Quality Management System Two types of Data

Module 1 • Attributes data: discrete data; often

in the form of counts
Chapter 1: Quality Improvement in the • Variables data: continuous
Modern Business Environment measurements; length, weight
1-1.1 Dimensions of Quality Specifications
• Performance
• Reliability • Where measured quality
• Durability characteristics are often being
• Serviceability compared to
• Nominal or target value
• Aesthetics
• Upper Specification Limit (USL)
• Features
• Lower Specification Limit (LSL)
• Perceived Quality
• Conformance to Standards Nonconforming
Quality • A component or product does not
meet specifications
• Fitness for use
• Quality of design Nonconforming product
• Quality of conformance
• Defective if it has one or more
• Inversely proportional to variability
defects
Quality Improvement
Defects
• Reduction of variability in process
• Nonconformities that may seriously
and products
affect the safe or effective use of the
• Waste reduction
product
1-1.2 Quality Engineering Terminologies
Concurrent Engineering
Quality Characteristics
• Team approach to design
• Physical - length, weight, voltage, • Specialists that work together for
viscosity product or process improvement
• Sensory - taste, appearance, color
History of Quality Control and Improvement
• Time Orientation - reliability,
durability, serviceability • Walter Shewhart (1924) introduced
statistical control chart concepts.
Quality Engineering
• The American Society for Quality
• set of operational, managerial, and
Control formed in 1946 (now known
engineering activities that a company
as the American Society for Quality
uses to ensure that the quality
(ASQ)).
characteristics of a product are at the
nominal or required levels.
 • 1950s and 1960s saw an increase in 3. Acceptance sampling
reliability engineering, experimental • The inspection and classification of a
design, and statistical quality control sample of the product selected at a
random from a larger batch or lot
• Competition from foreign industries
and the ultimate decision about
(Japan) increases during the 1970s
disposition of the lot
and 1980s.
Two Types:
• Statistical methods for quality
improvement use increases in the a. Outgoing Inspection: follows
United States during the 1980s production
b. Incoming Inspection: before use in
• Total Quality Management (TQM)
production
emerges during 1970s and into the
1980s as an important management Total Quality Management
tool to implement statistical
• A managerial framework to
methods.
accomplish quality improvement
• Malcolm Baldridge National Quality • Company-wide quality control
Award is established in 1988. (CWQC), Total Quality Assurance
(TQA), Six Sigma
• ISO 9000 certification activities
increase in U.S. industry in the 1.1-4 Other Aspects of Quality Control
1990s. and Improvement
• Motorola’s Six-Sigma initiative 1.1-4.1 Three Important Leaders
begins in the 1990s.
1. W. Edwards Deming
1.1-3 Statistical Methods for Quality • Emphasis on statistical methods in
Control and Improvement quality improvement
2. Joseph Juran
Three Major Areas:
• Emphasis on managerial role in
1. Statistical Process Control (SPC) quality implementation
• An on-line quality control tool 3. Armand V. Feigenbaum
• Control charts are used for process • Emphasis on organizational
monitoring and variability reduction structure
2. Design of Experiments
• An off-line tool
• An approach to systematically • Total Quality Management (TQM)
varying the controllable input factors • Quality Standards and Registration
in the process and determine the • ISO 9000
effect these factors have on the • Six Sigma
output responses • Just-In-Time, Lean Manufacturing,
• Crucial for variability reduction Poka-Yoke, etc.
 • Effective quality improvement can Quality Gurus
be instrumental in increasing
productivity and reducing cost. Joseph Juran (Dec 24, 1904 – Feb 28,
• The cost of achieving quality 2008)
improvements and increased ➢ Best known for:
productivity is often negligible. o Quality Control Handbook –
Quality Costs published first edition in
1951
• Categories of costs that are o Cost of Quality as tangible
associated with producing, and intangible costs
identifying, avoiding, or repairing o Pareto Principle application
products that do not meet (80/20 Rule) in Quality
requirements Management
• Prevention costs
• Appraisal costs ➢ Introduction
• Internal failure costs • He was a management
• External failure costs consultant specializing in
The re-emergence of quality assurance as an managing for quality
important business strategy is in part a result • Authored hundred of papers
of and 12 books including
Quality Control Handbook,
▪ Consumerism Quality Planning and
▪ Product Liability Analysis, and Juran on
Leadership for Quality
➢ Mid 50’s: Juran travelled to Japan to
conduct the Quality Management
• Strategic Management of Quality
seminars for top and middle-level
• Almost all successful efforts have
executives
been management-driven.
➢ Juran’s Trilogy
• Too much emphasis on registration • An approach to cross-
and certification programs (ISO, QS) functional management that
o Insufficient focus on quality is composed of three
planning and design, quality managerial processes
improvement, overemphasis 1. Quality Planning – activity of
on quality assurance developing the products and
o Poor use of available processes required to meet
resources customer’s needs
• Establish quality goals
• Identify the customers- those who
will be impacted by the efforts to
meet the goal.
• Determine the customers' needs
 • Develop product features that Planning New Product Development and
respond to customers' needs Testing, Development of a Quality
• Develop processes that can produce Management System (QMS), Proper
those product features Employee Training
• Establish process controls, and
Appraisal Costs – costs incurred to maintain
transfer the resulting plans to the
acceptable product quality levels; can
opera ng forces
include, but not limited to, Incoming
Material Inspections, Process Controls,
Check Fixtures, Quality Audits, Supplier
2. Quality Control – this process
Assessments
consists of the following steps:
• Evaluate actual quality
performance
Cost of Poor Quality
• Compare actual performance to
quality goals Internal Failure Costs - Costs associated
• Act on the difference with defects found before the product or
service reaches the customer. Internal
Failures may include, but are not limited to,
3. Quality Improvement – means the following examples: Excessive Scrap,
raising quality performance to Product Re-work, Waste due to poorly
unprecedented levels (breakthrough) designed processes, Machine breakdown
due to improper maintenance, Costs
Quality Improvement Activities
associated with failure analysis
• Establish the quality improvement External Failure Costs - Costs associated
infrastructure. with defects found after the customer
• Identify the improvement projects. receives the product or service. External
• For each project establish a project Failures may include, but are not limited to,
team with clear responsibility. the following examples: Service and Repair
• Provide the resource, motivation, and Costs, Warranty Claims, Customer
training needed by the team Complaints, Product or Material Returns,
Incorrect Sales Orders, Incomplete BOMs,
Cost of Quality
Shipping Damage due to Inadequate
• Not getting it right the first time Packaging
• Should be recorded, analyzed, and
Quality Improvement – 10 Steps
classified into failure costs, appraisal
costs, and prevention costs 1. Build awareness of the need
and opportunity to improve
Cost of Good Quality
2. Set goals for that
Prevention Costs - costs incurred from improvement
activities that intend to keep failures to a 3. Create plans to reach that
minimum. Including, but not limited to, goals
Establishing Product Specifications, Quality 4. Provide training
 5. Conduct projects to solve • Must be zero defects, not “close
problems enough”
6. Report on progress • Measurement of quality is the Price
7. Give recognition for success of Conformance, not indices
8. Communicate results
9. Keep score The Crosby Quality Vaccine
10. Maintain Momentum ▪ Integrity - Treat quality seriously
throughout the whole business
organization from top to bottom.
Philip Crosby That the company’s future will be
judged on its performance on quality.
➢ Best known for:
o Quality Is Free – hist first
▪ Systems – appropriate measures and
book that made him famous
systems should be put in place for
o Zero Defects – one of his
quality costs, education, quality,
four absolutes of quality
performance, review, improvement,
o The four absences of quality
and customer satisfaction
o The Crosby Vaccine –
▪ Communication – The
management to prevent poor
communication systems are of
quality
paramount importance to
➢ Introduction
communicate requirements and
o Founder and chairman of the
specifications and improvement
board of Career IV, an executive
opportunities
management consulting firm
- Customers and
o Founded Philip Crosby
operators know what
Associates Inc. and the Quality
needs to be put in
College
place to improve and
o Authored many books including
listening to them will
Quality without Tears, Let’s Talk
give you the edge
Quality, and Leading: The Art of
▪ Operations – Work with and develop
becoming An Executive
suppliers. Processes should be
o Originated the concept of Zero
capable and improvement culture
Defects
should be the norm.
➢ 1979: He started Philip Crosby
▪ Policies – must be clear and
Associates Inc. and published his
consistent throughout the business.
first business book, Quality is Free
Four Absolutes of Quality – doing it right
the first time The Fourteen Steps to Quality Improvement
• Conformance to requirements, not 1. Management Commitment –
goodness or elegance Make it clear that
• System for causing quality is management is committed to
prevention, not appraisal quality.
2. Quality Improvement Teams 13. Quality Councils – Establish
– Form quality improvement quality councils to
teams with senior communicate on a regular
representatives from each basis.
department. 14. Repeat the cycle – Do it all
3. Measure Processes – To over again to emphasize that
determine where current and the quality improvement
potential quality problems lie process never ends.
4. Cost of Quality – Evaluate
the cost of quality and
explain its use as a Edwards Deming
management tool
5. Quality Awareness – Raise ➢ Best known for:
the quality awareness and o The 14 points of Managing are
personal concern of all management for transformation
employees o The Deming Cycle, PDCA
6. Correct Problems – Take Cycle, for continual
actions to correct problems improvement.
identified through previous o The System of Profound
steps. Knowledge (How managers
7. Monitor Progress – Establish should acquire new knowledge of
progress monitoring for the the system?)
improvement process. ➢ Introduction
8. Train Supervisors – To o October 14, 1900 (Sioux City,
actively carry out their part of Iowa) – December 20, 1993
the quality improvement o BS Electrical Engineering,
program. University of Wyoming (1921)
9. Zero Defects Day – Hold a o MS in Mathematics &
zero defects day to reaffirm Mathematical Physics,
management commitment. University of Colorado (1925)
10. Establish Improvement Goals o PHD in Mathematics &
– Encourage individuals to Mathematical Physics, Yale U
establish improvement goals (1928)
for themselves and their o Mathematical Physicist, US Dept
group. of Agriculture (1927-39)
11. Remove Fear – Encourage o Statistical Advisor US Census
employees to tell Bureau (1935-1945)
management about obstacles o Statistics Professor, NYU (1946-
to improving quality. 1993)
12. Recognize – Recognize and o As a census consultant, under
appreciate those who Douglas McArthur, taught
participate. statistical control methods to
Japanese business leaders
 o Taught Japanese engineers and o This TV documentary is credited
managers statistical process with beginning the Quality
controls; improving quality will Revolution in America and
reduce expenses while increasing introducing the methods of W.
productivity and market share Edward Deming to American
(1947) managers.
o Credited with enabling Japan to
become a world business power
due to image of quality (1980s) The Deming Cycle – PDCA
o Worked for Ford Motor Co
(1979-1982): credited for making • Plan – Plan the action. Assess the
Ford the most profitable US Auto current state, and the future state, and
manufacturer by 1986 plan how to close the gap. Identify
o Has published more than 200 alternate solutions.
works including well-known • Do – Try or test out the solutions
books “Quality, Productivity and (sometimes at a pilot level).
Competitive Position” and “Out • Check – Check to see if the tested
of the Crisis” solutions accomplished the objective.
➢ Timeline • Act – Analyze the difference
o 1946: He went to Japan to help between actual and planned results.
the nation recover from its If the gap is significant, determine
wartime losses. Deming taught the root cause and request a
Statistical Process Control (SPC) corrective action.
to the leaders of prominent
Japanese organizations.
o 1951: The Deming Prize was The Deming System of Profound
established. The first Deming Knowledge
Prize ceremony was held on Sept
- Every business is made up of related
22,1951.
people and processes who work
o 1956: Deming was awarded the
together, and that the success of the
Shewhart Medal by the American
system depends on the ability to
Society for Quality Control
manage those components
(ASQC – now ASQ)
successfully.
o 1960: Deming was honored by
• Appreciation for a System – The
the Japanese Emperor with the
need for managers to understand the
Second Order of the Sacred
relationships between functions and
Treasure for his teachings.
activities, and the long-term aim is
➢ If Japan can, Why Can’t We?
for everyone to win employees,
o An American television episode
shareholders, customers, suppliers,
broadcast by NBC News. This
and the environment.
was as part of the television show
• Knowledge of Variation –
NBC White Paper on June 24,
Knowledge and understanding of
1980.
variation., process capability, control
 charts, interactions, and the loss 7. Institute leadership – The aim of
function supervision should be to help people
• Theory of Knowledge – As all plans and machines and gadgets to do a
require prediction based on historical better job. Supervision of
information, the theory must be management is in need of an
understood before it can successfully overhaul, as well as supervision of
be copied. production workers.
• Knowledge of Psychology – The 8. Drive out fear – so that everyone
understanding of human interactions, may work effectively for the
how people are motivated and what company.
disillusions them 9. Break down barriers – between
departments. People in research
design, sales, and production must
Deming’s 14 Points for TQM work as a team, to foresee problems
of production and in use that may be
1. Create constancy of Purpose – encountered with the product or
toward improvement of product and service.
service, with the aim to become 10. Eliminate slogans, exhortation, and
competitive and to stay in business, targets – Eliminate work standards
and to provide jobs. (quotas) on the factory floor.
2. Adopt the new philosophy – We are Eliminate management by numbers,
in a new economic age. Western numerical goals. Substitute
management must awaken to the leadership.
challenge, must learn their 11. Pride of workmanship – Remove
responsibilities, and take on barriers that rob the hourly workers
leadership for change. of his right to pride of workmanship.
3. Cease dependence on inspection – to The responsibility of supervisors
achieve quality. Eliminate the need must be changed from sheer numbers
for inspection on a mass basis by to quality.
building quality into the product in 12. Abolishment of the annual or merit
the first place. rating – Remove barriers that rob
4. End the practice of awarding people in management and
business on the basis of price tag. – engineering of their right to pride of
Minimize the total cost instead. workmanship.
Move toward a single supplier for 13. Education and self-improvement –
any one item, on a long-term Institute a vigorous program of
relationship of loyalty and trust. education and self-improvement.
5. Improve constantly – and forever the 14. Transformation – Put everybody in
system or production and service, to the company to work to accomplish
improve quality and productivity, the transformation. The
and thus constantly decrease costs. transformation is everybody’s job.
6. Institute training. – Institute the
training on the job.
Module 2: TQM and ISO • 2000 – ISO 9001 Quality
Management Systems – Series of
Introduction to Quality Management Revisions
System & ISO • 2008 – ISO 9001 Quality
Management Systems –
Requirements
Definition of Quality (ISO 9001:2015) • 2015 – ISO 9001 Quality
- The degree to which a set of inherent Management Systems –
characteristics fulfills requirements Requirements
(needs or expectation) that is stated,
generally implied or obligatory.
ISO 9001:2015
Quality Management System
- Fifth edition of ISO 9001 standard
- A set of policies, processes, and - Published on September 15, 2015
procedures required for planning - Employs the process, approach,
and execution which incorporates the Plan-DO-
(production/development/service) in Check-Act (PDCA) Cycle and risk-
the core business area of an based thinking
organization. (i.e. areas that can
impact the organizations ability to PDCA Cycle
meet customer requirements.) - Plan, Do, Check, Act (sometimes
ISO (International Organization for Plan, Do, Check, Adjust)
Standardization) - A repetitive four-stage model for
continuous improvement (CI) in
- Based in Geneva, Switzerland business process management
- Worldwide federation of national - Deming circle/cycle/wheel,
standards (ISO member bodies) Shewhart cycle, control circle/cycle,
- First approached subject of quality in or Plan-Do-Study-Act (PDSA)
1979
- Came from the Greek word isos – Risk-Based Thinking
the same as - One of the key elements of ISO
9001:2015 is to establish a
systematic approach to considering
ISO 9001 risk, rather that treating “prevention”
• 1979 – BS 5750 Quality Assurance as a separate component of a QMS.
Standards - Risk is inherent in all aspects of a
QMS
• 1987 – ISO 9001, ISO 9002, ISO
9003 Quality Assurance Standards 7 Quality Management Principles
• 1994 – ISO 9001, ISO 9002, ISO
1. Customer Focus
9003 Quality Assurance Standards
2. Leadership
Revisions
3. Engagement of People
 4. Process Approach Mandatory Records
5. Continual Improvement
➢ Management Review meetings – an
6. Evidenced-Based Decision Making
important opportunity to:
7. Relationship Management
• Bring together an overview of
the management system
• To assess its performance
ISO 9001:2015 Framework
• To identify any opportunities
where it can be improved
- Held at least once per year, it’s also a
time to review the company’s quality
policy and set new objectives for the
coming year
- It’s essential that “top management”
be involved
Internal Quality Audit & Management Corrective Action Request (CAR)
Review
➢ Corrective actions – are reactive;
➢ System Audit – conducted on a something has gone wrong and these
management system are the actions taken to deal with the
➢ Internal Audit Program and Results – problem
can be described as a documented - Resolves non-conformances
activity performed to verify, by - This will include the immediate
examination and evaluation of corrective actions you take to
objective evidence, that applicable keep your customer happy
elements of the system are - Dealing with it for ISO 9001
appropriate and effective and have means that you eliminate the
been developed, documented, and problem and make sure it won’t
implemented in accordance and in happen again
conjunction with specified - The problem might be identified
requirements. in processes, materials, suppliers,
- Evaluates an existing quality the product, the service, the
program to determine its workplace, or the management
conformance to company system itself
policies, contract and
commitments, and regulatory
requirements. Risk-Based Thinking
- A first-party audit is an internal
audit conducted by auditors who ➢ Risk – an uncertain event or
are employed by the organization condition that, if it occurs, has an
being audited but who have no effect on at least one objective
vested interest in the audit results • Positive Risk – an upside
of the area being audited. opportunity for an individual or
corporate entity
 • Negative risks – unwanted and o Put your customers first, making
potentially can cause serious sure you consistently meet their
problems and derail the project needs and exceed their
expectations. This can lead to
repeat customers, new clients,
➢ Risk Based Thinking and increased business for your
o Preventive Action organization.
o Everybody’s business o Work in a more efficient way as
o Not just the responsibility of the all your processes will be aligned
management and understood by everyone in
o Must become an integral part of the business or organization. This
the organizational culture increases productivity and
efficiency, bringing internal costs
down.
➢ Why Should I Adopt Risk Based o Meet the necessary statutory and
Thinking? regulatory requirements.
o To improve customer confidence o Expand into new markets, s some
and satisfaction sectors and clients require ISO
o To assure consistency of quality 9001 before doing business.
goods and services o Identify and address the risks
o To establish a proactive culture associated with your
of Prevention and improvement organization.
o Successful companies intuitively
take a risk-based approach

➢ What Should I do?

o Identify what the risks and
opportunities are in your
organization – it depends on
context.

➢ Why ISO?
• Benefits of Implementing ISO
o Assess the overall context of
your organization to define who
is affected by your work and
what they expect from you. This
will enable you to clearly state
your objectives and identify new
business opportunities.