SYNTHESIS

Lesson 1: TOTAL QUALITY MANAGEMENT

TQM can be summarized as a management system for a customer-focused

organization that involves all employees in continual improvement. It uses strategy,
data, and effective communications to integrate the quality discipline into the culture and
activities of the organization. Many of these concepts are present in modern quality
management systems, the successor to TQM. Here are the 8 principles of total quality
management:

1. Customer-focused: The customer ultimately determines the level of quality. No

matter what an organization does to foster quality improvement—training employees,
integrating quality into the design process, or upgrading computers or software—the
customer determines whether the efforts were worthwhile.
2. Total employee involvement: All employees participate in working toward common
goals. Total employee commitment can only be obtained after fear has been driven
from the workplace, when empowerment has occurred, and when management has
provided the proper environment. High-performance work systems
integrate continuous improvement efforts with normal business operations. Self-
managed work teams are one form of empowerment.
3. Process-centered: A fundamental part of TQM is a focus on process thinking. A
process is a series of steps that take inputs from suppliers (internal or external) and
transforms them into outputs that are delivered to customers (internal or external).
The steps required to carry out the process are defined, and performance measures
are continuously monitored in order to detect unexpected variation.
4. Integrated system: Although an organization may consist of many different
functional specialties often organized into vertically structured departments, it is the
horizontal processes interconnecting these functions that are the focus of TQM.
 Micro-processes add up to larger processes, and all processes aggregate into the
business processes required for defining and implementing strategy. Everyone must
understand the vision, mission, and guiding principles as well as the quality policies,

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 objectives, and critical processes of the organization. Business performance must be
monitored and communicated continuously.
 An integrated business system may be modeled after the Baldrige Award criteria
and/or incorporate the ISO 9000 standards. Every organization has a unique work
culture, and it is virtually impossible to achieve excellence in its products and
services unless a good quality culture has been fostered. Thus, an integrated system
connects business improvement elements in an attempt to continually improve and
exceed the expectations of customers, employees, and other stakeholders.
5. Strategic and systematic approach: A critical part of the management of quality is
the strategic and systematic approach to achieving an organization’s vision, mission,
and goals. This process, called strategic planning or strategic management, includes
the formulation of a strategic plan that integrates quality as a core component.
6. Continual improvement: A large aspect of TQM is continual process improvement.
Continual improvement drives an organization to be both analytical and creative in
finding ways to become more competitive and more effective at
meeting stakeholder expectations.
7. Fact-based decision making: In order to know how well an organization is
performing, data on performance measures are necessary. TQM requires that an
organization continually collect and analyze data in order to improve decision making
accuracy, achieve consensus, and allow prediction based on past history.
8. Communications: During times of organizational change, as well as part of day-to-
day operation, effective communications plays a large part in maintaining morale and
in motivating employees at all levels. Communications involve strategies, method,
and timeliness.

BENEFITS OF TOTAL QUALITY MANAGEMENT

Note: Total quality management (TQM) as a term to describe an organization's quality

policy and procedure has fallen out of favor as international standards for quality
management have been developed. Please see our series of pages on quality
management systems for more information.

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TOTAL QUALITY MANAGEMENT BENEFITS AND ADVANTAGES:

 Strengthened competitive position

 Adaptability to changing or emerging market conditions and to environmental and
other government regulations
 Higher productivity
 Enhanced market image
 Elimination of defects and waste
 Reduced costs and better cost management
 Higher profitability
 Improved customer focus and satisfaction
 Increased customer loyalty and retention
 Increased job security
 Improved employee morale
 Enhanced shareholder and stakeholder value
 Improved and innovative processes

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 Total Quality Management (TQM) Benefit: Methodology Creates an Adaptive
Organization

ASQ has collected a series of total quality management case studies to illustrate the
impact a TQM system can have on your organization.

TQM IMPLEMENTATION AND SYSTEMS

Note: Total quality management (TQM) as a term to describe an organization's quality

policy and procedure has fallen out of favor as international standards for quality
management have been developed. Please see our series of pages on quality
management systems for more information.

When planning and implementing a total quality management system or quality

management strategy, there is no one solution for every situation or workplace.

Each organization is unique in terms of the culture, management practices, and the
processes used to create and deliver its products and services. Quality management
strategy vary from organization to organization; however, a set of primary
elements should be present in some format.

GENERIC STRATEGY MODEL FOR IMPLEMENTING TQM SYSTEMS

1. Top management learns about and decides to commit to TQM. TQM is identified as
one of the organization’s strategies.
2. The organization assesses current culture, customer satisfaction, and quality
management systems.
3. Top management identifies core values and principles to be used, and
communicates them.
4. A TQM master plan is developed on the basis of steps 1, 2, and 3.

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5. The organization identifies and prioritizes customer demands and aligns products
and services to meet those demands.
6. Management maps the critical processes through which the organization meets its
customers’ needs.
7. Management oversees the formation of teams for process improvement efforts.
8. The momentum of the TQM effort is managed by the steering committee.
9. Managers contribute individually to the effort through hoshin planning, training,
coaching, or other methods.
10. Daily process management and standardization take place.
11. Progress is evaluated and the plan is revised as needed.
12. Constant employee awareness and feedback on status are provided and a
reward/recognition process is established.

EXAMPLES OF TOTAL QUALITY MANAGEMENT SYSTEM STRATEGIES

Imprints of TQM concepts can be found in modern approaches to quality management,

such as the Malcolm Baldrige National Quality Award (MBNQA) criteria, ISO 9001, Six
Sigma and lean manufacturing, as well as the examples below.

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 TOTAL QUALITY MANAGEMENT (TQM) IMPLEMENTATION STRATEGIES

Strategy 1: The TQM element approach

The TQM element approach takes key business processes and/or organizational
units and uses the tools of TQM to foster improvements. This method was widely used
in the early 1980s as companies tried to implement parts of TQM as they learned them.
Examples of this approach include quality circles, statistical process control, Taguchi
methods, and quality function deployment.

Strategy 2: The guru approach

The guru approach uses the teachings and writings of one or more of the leading
quality thinkers as a guide against which to determine where the organization has
deficiencies. The organization makes appropriate changes to remedy those
deficiencies. For example, managers might study Deming’s 14 points or attend the
Crosby College. Afterward, they would work on implementing the approach learned.

Strategy 3: The organization model approach

In this approach, individuals or teams visit organizations that have taken a

leadership role in TQM and determine their processes and reasons for success. They
then integrate these ideas with their own ideas to develop an organizational model
adapted for their specific organization. This method was used widely in the late 1980s
and is exemplified by the initial recipients of the Malcolm Baldrige National Quality
Award.

Strategy 4: The Japanese total quality approach

Organizations using the Japanese total quality approach examine the detailed
implementation techniques and strategies employed by Deming Prize-winning
companies and use this experience to develop a long-range master plan for in-house
use. This approach was used by Florida Power and Light—among others—to
implement TQM and to compete for, and win, the Deming Prize.

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Strategy 5: The award criteria approach

When using this model, an organization uses the criteria of a quality award (e.g.,
the Deming Prize, the European Quality Award, or the Malcolm Baldrige National
Quality Award), to identify areas for improvement. Under this approach, TQM
implementation focuses on meeting specific award criteria.

Although some argue that this is not an appropriate use of award criteria, some
organizations do use this approach and it can result in improvement.

Adapted from The Certified Manager of Quality/Organizational Excellence Handbook.

Fourth Edition, ASQ Quality Press.

HISTORY OF TOTAL QUALITY MANAGEMENT

The history of total quality management (TQM) began initially as a term coined
by the Naval Air Systems Command to describe its Japanese-style management
approach to quality improvement. An umbrella methodology for continually improving
the quality of all processes, it draws on a knowledge of the principles and practices of:

 The behavioral sciences

 The analysis of quantitative and nonquantitative data
 Economics theories
 Process analysis

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History of Total Quality Management (TQM)

1920s  Some of the first seeds of quality management were planted as the
principles of scientific management swept through U.S. industry.
 Businesses clearly separated the processes of planning and carrying
out the plan, and union opposition arose as workers were deprived of a
voice in the conditions and functions of their work.
 The Hawthorne experiments in the late 1920s showed how worker
productivity could be impacted by participation.

1930s  Walter Shewhart developed the methods for statistical analysis and
control of quality.

1950s  W. Edwards Deming taught methods for statistical analysis and control
of quality to Japanese engineers and executives. This can be
considered the origin of TQM.
 Joseph M. Juran taught the concepts of controlling quality and
managerial breakthrough.
 Armand V. Feigenbaum’s book Total Quality Control, a forerunner for
the present understanding of TQM, was published.
 Philip B. Crosby’s promotion of zero defects paved the way for quality
improvement in many companies.

1968  The Japanese named their approach to total quality "companywide

quality control." It is around this time that the term quality management
systems arises.
 Kaoru Ishikawa’s synthesis of the philosophy contributed to Japan’s

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 ascendancy as a quality leader.

Today  TQM is the name for the philosophy of a broad and systemic approach
to managing organizational quality.
 Quality standards such as the ISO 9000 series and quality award
programs such as the Deming Prize and the Malcolm Baldrige National
Quality Award specify principles and processes that comprise TQM.
 TQM as a term to describe an organization's quality policy and
procedure has fallen out of favor as international standards for quality
management have been developed. Please see our series of pages
on quality management systems for more information.

Adapted from The Certified Manager of Quality/Organizational Excellence Handbook,

Fourth Edition, ASQ Quality Press.

W. EDWARDS DEMING’S 14 POINTS FOR TOTAL QUALITY MANAGEMENT

Deming’s 14 Points on Quality Management, or the Deming Model of Quality

Management, a core concept on implementing total quality management (TQM), is a set
of management practices to help companies increase their quality and productivity.

Deming's 14 Points for Total Quality Management

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 W. EDWARDS DEMING’S 14 POINTS

1. Create constancy of purpose for improving products and services.

2. Adopt the new philosophy.
3. Cease dependence on inspection to achieve quality.
4. End the practice of awarding business on price alone; instead, minimize total cost
by working with a single supplier.
5. Improve constantly and forever every process for planning, production and service.
6. Institute training on the job.
7. Adopt and 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 for the workforce and numerical goals for management.
12. Remove barriers that rob people of pride of workmanship, and eliminate the annual
rating or merit system.
13. Institute a vigorous program of education and self-improvement for everyone.
14. Put everybody in the company to work accomplishing the transformation.

These total quality management principles can be put into place by any
organization to more effectively implement total quality management. As a total quality
management philosophy, Dr. Deming’s work is foundational to TQM and its
successor, quality management systems.

BUSINESS LEADERSHIP AND THE BOTTOM LINE

In business, leadership is linked to performance, and any leadership definition

has to take that into account. While it's not solely about profit, those who are viewed as
effective leaders are the ones who increase their company's bottom lines. If an
individual in a leadership role does not meet profit expectations set by boards, higher
management, or shareholders, they may be terminated.

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 The terms "leadership" and "management" tend to be used interchangeably.
Management refers to a company's management structure as its leadership, or to
individuals who are actually managers as the "leaders" of various management teams.

Leadership, however, requires traits that extend beyond management duties. To be

effective, a leader certainly has to manage the resources at their disposal. But
leadership also involves communicating, inspiring and supervising—just to name three
more of the primary skills a leader has to have to be successful.

LEADERS: BORN OR MADE?

While there are people who seem to be naturally endowed with more leadership
abilities than others, anyone can learn to become a leader by improving particular skills.
History is full of people who, while having no previous leadership experience, have
stepped to the fore in crisis situations and persuaded others to follow their suggested
course of action. They possessed traits and qualities that helped them to step into roles
of leadership.

Writing in Forbes magazine, Erika Andersen, author of "Leading So People Will

Follow," says that, like most things, leadership capability falls along a bell curve. So the
fact is that most folks who start out with a modicum of innate leadership capability can
actually become very good, even great leaders.

THE EVOLUTION OF A LEADER

Steve Jobs is a classic example of someone who learned to lead despite not
being born a natural leader. After starting Apple Computer with Steve Wozniak in 1976,
he was fired by the board of directors in 1985 when the company was facing intense
competition and internal disagreement about the future direction of the business. Later,
after founding Pixar Animation Studios and NeXT Computer, he was eventually rehired
by Apple in 1997 as CEO and went on to develop the revolutionary iPod, iPhone, and
many other products.

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 By all accounts, Steve Jobs was a mercurial genius who, early in his career,
routinely yelled at employees, co-workers, partners, and vendors. According to some
ex-employees of Apple and NeXT, he was intolerant of anything he viewed as a failure,
and his foul-mouthed tirades were the stuff of legend. He apparently believed in brutal
honesty and considered other people's feelings irrelevant. He did not conduct formal
reviews with employees and was sparing with praise for a job well done.

However, according to biographies, such as "Steve Jobs" by Walter Isaacson, as

Jobs matured his management style began to shift. He started to moderate some of his
more negative traits and showed more empathy toward others, realizing that people had
limits. Upon his return to Apple, he was forced to cut staff and was quoted as
expressing concern for families of employees who were laid off.

Jobs died on October 5, 2011, at the age of 56. Even after his death, his
reputation and his company lives on. An October 2018 article in Forbes
magazine stated, "Today, precisely seven years after [Jobs'] passing, his name is still
synonymous with visionary, genius, innovator, and icon." He could not have
accomplished much of what he did—and Apple probably woudn't be around today—had
Jobs not developed into a leader.

Strategic planning is an organization's process of defining its strategy, or

direction, and making decisions on allocating its resources to pursue this strategy. It
may also extend to control mechanisms for guiding the implementation of the strategy.
Strategic planning became prominent in corporations during the 1960s and remains an
important aspect of strategic management. It is executed by strategic planners
or strategists, who involve many parties and research sources in their analysis of the
organization and its relationship to the environment in which it competes.[1]

Strategy has many definitions, but generally involves setting strategic goals,
determining actions to achieve the goals, and mobilizing resources to execute the
actions. A strategy describes how the ends (goals) will be achieved by the means
(resources). The senior leadership of an organization is generally tasked with

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determining strategy. Strategy can be planned (intended) or can be observed as a
pattern of activity (emergent) as the organization adapts to its environment or competes.

Strategy includes processes of formulation and implementation; strategic planning helps

coordinate both. However, strategic planning is analytical in nature (i.e., it involves
"finding the dots"); strategy formation itself involves synthesis (i.e., "connecting the
dots") via strategic thinking. As such, strategic planning occurs around the strategy
formation activity.

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 SYNTHESIS

Lesson 2: TOTAL QUALITY MANAGEMENT PRINCIPLES

1. CUSTOMER SATISFACTION

Is a term frequently used in marketing. It is a measure of how products and

services supplied by a company meet or surpass customer expectation. Customer
satisfaction is defined as "the number of customers, or percentage of total customers,
whose reported experience with a firm, its products, or its services (ratings) exceeds
specified satisfaction goals."[1]

The Marketing Accountability Standards Board (MASB) endorses the definitions,

purposes, and constructs of classes of measures that appear in Marketing Metrics as
part of its ongoing Common Language in Marketing Project.[2] In a survey of nearly 200
senior marketing managers, 71 percent responded that they found a customer
satisfaction metric very useful in managing and monitoring their businesses.

It is seen as a key performance indicator within business and is often part of a Balanced
Scorecard. In a competitive marketplace where businesses compete for customers,
customer satisfaction is seen as a key differentiator and increasingly has become a key
element of business strategy.

PURPOSE OF CUSTOMER SATISFACTION

"Customer satisfaction provides a leading indicator of consumer purchase

intentions and loyalty. Customer satisfaction data are among the most frequently
collected indicators of market perceptions. Their principal use is twofold:" [1]

1. "Within organizations, the collection, analysis and dissemination of these data

send a message about the importance of tending to customers and ensuring that
they have a positive experience with the company's goods and services." [1]
2. "Although sales or market share can indicate how well a firm is
performing currently, satisfaction is perhaps the best indicator of how likely it is
that the firm’s customers will make further purchases in the future. Much
research has focused on the relationship between customer satisfaction and

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 retention. Studies indicate that the ramifications of satisfaction are most strongly
realized at the extremes."

On a five-point scale, "individuals who rate their satisfaction level as '5' are likely to
become return customers and might even evangelize for the firm. (A second important
metric related to satisfaction is willingness to recommend. This metric is defined as "The
percentage of surveyed customers who indicate that they would recommend a brand to
friends." When a customer is satisfied with a product, he or she might recommend it to
friends, relatives and colleagues. This can be a powerful marketing advantage.)
"Individuals who rate their satisfaction level as '1,' by contrast, are unlikely to return.
Further, they can hurt the firm by making negative comments about it to prospective
customers. Willingness to recommend is a key metric relating to customer satisfaction

2. CUSTOMERS’ PERCEPTIONS OF PRODUCT QUALITY

As opposed to objective quality—drive preferences and consequently

satisfaction, loyalty, sales, and profitability, but customers’ perceptions of quality are
imperfect and slow to take into account changes in objective quality. What, then, is the
relationship between quality and customer perceptions of quality over time? How do
improvements or declines in quality affect customers’ perceptions of quality? And how
does brand reputation affect these questions? Those are just some of the questions that
Debanjan Mitra and Peter Golder set out to answer with their longitudinal study of the
relationship between objective and perceived quality for 241 products in 46 product
categories over a period of 12 years.

They hypothesize that objective quality does have a positive effect on perceived
quality contemporaneously, in the short term, and in the long term. They also
hypothesize that a decrease in objective quality has a greater effect on customers’
perceptions than does an increase. Further, they suggest that increases in quality will
have larger short-term effects for brands with good reputations than for brands with poor
reputations and that decreases in quality will have larger short-term effects for brands
with poor reputations than for brands with good reputations.

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 On average, they find that the effect of a change in objective quality is not fully
reflected in customers’ perceptions of quality until after about six years. In the first year
after a quality change, only about 20% of the total customer reaction over time is
realized. These reactions are significantly larger and occur more quickly for a decrease
in quality than for an equivalent increase. Interestingly, they also find that brand
reputation has a double advantage. High-reputation brands are rewarded three years
earlier than low-reputation brands for an increase in quality and punished one year
slower for a decrease in quality. These differences in response time are a meaningful
measure of brand equity.

3. CUSTOMER COMPLAINT

A consumer complaint or customer complaint is "an expression of

dissatisfaction on a consumer's behalf to a responsible party" (London, 1980). It can
also be described in a positive sense as a report from a consumer providing
documentation about a problem with a product or service. In fact, some modern
business consultants urge businesses to view customer complaints as a gift.

Consumer complaints are usually informal complaints directly addressed to a

company or public service provider, and most consumers manage to resolve problems
with products and services but it sometimes requires persistence.
An instrumental complaint is a complaint made to a person or organization that could
take some action and bring about a specific remedy. An expressive complaint is a
complaint made for the purpose of expressing feelings, without any realistic chance of
anything being done. Most online complaints are expressive complaints.

Service quality generally refers to a customer’s comparison of service expectations as it

relates to a company’s performance. A business with a high level of service quality is
likely capable of meeting customer needs while also remaining economically
competitive in their respective industry. Successful businesses who remain competitive
and relevant in the marketplace work proactively to obtain information from their current
or potential customer base so they can ensure they are meeting their needs.

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No amount of discussing with professionals, friends, or colleagues will ever replace the
information that a company can receive from a real customer.

The following questions are crucial when obtaining customer feedback:

 What does the customer like?

 What do they dislike?

 How can things be improved?

 Are their needs and expectations being met?

 How much will they pay for something?

 Is convenience important?

 Should items be packaged together?

 Is after-sales service critical?

Customer feedback can be collected by:

 Asking consumers directly: This tactic comes across particularly effective during
the point-of-purchase at a retail store because consumers are being probed on
their experiences while they are shopping.

 Questionnaires: Distribute one-page questionnaires that ask some key questions

and encourage customers to fill them out. These can be mailed out as pre-paid
postcards or emailed to consumers who give their permission to be contacted.

 Focus groups: This involves gathering a number of customers, sitting them down,
and discussing a range of issues relevant to a company’s business. The
advantage of using this method over a questionnaire is that it will yield more
detailed information and feedback, rather than “tick the box” style responses from
a questionnaire. In-person focus groups and one-on-one interviews are helpful
tools that provide explanation of product or consumer-related issues because you
are going to the main source directly.

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  Telephone: Some surveys can be conducted via phone. These yield a more
private conversation exchange between the customer and the service provider.

Telephone Survey: Telephone surveys enable a private conversation to take place

between the customer and service provider.
 Virtual online communities or private consumer panels: Technology has made it
increasingly easier for companies to obtain feedback from their customers. With
the explosion of technology in the marketplace and the consumer’s everyday life,
many companies are now building their own proprietary online panels of
consumers which give them unencumbered access to their target market on an
ongoing basis. In exchange for their honest opinions and feedback, customers are
incentivized for their time. Community blogs and forums also enable customers to
provide detailed explanations of both negative as well as positive experiences with
a company.

Instant feedback

Recently, many organizations have implemented feedback loops that allow them to
capture feedback at the point of experience. For example, National Express, one of the
UK’s leading travel companies, has invited passengers to send text messages while
riding the bus. This has been shown to be useful, as it allows companies to improve
their customer service before the customer defects, thus making it far more likely that
the customer will return next time.

4. JURAN’S QUALITY TRILOGY

x
The famous Quality Trilogy was first developed and written by Joseph M. Juran.
As you all know, Juran is a management consultant and an Engineer, specialized in
Quality management.

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 The Quality Trilogy explained by Juran is: Any organization taking up a journey in
Quality Management will have to have three Processes in place, which are: i) Quality
Planning ii) Quality Control and iii) Quality Improvement. Though the above three may
sound similar, they have different objectives and serve different purposes of Quality
Management.

Let us have a look at these components one by one:

i. Quality Planning: As with all

management activities and
processes, Quality journey
begins with planning the
activities that needs to be done
to adhere to the Vision, Mission
and Goals of the organization
and to comply with customer and
compliance requirements.Quality
Planning comprises of i)
Understanding the customer, ii)
Determining their needs, iii)
Defining the product/service
features, specifications
iv)Designing the product/service v) Devising the processes that will enable to meet
the customer needs.

ii. Quality Control: Once the processes are defined, the responsibility is now with
operations, to adhere to the processes and specifications required by the
product/service. For this purpose periodic checks and inspection has to be done,
metrics need to be tracked, to ensure that the process is in control and meets
specifications and the metrics need the set target. Wherever there is a defect a

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corrective and preventive action needs to be done, and root cause has to be arrived at.
Also the deviation in the metrics and process audit results need to be monitored and
corrected for meeting the required target as specified by the processes.

iii. Quality Improvement: However robust the process design and the product features
are, there are chances that it may fail to meet customer requirements and design
targets. It might be due to some special causes that are present in the system and
might be due to change in business scenarios, customer requirements, market
completion and many more forces. The role of Quality Improvement is to identify and
prove the need for improvement from the exiting performance levels even though they
meet the target and devise means and ways to achieve the new target and implement
them successfully.
All the three processes are interlinked and will affect one another in due course
of the journey. Thus the processes are corrected individually and streamlined to help
each other in Quality Management journey, the end objective.

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 SYNTHESIS

Lesson 3: STATISTICAL PROCESS COTROL

Introduction to Statistical Process Control (SPC)

Statistical Process Control (SPC) is not new to industry. In 1924, a man at Bell
Laboratories developed the control chart and the concept that a process could be in
statistical control. His name was William A. Shewart. He eventually published a book
titled “Statistical Method from the Viewpoint of Quality Control” (1939). The SPC
process gained wide usage during World War II by the military in the munitions and
weapons facilities. The demand for product had forced them to look for a better and
more efficient way to monitor product quality without compromising safety. SPC filled
that need. The use of SPC techniques in America faded following the war. It was then
picked up by the Japanese manufacturing companies where it is still used today. In the
1970s, SPC started to gain acceptance again due to American industry feeling
pressure from high quality products being imported from Japan. Today, SPC is a
widely used quality tool throughout many industries.

WHAT IS STATISTICAL PROCESS CONTROL (SPC)

SPC is method of measuring and controlling quality by monitoring the

manufacturing process. Quality data is collected in the form of product or process
measurements or readings from various machines or instrumentation. The data is
collected and used to evaluate, monitor and control a process. SPC is an effective
method to drive continuous improvement. By monitoring and controlling a process, we
can assure that it operates at its fullest potential. One of the most comprehensive and
valuable resources of information regarding SPC is the manual published by the
Automotive Industry Action Group (AIAG).

Why Use Statistical Process Control (SPC)

Manufacturing companies today are facing ever increasing competition. At the

same time raw material costs continue to increase. These are factors that companies,
for the most part, cannot control. Therefore companies must concentrate on what they
can control: their processes. Companies must strive for continuous improvement in

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quality, efficiency and cost reduction. Many companies still rely only on inspection after
production to detect quality issues. The SPC process is implemented to move a
company from detection based to prevention based quality controls. By monitoring the
performance of a process in real time the operator can detect trends or changes in the
process before they result in non-conforming product and scrap.

How to Use Statistical Process Control (SPC)

Before implementing SPC or any new quality system, the manufacturing process
should be evaluated to determine the main areas of waste. Some examples of
manufacturing process waste are rework, scrap and excessive inspection time. It would
be most beneficial to apply the SPC tools to these areas first. During SPC, not all
dimensions are monitored due to the expense, time and production delays that would
incur. Prior to SPC implementation the key or critical characteristics of the design or
process should be identified by a Cross Functional Team (CFT) during a print review
or Design Failure Mode and Effects Analysis (DFMEA) exercise. Data would then
be collected and monitored on these key or critical characteristics.

Collecting and Recording Data

SPC data is collected in the form of measurements of a product dimension /

feature or process instrumentation readings. The data is then recorded and tracked on
various types of control charts, based on the type of data being collected. It is
important that the correct type of chart is used gain value and obtain useful information.
The data can be in the form of continuous variable data or attribute data. The data can
also be collected and recorded as individual values or an average of a group of
readings. Some general guidelines and examples are listed below. This list is not all
inclusive and supplied only as a reference.

Variable data

 Individual – Moving Range chart: to be used if your data is individual values

 Xbar – R chart: to be used if you are recording data in sub-groups of 8 or less
 Xbar – S chart: to be used if your sub-group size is greater than 8

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Attribute data

 P chart – For recording the number of defective parts in a group of parts

 U chart – For recording the number of defects in each part

Control Charts

One of the most widely used control charts for variable data is the X-bar and R
chart. X-bar represents the average or “mean” value of the variable x. The X-bar chart
displays the variation in the sample means or averages. The Range chart shows the
variation within the subgroup. The range is simply the difference between the highest
and lowest value. The following steps are required to build an X-bar and R chart:
 Designate the sample size “n”. Usually 4 or 5 are common sample sizes used in
many industries. Remember the sample size should be 8 or less. Also determine
the frequency that the sample measurements will be collected.
 Start collecting your initial set of samples. A general rule is to collect 100
measurements in groups of 4 which would result in 25 data points.
 Calculate the average value for each of the 25 groups of 4 samples.
 Calculate the range of each of the 25 samples of 4 measurements. The range is
the difference between the highest and lowest value in each set of 4 sample
measurements.
 Calculate X-dbar (the average of the averages), which is represented on the X-
bar chart by a solid centerline.
 Calculate the average of the sample ranges or “R” values. This will be the
centerline of the Range chart.
 Calculate the Upper and Lower Control Limits (UCL, LCL) for each chart. To be
clear, the control limits are not the spec limits set by the engineer on the drawing.
The control limits are derived from the data. Most engineers utilize statistical
software that will perform the calculations automatically.
Once the chart is setup, the operator or technician will measure multiple samples,
add the values together then calculate the average. This value is then recorded on a
control chart or X-bar chart. The range of the subgroups is also recorded. The sample
measurements should be taken and recorded in regular intervals, including date and

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time to track the stability of the process. Watch for any special or assignable causes
and adjust the process as necessary to maintain a stable and in control process.
The X-bar and R chart is merely one example of the different control charts available
for process monitoring and improvement. For assistance in determining the best
practices to improve your processes, contact one of the many professionals at Quality-
One.

Analyzing the Data

The data points recorded on a control chart should fall between the control limits,
provided that only common causes and no special causes have been identified.
Common causes will fall between the control limits whereas special causes are
generally outliers or are outside of the control limits. For a process to be deemed in
statistical control there should be no special causes in any of the charts. A process in
control will have no special causes identified in it and the data should fall between the
control limits. Some examples of common cause variation are as follows:
 Variation in material properties within specification
 Seasonal changes in ambient temperature or humidity
 Normal machine or tooling wear
 Variability in operator controlled settings
 Normal measurement variation
Adversely, special causes generally fall outside of the control limits or indicate a drastic
change or shift in the process. Some examples of special cause variation are below:
 Failed controllers
 Improper equipment adjustments
 A change in the measurement system
 A process shift
 Machine malfunction
 Raw material properties out of design specifications
 Broken tool, punch, bit, etc.
 Inexperienced operator not familiar with process

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 When monitoring a process through SPC charts the inspector will verify that all data
points are within control limits and watch for trends or sudden changes in the process.
If any special causes of variation are identified, appropriate action should be taken to
determine the cause and implement corrective actions to return the process to a state
of statistical control.
There are other variations or patterns of data points within the control limits that should
also be tracked and investigated. These include but are not limited to:
 Runs where 7 or more data points are in a row on one side of the process
centerline
 Changes in the normal spread of data, where multiple data points fall either
farther apart or closer together
 Trends which are represented by 7 or more data points consistently raising or
declining
 Shifts in the data spread above or below the normal mean
By addressing any special causes, trends or shifts in the process we can assure we
are producing parts that meet the customer’s requirements. Remember the control
limits should always fall between the spec limits determined by the engineer and / or
the customer. For more information regarding the SPC process and available tools,
mentoring, training or assistance in implementation of SPC, contact one of the Subject
Matter Experts (SME) at Quality-One. We are always ready to provide any assistance
or information you made need.

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 SPC - Control Charts

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 SYNTHESIS

Lesson 4: TOTAL QUALITY MANAGEMENT (TQM) TOOLS

Total quality management (TQM) tools help organizations to identify, analyze and
assess qualitative and quantitative data that is relevant to their business. These tools
can identify procedures, ideas, statistics, cause and effect concerns and other issues
relevant to their organizations. Each of which can be examined and used to enhance
the effectiveness, efficiency, standardization and overall quality of procedures, products
or work environment, in accordance with ISO 9000 standards (SQ, 2004). According to
Quality America, Inc. the number of TQM tools is close to 100 and come in various
forms, such as brainstorming, focus groups, check lists, charts and graphs, diagrams
and other analysis tools. In a different vein, manuals and standards are TQM tools as
well, as they give direction and best practice guidelines to you and/or your staff. TQM
tools illustrate and aid in the assimilation of complicated information such as:

1) Identification of your target audience

2) Assessment of customer needs
3) Competition analysis
4) Market analysis
5) Brainstorming ideas
6) Productivity changes
7) Various statistics
8) Staff duties and work flow analysis
9) Statement of purpose
10) Financial analysis
11) Model creation
12) Business structure
13) Logistic analysis

The list goes on, though essentially TQM tools can be used in any situation, for any

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number of reasons, and can be extremely effective if used properly.

TQM Tools

The following are some of the most common TQM tools in use today. Each is used for,
and identifies, specific information in a specific manner. It should be noted that tools
should be used in conjunction with other tools to understand the full scope of the issue
being analyzed or illustrated. Simply using one tool may inhibit your understanding of
the data provided, or may close you off to further possibilities.

1) Pie Charts and Bar Graphs

Used to identify and compare data units as they relate to one issue or the whole, such
as budgets, vault space available, extent of funds, etc.

2) Histograms
To illustrate and examine various data element in order to make decisions regarding
them Effective when comparing statistical, survey, or questionnaire results.

3) Run Chart

Follows a process over a specific period of time, such as accrual rates, to track high
and low points in its run, and ultimately identify trends, shifts and patterns.

a) Pareto Charts / Analysis

Rates issues according to importance and frequency by prioritizing specific
problems or causes in a manner that facilitates problem solving. Identify groupings of
qualitative data, such as most frequent complaint, most commonly purchased
preservation aid, etc. in order to measure which have priority.· Can be scheduled over
select periods of time to track changes. They can also be created in retrospect, as a
before and after analysis of a process change.

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4) Force Field Analysis
To identify driving and restraining forces occurring in a chosen process in order to
understand why that particular process functions as it does. For example, identifying the
driving and restraining forces of catering predominantly to genealogists. To identify
restraining forces that need to be eradicated, or driving forces that need to be improved,
in order to function at a higher level of efficiency.

5) Focus Groups
Useful for marketing or advertising organizations to test products on the general
public.

· Consist of various people from the general public who use and discuss your product,
providing impartial feedback to help you determine whether your product needs
improvement or if it should be introduced onto the market.

6) Brainstorming and Affinity Diagrams

Teams using creative thinking to identify various aspects surrounding an issue.

An affinity diagram, which can be created using anything from enabling software to
post-it notes organized on a wall, is a tool to organize brainstorming ideas

.7) Tree Diagram

· To identify the various tasks involved in, and the full scope of, a project.

· To identify hierarchies, whether of personnel, business structure, or priorities.

· To identify inputs and outputs of a project, procedure, process, etc

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.8) Flowcharts and Modeling Diagrams

· Assist in the definition and analysis of each step in a process by illustrating it in a

clear and comprehensive manner.

· Identify areas where workflow may be blocked, or diverted, and where workflow is
fluid.

· Identify where steps need to be added or removed to improve efficiency and create
standardized workflow

.9) Scatter Diagram

· To illustrate and validate hunches

· To discover cause and effect relationships, as well as bonds and correlations,

between two variables

· To chart the positive and negative direction of relationships

10) Relations Diagram

· To understand the relationships between various factors, issues, events, etc. so as to

understand their importance in the overall organizational view.

11) PDCA

· The Plan-Do-Check-Act style of management where each project or procedure is

planned according to needs and outcome, it is then tested, examined for efficiency and
effectiveness, and then acted upon if anything in the process needs to be altered.

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 · This is a cyclical style to be iterated until the process is perfected. All of these TQM
tools can be easily created and examined by using various types of computer software
or by simply mapping them out on paper. They can also be easily integrated into team
meetings, organizational newsletters, marketing reports, and for various other data
analysis needs. Proper integration and use of these tools will ultimately assist
in processing data such as identifying collecting policies, enhancing work flow such as
mapping acquisition procedures, ensuring client satisfaction by surveying their needs
and analyzing them accordingly, and creating an overall high level of quality in all areas
of your organization.

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 SYNTHESIS

Lesson 5: QUALITY SYSTEM

A quality management system (QMS) is a set of policies, processes and

procedures required for planning and execution (production/development/service) in the core
business area of an organization (i.e., areas that can impact the organization’s ability to meet
customer requirements). ISO 9001 is an example of a Quality Management System.

ISO 9000

is defined as a set of international standards on quality management and quality

assurance developed to help companies effectively document the quality system
elements needed to maintain an efficient quality system. They are not specific to any
one industry and can be applied to organizations of any size.

ISO 9000 can help a company satisfy its customers, meet regulatory requirements, and
achieve continual improvement. It should be considered to be a first step or the base
level of a quality system.

DESCRIPTION

This American National Standard (ANS) is an identical adoption of ISO 9000:2015. The
text of this ANS does not differ in any way from ISO 9000:2015.

This standard provides the fundamental concepts, principles and vocabulary for quality
management systems (QMS) and provides the foundation for other QMS standards.
This International Standard is intended to help the user to understand the fundamental
concepts, principles and vocabulary of quality management, in order to be able to
effectively and efficiently implement a QMS and realize value from other QMS
standards.

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 This standard describes the fundamental concepts and principles of quality
management which are universally applicable to the following:

 organizations seeking sustained success through the implementation of a quality

management system;
 customers seeking confidence in an organization’s ability to consistently provide
products and services conforming to their requirements;
 organizations seeking confidence in their supply chain that product and service
requirements will be met;
 organizations and interested parties seeking to improve communication through a
common understanding of the vocabulary used in quality management;
 organizations performing conformity assessments against the requirements of ISO
9001;
 providers of training, assessment or advice in quality management;
 developers of related standards.

This standard specifies the terms and definitions that apply to all quality management
and quality management system standards developed by ISO/TC 176.

Introduction to IATF 16949

IATF 16949:2016 (replaces ISO/TS 16949:2009) is a standard that establishes the

requirements for a Quality Management System (QMS), specifically for the automotive sector.
The ISO/TS 16949 was originally created in 1999 to harmonize different assessment and
certification schemes worldwide in the supply chain for the automotive sector.
The primary focus of the IATF 16949 standard is the development of a Quality Management
System that provides for continual improvement, emphasizing defect prevention and the
reduction of variation and waste in the supply chain. The standard, combined with applicable
Customer-Specific Requirements (CSR’s), define the QMS requirements for automotive
production, service and/or accessory parts.
IATF 16949:2016 is an independent QMS standard that is fully aligned with the structure and
requirements of ISO 9001:2015. Therefore, the IATF 16949 cannot be implemented alone as

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a stand-alone document, but must be implemented as a supplement and in conjunction with
ISO 9001:2015.
After October 01, 2017, audits cannot be conducted to ISO/TS 16949 and organizations must
transition to the new IATF 16949 in line with their current audit cycle, according to the
allowable timing requirements. Failure to conduct the audit within the allowable timing
requirements requires the organization to start over with an initial certification audit. The
transition audit shall be the duration of a recertification audit plus additional time for a
documentation review. All supporting functions on site or at a remote location shall be
included in the transition process.
A Quality Management System based on IATF 16949:
 Is a method of defining how an organization can meet the requirements of its
customers and other stakeholders
 Promotes the idea of continual improvement
 Requires organizations to define objectives and continually improve their processes
in order to reach them
 Emphasizes defect prevention
 Includes specific requirements and core tools from the automotive industry
 Advanced Product Quality Planning (APQP)
 Failure Mode and Effects Analysis (FMEA)
 Statistical Process Control (SPC)
 Measurement Systems Analysis (MSA)
 Production Part Approval Process (PPAP)
 Promotes reduction of variation and waste in the supply chain
 Requires documented and implemented corporate responsibility polices

What is IATF 16949

The IATF 16949 standard provides guidance and tools for companies and organizations who
want to ensure that their products consistently meet customer requirements and that quality
and customer satisfaction are consistently improved. Requirements for certification to IATF
16949 are defined in the 2016 Revision 5 of the rules for achieving and maintaining IATF
recognition.

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The IATF 16949 standard is a supplemental standard and is used in conjunction with the ISO
standards:
 IATF 16949 – establishes the Automotive supplemental requirements of a quality
management system
 ISO 9001 – defines the base requirements of a quality management system
 ISO 9000 – covers the basic concepts and language
 ISO 9004 – focuses on how to make a quality management system more efficient
and effective
 ISO 19011 – provides guidance on internal (1st party) and external (2nd party)
audits of quality management systems
 ISO 31000 – outlines risk management principles and guidelines
IATF 16949 defines the criteria for an automotive-based QMS with the goal to become 3rd
party registered. It can be used by any supplier, large or small, and should be applied
throughout the automotive supply chain. In fact, there over 65,000 suppliers worldwide which
are currently certified to ISO/TS 16949. All requirements of IATF 16949 are applicable unless
suppliers do not provide product design related functions. Requirements are generic and are
intended to be applicable to any supplier providing design and development, production and,
when relevant, assembly, installation and services of automotive related products, including
products with embedded software. The IATF 16949 standard is applicable to sites of the
organization where manufacturing of customer-specified production parts, service parts,
and/or accessory parts occur.
The standard is based on seven Quality Management Principles, including a strong customer
focus, the motivation and implication of top management, the process approach and continual
improvement.
These Quality Management Principles are defined as follows:
1. Customer focus
2. Leadership
3. Engagement of people
4. Process approach
5. Improvement
6. Evidence-based decision making
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 7. Relationship management

QUALITY MANAGEMENT PRINCIPLES

Why Implement IATF 16949

Implementing IATF 16949 ensures that customers receive consistent, good quality products
and services, which in turn may bring many business benefits. IATF 16949 specifies
requirements for a Quality Management System when an organization wants to:
 Demonstrate its ability to consistently provide products that meet customer and
applicable statutory, regulatory and product safety requirements
 Enhance customer satisfaction through the effective application of the system
 Implement processes for improvement of the system
 Define overall context, who is affected and what they expect
 Clearly state objectives and identify new business opportunities
 Put customers first, making sure their needs are consistently met and enhance their
satisfaction
 Have repeat customers, increase customer loyalty, add new clients and increase
business
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  Expand into new markets, as some sectors and clients require IATF 16949 before
doing business
 Identify and address the risks associated with your organization
 Work in a more efficient way to increase productivity and efficiency, bringing internal
costs down
 Become more socially responsible through the documentation and implementation
of corporate responsibility polices

When to Implement IATF 16949

Compliance to the IATF 16949 standard can be done at any time but is typically used when:
 Customers specify this requirement as part of the contract
 Organizations want to improve their products and customer satisfaction

How to Implement IATF 16949

Organizations’ deciding to develop and implement any new or improved QMS is a strategic
decision. All efforts should be focused on the identification and minimization of risk while
meeting and exceeding customer and organizational goal and objective requirements.
Organizations should make a commitment to:
 Recognize direct and indirect customers as those who receive value from the
organization
 Understand customers current and future needs and expectations
 Link the organization’s objectives to customer needs and expectations
 Communicate customer needs and expectations throughout the organization
 Plan, design, develop, produce, deliver and support products to meet customer
needs and expectations
 Measure and monitor customer satisfaction and take appropriate actions
 Determine and take actions on interested parties needs and expectations that can
affect customer satisfaction
 Actively manage relationships with customers to achieve sustained success
 Become more socially responsible
 Provide necessary resources to ensure product safety requirements are met

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IATF 16949 Compliance can be achieved through Quality-One’s Seven Phase Approach:
1. Executive and Management Overview / Planning
2. Gap Assessment and Planning
3. Documentation
4. Implementation and Training
5. Internal Assessment and Management Review
6. 3rd Party Registration Assessment
7. Sustain and Continual Improvement

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