Course outline Introduction to Quality

Instructor: Marie A. Graves
Introduction to Quality
TOC: Table of Contents
Course Name: Introduction to Quality
Chapter 1: Chapter 1 Title – Brief history of Quality
Chapter 2: What is Quality and why is Quality Important
2.1 What is Quality
2.2 why is Quality Important
Chapter 3: Exploring Business Operations
3.1 Exploring Business Operations- ISO 9001
3.2 Exploring Business Operations- Total Quality Management
3.3 Exploring Business Operations- Six Sigma
Chapter 4: How do you Measure Quality?
4.1 Measuring Tools For Service and Products
4.2 Key Performance Indicators
Chapter 5: Conclusion / Summary
Conclusion Paragraph: Let’s recap on the course content and basic ideas that we covered;
We covered a brief history of Quality from the early concepts in the 13th
century to the WWII drive to
produce consistent products. We discussed what quality is and why Quality is Important to create
streamlined processes, reproducible results, and goals. We Explored Business Operations and discussed
ISO 9001, Total Quality Management, Six Sigma concepts. We discussed how Quality is measured for
Service and Products. And finally, we covered Key Performance Indicator steps for implementation and
development.

Test
Chapter 1
1) True or False: The birth of ‘Total Quality’ was in the early 1970’s.
2) True or False: Juran and Deming were considered pioneers of proactive defect
prevention.
3) True or False: The first organizational approaches to Quality were in the 1800’s with the
formation of “guilds”.
Chapter 2
Lesson 2.1
1) True or False: Statistical Process Control (SPC) is used as a monitoring method for
quality.
2) True or False: Conformity is defined as a set of recurring activities that are carried out in
order to enhance performance.
3) True or False: Quality objectives are an overall commitment and objectives to meet a
defined customer/market need.
Lesson 2.2
1) True or False: New product development cannot be performed in a uniform way.
2) True or False: In general, when actions are conducted in a planned manner the results
are not measurable.
3) True or False: Cost = waste and defects = cost
Chapter 3
Lesson 3.1
1) Continuous improvement methods of ISO 9001 include; (ALL THREE)
• Management review
• Audits
• CAPA
2) True or False: ISO 9001 requires processes to be documented.
3) True or False: Organizations cannot get certified to an ISO standard.
Lesson 3.2
1) TQM in action includes all of the following except:

1. Employee Involvement
2. Focus on the Customer
3. Benchmarking
4. Defined Objectives (Continuous Improvement is the missing answer)
2) True or False: Employee Involvement does not emphasize allowing employees to own a
process because they may cause more defects.
3) True or False: Continuous Improvement is based on the idea that everyone has a
responsibility to improve.
Lesson 3.3
1) True or False: Sigma is a statistical term for measuring employee involvement.
2) True or False: Quality in business is often called Perfection or Zero defects.
3) The steps of Six Sigma include all of the following except:
(1) Define
(2) Measure
(3) Analyze
(4) Benchmark (Improve)
(5) Correct (Control)
Chapter 4
Lesson 4.1
1) True or False: Services can only be measured qualitatively.
2) True or False: Statistical Process Control (SPC) is a reactive way pf monitoring quality
3) True or False: Scrap rate can be the total cost of scrap vs. the total cost to manufacture
over a defined period of time.
Lesson 4.2
1) True or False: The first step in establishing a KPI is to determine what you want to
monitor.
2) True or False: KPI’s can be established for any process
3) True or False: KPI’s should never include a frequency of review.
Course Transcription: Introduction to Quality

Slide 3: The quality movement can trace its roots back to medieval Europe, where craftsmen
began organizing into unions called guilds in the late 13th century.
Until the early 19th century, manufacturing in the industrialized world tended to follow this
craftsmanship model. The factory system, with its emphasis on product inspection, started
in Great Britain in the mid-1750s and grew into the Industrial Revolution in the early 1800s.
In the early 20th century, manufacturers began to include quality processes in quality
practices.
Slide 4: After the United States entered World War II, quality became a critical component
of the war effort: Bullets manufactured in one state, for example, had to work consistently
in rifles made in another. The armed forces initially inspected virtually every unit of product;
then to simplify and speed up this process without compromising safety, the military began
to use sampling techniques for inspection, aided by the publication of military-specification
standards and training courses in Walter Shewhart’s statistical process control techniques.
Slide 5: The birth of total quality in the United States came as a direct response to the
quality revolution in Japan following World War II. The Japanese welcomed the input of
Americans Joseph M. Juran and W. Edwards Deming and rather than concentrating on
inspection, focused on improving all organizational processes through the people who used
them.
By the 1970s, U.S. industrial sectors such as automobiles and electronics had been
broadsided by Japan’s high-quality competition. The U.S. response, emphasizing not only
statistics but approaches that embraced the entire organization, became known as total
quality management (TQM).
By the last decade of the 20th century, TQM was considered a fad by many business leaders.
But while the use of the term TQM has faded somewhat, particularly in the United States, its
practices continue.
In the few years since the turn of the century, the quality movement seems to have
matured beyond Total Quality. New quality systems have evolved from the foundations of
Deming, Juran and the early Japanese practitioners of quality, and quality has moved
beyond manufacturing into service, healthcare, education and government sectors.
Slide 9: A quality management system (QMS) is a collection of business processes focused
on achieving quality policy and quality objectives to meet customer requirements. It is

expressed as the organizational structure, policies, procedures, processes and resources
needed to implement quality management.
The Quality management system typically begins with a purpose, called “A Quality Policy”,
then Quality Objectives are developed to measure the outcomes of company’s activities
intended to meet the quality policy. The company has to develop procedures, and
processes, with defined responsibilities for each member of the organization. This is to
ensure that practices are consistent and optimized to deliver the highest quality products /
processes to customers.
Slide 16: Let’s start with making sense. I would like all of you to think about the last time
that you had a goal planned out for yourself. It may be something as simple as regular
weekend chores. You may have a list in your mind of all the things that you need to do. For
example; laundry, dishes, taking the kids to soccer games. Now think about how you plan
out what time you are going to do these activities in order to accomplish what needs to be
done. All of us plan out our daily activities in order to be more effective and do things that
makes sense. Now I want you all to think about a company, the way that we work every day
has a huge impact on the organization. If one person, or department or function is not on
board with the company goals and objectives, it throws off everyone's ‘Plan’. Quality gives
an organization a roadmap on how to make sure that all of the people in the company know
what is expected, knows how to do the things they are tasked with, and a way to measure
how well resources are spent.
Slide 17: (Requirements) For European markets, the ISO standards are a way for regulatory
agencies (the equivalent of the FDA in Europe) to make sure that a company is delivering
quality products that are safe and effective. And that companies have a way to monitor their
own product performance in the marketplace (customer feedback).
For the US market, the FDA requires that medical device manufacturers comply with the
Quality System Regulation or ‘QSR’s’ in order to make sure that products are safe for human
use and manufactured with consistent quality standards. In summary, a QMS is good for
business and required in order to sell our products.
Slide 21: Quality is often defined as 'fitness for purpose'. In other words a quality product is
one that meets the needs and requirements of its consumer. The consumers' perception of
the quality of a product or service is the most important factor in determining its success.
Quality as defined by the consumer, is more important than price in determining demand
for most goods and services. Consumers will be prepared to pay for the best quality. Value is
thus added by creating those quality standards required by consumers.
Consumer quality standards involve:

Creating consumer satisfaction
Exceeding consumer expectations
Keeping the consumer happy
ISO is the international standards organization. Companies can obtain an ISO certification
for any ISO standard by going through a notified boy (independent auditor) and
implementing a Quality Management System or QMS. A QMS per ISO 9001 is designed to
Promote awareness to customer, business, and regulatory changes
Educate employees, through functional sessions, how quality relates to their job
Reinforce the company’s commitment to quality
Drives quality linkage with corporate goals, initiatives, and day-to-day activities
Slide 22:
Document Control
Procedures must be documented
These documents must be approved by the people who perform the work and Quality
Procedures can be changed, with a reason and a re-approval
Forms and Records need to be controlled (same as procedures)
Quality Records
Records are controlled forms that are completed and support functions of the QMS.
Examples: Receiving records, complaint forms, lot release testing records, training records.
Design Control
Design planning
Design input (Marketing and Customer needs)
Design output (How were inputs achieved?)
Design review (each phase of development needs a review to make sure you are on track)
Design verification
Design validation
Design Transfer
Design changes (Document changes and document control)

Purchasing and Supplier Control
Procedures are required to
Evaluate suppliers
Approve suppliers
Monitor suppliers
Suppliers approval is happens before you purchase
Storage, handling, and identification of products
Procedures for receiving purchased materials
Procedures for how temperature and other special storage conditions are maintained.
Procedures for how you identify where items are stored.
Production and process control
Procedures for how to calibrate and inspect equipment
Procedures for how to use equipment
Procedures for how to monitor the product
Procedures for how to inspect the product
Acceptance activities and Release testing
Records to document that the product requirements have been met
Records documenting the release of products
Slide 23:
Nonconformance's, Corrective And Preventive Actions (CAPA), Audits
Procedures for how to handle when a product does not meet the documented requirements
(Nonconformance's)
Procedures for how to correct and prevent defects from happening (CAPA)
Procedures for how the company monitors itself (Audits)
Customer service and support / Complaints (Internal and External)

Procedures for how to investigate and assess a customer complaint
Procedures for how to handle orders and feedback (customer support)
Training and Resources (building and infrastructure)
Procedures for how to train employees
Procedures for how to assess training was effective
Records for training
Procedures for how on-going training is done
Management Reviews & Improvement
Management review inputs include;
Follow up activities, results of audits, customer feedback, Product and Process conformity
review, Status of CAPA’s, changes that may affect the QMS, improvement
recommendations, new/revised regulatory requirements, quality policy review, resource
needs.
Slide 35: In 1986, Bill Smith at Motorola Corporation developed a set of process
improvement strategies known as Six Sigma. The term Six Sigma refers to a highly
capable process designed to produce outputs within highly demanding specifications.
The goal of Six Sigma is to systematically improve processes by eliminating defects. Six
Sigma is first and foremost "a business process that enables companies to increase profits
dramatically by streamlining operations, improving quality and eliminating defects or
mistakes in everything a company does.
Six Sigma's implicit goal is to improve all processes to that level of quality or better. The
principles of Six Sigma are especially important to companies engaged in the manufacture of
high-end computer and communications equipment.
Slide 36: Six Sigma is a highly disciplined process that helps a business (or organization)
focus on developing and delivering near-perfect products and services. Why "Sigma"? The
word is a statistical term that measures how far a given process deviates from perfection.
The central idea behind Six Sigma is that if you can measure how many "defects" you have in
a process, you can systematically figure out how to eliminate them and get as close to "zero
defects" as possible. In order to realize the exacting standards of Six Sigma, a business
process should not produce more than 3.4 defects per million opportunities.

A “defect” is defined as a failure to deliver what the customer want. An "opportunity" is
defined as a chance for nonconformance, or not meeting the required specifications. This
means that an organization needs to be nearly perfect in executing its key processes
In the early 1990s, then GE CEO, Jack Welch was told was told that Six Sigma, the quality
program pioneered by Motorola, could have a significant effect on improving GE’s
operational performance.
Although skeptical at first, Welch initiated a major strategy initiative to infuse Six Sigma
thinking into every aspect of GE’s business operations. He made quality the responsibility
of every employee on the shop floor.
All senior managers were expected to undertake Six Sigma training. Their promotions and
bonuses were directly tied to Six Sigma results within the company. Six Sigma, in Welch’s
view, did more to change the DNA of how GE did business than any other program.
Slide 37: Central to the discussion of Six Sigma are three important elements: the customer,
the process and the employee.
The Customer.
The customer should form the center of the universe for a business. Their expectations
include, a high quality product or service, on-time delivery, competitive prices, reliability and
good customer support.
The Process.
Achieving Six Sigma level of performance presupposes the ability to look at business process
from the perspective of one’s customers. They understand better than anyone what works
best and least in terms of their interaction with the company or organization. The
customer’s routine feedback provides the basis for making on-going improvements as a
whole.
The Employee.
People make the difference. One of the important goals of Six Sigma training and thinking is
to empower managers and employees to make decisions on the shop floor. Quality is the
responsibility of every employee.
Slide 37: In the early 1990s, then GE CEO, Jack Welch was told was told that Six Sigma, the
quality program pioneered by Motorola, could have a significant effect on improving GE’s
operational performance.

Although skeptical at first, Welch initiated a major strategy initiative to infuse Six Sigma
thinking into every aspect of GE’s business operations. He made quality the responsibility
of every employee on the shop floor.
All senior managers were expected to undertake Six Sigma training. Their promotions and
bonuses were directly tied to Six Sigma results within the company. Six Sigma, in Welch’s
view, did more to change the DNA of how GE did business than any other program.
Slide 44: Service business operators often assess the service quality provided to their
customers in order to improve their service, to quickly identify problems, and to better
assess client satisfaction.
Most businesses that produce goods for sale have a product quality or assurance
department that monitors outgoing products for consumer acceptability.
Slide 45: Giving customer’s surveys after services have been provided.
Administering a questionnaire that has a rating scale and can be analyzed.
Monitoring feedback that is not solicited on the internet. Facebook, Instagram, blogs, etc.
Web analytics - For example, let's say that you operate a company that lets users pay to
watch DIY car repair videos made by expert mechanics. Using an analytics tool that lets you
monitor the traffic to each page, you discover that 90% of visitors make it to the pricing
information page but only 5% go on to select one of the service options. This may be a sign
that your pricing scheme isn't competitive — perhaps lowering your prices may get you a
more favorable sales rate
Slide 51: Identify the results you expect. In order to measure your organization’s
performance with key performance indicators, you first need to know what the goals
actually are. It is, after all, difficult to establish rate of success without an expectation for
success. Establish clear goals that reflect various areas of the company: asset management,
revenue and profit, spending, safety and so forth. Key performance indicators are not
limited to income; focus on a variety of areas. Review the company’s business goals, and
apply these to the desired results.
Establish the numbers the company needs to reach its goals. This step goes beyond just
identifying the results; it gives shape to those results with actual numbers that represent
objectives. Ask yourself how much profit the company needs to make, how many new
customers it needs to add, how much money it needs to save, how many safety violations it
needs to avoid and so forth. A company that makes $10 million a year might have a goal of
making $15 million a year. That $15 million is a specific, clear goal–more than just a goal of
“increasing company profits.”

Slide 52: Identify the progress that has occurred so far. Key performance indicators work
alongside specific company activities, and developing indicators for future activities requires
an understanding of what has already occurred or is in the process of occurring. If the
company has a goal of making $15 million a year and is currently making $10 million a year,
the company is approximately 67 percent of the way toward its goal.
Determine the percentage of change that has occurred within each area of review. In other
words, take a closer look at the current numbers–not focusing right now on the future
numbers–and consider what has happened in the past. Doing so will enable you to create
more effective goals for the future. Look at the percentage of change on different scales:
the change in profits from one July to the next, or the number of safety violations between
one month and the next.
Establish the frequency of reviewing these indicators. Looking at key performance indicators
should not occur just once but should be a process that occurs at stated intervals over time.
And each area of a company studied will require a different frequency. Company profits
might need to be reviewed only quarterly, whereas safety issues should be reviewed
monthly. Determine the frequency based on the nature of the company sector.

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