Ver.3.

QC KENTEI (The Quality Management and

Quality Control Examination)

Grade 4 Textbook

Japanese Standards Association

QC KENTEI Center
 Introduction

“QC KENTEI” is an abbreviation of “Quality Management and Quality Control Examination.” This textbook
provides a simple explanation of the scope of Grade 4 of QC KENTEI for those preparing to take this Exam.
Although there are many types of companies and organizations, quality management is essential at every
workplace. This textbook provides easy to understand guidance on the basics of quality management. Quality
control (QC) activities have long been a base of the higher quality of products made in Japan, but they also
include common approaches and methodologies that everyone should understand, not just to support Japanese
industries but also the lives of people around the world for a better future.

This textbook comprises three chapters and an explanation of terminology. Chapter 1 explains the importance of
the ideas and ways of quality management to ensure that an organization produces good products and services and
also discusses approaches to work and its improvement. Chapter 2 introduces principles of quality improvement
activities by explaining how the clarification and steady execution of processes is fundamental to the production
of high-quality products; how, to improve processes and quality, it is important to make decisions based on facts
and data; and how statistical methods such as the QC seven tools are useful for utilizing data effectively. Chapter 3
explains fundamental approaches to organizational activities for making better products, such as the Ho-Ren-So of
reporting, contacting, and consulting in an organization; 5W1H; sangen-shugi (three real-ism); 5-gen-shugi;
manners as a member of an organization; the 5S (Seiri, Seiton, Seisou, Seiketsu, and Shitsuke: Sorting, Setting in
Order, Shining, Standardizing and Sustaining the Discipline); and the importance of health and safety in the
workplace.

Words and phrases used throughout this textbook with superscript figures attached in the form of *1, *2, etc., such
as “product*1,” are explained in Chapter 4, “Explanation of terminology” as technical terminology. These
explanations introduce the definitions and meanings of terms prescribed in standards, etc. in the quality
management field and are written in an easy-to-understand way.

In addition, sections such as “rules for …1)” with superscript figures in the form of 1), 2), etc., are quotations from
related documents or are provided for reference purposes. A list of these is provided in the Appendix under
“Citations and Reference Literature.”

People normally work within an organization of some kind, and these organizations include not only companies,
but hospitals, schools, etc. In this textbook, the terms “company” or “corporation” may be used to signify
organizations. In addition, organizations vary greatly in terms of their operations. They can include manufacturers,
supermarkets, convenience stores, hotels, restaurants, banks, and securities companies; however, the fundamental
approaches and methods of quality management apply to all these organizations.

These organizations supply customers with products or services. While this textbook may classify “products and
services,” please note that their service to a customer can also be interpreted as a product for the customer, and
that useful approaches or methods to improve products will often also apply to services.

When an organization manufactures a product or provides a service, it must ensure that it is somehow good for the
customer. A good product or service means a product or service of high-quality. It is also essential for an
organization to assure that there is no significant variation among the quality of products or services provided to
the customers, because if the organization supplies its products or services with different quality at the same price,
customers who have purchased them may feel dissatisfied or that they have been treated unfairly. The purpose of
quality management is to design organizational activities to ensure that customers feel no trace of dissatisfaction
and perceive no unfairness at all with respect to their purchased products or services and continue to feel satisfied
and delighted during the life cycle of the products or services. Nowadays every organization does its best every
day to get its competitiveness by maintainging or improving customer satisfaction of the products and serevices.
As a result, quality management has become one of the most important methodologies. Everyone who works in an
organization needs to learn about quality management and strive to enhance quality and deliver improvements.

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We hope that everyone who is planning to join and work in an organization in the future and everyone who has
just joined an organization will study quality management and improve their knowledge of it by taking Grades 4,
3, 2, and 1 of the QC KENTEI, in that order.

For details of the QC KENTEI system, information on how to apply to take it, and so on, please refer to the
website of the QC KENTEI Center, Japanese Standards Association.

November 2009

Steering Committee for the Quality Management and Quality Control Examination

Tadashi Yoshizawa, Chairman

Information concerning revisions to the Grade 4 Textbook

The QC KENTEI was established with the aim of supporting the general improvement of Japanese industry as a
whole by equipping examinees with knowledge of the fundamental approaches of quality management, the
purpose of which is to maintain and enhance the quality of products and services and to reduce costs and improve
delivery in terms of quantity and delivery dates by leading work and organizational activities in the proper
direction that should be taken. Since its launch, the examination has targeted working people and students,
providing a means of assessing and certifying their knowledge of approaches, methods of implementation, and
techniques relating to quality management as well as their competence to apply that knowledge.

In the decade since the exam was first held in 2005 to the 17th time it was held in March 2014, more than 500,000
applications to take the exam have been received, and in 2013 we received applications from over 100,000 people.
This can be regarded as proof that the QC KENTEI is well respected by society and has acquired a certain level of
trust. I would therefore like to take this opportunity to extend my deepest gratitude to all the examinees who have
made the QC KENTEI such a success, as well as all the people who have supported them.

This, the Grade 4 Textbook, was produced to provide people who are thinking of taking Grade 4 of the QC
KENTEI with information on the scope of the exam and guidance comprising straightforward explanations of the
knowledge required for Grade 4. Five years have now passed since the last revision in 2010.

Taking on board the opinions of numerous people who have taken the QC KENTEI, and also taking into account
the needs of industry in Japan and overseas and the importance of equipping people with “knowledge and
competencies required for quality management” and related knowledge, which continue to change in conjunction
with the development of quality management and related information technologies, we have decided to
periodically review and revise the QC KENTEI Table. In accordance with the latest revision of this table, we have
also updated this Grade 4 Textbook.

We performed the revisions after obtaining input from various quarters, including schools and corporations, and
collecting various types of information. This included the “Expectations for students taking the QC KENTEI,”
which forms part of the section introducing organizations that have actively used the QC KENTEI on the QC
KENTEI Center website. From the information we received, we found that not only is this textbook used for
preparing for the Grade 4 Exam, it is employed as a textbook for obtaining a basic education and knowledge
essential for ordinary citizens.

Therefore, in making the revisions, we made the material covered in Grade 4 of the QC KENTEI Table the core
content, but also endeavored to include a range of essential information that not only people taking the Grade 4
Exam but also other people might wish to acquire as baseline knowledge for ordinary citizens. Thus, we
maintained the same chapter structure as in the previous edition but also added some extra information.

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Quality management is an effective way for enabling personnel to achieve high levels of growth as a key
organizational resource. We hope that the fundamental approaches and methods of quality management will
become widely applied throughout Japan, not just in certain organizations or departments. “Quality management
begins and ends with education”—as this statement indicates, if you want to improve quality, it is essential to
provide everyone who belongs to the organization with thorough education on quality management, including
education that raises their awareness, on a continuing basis.

We hope that this textbook will provide a starting point for beginning quality management and that it will be of
help in your activities in the future.

Additionally, if possible, it is our hope that you will eventually continue past Grade 4 to tackle the challenges
presented by Grades 3, 2, and 1 step by step.

For details on the QC KENTEI system, information on how to apply to take it, and so on, please refer to the
website of the QC KENTEI Center, Japanese Standards Association.

Steering Committee for the Quality Management and Quality Control Examination

Hiroe Tsubaki

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 Contents
Page

Introduction ................................................................................................................................................ 2
Information concerning revisions to the Grade 4 Textbook ....................................................................... 3
Chapter 1 What is quality management? —Making good products in an organization— ...................... 6
1.1 What is quality? ........................................................................................................................... 6
(1) Definition of quality (2) Targetted quality
1.2 What is quality management? ..................................................................................................... 7
(1) Problems and issues concerning quality (2) Fundamentals of quality management activities
(3) Fundamentals of quality management in the workplace (PDCA cycle)
(4) Quality in the broad sense (QCD + PSME) (5) Focal points for improvement (Muri/Mura/Muda)
1.3 The quality-orientation approach ................................................................................................ 9
(1) What is quality orientation? (2) The market-in approach
1.4 Management activities (maintenance activities and improvement activities) ........................... 10
1.5 An approach to work (PDCA) .................................................................................................... 10
(1) PDCA cycle (2) SDCA cycle
1.6 Kaizen and QC story ................................................................................................................. 12
(1) QC story (2) Small group improvement activities (Quality circle activities, QC circle activities)
1.7 The priority oriented approach .................................................................................................. 13
1.8 What is standardization? ........................................................................................................... 13
1.9 What are inspections?............................................................................................................... 14
Chapter 2 Basic knowledge related to quality management activities.................................................. 15
2.1 Process ..................................................................................................................................... 15
2.2 Decisions based on facts and data ........................................................................................... 16
(1) Populations and samples (2) Types of data (3) How to take a sample (4) How to summarize data
2.3 QC seven tools .......................................................................................................................... 19
(1) Pareto diagrams (2) Cause and effect diagrams (3) Histograms (4) Graphs (5) Control charts
(6) Check sheets (7) Scatter diagrams (8) Stratification (9) Utilizing the QC seven tools

Chapter 3 Preparation and action for making better products .............................................................. 27

3.1 Ho-Ren-So (reporting, contacting, and consulting) ................................................................... 27
(1) Key points concerning reporting (2) Key points concerning contacting (3) Key points concerning consulting
3.2 5W1H ........................................................................................................................................ 28
3.3 Sangen-shugi ............................................................................................................................ 29
3.4 5-gen-shugi ............................................................................................................................... 29
3.5 Manners .................................................................................................................................... 29
(1) Be a responsible member of society (2) Be on time (3) Exchange greetings
(4) Pay attention to the words you use (5) Wear the right clothes (6) Don’t mix business with personal matters
(7) Be organized and tidy (seiri and seiton) (8) Protect the environment
3.6 5S .............................................................................................................................................. 31
3.7 Health and safety activities ....................................................................................................... 31
Chapter 4 Explanation of terminology................................................................................................... 33
Index ........................................................................................................................................................ 45
Citations and Reference Literature .......................................................................................................... 48

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 Chapter 1 What is quality management?
—Making good products in an organization—

1.1 What is quality?

(1) Definition of quality

The quality*2 of a product or service*1 is normally defined as “fitness for use. ” However, unless the
customer*3 is satisfied as a result with quality, efforts to achieve good quality will be in vain. So, in a broader
sense, the quality is related to the “satisfaction delivered to the customer,” which is sometimes referred to as
customer satisfaction (CS) .

For example, a customer who is thinking about buying a large screen 4K LCD television that the entire family can
enjoy watching in his/her ample living room might want or expect the following features of the television and also
of the services bundled with it:

<Demands and expectations concerning the product itself>

 Image and sound quality that makes you feel like you’re really there
 Clearly viewable from any angle in a bright room
 Color and design that matches the furniture
 Many useful functions, such as recording
 Connectable to PCs, game consoles, etc., via wireless LAN
 No need for cables or a power cord
 Can be operated even by elderly people and children without a manual.
 Doesn’t break even if handled roughly.
 Won’t fall over even in the event of a large earthquake.
 Works even during a power outage.
 Uses much less power.
 Can be moved to any location with ease.
And others

<Demands and expectations concerning services>

 Setup and connection are performed free of charge.
 The television is inspected regularly.
 Someone will come to help immediately whenever there’s a problem.
 Service will be provided over the lifetime of the product, covering trade-ins, moving house, disposal.
And others

If demands and expectations like these, which a customer has in advance, are actually met by the product or
service provided, the customer will probably be extremely satisfied. Conversely, if such demands and expectations
are not met, no matter how much the seller argues that it is a high-quality television, it cannot be so from the
customer’s point of view.

In other words, quality is the customer’s assessment of the product or service provided. So when we think about
quality, the starting question is: who are our customers? After that, we need to look at whether the demands
and expectations of customers are actually being met by providing the product or service.

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(2) Targetted quality

If the seller is to deliver the quality demanded/expected by customers, it needs to listen carefully to what
customers have to say about each product and service and perform a detailed investigation of how customers are
receiving current products and services and how these products and services satisfy them. This is expressed as
“listening to the Voice of Customer (VOC)*4.” By analyzing the VOC, the customer’s problems, the
environment that surrounds the customer, and so on, we must clearly define the required state or the ideal
state of the product or service from the standpoint of the customer. This is referred to as setting the targetted
quality.

1.2 What is quality management?

(1) Problems and issues concerning quality

After determining the targetted quality as discussed in the previous section, the next step is quality
management*5. Quality management refers to the systematic activities conducted by the organization for the
purpose of delivering the targetted quality. To deliver targetted quality, it is first necessary to identify the situation
concerning the product or service actually being provided as its current state, then to investigate whether there
is a gap between that and the targetted quality. An obvious gap between the two indicates a problem*6 or
issue*6 with quality, and eliminating that gap is the foundation for quality-related problem solving*7 and task
(issue) achieving*7.

Normally, to solve a problem, you identify the characteristics of the problem based on the facts. Then, based on
those characteristics, you identify their root causes and relationship with the causes and effects that led to the
problem. Then, by taking action to tackle the identified causes or processes, you endeavor to solve the problem.
To achieve a task (issue), on the other hand, you make a list, from various angles, of ideas that could deliver the
ideal state. You then narrow this list to the ideas that are the most effective means of achieving the objective. After
that, you endeavor to achieve the task by increasing the degree to which the means can be executed while taking
into account elements that could hinder execution. Activities for improving quality, like the problem solving and
task achievement discussed here, play a vital role in ensuring that customers are continuously provided with
products and services that truly delight them.

(2) Fundamentals of quality management activities

The history of quality management began with efforts to provide “good things” to customers and to maintain the
quality of these things at a certain level. “Good products/services” refer to products and services that satisfy
customers with good quality. It is obviously necessary to reduce variation*8. This is because if products or
services that vary in terms of quality are sold for the same price, it would seem unfair to the customers who
purchased them, and the initial objective of providing the same level of satisfaction to every customer would not
be achieved.

Some of you might think that all that needs to be done is to alter the price to reflect the variation of quality. Of
course, in cases such as the sale of vegetables on an individual basis or the sale of drinks, where the price varies
based on quantity rather than quality, it is not difficult to explain why prices are different. But adjusting the price
of each and every product or service based on differences in quality is not necessarily easy for the supplier to do.
The reason is that it is incredibly difficult to explain the relationship between differences in price and quality to
customers in such a way that is acceptable to them. And obviously, the customers that purchase the product or
service will not be satisfied if they have to spend time and effort checking the price and quality differences of
every single product or service before buying it.

For example, if hamburgers were always sold in such a way that the same size
of bun contained the same size of patty cooked to the same degree with the
same amount of sauce of the same taste on it, every customer would have the
peace of mind that they could eat the same hamburger whenever or wherever
they liked.

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To ensure that the quality of products and services provided to customers is adequate and to maintain this quality
at a certain level, it is necessary, before you start supplying them to customers, to distinguish between good things
and bad things, and to take action to ensure that only good things are provided to customers. However, this alone
will not eliminate bad things and is not necessarily economical. Things won’t go well unless you can make good
things to begin with by creating a mechanism for ensuring a fixed level of quality at every phase, from the
procurement of materials to the production and sale of the products. Quality management has evolved as an
activity for implementing initiatives like these.

However, the following problems often arise on the frontlines of manufacturing:

 Incessant complaints*9 from customers*3

 Products keep being returned or needing to be repaired.
 Nonconformities*10 occur even after mass production has begun.
 Nonconforming items*10 with the same type of nonconformity keep
being discovered during delivery inspections.
 Machines and equipment are not being properly maintained, and
nonconforming items frequently have to be discarded during the process.
 Lots of parts received often fail inspections, and the line is halted frequently.
 Workers often make careless mistakes.
 Workers keep making the same mistakes.
 Workplace leaders (foremen) and workers focus solely on work periods, delivery dates, and costs.
 Procedures for performing new jobs are vague, and workers all do things in different ways.

Quality management is an activity for solving quality problems like these. To ensure that this activity is conducted
effectively and efficiently, it is not enough for each employee to be individually engaged. There needs to be
cooperation within each workplace and among workplaces in order to solve problems.

Recently, emphasis has been placed not just on solving current quality problems but on determining issues or tasks
and taking action to ensure that these tasks are achieved, with the aim of providing attractive and impressive
products and services that actually surpass the demands and expectations of customers.

(3) Fundamentals of quality management in the workplace (PDCA cycle)

For quality management in the workplace, it is particularly important to plan, do, and then make improvements. In
other words, you must:

ⅰ. Thoroughly understand the objectives and nature of your work, set goals, and plan the way you are going to
work. (Plan)

ⅱ. Decide how you should do it, make preparations, and implement it together. (Do)

ⅲ. Grasp the implementation status, find out whether activities are being conducted appropriately,
confirm/analyze whether the results are as expected, and shed light on problems and their causes. (Check)

ⅳ. Based on the causes identified, determine what should be improved, then make the improvements. (Act)

The first principle is to execute the above four activities in order. This approach is fundamental for performing
work and is normally referred to as following the PDCA*11 cycle. PDCA will be explained in detail in section
1.5.

*12
(4) Quality in the broad sense (QCD + PSME)

When manufacturing products or providing services, you need to think about things in a comprehensive fashion.
In addition to ensuring quality, you need to keep costs as low as possible, and you need to ensure delivery of

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the quantity of the products promised to the customer on the day (delivery date) promised. Quality, cost, and
delivery terms (i.e., quantity and date/time) are referred to as QCD*12, and are sometimes also regarded as
constituting quality in the broad sense.

In addition, when making products in the workplace, productivity (P) is

emphasized alongside quality. However, what’s more important than
anything else is safety (S) and mental health (M: morale, morality). This
approach makes people the foundation of everything, with various activities
performed within that scope. In other words, the organization as a whole
works together to ensure safety. It is important that everyone involved in the
activities of the organization remain free of injury, stay healthy, and feel
respected as human beings. Activities designed to maintain health (including mental health) and safety are
sometimes termed occupational health and safety*13 activities. Furthermore, activities that guarantee the
safety of everyone who interacts with a product (including its users) over its lifecycle (the period from the
purchase of the product to its subsequent use and eventual disposal) are also important. This is referred to as
product safety*14 and is another important element in quality management. In addition, activities to protect
the global environment*15 (E) have also come to be emphasized recently.

(5) Focal points for improvement (Muri/Mura/Muda)

In improvement activities, we are always considering the best working methods to ensure the level of quality
demanded for products or services. When making improvements, our focus is on finding and endeavoring to
eliminate the Muri/Mura/Muda, which stand for the Japanese words Muri (unreasonableness), Mura
(inconsistency), and Muda (waste). If there is too much unreasonableness in the way work is performed or in
scheduling, the workers will get tired, which will result in quality problems. Meanwhile, work that has
inconsistency leads to uneven quality. Finally, work that involves a lot of waste, as well as waste resulting from
the repair or disposal of poor-quality products, can lead to higher costs.

1.3 The quality-orientation approach

(1) What is quality orientation?

For an entire organization to engage in quality management, the approaches and goals of everyone involved must
be aligned based on the view that quality takes priority. A quality orientation means that priority is placed not
on the pursuit of short-term profits or sales expansion, but on supplying higher-quality products and services. Of
course, activities such as reducing costs, trimming inventory, and delivering products on time are also important
tasks for the organization, but unless quality, which is essential, is good, all that will happen is that costs will
increase, inventory will accumulate, and deliveries will be made late. Normally, a set of principles for action
called a quality policy*16 is formulated to ensure that the whole organization shares this quality-orientation view.
Other terms, such as quality first or supremacy of quality, are also sometimes used to express this
quality-orientation approach.

(2) The market-in approach

At the heart of quality orientation is the idea that you don’t prioritize the logic of the supplier, but that of the
customer. The latter approach is called market in*17, while the former is referred to as product out*17. Standing
in the customer’s shoes means that you are customer-oriented in everything you do, including the elements
described in section 1.2 (4) that comprise quality in the broad sense (QCD + PSME). These are Q: the level of
product quality demanded by the customer, C: the cost paid by the customer, D: the delivery terms (i.e., quantity
and date/time), P: productivity for the customer, S & M: the safety and mental health of everyone involved,
including the customer, and E: the protection of the global environment. The market-in approach is based on
achieving these objectives based not on the logic of the supplier, but that of the customer.

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We often hear the expression safety first, which is based on the notion that because safety relates to human life,
it should take priority over everything else. As mentioned earlier, the phrase “quality first” has also been used for
many years in discussions of quality. Both are important ideas, but to avoid unnecessary confusion, it has become
common when talking about quality to replace the expression “quality first” with “quality orientation.”

1.4 Management activities (maintenance activities and improvement activities)

When we think about what constitutes good work, one important thing is that the work is conducted in accordance
with standards and therefore results in the stable and continuous supply of products and services that serve their
purpose and exhibit no variation. This is referred to as maintenance activities. To ensure that these
maintenance activities are properly performed, appropriate standards need to be set and education and training
provided. However, because the environment surrounding us is always changing, unthinking adherence to the
same method of working and the same standards to stably and continuously produce good products or services
will not promote continuous maintenance in the true sense of the word. For this reason, the SDCA*11 cycle which
will be described later, needs to be followed at all times.

Other important considerations are reducing the number of mistakes made to improve current levels of quality and
reducing costs and changing work methods in ways that make it easier for other departments (particularly those
that perform next/downstream processes) to perform their jobs. These are called improvement activities.
Obviously, though, it is also important to improve your techniques and skills to enable you to work more
effectively and efficiently.

So what we should be doing is engaging in activities that continuously maintain favorable circumstances. We also
need to engage in activities to improve the quality of our products and services as well as the quality of our
work, which generates these products and services. These activities are collectively referred to as management
activities. If management activities such as these can be performed continuously by every organization and every
individual, and the quality of work and the quality of people can be improved thereby, the QCD of products and
services will improve, and, as a result, a healthy organization that can efficiently and continuously achieve
business objectives such as sales and profits will be established.

1.5 An approach to work (PDCA)

(1) PDCA cycle

To ensure that the objectives that have been set for an organization are achieved, it is important to break down the
work that constitutes the means to that end into the following four steps:

P (Plan)

Think hard about and define the purpose of the work, the output of the work, and what sorts of things good work
will result in. This is referred to as articulating goals. Objectives/targets are goals in more concrete form.
An objective normally has three components: the objective item, the objective value, and achievement date. Next,
you are going to consider what kinds of things you should do to bring about these good circumstances, the
methods you will adopt, the actions you will take, the procedures to follow, how you will proceed, and what
resources and criteria will be required. Specifically, you will be defining the what, who, where, when, and how.
These, along with the original goal (i.e., the why) are referred to as 5W1H. (5W1H is discussed in detail in
Chapter 3). This series of activities is called planning.

D (Do)

Carefully and in accordance with the plan (5W1H) you formulated, perform activities including the required
preparatory activities to ensure that the methods and actions for bringing about good circumstances, as well as
actions such as the provision of education and training, are properly implemented. Additionally, continuously
monitor the situation as it is implemented. This is called doing.

Note that if the Do period is fairly long, things not foreseen during the planning phase will frequently arise,
making it necessary to follow small PDCA cycles several times during the Do period.

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C (Check) – i.e., confirm, inspect, assess, and reflect

Find out whether the results were good and whether the approach was good by comparing them to the plan,
thereby confirming differences between the plan and actual performance. If activities are being conducted in
accordance with the plan and results are being achieved in accordance with the plan, then the plan and its
implementation can be deemed to have been more or less appropriate. However, if the results differ from the
initial aims or if activities could not be performed in accordance with the plan, you need to find out why. You will
need to analyze the causes based on facts to shed light on the causes of things that didn’t go well and reflect on
their poor implementation. This series of activities is referred to as checking (i.e., confirming, inspecting,
assessing, and reflecting). At the checking step, it helps to prepare numerical scales (indicators) that enable
you to objectively assess what was good and bad about the results you achieved and the approach you employed.
Such indicators, which are designed to assess what was good and bad about your activities, are called
monitoring items*18. These monitoring items include result-type items and factor-type items, and the cause-type
items are sometimes specifically referred to as check items*18.

A (Act)

If there is no difference between the plan and the actual results achieved, you can conclude that the working
method was appropriate and continue working in the same way as you implement the next plan. However, if a
difference is discovered and its cause is clear, you will need to take some sort of action to eliminate that cause and
its effects. The cause of a difference is often a problem in the working method or with a mechanism—for example,
the way the plan was put together or how it was implemented. If you just leave things the way they are, when it
comes to implementing the next plan, you will fall short of the goals of the plan for the same causes. You must do
something to keep this from happening over and over again. Taking steps to address the process involved,
including the causes of differences between the plan and the results and their impact, is called acting. Obviously,
you must check the results of the action taken and incorporate them into your next plan (P).

P (Plan) D (Do) C (Check) A (Act)

This system of following the four steps of “P  D  C  A” in order is called following the PDCA cycle or
following the management cycle. It forms a common foundation for approaching work in every field.

(2) SDCA cycle

In cases where you have enough past experience or for which technology has been established, planning (P) can
be replaced with the standardization*19 of methods proven to be successful, such that you follow a management
cycle comprising “S  D  C  A.” If work is performed in line with these standards, problems will hardly
ever arise. Having said that, on occasion problems will still occur. Such occasions would be cases in which a work
method that differs from the standards is employed, cases in which work is performed in accordance with
standards but the standards themselves are partly inappropriate, or cases in which the surrounding environment or
other circumstances have changed. In cases like these, you must improve the method of implementation or revise
the standards themselves.

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As Figure 1.1 illustrates, the true objective of management activities is to raise the level of the work method by
following the PDCA or SDCA cycle on a continuing basis.

Work level
A P

A S C D

C D
A P

A S C D Maintain Continual improvement

Raise the level of the work
C D
Improve method
Time

Figure 1.1 Management cycle

1.6 Kaizen and QC story

(1) QC story

Improvement*20 in the context of QM/QC is defined as the “activity of continuously reviewing the management
system as a whole, or parts of it, in order to improve its capabilities.” The activities involving improvement are
called as “improvement activities.” Improvement is an important part of activities in quality control and quality
management that have evolved and developed in Japan. Kaizen is a well known Japanese word to express
improvement activities outside Japan. Improvement activities can also be described as activities whereby you
identify problems with your current work, eliminate the causes of these problems, and create a situation in which
better work is performed. The problems are identified as the gap between the required state and the current state.
In organizations that engage in a lot of improvement activities, problem-solving procedures are utilized for
making improvements. One typical set of procedures is the QC story*21, as shown in Figure 1.2. A QC story
involves more than just simply mastering a series of steps. For example, if, at the “effect confirmation” phase,
effects are inadequate and objectives are not being met, you will return to the appropriate phase in the past and
repeat the activities. Sometimes, you may even have to redo everything from the planning phase onwards, but it is
important to persevere and keep taking action. In other words, it is important that the organization perform
activities to improve quality, processes, work, etc., repeatedly and continuously. Such an approach to improvement
is referred to as continual improvement*20.

ⅰ. Theme selection (selection of themes/objectives and their backgrounds)

ⅱ. Current-status review (finding out how bad things are)

Feedback/repetition

ⅲ. Analysis (identification of cause-and-effect relationships)

Start the next improvement

ⅳ. Countermeasure consideration

ⅴ. Countermeasure implementation

ⅵ. Effect confirmation

ⅶ. Standardization (standardization and propagation of management)

ⅷ. Reflection and future plan

Figure 1.2 Example of QC story

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In a broad sense, as pointed out in section 1.2 (1), improvement is about more than problem solving. It is also an
activity for achieving tasks—i.e., closing the gap between the current state and the ideal state. As a means of doing
this, task-achieving QC stories have been proposed as a separate measure.

Originally, QC stories were created as a procedure for solving problems, but later, various types of QC stories
came to be recommended, so QC stories that specifically indicate a procedure for problem solving are now known
as problem-solving QC stories.

First, you need to understand that the procedure for a QC story is not necessarily set in stone. For example, the
procedure shown in Figure 1.2 and the procedure shown on p.38 (*21), in the chapter explaining terminology,
differ from each other somewhat in terms of content. So QC stories are probably continuously evolving to ensure
that improvements continue to be performed effectively and efficiently in the future. For example, depending on
the target and scope of improvement, the steps of QC stories are being modified and various new procedures for
improvement are being created and devised.

(2) Small group improvement activities (Quality circle activities, QC circle activities)

When performing improvement activities, colleagues in a workplace may form small groups to improve their
workplaces. These are referred to as small group improvement activities. In Japan in particular, a
fundamental principle is that activities are administered independently. Well-known are small group activities
called Quality circle activities,*22 which has goals beyond simply improving the workplace. They are designed
to increase ability through studying, revitalizing workplaces, and making work seem more worthwhile. These
Quality circle activities are also attracting attention from overseas and are currently being implemented in over 80
countries and territories.

1.7 The priority oriented approach

In the real world, there is generally a strong tendency to begin by improving things that are
close at hand rather than making improvements that can produce big benefits. However, given
the limited resources available to an organization, in terms of people, time, and funding, it is
more effective and efficient for an organization as a whole to focus on high-priority issues,
which, though hard to solve, can have a big impact on the organization or on results. This
approach, whereby activities are narrowed to target the most important issues, is known as the
priority oriented approach.

When analyzing factors behind nonconforming items, for example, it is common to identify a
few factors that determine most of the results by plotting appearance frequencies and degrees
of impact in the form of a Pareto diagram [see section 2.3 (1), p.19], and then targeting these
elements. This method of analysis is called Pareto analysis, and the rule of thumb that a few factors
determine most of the results is known as the Pareto principle. By skillfully applying the Pareto principle to
workplace problems, we can put the priority oriented approach into practice.

1.8 What is standardization?

When several people have to work together to perform a task, unless the method for carrying out the task is clear,
each individual will go about things in their own way. This makes it more likely that the task will not be
performed as intended or that it will produce inefficient results. To ensure that an assigned task is performed
efficiently, it is essential that the most rational method (rules) as perceived at the time is identified and that
everyone in the group follows this method. This is what the standardization*19 of work tasks refers to.

Rules that have been prescribed in accordance with certain rational principles are called the standards*23. Some
standards relate to work, while others relate to products. Organizational activities become more efficient when the
technology and experience possessed by the organization is combined and, with the agreement of everyone
involved, work methods and management rules are prescribed with the objectives of harmonization and
simplification. In other words, standardization can help stabilize quality, prevent work mistakes, enhance
efficiency, make work more reliable, and so on. In addition, standards (product-related standards) include

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component standards, design standards, and drawing standards, all of which specify the basic structure of a
product, and materials standards, which prescribe the materials required to ensure product quality. So various
types of standards suit different purposes.

Standardization is linked to the SDCA approach discussed in section 1.5 (2). Specifically, merely producing
standards does not constitute standardization. It is essential to understand that standardization is meaningful only
if the SDCA cycle, which encompasses education and training concerning the standards, compliance with
standards, as well checking and acting, is properly followed to ensure consistency in all the activities performed.

1.9 What are inspections?

To provide products and services that are deeply satisfying to customers, not
only must processes be carefully managed, the products and services themselves
must be checked and unacceptable ones removed before they are sold. This
activity is called an inspection*24. Inspections involve aspects like the
measurements*25 and tests of products and services to judge whether they
are appropriate and whether they meet requirements such as product-related
standards. Measurements and tests simply involve collecting data; they differ
from inspections in that in addition to measurements and tests, they also have a judgement function. During the
judgement phase of an inspection, a product that meets prescribed requirements such as product-related standards
is called a conforming item, while one that does not is called a nonconforming item. In addition, some
inspections target not individual products and services, but groups of products and services (called a lot*26). Those
that meet pre-prescribed “criteria for lots” are described as accepted, while those that do not are described as
rejected.

Inspections are normally performed in three main phases. There are the receiving inspections or purchasing
inspections carried out when raw materials, partially processed products, etc., are received; the in-process
inspections or intermediate inspections carried out in the middle of a series of processes; and the final
inspections or delivery inspections carried out on finished products. In addition, methods of inspection
include 100% inspections, where all items are inspected; sampling inspections, where a sample is taken
from the lot to determine whether to accept or reject the lot as a whole; and inspections without
measurements or tests, where the decision to accept or reject the lot is based solely on materials provided,
with no measurements performed. Furthermore, besides inspections performed using measurement equipment to
assess quality characteristics such as length, weight, performance, quantity of active ingredients, etc., there are
also sensory evaluations, where measurements and judgements are performed based on a person’s five senses,
which include touch, taste, hearing, and sight. There are also various other types of inspection, such as
destructive tests, where measurement leads to the loss of the functionality of the item inspected.

The basic purpose of inspections is to ensure that only good quality items are passed on to the next process, based
on a judgement of whether they are good or bad. The results of the good/bad judgement also serve as an
alternative characteristic*27 of activities performed in upstream processes. Thus, we must not forget the
importance of providing quality information obtained from inspections as feedback to upstream processes for
determining the good and bad elements of a process and for making subsequent improvements.

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activities

2.1 Process

Products do not start out as products. They become products only after passing through various phases. In the
quality management field, these phases are called processes*28. Processes include not only production processes
such as machining and assembly, but various other activities, including the planning and design of products and
services, the procurement of raw materials and essential equipment, the standardization of manufacturing and
other activities, and the supply, inspection, and improvement of products and services. For an organization to
provide products and services, it is essential that the activities required to meet the demands and expectations of
customers are properly connected and function as a whole.

When we consider individual processes, we think about inputs and outputs. In the case of a machining process,
raw materials constitute the inputs, while the machined products constitute the outputs. In terms of staff function,
aspects like the specific information required to perform a function constitute inputs, while the materials prepared
or information analyzed constitute outputs. A process is regarded as an activity that adds value to an input to
produce an output.

Work and products are not completed through one process alone. All departments within a company or
organization perform their respective work, which is then passed on to the next process, before eventually
reaching the customer. Such process linkages and interfaces are also important. The processes immediately
before and after the process in question are particularly important because they are directly connected to that
process. These processes are called the upstream processes and downstream processes (the immediate
downstream process is also called the next process).

In the field of quality management, the right attitude toward processes can be summed up in expressions like
“Build in quality during processes” or “The next processes are our customers.” Although
confirming the quality of work or products by performing inspections*24 is important, it is far more important to
perform proper work during the processing phase to keep nonconformities from arising. This is the meaning of the
statement “Build in quality during processes.” In addition, the statement “The next processes are our customers”
reflects the attitude of trying to satisfy all those who work on downstream processes.

Breaking down each process into its constituent elements generally results in four elements, shown in Figure 2.1.
These are man, machine, material, and method. Since all these words begin with M, they are called the “ 5M”
of production. To perform good work, you must manage these 4M properly.

Note that sometimes people add another M, measurement*25, and talk about the 5M.

Man Material

Machine Method

Figure 2.1 Diagram of the 4M

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2.2 Decisions based on facts and data

(1) Populations and samples

In the field of quality management, it is important to make decisions based on facts and data. In other words,
we must not rely on past technology, experiences, or gut feelings, but instead correctly identify facts using data*30
such as observed values*29 and measured values*29 to make objective decisions. Even if you believe you
performed an experiment or a work task under the same conditions or circumstances, various factors that are
beyond your control inevitably result in variation in the characteristics*31 of the results. In other words, the data
you gather always contain variation*8.

Deciding whether something is good or bad or taking action such as changing manufacturing conditions or
reviewing the materials used based on just a few items of data will lead to the wrong action. It is essential not just
to accept the results appearing in the data unquestioningly, but to consider whether those results, due to variation
in the data, have occurred by chance and whether they are true.

Because variation is a natural characteristic of data, we need to make some sort of judgement about a
population*33 based on data gathered by performing measurements on a sample*32. The relationship between a
population and a sample is shown in Figure 2.2.

For example, suppose a teacher at a Tokyo high school wants to identify trends in the height of the school’s
students to find out how they are growing. She selects 30 students at random and measures their heights. She
determines trends in the heights of all students based on the 30 selected students while also looking at the degree
of variation in the data. In other words, she uses data from a sample of people that is smaller than the total number
of people. For this example, in the relationship between population and sample, the group of all high school
students constitutes the population, while the 30 students selected constitute the sample.

Decide/act

Population Sample Data

Sampling Measurement

Estimation/Judgement

Figure 2.2 Relationship between population and sample

(2) Types of data

Numerical data used in the field of quality management can be broadly classified as continuous data (i.e.,
measurable as a continuous quantity) such as weight, length, time, and temperature, and attribute data (i.e.,
enumerated data that can be counted in the form 1, 2, 3), such as the number of nonconforming items, number of
accidents, or number of scratches (nonconformities). Table 2.1 gives some concrete examples.
Table 2.1 Examples of continuous and attribute data

Examples of Concentration of an aqueous solution (unit: %), yield (unit: %), amount of active ingredient in
continuous a tablet (unit: g), thickness of a steel sheet (unit: mm), height of a human being (unit: cm),
data tensile strength of a wire (unit: N/mm2), commuting time to school (unit: minutes)

No. of times a machine has broken down (unit: times), no. of scratches per 1 m2 of plywood
Examples of (unit: scratches), no. of bubbles in a sheet of glass (unit: places), no. of nonconforming
attribute data components (unit: pieces), no. of absences from class (unit: times), no. of people who pass an
exam (unit: people), nonconformity rate (unit: %)

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Besides these, there is also non-numerical data. Examples include product quality grades such as Grade 1 and
Grade 2, the gender and experience level of workers, and the types of machines used.

Note that numerical data is sometimes called quantitative data and that non-numerical data is sometimes called
qualitative data.

(3) How to take a sample

If you extract a sample from a population and measure its contents, you can obtain data. Extracting a sample from
a population is called the sampling*32. The purpose of sampling is to get an idea of the characteristics of the
population from the data obtained from the sample. This means the sample must be as similar to the population as
possible. It is therefore necessary to take an unbiased, random sample. This method of sampling is known as
random sampling, and it refers to a method whereby all the elements comprising the population have an equal
probability of being included in the sample.

In reality, it is extremely difficult to take a perfectly random sample. Even so, it is important, when gathering data,
to always ask yourself whether the sampling method you’re using might be biased.

Consider a case that involves identifying trends in the heights of high school students, first considered in (1). We
assumed that a sample of 30 was taken from the population, i.e., the entire student body. But if we took 25 first
graders, with the remaining five from the second and third grades, would the results obtained from the sample
allow us to make accurate inferences about the entire population (Figure 2.3)? In this case, the inferences
concerning height would clearly be biased toward the first graders. We need to select a random sample that is not
biased toward any particular grade. One way to do this is to regard each grade as a separate stratum [see section
2.3 (8), p.24] and to take a sample from each.

Population Sample Data

All students at Height data for

a high school 30 students
Sampling Measurement
*32
Sample size n = 30

Can the trend concerning the height of all students be accurately estimated?

Figure 2.3 Bias in sampling

(4) How to summarize data

Even if you believe you performed an experiment or a work task under the same conditions or circumstances, the
data will contain variation. To grasp the situation and trends in the population from the data obtained by
performing measurements on the sample, you need to look not just at the location of the data, but also the
dispersion of the data.

Let’s consider, for example, the time it takes for Boy A to commute to school. Boy A does not use a train, a bus, or
a bicycle. Instead, he walks to school every day. Even so, he has noticed that even if he leaves home at the same
time, he does not necessarily get to school at the same time every day. Sometimes he arrives well ahead of time
for class, whereas at other times he’s just in time, and at other times he’s actually late. In other words, there is
variation in his commuting time.

To confirm his actual commuting times, Boy A obtained data by measuring his commuting time for five days
under the same conditions. For example, he made sure that he left home at the same time every day and was
carrying the same things. The results are shown in Table 2.2.

Note that he actually measured the times in seconds, but to simplify things we present them in minutes.

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Table 2.2 Data on Boy A’s commuting time

Day Monday Tuesday Wednesday Thursday Friday
Commuting time 15 minutes 13 minutes 16 minutes 20 minutes 17 minutes

When using data obtained to investigate commuting time, we normally use the mean x (x-bar) or the median
~
x as location scales (i.e., indicators of the nature of the population) and the range R as a scale of dispersion.
x, ~
x, and R calculated from the data obtained by measuring a sample are called statistics.

■ Location scales

ⅰ. The mean x is the center of the data and is calculated as follows:

n

x1  x 2  x 3    x n
i 1
xi
Total of the data
データの合計
x   
n n Number
データ数 of data items

Here, n denotes the number of data items (sample size*32), while x1, x2, … xn denote each data item.
n
In addition, the total from the first data item to the nth data item is expressed using the symbol  . Here,
i 1

i = 1 and n are sometimes omitted, and just the sigma symbol Σ (sigma) is used. The mean x should be
rounded to one decimal place less than the measured data—to two decimal places if n is 20 or more.

If we perform these calculations using the data from Table 2.2, the result is:

15  13  16  20  17 81
x   16 .2 (minutes)
5 5
Boy A’s mean commuting time is therefore 16.2 minutes.

ⅱ. When the data items are lined up in order of size, the median ~
x is the middle value if the number of data
items is odd and the mean of the two middle values if the number of data items is even.

Lining up the data from Table 2.2 in order gives:

13, 15, 16, 17, and 20.

Because the number of data items (five) is odd, the median ~

x is 16 minutes.
If the number of data items had been four (e.g., 13, 15, 16, and 20), the median would have been:

~ 15  16
x  15.5 (minutes)
2

■ Dispersion scales

The following formula is used to calculate range R:

R = maximum value – minimum value = xmax – xmin

Here, the maximum value and the minimum value are respectively written as xmax, xmin.

The data from Table 2.2 is:

R = 20 – 13 = 7 (minutes)

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So, even though he believed he commuted under unchanging conditions, the data for five days shows that there
was as much seven minutes in range in Boy A’s commuting times.

To make effective use of the results obtained, it is important to consider why the dispersion might exist.
Dispersion has causes. In the case of Boy A, the dispersion might be caused by him meeting friends along the
way or waiting a long time at traffic lights.

Besides range R, the sum of squares S*34, the variance V*34, and the standard deviation s*35 are also used as
dispersion scales.

2.3 QC seven tools

When performing quality management, it is important to gather data, process the data in accordance with the
purpose of analysis, and carefully extract information from it. Although the methods of processing data include
some that require advanced knowledge, other useful techniques are straightforward. Of these, ones that are highly
effective when applied to quality management have been selected and named the QC seven tools which are also
called seven basic quality tools.

To use the QC seven tools to make improvements in workplaces or circles, we must first study them to grasp the
purpose of using them. While most of the QC seven tools deal with figures, the New QC seven tools (N7 or
New Quality Management tools), techniques for handling linguistic data*30, cannot be expressed
numerically.

The techniques selected for the QC seven tools are Pareto diagrams, cause and effect diagrams,
histograms, graphs/control charts, check sheets, scatter diagrams, and stratification. Below in this
section, we will provide simple explanations and graphic examples of these techniques using the definitions
contained in documents such as the Japanese Industrial Standards (JIS)*23.

(1) Pareto diagrams

A Pareto diagram is a “diagram that stratifies items, arranges them in order of frequency of appearance, and shows
the cumulative sum.”7)

Pareto diagrams are used to confirm the impact on the whole of matters that need to be addressed (i.e., problems),
the effectiveness of the improvements made, and so on.

The field of quality management includes an approach ％

n = 180
called the priority oriented approach (see section 1.7, Period: October 1-30
p.13), which is used when selecting targets for problem
solving. When doing this, we must know what is
No. of nonconforming items

important and what proportion of the whole this accounts

Cumulative percentage

for. A Pareto diagram is a tool that clearly shows

important phenomena and the causes of such phenomena.

For example, let’s classify nonconforming items by the

nature of their nonconformity and arrange them in order of
number of nonconforming items to produce a Pareto
diagram. Types of nonconformity for which there is little
data and that have little impact are bundled together as
“Other” and are drawn last, after the other types. Next,
types for which we have lots of data (i.e., types frequently Deformed Scratched Twisted Warped Bent Other
observed) are gradually added together to calculate
cumulative sums. Calculating the cumulative percentages
20)
of all the data gives us the proportions of the whole for Figure 2.4 Example of Pareto diagram
specific nonconformity types and clarify what
nonconformity types we should focus on tackling.

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The Pareto diagram in Figure 2.4 shows that the total number of nonconforming items for which the
nonconformity is caused by “deformation” or “scratch” accounts for approximately 70% of the total. If we focus
on eliminating these types of nonconformities, we should be able to achieve significant reductions in the number
of nonconforming items.

(2) Cause and effect diagrams

A cause and effect diagram is a “diagram that shows the relationship between a specific result (characteristic) and
the factors behind it in a structured fashion.”7)

A cause and effect diagram, also known as a “fishbone diagram or Ishikawa diagram,” is useful for organizing the
cause-and-effect relationship of a problem to investigate the (root) causes*36 of the problem. Moreover, by
illustrating the connections between results such as quality
characteristics*31 and nonconforming parts and factors, they show Factor
which processes led to such results, thereby allowing us to organize Large bone

the cause-and-effect relationships underlying a problem, to discover Small bone

Medium bone
the factors likely to be important, and to take action to address
them. Specific
result Backbone

Characteristics (showing results) are placed at the tip of the

arrowhead (right end) in a cause and effect diagram (Figure 2.5),
while factors that have an impact on the results are placed at the
bone part. Sometimes factors corresponding to the 4M’s (man, Figure 2.5 Structure of cause and effect
machine, material, and method) are placed on a large bone.1) diagram

When we prepare cause and effect diagrams, it is important to bring

together everyone connected to the problem being investigated and to use methods like brainstorming*37 to
encourage the free sharing of opinions and promote the identification of all possible factors. Another good idea is
to circle those factors shown in the cause and effect diagram that are likely to have a significant impact on the
results. An example of this is shown in Figure 2.6.

Man Machine/equipment
Program error
Inadequate training Power outage
Inadequate operating Misreading of a scale
Inadequate skills environment
Inadequate health
management Abnormal operation
Lack of instruction Lack of knowledge Inadequate oiling Contamination
with dirt
of important points Deterioration
Faulty operation
Complaints about Product A arise

in concentration
Hostile workplace environment Wrong product repaired
Hurried work
Low level of work
awareness Poor processing
performance
Poor morale Inadequate maintenance Aging

Lack of work standards Vague safety standards Wrong shape Wrong weight

Standard work Nonconforming

undefined materials Rust
Inaccurate description
Inadequacy in5S Aged
Wrong materials used
Inadequate work Inadequate work component
Shortage of personnel configuration standards Flooding Erroneous
Small Inadequate component Wear
Inappropriate line space Hard to storage of selection
configuration understand components
Inadequate Malfunctioning product
working Products falling down
Inadequate process configuration
environment
Work method Dark Material Erroneous Inadequate bonding
installation

( denotes an important factor.)

Figure 2.6 Example of cause and effect diagram

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(3) Histograms

A histogram is a “diagram in which the

range of measured values is divided into a
number of classes, with each class serving
as the base of a rectangle whose area Lower limit of Upper limit of
specification specification
represents the frequency of measured

Frequency
values belonging to the class.”9)

A histogram is a type of bar graph, but as

Figure 2.7 shows, it is also a way of
displaying a frequency distribution, with a
characteristic of continuous data plotted
on the horizontal axis. Thus, a distinctive
feature of a histogram is that it illustrates
the location, dispersion, and distribution Size (mm)

pattern of the measured values (how the

22)
measured values are dispersed). Figure 2.7 Example of histogram
Histograms are useful when you want to
know, for example, whether the quality of a product is meeting the specification. Furthermore, by calculating other
variables such as the number of data items n, the mean x, the specification deviation s, the maximum value xmax,
the minimum value xmin, and the range R, you can observe patterns in the distribution of the measured values.

When you draw a histogram, you might see one of a variety of distributions, which are shown in Figure 2.8,
depending, for example, on the quality of the product. Although the histogram shown in Figure 2.7 has a
normal-shaped (bell-shaped) distribution, you can see that the mean is some distance from the center of the
specification range and that some measured values exceed the lower limit of the specification.

Shape of histogram Characteristics

Normal shape (Bell-shaped)
 The shape is symmetrical.
 This is the shape typically seen. Values tend to cluster around the
center, and the number of values gradually decreases as you move
further from the center.
Double-peaked shape
 There are two peaks.
 There is a peak on the left and the right, indicating that it is possible
this is a mixture of two distributions with different means. In cases
like this, it's a good idea to attempt to stratify the data [section 2.3
(8), p.24].
Isolated-peaked shape
 There is a small peak some distance from the main peak.
 This shape appears when data from a different distribution is mixed.

Truncated shape
 One side appears to be missing.
 This shape often appears when items not meeting specifications are
excluded.

Comb shape
 The frequency of each class increases and decreases alternately.
 This shape appears when there is a problem with the measurement
method or when the classes have not been determined appropriately.

Figure 2.8 Various histogram shapes

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(4) Graphs

A graph is “a diagram that shows sizes of data graphically or shows changes in size of data in a visually appealing
way to make the data easy to understand.”7)

There are various types of graphs. Some of the most common are bar graphs, which compare quantities; line
graphs, which illustrate changes over time (Figure 2.9); and pie charts, which break down data into categories
(Figure 2.10).

Organizing data in the form of a graph makes it easier to grasp information in ways that might not be apparent
from viewing the data table alone. It is therefore important to consider what your argument is and what you want
people to focus on and to choose a graph that fits your goals.

Items causing customer dissatisfaction

Number of nonconformities (cases)

Other
11%
Opening
hours
6%

Price
Store 35%
atmosphere
12%

Aftersales
service Product
lineup
15%
21%
Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec

7)
Figure 2.9 Example of line graph Figure 2.10 Example of pie chart

(5) Control charts

A control chart is “a diagram that contains an upper control limit line and/or lower control limit line and shows
continuously observed values or statistics of a subgroup*38, which are normally plotted in order of time or in the
order of sample number.”7) In addition, a control chart also “contains a centre line for investigating the tendency of
the plotted values to move toward one of the control limits.”10)

Control charts are used to detect process abnormalities by making visible changes or trends in processes over time.
Data from the process is collected and plotted in the form of a line graph. A control chart contains three control
lines: a centre line (CL), an upper control limit (UCL) line, and a lower control limit (LCL) line.

If out of control signal*39 is present—e.g., if one or more dots lie outside the control limit lines or a series of
dots is successively plotted above or below the
centre line—it is deemed that “the process
is out of control.” A situation like this
indicates that the variation in the results has
occurred due to an assignable cause*40.

Although there are various types of control

charts, the most common one is the X  R
control chart, an example of which is shown in
Figure 2.11. An X  R control chart shows
the mean and range of the characteristic
values.

In the control chart in Figure 2.11, the point

for subgroup number 22 in the X control chart
exceeds the UCL, based on which it is deemed Figure 2.11 Example of X  R control chart
that “the process is out of control.”

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(6) Check sheets

A check sheet is “a table or diagram that makes it easy to see into what categories data is concentrated after
attribute data is gathered.”7)
In the case of a check sheet, to make it easier to collect and organize the data, we print the categories and diagrams
we will need when collecting data on a form in advance. We can then record the data in a simple way. For
example, data, results, inspection results, etc., can be recorded as figures or symbols such as circles, crosses, or
checks.
As you prepare a check sheet, it is important to think hard about what kind of data you want, what kind of data
you should collect, what format will make the data easy to collect, and so on.
A check sheet lets you gather data in an organized fashion and without omissions. Processing the data after
collection is also easy.
Check sheets come in various formats, depending on the purpose of the investigation, but they can be broadly
classified into recording/surveying check sheets (Figure 2.12, Figure 2.13), which are used to collect data to
achieve a particular goal, and inspection/confirmation check sheets (Figure 2.14, Figure 2.15), which are used
to investigate whether inspection criteria determined in advance have been met.
Processing precision frequency distribution survey check sheet
Check sheet for nonconformities in package seals for powdered milk Lot no. Total Frequency
Product name: Powdered milk M5 Machine name: MC-K1 Lot no.: MF5 Class
Process name: Filling/packaging Measurement method: 100% visual Period: October 1-6, 2009

Month/date
Type of Total
nonconformity

Torn edges

Powder stuck

Creased seal

Defective seal
temperature

Other

Total

Checker

Total

Figure 2.12 Example of recording/surveying Figure 2.13 Example of recording/surveying

24) 22)
check sheet check sheet
Quality circle activity status interview sheet
No. Question item Interview topics
1. How to raise topics
Are circle
2. How meetings are organized
activities
autonomous? 3. Preparing activity plans
4. How objectives are determined
Work standards compliance check sheet 1.
Group
(Name of process: Rolling) activities in 2. When a meeting is held, does everyone speak?
(Twice a week, one hour after start of work, patrol) which
Month/date everyone 3. How are study meetings administered?
July 10 July 13 July 16 July 19
participates 4. Have relationships among employees improved?
Check item Time
1. Are meetings being held in an organized fashion?
Have the period for retaining kneaded rubber
used and the passing rubber no. confirmation 2. Are appropriate preparations for meetings being made?
Mixing signature been entered? Circle
Does the rolling temperature comply with the meetings 3. Are meetings administered effectively?
standard?
4. Are minutes prepared when necessary?
Does the injected rubber rolling temperature
comply with the standard? 5. How is homework performed?
Heating Does the calendar surface temperature
comply with the standard? 1. What is the most difficult thing to administer? How has that
Does the calendar setting width meet the difficulty been addressed?
requirements? Background to
Does the sheet thickness meet the circle activities 2.
requirements?
Has the control chart been completed? 3.
Gauge
Visual inspection of sheet, checking for
presence of air Methods of 1.
Does the calendar speed comply with the
self-developme
nt and mutual 2. Do you read books about QC?
standard?
Sheet width development
Has the sheet width/length confirmation F
been completed? 1. How many of the annual topics have been resolved?
Results of
Winding Does the cooling method comply with the 2. How interested is your superior in the circle activities?
standard? activities
3.
Is the sheet winding temperature 40°C or
lower? Total points for
activities

(Problems/Matters requiring guidance)

○: OK, ×: Requires attention
△: Requires investigation/improvement Comments

Figure 2.14 Example of inspection/confirmation Figure 2.15 Example of inspection/confirmation

23) 20)
check sheet check sheet

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(7) Scatter diagrams

A scatter diagram is “a diagram in which two characteristics constitute the horizontal (x) and vertical (y) axes and
the observed values are plotted as a graph.”7)
Viscosity (y)
Scatter diagrams are used to investigate the
interrelationship between two contrasting (paired)
characteristics (i.e., variables).

When looking at a scatter diagram, you need to

answer questions like the following:

 Does the way the dots are arranged indicate a

trend?
 Is the trend linear or curved?
 How much deviation is there from the trend?

You must also carefully check the following:

 Are there any outliers*41?

 Are there clusters of dots? If so, should they be Amount of additive (x)
stratified [see section 2.3 (8), p.24]?
Figure 2.16 Example of scatter diagram
Figure 2.17 shows scatter diagrams with typical
data distributions. In (a), the correlation between two characteristics x and y is that y increases as x increases;
there is a “positive correlation” between x and y. In (c), y decreases as x increases; there is a “negative correlation”
between x and y. In (b), an increase in x does not appear to have any effect on y, so there is “no correlation”
between x and y.

In the scatter diagram shown in Figure 2.16, when the amount of additive (x) increases, the viscosity (y) also
rises, so there is a positive correlation between the amount of additive and viscosity.

21)
Figure 2.17 Relationships between two characteristics

(8) Stratification

Stratification is the process of slicing the population into a number of strata. The strata are a type of
subpopulation*33. They do not share any components, and when all strata are assembled, the result is equivalent
to the population.10) It is therefore important to define strata such that each stratum is uniform in relation to the
characteristics being studied.

Stratification is useful for investigating differences in distribution among different strata, distributions within a
stratum, and the causes of variation. It is particularly effective when used in conjunction with Pareto diagrams,
histograms, scatter diagrams, control charts, etc. However, collecting vast quantities of data is not of itself
sufficient to identify causes and to determine appropriate actions for addressing causes. When investigating a
problem, you can obtain clues about causes by asking yourself whether there are any differences in characteristics
depending on the machine used for manufacturing, the materials used, the worker performing the job, and so on,

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then dividing the data, and processing it by turning it into a graph, etc. for comparison.

The word “classification” is also used with a meaning similar to stratification. Classification is “the process and
method of sorting a sample into categories that have been prepared beforehand;”14) be careful to avoid using the
terms interchangeably.

In Figure 2.18, the histogram for all data is double peaked, and the upper limit of the specification (SU) is
exceeded. Histograms stratified for each worker were prepared. Stratification shows that while Worker A meets
the specification, the mean is skewed toward the lower limit of specification (SL). In the case of Worker B,
meanwhile, we see that the mean is close to the upper limit of the specification and that in some cases the upper
limit is exceeded.

The total scatter diagram in Figure 2.19 shows the results of manufacturing using two machines. From the total
scatter diagram alone, we cannot tell whether there is a correlation between the amount of additive and production
volumes; but when we produce a scatter diagram for each machine, we see a positive correlation between the
amount of additive and production volumes for both machines.

Total
Frequency

SL: Lower limit of specification

SU: Upper limit of specification

Weight (g)

Worker A
Frequency

Weight (g)

Worker B
Frequency

Weight (g)

Figure 2.18 Example of stratification (histograms)

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Total
Production volume (kg)

Amount of additive (%)

Machine 1 Machine 2
Production volume (kg)

Production volume (kg)

Amount of additive (%) Amount

Amount
of additive
of additive
(%) (%)

Figure 2.19 Example of stratification (scatter diagrams)

(9) Utilizing the QC seven tools

In quality management, it is important to identify problems based on facts, to determine what is good and bad
about a process, and to make improvements while following the PDCA cycle. To that end, it is essential to choose
the QC tools best suited to the objectives of an analysis and to gather information on the processes that constitute
the population. For example, based on the data obtained from a sample, you will want to identify the mean, the
extent of the variation, and so on.

The QC seven tools are essential and fundamental weapons for objectively grasping facts and phenomena. It is
comparatively easy to use each technique to present data graphically, but the most important thing is to read and
comprehend the information shown. Presenting the data obtained in the form of a diagram or table is not the be-all
and end-all. You must look at the diagram or table and ask yourself: “What could I say about this?” You need to
formulate your own opinions. This is especially true in the case of data collected for a specific purpose. It is
important to consider that purpose and ask: “What have I learned?” Then, you should ask yourself: “What should I
do next?” Finally, you need to translate the answers to those questions into future action.

The QC seven tools are just that: tools. Each is nothing more than a single technique. Your goal is to use these
tools to collect and analyze data and to solve problems or achieve tasks. To that end, you need to use the QC seven
tools to obtain accurate information about a process and carefully answer this question: “What should I do about
this process?” Then you need to make the specific answer to that question your next action.

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3.1 Ho-Ren-So (reporting, contacting, and consulting)

An organization normally comprises a large number of employees who

perform tasks based on instructions and orders issued by their superior. The
Ho-Ren-So serves as a kind of lubricant to make the workflow smoother.
Horenso is shorthand for the Japanese words hokoku (reporting), renraku
(contacting), and sodan (consulting).

Once instructions and orders have been issued, it is important for the
performance of work that superiors or customers are swiftly informed about
how things are going and what the results are. In other words, an instruction is
issued or a request is made, and then a report is made in response.

Unforeseeable accidents may occur on the frontlines. Contacting the necessary

departments to inform them of such day-to-day changes in the situation on the
frontlines is important for minimizing the harm caused by unexpected incidents. The function of independently
providing the necessary people with the necessary information, even when no instructions to do so have been
issued by one’s superior, is known as contacting.

Each organization inevitably has responsibilities and authority that have been delegated to it, while each
individual belonging to the organization is also assigned responsibilities and authority. The organization and each
individual comprising it perform their work on a day-to-day basis within the scope of the responsibilities and
authority assigned. However, events in the real world do not occur conveniently within such predetermined scopes
of responsibilities and authority. It is often the case that you can’t make a judgement on your own or that you do
not know how to respond within the scope of your own authority. In such situations, it's crucial that you do not
make a judgement call and take action independently, but instead go to the person who can make the judgement
call or the person who can make the decision in order to consult with them.

This organizational practice of reporting, contacting, and consulting by the individuals that comprise the
organization is a vital action principle for administering the entire organization in an organic fashion.

If Ho-Ren-So is properly applied, it leads to effective communication with superiors and seniors, which in turn
results in better work efficiency. To that end, it is necessary to grasp the key points using the 5W1H framework
(see section 3.2, p.28) and to ensure that the reporting, contacting, and consulting are accurate, concise, clear, and
specific. It is also better to express things numerically wherever possible rather than using vague expressions such
as “usually” or “about.”

(1) Key points concerning reporting

When you have completed the work you have been assigned, report the results to the person who issued the
instruction or order without delay. If the work takes a long time to complete, make interim reports on your
progress, your future actions, and so on. If it does not look as though you will be able to keep the predetermined
deadline for delivery or if you have made mistakes or a problem has emerged in the course of performing the work,
it is important that you swiftly report this to your superior or supervisor and follow their instructions.

When making a report, try to convey the key points accurately and in an easy-to-understand fashion. You can do
so orally or in writing, but you are going to start by briefly stating your conclusion. Depending on the situation, it
is often helpful to use actual articles, materials, diagrams, etc.

The attitude of the person receiving the report is also important. If we grow angry and begin complaining that so
and so hasn’t arrived with their report or that they are late in submitting the report, this is basically our problem. It
is also unhelpful to lose one’s temper and to scream and shout after receiving a bad report. To receive accurate
reports in a timely fashion, the most important thing is to establish an atmosphere in which people feel
comfortable making reports. We must remain acutely aware that a key factor in enhancing the quality of reports is

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the readiness and attitude of the recipient. Everything hinges on this.

(2) Key points concerning contacting

Contacting means sharing information that should be shared with the relevant people. When doing this, try to
leave out your own opinions or conjecture. When you are contacting, choose a method that reflects the situation at
the time—e.g., the person you are contacting, the information you are going to convey, the importance, the
urgency, etc. In addition, by maintaining close contact, you can prevent problems or accidents; if a problem or
accident should occur, you can minimize the damage that results.

If possible, it is a good idea for the organization to determine what kinds of information should be conveyed and
to establish rules for the workplace that prescribe which departments and people should be contacted if such
information is obtained and within what time frame and using what contact methods. This is the same as the
emergency telephone trees most organizations prepare for use in the event of an emergency.

(3) Key points concerning consulting

As you perform your work, problems that you had not foreseen may arise, and events may arise for which you
cannot determine countermeasures yourself. At times like this, it is important not just sit to there and think about
what to do on your own, but to first consult your superiors or seniors (although sometimes a superior may consult
his or her subordinates). When consulting, it is important to be clear about the nature of the advice you want, and
if necessary, to prepare materials, data, etc. Furthermore, if you come up with your own ideas or measures for
solving the problem, you will be able to receive more appropriate advice.

As with reporting, the attitude of the person being consulted is incredibly important. If someone comes to you for
advice but your mind is elsewhere and you do not listen, or if you look away and act as if it has nothing to do with
you, the consultation function will break down. When asked for advice, you must remain keenly aware that you
are in a position to be consulted and to offer advice from a place of empathy.

3.2 5W1H

We should take the view that our actions comprise the six 5W1H elements. However, when a person observes or
focuses on a certain action, he or she can overthink things and notice only the elements that make a particularly
strong impression or seem very important. For this reason, when you investigate a situation, it is easy to overlook
problematic behavior and to plan and take unnecessary actions as a result. Before we take action, it is important to
always take a fresh look at the action we are thinking of taking and ensure that it incorporates the six 5W1H
elements, without omissions.

What: the object

When: the date/time, the time period
Who: the person/people
Where: the place, the organization
Why: the goal, the reason, the background
How: the method, the degree

Sometimes “how much” (cost) is added to this list to give 5W2H.

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3.3 Sangen-shugi

Sangen-shugi is a Japanese term for the three “gens,” which are genba (actual place), genbutsu (actual article), and
genjitsu (reality). When a problem occurs, or when efforts are being made to make improvements in a workplace,
it's important to visit the work site, to look at actual articles, and to think in realistic terms. Sangen-shugi reflects
this approach to action.

Specifically, the meanings of the three gens are as follows:

ⅰ. Genba means the place where the phenomenon is happening. It can also refer to the act of going to that
place.
ⅱ. Genbutsu means the product (article) that is the subject of the phenomenon.
ⅲ. Genjitsu means the actual situation (i.e., what is actually happening).

By making these three gens core principles for your behavior, you will be able to solve problems and make
various improvements in a steadier fashion.

3.4 5-gen-shugi

Sometimes another two gens (genri and gensoku) are added to sangen-shugi Sangen-shugi
to give 5-gen-shugi.

On the frontlines, it's impossible to discover and recognize problems exactly

by only looking at them. But as you implement sangen-shugi, if you make
comparisons with principles and look at things based on certain criteria,
problems will come into focus, and you will be able to observe the facts
5-gen-shugi
clearly. This is why 5-gen-shugi has been advocated.

ⅰ. Genri means “basic principles through which phenomena and

recognition thereof occur.”18)
ⅱ. Gensoku means “basic rules and laws that apply to most situations.”
18)

Genri, which includes things like the “principle of leverage” and

“Archimedes’ principle,” is universal rules that apply to things and go
beyond human wisdom. As a result, while it can be used, it cannot be
changed intentionally. Gensoku, on the other hand, includes formulations like “the three rules for preventing food
poisoning,” “corporate accounting rules,” and so on. These are rules created by people based on past experience
and values. For this reason, it can be changed in response to the conditions applied and can also be altered
intentionally.

Consider the example of welding process. The genri is “amalgamation by using the heat generated by passing a
strong electric current through iron to melt the iron, applying pressure, cooling, and causing crystallization.” The
gensoku, meanwhile, is to “pass an electric current of XX ampere for YY seconds so that the iron reaches melting
temperature.”

In addition, basic rules or approaches that people engaged in various activities within organizations and society
should follow are also sometimes described as gensoku. Take the example of garbage disposal. The idea that
“garbage should be disposed of as close as possible to the place where it was generated—i.e., that it should not be
transported to a distant location”—can also be described as gensoku.

3.5 Manners

In workplaces in which many people work, rules are prescribed to ensure that the organization is administered
smoothly or to make the time spent at work more comfortable. When codified in writing, these rules take the form
of rules of employment, health and safety rules, and so on. The specifics of these rules differ from workplace to
workplace. The people who work in the organization obviously have to comply with these rules, but other rules,

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while not codified in writing, are regarded as common sense for those in their professional lives. These rules,
which we refer to as “manners,” facilitate smooth human relationships and are tacitly understood. In Japan, basic
manners that absolutely must be followed are described below:

(1) Be a responsible member of society

The most fundamental business manner of all is being aware that you are a member of society. You must regard
yourself as a professional who is paid for your work and must therefore perform it responsibly. Rather than
waiting for someone around you to tell you what to do, you must learn, think, and take action on your own. This is
the quickest route to becoming a professional. Beyond this, you must remain aware at all times that you are a
member of an organization. Refrain from acting selfishly. Report in a timely and proper fashion on how you are
progressing. It is also important to understand that not only are you a member of your organization, you are also a
member of society. By adhering to rules as a member of society, you will gain trust from various quarters.

A related word is compliance. Compliance is defined as “adhering to demands and orders and, in particular,
adherence by companies to laws, social norms, and corporate ethics.”17) Compliance, sometimes called “legal
compliance,” is essential to ensuring that organizations pursue sound business activities.

(2) Be on time

If one person is late, the whole job can get delayed, resulting in
significant repercussions to the organization. Don’t think that it’s
enough just to be on time. Rather, you should always behave with the
attitude that you could even do things before the designated time. For
example, you could arrive your workplace at least five minutes before
work begins so that you are ready to get to work right away. It is also
important to make a clear distinction between break times and working
time.

(3) Exchange greetings

Greeting others is about approaching people openheartedly. To maintain smooth relations with others in your
workplace, it is important to be proactive in greeting them. Get into the habit of looking people in the eye and
greeting them confidently. Greetings are the starting point for establishing good communications.

(4) Pay attention to the words you use

Respecting other people and using words with care is fundamental to forging good human relations. If you
approach an interaction with the intent to respect and value the other person, you will choose the right words as a
matter of course. It’s assumed that you will speak to your superiors and seniors politely; but the same should hold
true, even if you are talking to someone younger than you. Being careful with the words you use should be
common sense for all members of society.

(5) Wear the right clothes

Appearance matters. So important, in fact, that an individual’s appearance affects the way their organization is
perceived. Regarding appearance, the most important thing is to be clean and not make other people feel
uncomfortable. It’s not about being stylish. Furthermore, if you are performing dangerous work, proper outfit
(overalls, a hat, boots, etc.) must be prescribed and worn in accordance with these hazards.

(6) Don’t mix business with personal matters

Do not use property belonging to the organization for personal ends. Don't use workplace equipment for personal
matters or order junior employees to do things for you in a personal capacity. Avoid activities involving your
personal life, like emailing or calling friends, during work hours. Engaging in activities like this can damage the

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atmosphere in the workplace and interfere with discipline.

(7) Be organized and tidy (seiri and seiton)

Desks and lockers in the workplace are not personal possessions. You are borrowing them from the company.
Keeping them organized and tidy at all times lets both you and those around you happily focus on your work (see
section 3.6).

(8) Protect the environment

This might seem obvious, but be sure to properly sort the garbage before disposal. Be proactive in activities
related to environmental awareness, like minimizing garbage volumes. Creating a pleasant environment in this
way is also an example of good manners.

3.6 5S

The 5S stand for the Japanese words seiri (organized), seiton (tidy), seisou
(clean), seiketsu (hygienic), and shitsuke (disciplined). They denote desirable
characteristics for workplaces and can be said to the form the foundations for
every type of work. The 5S are actually the 4S with “shitsuke” added. The fifth S
was added to help people fully internalize the 4S and to implement them without
actively thinking of them. Furthermore, since “discipline” conjures up feelings of
being told to do something from those above, “shukan” (habitual) is sometimes
used instead of shitsuke. Depending on the workplace, “safety” or “speed” may
also be used as an alternative S.

The 5S are normally used with the following meanings:

ⅰ. Seiri (organized) is about deciding on things you need and throwing away the things you don’t.
ⅱ. Seiton (tidy) is about putting things in their designated places to ensure they are always available for use.
ⅲ. Seisou (clean) is about cleaning all the time to keep the workplace clean.
ⅳ. Seiketsu (hygienic) is about keeping things seiri, seiton, and seisou.
ⅴ. Shitsuke (disciplined) is about acquiring the habit of properly following rules.

The concept of the 5S is known worldwide and their meanings are sometimes described by the following
expressions:

ⅰ. Seiri : Sorting
ⅱ. Seiton : Setting in Order
ⅲ. Seisou : Shining
ⅳ. Seiketsu : Standardizing
ⅴ. Shitsuke : Sustaining the Discipline

3.7 Health and safety activities

In workplaces, various steps are taken to ensure that time spent in the workplace is spent safely. For example,
problems in the working environment must be eliminated to ensure safety, particularly in factories. In addition, action
must be taken to prevent employees from having traffic accidents while commuting, health examinations are
conducted periodically, and special health examinations are conducted on workers engaged in specific types of jobs.
Moreover, during events called “safety weeks,” everyone helps perform different safety inspections each day and
takes action to address areas with hazard risks. Events are also held to educate employees about safety. Of course,
safety isn’t just something to work on during safety events. It’s important to ensure safety on a day-to-day basis.

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At factories and construction sites, you often see flags and posters carrying a green cross. This is a safety
campaign symbol intended to raise awareness among employees of health and safety. The green cross is also often
used alongside the slogan “safety first.” In workplaces, many activities are conducted to ensure proper health
and safety management. They include activities for preventing industrial accidents and achieving zero disasters.
Specific activities include near-miss activities, KY activities, and pointing and calling method.

A near miss (incident) is a term used to describe dangerous situations or actions that arose but ultimately did not
result in harm or damage. When a near miss occurs, you report it by completing a form based on 5W1H. You also
describe the action you are going to take to prevent a recurrence. It is important to share this information on near
misses in the workplace and to think of how to eradicate the causes. KY activities, meanwhile, refer to kiken
(hazard) yochi (prediction) katsudo (activities); the abbreviation KYK*42 is sometimes used instead. These
activities involve predicting/forecasting dangerous places or actions and taking action to prevent incidents before
starting work.

Kiken yochi training (KYT*42) is a training activity in which workers use illustrations or photographs of their
workplace to visually identify dangerous places or actions. After that, they consider measures to tackle these
dangers.

Pointing and calling method is a type of KY activity intended to confirm safety. You point at objects and call
out the name of the action you should take in a loud voice. Calling out specific names is important; the technique
is useful for preventing accidents resulting from human error.

One approach to preventive management and industrial accident Major

prevention is Heinrich’s Law. Heinrich, a safety engineer in the United injury
States, investigated many accidents and concluded that “for every Minor
accident that causes a major injury, there are 29 accidents that cause injury
minor injuries and 300 accidents that cause no injuries (near misses or Near miss
incidents).” It can therefore be said that activities designed to eliminate
the causes of the near misses that occur on a daily basis on the frontlines
will be effective in preventing accidents that cause actual injuries. These
activities are sometimes called 300 campaigns. At any rate, it is
important to identify dangerous places and actions and eliminate them
before they cause problems.

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This chapter introduces the definitions and meanings of some of the terms used in Chapter 1 through Chapter 3
and provides simple explanations of these terms. The terms selected are not obvious specialist terminology used in
the standards for quality management, specialist terms specified by the Japanese Society for Quality Control
(JSQC), and so on.

Read this chapter to learn more about terms such as product*1 with attached superscript figures in the form*1,*2,
etc., that appeared in Chapter 1 through Chapter 3. Definitions and meanings from the JSQC are provided, along
with explanations that will give a deeper understanding of the content of the main part of the textbook.

Superscript figures displayed next to each definition [ ] in the form of 1) are included in the Appendix under
“Citations and Reference Literature.”

*1 Product (products and services, products/services)

[Something that is the result of a process, is supplied to customers, and generates value]1)

Products come in various forms, including hardware, materials, software, services, energy, and information. Few
of the products we handle day to day come in just one of these forms. Most are a mixture of one or more forms.
Services, a type of product, are activities that occur between customers and organizations (suppliers) that provide
benefits to the customer. In this textbook, when we want to refer to services explicitly, we add the word “services”
(e.g., “products and services” or “products/services”).

*2 Quality

[The degree to which the object concerned (e.g., product/service, process, system, management,
corporate climate, etc.) satisfies explicit or implicit needs]1)

In a diverse and mature market, it is important not only to satisfy needs clearly stated by customers, but to
proactively identify and satisfy latent customer needs. In other words, it is important to deliver customer
satisfaction by engaging customer emotions. Needs are sometimes limited to customer needs, but the needs of
society, etc., are sometimes also included. Be careful when using this term.

Sometimes elements of quality such as functionality, performance, usability, availability, economy, reliability,
safety, and eco-friendliness are simply referred to as “quality.” Quality in Japanese, hinshitsu, is sometimes
reworded to “shitsu” when speaking of the quality of intangible objects rather than tangible products (e.g., quality
of work, quality of medical care, and quality of service) especially in the service sector.

*3 Customer

[The organization or person that receives a product/service]1)

In the field of quality management, a great deal of attention is paid to the recipients of products and services. The
term “customers” is not used in the narrow sense of only the direct purchasers who pay for products and services
supplied by organizations. It encompasses a wide range of people, including consumers, end users, clients,
retailers, beneficiaries, and potential customers. Furthermore, it is regarded to include not only customers external
to the organization, but customers inside the organization, such as other departments and people who perform
downstream processes (i.e., the next process) of the process done by your own department. This view is summed
up in the expression, “The next processes are our customers.” Based on this approach, the entire organization
performs quality management activities, allowing it to effectively and efficiently produce and provide
products/services that meet the needs of customers.

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*4 Voice of Customer (VOC)

[What customers require from products]8)
This term refers to the raw opinions of customers (e.g., something should be easy to use, clean, etc.), gathered
with the goal of identifying the diverse needs customers have with regard to products/services, including quality.
These opinions are analyzed and translated into quality requirements (portability, high resolution, etc.) to shed
light on the products/services that should be offered and to identify problems and issues from a quality assurance
perspective. The Voice of Customer, abbreviated VOC, is alternatively referred to as source information, source
data, or linguistic information.

*5 Quality management, quality control

[Activities for effectively and efficiently delivering product/service quality to meet the needs of
customers/society]1)
The goal of quality management is to meet diverse needs, like needs for product/service safety, operability,
reliability, economy, and eco-friendliness. To that end, it is important to articulate the quality targeted and to
steadily implement management of the processes to deliver this quality.
When articulating quality, take into account the users, potential customers, target market, society, and so on.
Management (control), meanwhile, is about following the PDCA*11 cycle—in other words, it refers to all
activities related to planning and implementing the optimal use of operational resources like people, things, money,
and information in accordance with management objectives to meet these objectives continuously and efficiently.

*6 Problem, issue
Problem: [a gap between a predetermined objective and reality that needs to tackled and overcome]7)
Issue: [a gap between a to-be-determined objective and reality that needs to be addressed]7)
In everyday life, we often don’t distinguish between problems and issues, regarding them all as problems. But in
the field of quality management, these two terms are sometimes used with different meanings. In such cases, a
problem is a gap between an objective and the reality that has occurred as a result of determining an objective,
deciding on the process for achieving that objective, and then performing that process. An issue, however, is a gap
between a new objective that is going to be set and reality, or between a future “ideal state” and reality. For
example, you can regard the gap between a current product and the current standards for that product as a problem,
and the gap between a new standard slated to be set to deliver customer satisfaction and the current standard as an
issue.

*7 Problem solving, task (issue) achieving

Problem-solving: [A series of activities for addressing a problem; involves specifying the cause, taking
action, and confirming the effectiveness of that action]1)
Task (issue) achieving: [A series of activities for achieving an objective; involves defining a new objective
and designing processes and/or systems for achieving that objective]1)
Sometimes people don’t distinguish between problems and issues and use the phrase “problem-solving” to include
the achievement of tasks (i.e., the resolution of issues). A typical procedure for problem-solving is a
problem-solving QC story; one for task-achieving is a task-achieving QC story (see section 1.6 (1), p.13).

*8 Variation
[The observed values or measurement results are uneven; also used to refer to the degree of
unevenness]10)
Even if you perform the same tasks using the same work procedure, the data*30 obtained will not be uniform.
There will inevitably be variation. This is because the numerous factors that affect the outcome are never constant.
The degree of variation can be expressed using statistics such as standard deviation*35, but, in this textbook, we
use “range” (R), which is the difference between the maximum and minimum values in the data obtained. Please
refer to section 2.2 (4) (pp.17-19) for more details.

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*9 Complaint
[An expression of dissatisfaction from a customer or other interested party to a supplier (or to a third
party who can influence the supplier) due to a product/service or organizational activity that does not
meet the needs of the customer or other interested party]2)
A complaint refers to an expression of dissatisfaction about a supplier or third party (consumer organization,
regulatory body, etc.). “Dissatisfaction” refers to the feeling that something doesn’t meet one’s needs. For example,
the unpleasant sensation caused by a loud noise from a construction site is a form of dissatisfaction; when a
complaint is about it is made to the authorities, the issue becomes a complaint. Among complaints directed at
suppliers, those that include a demand for compensation or restitution are referred to as claims (for damages). In
fact, the term “complaint” is sometimes used to describe a simple gripe. You may need to distinguish between the
two terms on occasion.
“Needs” refer to expectations concerning functions and performance specifications, which are clearly stated in
catalogs, instruction manuals, etc., as well as tacit expectations such as safety as a matter of course. They also
refer to the provision of products/services (e.g., finished buildings) themselves and the process of achieving that
provision (e.g., noise generated during construction).

*10 Nonconformity, nonconforming item

Nonconformity: [Non-fullfillment of a requirement]10)
Nonconforming item: [An item with one or more nonconformities]10)
If a component, etc., is processed and inspected and the results of that inspection*24 reveal that the component
does not meet criteria or standards, the situation is called a nonconformity. The term “nonconforming item” is
used for nonconforming articles like components.
In the past, futekigohin (nonconforming item) was referred to as furyohin (nonconforming or defective item), but
nowadays a distinction is made between the two terms. Futekigo (nonconformity) refers to a failure to meet
prescribed requirements, while furyo (defect) refers to a failure to meet requirements for use.

*11 PDCA, SDCA

[An approach for improving processes by continuously following a cycle comprising planning, doing,
checking, and acting]1)
PDCA is also referred to as the “PDCA cycle,” the “management cycle,” or the “management circle.” It is a
version of the cycle of product processes described by the statistician W.E. Deming (design–manufacture–
inspection/sale–service/survey) expanded for general use.
A similar approach to PDCA called “plan–do–see” existed in the past, but the “see” element was misunderstood as
meaning that all one needed to do was look at results. Therefore ,“see” was broken down into “check” and “act” to
emphasize the importance of remedying problems and preventing recurrences. (In the past, “action” was used in
place of “act” in Japan.)
The P in PDCA includes the notions of “planning to break free of the current situation” and “planning to maintain
the current situation.” Because PDCA is implemented with the latter as the basis for defining standards that
prescribe work methods or standard procedures essential for performing day-to-day tasks in the workplace, the
approach is sometimes called “SDCA,” in which the S stands for “standardize.”

*12 QCD, QCD + PSME

QCD, which stands for Quality, Costs, and Delivery (production volume, delivery date, work period, etc.), is a
term used to refer to quality in the broad sense.
In the workplace, it is customary to add P (productivity), S (safety), M (morale/morality), and E (environment) to
give QCD + PSME, which provides an even broader notion of quality and for monitoring items*18 to be
established and controlled for each element.
The following table shows some examples of monitoring items:

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Category Examples of monitoring items

Q Nonconforming item ratio for each process, number of nonconforming items occurring with each worker,
etc.
C Proportion of cost reduction target achieved by each component, variance between the workplace’s budget
and its actual performance, etc.
D Ability to deliver on time, inventory trends, etc.
P Production volume per person per day, production value per hour, etc.
S Number of accidents, number of continuous operation hours without an accident, etc.
M Absence rate, work attendance by each worker, number of improvements proposed by each worker, etc.
E Carbon dioxide (CO2) emissions, specific environmental risks pointed out (the E is sometimes used to
refer to ecology or education), etc.

*13 Occupational health and safety

[Conditions and factors that affect or could affect the health and safety of employees, other workers
(including temporary workers and subcontractors), visitors, and all other people in the workplace]16)
Occupational health and safety covers everything concerned with maintaining the health and safety of all those
involved in the business activities of the organization, including physical and mental safety in the workplace,
safety while commuting to and from work, and health examinations. The Industrial Safety and Health Law
stipulates that organizations must safeguard the health and safety of workers in the workplace and promote
formation of a pleasant working environment. To achieve these objectives, business operators have a duty to
establish hazard-prevention standards for preventing occupational accidents, to clarify responsibility systems, to
promote voluntary activities, to implement comprehensive and strategic measures, and so on. It is not enough
simply to abide by standards for preventing occupational accidents. The Act requires workplaces to offer peace of
mind, comfort, and a pleasing atmosphere to strengthen health and safety. It must also not be forgotten that
business operators have occupational health and safety responsibilities for those not directly involved in their
operations. For example, they must take action to prevent the pollution of the atmosphere, water, etc. Events
promoting these activities, such as National Safety Week in July and National Industrial Health Week in October,
are held nationwide each year.

*14 Product safety

[Measures taken to ensure the safety of products from a PLP (product liability prevention) perspective.
Refers to measures taken to prevent the occurrence of accidents that lead to product liability claims, i.e.,
corporate activities for the creation of safer products.]3)
The term “product safety” is sometimes abbreviated PS. In addition, PLP stands for “product liability
prevention”; PL alone stands for “product liability.”

*15 Global environmental protection

[Refers to environmental protection related to phenomena affecting the entire global environment or a
large part of it, such as global warming resulting from human activity, the progressing destruction of the
ozone layer, marine pollution, and reduced biodiversity. Global environmental protection contributes to
the welfare of mankind and helps citizens lead healthy and culturally fulfilling lives.] (from The Japanese
National Basic Environment law)
This term refers to protecting the earth’s environment and making it safe. As a result of growing industrialization,
which began about 250 years ago with the industrial revolution, numerous global-level environmental problems
have emerged. These include the destruction of the ozone layer, acid rain, global warming, the depletion of
resources such as fresh water and forests, desertification, air and marine pollution, and waste. Protecting the earth
and making it safe has become a pressing task for mankind, and concerted action on a global scale is urgently
required.
To protect the earth’s environment, it is important to think in broad terms about various issues, including the
adverse environmental impact of factories that emit pollutants externally, the environmental impact that occurs
during phases in which products are used and disposed of, the environments that affect people who work in an
organization, and the impact of the environment surrounding products during the manufacturing phase.

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*16 Quality policy

[Policy related to quality]5)

A quality policy is a formal expression by top management of the organization’s overall intention and direction
concerning the quality of products and services. It forms part of, or is consistent with, corporate policy and
operating policy and is a key policy for determining direction when maintaining/improving quality or
building/maintaining an ISO*23-compliant quality management system.

*17 Market in, product out

Market in: [An approach that places priority on identifying the needs of customers/society and supplying
products/services that meet those needs]2), [an activity whereby a manufacturer plans, designs,
manufactures, and sells products that meet the needs of the market]13)
Product out: [An approach whereby you sell as many of the products you have produced as you can]3)

“Market in” and “product out” are opposites. “Market in” refers to an approach whereby you consider everything
from the customer’s standpoint and make decisions and take action accordingly; “product out” refers to an
approach whereby you ignore the other person’s point of view and act with the goal of enabling the organization
to supply its products/services from a one-sided standpoint.

*18 Monitoring items (management points, control points), check items (checkpoints)

Monitoring items: [Items selected as evaluation scales for managing the achievement of objectives]6)
Check items: [Those monitoring items that are used for checking causes]3)

Monitoring items are evaluation scales used for determining whether a process is being implemented as intended
and, if not, for identifying causes and taking necessary action such as measures to prevent recurrences (see the
table in *12 for examples of monitoring items).

Monitoring items, which can be split into items for checking results (referred to as result-type monitoring items,
etc.) and items for checking causes (referred to as check items, checkpoints, cause-type monitoring items, etc.),
are used to determine numerical targets, control limits, frequency of checks, etc. Normally, managers employ
monitoring items for checking results, while rank-and-file employees use monitoring items for checking causes.

*19 Standards, standardization

Standards: [(1) Rules prescribed for the purpose of harmonization/simplification in order to ensure that
all parties involved can profit or benefit fairly. (2) Methods or things that express quantities used as
criteria prescribed to ensure universality in measurement]4)
Standardization: [Activities involving the setting and utilization of rules for facilitating common and
repeated use with the aim of ensuring effective and efficient organizational administration]1)

The goal of standardization is to prevent disorderly complexity and to achieve rational simplification and
harmonization. Standardization promotes mutual understanding and communication, ensures quality, enhances
usability, ensures compatibility, increases productivity, and promotes maintenance/improvements. Standards are of
two types: ⅰ. objects/bodies, performance, capability, layout, condition, operation, steps, methods, procedures,
duties, responsibilities, authority, approaches, concepts, etc., and ⅱ. prototype kilogram, standard hardness, etc.

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*20 Improvement (continual improvement)

[A repeatedly performed activity whereby standards for products, services, processes, systems, etc., are
set at a higher level than they are now, problems and issues are defined, and problems are solved and
tasks are achieved]1)
Improvement (Kaizen in Japanese) is a key characteristic of Japanese-style quality management. It is important to
make improvements rationally, scientifically, efficiently, and continuously based on procedures for
problem-solving (problem-solving QC stories) and task achieving (task-achieving QC stories). These are more
specific forms of the PDCA approach, which lies at the heart of Kaizen.

*21 QC story

[A basic procedure for rationally and scientifically conducting improvement activities in effective and
efficient ways based on data]2)
QC stories originated as a way to provide easy-to-understand explanations of actual examples of improvements at
meetings of Quality circles and other forums. The term derives from Quality circles. Later, QC stories became
widely recognized as an effective procedure for solving problems (problem solving method by QC approach) and
came to be used for a wide range of improvement activities, not only for presenting examples of actual
improvements. This situation continues to this day.
The QC stories used for improvement activities by Quality circles generally comprise eight steps: theme selection ,
status quo review and goal setting, analysis, countermeasure consideration, countermeasure implementation, effect
confirmation, standardization (brake of an effect standardization for effect mar), and reflection and future plan.
However, besides problem-solving QC stories like these, task-achieving QC stories have been developed as an
effective procedure for tackling the challenge of new tasks, adapting to new business operations, and making great
leaps forward. Recently, even newer forms have emerged, such as policy-implementation-type and
prevention-type QC stories.
In addition, various improvement procedures have been devised in the United States. These include the KT
method (Kepner-Tregoe method) and Six Sigma.

*22 Quality circle

[A small group for enabling frontline workers to continuously maintain, improve, and innovate the quality
of products/services or processes that relate to their work]1)

The basic philosophy of Quality circle activities comprises three elements: ⅰUnleashing the capabilities and
unlimited potential of people; ⅱ respecting humanity and creating fulfilling, cheerful workplaces; and ⅲ
contributing to the improvement and development of the company constitution. Quality circles run voluntarily.
They utilize QC approaches, techniques, etc., to foster creativity and promote self- and mutual development. The
activities of Quality circles seek to improve the abilities of their members, enabling them to achieve
self-actualization, making the workplace fulfilling, cheerful, and full of vitality, improving customer satisfaction,
and contributing to society.
Quality circle activities are one of the best-known small group improvement activities. The purpose of small
group activities, the way they are administered, and so on vary greatly depending on the organization. The forms
they take and the names used for them also vary, as they reflect these differences. Examples are JK (jishu-kanri:
self-management) activities, Kaizen activities, ZD (zero defects) programs, CFTs (cross-functional teams), and
project teams.
ZD programs, which seek to eliminate work defects, involve individual employees exercising care and ingenuity.
CFTs are put together to achieve a specific goal. Comprising members from the different departments involved in
working toward the goal, they are typically disbanded once the goal has been achieved.

*23 Standards(kikaku), Japanese Industrial Standards, international standards

Standard(kikaku): [Hyojun (standards) prescribing technical specifications relating to products. However,

“kikaku” is often used instead of hyojun, e.g. sagyo kikaku (work standards), kokka kikaku (national
standards), dantai kikaku (industry-body standards), etc.]3)

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Japanese Industrial Standards: [Japanese national standards established in accordance with the
Industrial Standardization Law]3)
International standards: [Standards that can be used by the public and have been adopted by
international bodies for standardization and standard setting]19)
Japanese Industrial Standards, which are referred to as JIS, are applied to the development, production,
distribution, and use of industrial products in sectors other than food, agriculture, and forestry.
International standards refer to standards set by such bodies as the ISO (International Organization for
Standardization) and the IEC (International Electrotechnical Commission).
The ISO and IEO are both nongovernmental organizations. The latter sets international standards in the field of
electrical and electronic engineering, while the former does the same for other fields.

*24 Inspection

[The act of determining whether one or more characteristic values concerning a product or service meets
prescribed requirements through measurement, test, comparison with a gauge, etc.]1)
Inspections are designed to prevent nonconforming items (rejected lots) from being passed on to downstream
processes or customers. They involve comparing results of measurement on the product, which have been
obtained using some sort of measurement method, with acceptance criteria to determine whether a single product
or a group of products (called a “lot”) is conforming or nonconforming and taking appropriate action based on the
results.
Inspections can be classified into various types based on method of inspection, manufacturing phase, type of
production (i.e., mass or many kinds in small quantities), location of the inspection, lot, and so on. It =is important
to consider the cost and adopt an inspection system that meets your objectives. Inspection methods include 100%
inspections, sampling inspections, and inspections without tests or measurements. In terms of inspection
characteristics, inspections can be classified as destructive, nondestructive, sensory, etc.

*25 Measurement

Keisoku (measurement/instrumentation): [In accordance with specific objectives, selecting and

implementing a method/means of quantitatively assessing an article and using the results to meet
desired objectives]11)
Sokutei (measurement): [Comparing a quantity with a standard quantity and expressing that quantity
using a figure or symbol]11)
“Keisoku” and “sokutei” have similar meanings. Measurement refers to perceiving things quantitatively. Whereas
instrumentation targets objectives, measurement is an operation unrelated to objectives. It is simply one means of
keisoku.
For example, when you use a thermometer to determine the temperature of a room, it’s sokutei; when you use a
thermometer to check whether the room temperature is appropriate or needs to be adjusted, it’s keisoku.

*26 Lot

[Definite part of a population constituted under essentially the same conditions as the population with
respect to the sampling purpose]10)
A group that is used as a unit for the production or shipping of products, components, or materials. The term “lot”
can also be used for a group of services provided under the same conditions. In the case of sampling inspections,
the lot is the bundle of products, materials, or services submitted for testing. The number of articles contained in
one lot is referred to as the “lot size.”

*27 Alternative characteristic

[Another quality characteristic that is used to perform the same or a similar assessment when it is difficult
to directly measure the required quality characteristic]2)
It is sometimes technically difficult to measure and assess a quality characteristic because doing so would

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necessitate the destruction of the object of testing, would take a long time, would cost a lot, etc. In cases like this,
the quality characteristic that you measure instead is referred to as an “alternative characteristic.”
For example, to check whether welding has been performed properly, you could try pulling the welded pieces
apart to test the strength. But doing so could result in destruction. So, instead, you might conduct ultrasonic tests
and measure the echo height or transmission pulse amplitude. Quality characteristics resulting from the translation
of linguistic information such as the Voice of Customer (VOC*4) into product/service performance requirements,
quality objectives, etc., are also alternative characteristics.
In the case of alternative characteristics, the required quality characteristics are not being directly measured. It is
therefore necessary to adequately confirm the relationship between the required quality characteristics and the
alternative characteristics.

*28 Process

Process: [Set of interrelated or interacting activities that use inputs to deliver an intended result]5)
Kotei (process): [The source of the creation of products or services]10)
A process is an activity whereby you obtain the materials, information, energy, etc. that will form the basis for the
output, add value to them, and produce them as output. This activity is performed using management resources
such as people, equipment, technology, know-how, and money. The definition, “a series of interrelated or
interacted activities for converting inputs into output” indicates a group of actions, each of which has its own role
to play in achieving a specific objective.
The concept of a “kotei” originated in the manufacturing field, then began to be used in the fields of clerical works,
sales, and service. But people in these fields were unfamiliar with it, so the term “process” came to be widely used
instead. In the business world, process and kotei are regarded as synonymous. They refer to all the steps through
which factors*36 such as the 4M (man, machine, material, and method) that affect the various characteristics of
products/services interact with each other over time to produce the final output. It is important to strive for high
quality by identifying important factors in a process (kotei), restricting variation*8 in these important factors, and
making them the target for maintenance, improvement, and innovation.

*29 Observed value (measured value)

[Obtained value of a property associated with one member of a sample]9)

[The characteristic values of a sample obtained by performing observations for a prescribed period
under prescribed conditions]12)
The value for a characteristic of an article obtained as a result of a single measurement. Examples are the size,
weight, and strength of a component. The term “measured value” is used synonymously with “observed value.”

*30 Data (numerical data, linguistic data)

[Information gathered for a specific purpose]3)

There are various types of data, including numerical data, which are expressed as figures, and linguistic data,
which cannot be expressed as figures.
Numerical data is typically divided into two categories, continuous and attribute. Continuous data comprises
values obtained by measurement using some sort of benchmark and is usually used in conjunction with a unit (kg,
m, etc.). It is a continuous quantity (i.e., it is connected in the form of an infinite chain with no points of
separation). Attribute data, meanwhile, comprises values obtained by counting. It is expressed using integers (i.e.,
whole numbers that are counted in the order of 1, 2, 3, etc.). Examples would be numbers of people, numbers of
sheets of paper, or numbers of nonconforming items. It is a discrete quantity (i.e., only discrete numbers exist).
This means that when, for example, the number of nonconforming items is divided by the number of products
manufactured (to calculate the proportion of products that are nonconforming), the denominator and numerator
consist of attribute data (i.e., discrete numbers). The data obtained as a result is basically discrete numbers and
treated as attribute data even if the quotient is not an integer. In addition, items arranged in order based on some
sort of criteria such as quality or size, which are given a score or a rank, are also treated in a similar way as
numerical data.

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Linguistic data, on the other hand, is data that is expressed using words instead of figures. If the article or
phenomenon concerned is perceived using human senses, and described using adjectives such as being beautiful,
large, happy, etc., it is called sensibility data. If the article or phenomenon concerned is simply given a specific
name, such as bird, cat, or moon, to distinguish it, explain it, or classify it, it is called nominal data. So there are
various types of linguistic data. Some people are under the impression that compared with numerical data,
linguistic data is less objective and not particularly useful, but it is important to understand that the Voice of
Customer (VOC*4), is valuable linguistic data that shows what the market actually thinks about the quality of
products/services and therefore provides us with a lot of useful information. It takes the form of expressions such
as “this camera is easy to use,” “this television has a great picture,” and “this cake is sweet” that describe how the
product/service feels to use, its design, its color, and so on.

*31 Characteristic

[Distinguishing feature]5)

There are various types of characteristic, including ones that can be expressed numerically and ones that can’t,
such as noncontiguous changes in an attribute. Examples of types are functional (e.g. distance flown by an
aircraft), behavioral (e.g. politeness, directness, honesty), sensory (e.g. smell, touch, taste, sight, and hearing),
temporal (e.g. accuracy of time, reliability), material (e.g. mechanical, electrical, chemical, biological), and
ergonomic (e.g. matters relating to human safety).

*32 Sample, sampling, sampling units, sample size

Sample: [Subset of a population made up of one or more sampling units]10)

Sampling: [Act of drawing or constituting a sample]10)
Sampling units: [one of the individual parts into which a population is divided]10)
Sample size: [Number of sampling units in a sample]10)

In the case of discrete items, it is the number of products in the sample. If the sample is obtained from a liquid,
powder, etc., it is the number of sampling units taken.

*33 Population, population size

Population: [Totality of items under consideration9)

Population size: [The number of sampling units contained in the population]10)

The term “population” normally refers to the object to which action is going to be applied based on the sample. In
the case of a sampling inspection, the inspected lot is the population, and when a sample is taken from a process in
order to manage it, the process is the population.

The former is described as a finite population because the number of samples contained in the population is
limited, whereas the latter is described as an infinite population because as long as production isn’t suspended, an
unlimited number of samples can be obtained. Sometimes, the term “infinite population” is used to describe a
population of unlimited size that cannot be restricted, and the term “finite population” is used to describe a
situation in which the number of objects is limited.

In addition, the term subpopulation is sometimes used for a group defined as part of the population.

*34 Sum of squares, variance

Sum of squares: [The sum of the squared difference between each the mean]15)
Variance: [Moment of order r where r equals 2 in the centred probability distribution of the random
variable]9)

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The sum of squares is calculated by taking the difference (deviation) between each measured value and the mean,
squaring it, and adding them all together. It shows how much variation there is in the measured values. Obviously,
if the set of measured values obtained (i.e., the sample) changes, the sum of squares will also change, as it is based
on those measured values. It therefore changes stochastically.

Regarding the variance, as you can see from the definition above, it is not calculated directly from the measured
values. It refers to the “value that would be expected if the test were performed an infinite number of times” and is
determined based on the nature of the population. This means that when you don’t know the nature of the
population, the variance is unknown. If you want to know what it is, all you can do is take a sample from the
population and make an estimate based on that. In such cases, it is known that if you take n measured values from
the population, calculate the sum of squares, divide it by n – 1, and use that value, the estimate of the variance will
not be biased. This is known as the “unbiased variance.” Obviously, the unbiased variance changes stochastically
based on the sample taken.

Note that as long as it doesn’t lead to confusion, the unbiased variance is often simply referred to as the
“variance.”

*35 Standard deviation

[A scale of the degree of dispersion in the data]3)

The difference between individual measured values and the mean is referred to as the “deviation.” It constitutes
basic information for expressing the degree of dispersion in the data. However, if the deviations are summed, the
net result is ±0 (zero). Because of this, the deviations are squared and averaged to provide a scale of dispersion.
The square of the deviation is known as the “squared deviation,” and the total of the squared deviations for all the
measured values is known as the “sum of squared deviations” (S). Dividing that by n – 1 gives the “unbiased
variance” (V), and the square root of this is the “standard deviation” (s). Because the standard deviation is the
square root of the unbiased variance, the scale for dispersion is aligned with the dimension of the measured
values.

Some of you may be wondering why we divide by n – 1 instead of n when averaging the squared deviation. The
reason is that dividing by n – 1 can be expected to produce a value that is closest to the variance of the population
as a whole (called the “population variance”). The structure of the formula means that the smaller dispersion there
is in the data, the smaller the standard deviation will be.

The true variance of the population, which is known theoretically, and the variance of the population as a whole
are referred to as “population variance” (written as σ2 and pronounced “sigma squared”), and the standard
deviation thereof is referred to as “population standard deviation” (written as σ and pronounced “sigma”).

*36 Factor, cause/root cause

Factor: [(1) Something that may result in a certain phenomenon or a variable that is likely to influence the
outcome (2) A variable that is the object of an experiment or discussion]1)
Cause/root cause: [(1) A source from which a certain thing happens (2) A factor that has been
determined as the cause of a certain phenomenon. Note: Definition (2) is useful for problem solving.]1)

The terms “factor” and “(root) cause” have similar meanings, and in everyday life hardly any distinction is made
between them, so please make sure you are aware of the difference between them in the context of quality
management. The term “factor” is used to mean something that influences or may influence the outcome, so it has
the same meaning in both everyday life and in a quality management context. However, in a quality management
context a clear distinction is made between a “factor” and a “(root) cause.” Something that may influence the
outcome is referred to as a “factor,” while “(root) cause” refers to a factor that has a clear cause-and-effect
relationship with the outcome.

*37 Brainstorming

[A technique for considering matters as a group that is aimed at developing creativity. It is a method
whereby people at a meeting express their opinions and thoughts freely in order to extract good ideas]17)

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Brainstorming, sometimes abbreviated as BS, is a method of “triggering a storm in the brain” developed by A. F.
Osborn in the United States. It's frequently used at meetings such as Quality circle meetings and as a means of
generating ideas. Normally, five to ten people get together and follow four rules: don’t say whether an idea is good
or bad (withhold criticism), encourage the free expression of ideas (welcome wild ideas), encourage people to
express a large number of ideas (go for quantity), and take advantage of other people’s ideas (combine and
improve ideas).

*38 Subgroup

[A block forming part of a process classified temporally according to the order of production, e.g., day,
work shift, processing lots]3)

Blocks constitute a process that has been broken down temporally so that the elements of the process have
comparatively uniform conditions. To form a subgroup rationally, it is important to assume that variation within
the block (referred to as “within subgroup variation”) is the result of a chance cause and that variation between
blocks (referred to as “between subgroup variation”) can be detected and is due to an important, assignable cause.

In an X  R control chart, the size of the subgroup (n is usually used for the number of observed values in a
subgroup) is often n = 2, 4, 5, and is normally written at the top left of the X control chart. So the size of the
subgroup in the X  R control chart in Figure 2.11 (p.22) is n = 5.

*39 Out of control signal

This is used as a criterion for determining whether or not a process*28 is out of control using a control chart.

On rare occasions, even if the dots on a control chart are within the control limit lines, the way the dots are
arranged or scattered cannot be considered normal. This means the process is out of control. For example, when
the control limit lines lie ±3 standard deviations from the centre line, if the dots are continuous and 9 dots are on
the same side of the centre line, if 6 dots (including both sides) are increasing or decreasing, if 14 dots are
increasing and decreasing alternately, if 2 out of 3 dots are within ±2 and ±3 standard deviations, if 4 out of 5 dots
are beyond ±1 standard deviation, if 15 dots are within ±1 standard deviation of the centre line, if 8 dots are not
within ±1 standard deviation, etc., you must suspect an abnormality in the process.

*40 Assignable cause/Special cause

[A causal factor that can be detected and identified as the cause of a change in a quality characteristic or
process level]10)

An assignable cause is a cause of a change in a characteristic or process level that can be identified and eliminated
or that must be eliminated. Assignable causes are also described as “causes that cannot be ignored,” “causes with
reasons,” and “avoidable causes.” If the assignable cause is in the process, the dots on the control chart will be
outside the control limit lines, or there will be some sort of out of control signal in the way they are arranged or
scattered.

Chance cause/Common cause/Random cause

[A causal factor that is a cause of variation. Normally, there are many of them, but they are relatively
unimportant. They have not necessarily been identified, but even if they have been, it is difficult for
technical or economic reasons to eliminate them.]10)

A chance cause is a cause that is difficult to identify and eliminate or the elimination of which is pointless. Chance
causes are also described as “unavoidable causes.”

To ensure that a process can maintain quality at a certain level, it is important to decide whether change is an
unavoidable variation*8, which is always occurring, or variation that is the result of a cause that is unusual and
cannot be ignored. In the case of the former (chance cause), no special action needs to be taken; in the case of the
latter, the cause must be pinpointed and eliminated. By performing such activities on a continuous basis, it is
possible to ensure the stability of processes.

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 Chapter 4 Explanation of terminology

*41 Outlier

[An observed value in a group of observed values so different from the other observed values that it may
have come from a separate population or may be the result of measurement error.]9)

*42 Kiken yochi katsudo (KYK) (hazard prediction activity), kiken yochi training (KYT)

Kiken yochi katsudo (KYK) is a safety management tool for eradicating accidents. It includes such activities as
workers themselves identifying work-related hazards that are hidden in the workplace and eliminating them before
they result in an accident. KYK improves the ability to predict accidents (kiken yochi) as well as the ability to
focus on safe work procedures. This makes work safer and ensures that workers don’t have accidents. The term is
often abbreviated to “KYK” or “KY activities.”

KYK is useful for many things. It sharpens individuals’ sensitivity to dangers, promotes a shared awareness of
unseen dangers residing in work practices, fosters teamwork based on the notion that “we protect our safety by
ourselves,” and gets everyone to voluntarily abide by rules that they have discussed and agreed on together.

KYK is often performed close to the work frontline and comprises four rounds: status quo grasping, investigation
of the essence, formulation of measures, and goal setting. It is often bundled in with the pointing and calling
method, and touching and calling activities that are performed before starting work and at the end of work.

Kiken yochi training (KYT) refers to education and training in safety management for the purposes of properly
performing KYK. It is often abbreviated “KYT.”

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 Index

Numbers control chart 19, 22, 43 Ho-Ren-So 27

100% inspection 14 control limit 22 human error 32
300 campaigns 32 cost 9, 35 I
5-gen-shugi 29 CS 6 ideal state 7, 34
5W1H 10, 27, 28 current state 7 IEC 39
5W2H 28 customer 6, 8, 33 imprecision 34
customer satisfaction 6 improvement 12, 38
A
D improvement activity 10, 12
A (Act) 8, 11, 35
accepted 14 D (Do) 8, 10, 35 incident 32
Act 8, 11, 35 data 16, 17, 40 in-process inspection 14
actual article 29 decision based on facts 16 input 15, 40
actual place 29 delivery 8, 9, 35, 36 inspect 11
alternative characteristic 14, delivery inspection 14 inspection 14, 15, 39
39 destructive inspection 14 inspection without
articulating goal 10 dispersion 17, 18, 19 measurement or test 14
assess 11 Do 8, 10, 35 interface 15
assignable cause 22, 43 downstream process 15 intermediate inspection 14
attribute data 16, 40 E international standards 39
E (environment) 9, 35 ISO 37, 39
B
environment 31, 35 issue 7, 34
brainstorming 20, 42
issue achieving 7, 34
BS 43 F
J
C factor 42
final inspection 14 Japanese Industrial Standards
C (Check) 8, 11, 35
fitness for use 6 19, 39
cause 20, 42
5M 15 JIS 19, 39
cause and effect diagram 19,
5S 31 judgement 14
20
4M 15, 20 K
centre line 22
chance cause 43 4S 31 Kaizen 12, 38
characteristic 16, 20, 41 furyohin 35 keisoku 14, 39
Check 8, 11, 35 G kikaku 38
check item 11, 37 Genba 29 kiken yochi katsudo 32, 44
check sheet 19, 23 Genbutsu 29 Kiken yochi training 32, 44
checking 11 Genjitsu 29 KY activity 32, 44
CL 22 Genri 29 KYK 32, 44
claim 35 Gensoku 29 KYT 44
classification 25 global environmental protection L
complaint 8, 35 9, 36 LCL 22
compliance 30 graph 19, 22 linguistic data 19, 40
confirm 11 H lot 14, 39
conforming item 14 hazard prediction activity 32, lower limit of specification 21,
consult 27, 28 44 25
contact 27, 28 health and safety 31 M
continual improvement 12, 38 Heinrich’s Law 32 M (morale/morality) 9, 35
continuous data 16, 40 histogram 19, 21, 25 machine 15

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 Index

maintenance activity 10 pointing and calling method rejected 14

man 15 32, 44 report 27
management activity 10 population 16, 41 reporting, contacting, and
management cycle 11, 12, 35 population mean 41 consulting 27
manners 29 population size 41 required state 7
market in 9, 37 priority oriented approach 13, root cause 20, 42
material 15 19 rules of employment 29
maximum value 18, 21 problem 7, 34 S
mean 18, 21 problem solving 7, 34 s 19, 21, 42
measured value 16, 40 problem solving method by QC S 19, 42
measurements 39 approach 38 S (safety) 9, 35
median 18 problem-solving procedure 12 safety 9, 35
method 15 problem-solving QC story 13, safety first 10, 32
minimum value 18, 21 34, 38 sample 16, 17, 41
monitoring item 11, 35, 37 process 15, 22, 26, 40 sample size 17, 41
morale/morality 9, 35 product 6, 33 sampling 17, 41
Muda 9 product liability 36 sampling inspection 14
Mura 9 product liability prevention sampling unit 41
Muri 9 36 sangen-shugi 29
N product out 9, 37 scale 11, 18
n 21 product safety 9, 36 scatter diagram 19, 24, 26
national standards 39 productivity 9, 35 SDCA 10, 11, 12, 14, 35
near-miss activity 32 purchasing inspection 14 sensory inspection 14
next process 15 Q service 6, 33
nonconforming item 8, 14, 35 QC seven tools 19, 26 seven management tools for QC
nonconformity 8, 15, 35 QC story 12, 38 (N7) 19
non-numerical data 17 QCD 9, 35 SL 25
numerical data 16, 17, 40 QCD + PSME 8, 9, 35 small group improvement
O qualitative data 17 activity 13, 38
objective/target 10 quality 6, 8, 33, 35 sokutei 39
observed value 16, 40 Quality circle 38 standard 11, 13, 37, 38
occupational health and safety Quality circle activity 13, 38 standard deviation 19, 21, 42
9, 36 quality control 2, 34 standardization 11, 13, 37
out of control signal 22, 43 quality first 9 standardize 35
outlier 24, 44 quality in the broad sense 9 statistics 18
output 10, 15, 40 quality management 7, 34 stratification 17, 19, 24, 25,
quality management activity 7 26
P
quality orientation 9 stratum 24
P (Plan) 8, 10, 35
quality policy 9, 37 SU 25
P (productivity) 9, 35
quantitative data 17 subgroup 22, 43
Pareto analysis 13
quantity 9 subpopulation 24, 41
Pareto diagram 13, 19
R substitute characteristic 39
Pareto principle 13
R 18, 19, 21, 34 sum of squares 19, 41
PDCA 8, 10, 12, 35
random 17 supremacy of quality 9
PDCA cycle 8, 10, 11, 35
random sampling 17 T
PL 36
Plan 8, 10, 35 range 18, 19, 21, 34 targetted quality 7
plan–do–see 35 reality 29 task achieving 7, 34
PLP 36 receiving inspection 14 task-achieving QC story 13,

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 Index

34, 38
tests 14
The next processes are our
customers 15, 33
U
UCL 22
upper limit of specification 21,
25
upstream process 15
V
V 19, 42
variance 19, 41
variation 7 16, 34
VOC 7, 34, 41
Voice of Customer 7, 34
X
~
x 18
x 18, 21
X  R control chart 22
xmax 18, 21
xmin 18, 21
Z
zero disasters 32
Σ
σ 42
Σ 18

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 Citations and Reference Literature
1） 日本の品質を論ずるための品質管理用語 85 日本品質管理学会標準委員会編（2009）、日本規格
協会
2） 日本の品質を論ずるための品質管理用語 Part2 日本品質管理学会標準委員会編（2011）
、日本規
格協会
3） クォリティマネジメント用語辞典 編集委員長 吉澤 正（2004）
、日本規格協会
4） JIS Z 8101：1981（1999 年廃止） 品質管理用語
5） ISO 9000：2015 Quality management systems -- Fundamentals and vocabulary
6） JIS Q 9023：2003 マネジメントシステムのパフォーマンス改善－方針によるマネジメントの指
針
7） JIS Q 9024：2003 マネジメントシステムのパフォーマンス改善－継続的改善の手順及び技法の
指針
8） JIS Q 9025：2003 マネジメントシステムのパフォーマンス改善－品質機能展開の指針
9） ISO 3534-1：2006 Statistics -- Vocabulary and symbols -- Part 1: General statistical terms and terms used
in probability
10） ISO 3534-2：2006 Statistics -- Vocabulary and symbols -- Part 2: Applied statistics
11） JIS Z 8103：2000 計測用語
12） JIS Z 8115：2000 ディペンダビリティ（信頼性）用語
13） JIS Z 8141：2001 生産管理用語
14） JIS Z 8144：2004 官能評価分析－用語
15） JIS Z 9041-1：1999 データの統計的な解釈方法－第 1 部：データの統計的記述
16） OHSAS 18001：2007 労働安全衛生マネジメントシステム 日本語版と解説、日本規格協会
17） 広辞苑 第六版 新村 出 編（2008）
、岩波書店
18） 大辞林 第三版 松村 明 編（2006）
、三省堂
19） ISO/IEC Guide 2：2004 国際規格の構成及び原案作成の規則
20） 新版 QC 入門講座 5「データのまとめ方と活用Ⅰ」鐵 健司 編（2000）
、日本規格協会
21） 新版 QC 入門講座 8「統計的検定・推定」鐵 健司 編（2000）
、日本規格協会
22） 新版 品質管理便覧 第 2 版 朝香鐵一・石川 馨・山口 襄 共同監修（1988）
、日本規格協会
23） リニューアル版 やさしい QC 七つ道具 細谷 克也 編、石原 勝吉・廣瀬 一夫・細谷 克也・
吉間 英宣 共著（2009）
、日本規格協会
24） 土屋 昌弥（1980）
：体験談 1、大袋シール不良防止、FQC、No.214

First edition published on February 3, 2015

Complied by: Steering Committee for the Quality Management and Quality
Control Examination
Contact: QC KENTEI Center, Japanese Standards Association
Mita MT Bldg., 3-13-12, Mita, Minato-ku, Tokyo 108-0073
Tel.: 03-4231-8595
http://www.jsa.or.jp/

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