
Ltd., 1989), pp. 291–92.
Three of the Quality Gurus Compared (cont’d)

Source: Modified from John S. Oakland, Total Quality Management (London: Heinemann
Professional Publishing Ltd., 1989), pp. 291–92.
Three of the Quality Gurus Compared (cont’d)

Source: Modified from John S. Oakland, Total Quality Management (London: Heinemann Professional
Publishing Ltd., 1989), pp. 291–92.
The Quality Gurus (cont’d)

Walter A. Shewhart
Statistician at Bell Laboratories
Developed statistical control process methods to distinguish
between random and nonrandom variation in industrial
processes to keep processes under control.
Developed the “plan-do-check-act” (PDCA) cycle that
emphasizes the need for continuous improvement.
Strongly influenced Deming and Juran.
Shewhart’s Plan-Do-Check-Act
(PDCA) Cycle

Source: “The PDCA Cycle” from Deming Management at Work by Mary Walton, copyright © 1990
by Mary Walton. Used by permission of G. P. Putnam’s Sons, a division of Penguin Putnam, Inc.
The Quality Gurus (cont’d)

 W. Edwards Deming
Advocated Statistical Process Control (SPC)
Methods which signal shifts in a process that will likely
lead to products and/or services not meeting
customer requirements.
Emphasized an overall organizational approach to
managing quality.
Demonstrated that quality products are less costly
than poor quality products.
Identified 14 points critical for improving quality.
The Deming Prize
Highest award for industrial excellence in Japan.
 Deming’s 14-Point Program for Improving Quality

1. Create constancy of purpose for improvement of product and service.

2. Adopt the new philosophy.
3. Cease dependence on mass inspection.
4. End the practice of awarding business on the price tag alone.
5. Improve constantly and forever the system of production and training.
6. Institute training.
7. Institute leadership.
8. Drive out fear.
9. Break down barriers between staff areas.
10. Eliminate slogans, exhortations, and targets for the workforce.
11. Eliminate numerical quotas.
12. Remove barriers to pride in workmanship.
13. Institute a vigorous program of education and retraining.
14. Take action to accomplish the program.
Source: “14 Point System” from Deming Management at Work by Mary Walton, copyright © 1990 by Mary
Walton. Used by permission of G. P. Putnam’s Sons, a division of Penguin Putnam, Inc.
32 The Deming philosophy

14 points for management:

1. Create and publish to all employees a statement of the
aims and purposes of the company. The management
must demonstrate their commitment to this statement.
2. Learn the new philosophy.
3. Understand the purpose of inspection – to reduce the cost
and improve the processes.
4. End the practice of awarding business on the basis of
price tag alone.
5. Improve constantly and forever the system of production
and service.
33 The Deming philosophy

6. Institute training
7. Teach and institute leadership.
8. Drive out fear. Create an environment of innovation.
9. Optimize the team efforts towards the aims and purposes
of the company.
10. Eliminate exhortations for the workforce.
11. Eliminate numerical quotas for production.
12. Remove the barriers that rob pride of workmanship.
13. Encourage learning and self-improvement.
14. Take action to accomplish the transformation.
34 The Deming philosophy

 “A System of Profound Knowledge”

1. Appreciation for a system - A system is a set of
functions or activities within an organization
that work together to achieve organizational
goals. Management’s job is to optimize the
system. (not parts of system, but the whole!).
System requires co-operation.
2. Psychology – The designers and implementers
of decisions are people. Hence understanding
their psychology is important.
35 The Deming philosophy

3. Understanding process variation – A

production process contains many sources of
variation. Reduction in variation improves
quality. Two types of variations- common
causes and special causes. Focus on the special
causes. Common causes can be reduced only
by change of technology.
4. Theory of knowledge – Management decisions
should be driven by facts, data and justifiable
theories. Don’t follow the managements fads!
The Quality Gurus (cont’d)

 Joseph M. Juran
Emphasized the importance of producing quality
products through an approach focused on quality
planning, control, and improvement.
Defined product quality as “fitness for use” as viewed
by the customer in:
Quality of design • Quality of conformance
Availability • Safety • Field use
Categorized the cost of quality as:
Cost of prevention
Cost of detection/appraisal
Cost of failure
37 The Juran philosophy

 Pursue quality on two levels:

1. The mission of the firm as a whole is to achieve
high product quality.
2. The mission of each individual department is to
achieve high production quality.

 Quality should be talked about in a language senior

management understands: money (cost of poor
quality).
 At operational level, focus should be on
conformance to specifications through elimination
of defects- use of statistical methods.
38 The Juran philosophy

Quality Trilogy –
1. Quality planning: Process of preparing to meet
quality goals. Involves understanding customer
needs and developing product features.
2. Quality control: Process of meeting quality goals
during operations. Control parameters. Measuring
the deviation and taking action.
3. Quality improvement: Process for breaking through
to unprecedented levels of performance. Identify
areas of improvement and get the right people to
bring about the change.
The Quality Gurus (cont’d)

Armand Feigenbaum
Proposed the concept of “total quality control,”
making quality everyone’s responsibility.
Stressed interdepartmental communication.
Emphasized careful measurement and report
of quality costs
Philip Crosby
Preached that “quality is free.”
Believed that an organization can reduce overall
costs by improving the overall quality of its
processes.
40 The Crosby philosophy

Absolute’s of Management
 Quality means conformance to requirements not elegance.
 There is no such thing as quality problem.
 There is no such thing as economics of quality: it is always
cheaper to do the job right the first time.
 The only performance measurement is the cost of quality:
the cost of non-conformance.
Basic Elements of Improvement
 Determination (commitment by the top management)
 Education (of the employees towards Zero Defects (ZD))
 Implementation (of the organizational processes towards
ZD)
The Quality Gurus (cont’d)

Genichi Taguchi
Emphasized the minimization of variation.
Concerned with the cost of quality to
society.
Extended Juran’s concept of external failure.
Kaoru Ishikawa
Developed problem-solving tools such as the
cause-and-effect (fishbone) diagram.
Called the father of quality circles.
42
Cost of Quality
The Cost of Quality

Cost of Quality
Framework for identifying quality
components that are related to producing
both high quality products and low quality
components, with the goal of minimizing
the total cost of quality.
Costs of poor quality:
 Detection/appraisal costs
 Internal failure costs
 External failure costs
 The Cost of Quality (Juran’s
Model)
Cost Category
Cost of prevention Costs associated with the development of
programs to prevent defectives from
occurring in the first place
Cost of detection/ Costs associated with the test and
appraisal inspection of subassemblies and products
after they have been made.
Cost of failure Costs associated with the failure of a
defective product.
Internal failure costs—producing
defective products that are identified
before shipment.
External failure costs—producing
defective products that are delivered to
the customer.
The Cost of Quality (Cont.)
 “Costs” of Quality
Quality Cost Management shows how increased
Prevention Costs reduce the Total Quality Costs.
 Typical Quality Cost Ratios

Source: A. V. Feigenbaum, Total Quality Control, 3rd ed. (New York: McGraw-Hill, 1983), p. 112;
and Joseph M. Juran and F. M. Gryna, Quality Planning and Analysis (New York: McGraw-Hill,
1970), p. 60.
Elements of TQM &
Implementation
Elements of TQM

Leadership
Top management vision, planning and support
Employee involvement
All employees assume responsibility for
inspecting the quality of their work.
Product/Process Excellence
Involves product design quality and monitoring
the process for continuous improvement.
Elements of TQM (cont’d)

Continuous Improvement
A concept that recognizes that quality
improvement is a journey with no end and that
there is a need for continually looking for new
approaches for improving quality.
Customer Focus (on “Fitness for Use”)
Design quality
Specific characteristics of a product that
determine its value in the marketplace.
Conformance quality
The degree to which a product meets its
design specifications.
Implementing TQM

Successful Implementation of TQM

Requires total integration of TQM into
day-to-day operations.
Causes of TQM Implementation Failures
Lack of focus on strategic planning
and core competencies.
Obsolete, outdated organizational
cultures.
Implementation of TQM
For TQM to be successful, the organization must
concentrate on the following key elements:

Integrity
Ethics
Trust
Training
Teamwork
Communication
Recognition
Leadership
 Implementation of TQM
(Cont.)
The key elements of TQM can be divided into four
groups according to their function:

Foundation: Integrity, Ethics, Trust

Building Bricks: Leadership,
Teamwork, Training
Roof: Recognition (Motivation)
Binding Mortar: Communication
Process Management
Statistical Process Control (SPC)
55 Process management

 Planning and administrating the activities necessary to

achieve high quality in business processes; and also
identifying opportunities for improving quality and
operational performance – ultimately, customer
satisfaction.
 Process simplification reduces opportunities for errors and
rework.
 Processes are of two types – value-added processes and
support processes.
 Value-added processes – those essential for running the
business and achieving and maintaining competitive
advantage. (Design process, Production/Delivery process)
Process management

 Support processes – Those that are important to an

organization’s value-creation processes, employees and
daily operations.
 Value creation processes are driven by external customer
needs while support processes are driven by internal needs.
 To apply the techniques of process management, a process
must be repeatable and measurable.
 Process owners are responsible for process performance
and should have authority to manage the process. Owners
could range from high-level executive to workers who run
a cell.
 Assigning owners ensures accountability.
Process control

 Control is the activity of ensuring the conformance

to the requirements and taking corrective action
when necessary.
 Two reasons for controlling the process
1. Process control methods are the basis of effective
daily management of processes.
2. Long-term improvements can not be made to a
process unless the process is first brought under
control.
 Short-term corrective action should be taken by the
process owners. Long-term remedial action should
be the responsibility of the management.
Process control

Effective quality control systems include

1. Documented procedures for all key processes
2. A clear understanding of the appropriate
equipment and working environment
3. Methods of monitoring and controlling critical
quality characteristics
4. Approval processes for equipment
5. Criteria for workmanship: written standards,
samples etc.
6. Maintenance activities
 Process improvement
 Customer loyalty is driven by delivered value.
 Delivered value is created by business processes.
 Sustained success in competitive markets require a business to
continuously improve delivered value.
 To continuously improve value creation ability, a business
must continuously improve its value creation processes.
 Continuous process improvement is an old management
concept dating back to 1895. However, those approaches were
mainly productivity related.
 More recently (1951) Toyota implemented Just-In-Time which
relies on zero defects with minimum inventories and hence
continuous improvement!
Process improvement:
Kaizen
 Japanese for gradual and orderly continuous
improvement over a long period of time with
minimum financial investment, and with
participation by everyone in the organization.
 Improvement in all areas of business serves to
enhance quality of the firm.
 Three things required for successful kaizen
program: operating practices, total involvement,
and training.
 Operating practices expose opportunities for
improvement. JIT reveals waste and inefficiency
as well as poor quality.
Process improvement:
Kaizen
 Every employee strives for improvement. Top management
views improvement as part of strategy and supports it.
Middle management can implement top management’s
improvement goals by establishing, maintaining, and
upgrading operating standards. Workers can engage
through suggestions, small group activity.
 Middle management can help create conducive
environment for improvement by improving cooperation
amongst departments, and by making employees conscious
of their responsibilities for improvement.
 Supervisors can direct their attention more on improvement
than supervision, which will facilitate communication.
 Kaizen: Implementation
 The Deming cycle: Originally developed by Walter Shewart,
but renamed in 1950s because Deming promoted it
extensively.
Kaizen: Implementation

 Plan – Study the current system; identifying

problems; testing theories of causes; and
developing solutions.
 Do – Plan is implemented on a trial basis. Data
collected and documented.
 Check– Determine whether the trial plan is
working correctly by evaluating the results.
 Act – Improvements are standardized and final
plan is implemented.
Kaizen: Implementation

Juran’s breakthrough sequence:

1. Proof of the need
2. Project identification
3. Organization for breakthrough – two paths
identified: symptom to cause (diagnostic) and cause
to remedy (remedial) paths.
4. Diagnostic journey
5. Remedial journey
6. Holding the gains.
The Seven TQM Tools

With correct implemention of the Seven TQM

Tools 95% of quality related problems can be
solved.
 The Seven TQM Tools

1. Check Sheets
2. Histograms
3. Scatter Diagrams
4. Control Charts
5. Run Charts
6. Ishikawa Diagram
7. Pareto Diagram
Check Sheets

Check Sheets are simple documents

that are used for collecting data in
real-time.
A Check Sheet is typically a blank
form that is designed for the quick,
easy and efficient recording of the desired information,
which can be either quantitative or qualitative.
When the information is quantitative, the check sheet is
called a Tally Sheet.
Histograms
A histogram divides
up the range of
possible values in a
data set into classes or
groups.
For each group, a
rectangle is constructed
with a base length equal to the range of values in that
specific group, and an area proportional to the number
of observations falling into that group.
Workshop
Scatter Diagrams
Scatter Diagrams are
used to present
measurements of two
or more related variables.
A Scatter Diagram does
not specify dependent or
independent variables.
Either type of variable can be plotted on either axis.
Scatter Diagrams represent the association (not
causation) between two variables.
Workshop
Control Charts
A control chart consists
of the following:

A Centre Line (CL) drawn

at the process mean value.
Lower and Upper Control Limits that indicate the
threshold at which the process output is considered
statistically unlikely.
Workshop
 Run Charts
Run Charts are
similar in some
regards to Contol
Charts, but do
not show the
control limits of
the process.
They are therefore
simpler to produce, but do not allow for the full range of analytic
techniques supported by Control Charts.

• Run chart: Measurement against progression of time.

• Control chart: Add Upper Control Limit and Lower Control Limit
to the run chart.
Workshop
 Also called fishbone diagrams (because of
their shape) or Ishikawa diagrams.
Helps in identifying root causes of the
quality failure. (Helps in the diagnostic
Ishikawa Diagram journey.)

Machine Manpower

Problem

Method Material

Ishikawa Diagram is also called Cause-and-Effect

Diagram. Often are four generic heading used: 4 M´s!
Workshop
Pareto Diagram
The purpose of the Pareto Diagram is to highlight the
most important set of factors among a typically large
amount of causes for a problem.

In order to develop the Pareto Diagram for a specific

process, the knowledge of Frequncy, Relative
Frequency, Cumulative Frequency and Percentage
Frequency is needed.
Pareto Charts (Cont.)
Workshop
Other tools: Flow charts

 Process map identifies the sequence of activities or

the flow in a process.
 Objectively provides a picture of the steps needed to
accomplish a task.
 Helps all employees understand how they fit into the
process and who are their suppliers and customers.
 Can also pinpoint places where quality-related
measurements should be taken.
 Also called process mapping and analysis.
 Very successfully implemented in various
organizations. e.g. Motorola reduced manufacturing
time for pagers using flow charts.
Scatter diagrams

 Graphical components of the regression analysis.

 Often used to point out relationship between
variables. Statistical correlation analysis used to
interpret scatter diagrams.
Workshop
Six Sigma

 Business improvement approach that seeks to find and

eliminate causes of defects and errors in processes by
focusing on outputs that are critical to customers.
 The term Six Sigma is based on a statistical measure that
equates 3.4 or fewer errors or defects per million
opportunities.
 Motorola pioneered the concept of Six Sigma.
 The late Bill Smith, a reliability engineer is credited with
conceiving the idea of Six Sigma.
 GE (specifically CEO Jack Welch) extensively promoted it.
Six Sigma

Core philosophy based on key concepts:

 Think in terms of key business processes and customer
requirements with focus on strategic objectives.
 Focus on corporate sponsors responsible for championing
projects.
 Emphasize quantifiable measures such as defects per
million opportunities (dpmo).
 Ensure appropriate metrics is identified to maintain
accountability.
 Provide extensive training.
 Create highly qualified process improvement experts -
“belts”.
 Set stretch objectives for improvement.
Six Sigma

Contrasts between traditional TQM and Six Sigma (SS) -

 TQM is based largely on worker empowerment and
teams; SS is owned by business leader champions.
 TQM is process based; SS projects are truly cross-
functional.
 TQM training is generally limited to simple
improvements tools and concepts; SS is more
rigorous with advanced statistical methods.
 TQM has little emphasis on financial accountability;
SS requires verifiable return on investment and focus
on bottom line.
 Quality Performance Levels
for Various Processes

Source: Dave Harold, “Designing for Six Sigma Capability,”

Control Engineering, January, 1999.
Quality Management
Standards
•ISO 9000
Definition of Standards

 standards are documented agreements containing

technical specifications or other precise criteria to be
used consistently as rules, guidelines, or definition of
characteristics
 History Quality standards

 Quality used to be about making sure the product

was right and with an emphasis on the manufacturer
being required to produce something that could be
inspected against a specific dimension or criteria
 There were 18 major items which are most common ,
or root cause of all the problems experienced for
example:
 Wrong materials obtained
 Items made to wrong dimensions
 History Quality standards
(cont.)
 1979: was an important year for quality standards within the
United Kingdom
 1981: the department of Trade and Industry (DTI) formed a
committee called ‘FOCUS’
 1987: ISO 9000 set of standards were very heavily based on BS
5750:1979 parts 1,2
 1994: ISO realizing the problems of calling the same document by
a variety of different names was confusing, reproduced (in
March 1994) the ISO 9000:1994
 2000: the members of ISO set about seeking the views of their
members too see how the current standard could be improved.
the result was the development of ISO 9001:2000
 2015: the members of ISO developed standard to introduce risk
assessment as a significant part of implementation
 ISO 9000
The International Organization for Standardization
(ISO)
ISO 9000 Series of Quality Standards
An international set of standards for documenting
the processes that an organization uses to
produce its goods and services.
ISO 9001 Quality Management Systems:
Requirements
ISO 9004 Quality Management Systems: Guidelines
for Performance Improvement

ISO 9000 Quality Management Systems:

Fundamentals and Standards
 ISO 9000 (cont’d)
ISO 9000 Certification
First party certification—A firm audits itself.
Second party certification—Customers audit their
suppliers.
Third party assessment—Company is assessed by
outside registrars from ASQ’s Registration
Accreditation Board (RAB).
ISO 9000/Q90 Registration Process
Application to registrar
Preliminary assessment
Full audit
 ISO 9001:2015

0.1 General • introduces the rationale

0.2 Quality management for the Standard
principles • more formally structured.
0.3 Process approach
0.4 Relationship with other
MSS
0.1 General

 identifies potential benefits

 it is not the intent of the standard to imply:
 uniformity in the structure of different quality management
systems
 uniformity of documentation to align to the clauses of the
Standard
 impose specific terminology to be used.
0.2 Quality management
principles
 ISO 9001:2008 was based on eight quality
management principles whereas the revised version
refers to just seven
 the principle of “a systems approach to
management” has been dropped
 the last principle is now called “Relationship
management” instead of “Mutually beneficial supplier
relationships”.
 New Principles
1. Customer Focus 1. Customer Focus
2. Leadership 2. Leadership
3. Involvement of People 3. Engagement of People
4. Process Approach 4. Process Approach
5. System Approach to
Management 5. Improvement
6. Continual Improvement
7. Factual Approach to 6. Evidence-based
Decision Making Decision Making
8. Mutually Beneficial 7. Relationship
Supplier Relationships Management.
0.3 Process Approach

 understand and manage interrelated processes as a

system
 enables consistent and predictable results
 PDCA cycle is fundamental
 introduces risk based thinking
0.4 Relationship with other
standards
 now a framework to improve alignment among all
International Standards for management systems
 better facilitates immigration.
Section 1 - Scope

 consistently provide products and services to meet

requirements and enhance customer satisfaction – no
change
 all requirements are intended to be applicable to all
organisations, regardless of type, size and product
provided – no change
Section 2 – Normative
references
 ISO 9000:2015, Quality management systems –
Fundamentals and vocabulary
 also describes quality management principles in detail.

Section 3 – Terms and

Definitions
 reference to ISO 9000 – no change
 maintains clause numbering for consistency.
Some Terms (docs)

 document – information and the medium on which it is contained

 procedure – specified way to carry out an activity or a process (can be
documented or not)
 record – document stating results achieved or providing evidence of
activities performed.
 improvement – activity to enhance performance
 objective – result to be achieved
 nonconformity – non-fulfilment of a requirement
 correction – action to eliminate a detected nonconformity
 corrective action – action to eliminate the cause of a nonconformity and
prevent recurrence
 preventive action – action to eliminate the cause of a potential
nonconformity or other undesirable situation
 risk - effect (positive or negative) of uncertainty
 outsource - to make an arrangement where an external organisation
performs part of an organisation’s function or process
 Section 4 – Context of the
Organisation
4.1 Understanding the
• this is a new clause and
organisation and its context
provides a key insight
4.2 Understanding the needs into the organisation
and expectations of
interested parties
What constitutes the
4.3 Determining the scope of organisation’s quality
the quality management management system.
system
4.4 Quality management
system and its processes
Section 4 – Context of the
organisation
 4.1 Understanding the organisation and its context
 determine external and internal issues relevant to the
QMS
 must monitor these issues.
 4.2 Understanding the needs and expectations of
interested parties
 determine interested parties relevant to the QMS
 determine their needs and expectations
 must monitor information about interested parties’
requirements.
Section 4 – Context of the
organisation
 4.3 Determining the scope of the quality management
system
 establish scope by determining boundaries and
applicability of the QMS to consider external/internal
issues, requirements of interested parties and the
organisation’s products and services
 scope must be documented and available, justify any
clauses of ISO 9001 that is not applicable
 any N/A clauses must not effect conformity of
products/services and customer satisfaction.
Section 4 – Context of the
organisation
 4.4 Quality management system and its processes
 must establish, implement, maintain and continually
improve the QMS
 interaction of processes required (but not documented!)
 assign responsibilities and authorities for processes
 retain documented information to ensure in the
processes
 Documented procedures are not necessarily required….
except where they are needed!
 Section 5 – Leadership

5.1 Leadership and • top management to now

commitment have a greater involvement
in the QMS
5.2 Policy
5.3 Organisational roles, What is required by top
responsibilities and management.
authorities
Section 5 - Leadership

 5.1 Leadership and commitment

 5.1.1 General
 new clause
 must take accountability for the QMS’ effectiveness
 ensure Quality Policy and quality objectives are established
 ensure QMS is integrated into business processes
 ensure resources are available;
 communicate importance of effective QMS and
conformance
 ensure QMS achieves intended results
 promote improvement
 support other management to demonstrate leadership.
Section 5 - Leadership

 5.1 Leadership and commitment

 5.1.1 General
 5.1.5 Customer focus
 top management must ensure:
 customer and regulatory requirements are met
 risks and opportunities are determined and addressed
 focused on enhancing customer satisfaction.
Section 5 – Leadership

 5.1 Leadership and commitment

 5.2 Policy
 now split into two sub-clauses to save the confusion in the
previous version of what must be in the policy and what
must be done with the policy
 must be documented
 must be available internally and to interested parties.
Section 5 – Leadership

 5.1 Leadership and commitment

 5.3 Organisational roles, responsibilities and authorities
 ensures responsibilities and authorities for relevant roles
are assigned, communicated and understood
 no formal requirement for specific management
representative
 specific mention of changes to QMS.
 Section 6 – Planning

6.1 Actions to address risks • introduces risk based

and opportunities
approach to planning
6.2 Quality objectives and • addresses risks,
planning to achieve opportunities and quality
them objectives
6.3 Planning of changes
How quality planning is
achieved.
Section 6 – Planning

 6.1 Actions to address risks and opportunities

 when planning, must consider external/internal issues and
interested parties
 determine risks to ensure QMS achieves results, enhance
desirable effect and achieve improvement
 must evaluate effectiveness of actions
 must be risk based.
Section 6 – Planning

 6.2 Quality objectives and planning to achieve them

 quality objectives need to be established at relevant
functions, levels and processes
 these objectives should be:
 consistent with the Quality Policy, measurable and take into
account applicable requirements
 relevant to conformity of products and services, and the
enhancement of customer satisfaction
 monitored, communicated and updated as appropriate

 must determine what, how, who, when, etc

 quality objectives must be documented.
Section 6 – Planning

 6.3 Planning of changes

 where change is needed, it needs to be carried out in a

planned and systemic manner
 must ensure integrity of QMS.
 Section 7 - Support
7.1 Resources • newly constructed clause
7.2 Competence • much of what was in 2008
Version Clauses 4,5 & 6
7.3 Awareness

7.4 Communication The support required to meet

the organisation’s goals.
7.5 Documented information
Section 7 - Support

 7.1 Resources
 7.1.1 General
 must provide resources for the implementation and
maintenance of the QMS
 must consider constraints of existing resources and what
may be provided from external providers.
Section 7 - Support

 7.1 Resources
 7.1.2 People
 new clause
 must determine and provide people necessary for
effective information of QMS and operations/control of
processes.
Section 7 - Support

 7.1 Resources
 7.1.5 Monitoring and measuring resources
 determine resources needed to ensure valid and reliable
monitoring and measuring results
 resources must be suitable for the activity and
maintained as fit for purpose
 evidence of fit for purpose must be retained
 other requirements for measuring equipment
unchanged.
Section 7 - Support

 7.3 Awareness
 specific clause for awareness
 must be aware of Quality Policy, quality objectives,
contribution to effective QMS and implication of not
conforming with QMS.
 7.4 Communication
 much expanded clause for communication
 must now determine what will be communicated
internally and externally about the QMS, when, to whom,
how and by whom.
 Section 8 - Operation
8.1 Operational planning and control • covers many of the
8.2 Requirements for products and Product Realisation
services requirements
contained in Clause 7
8.3 Design and development of
of the 2008 version
products and services
8.4 Control of externally provided
The heart of the
processes, products and services
management system
8.5 Production and service provision (the business).
8.6 Release of products and services
8.7 Control of nonconforming outputs
Section 8 - Operation

 8.1 Operational planning and control

 must plan, implement and control processes needed to
meet requirements for the provision of products and services
 must control planned changes and review unintended
changes
 any outsourced processes must be controlled.
 8.3 Design and development of products and services
 the organisation shall establish, implement and maintain a
design and development process;
 there is, however, a significantly increased focus on the role
the customer has in all stages of the design process
 any changes made to design inputs and design outputs
during the design and development must be clearly
identified.
Section 8 - Operation

 8.4 Control of externally provided processes, products

and services
 changes are mainly terminology and revised wording (ie
suppliers become ‘external providers!’)
 much as before, each stage of the purchasing process,
including evaluation, selection, performance monitoring
and re-evaluation remains a key requirement
 there is a significant increase in the steps needed to
control external provision.
Section 8 - Operation

 8.5 Production and service provision

 8.5.6 Control of changes
 specific clause for control of changes to ensure
continuing conformity
 documented information must be retained describing
the review of changes and any action arising.
Section 8 - Operation

 8.6 Release of products and services

 must verify that product and service requirements have
been meet and evidence of conformity retained
 release to customer does not proceed until the planned
verification of conformity has been satisfactorily
completed, unless otherwise approved by a relevant
authority and by the customer
 documented information to provide traceability to the
person(s) authorising release for delivery to the customer.
 8.7 Control of nonconforming outputs
 documented information required describing
nonconformity, actions taken, any concessions and
authority for taking action.
 Section 9 – Performance
Evaluation
9.1 Monitoring, Determining what is to be
measurement, analysis monitored, measured, analysed
and evaluation and evaluated will enable the
organisation to determine ‘if the
9.2 Internal audit management system suitable,
9.3 Management review adequate and effective ?’

How performance of the QMS

is evaluated.
Section 9 – Performance
Evaluation
 9.1 Monitoring, measurement, analysis and evaluation
 9.1.1 General
 must determine what needs to be monitored and
measured, the methods for monitoring, measurement,
analysis and evaluation, as applicable, to ensure valid
results
 additionally, when the monitoring and measuring is to be
performed and when the results from monitoring and
measurement is to be analysed and evaluated
 retain appropriate documented information as evidence
of the results.
Section 9 – Performance
Evaluation
 9.1 Monitoring, measurement, analysis and evaluation
 9.1.1 General
 9.1.2 Customer satisfaction
 9.1.3 Analysis and evaluation

 same as previous Clause 8.2.1.

Section 9 – Performance
Evaluation
 9.1 Monitoring, measurement, analysis and evaluation
 9.1.3 Analysis and evaluation
 information resulting from monitoring and measuring
appropriate data should be analysed and evaluated
 the results of analysis is to be used to evaluate seven
specific criteria described.
 Section 10 - Improvement

10.1 General • QMS must continually

improve
10.2 Nonconformity and
corrective action • nonconformities must be
identified and reacted to
10.3 Continual improvement • corrective action must be
considered
Continual improvement
remains a core focus of the
QMS.
Section 10 – Improvement

 10.1 General
 opportunities for improvement must be determined
 action must be taken to meet customer requirements
and enhance customer satisfaction:
 improve products and service
 correcting, preventing or reducing undesired effects
 improve performance and effectiveness of the QMS.
Section 10 - Improvement

 10.2 Nonconformity and corrective action

 nonconformities (including complaints) must be reacted
to and applicable action taken
 root cause analysis must be considered based on its
significance
 effectiveness of corrective action must be reviewed
 change QMS if required
 evidence of action taken from nonconformities must be
documented
 evidence of results of corrective action must be
documented.
Section 10 – Improvement

 10.3 Continual improvement

 organisations must continually improve the suitability,
adequacy and effectiveness of the QMS
 must consider results of analysis and evaluation, and
outputs from management review.
Workshop
Quality Management
Awards and Framework
•Awards: Malcolm Baldrige National
Quality Award, EFQM Model, Deming Prize
Recognizing and Rewarding
Quality

Promotion of High Quality Goods and

Services
Malcolm Baldrige National Quality
Award (MBNQA) (United States)
Deming Prize (Japan)
European Quality Award (European
Union)
ISO9000 certification
Malcolm Baldrige National
Quality Award (MBNQA)
 Background
 Established in 1987 to recognize total quality
management in American industry.
 Purpose
 Stimulate U.S. companies to improve quality and
productivity.
 Establish guidelines and criteria to evaluate quality.
 Recognize those firms that improve their quality.
 Provide guidance in how to achieve quality.
 The Integrated Framework of
the Baldrige Award Criteria

Source: 2004 Criteria for Performance Excellence, U.S. Dept. of Commerce,

Baldrige National Quality Program, National Institute of Standards and Technology,
Gaithersburg, MD 20899. (www.quality.nist.gov)
 2001 Award Criteria—Item
Listing

Source: 2004 Criteria for Performance Excellence, U.S. Dept. of Commerce,

Baldrige National Quality Program, National Institute of Standards and Technology,
Gaithersburg, MD 20899. (www.quality.nist.gov)
Benefits of the Baldrige
Quality Criteria
 Baldrige guidelines can be used to:
 Help define and design a total quality system.
 Evaluate ongoing internal relationships among
department, divisions, and functional units within an
organization.
 Assess and assist outside suppliers of goods and services
to a company.
 Assess customer satisfaction.
European Quality Award
(EQA)
 European Foundation for Quality Management
(EFQM)
 Stimulate and assist European organizations in quality
improvement activities.
 Support managers in the adoption of TQM.
 EFQM Excellence Model
 A non-prescriptive frame work based on nine criteria that
recognizes that there are many approaches to achieving
sustainable excellence.
Overview of the EFQM
Excellence Model

Copyright © 2005 The McGraw-Hill Companies. All rights reserved.

Popular Winners of the
European Quality Award

Copyright © 2005 The McGraw-Hill Companies. All rights reserved.

The Deming Prize

 Deming Prize
 Initiated by Japan in 1951 to recognize the importance of
high quality products.
 Name after W. Edwards Deming
 Categories of the Deming Prize:
 The Deming Prize for Individuals
 The Deming Application Prize
 The Quality Control Award for Operations/ Business Units
 Thanks
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