Unit 1 

Quality Concepts {Book}

Evolution of Quality Management

Evolution of Quality Management

Quality management has been a part of many different cultures throughout history. It is nothing new and
can be traced as far back as 2000 BC in Babylonia. King Hummurabi of Babylon introduced the concept
of product quality and liability into the building industry of the times. In the time of Egyptian pharaohs,
the burial of the nobility was documented systematically. The manner of carrying out the necessary rituals
and the funerary goods to be buried with the deceased are stated in each Book of the Dead. A systematic
document is one of the fundamentals in quality management to ensure consistency. The same steps will
be followed by different persons performing the same task. In doing so, the deviation from the
requirements can be minimized.

The first Emperor of China, Qin Shi Huangdi, decreed that all goods supplied for use in the imperial
household should carry a mark so that any maker who produced goods with faults could be traced and
punished. During the Middle Ages, merchant guilds were established to guarantee the quality of
workmanship and to define the standards to be expected by the buyers. The emergence of mass
production in the twentieth century increased the demand of control of product quality. In addition, the
demand of consistency in ammunition in war times pushed the need for more stringent product quality. If
we look back at this brief history of the development of quality management, it can be seen that we have
gone through various phases from quality control to quality assurance and ultimately to total quality
management.

(i) Quality Control

Quality control is basically concerned with complying with requirements by inspecting the products and
eliminating nonconforming items. It does not address the root causes of nonconforming. This type of
control was developed during World War II to ensure the consistency of ammunition being produced.

(ii) Quality Assurance

Similar to quality control, quality assurance originated from the military’s need for consistency of
military hardware. The success of Japanese manufacturers during the 1960s and 1970s shifted the focus
from quality control to quality assurance. In comparison to quality control though, quality assurance
focuses on the procedure of compliance and product conformity to specification through activities such as
vendor appraisal, line or shop floor trouble shooting, laboratory work, field problems and method
development in the production process. However, quality assurance is still basically an inspection
process, though it checks more than just the product.

(iii) Total Quality Control

Total quality control is an expansion of quality control from manufacturing to other areas of an
organization. The concept was introduced by the American scholar Dr Armand Feigenbaum in the late
1950s. The Japanese adopted this concept and renamed it as company-wide quality control (CWQC). It
tries to look for long term solutions rather than responding to short term variations. It focuses on pursuit
of quality through elimination of waste and non-value-added process. Also, the concept is to expand
quality control beyond the production department. Quality control should be covered all the other
departments of an organization such as marketing, design, accounting, human resources, logistics and
customer services. Quality is not just the responsibility of production.

(iv) Total Quality Management (TQM) 

Total quality management (TQM) evolved from the Japanese after World War II with the inspiration from
quality experts like Juran and Deming. As it evolved, it changed from process driven by external controls
to a customer oriented process. Quality is achieved through prevention rather than inspection. It shifts the
main concept from control to management. No matter how stringent the control there is still a chance to
have mistakes or defectives. The concept of management is to have a strategic plan starting from
identifying customer requirements to after-sales services to producing product meetings or exceeding the
customer requirements.

From the evolution of quality management, we can also identify some key attributes of quality. We start
by producing product in a consistent manner by meeting the necessary requirements. It is important to
trace and isolate defective items preventing further usage. If it is found that a certain batch of products has
safety problems after being sold in the market, it is important that it can be identified and recalled. Means
are developed to control quality at the initial stage.

This is primary achieved through inspection. Later, the scope was shifted to quality assurance. That is,
mechanisms are developed to ensure the production process conforms to the requirements of producing
good products. The concept of control was extended beyond the production department to include all
departments of an organization. To deliver quality product, it requires cooperation and integration of all
departments. If the logistics department does not ship the products on time, the customer will not be
happy. At the final stage, quality should not rely on control only. Quality is built upon by customer focus,
defect prevention and so on. This is total quality management.

Concepts of Product and Service Quality

It is not easy to define the word Quality since it is perceived differently by the different set of
individuals. If experts are asked to define quality, they may give varied responses depending on their
individual preferences. These may be similar to following listed phrases.

According to experts, the word quality can be defined either as;

 Fitness for use or purpose.

 To do a right thing at first time.
 To do a right thing at the right-time.
 Find and know, what consumer wants?
 Features that meet consumer needs and give customer satisfaction.
 Freedom from deficiencies or defects.
 Conformance to standards.
 Value or worthiness for money, etc.
Product Quality
“Product quality means to incorporate features that have a capacity to meet consumer needs (wants) and
gives customer satisfaction by improving products (goods) and making them free from any deficiencies or
defects.”

Meaning of Product Quality

Product quality mainly depends on important factors like:

(i) The type of raw materials used for making a product.

(ii) How well are various production-technologies implemented?

(iii) Skill and experience of manpower that is involved in the production process.

(iv) Availability of production-related overheads like power and water supply, transport, etc.

Product quality has two main characteristics viz; measured and attributes

1. Measured characteristics

Measured characteristics include features like shape, size, color, strength, appearance, height, weight,
thickness, diameter, volume, fuel consumption, etc. of a product.

2. Attributes characteristics

Attributes characteristics checks and controls defective-pieces per batch, defects per item, number of
mistakes per page, cracks in crockery, double-threading in textile material, discoloring in garments, etc.

Based on this classification, we can divide products into good and bad.

So, product quality refers to the total of the goodness of a product.

(i) Quality of design: The product must be designed as per the consumers’ needs and high-quality
standards.

(ii) Quality conformance: The finished products must conform (match) to the product design
specifications.

(iii) Reliability: The products must be reliable or dependable. They must not easily breakdown or
become non-functional. They must also not require frequent repairs. They must remain operational for a
satisfactory longer-time to be called as a reliable one.
(iv) Safety: The finished product must be safe for use and/or handling. It must not harm consumers in any
way.

(v) Proper storage: The product must be packed and stored properly. Its quality must be maintained until
its expiry date.

Importance of Product Quality

Image depicts importance of product quality for company and consumers.

(i) For Company: Product quality is very important for the company. This is because, bad quality
products will affect the consumer’s confidence, image and sales of the company. It may even affect the
survival of the company. So, it is very important for every company to make better quality products.

(ii) For Consumers: Product quality is also very important for consumers. They are ready to pay high
prices, but in return, they expect best-quality products. If they are not satisfied with the quality of product
of company, they will purchase from the competitors. Nowadays, very good quality international products
are available in the local market. So, if the domestic companies don’t improve their products’ quality,
they will struggle to survive in the market.

Dimensions of Quality

Dimensions of Quality
Important Dimensions of Quality formulated by David A. Garvin

David A. Garvin, a specialist in the area of quality control, argues that quality can be used in a strategic
way to compete effectively and an appropriate quality strategy would take into consideration various
important dimensions of quality

Eight dimensions of product quality management can be used at a strategic level to analyze quality
characteristics. The concept was defined by David A. Garvin, formerly C. Roland Christensen Professor
of Business Administration at Harvard Business School (died 30 April 2017). Some of the dimensions are
mutually reinforcing, whereas others are not—improvement in one may be at the expense of others.
Understanding the trade-offs desired by customers among these dimensions can help build a competitive
advantage.

Garvin’s eight dimensions can be summarized as follows:

1. Performance

It involves the various operating characteristics of the product. For a television set, for example, these
characteristics will be the quality of the picture, sound and longevity of the picture tube.

2. Features
These are characteristics that are supplemental to the basic operating characteristics. In an automobile, for
example, a stereo CD player would be an additional feature.

3. Reliability

Reliability of a product is the degree of dependability and trustworthiness of the benefit of the product for
a long period of time.

It addresses the probability that the product will work without interruption or breaking down.

4. Conformance

It is the degree to which the product conforms to pre- established specifications. All quality products are
expected to precisely meet the set standards.

5. Durability

It measures the length of time that a product performs before a replacement becomes necessary. The
durability of home appliances such as a washing machine can range from 10 to 15 years.

6. Serviceability

Serviceability refers to the promptness, courtesy, proficiency and ease in repair when the product breaks
down and is sent for repairs.

7. Aesthetics

Aesthetic aspect of a product is comparatively subjective in nature and refers to its impact on the human
senses such as how it looks, feels, sounds, tastes and so on, depending upon the type of product.
Automobile companies make sure that in addition to functional quality, the automobiles are also
artistically attractive.

8. Perceived quality

An equally important dimension of quality is the perception of the quality of the product in the mind of
the consumer. Honda cars, Sony Walkman and Rolex watches are perceived to be high quality items by
the consumers.

Quality Philosophies; Deming’s

Quality Philosophies: Deming’s

Deming’s 14 Points on Quality Management, or the Deming Model of Quality Management, a core
concept on implementing total quality management (TQM), is a set of management practices to help
companies increase their quality and productivity.
As a management consultant, William Edwards Deming is known for the so-called PDCA (Plan-Do-
Check-Act) Circle. Herein he emphasizes the importance of continuous improvement within an
organization, as opposed to making changes after the fact.

Deming’s 14 points for Management were first presented in his book Out of the Crisis. With the 14
important management principles he offered a way to drastically improve the company’s effectiveness.
Many of these management principles are philosophical in nature, and some are more programmatic.

1. Create constancy of purpose

Strive for constant improvement in products and services, with the aim of becoming competitive and
ensuring consistency in the way business is done, which will ensure retention of employment. Do not just
make adjustments at the end of the production process, but evaluate if improvements are necessary during
the process and get started immediately.

2. The new philosophy

A new (economic) time offers new chances and challenges, and management must take responsibility for
being open to such changes. Without change, a company can not sustain itself in a time when innovation
occurs every day.

3. Cease dependence on inspection

End the dependence on inspections and final checks to ensure quality. It is better to that quality checks
take place during the process so that improvements can be made earlier. This section links back to the
first point, which promotes the importance of interim improvements.

4. End ‘lowest tender’ contract

Move towards a single supplier for any one item. Stop doing business and negotiate with suppliers based
on the lowest price. It is worthwhile in the long term to build a good and long-standing relationship with
suppliers, which fosters trust and increases loyalty. An organization should be able to rely on their
suppliers; they supply the parts for the production line and are the first link to a high quality product.

5. Continually seek out problems

Improve constantly and forever. Continuous process improvement of production and service results in
improved quality and productivity, which in turn leads to cost reduction. This part also relates to the first
and third points. Improved quality leads to less waste of other raw materials, which subsequently has a
cost-effective effect.

6. Institute training on the job

Training and development of employees is necessary for the survival of an organization. By integrating it
into the organization, it will be considered as normal for the employees, as part of their Personal
Development Plan.
 7. Institute supervision

Adopt and institute leadership. Leadership needs to be stimulated. By leading and supervising, managers
are able to help employees and make machines work better. Their helicopter view ensures that they can
see everything that happens on the workplace. They will also have to delegate more tasks so that they can
fully focus on the big picture.

8. Drive out fear

Fear is paralysing. Therefore, fear must be eliminated on the work floor so that everyone can work
effectively for the company, feel safe and take risks. Transparent communication, motivation, respect and
interest in each other and each other’s work can contribute to this.

9. Break down barriers

By eliminating the boundaries between departments, cooperation can be better and different expert teams
will understand each other better. This can be done by, for example, the creation of multifunctional teams,
each with an equal share and open to each other’s ideas.

10. Eliminate exhortations

Remove ‘stimulating’ slogans from the workplace. Such slogans, warnings and exhortations are perceived
as being patronising. Quality and production problems do not arise from the individual employee, but
from the system itself.

11. Eliminate targets

No more focus on achieving certain margins; that impedes professionals from performing their work well
and taking the necessary time for it. Rushing through the work can cause production errors. Managers
should therefore focus on quality rather than quantity.

12. Permit pride of workmanship

Let employees be proud of their craftsmanship and expertise again. This relates back to the eleventh
point. Employees feel more satisfaction when they get a chance to execute their work well and
professionally, without feeling the pressure of deadlines.

13. Institute education

Integrate and promote training, self-development and improvement for each employee. This directly
connects to the sixth point. By encouraging employees to work for themselves and to see their studies and
training as a self-evident part of their jobs, they are able to elevate themselves to a higher level.

14. The transformation is everyone’s job

Transformation is the work of everyone. Set forth concrete actions to implement and realise
transformation and change throughout the organization.

Quality Philosophies; Juran’s

Juran was a great Founding Father of quality, and was responsible for the famous Juran Trilogy concept.
Juran’s approach to quality control had Japanese roots. While Japan was price-competitive with the rest
of the world, the quality of product did not measure up. This quality philosophy consists of three steps:
Quality Planning, Quality Control and Quality Improvement.

1. Quality Planning

 The quality planning phase is the activity of developing products and processes to meet customers’
needs.  Involves building an awareness of the need to improve, setting goals and planning for ways goals
can be reached. This begins with management’s commitment to planned change. It also requires a highly
trained and qualified staff. It deals with setting goals and establishing the means required to reach the
goals. Below are the steps in the quality planning process:

 Establish quality goals

 Identify the customers: those who will be impacted by the efforts to meet the goals
 Determine the customer’s needs
 Develop processes that can produce the product to satisfy customers’ needs and meet
quality goals under operating conditions.
 Establish process controls, and transfer the resulting plans to the operating forces

(ii) Quality Control

 This process deals with the execution of plans and it includes monitoring operations so as to detect
differences between actual performance and goals. means to develop ways to test products and services
for quality. Any deviation from the standard will require changes and improvements. It is outlined with
three steps:

 Evaluate actual quality performance

 Compare actual performance to quality goals
 Act on the difference

(iii) Quality Improvement

 It is a continuous pursuit toward perfection. Management analyses processes and systems and reports
back with praise and recognition when things are done right this is the process is for obtaining
breakthrough in quality performance, and it consists of several steps:

 Establish the infrastructure needed to secure annual quality improvement

 Identify the specific needs for improvement- the improvement projects
  Establish project teams with clear responsibility for bringing the project to a
successful conclusion
 Provide the resources, motivation, and training needed by the teams to- diagnose the
cause, stimulate establishment of remedies, and establish controls to hold the gains.

Crosby’s Quality Philosophy

The 14 Steps of Crosby – Philip Crosby, not Bing Crosby – formulate a program for Total Quality
Management efforts. Crosby’s fourteen steps rely on the foundational thought that any money a company
spends upon quality improvement is money that is well-spent. In Crosby’s theory, he cites four absolutes
of quality management:

A company ought to define quality not as something that is “good” or something that is “exquisite” but
instead as something that conforms to company, stakeholder, or end-user requirements.

Quality starts with prevention – defects should be prevented rather than found after the fact. By
preventing defects and other obstacles to quality, companies save money.

The standard for performance for any company needs to be “zero defects.” Otherwise, it just doesn’t cut
it.

In order to measure quality, rather than relying upon intricate indices, companies need to focus on the
Price of Non-conformance. The price of non-conformance, sometimes called the cost of quality, is a
measure of the costs associated with producing a product or service of low quality.

The 14 Steps of Crosby are meant to keep your quality improvement project on track.

1. Commitment of Management

First and foremost, management must be committed to improving the quality in a company. This
commitment must also be transparent to all employees so that proper attitudes towards a Zero Defect
product or service line are modeled.

2. Formulate the Quality Improvement Team

Forming a quality improvement team is the second step to achieving total quality management. Search for
team members who will model quality improvement commitment, and who are not already over-
committed to other projects. The quality improvement team should be able to effectively commit
themselves to improvement of quality.

3. Measure for Quality in Current Practices

Before you can establish a plan for improving quality, you first have to know exactly where your products
and services lie when it comes to conforming to requirements. Thus, the third step on Crosby’s list is to
measure quality. Determine where there is room for improvement and where potential for improvement
exists.
 4. What Will the Cost of Quality Be?

How much is your cost of non-conformance to standards? What is the cost for quality? By answering
these questions, you can demonstrate to all company employees that there is a need for a quality
improvement system. Explain how the cost of quality figures into the overall company plan.

5. Quality Awareness is Central to Success

You will need to raise employee awareness to the importance of quality management. By doing this, and
making quality a central concern to employees, you will increase the likelihood that your quality
improvement efforts will be realized.

6. Remember the Quality Problems? Take Corrective Action

By now, you will have determined what your company’s quality problems are. It is now time to take
corrective action to eliminate the defects that have been identified. Be sure that you install a system, using
causal analysis techniques, to ensure that these problems don’t reoccur in the future.

7. Plan for Zero Defects

You need to create a committee to ensure that there are zero defects in your products and services. For
Crosby, it’s not enough, remember to have “as few as possible” defects. Instead, you really need to have
this number at zero – establish a zero-defect tolerance in your company.

8. Practice Effective Training for Supervisors

Ensure that your supervisors can carry out the tasks required of them for maintaining quality. By
practicing supervisor training, with quality in mind (and the four absolutes), then you will be more likely
to acheive zero-defect status.

9. Happy Zero Defects Day!

Hold a quality event, called a zero defects day, where all employees are made aware of the change that
has taken place. By holding a zero defects day in your company when implementing a total quality
management project, you can be sure that you are increasing awareness for quality in your workplace.

10. Involve Everyone in Goal Setting

After implementing a change, you will need to ensure that you involve everyone – both employees and
supervisors – in the goal setting process. By bringing everyone in the company in on setting goals for
improvement, you can ensure greater commitment to achieving zero defects.

11. Eliminate Causes of Errors

Error-cause removal is necessary for the successful implementation of any quality improvement effort.
Encourage your employees to come to management with any obstacles or issues that arrise in attempting
to meet improvement goals. By having employees communicate obstacles before they become crises, you
can avert many of the dampers for quality improvement efforts.

12. Implement Recognition for Participants

The twelfth step of Crosby’s 14 Steps is the implementation of employee recognition. By regularly
recognizing those who participate in quality improvement efforts, employees will be much more likely to
continue to participate.

13. Create Quality Councils

By bringing together specialists and employees, you can create a focused effort towards creating lasting
quality improvement implementations. Make sure your quality councils meet on a regular basis.

14. Lather…Rinse…REPEAT!!!

Quality improvement doesn’t end because you have run out of the 14 Steps of Crosby! In order to really
make improvements in the quality of your products and services, you will need to do it over again…and
again…and again. Now go get started on your quality improvement projects!

Quality Cost

Cost of Quality (COQ) is a measure that quantifies the cost of control/conformance and the cost of
failure of control/non-conformance. In other words, it sums up the costs related to prevention and
detection of defects and the costs due to occurrences of defects.

Definition by ISTQB

Cost of quality: The total costs incurred on quality activities and issues and often split into prevention
costs, appraisal costs, internal failure costs and external failure costs.

Definition by QAI

Money spent beyond expected production costs (labor, materials, equipment) to ensure that the product
the customer receives is a quality (defect free) product. The Cost of Quality includes prevention,
appraisal, and correction or repair costs.

Quality costs are categorized into four main types. Theses are:

 Prevention costs
 Appraisal costs
 Internal failure costs and
 External failure costs.

These four types of quality costs are briefly explained below:

(i) Prevention costs

It is much better to prevent defects rather than finding and removing them from products. The costs
incurred to avoid or minimize the number of defects at first place are known as prevention costs. Some
examples of prevention costs are improvement of manufacturing processes, workers training, quality
engineering, statistical process control etc.

(ii) Appraisal costs

Appraisal costs (also known as inspection costs) are those cost that are incurred to identify defective
products before they are shipped to customers. All costs associated with the activities that are performed
during manufacturing processes to ensure required quality standards are also included in this category.
Identification of defective products involve the maintaining a team of inspectors. It may be very costly for
some organizations.

(iii) Internal failure costs

Internal failure costs are those costs that are incurred to remove defects from the products before shipping
them to customers. Examples of internal failure costs include cost of rework, rejected products, scrap etc.

(iv) External failure costs

If defective products have been shipped to customers, external failure costs arise. External failure costs
include warranties, replacements, lost sales because of bad reputation, payment for damages arising from
the use of defective products etc. The shipment of defective products can dissatisfy customers, damage
goodwill and reduce sales and profits.

FORMULA / CALCULATION

Cost of Quality (COQ) = Cost of Control + Cost of Failure of Control

 where

Cost of Control = Prevention Cost + Appraisal Cost

 and

Cost of Failure of Control = Internal Failure Cost + External Failure Cost

NOTES

 In its simplest form, COQ can be calculated in terms of effort (hours/days).

 A better approach will be to calculate COQ in terms of money (converting the effort
into money and adding any other tangible costs like test environment setup).
  The best approach will be to calculate COQ as a percentage of total cost. This allows
for comparison of COQ across projects or companies.
 To ensure impartiality, it is advised that the Cost of Quality of a project/product be
calculated and reported by a person external to the core project/product team (Say,
someone from the Accounts Department).
 It is desirable to keep the Cost of Quality as low as possible. However, this requires a
fine balancing of costs between Cost of Control and Cost of Failure of Control. In
general, a higher Cost of Control results in a lower Cost of Failure of Control. But,
the law of diminishing returns holds true here as well.

Quality Leadership

Quality leadership is a precondition for implementing quality management. How organizational leaders
structure and direct an organization as well as how they behave within an organization are critical
elements to the success of an effective quality management process. This article addresses these
leadership issues and presents a plan for quality management implementation. Several behavioral tools
are described that address potential obstacles to the implementation process.

Those following the teachings of quality gurus such as Deming, Juran and Feigenbaum and implementing
quality culture, tools and techniques are following approaches that tend toward leadership traits that
include, empowerment, a focus on people a strong strategic viewpoint and an awareness of integrating
different disciplines. Other traits include strong integrity and an awareness of social responsibilities.

Quality Leadership Characteristics

1. Values: Integrity, Trust and Culture

2. Vision: Strategic Focus
3. Inspiration: Communications Skills, Role Model, Motivational and Mentor
4. Innovative: Change Agent
5. Systems View: Interactive
6. Empowering: Focus on Employees
7. Customer Focus: Society
8. Business and Quality Knowledge

Unit 2 Quality Management System (QMS) & Process Quality Improvement

7QC Tools

The Seven Basic Tools of Quality (also known as 7 QC Tools) originated in Japan when the country
was undergoing major quality revolution and had become a mandatory topic as part of Japanese’s
industrial training program. These tools which comprised of simple graphical and statistical techniques
were helpful in solving critical quality related issues. These tools were often referred as Seven Basics
Tools of Quality because these tools could be implemented by any person with very basic training in
statistics and were simple to apply to solve quality-related complex issues.

7 QC tools can be applied across any industry starting from product development phase till delivery. 7QC
tools even today owns the same popularity and is extensively used in various phases of Six Sigma
(DMAIC or DMADV), in continuous improvement process (PDCA cycle) and Lean management
(removing wastes from process).

The seven QC tools are:

1. Stratification (Divide and Conquer)

2. Histogram
3. Check Sheet (Tally Sheet)
4. Cause-and-effect diagram (“fishbone” or Ishikawa diagram)
5. Pareto chart (80/20 Rule)
6. Scatter diagram (Shewhart Chart)
7. Control chart

1. Stratification (Divide and Conquer)

Stratification is a method of dividing data into sub–categories and classify data based on group, division,
class or levels that helps in deriving meaningful information to understand an existing problem.

The very purpose of Stratification is to divide the data and conquer the meaning full Information to solve
a problem.

 Un–stratified data (An employee reached late to office on following dates)

 5-Jan, 12-Jan,13-Jan, 19-Jan, 21-Jan, 26-Jan,27-Jan
 Stratified data: (Same data classified by day of the week )

Day MON TUE WED THUS FRI SAT

Frequency-Late in 4 2 1 0 0 0
Office

2. Histogram

Histogram introduced by Karl Pearson is a bar graph representing the frequency distribution on each bars.

The very purpose of Histogram is to study the density of data in any given distribution and understand the
factors or data that repeat more often.
Histogram helps in prioritizing factors and identify which are the areas that needs utmost attention
immediately.

3. Check sheet (Tally Sheet)

A check sheet can be metrics, structured table or form for collecting data and analysing them. When the
information collected is quantitative in nature, the check sheet can also be called as tally sheet.

The very purpose of checklist is to list down the important checkpoints or events in a tabular/metrics
format and keep on updating or marking the status on their occurrence which helps in understanding the
progress, defect patterns and even causes for defects.

4. Cause-and-effect diagram. (“Fishbone” or Ishikawa diagram)

Cause–and–effect diagram introduced by Kaoru Ishikawa helps in identifying the various causes (or
factors) leading to an effect (or problem) and also helps in deriving meaningful relationship between
them.

The very purpose of this diagram is to identify all root causes behind a problem.

Once a quality related problem is defined, the factors leading to the causal of the problem are identified.
We further keep identifying the sub factors leading to the causal of identified factors till we are able to
identify the root cause of the problem. As a result we get a diagram with branches and sub branches of
causal factors resembling to a fish bone diagram.

In manufacturing industry, to identify the source of variation the causes are usually grouped into below
major categories:

 People
 Methods
 Machines
 Material
 Measurements
 Environment

5. Pareto chart (80 – 20 Rule)

Pareto chart is named after Vilfredo Pareto. Pareto chart revolves around the concept of 80-20 rule which
underlines that in any process, 80% of problem or failure is just caused by 20% of few major factors
which are often referred as Vital Few, whereas remaining 20% of problem or failure is caused by 80% of
many minor factors which are also referred as Trivial Many.

The very purpose of Pareto Chart is to highlight the most important factors that is the reason for major
cause of problem or failure.
Pareto chart is having bars graphs and line graphs where individual factors are represented by a bar graph
in descending order of their impact and the cumulative total is shown by a line graph.

Pareto charts help experts in following ways:

 Distinguish between vital few and trivial many.

 Displays relative importance of causes of a problem.
 Helps to focus on causes that will have the greatest impact when solved.
 Scatter Diagram

Scatter diagram or scatter plot is basically a statistical tool that depicts dependent variables on Y – Axis
and Independent Variable on X – axis plotted as dots on their common intersection points. Joining these
dots can highlight any existing relationship among these variables or an equation in format Y = F(X) + C,
where is C is an arbitrary constant.

Very purpose of scatter Diagram is to establish a relationship between problem (overall effect) and causes
that are affecting.

The relationship can be linear, curvilinear, exponential, logarithmic, quadratic, polynomial etc. Stronger
the correlation, stronger the relationship will hold true. The variables can be positively or negatively
related defined by the slope of equation derived from the scatter diagram.

7. Control Chart (Shewhart Chart)

Control chart is also called as Shewhart Chart named after Walter A. Shewhart is basically a statistical
chart which helps in determining if an industrial process is within control and capable to meet the
customer defined specification limits.

The very purpose of control chart is to determine if the process is stable and capable within current
conditions.

In Control Chart, data are plotted against time in X-axis. Control chart will always have a central line
(average or mean), an upper line for the upper control limit and a lower line for the lower control limit.
These lines are determined from historical data.

By comparing current data to these lines, experts can draw conclusions about whether the process
variation is consistent (in control, affected by common causes of variation) or is unpredictable (out of
control, affected by special causes of variation). It helps in differentiating common causes from special
cause of variation.

Control charts are very popular and vastly used in Quality Control Techniques, Six Sigma (Control
Phase) and also plays an important role in defining process capability and variations in productions. This
tool also helps in identifying how well any manufacturing process is in line with respect to customer’s
expectation.
Control chart helps in predicting process performance, understand the various production patterns and
study how a process changes or shifts from normally specified control limits over a period of time.

Why use the 7 QC tools?

The 7 QC tools is a title given to a fixed set of graphical techniques identified as being most helpful in
troubleshooting issues related to quality. The 7 QC tools are fundamental instruments to improve the
process and product quality. They are used to examine the production process, identify the key issues,
control fluctuations of product quality, and give solutions to avoid future defects.

These are the tools which facilitate the organization to resolve the basic problems. When an organization
starts the journey of quality improvements, the organization normally has many low hanging fruits; which
should be tackled with these basic 7 QC tools. These 7 QC tools are easy to understand and implement
and does not need complex analytical/ statistical competence.

When to use the 7 QC Tools?

Collectively, these tools are commonly referred to as the 7 QC tools. In the Define phase of the DMAIC
process, Flowcharts are very important. In the Measure phase, the first three of the 7 QC tools are
relevant: Fishbone Diagram, Pareto Chart, and Control Charts. In the Analyze phase, the Scatter Diagram,
Histogram, and Checklist are relevant. The Control Chart is also relevant in the Improve phase.

Regression Control Charts

In statistical quality control, the regression control chart allows for monitoring a change in a process
where two or more variables are correlated. The change in a dependent variable can be detected and
compensatory change in the independent variable can be recommended.

Regression control chart differs from a traditional control chart in four main aspects:

 It is designed to control a varying (rather than a constant) average.

 The control limit lines are parallel to the regression line rather than the horizontal
line.
 The computations here are much more complex.
 It is appropriate for use in more complex situations.

The general idea of the regression control chart is as follows: Suppose one is monitoring the relationship
between the number of parts produced and the number of work hours expended. Within reasonable limits,
on may expect that the greater the number of work hours, the more parts are produced. One could
randomly draw 5 sample work days from each month, and monitor that relationship. The control limits
established in the regression control chart will allow one to detect, when the relationship changes, for
example, when productivity drops and more work hours are necessary to produce the same number of
parts.
Process Capability analysis

Process capability analysis is a set of tools used to find out how well a given process meets a set of
specification limits. In other words, it measures how well a process performs.

In practice, it compares the distribution of sample values—representing the process outcome—to the
specification limits, which are the limits of what we want achieved. Sometimes it compares to a
specification target as well.

Process capability indices are usually used to describe the capability of a process. There are a number of
different process capability indices, and whether you calculate one or all may depend on your analysis
needs. But to calculate any process capability indices you assume stability of your process; for unstable
processes process capability indices are meaningless. So a first step in process capability analysis is a
check for stability throughout the process.

An important technique used to determine how well a process meets a set of specification limits is called
a process capability analysis. A capability analysis is based on a sample of data taken from a process and
usually produces:

1. An estimate of the DPMO (defects per million opportunities).

2. One or more capability indices.
3. An estimate of the Sigma Quality Level at which the process operates.

Capability Analysis for Measurement Data from a Normal Distribution

This procedure performs a capability analysis for data that are assumed to be a random sample from a
normal distribution. It calculates capability indices such as Cpk, estimates the DPM (defects per million),
and determines the sigma quality level (SQL) at which the process is operating. It can handle two-sided
symmetric specification limits, two-sided asymmetric limits, and one-sided limits. Confidence limits for
the most common capability indices may also be requested.

Capability Analysis for Measurement Data from Non-Normal Distributions

This procedure performs a capability analysis for data that are not assumed to come from a normal
distribution. The program will fit up to 25 alternative distribution and list them according to their
goodness-of-fit. For a selected distribution, it then calculates equivalent capability indices, DPM, and the
SQL.

Capability Analysis for Correlated Measurements

When the variables that characterize a process are correlated, separately estimating the capability of each
may give a badly distorted picture of how well the process is performing. In such cases, it is necessary to
estimate the joint probability that one or more variables will be out of spec. This requires fitting a
multivariate probability distribution. This procedure calculates capability indices, DPM, and the SQL
based on a multivariate normal distribution.
Capability Analysis for Counts or Proportions

When examination of an item or event results in a PASS or FAIL rather than a measurement, the process
capability analysis must be based on a discrete distribution. For very large lots, the relevant distribution is
the binomial. For small lots or cases of limited opportunities for failure, the hypergeometric distribution
must be used:

Measurement system Analysis

Measurement system Analysis (MSA) is defined as an experimental and mathematical method of

determining the amount of variation that exists within a measurement process. Variation in the
measurement process can directly contribute to our overall process variability. MSA is used to certify the
measurement system for use by evaluating the system’s accuracy, precision and stability.

A measurement systems analysis (MSA) is a thorough assessment of a measurement process, and

typically includes a specially designed experiment that seeks to identify the components of variation in
that measurement process.

Just as processes that produce a product may vary, the process of obtaining measurements and data may
also have variation and produce incorrect results. A measurement systems analysis evaluates the test
method, measuring instruments, and the entire process of obtaining measurements to ensure the integrity
of data used for analysis (usually quality analysis) and to understand the implications of measurement
error for decisions made about a product or process. MSA is an important element of Six Sigma
methodology and of other quality management systems.

MSA analyzes the collection of equipment, operations, procedures, software and personnel that affects
the assignment of a number to a measurement characteristic.

A measurement systems analysis considers the following:

 Selecting the correct measurement and approach

 Assessing the measuring device
 Assessing procedures and operators
 Assessing any measurement interactions
 Calculating the measurement uncertainty of individual measurement devices and/or
measurement systems

Why Perform Measurement System Analysis (MSA)

An effective MSA process can help assure that the data being collected is accurate and the system of
collecting the data is appropriate to the process. Good reliable data can prevent wasted time, labor and
scrap in a manufacturing process. A major manufacturing company began receiving calls from several of
their customers reporting non-compliant materials received at their facilities sites. The parts were not
properly snapping together to form an even surface or would not lock in place. The process was audited
and found that the parts were being produced out of spec. The operator was following the inspection plan
and using the assigned gages for the inspection. The problem was that the gage did not have adequate
resolution to detect the non-conforming parts.  An ineffective measurement system can allow bad parts to
be accepted and good parts to be rejected, resulting in dissatisfied customers and excessive scrap. MSA
could have prevented the problem and assured that accurate useful data was being collected.

How to Perform Measurement System Analysis (MSA)

MSA is a collection of experiments and analysis performed to evaluate a measurement system’s

capability, performance and amount of uncertainty regarding the values measured. We should review the
measurement data being collected, the methods and tools used to collect and record the data. Our goal is
to quantify the effectiveness of the measurement system, analyze the variation in the data and determine
its likely source. We need to evaluate the quality of the data being collected in regards to location and
width variation. Data collected should be evaluated for bias, stability and linearity.

During an MSA activity, the amount of measurement uncertainty must be evaluated for each type of gage
or measurement tool defined within the process Control Plans. Each tool should have the correct level of
discrimination and resolution to obtain useful data. The process, the tools being used (gages, fixtures,
instruments, etc.) and the operators are evaluated for proper definition, accuracy, precision, repeatability
and reproducibility.

Design and Analysis of Experiment (DOE)

The term experiment is defined as the systematic procedure carried out under controlled conditions in
order to discover an unknown effect, to test or establish a hypothesis, or to illustrate a known effect.
When analyzing a process, experiments are often used to evaluate which process inputs have a significant
impact on the process output, and what the target level of those inputs should be to achieve a desired
result (output). Experiments can be designed in many different ways to collect this information. Design of
Experiments (DOE) is also referred to as Designed Experiments or Experimental Design – all of the terms
have the same meaning.

Experimental design can be used at the point of greatest leverage to reduce design costs by speeding up
the design process, reducing late engineering design changes, and reducing product material and labor
complexity. Designed Experiments are also powerful tools to achieve manufacturing cost savings by
minimizing process variation and reducing rework, scrap, and the need for inspection.

This Toolbox module includes a general overview of Experimental Design and links and other resources
to assist you in conducting designed experiments. A glossary of terms is also available at any time
through the Help function, and we recommend that you read through it to familiarize yourself with any
unfamiliar terms.

Design of Experiments (DOE)

Design of Experiments (DOE) is a branch of applied statistics focused on using the scientific method for
planning, conducting, analyzing and interpreting data from controlled tests or experiments. DOE is a
mathematical methodology used to effectively plan and conduct scientific studies that change input
variables (X) together to reveal their effect on a given response or the output variable (Y). In plain, non-
statistical language, the DOE allows you to evaluate multiple variables or inputs to a process or design,
their interactions with each other and their impact on the output. In addition, if performed and analyzed
properly you should be able to determine which variables have the most and least impact on the output.
By knowing this you can design a product or process that meets or exceeds quality requirements and
satisfies customer needs.

Why Utilize Design of Experiments (DOE)?

DOE allows the experimenter to manipulate multiple inputs to determine their effect on the output of the
experiment or process. By performing a multi-factorial or “full-factorial” experiment, DOE can reveal
critical interactions that are often missed when performing a single or “fractional factorial” experiment.
By properly utilizing DOE methodology, the number of trial builds or test runs can be greatly reduced. A
robust Design of Experiments can save project time and uncover hidden issues in the process. The hidden
issues are generally associated with the interactions of the various factors. In the end, teams will be able
to identify which factors impact the process the most and which ones have the least influence on the
process output.

When to Utilize Design of Experiments (DOE)?

Experimental design or Design of Experiments can be used during a New Product / Process Introduction
(NPI) project or during a Kaizen or process improvement exercise. DOE is generally used in two different
stages of process improvement projects.

 During the “Analyze” phase of a project, DOE can be used to help identify the Root
Cause of a problem. With DOE the team can examine the effects of the various inputs
(X) on the output (Y). DOE enables the team to determine which of the Xs impact the
Y and which one(s) have the most impact.
 During the “Improve” phase of a project, DOE can be used in the development of a
predictive equation, enabling the performance of what-if analysis. The team can then
test different ideas to assist in determining the optimum settings for the Xs to achieve
the best Y output.

Some knowledge of statistical tools and experimental planning is required to fully understand DOE
methodology. While there are several software programs available for DOE analysis, to properly apply
DOE you need to possess an understanding of basic statistical concepts.

Components of Experimental Design

Consider the following diagram of a cake-baking process. There are three aspects of the process that are
analyzed by a designed experiment:

1. Factors, or inputs to the process

Factors can be classified as either controllable or uncontrollable variables. In this case, the controllable
factors are the ingredients for the cake and the oven that the cake is baked in. The controllable variables
will be referred to throughout the material as factors. Note that the ingredients list was shortened for this
example – there could be many other ingredients that have a significant bearing on the end result (oil,
water, flavoring, etc). Likewise, there could be other types of factors, such as the mixing method or tools,
the sequence of mixing, or even the people involved. People are generally considered a Noise Factor (see
the glossary) – an uncontrollable factor that causes variability under normal operating conditions, but we
can control it during the experiment using blocking and randomization. Potential factors can be
categorized using the Fishbone Chart (Cause & Effect Diagram) available from the Toolbox.

2. Levels, or settings of each factor in the study

Examples include the oven temperature setting and the particular amounts of sugar, flour, and eggs
chosen for evaluation.

3. Response, or output of the experiment

In the case of cake baking, the taste, consistency, and appearance of the cake are measurable outcomes
potentially influenced by the factors and their respective levels. Experimenters often desire to avoid
optimizing the process for one response at the expense of another. For this reason, important outcomes
are measured and analyzed to determine the factors and their settings that will provide the best overall
outcome for the critical-to-quality characteristics – both measurable variables and assessable attributes.

Acceptance Sampling Plan

Acceptance Sampling Plan

An inspection of a product or service that determines whether or not the product will be accepted. For
example, a furniture manufacturer would use an acceptance sampling plan to make acceptance decisions
related to the type and quality of wood and similar raw materials they purchase for inclusion into their
finished products.

Meaning of Acceptance Sampling or Sampling Inspection

One method of controlling the quality of a product is 100% inspection which requires huge expenditure in
terms of time, money and labour. Moreover due to boredom and fatigue involved in repetitive inspection
process, there exists a possibility to overlook and some defective products may pass the inspection point.

Also when the quality of a product is tested by destructive testing (e.g., life of a candle or testing of
electrical fuses) then 100% inspection shall destroy all the products.

The alternative is statistical sampling inspection methods. Here from the whole lot of products/items to be
inspected, some items are selected for inspection.

If that sample of items conforms to be desired quality requirements then the whole lot is accepted, if it
does not, the whole lot is rejected. Thus the sample items are considered to be the representative of the
whole lot. This method of acceptance or rejection of a sample is called Acceptance Sampling.

In general acceptance sampling method proves to be economical and is used under the assumption when
the quality characteristics of the item are under control and relatively homogeneous.

Classification of Acceptance Sampling Plan

Depending upon the type of inspection acceptance sampling may be classified in two ways:

(i) Acceptance sampling on the basis of attributes i.e. GO and NOT GO gauges, and

(ii) Acceptance sampling on the basis of variables.

In acceptance sampling by attributes, no actual measurement is done and the inspection is done by way of
GO & NOT GO gauges. If the product conforms to the given specifications it is accepted, otherwise
rejected. The magnitude of error is not important in this case.

For example if cracks is the criteria of inspection/the products with cracks will be rejected and without
cracks accepted the shape and size of the cracks shall not be measured and considered.

In acceptance sampling by variables, the actual measurements of dimensions are taken or physical and
chemical testing of the characteristics of sample of materials/products is done. If the results are as per
specifications the lot is accepted otherwise rejected.

Advantages of Acceptance Sampling Plan

(i) The method is applicable in those industries where there is mass production and the industries follow a
set production procedure.

(ii) The method is economical and easy to understand.

(iii) Causes less fatigue boredom.

(iv) Computation work involved is comparatively very small.

(v) The people involved in inspection can be easily imparted training.

(vi) Products of destructive nature during inspection can be easily inspected by sampling.

(vii) Due to quick inspection process, scheduling and delivery times are improved.

Limitations of Acceptance Sampling Plan

(i) It does not give 100% assurance for the confirmation of specifications so there is always some
likelihood/risk of drawing wrong inference about the quality of the batch/lot.

(ii) Success of the system is dependent on, sampling randomness, quality characteristics to be tested,
batch size and criteria of acceptance of lot. 
Terms Used in Acceptance Sampling
Following terms are generally used in acceptance sampling:

1. Acceptable Quality Level (AQL)

It is the desired quality level at which probability of a acceptance is high. It represents maximum
proportion of defectives which the consumer finds acceptable or it is the maximum percent defectives that
for the purpose of sampling inspection can be considered satisfactory.

2. Lot Tolerance Percent Defective (LTPD) or Reject able Quality Level (RQL)

It is the quality level at which the probability of acceptance is low and below this level the lots are
rejected. This prescribes the dividing line between good and bad lots. Lots at this quality level are
considered to be poor.

3. Average outgoing Quality (A.O.Q)

Acceptance sampling plans provides the assurance that the average quality level or percent defectives
actually going to consumers will not exceed certain limit. Fig demonstrates the concept of average
outgoing quality related with actual percent defectives being produced.

The AOQ curve indicates that as the actual percent defectives in a production process increases, initially
the effect is for the lots to be passed for acceptance even though the number of defectives has gone up and
the percent defectives going to the consumer increases.

If this upward trend continues, the acceptance plan beings to reject lots and when lots are rejected, 100%
inspection is followed and defective units are replaced by good ones. The net effect is to improve the
average quality of the outgoing products since the rejected lots which to be ultimately accepted contain all
non-defective items (because of 100% inspection).

4. Operating Characteristic Curve or O.C. Curve

Operating characteristic curve for a sampling plan is a graph between fraction defective in a lot and the
probability of acceptance. In practice the performance of acceptance sampling for distinguishing
defectives and acceptable or good and bad lots mainly depends upon the sample size (n) and the number
of defectives permissible in the sample.

The O.C. curve shown in Fig. is the curve of a 100 percent inspection plan is said to be an ideal curve,
because it is generated by and acceptance plan which creates no risk either for producer or the consumer.
Fig.  Shows the O.C. curve that passes through two stipulated points i.e. two pre-agreed points AQL and
LTPD by the producer and the consumer.

Usually the producer’s and consumer’s risks are agreed upon Fig. and explicitly recorded in quantitative
terms.
The merit of any sampling plan depends on the relationship of sampling cost to risk. As the cost of
inspection go down the cost of accepting defectives increases.

Characteristics of O.C. Curve

(i) The larger the sample size and acceptance number steeper will be the slope of O.C. curve.

(ii) The O.C. curve of the sampling plans with acceptance number greater than zero are superior to those
with acceptance number as zero.

(iii) Fixed sample size tends towards constant quality production.

Different Cost associated with Quality like Assurance cost, Failure cost,
Prevention cost, Rectification cost, Appraisal cost

Quality Cost
Cost of Quality (COQ) is a measure that quantifies the cost of control/conformance and the cost of
failure of control/non-conformance. In other words, it sums up the costs related to prevention and
detection of defects and the costs due to occurrences of defects.

Definition by ISTQB

Cost of quality: The total costs incurred on quality activities and issues and often split into prevention
costs, appraisal costs, internal failure costs and external failure costs.

Definition by QAI

Money spent beyond expected production costs (labor, materials, equipment) to ensure that the product
the customer receives is a quality (defect free) product. The Cost of Quality includes prevention,
appraisal, and correction or repair costs.

Quality costs are categorized into four main types. Theses are:

 Prevention costs
 Appraisal costs
 Internal failure costs and
 External failure costs.

These four types of quality costs are briefly explained below:

(i) Prevention costs

It is much better to prevent defects rather than finding and removing them from products. The costs
incurred to avoid or minimize the number of defects at first place are known as prevention costs. Some
examples of prevention costs are improvement of manufacturing processes, workers training, quality
engineering, statistical process control etc.

(ii) Appraisal costs

Appraisal costs (also known as inspection costs) are those cost that are incurred to identify defective
products before they are shipped to customers. All costs associated with the activities that are performed
during manufacturing processes to ensure required quality standards are also included in this category.
Identification of defective products involve the maintaining a team of inspectors. It may be very costly for
some organizations.

(iii) Internal failure costs

Internal failure costs are those costs that are incurred to remove defects from the products before shipping
them to customers. Examples of internal failure costs include cost of rework, rejected products, scrap etc.

(iv) External failure costs

If defective products have been shipped to customers, external failure costs arise. External failure costs
include warranties, replacements, lost sales because of bad reputation, payment for damages arising from
the use of defective products etc. The shipment of defective products can dissatisfy customers, damage
goodwill and reduce sales and profits.

FORMULA / CALCULATION

Cost of Quality (COQ) = Cost of Control + Cost of Failure of Control

 where

Cost of Control = Prevention Cost + Appraisal Cost

 and

Cost of Failure of Control = Internal Failure Cost + External Failure Cost

NOTES

 In its simplest form, COQ can be calculated in terms of effort (hours/days).

 A better approach will be to calculate COQ in terms of money (converting the effort
into money and adding any other tangible costs like test environment setup).
 The best approach will be to calculate COQ as a percentage of total cost. This allows
for comparison of COQ across projects or companies.
  To ensure impartiality, it is advised that the Cost of Quality of a project/product be
calculated and reported by a person external to the core project/product team (Say,
someone from the Accounts Department).
 It is desirable to keep the Cost of Quality as low as possible. However, this requires a
fine balancing of costs between Cost of Control and Cost of Failure of Control. In
general, a higher Cost of Control results in a lower Cost of Failure of Control. But,
the law of diminishing returns holds true here as well.

Process failure Mode and effect analysis (PFMEA)

Introduction to Process Failure Mode and Effects Analysis (PFMEA)

Manufacturing and Process Engineers envision a process is free of errors. Unfortunately, errors and
especially errors propagated when people are present can be quite catastrophic. Process Failure Mode and
Effects Analysis (PFMEA) looks at each process step to identify risks and possible errors from many
different sources. The sources most often considered are:

 Man
 Methods
 Material
 Machinery
 Measurement
 Mother Earth (Environment)

What is Process Failure Mode and Effects Analysis (PFMEA)?

PFMEA is a methodical approach used for identifying risks on process changes. The Process FMEA
initially identifies process functions, failure modes their effects on the process. If there are design inputs,
or special characteristics, the effect on end user is also included. The severity ranking or danger of the
effect is determined for each effect of failure. Then, causes and their mechanisms of the failure mode are
identified. The assumption that the design is adequate keeps the focus on the process. A high probability
of a cause drives actions to prevent or reduce the impact of the cause on the failure mode. The detection
ranking determines the ability of specific tests to confirm the failure mode / causes are eliminated. The
PFMEA also tracks improvements through Risk Priority Number (RPN) reductions. By comparing the
before and after RPN, a history of improvement and risk mitigation can be chronicled.

Risk is the substitute for failure on new processes. It is a good practice to identify risks for each process
step as early as possible. The main goal is to identify risk prior to tooling acquisition. Mitigation of the
identified risk prior to first article or Production Part Approval Process (PPAP) will validate the
expectation of superior process performance.

Risks are identified on new technology and processes, which if left unattended, could result in failure.
The PFMEA is applied when:

 There is a new technology or new process introduced

 There is a current process with modifications, which may include changes due to
updated processes, continuous Improvement, Kaizen or Cost of Quality (COQ).
  There is a current process exposed to a new environment or change in location (no
physical change made to process)

How to Perform Process Failure Mode and Effects Analysis (PFMEA)?

There are five primary sections of the Process FMEA. Each section has a distinct purpose and a different
focus. The PFMEA is completed in sections at different times within the project timeline, not all at once.
The Process FMEA form is completed in the following sequence:

PFMEA Section 1 (Quality-One Path 1)

Process Name / Function

The Process Name / Function column permits the Process (PE) or Manufacturing Engineer (ME) to
describe the process technology that is being analyzed. The process can be a manufacturing operation or
an assembly. The function is the “Verb-Noun” that describes what the process operation does. There may
be many functions for any one process operation.

Requirement

The requirements, or measurements, of the process function are described in the second column. The
requirements are either provided by a drawing or a list of special characteristics. A Characteristics Matrix,
which is form of Quality Function Deployment (QFD), may be used and will link characteristics to their
process operations. The requirement must be measurable and should have test and inspection methods
defined.  These methods will later be placed on the Control Plan. The first opportunity for recommended
action may be to investigate and clarify the requirements and characteristics of the product with the
design team and Design FMEA.

Failure Mode

Failure Modes are the anti-functions or requirements not being met. There are 5 types of Failure Modes:

(i) Full Failure

(ii) Partial Failure

(iii) Intermittent Failure

(iv) Degraded Failure

(v) Unintentional Failure

Effects of Failure
The effects of a failure are focused on impacts to the processes, subsequent operations and possibly
customer impact. Many effects could be possible for any one failure mode. All effects should appear in
the same cell next to the corresponding failure mode. It is also important to note that there may be more
than one customer; both internal and external customers may be affected.

Severity

The Severity of each effect is selected based on both Process Effects as well as Design Effects. The
severity ranking is typically between 1 through 10.

Typical Severity for Process Effects (when no Special Characteristics / design inputs are given) is as
follows:

 2-4: Minor Disruption with rework / adjustment in stations; slows down production
(does not describe a lean operation)
 5-6: Minor disruption with rework out of station; additional operations required (does
not describe a lean operation)
 7-8: Major disruption, rework and/or scrap is produced; may shutdown lines at
customer or internally within the organization
 9-10: Regulatory and safety of the station is a concern; machine / tool damage or
unsafe work conditions

Typical Severity for Design Effects (when Special Characteristics / design inputs are given) is as follows:

 2-4: Annoyance or squeak and rattle; visual defects which do not affect function
 5-6: Degradation or loss of a secondary function of the item studied
 7-8: Degradation or loss of the primary function of the item studied
 9-10: Regulatory and / or Safety implications

The highest severity is chosen from the many potential effects and placed in the Severity Column.
Actions may be identified to can change the design direction on any failure mode with an effect of failure
ranked 9 or 10. If a recommended action is identified, it is placed in the Recommended Actions column
of the PFMEA.

Classification

Classification refers to the type of characteristics indicated by the risk. Many types of special
characteristics exist in different industries. These special characteristics typically require additional work,
either design error proofing, process error proofing, process variation reduction (Cpk) or mistake
proofing. The Classification column designates where the characteristics may be identified and later
transferred to a Control Plan.

PFMEA Section 2 (Quality-One Path 2)

Potential Causes / Mechanisms of Failure
Causes are defined for the Failure Mode and should be determined for their impact on the Failure Mode
being analyzed. Causes typically follow the Fishbone / Ishikawa Diagram approach, with the focus of
cause brainstorming on the 6M’s: Man, Method, Material, Machine, Measurement and Mother Earth
(Environment). Use of words like bad, poor, defective and failed should be avoided as they do not define
the cause with enough detail to make risk calculations for mitigation.

Current Process Controls Prevention

The prevention strategy used by a manufacturing or process team may benefit the process by lowering
occurrence or probability. The stronger the prevention, the more evidence the potential cause can be
eliminated by process design. The use of verified process standards, proven technology (with similar
stresses applied), Programmable Logic Controllers (PLC), simulation technology and Standard Work help
are typical Prevention Controls.

Occurrence

The Occurrence ranking is an estimate based on known data or lack of it. The Occurrence in Process
FMEAs can be related to known / similar technology or new process technology. A modification to the
ranking table is suggested based on volumes and specific use.

Typical Occurrence rankings for new process technology (similar to DFMEA Occurrence Ranking) are as
follows:

 1: Prevented causes due to using a known design standard

 2: Identical or similar design with no history of failure
 This ranking is often used improperly. The stresses in the new application and a
sufficient sample of products to gain history are required to select this ranking value.
 3-4: Isolated failures
 Some confusion may occur when trying to quantify “isolated”
 5-6: Occasional failures have been experienced in the field or in development /
verification testing
 7-9: New design with no history (based on a current technology)
 10: New design with no experience with technology

Typical Occurrence rankings for known / similar technology are as follows:

 1: Prevented through product / process design; error proofed

 2: 1 in 1,000, 000
 3: 1in 100,000
 4: 1 in 10,000
 5: 1 in 2,000
 6: 1 in 500
 7: 1 in 100
 8: 1 in 50
 9: 1 in 20
  10: 1 in 10

Actions may be directed against causes of failure which have a high occurrence. Special attention must be
placed on items with Severity 9 or 10. These severity rankings must be examined to assure that due
diligence has been satisfied.

PFMEA Section 3 (Quality-One Path 3)

Current Process Controls Detection

The activities conducted to verify the product meets the specifications detailed by the product or process
design are placed in the Current Process Controls Detection column. Examples are:

 Error proofing devices (cannot make nonconforming product)

 Mistake proofing devices (cannot pass nonconforming product)
 Inspection devices which collect variable data
 Alarms for unstable process parameters
 Visual inspection

Detection Rankings

Detection Rankings are assigned to each method or inspection based on the type of technique used.  Each
detection control is given a detection ranking using a predetermined scale. There is often more than one
test / evaluation technique per Cause-Failure Mode combination. Listing all in one cell and applying a
detection ranking for each is the best practice. The lowest of the detection rankings is then placed in the
detection column. Typical Process Controls Detection Rankings are as follows:

 1: Error (Cause) has been fully prevented and cannot occur

 2: Error Detection in-station, will not allow a nonconforming product to be made
 3: Failure Detection in-station, will not allow nonconforming product to pass
 4: Failure Detection out of station, will not leave plant / pass through to customer
 5-6: Variables gage, attribute gages, control charts, etc., requires operator to complete
the activity
 7-8: Visual, tactile or audible inspection
 9: Lot sample by inspection personnel
 10: No Controls

Actions may be necessary to improve inspection or evaluation capability. The improvement will address
the weakness in the inspection and evaluation strategy. The actions are placed in the Recommended
Actions Column.

PFMEA Section 4
Risk Priority Number (RPN)
The Risk Priority Number (RPN) is the product of the three previously selected rankings, Severity *
Occurrence * Detection.  RPN thresholds must not be used to determine the need for action. RPN
thresholds are not permitted mainly due to two factors:

 Poor behavior by design engineers trying to get below the specified threshold
 This behavior does not improve or address risk. There is no RPN value above which
an action should be taken or below which a team is excused of one.
 “Relative Risk” is not always represented by RPN

Recommended Actions

The Recommended Actions column is the location within the Process FMEA that all potential
improvements are placed. Completed actions are the purpose of the PFMEA. Actions must be detailed
enough that it makes sense if it stood alone in a risk register or actions list. Actions are directed against
one of the rankings previously assigned. The objectives are as follows:

 Eliminate Failure Modes with a Severity 9 or 10

 Lower Occurrence on Causes by error proofing, reducing variation or mistake
proofing
 Lower Detection on specific test improvements

Responsibility and Target Completion Date

Enter the name and date that the action should be completed by. A milestone name can substitute for a
date if a timeline shows the linkage between date and selected milestone.

PFMEA Section 5
Actions Taken and Completion Date

List the Actions Taken or reference the test report which indicates the results. The Process FMEA should
result in actions which bring higher risks items to an acceptable level of risk. It is important to note that
acceptable risk is desirable and mitigation of high risk to lower risk is the primary goal.

Re-Rank RPN

The new (re-ranked) RPN should be compared with the original RPN. A reduction in this value is
desirable. Residual risk may still be too high after actions have been taken. If this is the case, a new action
line would be developed. This is repeated until an acceptable residual risk has been obtained.

Process Failure Mode and Effects Analysis (PFMEA) Services

The Process FMEA Services available from Quality-One are PFMEA Consulting, PFMEA Training and
PFMEA Support, which may include Facilitation, Auditing or Contract Services. Our experienced team
of highly trained professionals will provide a customized approach for developing your people and
processes based on your unique PFMEA needs. Whether you need Consulting to assist with a plan to
deploy PFMEA, Training to help understand and drive improvement or hands-on Project Support for
building and implementing your PFMEA process, Quality-One can support you! By utilizing our
experienced Subject Matter Experts (SME) to work with your teams, Quality-One can help you realize
the value of Process FMEA in your organization.

SERVQUAL Model with Application

The SERVQUAL Model is an empiric model by Zeithaml, Parasuraman and Berry to compare service
quality performance with customer service quality needs. It is used to do a gap analysis of an
organization’s service quality performance against the service quality needs of its customers. That’s why
it’s also called the GAP model.

It takes into account the perceptions of customers of the relative importance of service attributes. This
allows an organization to prioritize.

There are five core components of service quality:

1. Tangibles: physical facilities, equipment, staff appearance, etc.

2. Reliability: ability to perform service dependably and accurately.
3. Responsiveness: willingness to help and respond to customer need.
4. Assurance: ability of staff to inspire confidence and trust.
5. Empathy: the extent to which caring individualized service is given.

The four themes that were identified by the SERVQUAL developers were numbered and labelled as:

1. Consumer expectation – Management Perception Gap (Gap 1):

Management may have inaccurate perceptions of what consumers (actually) expect. The reason for this
gap is lack of proper market/customer focus. The presence of a marketing department does
not automatically guarantee market focus. It requires the appropriate management processes, market
analysis tools and attitude.

2. Service Quality Specification Gap (Gap 2):

There may be an inability on the part of the management to translate customer expectations into service
quality specifications. This gap relates to aspects of service design.

3. Service Delivery Gap (Gap 3):

Guidelines for service delivery do not guarantee high-quality service delivery or performance. There are
several reasons for this. These include: lack of sufficient support for the frontline staff, process problems,
or frontline/contact staff performance variability.

4. External Communication Gap (Gap 4):

Consumer expectations are fashioned by the external communications of an organization. A realistic
expectation will normally promote a more positive perception of service quality. A service organization
must ensure that its marketing and promotion material accurately describes the service offering and the
way it is delivered

5. These four gaps cause a fifth gap (Gap 5)

Which is the difference between customer expectations and perceptions of the service actually
received Perceived quality of service depends on the size and direction of Gap 5, which in turn depends
on the nature of the gaps associated with marketing, design and delivery of services. So, Gap 5 is the
product of gaps 1, 2, 3 and 4. If these four gaps, all of which are located below the line that separates the
customer from the company, are closed then gap 5 will close.

How to measure Service Quality?

1. Mystery Shopping

This is a popular technique used for retail stores, hotels, and restaurants, but works for any other service
as well. It consists out of hiring an ‘undercover customer’ to test your service quality – or putting on a
fake moustache and going yourself, of course.

The undercover agent then assesses the service based on a number of criteria, for example those provided
by SERVQUAL. This offers more insights than simply observing how your employees work. Which will
probably be outstanding — as long as their boss is around.

2. Post Service Rating

This is the practice of asking customers to rate the service right after it’s been delivered.

With Userlike’s live chat, for example, you can set the chat window to change into a service rating view
once it closes. The customers make their rating, perhaps share some explanatory feedback, and close the
chat.

Something similar is done with ticket systems like Help Scout, where you can rate the service response
from your email inbox.

It’s also done in phone support. The service rep asks whether you’re satisfied with her service delivery, or
you’re asked to stay on the line to complete an automatic survey. The latter version is so annoying,
though, that it kind of destroys the entire service experience.

Different scales can be used for the post service rating. Many make use of a number-rating from 1 – 10.
There’s possible ambiguity here, though, because cultures differ in how they rate their experiences.

3. Follow-Up Survey
With this method you ask your customers to rate your service quality through an email survey – for
example via Google Forms. It has a couple advantages over the post-service rating.

For one, it gives your customer the time and space for more detailed responses. You can send a
SERVQUAL type of survey, with multiple questions instead of one. That’d be terribly annoying in a
post-service rating.

It also provides a more holistic overview of your service. Instead of a case-by-case assessment, the
follow-up survey measures your customers’ overall opinion of your service.

It’s also a useful technique if you didn’t have the post service rating in place yet and want a quick
overview of the state of your service quality.

4. In-App Survey

With an in-app survey, the questions are asked while the visitor is on the website or in the app, instead of
after the service or via email. It can be one simple question – e.g. ‘how would you rate our service’ – or it
could be a couple of questions.

Convenience and relevance are the main advantages. SurveyMonkey offers some great tools for
implementing something like this on your website.

5. Customer Effort Score (CES)

This metric was proposed in an influential Harvard Business Review article. In it, they argue that while
many companies aim to ‘delight’ the customer – to exceed service expectations – it’s more likely for a
customer to punish companies for bad service than it is for them to reward companies for good service.

While the costs of exceeding service expectations are high, they show that the payoffs are marginal.
Instead of delighting our customers, so the authors argue, we should make it as easy as possible for them
to have their problems solved.

That’s what they found had the biggest positive impact on the customer experience, and what they
propose measuring.

6. Social Media Monitoring

This method has been gaining momentum with the rise of social media. For many people, social media
serve as an outlet. A place where they can unleash their frustrations and be heard.

And because of that, they are the perfect place to hear the unfiltered opinions of your customers – if you
have the right tools. Facebook and Twitter are obvious choices, but also review platforms like
TripAdvisor or Yelp can be very relevant. Buffer suggests to ask your social media followers for
feedback on your service quality.
 7. Documentation Analysis

With this qualitative approach you read or listen to your respectively written or recorded service records.
You’ll definitely want to go through the documentation of low-rated service deliveries, but it can also be
interesting to read through the documentation of service agents that always rank high. What are they
doing better than the rest?

The hurdle with the method isn’t in the analysis, but in the documentation. For live chat and email
support it’s rather easy, but for phone support it requires an annoying voice at the start of the call: “This
call could be recorded for quality measurement”.

8. Objective Service Metrics

These stats deliver the objective, quantitative analysis of your service. These metrics aren’t enough to
judge the quality of your service by themselves, but they play a crucial role in showing you the areas you
should improve in.

 Volume per channel. This tracks the amount of inquiries per channel. When
combined with other metrics, like those covering efficiency or customer satisfaction,
it allows you to decide which channels to promote or cut down.
 First response time. This metric tracks how quickly a customer receives a response
on her inquiry. This doesn’t mean their issue is solved, but it’s the first sign of life –
notifying them that they’ve been heard.
 Response time. This is the total average of time between responses. So let’s say your
email ticket was resolved with 4 responses, with respective response times of 10, 20,
5, and 7 minutes. Your response time is 10.5 minutes. Concerning reply times, most
people reaching out via email expect a response within 24 hours; for social channels
it’s 60 minutes. Phone and live chat require an immediate response, under 2 minutes.
 First contact resolution ratio. Divide the number of issues that’s resolved through a
single response by the number that required more responses. Forrester research
showed that first contact resolutions are an important customer satisfaction factor for
73% of customers.
 Replies per ticket. This shows how many replies your service team needs on average
to close a ticket. It’s a measure of efficiency and customer effort.
 Backlog Inflow/Outflow. This is the number of cases submitted compared to the
number of cases closed. A growing number indicates that you’ll have to expand your
service team.
 Customer Success Ratio. A good service doesn’t mean your customers always finds
what they want. But keeping track of the number that found what they looked for
versus those that didn’t, can show whether your customers have the right ideas about
your offerings.
 ‘Handovers’ per issue. This tracks how many different service reps are involved per
issue. Especially in phone support, where repeating the issue is necessary, customers
hate HBR identified it as one of the four most common service complaints.
  Things Gone Wrong. The number of complaints/failures per customer inquiry. It
helps you identify products, departments, or service agents that need some ‘fixing’.
 Instant Service / Queuing Ratio. Nobody likes to wait. Instant service is the best
service. This metric keeps track of the ratio of customers that were served instantly
versus those that had to wait. The higher the ratio, the better your service.
 Average Queueing Waiting Time. The average time that queued customers have to
wait to be served.
 Queueing Hang-ups. How many customers quit the queueing process. These count
as a lost service opportunity.
 Problem Resolution Time. The average time before an issue is resolved.
 Minutes Spent Per Call. This can give you insight on who are your most efficient
operators.

Some of these measures are also financial metrics, such as the minutes spent per call and number of
handovers. You can use them to calculate your service costs per service contact. Winning the award for
the world’s best service won’t get you anywhere if the costs eat up your profits.

Some service tools keep track of these sort of metrics automatically, like Talkdesk for phone and User
like for live chat support. If you make use of communication tools that aren’t dedicated to service,
tracking them will be a bit more work.

One word of caution for all above mentioned methods and metrics: beware of averages, they will deceive
you. If your dentist delivers a great service 90% of the time, but has a habit of binge drinking and pulling
out the wrong teeth the rest of the time, you won’t stick around long.

A more realistic image shapes up if you keep track of the outliers and standard deviation as well. Measure
your service, aim for a high average, and improve by diminishing the outliers.

Unit 3 Product Quality Improvement {Book}

Quality function Deployment

The average consumer today has a multitude of options available to select from for similar products and
services. Most consumers make their selection based upon a general perception of quality or value.
Consumers typically want “the most bang for their buck”. In order to remain competitive, organizations
must determine what is driving the consumer’s perception of value or quality in a product or service.
They must define which characteristics of the products such as reliability, styling or performance form the
customer’s perception of quality and value. Many successful organizations gather and integrate the Voice
of the Customer (VOC) into the design and manufacture of their products. They actively design quality
and customer perceived value into their products and services. These companies are utilizing a structured
process to define their customer’s wants and needs and transforming them into specific product designs
and process plans to produce products that satisfy the customer’s needs. The process or tool they are
using is called Quality Function Deployment (QFD).
Quality Function Deployment (QFD)
Quality Function Deployment (QFD) is a process and set of tools used to effectively define customer
requirements and convert them into detailed engineering specifications and plans to produce the products
that fulfill those requirements. QFD is used to translate customer requirements (or VOC) into
measureable design targets and drive them from the assembly level down through the sub-assembly,
component and production process levels. QFD methodology provides a defined set of matrices utilized
to facilitate this progression.

QFD was first developed in Japan by Yoji Akao in the late 1960s while working for Mitsubishi’s
shipyard. It was later adopted by other companies including Toyota and its supply chain. In the early
1980s, QFD was introduced in the United States mainly by the big three automotive companies and a few
electronics manufacturers. Acceptance and growth of the use of QFD in the US was initially rather slow
but has since gained popularity and is currently being used in manufacturing, healthcare and service
organizations.

Why Implement Quality Function Deployment (QFD)

Effective communication is one of the most important and impactful aspects of any organization’s
success. QFD methodology effectively communicates customer needs to multiple business operations
throughout the organization including design, quality, manufacturing, production, marketing and sales.
This effective communication of the Voice of the Customer allows the entire organization to work
together and produce products with high levels of customer perceived value. There are several additional
benefits to using Quality Function Deployment:

 Customer Focused: QFD methodology places the emphasis on the wants and needs of
the customer, not on what the company may believe the customer wants. The Voice
of the Customer is translated into technical design specifications. During the QFD
process, design specifications are driven down from machine level to system, sub-
system and component level requirements. Finally, the design specifications are
controlled throughout the production and assembly processes to assure the customer
needs are met.
 VOC Competitor Analysis: The QFD “House of Quality” tool allows for direct
comparison of how your design or product stacks up to the competition in meeting the
VOC. This quick analysis can be beneficial in making design decisions that could
place you ahead of the pack.
 Shorter Development Time and Lower Cost: QFD reduces the likelihood of late
design changes by focusing on product features and improvements based on customer
requirements. Effective QFD methodology prevents valuable project time and
resources from being wasted on development of non-value added features or
functions.
 Structure and Documentation: QFD provides a structured method and tools for
recording decisions made and lessons learned during the product development
process. This knowledge base can serve as a historical record that can be utilized to
aid future projects.
Companies must bring new and improved products to market that meet the customer’s actual wants and
needs while reducing development time. QFD methodology is for organizations committed to listening to
the Voice of the Customer and meeting their needs.

How to Implement Quality Function Deployment (QFD)

The Quality Function Deployment methodology is a 4-phase process that encompasses activities
throughout the product development cycle.  A series of matrices are utilized at each phase to translate the
Voice of the Customer to design requirements for each system, sub-system and component. The four
phases of QFD are:

1. Product Definition: The Product Definition Phase begins with collection of VOC and
translating the customer wants and needs into product specifications. It may also
involve a competitive analysis to evaluate how effectively the competitor’s product
fulfills the customer wants and needs. The initial design concept is based on the
particular product performance requirements and specifications.
2. Product Development: During the Product Development Phase, the critical parts and
assemblies are identified. The critical product characteristics are cascaded down and
translated to critical or key part and assembly characteristics or specifications. The
functional requirements or specifications are then defined for each functional level.
3. Process Development: During the Process Development Phase, the manufacturing and
assembly processes are designed based on product and component specifications. The
process flow is developed and the critical process characteristics are identified.
4. Process Quality Control: Prior to production launch, the QFD process identifies
critical part and process characteristics. Process parameters are determined and
appropriate process controls are developed and implemented. In addition, any
inspection and test specifications are developed. Full production begins upon
completion of process capability studies during the pilot build.

Effective use of QFD requires team participation and discipline inherent in the practice of QFD, which
has proven to be an excellent team-building experience.

Level 1 QFD

The House of Quality is an effective tool used to translate the customer wants and needs into product or
service design characteristics utilizing a relationship matrix. It is usually the first matrix used in the QFD
process. The House of Quality demonstrates the relationship between the customer wants or “Whats” and
the design parameters or “Hows”. The matrix is data intensive and allows the team to capture a large
amount of information in one place. The matrix earned the name “House of Quality” due to its structure
resembling that of a house. A cross-functional team possessing thorough knowledge of the product, the
Voice of the Customer and the company’s capabilities, should complete the matrix. The different sections
of the matrix and a brief description of each are listed below:

 “Whats”: This is usually the first section to be completed. This column is where the
VOC, or the wants and needs, of the customer are listed.
  Importance Factor: The team should rate each of the functions based on their level of
importance to the customer. In many cases, a scale of 1 to 5 is used with 5
representing the highest level of importance.
 “Hows” or Ceiling: Contains the design features and technical requirements the
product will need to align with the VOC.
 Body or Main Room: Within the main body or room of the house of quality the
“Hows” are ranked according to their correlation or effectiveness of fulfilling each of
the “Whats”. The ranking system used is a set of symbols indicating either a strong,
moderate or a weak correlation. A blank box would represent no correlation or
influence on meeting the “What”, or customer requirement. Each of the symbols
represents a numerical value of 0, 1, 3 or 9.
 Roof: This matrix is used to indicate how the design requirements interact with each
other. The interrelationships are ratings that range from a strong positive interaction
(++) to a strong negative interaction (–) with a blank box indicating no
interrelationship.
 Competitor Comparison: This section visualizes a comparison of the competitor’s
product in regards to fulfilling the “Whats”. In many cases, a scale of 1 to 5 is used
for the ranking, with 5 representing the highest level of customer satisfaction. This
section should be completed using direct feedback from customer surveys or other
means of data collection.
 Relative Importance: This section contains the results of calculating the total of the
sums of each column when multiplied by the importance factor. The numerical values
are represented as discrete numbers or percentages of the total. The data is useful for
ranking each of the “Hows” and determining where to allocate the most resources.
 Lower Level / Foundation: This section lists more specific target values for technical
specifications relating to the “Hows” used to satisfy VOC.

Upon completion of the House of Quality, the technical requirements derived from the VOC can then be
deployed to the appropriate teams within the organization and populated into the Level 2 QFDs for more
detailed analysis. This is the first step in driving the VOC throughout the product or process design
process.

Level 2 QFD

The Level 2 QFD matrix is a used during the Design Development Phase. Using the Level 2 QFD, the
team can discover which of the assemblies, systems, sub-systems and components have the most impact
on meeting the product design requirements and identify key design characteristics. The information
produced from performing a Level 2 QFD is often used as a direct input to the Design Failure Mode and
Effects Analysis (DFMEA) process. Level 2 QFDs may be developed at the following levels:

 System Level: The technical specifications and functional requirements or “Hows”

identified and prioritized within The House of Quality become the “Whats” for the
system level QFD. They are then evaluated according to which of the systems or
assemblies they impact. Any systems deemed critical would then progress to a sub-
system QFD.
  Sub-system Level: The requirements cascaded down from the system level are re-
defined to align with how the sub-system contributes to the system meeting its
functional requirements. This information then becomes the “Whats” for the QFD and
the components and other possible “Hows” are listed and ranked to determine the
critical components. The components deemed critical would then require progression
to a component level QFD.
 Component Level: The component level QFD is extremely helpful in identifying the
key and critical characteristics or features that can be detailed on the drawings. The
key or critical characteristics then flow down into the Level 3 QFD activities for use
in designing the process. For purchased components, this information is valuable for
communicating key and critical characteristics to suppliers during sourcing
negotiations and as an input to the Production Part Approval Process (PPAP)

Level 3 QFD

The Level 3 QFD is used during the Process Development Phase where we examine which of the
processes or process steps have any correlation to meeting the component or part specifications. In the
Level 3 QFD matrix, the “Whats” are the component part technical specifications and the “Hows” are the
manufacturing processes or process steps involved in producing the part. The matrix highlights which of
the processes or process steps have the most impact on meeting the part specifications. This information
allows the production and quality teams to focus on the Critical to Quality (CTQ) processes, which flow
down into the Level 4 QFD for further examination.

Level 4 QFD

The Level 4 QFD is not utilized as often as the previous three. Within the Level 4 QFD matrix, the team
should list all the critical processes or process characteristics in the “Whats” column on the left and then
determine the “Hows” for assuring quality parts are produced and list them across the top of the matrix.
Through ranking of the interactions of the “Whats” and the “Hows”, the team can determine which
controls could be most useful and develop quality targets for each. This information may also be used for
creating Work Instructions, Inspection Sheets or as an input to Control Plans.

The purpose of Quality Function Deployment is not to replace an organization’s existing design process
but rather support and improve an organization’s design process. QFD methodology is a systemic, proven
means of embedding the Voice of the Customer into both the design and production process. QFD is a
method of ensuring customer requirements are accurately translated into relevant technical specifications
from product definition to product design, process development and implementation. The fact is that
every business, organization and industry has customers. Meeting the customer’s needs is critical to
success.  Implementing QFD methodology can enable you to drive the voice of your customers
throughout your processes to increase your ability to satisfy or even excite your customers.

Robust Design and Taguchi Method

The Taguchi Method was named after Dr. Genichi Taguchi and is also labeled as the Robust Design
technique. Dr. Genichi Taguchi was the man who pioneered the design after World War II ended and that
has developed over the years.
Unlike the Six Sigma method which aims to reduce waste in the manufacturing and during the operations
phase mainly focuses on:

1) Increasing engineering productivity to quickly develop new products at a low rate, and

2) Management which is based on value; the Robust Design centers on improving engineering

productivity.

This Robust Design is focused on the improvement of the significant function or role of a process or a
product itself, therefore smoothing the progress of strategies and coexisting engineering. The Taguchi
(Robust Design) approach rooted on a so called Energy Transformation method for engineering systems
like electrical, chemical, mechanical and the like. It is a unique method which makes use of the ideal
function of a process or product in contrast to the conventional approaches which mainly
concentrate on “symptom analysis” as a source for development or improvement towards the
achievement of Robustness and Quality Assurance.

To ensure or guarantee customer satisfaction, the Robust Design approach takes into account both

1) The noise considered as the variation from environmental to manufacturing and component failure,
and

2) The cost considered as the rate of deterioration in the area. It is a technique for performing experiments
to look into processes or investigate on processes where the end result depends on several factors such as
inputs and variables without having a mind-numbing and inefficient or too costly operation with the use
of possible and feasible mixture of values of the said variables. With a systematic choice of variable
combination, dividing their individual effects is possible.

The Robust Design method is an exclusive alternative for DOE or Design of Experiments which

differentiates itself from the traditional Design of Experiments focusing on the most favorable design
parameters to reduce discrepancy prior to attaining the average values on output parameters. This
innovative design to engineering signifies the most important leap in process and product method ever
since the beginning of the Quality revolution. The Robust Design method or the Taguchi approach makes
it possible for engineers to:

 Improve processes and products which are intended under a broad variety of
consumer’s circumstances in their life cycle and making processes reliable and
products durable
 Capitalize and get the most out of robustness by developing the planned function of a
product by improving and expanding insensitivity to factors of noise which somehow
discredit performance
 Alter and develop formulas and processes of a product to arrive at the performance
desired at a reduced cost or the lowest rate possible but, at the shortest turnaround or
time frame
 Make designs easier and processes at a reduced cost
Over the years, Six Sigma has made it possible to reduce cost by uncovering problems which occur
during manufacturing and resolving instant causes in the life cycle of a product. Robust Design on the
other hand has made it feasible to prevent issues or problems by rigorously developing designs for both
manufacturing process and product. The Robust Design follows a crucial methodology to ensure a
systematic process to attain a good output. Below are the 5 primary tools used in the Robust Design
approach:

1. The P-Diagram. This is used to categorize variables into noise, signal or the input,
response or the output, and control factors related with a product.
2. The Ideal function. This Ideal Function is utilized to statistically or mathematically
identify the ideal or ultimate outline of the signal-response association as represented
by the design idea for developing the higher-level system work fault free.
3. Quadratic Loss Function. This is also termed the Quality Loss Function and is used
to measure the loss earned or acquired by the consumer or user from the intended
performance due to a deviation from it.
4. Signal-to-Noise Ratio. This is used to predict the quality of the field by going
through systematic laboratory tests or experiments.
5. Orthogonal Arrays. These are used to collect and gather reliable information about
control factors which are considered the design parameters with minimal number of
tests and experiments.

The following are the 4 main steps in Robust Parameter method:

1. Problem Formulation. This step would incorporate the identification of the main

function, development of the P-diagram, classifying the best function and signal to
noise or S/N ratio, and planning or strategizing the experiments. The tests or
experiments would involve altering the noise, control as well as the signal factor
logically and efficiently utilizing orthogonal arrays.
2. Gathering of Data. This is the stage where experiments or tests are performed in
either simulation or hardware. Having a full-scale example of the product for
experimentation purposes is not considered necessary or compulsory in this step.
What’s important or significant in this stage is to have a vital model or example of the
product which satisfactorily encapsulates the design idea or concept. As a result,
experiments or tests can be performed at a low cost or economically.
3. Factor Effects Analysis. This is the stage where results or outcome of the control
factors are estimated and such results are evaluated to identify and classify the most
favorable arrangement of the control variables or factors.
4. Prediction/Confirmation. This is the stage wherein predicting the performance or
operation of the product model under the most favorable arrangement of the control
variables or factors to confirm best conditions is done. After which, experiments are
done under such conditions as well as comparing the results observed with the
underlying predictions. If the outcome or results of the experiments done corresponds
with the predicted results or predictions, final results are then implemented. However,
if predictions do not match with the final results, the steps need to be repeated.
A lot of companies worldwide have saved millions of dollars or even hundreds of millions just by using
the Taguchi approach. Telecommunications, software, electronics, xerography, automobiles and other
engineering fields are just some of the few businesses which have already practiced the Robust Design
method. With the Robust approach, rapid achievement to the full technological capability of designs and
higher profit can be considered consistent.

Design failure Mode & Effect Analysis

DFMEA is a detailed, methodical method for identifying potential failure points and causes for projects.
While initially developed for rocketry (where rockets have a high risk of failure due to complexity and
failures are usually catastrophic), it is now used in many industries to reduce failures that can be avoided.

DFMEA is used to identify these failure states during each design and redesign phase of a projects. This
takes the form of a five step process:

1. Failure modes and Severity

In this section you define the individual systems and subsystems of a project, along with the Failure
Modes and Severity.

Failure modes:

 Full Failure
 Partial Failure
 Inconsistent Failure
 Degraded Failure
 Unintended Failure

Severity:

Usually ranked from 1-10, with a 1 being an insignificant failure:

2-4: A minor annoyance. Things like a loud screech of a microphone when turning on, or an occasional
visual “flutter” on a screen that doesn’t significantly impair function.

5-6: Degradation or complete loss of a minor or secondary function of a device, like the clock in a car or
the sound card in your computer.

7-8: Degradation or complete loss of a primary function of a device, like the ignition of your car or a
motherboard failure in your computer.

9-10: Catastrophic and dangerous implications, often violate regulations. Your car’s brakes failing and
airbag failing to deploy, or you computer overheating to the point it catches fire.

2. Causes and mechanisms of failure:

In this section you define the causes of failure; this varies by type. For example a car’s brake’s failing
may be due to inferior construction materials in the brake fluid line causing it to degrade quickly and
snap.

You then sign an Occurrence ranking of 1-10 for the likely failures based on your knowledge of the
design (and then reassign Severity):

1: A failure prevented by current processes.

2: Design is similar enough to an existing design that failures are unlikely.

3-4: Isolated failures; failures that are so rare as to be hard to replicate (and therefore hard to fix).

5-6: Occasional failures have been experienced in testing or in the field with the current or a similar
enough design.

7-9: New design with no data.

10: New design with no knowledge of technology (purely theoretical or experimental).

3. Current Design Controls Inspection: Actions done to verify design safety.

You assign tests based on severity, and carry out those tests if possible (i.e. you have a prototype). You
also define detection rankings, also on a 1-10 scale which varies from project to project. In general
though, this will be a range of 1 meaning a failure was prevented by the design and standards itself to 10
meaning it’s impossible to evaluate.

4. Risk Priority Number: The conglomerate of Severity Occurrence Detection.

This would put failures that are high Severity (high risk) that Occur frequently and are hard to Detect at
the top.

You then determine Recommended Actions:

 Eliminate high severity Failure Modes

 Lower Occurrence
 Lower Detection

5. Repeat until RPN is below desired threshold, or it is determined that this is

impossible. Record results.

Following these steps properly will result in less (preferably no) unexpected failures in design and
determine how common failure points can be avoided.
Product Reliability Analysis

Product Reliability is defined as the probability that a device will perform its required function,
subjected to stated conditions, for a specific period of time. Product Reliability is quantified as MTBF
(Mean Time

Between Failures) for repairable product and MTTF (Mean Time To Failure) for non-repairable product.

Now that we’ve defined it, how can we measure it, or better yet, how can we predict it?

The Famous Bathtub Curve

Figure 1 shows the reliability “bathtub curve” which models the cradle to grave instantaneous failure rate
vs. time, which we would see if we were to wait long enough and keep good records for a given lot of
devices. This curve is modeled mathematically by exponential functions. More on this later.

The life of a population of devices (a group of devices of the same type) can be divided into three distinct
periods:

Early Life

If we follow the slope from the leftmost start to where it begins to flatten out this can be considered the
first period. The first period is characterized by a decreasing failure rate. It is what occurs during the
“early life” of a population of units. The weaker units fail leaving a population that is more rigorous.

Useful Life

The next period is the flat bottom portion of the graph. It is called the “useful life” period. Failures occur
more in a random sequence during this time. It is difficult to predict which failure mode will occur, but
the rate of failures is predictable. Notice the constant slope.

Wearout

The third period begins at the point where the slope begins to increase and extends to the rightmost end of
the graph. This is what happens when units become old and begin to fail at an increasing rate. It is called
the “wearout” period.

The formula for calculating the MTBF is

MTBF= T/R where T = total time and R = number of failures

MTTF stands for Mean Time To Failure. To distinguish between the two, the concept of suspensions
must first be understood. In reliability calculations, a suspension occurs when a destructive test or
observation has been completed without observing a failure. MTBF calculations do not consider
suspensions whereas
MTTF does. MTTF is the number of total hours of service of all devices divided by the number of
devices.

It is only when all the parts fail with the same failure mode that MTBF converges to MTTF.

MTTF= T/N where T = total time and N = Number of units under test.

Example: Suppose 10 devices are tested for 500 hours. During the test 2 failures occur.

The estimate of the MTBF is:

MTBF= (10*500)/2 = 2,500 hours / failure.

Whereas for MTTF

MTTF= (10*500)/10 = 500 hours / failure.

If the MTBF is known, one can calculate the failure rate as the inverse of the MTBF. The formula for

Failure rate is:

failure rate= 1/MTBF = R/T where R is the number of failures and T is total time.

Once an MTBF is calculated, what is the probability that any one particular device will be operational at
time equal to the MTBF?

Unit 4 Total Quality Management

Quality Circles

A quality circle is a volunteer group composed of workers, usually under the leadership of their
supervisor, who are trained to identify, analyze and solve work-related problems and present their
solutions to management in order to improve the performance of the organization, and motivate and
enrich the work of employees. When matured, true quality circles become self-managing, having gained
the confidence of management.

Participative management technique within the framework of a company wide quality system in which
small teams of (usually 6 to 12) employees voluntarily form to define and solve a quality or performance
related problem. In Japan (where this practice originated) quality circles are an integral part of enterprise
management and are called quality control circles.

“A Quality Circle is volunteer group composed of members who meet to talk about workplace and
service improvements and make presentations to their management with their ideas.” (Prasad, L.M,
1998).
Quality circles enable the enrichment of the lives of the workers or students and creates harmony and high
performance. Typical topics are improving occupational safety and health, improving product design, and
improvement in the workplace and manufacturing processes.

Objectives of Quality Circle

The perception of Quality Circles today is ‘Appropriateness for use1 and the tactic implemented is to
avert imperfections in services rather than verification and elimination. Hence the attitudes of employees
influence the quality. It encourages employee participation as well as promotes teamwork. Thus it
motivates people to contribute towards organizational effectiveness through group processes. The
following could be grouped as broad intentions of a Quality Circle:

1. To contribute towards the improvement and development of the organization or a

department.
2. To overcome the barriers that may exist within the prevailing organizational structure
so as to foster an open exchange of ideas.
3. To develop a positive attitude and feel a sense of involvement in the decision making
processes of the services offered.
4. To respect humanity and to build a happy work place worthwhile to work.
5. To display human capabilities totally and in a long run to draw out the infinite
possibilities.
6. To improve the quality of products and services.

7. To improve competence, which is one of the goals of all organizations?

8. To reduce cost and redundant efforts in the long run.
9. With improved efficiency, the lead time on convene of information and its
subassemblies is reduced, resulting in an improvement in meeting customers due
dates.
10. Customer satisfaction is the fundamental goal of any library. It will ultimately be
achieved by Quality Circle and will also help to be competitive for a long time.

BENEFITS OF QUALITY CIRCLES

There are no monetary rewards in the QC’s. However, there are many other gains, which largely benefit
the individual and consecutively, benefit the business. These are:

(i) Self-development: QC’s assist self-development of members by improving self-confidence, attitudinal

change, and a sense of accomplishment.

(ii) Social development: QC is a consultative and participative programme where every member
cooperates with others. This interaction assists in developing harmony.

(iii) Opportunity to attain knowledge: QC members have a chance for attaining new knowledge by
sharing opinions, thoughts, and experience.

(iv) Potential Leader: Every member gets a chance to build up his leadership potential, in view of the
fact that any member can become a leader.
(v) Enhanced communication skills: The mutual problem solving and presentation before the
management assists the members to develop their communication skills.

(vi) Job-satisfaction: QC’s promote creativity by tapping the undeveloped intellectual skills of the
individual. Individuals in addition execute activities diverse from regular work, which enhances their self-
confidence and gives them huge job satisfaction.

(vii) Healthy work environment: QC’s creates a tension-free atmosphere, which each individual likes,
understands, and co-operates with others.

(viii) Organizational benefits: The individual benefits create a synergistic effect, leading to cost
effectiveness, reduction in waste, better quality, and higher productivity.

TQM

Total Quality Management (TQM)

Total Quality Management (TQM) is the continual process of detecting and reducing or eliminating errors
in manufacturing, streamlining supply chain management, improving the customer experience, and
ensuring that employees are up to speed with their training. Total quality management aims to hold all
parties involved in the production process accountable for the overall quality of the final product or
service.

A total approach to quality is the current thinking of today; which is popularly called total quality
management (TQM).

TQM is a philosophy that believes in a company-wide responsibility toward quality via fostering a quality
culture throughout the organization; involving continuous improvement in the quality of work of all
employees with a view to best meeting the requirements of customers.

Advantages of TQM
(i) Sharpens Competitive Edge of the Enterprise

TQM helps an organization to reduce costs through elimination of waste, rework etc. It increases
profitability and competitiveness of the enterprise; and helps to sharpen the organization’s competitive
edge, in the globalized economy of today.

(ii) Excellent Customer Satisfaction

By focusing on customer requirements, TQM makes for excellent customer satisfaction. This leads to
more and more sales, and excellent relations with customers.

(iii) Improvement in Organisational Performance

Through promoting quality culture in the organization, TQM lead to improvements in managerial and
operative personnel’s performance.

(iv) Good Public Image of the Enterprise

TQM helps to build an image of the enterprise in the minds of people in society. This is due to stress on
total quality system and customers’ requirements, under the philosophy of TQM.

(v) Better Personnel Relations

TQM aims at promoting mutual trust and openness among employees, at all levels in the organization.
This leads to better personnel relations in the enterprise.

Limitations of TQM
The philosophy of TQM suffers from the following major limitations

(i) Waiting for a Long Time

TQM requires significant change in organization; consisting of:

1. Change in methods, processes etc. of organization.

2. Change in attitude, behaviour etc. of people

Launching of TQM and acceptance of the philosophy of TQM requires a long waiting for the
organization. It is not possible to accept and implement TQM overnight.

(ii) Problem of Labour Management Relations

Success of TQM depends on the relationships between labour and management; because participation of
people at all levels is a pre-requisite for TQM programme implementation. In many organizations, here
and abroad, labour-management relations are quite tense. As such, launching, acceptance and
implementation of TQM programme is nothing more than a dream for such organizations.

Basic Principles of TQM

In TQM, the processes and initiatives that produce products or services are thoroughly managed. By this
way of managing, process variations are minimized, so the end product or the service will have a
predictable quality level.

Following are the key principles used in TQM

(i) Top management – The upper management is the driving force behind TQM. The upper management
bears the responsibility of creating an environment to rollout TQM concepts and practices.
(ii) Training needs – When a TQM rollout is due, all the employees of the company need to go through a
proper cycle of training. Once the TQM implementation starts, the employees should go through regular
trainings and certification process.

(iii) Customer orientation – The quality improvements should ultimately target improving the customer
satisfaction. For this, the company can conduct surveys and feedback forums for gathering customer
satisfaction and feedback information.

(iv) Involvement of employees – Pro-activeness of employees is the main contribution from the staff.
The TQM environment should make sure that the employees who are proactive are rewarded
appropriately.

(v) Techniques and tools – Use of techniques and tools suitable for the company is one of the main
factors of TQM.

(vi) Corporate culture – The corporate culture should be such that it facilitates the employees with the
tools and techniques where the employees can work towards achieving higher quality.

(vii) Continues improvements – TQM implementation is not one time exercise. As long as the company
practices TQM, the TQM process should be improved continuously

Six Sigma

Six Sigma is a business management strategy which aims at improving the quality of processes by
minimizing and eventually removing the errors and variations. The concept of Six Sigma was introduced
by Motorola in 1986, but was popularized by Jack Welch who incorporated the strategy in his business
processes at General Electric. The concept of Six Sigma came into existence when one of Motorola’s
senior executives complained of Motorola’s bad quality. Bill Smith eventually formulated the
methodology in 1986.

Quality plays an important role in the success and failure of an organization. Neglecting an important
aspect like quality, will not let you survive in the long run. Six Sigma ensures superior quality of
products by removing the defects in the processes and systems. Six sigma is a process which helps in
improving the overall processes and systems by identifying and eventually removing the hurdles which
might stop the organization to reach the levels of perfection. According to sigma, any sort of challenge
which comes across in an organization’s processes is considered to be a defect and needs to be
eliminated.

Organizations practicing Six Sigma create special levels for employees within the organization. Such
levels are called as: “Green belts”, “Black belts” and so on. Individuals certified with any of these belts
are often experts in six sigma process. According to Six Sigma any process which does not lead to
customer satisfaction is referred to as a defect and has to be eliminated from the system to ensure
superior quality of products and services. Every organization strives hard to maintain excellent quality
of its brand and the process of six sigma ensures the same by removing various defects and errors which
come in the way of customer satisfaction.
The process of Six Sigma originated in manufacturing processes but now it finds its use in other
businesses as well. Proper budgets and resources need to be allocated for the implementation of Six
Sigma in organizations.

Following are the two Six Sigma methods

 DMAIC
 DMADV

DMAIC focuses on improving existing business practices. DMADV, on the other hand focuses on
creating new strategies and policies.

DMAIC has Five Phases

D – Define the Problem. In the first phase, various problems which need to be addressed to are clearly
defined. Feedbacks are taken from customers as to what they feel about a particular product or service.
Feedbacks are carefully monitored to understand problem areas and their root causes.

M – Measure and find out the key points of the current process. Once the problem is identified,
employees collect relevant data which would give an insight into current processes.

A – Analyze the data. The information collected in the second stage is thoroughly verified. The root
cause of the defects are carefully studied and investigated as to find out how they are affecting the entire
process.

I – Improve the current processes based on the research and analysis done in the previous stage. Efforts
are made to create new projects which would ensure superior quality.

C – Control the processes so that they do not lead to defects.

DMADV Method
D – Design strategies and processes which ensure hundred percent customer satisfactions.

M – Measure and identify parameters that are important for quality.

A – Analyze and develop high level alternatives to ensure superior quality.

D – Design details and processes.

V – Verify various processes and finally implement the same.

Six Sigma for Process Improvement

Six Sigma follows the DMAIC model for quality improvement and problem reduction (For existing
processes). This well-defined process approach consists of five phases in order:
DMAIC Roadmap

 Define
 Measure
 Analyze
 Improve
 Control

It is an integral part of Lean Six Sigma process, but can be implemented as a standalone quality
improvement process. Indeed, it is the most preferred tool that can help improving the efficiency and the
effectiveness of any organization. Within the DMAIC framework, Six Sigma can utilize several quality
management tools.

Six Sigma in Product Development

As Product Development focuses more on innovation and the creation of new products, there are
difference core principles, placed with differing priority to that of standard Lean Production. Below are
these key principles, broken down into stages.

First Principle: Define Value to the Customer

1. Voice of the Customer 

2. Quality Function Deployment 
3. Lean Design 
4. Platforms and Design Re-Use 
5. Rapidly Explore Alternatives

Second Principle: Identify the Value Stream and Reduce Waste

6. Streamline the Development Process

7. 5S Workplace
8. Standardized Work 
9. Integration of Design Tools

Third Principle: Make the Value Creating Steps Flow

 Pipeline Management
 Flow Process and Pull Scheduling
 Reduce Batch Sizes
 Synchronize Activities
 Defer Commitment

Fourth Principle: Empower the Team

  Cross-Functional Team
 Workforce Empowerment
 Right Resources

Fifth Principle: Learn and Improve

 Amplify Learning

Ultimately, the successful implementation of Product Development should increase innovation within an
organization tenfold, as well as facilitating the introduction of new products – potentially even at a 400-
500% increase.

Design for Six Sigma

In the current global marketplace, competition for products and services has never been higher.
Consumers have multiple choices for many very similar products. Therefore, many manufacturing
companies are continually striving to introduce completely new products or break into new markets.
Sometimes the products meet the consumer’s needs and expectations and sometimes they don’t. The
company will usually redesign the product, sometimes developing and testing multiple iterations prior to
re-introducing the product to market. Multiple redesigns of a product are expensive and wasteful. It would
be much more beneficial if the product met the actual needs and expectations of the customer, with a
higher level of product quality the first time. Design for Six Sigma (DFSS) focuses on performing
additional work up front to assure you fully understand the customer’s needs and expectations prior to
design completion. DFSS requires involvement by all stakeholders in every function.  When following a
DFSS methodology you can achieve higher levels of quality for new products or processes.

Design for Six Sigma (DFSS)

Design for Six Sigma (DFSS) is a different approach to new product or process development in that there
are multiple methodologies that can be utilized. Traditional Six Sigma utilizes DMAIC or Define,
Measure, Analyze, Improve and Control. This methodology is most effective when used to improve a
current process or make incremental changes to a product design. In contrast, Design for Six Sigma is
used primarily for the complete re-design of a product or process. The methods, or steps, used for DFSS
seem to vary according to the business or organization implementing the process. Some examples are
DMADV, DCCDI and IDOV. What all the methodologies seem to have in common is that they all focus
on fully understanding the needs of the customer and applying this information to the product and process
design. The DFSS team must be cross-functional to ensure that all aspects of the product are considered,
from market research through the design phase, process implementation and product launch. With DFSS,
the goal is to design products and processes while minimizing defects and variations at their roots. The
expectation for a process developed using DFSS is reportedly 4.5 sigma or greater.

Why Implement Design for Six Sigma (DFSS)

When your company designs a new product or process from the ground up it requires a sizable amount of
time and resources. Many products today are highly complex, providing multiple opportunities for things
to go wrong. If your design does not meet the customer’s actual wants and expectations or your product
does not provide the value the customer is willing to pay for, the product sales will suffer. Redesigning
products and processes is expensive and increases your time to market.  In contrast, by utilizing Design
for Six Sigma methodologies, companies have reduced their time to market by 25 to 40 percent while
providing a high quality product that meets the customer’s requirements. DFSS is a proactive approach to
design with quantifiable data and proven design tools that can improve your chances of success.

When to Implement Design for Six Sigma (DFSS)

DFSS should be used when designing a completely new product or service. DFSS is intended for use
when you must replace a product instead of redesigning. When the current product or process cannot be
improved to meet customer requirements, it is time for replacement. The DFSS methodologies are not
meant to be applied to incremental changes in a process or design. DFSS is used for prevention of quality
issues. Utilize the DFSS approach and its methodologies when your goal is to optimize your design to
meet the customer’s actual wants and expectations, shorten the time to market, provide a high level of
initial product quality and succeed the first time.

How to Implement Design for Six Sigma (DFSS)

As previously mentioned, DFSS is more of an approach to product design rather than one particular
methodology. There are some fundamental characteristics that each of the methodologies share. The
DFSS project should involve a cross functional team from the entire organization. It is a team effort that
should be focused on the customer requirements and Critical to Quality parameters (CTQs). The DFSS
team should invest time studying and understanding the issues with the existing systems prior to
developing a new design. There are multiple methodologies being used for implementation of DFSS. One
of the most common techniques, DMADV (Define, Measure, Analyze, Design, Verify), is detailed below.

Define
The Define stage should include the Project Charter, Communication Plan and Risk Assessment /
Management Plan.

The Project Charter

The team should develop a Project Charter, which should include:

 Purpose or reason for project – preferably with quantifiable data or measurable targets
 Voice of Business – what the business expects to gain from completion of the project
 Project Scope – establish the scope and parameters of the project and determine
exactly what is in and out of scope for the project to prevent “project creep”
 Problem statement or identification of the gap between current and desired state
 Statement of the goals for improved revenue, customer satisfaction or market share
stated in measurable, well-defined targets
 Project timeline or schedule with well-defined gates and deliverables for each gate
review.
 Project Budget – Cost target for the project including any capital expenditures
 Identification of the project sponsor and key stakeholders
 Identification of the cross-functional team members
 Clarification of roles and responsibilities for the team members and other
stakeholders
The Communication Plan
During the Define phase, the team should develop a strategy for proper communication throughout the
life of the project.  The Communication Plan should be designed to address different aspects and
techniques for discussing the evaluation results. The plan should also guide the process to successfully
share results of the evaluation. To develop the Communication Plan, answer the following questions:

 Who is the primary contact on the team that is responsible for communicating?
 What are the main goals for the communication process?
 Who are you communicating to? (Identify target audience)
 When and how often will the communication occur?
 What methods will be used for communication?

The Risk Assessment or Risk Management Plan

The project manager should prepare a Risk Assessment or Risk Management Plan that includes, but is not
limited, to the following information:

 Risks associated with the project

 Impact of risks against the success of the project
 Outline / plan for managing any project risk

Measure
During the Measurement Phase, the project focus is on understanding customer needs and wants and then
translating them into measurable design requirements. The team should not only focus on requirements or
“Must Haves” but also on the “Would likes”, which are features or functions that would excite the
customer, something that would set your product apart from the competition. The customer information
may be obtained through various methods including:

 Customer surveys
 Dealer or site visits
 Warranty or customer service information
 Historical data
 Consumer Focus Groups

Analyze
In the Analyze Phase, the customer information should be captured and translated into measureable
design performance or functional requirements. The Parameter (P) Diagram is often used to capture and
translate this information. Those requirements should then be converted into System, Sub-system and
Component level design requirements. The Quality Function Deployment (QFD) and Characteristic
Matrix are effective tools for driving the needs of the customer from the machine level down to
component level requirements. The team should then use the information to develop multiple concept
level design options. Various assessment tools like benchmarking or brainstorming can be used to
evaluate how well each of the design concepts meet customer and business requirements and their
potential for success. Then the team will evaluate the options and select a final design using decision-
making tools such as a Pugh Matrix or a similar method.
Design
When the DFSS team has selected a single concept-level design, it is time to begin the detailed design
work using 3D modeling, preliminary drawings, etc. The design team evaluates the physical product and
other considerations including, but not limited to, the following:

 Manufacturing process
 Equipment requirements
 Supporting technology
 Material selection
 Manufacturing location
 Packaging

Once the preliminary design is determined the team begins evaluation of the design using various
techniques, such as:

 Finite Element Analysis (FEA)

 Failure Modes and Effects Analysis (FMEA)
 Tolerance Stack Analysis
 Design Of Experiment (DOE)

FMEA is a popular tool used to identify potential design risks, identify key characteristics and develop a
list of actions to either alter the design or add to the validation plan. Computer simulation and analysis
tools can allow the team to work through the processes and understand the process inputs and desired
outputs. The design phase is complete once the team has developed a solid design and validation plan for
the new product or process that will meet customer and business requirements. One popular tool
is Design Verification Plan and Report (DVP&R), which documents the validation plan and provides a
section for reporting results.

Verify
During the Verify Phase, the team introduces the design of the product or process and performs the
validation testing to verify that it does meet customer and performance requirements. In addition, the
team should develop a detailed process map, process documentation and instructions. Often a Process
FMEA is performed to evaluate the risk inherent in the process and address any concerns prior to a build
or test run. Usually a prototype or pilot build is conducted. A pilot build can take the form of a limited
product production run, service offering or possibly a test of a new process. The information or data
collected during the prototype or pilot run is then used to improve the design of the product or process
prior to a full roll-out or product launch. When the project is complete the team ensures the process is
ready to hand-off to the business leaders and current production teams. The team should provide all
required process documentation and a Process Control Plan. Finally, the project leaders, stakeholders
and sponsors complete the project documentation and communicate the project results. The entire team
should then celebrate project completion.

Other Variations of DFSS

DMADV seems to be the most prominently used process but as mentioned previously it is not the only
option. Even DMADV has a variation sometimes utilized, known as DMADOV, which adds the step
identified as Optimize or Optimization. This step can be beneficial for developing new or revised
business procedures. An additional variation of DFSS is known as DCCDI (Define Customer and
Concept, Design, Implement).  DCCDI has many similarities with DMAVD and contains similar define,
measure and design stages. Furthermore yet another variation is IDOV (Identify, Design, Optimize,
Verify). The IDOV method also adds the optimization phase. Companies could possibly implement any
one of these various methods according to their business culture and needs.

Benchmarking

Quality Benchmarking
Benchmarking is defined as the process of measuring products, services, and processes
against those of organizations known to be leaders in one or more aspects of their operations.
Benchmarking provides necessary insights to help you understand how your organization
compares with similar organizations, even if they are in a different business or have a different
group of customers.

Benchmarking can also help organizations identify areas, systems, or processes for
improvements either incremental (continuous) improvements or dramatic (business process re-
engineering) improvements.

Competitive Benchmarking

Competitive benchmarking compares how well (or poorly) an organization is doing with respect
to the leading competition, especially with respect to critically important attributes, functions, or
values associated with the organization’s products or services. For example, on a scale of one
to four, four being best, how do customers rank your organization’s products or services
compared to those of the leading competition? If you cannot obtain hard data, marketing efforts
may be misdirected and design efforts misguided.

Technical Benchmarking

Technical benchmarking is performed by design staff to determine the capabilities of products or

services, especially in comparison to the products or services of leading competitors. For
example, on a scale of one to four, four being best, how do designers rank the properties of
your organization’s products or services? If you cannot obtain hard data, the design efforts may
be insufficient, and products or services may be inadequate to be competitive.

Procedure

Considerations

Before an organization can achieve the full benefits of benchmarking, its own processes must
be clearly understood and under control.
Benchmarking studies require significant investments of manpower and time, so management
must champion the process all the way through, including being ready and willing to make
changes based on what is learned.

Too broad a scope dooms the project to failure. A subject that is not critical to the organization’s
success won’t return enough benefits to make the study worthwhile.

Inadequate resources can also doom a benchmarking study by underestimating the effort
involved or inadequate planning. The better you prepare, the more efficient your study will be.

Plan

 Define a tightly focused subject of the benchmarking study. Choose an issue

critical to the organization’s success.
 Form a cross-functional team. During Step 1 and 2, management’s goals and
support for the study must be firmly established.
 Study your own process. Know how the work is done and measurements of
the output.
 Identify partner organizations that may have best practices.

Collect

 Collect information directly from partner organizations. Collect both process

descriptions and numeric data, using questionnaires, telephone interviews,
and/or site visits.

Analyze

 Compare the collected data, both numeric and descriptive.

 Determine gaps between your performance measurements and those of your
partners.
 Determine the differences in practices that cause the gaps.

Adapt

 Develop goals for your organization’s process.

 Develop action plans to achieve those goals.
 Implement and monitor plans.

Quality Function Deployment (QFD)

The average consumer today has a multitude of options available to select from for similar products and
services. Most consumers make their selection based upon a general perception of quality or value.
Consumers typically want “the most bang for their buck”. In order to remain competitive, organizations
must determine what is driving the consumer’s perception of value or quality in a product or service.
They must define which characteristics of the products such as reliability, styling or performance form the
customer’s perception of quality and value. Many successful organizations gather and integrate the Voice
of the Customer (VOC) into the design and manufacture of their products. They actively design quality
and customer perceived value into their products and services. These companies are utilizing a structured
process to define their customer’s wants and needs and transforming them into specific product designs
and process plans to produce products that satisfy the customer’s needs. The process or tool they are
using is called Quality Function Deployment (QFD).

Quality Function Deployment (QFD)

Quality Function Deployment (QFD) is a process and set of tools used to effectively define customer
requirements and convert them into detailed engineering specifications and plans to produce the products
that fulfill those requirements. QFD is used to translate customer requirements (or VOC) into
measureable design targets and drive them from the assembly level down through the sub-assembly,
component and production process levels. QFD methodology provides a defined set of matrices utilized
to facilitate this progression.

QFD was first developed in Japan by Yoji Akao in the late 1960s while working for Mitsubishi’s
shipyard. It was later adopted by other companies including Toyota and its supply chain. In the early
1980s, QFD was introduced in the United States mainly by the big three automotive companies and a few
electronics manufacturers. Acceptance and growth of the use of QFD in the US was initially rather slow
but has since gained popularity and is currently being used in manufacturing, healthcare and service
organizations.

Why Implement Quality Function Deployment (QFD)

Effective communication is one of the most important and impactful aspects of any organization’s
success. QFD methodology effectively communicates customer needs to multiple business operations
throughout the organization including design, quality, manufacturing, production, marketing and sales.
This effective communication of the Voice of the Customer allows the entire organization to work
together and produce products with high levels of customer perceived value. There are several additional
benefits to using Quality Function Deployment:

 Customer Focused: QFD methodology places the emphasis on the wants and needs of
the customer, not on what the company may believe the customer wants. The Voice
of the Customer is translated into technical design specifications. During the QFD
process, design specifications are driven down from machine level to system, sub-
system and component level requirements. Finally, the design specifications are
controlled throughout the production and assembly processes to assure the customer
needs are met.
 VOC Competitor Analysis: The QFD “House of Quality” tool allows for direct
comparison of how your design or product stacks up to the competition in meeting the
VOC. This quick analysis can be beneficial in making design decisions that could
place you ahead of the pack.
 Shorter Development Time and Lower Cost: QFD reduces the likelihood of late
design changes by focusing on product features and improvements based on customer
requirements. Effective QFD methodology prevents valuable project time and
 resources from being wasted on development of non-value added features or
functions.
 Structure and Documentation: QFD provides a structured method and tools for
recording decisions made and lessons learned during the product development
process. This knowledge base can serve as a historical record that can be utilized to
aid future projects.

Companies must bring new and improved products to market that meet the customer’s actual wants and
needs while reducing development time. QFD methodology is for organizations committed to listening to
the Voice of the Customer and meeting their needs.

How to Implement Quality Function Deployment (QFD)

The Quality Function Deployment methodology is a 4-phase process that encompasses activities
throughout the product development cycle.  A series of matrices are utilized at each phase to translate the
Voice of the Customer to design requirements for each system, sub-system and component. The four
phases of QFD are:

1. Product Definition: The Product Definition Phase begins with collection of VOC and
translating the customer wants and needs into product specifications. It may also
involve a competitive analysis to evaluate how effectively the competitor’s product
fulfills the customer wants and needs. The initial design concept is based on the
particular product performance requirements and specifications.
2. Product Development: During the Product Development Phase, the critical parts and
assemblies are identified. The critical product characteristics are cascaded down and
translated to critical or key part and assembly characteristics or specifications. The
functional requirements or specifications are then defined for each functional level.
3. Process Development: During the Process Development Phase, the manufacturing and
assembly processes are designed based on product and component specifications. The
process flow is developed and the critical process characteristics are identified.
4. Process Quality Control: Prior to production launch, the QFD process identifies
critical part and process characteristics. Process parameters are determined and
appropriate process controls are developed and implemented. In addition, any
inspection and test specifications are developed. Full production begins upon
completion of process capability studies during the pilot build.

Effective use of QFD requires team participation and discipline inherent in the practice of QFD, which
has proven to be an excellent team-building experience.

Level 1 QFD

The House of Quality is an effective tool used to translate the customer wants and needs into product or
service design characteristics utilizing a relationship matrix. It is usually the first matrix used in the QFD
process. The House of Quality demonstrates the relationship between the customer wants or “Whats” and
the design parameters or “Hows”. The matrix is data intensive and allows the team to capture a large
amount of information in one place. The matrix earned the name “House of Quality” due to its structure
resembling that of a house. A cross-functional team possessing thorough knowledge of the product, the
Voice of the Customer and the company’s capabilities, should complete the matrix. The different sections
of the matrix and a brief description of each are listed below:

 “Whats”: This is usually the first section to be completed. This column is where the
VOC, or the wants and needs, of the customer are listed.
 Importance Factor: The team should rate each of the functions based on their level of
importance to the customer. In many cases, a scale of 1 to 5 is used with 5
representing the highest level of importance.
 “Hows” or Ceiling: Contains the design features and technical requirements the
product will need to align with the VOC.
 Body or Main Room: Within the main body or room of the house of quality the
“Hows” are ranked according to their correlation or effectiveness of fulfilling each of
the “Whats”. The ranking system used is a set of symbols indicating either a strong,
moderate or a weak correlation. A blank box would represent no correlation or
influence on meeting the “What”, or customer requirement. Each of the symbols
represents a numerical value of 0, 1, 3 or 9.
 Roof: This matrix is used to indicate how the design requirements interact with each
other. The interrelationships are ratings that range from a strong positive interaction
(++) to a strong negative interaction (–) with a blank box indicating no
interrelationship.
 Competitor Comparison: This section visualizes a comparison of the competitor’s
product in regards to fulfilling the “Whats”. In many cases, a scale of 1 to 5 is used
for the ranking, with 5 representing the highest level of customer satisfaction. This
section should be completed using direct feedback from customer surveys or other
means of data collection.
 Relative Importance: This section contains the results of calculating the total of the
sums of each column when multiplied by the importance factor. The numerical values
are represented as discrete numbers or percentages of the total. The data is useful for
ranking each of the “Hows” and determining where to allocate the most resources.
 Lower Level / Foundation: This section lists more specific target values for technical
specifications relating to the “Hows” used to satisfy VOC.

Upon completion of the House of Quality, the technical requirements derived from the VOC can then be
deployed to the appropriate teams within the organization and populated into the Level 2 QFDs for more
detailed analysis. This is the first step in driving the VOC throughout the product or process design
process.

Level 2 QFD

The Level 2 QFD matrix is a used during the Design Development Phase. Using the Level 2 QFD, the
team can discover which of the assemblies, systems, sub-systems and components have the most impact
on meeting the product design requirements and identify key design characteristics. The information
produced from performing a Level 2 QFD is often used as a direct input to the Design Failure Mode and
Effects Analysis (DFMEA) process. Level 2 QFDs may be developed at the following levels:
  System Level: The technical specifications and functional requirements or “Hows”
identified and prioritized within The House of Quality become the “Whats” for the
system level QFD. They are then evaluated according to which of the systems or
assemblies they impact. Any systems deemed critical would then progress to a sub-
system QFD.
 Sub-system Level: The requirements cascaded down from the system level are re-
defined to align with how the sub-system contributes to the system meeting its
functional requirements. This information then becomes the “Whats” for the QFD and
the components and other possible “Hows” are listed and ranked to determine the
critical components. The components deemed critical would then require progression
to a component level QFD.
 Component Level: The component level QFD is extremely helpful in identifying the
key and critical characteristics or features that can be detailed on the drawings. The
key or critical characteristics then flow down into the Level 3 QFD activities for use
in designing the process. For purchased components, this information is valuable for
communicating key and critical characteristics to suppliers during sourcing
negotiations and as an input to the Production Part Approval Process (PPAP)

Level 3 QFD

The Level 3 QFD is used during the Process Development Phase where we examine which of the
processes or process steps have any correlation to meeting the component or part specifications. In the
Level 3 QFD matrix, the “Whats” are the component part technical specifications and the “Hows” are the
manufacturing processes or process steps involved in producing the part. The matrix highlights which of
the processes or process steps have the most impact on meeting the part specifications. This information
allows the production and quality teams to focus on the Critical to Quality (CTQ) processes, which flow
down into the Level 4 QFD for further examination.

Level 4 QFD

The Level 4 QFD is not utilized as often as the previous three. Within the Level 4 QFD matrix, the team
should list all the critical processes or process characteristics in the “Whats” column on the left and then
determine the “Hows” for assuring quality parts are produced and list them across the top of the matrix.
Through ranking of the interactions of the “Whats” and the “Hows”, the team can determine which
controls could be most useful and develop quality targets for each. This information may also be used for
creating Work Instructions, Inspection Sheets or as an input to Control Plans.

The purpose of Quality Function Deployment is not to replace an organization’s existing design process
but rather support and improve an organization’s design process. QFD methodology is a systemic, proven
means of embedding the Voice of the Customer into both the design and production process. QFD is a
method of ensuring customer requirements are accurately translated into relevant technical specifications
from product definition to product design, process development and implementation. The fact is that
every business, organization and industry has customers. Meeting the customer’s needs is critical to
success.  Implementing QFD methodology can enable you to drive the voice of your customers
throughout your processes to increase your ability to satisfy or even excite your customers.
Taguchi’s quality engineering

Robust Design and Taguchi Method

The Taguchi Method was named after Dr. Genichi Taguchi and is also labeled as the Robust Design
technique. Dr. Genichi Taguchi was the man who pioneered the design after World War II ended and that
has developed over the years.

Unlike the Six Sigma method which aims to reduce waste in the manufacturing and during the operations
phase mainly focuses on:

1) Increasing engineering productivity to quickly develop new products at a low rate, and

2) Management which is based on value; the Robust Design centers on improving engineering

productivity.

This Robust Design is focused on the improvement of the significant function or role of a process or a
product itself, therefore smoothing the progress of strategies and coexisting engineering. The Taguchi
(Robust Design) approach rooted on a so called Energy Transformation method for engineering systems
like electrical, chemical, mechanical and the like. It is a unique method which makes use of the ideal
function of a process or product in contrast to the conventional approaches which mainly
concentrate on “symptom analysis” as a source for development or improvement towards the
achievement of Robustness and Quality Assurance.

To ensure or guarantee customer satisfaction, the Robust Design approach takes into account both

1) The noise considered as the variation from environmental to manufacturing and component failure,
and

2) The cost considered as the rate of deterioration in the area. It is a technique for performing experiments
to look into processes or investigate on processes where the end result depends on several factors such as
inputs and variables without having a mind-numbing and inefficient or too costly operation with the use
of possible and feasible mixture of values of the said variables. With a systematic choice of variable
combination, dividing their individual effects is possible.

The Robust Design method is an exclusive alternative for DOE or Design of Experiments which

differentiates itself from the traditional Design of Experiments focusing on the most favorable design
parameters to reduce discrepancy prior to attaining the average values on output parameters. This
innovative design to engineering signifies the most important leap in process and product method ever
since the beginning of the Quality revolution. The Robust Design method or the Taguchi approach makes
it possible for engineers to:

 Improve processes and products which are intended under a broad variety of
consumer’s circumstances in their life cycle and making processes reliable and
products durable
  Capitalize and get the most out of robustness by developing the planned function of a
product by improving and expanding insensitivity to factors of noise which somehow
discredit performance
 Alter and develop formulas and processes of a product to arrive at the performance
desired at a reduced cost or the lowest rate possible but, at the shortest turnaround or
time frame
 Make designs easier and processes at a reduced cost

Over the years, Six Sigma has made it possible to reduce cost by uncovering problems which occur
during manufacturing and resolving instant causes in the life cycle of a product. Robust Design on the
other hand has made it feasible to prevent issues or problems by rigorously developing designs for both
manufacturing process and product. The Robust Design follows a crucial methodology to ensure a
systematic process to attain a good output. Below are the 5 primary tools used in the Robust Design
approach:

1. The P-Diagram. This is used to categorize variables into noise, signal or the input,
response or the output, and control factors related with a product.
2. The Ideal function. This Ideal Function is utilized to statistically or mathematically
identify the ideal or ultimate outline of the signal-response association as represented
by the design idea for developing the higher-level system work fault free.
3. Quadratic Loss Function. This is also termed the Quality Loss Function and is used
to measure the loss earned or acquired by the consumer or user from the intended
performance due to a deviation from it.
4. Signal-to-Noise Ratio. This is used to predict the quality of the field by going
through systematic laboratory tests or experiments.
5. Orthogonal Arrays. These are used to collect and gather reliable information about
control factors which are considered the design parameters with minimal number of
tests and experiments.

The following are the 4 main steps in Robust Parameter method:

1. Problem Formulation. This step would incorporate the identification of the main

function, development of the P-diagram, classifying the best function and signal to
noise or S/N ratio, and planning or strategizing the experiments. The tests or
experiments would involve altering the noise, control as well as the signal factor
logically and efficiently utilizing orthogonal arrays.
2. Gathering of Data. This is the stage where experiments or tests are performed in
either simulation or hardware. Having a full-scale example of the product for
experimentation purposes is not considered necessary or compulsory in this step.
What’s important or significant in this stage is to have a vital model or example of the
product which satisfactorily encapsulates the design idea or concept. As a result,
experiments or tests can be performed at a low cost or economically.
3. Factor Effects Analysis. This is the stage where results or outcome of the control
factors are estimated and such results are evaluated to identify and classify the most
favorable arrangement of the control variables or factors.
 4. Prediction/Confirmation. This is the stage wherein predicting the performance or
operation of the product model under the most favorable arrangement of the control
variables or factors to confirm best conditions is done. After which, experiments are
done under such conditions as well as comparing the results observed with the
underlying predictions. If the outcome or results of the experiments done corresponds
with the predicted results or predictions, final results are then implemented. However,
if predictions do not match with the final results, the steps need to be repeated.

A lot of companies worldwide have saved millions of dollars or even hundreds of millions just by using
the Taguchi approach. Telecommunications, software, electronics, xerography, automobiles and other
engineering fields are just some of the few businesses which have already practiced the Robust Design
method. With the Robust approach, rapid achievement to the full technological capability of designs and
higher profit can be considered consistent.

Total Productive Maintenance

Total Productive Maintenance (TPM) is a system of maintaining and improving the integrity of

production and quality systems through the machines, equipment, processes, and employees
that add business value to an organization.

TPM focuses on keeping all equipment in top working condition to avoid breakdowns and delays
in manufacturing processes.

Objective of TPM

 Improving the effectiveness of machines

 Improving the efficiency, reliability and effectiveness of maintenance of
machine
 Scheduling maintenance for avoiding early maintenance
 Involving operation team also in smaller scale maintenance, such as machine
checklist inspection before starting and after closing the machines
 Arrangement of training for amending the skills of employees

The 8 pillars of TPM

1. Autonomous Maintenance: Operators monitor the condition of their own

equipment and work areas
2. Process & Machine Improvement: Team leaders collect information from
operators and work areas, then prioritize preventative maintenance and
improvements
3. Preventative Maintenance: Operators and team leaders share preventative
maintenance tasks and schedules
4. Early Management of New Equipment: Team leaders anticipate and plan
for parts of equipment lifecycles and report to mangers, based on
maintenance reports
 5. Process Quality Management: Shared responsibility for operation and
maintenance encourages quality improvement ideas from all areas of work
6. Administrative Work: Managers prioritize data from the previous pillars and
share outcomes with team leaders and work areas
7. Education & Training: Continuous improvement includes operator and work
area education and training which improves morale, retention and efficiency
8. Safety & Sustained Success: Facility-wide safety is prioritized, which
positively impacts sustained success of the TPM program

As maintenance is traditionally considered an inevitable and “not-for-profit” function, TPM is

considered the most difficult lean manufacturing tool to implement. Shifting cultural beliefs within
a facility, from the CEO to machinists and janitors, may take years but the pay off for both the
finished product and employee morale is worth the investment.

Benefits of TPM

Acknowledges the Importance of Maintenance to the Organization

For too long, maintenance has been viewed as a cost center that does not provide value to the
organization. Thankfully, times are changing. With approaches like TPM and reliability centered
maintenance (RCM), maintenance is now viewed as vitally important to the business. TPM’s
maintenance-oriented approach helps to reinforce the perception that maintenance is something
that adds value to the organization.

Less Unplanned Downtime

As machine operators become more familiar with their equipment, they can more easily
recognize when things seem out of the ordinary. Because they are on the front lines and able to
spot problems sooner, operators can alert the maintenance team before equipment breaks
down. Maintenance can then be planned for a time when it will not interrupt production.

Safer Work Environment

TPM also brings focus to workplace safety. Introducing or improving safety-related maintenance
tasks means that employees are able to work in low-risk environments. When accidents are
reduced and potentially dangerous situations are avoided, employees’ attitudes become more
positive, which can improve job satisfaction and productivity.

Lower Maintenance Costs

Unplanned downtime is costly. TPM’s focus on proactive and preventive maintenance reduces
maintenance costs in many ways. For example, equipment that is regularly cleaned, lubricated,
and inspected should experience fewer unexpected breakdowns, requiring less maintenance
resources.
Reduced Backlog

With everyone contributing to maintenance, less pressure is placed on the maintenance team.
Over time, the backlog of preventive maintenance jobs and maintenance requests will shrink,
freeing up the maintenance team to work on capital improvements and other projects.

Predictable maintenance activities allow for better control over MRO inventory stocking levels,
ensuring less overstock or expedited inventory purchases. Operators can identify emerging
problems with their equipment before they become major failures, resulting in potentially low-
cost, less significant repairs.

TPM can also help lower production costs. When equipment is not available, there is a
domino effect that can result in stopped production, defective product, idle employees, and
employee overtime, not to mention the increased stress of “catching up” when the problem is
fixed. When maintenance is viewed as a team effort, production losses due to poor
maintenance can be minimized.

Unit 5 Quality Standards {Book}

ISO (9000& 14000 SERIES)

The International Organization of Standardization (ISO) is a worldwide federation consisting of member
bodies from 91 countries, which promotes the development of international manufacturing, trade and
communication standards.

ISO 9000 is a set of international standards on quality management and quality assurance developed to
help companies effectively document the quality system elements to be implemented to maintain an
efficient quality system. They are not specific to any one industry and can be applied to organizations of
any size.

ISO 9000 can help a company satisfy its customers, meet regulatory requirements, and achieve continual
improvement. However, it should be considered to be a first step, the base level of a quality system, not a
complete guarantee of quality.

ISO 9000 refers to a generic series of standards published by the ISO that provide quality assurance
requirements and quality management guidance. ISO 9000 is a quality system standard, not a technical
product standard. The ISO 9000 series currently contains four standards – ISO 9001, ISO 9002, ISO 9003
and ISO 9004. Firms select the standard that is most relevant to their business activities. However, these
four standards will be revised in late 2000. More information is provided later in this paper under ISO
9000:2000.

ISO 9000 Series standards

The ISO 9000 family contains these standards:

  ISO 9001:2015: Quality management systems – Requirements
 ISO 9000:2015: Quality management systems – Fundamentals and vocabulary
(definitions)
 ISO 9004:2009: Quality management systems – Managing for the sustained success
of an organization (continuous improvement)
 ISO 19011:2011: Guidelines for auditing management systems

ISO 9000 principles of quality management

The ISO 9000:2015 and ISO 9001:2015 standards are based on seven quality management principles that
senior management can apply for organizational improvement:

 Customer focus
 Understand the needs of existing and future customers
 Align organizational objectives with customer needs and expectations
 Meet customer requirements
 Measure customer satisfaction
 Manage customer relationships
 Aim to exceed customer expectations

 Leadership
 Establish a vision and direction for the organization
 Set challenging goals
 Model organizational values
 Establish trust
 Equip and empower employees
 Recognize employee contributions

 Engagement of people
 Ensure that people’s abilities are used and valued
 Make people accountable
 Enable participation in continual improvement
 Evaluate individual performance
 Enable learning and knowledge sharing
 Enable open discussion of problems and constraints

 Process approach
 Manage activities as processes
 Measure the capability of activities
 Identify linkages between activities
 Prioritize improvement opportunities
 Deploy resources effectively

 Improvement
 Improve organizational performance and capabilities
  Align improvement activities
 Empower people to make improvements
 Measure improvement consistently
 Celebrate improvements

(6) Evidence-based decision making

 Ensure the accessibility of accurate and reliable data

 Use appropriate methods to analyze data
 Make decisions based on analysis
 Balance data analysis with practical experience
 See tools for decision making.

 Relationship management
 Identify and select suppliers to manage costs, optimize resources, and create value
 Establish relationships considering both the short and long term
 Share expertise, resources, information, and plans with partners
 Collaborate on improvement and development activities
 Recognize supplier successes

Why Consider ISO 9000 Registration

There are several benefits to implementing this series in your company. There is also a strong belief that
having a documented quality procedure gives a firm a strong advantage over its competitors. For
example, it will guide you to build quality into your product or service and avoid costly after-the-fact
inspections, warranty costs, and rework.

Most importantly, more contractors are working with ISO certified customers every year as the
certifications are more widely used and accepted in the United States.

ISO14000

ISO 14000 is a family of standards related to environmental management that exists to help organizations

(a) minimize how their operations (processes, etc.) negatively affect the environment (i.e. cause adverse
changes to air, water, or land);

(b) comply with applicable laws, regulations, and other environmentally oriented requirements; and

 (c) continually improve in the above.

ISO 14000 is similar to ISO 9000 quality management in that both pertain to the process of how a product
is produced, rather than to the product itself. As with ISO 9001, certification is performed by third-party
organizations rather than being awarded by ISO directly. The ISO 19011 and ISO 17021 audit standards
apply when audits are being performed.
The ISO 14000 series of environmental management standards are intended to assist organizations
manage the environmental effect of their business practices. The ISO 14000 series is similar to the ISO
9000 series published in 1987. The purpose of the ISO 9000 series is to encourage organizations to
institute quality assurance management programs. Although ISO 9000 deals with the overall management
of an organization and ISO 14000 deals with the management of the environmental effects of an
organization, both standards are concerned with processes, and there is talk of combining the two series
into one.

Both series of standards were published by ISO, the International Organization for Standardization. The
purpose of ISO is to facilitate international trade and cooperation in commercial, intellectual, scientific
and economic endeavors by developing international standards. ISO originally focused on industrial and
mechanical engineering standards. Now, it has ventured into setting standards for an organization’s
processes, policies, and practices.

The requirements of ISO 14001 are an integral part of the European Union’s Eco-Management and Audit
Scheme (EMAS). EMAS’s structure and material are more demanding, mainly concerning performance
improvement, legal compliance, and reporting duties. The current version of ISO 14001 is ISO
14001:2015, which was published in September 2015.

ISO 14000 refers to a series of standards on environmental management tools and systems. ISO 14000
deals with a company’s system for managing its day-to-day operations and how they impact the
environment. The Environmental Management System and Environmental Auditing address a wide range
of issues to include the following:

 Top management commitment to continuous improvement, compliance, and pollution

prevention.
 Creating and implementing environmental policies, including setting and meeting
appropriate targets.
 Integrating environmental considerations in operating procedures.
 Training employees in regard to their environmental obligations.
 Conducting audits of the environmental management system.

ISO 14001

ISO 14001:2015 specifies the requirements for an environmental management system that an

organization can use to enhance its environmental performance. ISO 14001:2015 is intended for use by an
organization seeking to manage its environmental responsibilities in a systematic manner that contributes
to the environmental pillar of sustainability.

ISO 14001:2015 helps an organization achieve the intended outcomes of its environmental management
system, which provide value for the environment, the organization itself and interested parties. Consistent
with the organization’s environmental policy, the intended outcomes of an environmental management
system include:
  Enhancement of environmental performance;
 Fulfilment of compliance obligations;
 Achievement of environmental objectives.

ISO 14001:2015 is applicable to any organization, regardless of size, type and nature, and applies to the
environmental aspects of its activities, products and services that the organization determines it can either
control or influence considering a life cycle perspective. ISO 14001:2015 does not state specific
environmental performance criteria.

ISO 14001:2015 can be used in whole or in part to systematically improve environmental management.

Claims of conformity to ISO 14001:2015, however, are not acceptable unless all its requirements are
incorporated into an organization’s environmental management system and fulfilled without exclusion.

ISO 22000

ISO 22000 is an international standard that defines the requirements of a food safety management system
covering all sizes of all organizations throughout the food chain.

Benefits of ISO 22000

 Introduce internationally recognized processes to your business

 Give suppliers and stakeholders confidence in your hazard controls
 Put these hazard controls in place across your supply chain
 Introduce transparency around accountability and responsibilities
 Continually improve and update your systems so it stays effective
 ISO 22000 contains the food safety management system requirements of FSSC 22000
(which is a Global Food Safety Initiative, GFSI recognised scheme) and is used along
with requirements for prerequisite programs for the appropriate industry sector.

ISO 27001

ISO 27001 (formally known as ISO/IEC 27001:2005) is a specification for an information security

management system (ISMS). An ISMS is a framework of policies and procedures that includes all legal,
physical and technical controls involved in an organisation’s information risk management processes.

According to its documentation, ISO 27001 was developed to “provide a model for establishing,
implementing, operating, monitoring, reviewing, maintaining and improving an information security
management system.”

ISO 27001 uses a topdown, risk-based approach and is technology-neutral. The specification defines a
six-part planning process:

1. Define a security policy.

2. Define the scope of the ISMS.
3. Conduct a risk assessment.
 4. Manage identified risks.
5. Select control objectives and controls to be implemented.
6. Prepare a statement of applicability.

The specification includes details for documentation, management responsibility, internal audits,
continual improvement, and corrective and preventive action. The standard requires cooperation among
all sections of an organisation.

The 27001 standard does not mandate specific information security controls, but it provides a checklist of
controls that should be considered in the accompanying code of practice, ISO/IEC 27002:2005. This
second standard describes a comprehensive set of information security control objectives and a set of
generally accepted good practice security controls.

ISO 27002 contains 12 main sections:

1. Risk assessment
2. Security policy
3. Organization of information security
4. Asset management 
5. Human resources security
6. Physical and environmental security
7. Communications and operations management
8. Access control 
9. Information systems acquisition, development and maintenance 
10. Information security incident management 
11. Business continuity management 
12. Compliance

Organisations are required to apply these controls appropriately in line with their specific risks. Third-
party accredited certification is recommended for ISO 27001 conformance.

Other standards being developed in the 27000 family are:

 27003: Implementation guidance.

 27004: An information security management measurement standard suggesting
metrics to help improve the effectiveness of an ISMS.
 27005: An information security risk management standard. (Published in 2008)
 27006: A guide to the certification or registration process for accredited ISMS
certification or registration bodies. (Published in 2007)
 27007: ISMS auditing guideline.
OHSAS 18001 and QS 9000

OHSAS 18001
BS OHSAS 18001 sets out the minimum requirements for occupational health and safety management
best practice. Work with us to bring work health and safety (h&s) into your business and you can achieve
the maximum return for your employees, your operations and your customers.

BS OHSAS 18001 is a framework for an occupational health and safety (ohs) management system and is
a part of the OHSAS 18000 (sometimes incorrectly identified as ISO 18000) series of standards, along
with OHSAS 18002. It can help you put in place the policies, procedures and controls needed for your
organization to achieve the best possible working conditions and workplace health and safety, aligned to
internationally recognized best practice.

QS 9000
QS9000 was a quality standard developed by a joint effort of the “Big Three” American automakers,
General Motors, Chrysler and Ford. It was introduced to the industry in 1994. It has been adopted by
several heavy truck manufacturers in the U.S. as well. Essentially all suppliers to the US automakers
needed to implement a standard QS9000 system, before its termination.

The standard is divided into three sections with the first section being ISO 9001 plus some automotive
requirements.

The second section is titled “Additional Requirements” and contains system requirements that have been
adopted by all three automakers – General Motors, Chrysler and Ford.

The third section is titled the “Customer Specific Section” which contains system requirements that are
unique to each automotive or truck manufacturer.

On December 14, 2006, all QS9000 certifications were terminated. With QS9000, the middle certification
between ISO 9001 and ISO/TS 16949, no longer valid, businesses had a choice between either ISO9001
or TS16949. QS9000 is considered superseded by ISO/TS 16949, now a standard published by IATF,
thus renamed IATF 16949:2016 (current version).

Indian Quality Standards

Manufacturers often sell their products with a quality mark of a product certification body. Quality marks
are meant to communicate the added value of the product. The extra quality may refer to one or more
aspects that a consumer may be unsure about. Such aspects can be environmental impact, product quality,
safety and hygiene, production standards, the absence of additives or preservatives, etc. Overall, a quality
mark gives the consumer a visual and easily identifiable quality assessment tool, originating from a
reliable source. Here, Ashok Kanchan, Food Desk, Consumer Voice, acquaints us with the quality marks
used in India.
ISI MARK

ISI is a certification marks scheme, operated by Bureau of Indian Standards (BIS), earlier known as
Indian Standards Institute (ISI), under the provisions of BIS Act, 1986. Any product that has the ISI mark
is supposed to be of minimum standard and safe for use by consumers.

The ISI mark is both mandatory and voluntary. Some mandatory ISI certification products include
cement, electrical appliances, LPG cylinder, Batteries, Oil pressure stove, Automobile Accessories,
Medical equipment, steel products, Stainless Steel, Chemicals, Fertilizers,  infant foods and packaged
drinking  water. Complete list of mandatory products is listed by BIS.

AGMARK

The Agmark certification is done of agricultural commodities for the benefit of consumers and
producers/manufacturers by Directorate of Marketing and Inspection, an agency of the Government of
India.  There are some 205 different commodities including Pulses, Cereals, Essential Oils, Vegetable
Oils, Fruits and Vegetables, and semi-processed products that have to have an AGMARK. The scheme is
legally enforced by Agricultural Produce (Grading & Marking) Act, 1937.

Manufacturers seeking to grade their commodities under Agmark have to obtain a Certificate of
Authorization from an Agmark laboratory. For this purpose, they should have adequate infrastructure to
process the commodity and access to an approved laboratory for determination of quality and safety
factors. The quality of a product is determined with reference to factors such as size, variety, weight,
colour, moisture and fat content. The grades incorporated are grades 1, 2, 3 and 4, or special, good, fair
and ordinary.

VEGETARIAN AND NON-VEGETARIAN MARKS

As per Food Safety & Standards (Packaging & Labelling) Regulations, 2011:

(i) Every package of ‘non-vegetarian’ food shall bear a declaration to this effect made by a symbol and
colour code as stipulated, to indicate that the symbol and colour product is non-vegetarian food. The
symbol shall consist of a brown colour-filled circle inside a square with brown outline, having sides
double the diameter of the circle.

(ii) Where any article of food contains egg only as non-vegetarian ingredient, the manufacturer or packer
or seller may give declaration to this effect in addition to the said symbol.

iii) Every package of vegetarian food shall bear a declaration to this effect by a symbol and colour code as
stipulated for this purpose to indicate that symbol and colour code the product is vegetarian food. The
symbol shall consist of a green colour-filled circle, having a diameter not less than the minimum size
specified, inside the square with green outline having size double the diameter of the circle.

The symbol shall be prominently displayed

 on the package having contrast background on principal display panel

 just close in proximity to the name or brand name of the product
 on the labels, containers, pamphlets, leaflets, advertisements in any media
Provided also that the provisions of above regulation shall not apply in respect of mineral water or
packaged drinking water or carbonated water or alcoholic drinks, or liquid milk and
milk powders.

For organic products read Organic Certification and Symbols for Organic Food in India

HALLMARK

The hallmarking scheme was launched by Bureau of Indian Standards (BIS) on behest of the Government
of India, for gold in the year 2000 and for silver jewelry in 2005. The scheme is voluntary in nature.

Consumers need to look out for the following markings on gold/silver jewelry:

1. BIS Standard Mark

2. Purity in Carat/fineness mark. With reference to gold, the marks are:

 916 corresponds to 22 carat

 750 corresponds to 18 carat
 585 corresponds to 14 carat

3. Assaying and Hallmarking Centre identification mark/Number: The logo of a BIS-

recognized Assaying and Hallmarking Centre where the jewellery has been assayed
and hallmarked
4. Jeweller’s identification mark: The logo of a BIS-certified jeweller/jewellery
manufacturer

Consumers need to look out for the following markings on gold/silver Bullion:

 BIS Standard Mark

 Fineness
 of bullion, bar or Coin in kg. or g
 Name of Manufacturer
 Serial no.

BEE’ STAR LABEL MARK

So as to provide consumers with a reference for energy saving, and thereby cost saving, aspects of
electrical household and other equipments, in 2006 the Bureau of Electrical Efficiency (BEE) of Ministry
of Power, Government of India, launched a scheme for BEE star on labels. The scheme was invoked for
frost-free (no frost) refrigerators, tubular fluorescent lamps, room air conditioners, direct cool
refrigerators, distribution transformers, induction motors, pump sets, ceiling fans, LPG stoves, electric
geysers and colour TVs.

The BEE star label has been applicable for following electrical products: To sell mandatory products, a
minimum 1 Star rating is mandatory.
Mandatory Appliances Voluntary Appliances
1.Room Air Conditioners 1. Induction Motors
2.Frost Free Refrigerators 2. Pump Sets
3.Tubular Florescent Lamp 3. Ceiling Fans
4. Distribution Transformer 4. LPG Stoves
5. Room Air Conditioner (Casettes, Floor 5. Washing Machine
Standing)
6. Direct Cool Refrigerator 6. Computer(Notebooks/ Laptops)
7. Color TV  7. Ballast ( Electronic/ Magnetic)
8. Electric Geysers 8. Office equipment’s ( Printer, Copier, Scanner,
MFD’s )
9. Variable Capacity Inverter  Air conditioners 9. Diesel Engine Driven Mono-set Pumps
10. LED Lamps 10. Solid State  Inverter 
11. DG Sets

Quality Audit

Quality audit is the process of systematic examination of a quality system carried out by an internal or
external quality auditor or an audit team. It is an important part of an organization’s quality management
system and is a key element in the ISO quality system standard, ISO 9001.

Quality audits are typically performed at predefined time intervals and ensure that the institution has
clearly defined internal system monitoring procedures linked to effective action. This can help determine
if the organization complies with the defined quality system processes and can involve procedural or
results-based assessment criteria.

With the upgrade of the ISO9000 series of standards from the 1994 to 2008 series, the focus of the audits
has shifted from purely procedural adherence towards measurement of the actual effectiveness of the
Quality Management System (QMS) and the results that have been achieved through the implementation
of a QMS.

Audits are an essential management tool to be used for verifying objective evidence of processes, to
assess how successfully processes have been implemented, for judging the effectiveness of achieving any
defined target levels, to provide evidence concerning reduction and elimination of problem areas. For the
benefit of the organization, quality auditing should not only report non-conformances and corrective
actions, but also highlight areas of good practice. In this way other departments may share information
and amend their working practices as a result, also contributing to continual improvement.

Quality audits can be an integral part of compliance or regulatory requirements. One example is the US
Food and Drug Administration, which requires quality auditing to be performed as part of its Quality
System Regulation (QSR) for medical devices (Title 21 of the US Code of Federal Regulations part 820).

Several countries have adopted quality audits in their higher education system (New Zealand, Australia,
Sweden, Finland, Norway and USA) Initiated in the UK, the process of quality audit in the education
system focused primarily on procedural issues rather than on the results or the efficiency of a quality
system implementation.

Audits can also be used for safety purposes. Evans & Parker (2008) describe auditing as one of the most
powerful safety monitoring techniques and ‘an effective way to avoid complacency and highlight slowly
deteriorating conditions’, especially when the auditing focuses not just on compliance but effectiveness.

The processes and tasks that a quality audit involves can be managed using a wide variety of software and
self-assessment tools. Some of these relate specifically to quality in terms of fitness for purpose and
conformance to standards, while others relate to Quality costs or, more accurately, to the Cost of poor
quality. In analyzing quality costs, a cost of quality audit can be applied across any organization rather
than just to conventional production or assembly processes.

Quality Awards

The Rajiv Gandhi National Quality Award is the national quality award given by the Bureau of Indian
Standards to Indian organisations that show excellence in their performance. It is named after Rajiv
Gandhi, the former Prime Minister of India, and was introduced in 1991 after his death. The award aims
to promote quality services to the consumers and to give special recognition to organisations that
contribute significantly towards the quality movement of India.

The award is presented annually as per the financial year, and is similar to other national quality awards
worldwide like the Malcolm Baldrige National Quality Award of the United States, European Quality
Award of the European Union and the Deming Prize of Japan.

The award is presented to organisations in five broad categories: large scale manufacturing, small scale
manufacturing, large scale service sector, small scale service sector and best overall. Furthermore, there
are 14 commendation certificates for organisations showing excellence in various fields, including but not
limited to biotechnology, chemicals, electronics, food and drugs, metallurgy, textiles, jewelry, education,
finance, healthcare and information technology.

Apart from the certificated and awards, the winner of Best of All gets a monetary prize of ₹500,000
(US$7,200), while the other four awards carry a cash prize of ₹200,000 (US$2,900). The commendation
certificate carries a financial incentive of ₹100,000 (US$1,400).