QM Guess Paper Solution 7th sem

ARYA COLLEGE OF ENGINEERING
GUESS PAPERS
( B.Tech. VII Semester 2024- 2025
Quality Management
Unit 1:
Short Answers:(2 Marks Each)
Q. 1Define Quality Management?
Ans. Quality management is the act of overseeing all activities and tasks that must be accomplished to maintain a
desired level of excellence. This includes the determination of a quality policy, creating and implementing quality
planning and assurance, and quality control and quality improvement. It is also referred to as total quality
management (TQM).
Quality management ensures that an organization, product or service is consistent. It has four main
components: quality planning, quality assurance, quality control and quality improvement. Quality management is
focused not only on product and service quality, but also on the means to achieve it. Quality management, therefore,
uses quality assurance and control of processes as well as products to achieve more consistent quality.
Q. 2 Explain the concept of Quality on the basis of Quality Management?

Ans.The key concepts of quality management
 Produce goods or services that respond specifically to customer needs.

 To ensure the survival of the company with profit obtained through quality.
 Identify the most critical problems and solve them with the highest priority.
 Talk to reason and make decisions based on factual data.
 Administer the company throughout the process and not by its results.
 Methodically reduce wastage by isolating the root causes.
 The customer is king. Do not serve them without quality products.
 Prevention should have the highest importance.
 When using ‘trial and error’ never allow a problem to repeat.
Q. 3How to do Quality Assurance?

Ans. Quality assurance has a defined cycle called PDCA cycle or Deming cycle. The phases of this cycle are:
 Plan
 Do
 Check
 Act
These above steps are repeated to ensure that processes followed in the organization are evaluated and improved on
a periodic basis. Let's look into the above steps in detail -
 Plan - Organization should plan and establish the process related objectives and determine the processes that
are required to deliver a high-Quality end product.
 Do - Development and testing of Processes and also "do" changes in the processes
 Check - Monitoring of processes, modify the processes, and check whether it meets the predetermined
objectives
 Act - Implement actions that are necessary to achieve improvements in the processes
An organization must use Quality Assurance to ensure that the product is designed and implemented with correct
procedures. This helps reduce problems and errors, in the final product.
Q. 4What are 4 types of Quality Control? Define them.

TOTAL QUALITY MANAGEMENT ( TQM)
Total Quality Management takes on an entire management system and is specifically focused on improving
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customer satisfaction. TQM uses scientific methods for assessing quality, the cost of said quality, and also shifts
the focus to improving quality control in the future. TQM requires a wholistic approach where all functions,
process, departments, and employees at all levels are relied upon to ensure the principles of quality control are an
ever-present guiding light in every facet of operations.
SIX SIGMA
When you look at a company obsessed with quality the way Motorola is, you know that their methods for quality
control simply work. Motorola came up with this model for improving business processes focused on reducing
errors. The term Six Sigma refers to a statistical measurement which means "3.4 defects per 1 million
opportunities." From an organizational standpoint, this means that decisions are made based on data, problems
are identified and eliminated, and defects are based on customer requirements and feedback.
LEAN PRODUCTION
Lean production, which is often credited to a Japanese adaptation of Deming's philosophy. Lean production is the
continuous flow of products and the moment customers need them. It places a focus on increasing both quality
and productivity while decreasing inventory and shortening lead times from floor to consumer. The principles of
lean production feature workplace safety, order, and cleanliness, as well as just-in-time production, and visual
management. Lean production also adopts the principles of Six Sigma production.
INTERNATIONAL STANDARDS ORGANIZATION QUALITY MANAGEMENT STANDARD

( ISO)S
One of, if not the most, instantly recognizable benchmarks for quality control is none other than International
Standards Organization's (ISO) Quality Management Standards (QMS). The ISO has a collection of certifications
that manufacturers and other businesses can earn. One such certification is the ISO-9001 certification, which is
akin to the gold standard for all manufacturers who seek a higher level of quality. ISO also has specific
certifications for automotive, aerospace, and telecom companies. Holding an ISO certification is evidence of an
organization which has achieved the highest standards for quality management systems.
Q. 5Give formula to control Cost of Quality?

Ans. Cost of Quality = P C + A C + IFC + EFC
Q. 6State the views of different Quality Gurus?

Ans. 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.
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Descriptive Answers: (6 to 15 Marks)
Q. 1Explain the term Quality Management. What are the different components of Quality Management?
Ans. Quality management is the act of overseeing all activities and tasks that must be accomplished to maintain a
desired level of excellence. This includes the determination of a quality policy, creating and implementing quality
planning and assurance, and quality control and quality improvement. A quality management system (QMS) is a
collection of business processes focused on consistently meeting customer requirements and enhancing their
satisfaction. ... It is expressed as the organizational goals and aspirations, policies, processes, documented
information and resources needed to implement and maintain it.
Components of quality management
Quality management consists of four key components, which include the following:
Quality Planning – The process of identifying the quality standards relevant to the project and deciding how to
meet them.
Quality Improvement – The purposeful change of a process to improve the confidence or reliability of the
outcome.
Quality Control – The continuing effort to uphold a process’s integrity and reliability in achieving an outcome.
Quality Assurance – The systematic or planned actions necessary to offer sufficient reliability so that a particular
service or product will meet the specified requirements.
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Q. 2What do you mean by Cost of Quality. Explain the types of cost of Quality in detail.
Ans. Cost of Quality is a methodology used to define and measure where and what amount of an
organization’s resources are being used for prevention activities and maintaining product quality as
opposed to the costs resulting from internal and external failures. The Cost of Quality can be
represented by the sum of two factors. The Cost of Good Quality and the Cost of Poor Quality equals
the Cost of Quality, as represented in the basic equation below:
CoQ = CoGQ + CoPQ
The Cost of Quality equation looks simple but in reality it is more complex. The Cost of Quality
includes all costs associated with the quality of a product from preventive costs intended to reduce or
eliminate failures, cost of process controls to maintain quality levels and the costs related to failures
both internal and external.
How to Measure Cost of Quality (COQ)
The methods for calculating Cost of Quality vary from company to company. In many cases, organizations like the
one described in the previous example, determine the Cost of Quality by calculating total warranty dollars as a
percentage of sales. Unfortunately this method is only looking externally at the Cost of Quality and not looking
internally. In order to gain a better understanding, a more comprehensive look at all quality costs is required.
The Cost of Quality can be divided into four categories.
1.They include Prevention,
2. Appraisal,
3. Internal Failure and
4.External Failure.
Within each of the four categories there are numerous possible sources of cost related to good or poor
quality.
The Cost of Good Quality (CoGQ)

Prevention Costs – costs incurred from activities intended to keep failures to a minimum. These can include,
but are not limited to, the following:
• Establishing Product Specifications
• Quality Planning
• New Product Development and Testing
• Development of a Quality Management System (QMS)
• Proper Employee Training

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• Appraisal Costs – costs incurred to maintain acceptable product quality levels.
• Appraisal costs can include, but are not limited to, the following:
• Incoming Material Inspections
• Process Controls
• Check Fixtures
• Quality Audits
• Supplier Assessments
The Cost of Poor Quality (CoPQ)

Internal Failures – costs associated with defects found before the product or service reaches the customer. Internal
Failures may include, but are not limited to, the following examples:
• Excessive Scrap
• Product Re-work
• Waste due to poorly designed processes
• Machine breakdown due to improper maintenance
• Costs associated with failure analysis
External Failures – costs associated with defects found after the customer receives the product or service. External
Failures may include, but are not limited to, the following examples:
• Service and Repair Costs
• Warranty Claims
• Customer Complaints
• Product or Material Returns
• Incorrect Sales Orders
• Incomplete BOMs
• Shipping Damage due to Inadequate Packaging
These four categories can now be applied to the original Cost of Quality equation. Our original equation stated
that the Cost of Quality is the sum of Cost of Good Quality and Cost of Poor Quality. This is still true however
the basic equation can be expanded by applying the categories within both the Cost of Good Quality and the Cost
of Poor Quality. The Cost of Good Quality is the sum of Prevention Cost and Appraisal Cost
(CoGQ = PC + AC)
The Cost of Poor Quality is the sum of Internal and External Failure Costs
(CoPQ = IFC + EFC)
By combining the equations, Cost of Quality can be more accurately defined, as shown in the equation below:
COQ = (PC + AC) + (IFC + EFC)
One important factor to note is that the Cost of Quality equation is nonlinear. Investing in the
Cost of Good Quality does not necessarily mean that the overall Cost of Quality will increase. In fact, when the
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resources are invested in the right areas, the Cost of Quality should decrease. When failures are prevented /
detected prior to leaving the facility and reaching the customer, Cost of Poor Quality will be reduced.
Q. 3How can you say that” Quality as winning Strategy”. Elaborate.

Ans: Let me first point out that the concept of Quality has evolved over time from a technical notion of a product
or service satisfying technical specifications set forth by governments and professional organizations to a broader
concept of a product or service satisfying customers’ expectations. Nowadays Quality is about delivering the full
expected value of a product to the buyer.
I can recall the first time in my life that I was confronted with a quality issue as a consumer. I was in college when I
proudly bought my first car, a second-hand Nissan Datsun. But I was shocked to hear my friends’ comments when I
presented my new car to them. One of them turned to me and said “Leo, haven’t you heard that these Japanese cars
don’t last because they are partially made with paper?” It was not the type of reaction I was expecting even though
the car was so tiny that my knees were frequently touching the wheel when driving. Nevertheless, the experience
raised my awareness about quality (real and perceived) in purchasing decisions.
Since then Japan has won the car war and Japanese car makers are leading globally in most high-end markets. They
copied and learned from US manufacturers and succeeded in completely revolutionizing the car
manufacturing process by investing and innovating in quality management.
Yet some people still doubt that quality is the best path to success as they watch the recent rise of China in the world
market with confusing signs. Quality does not seem be at the center of China’s industrial strategy since it has
primarily gained huge markets shares by massively manufacturing and dumping substandard cheap products into the
world market. Let me however point out that besides substandard quality products primarily designed for emerging
markets, China has also developed a high quality-based industry competing along the quality ladder in non-price-
based markets in developed countries. The example of China then ultimately also confirms that Quality remains a
powerful support for any long-term strategy for expansion.
I should acknowledge that my early exposure to quality issues has driven my interest during my career for quality
management as a business manager and when assisting in the setting- up of a quality standard organization. I had the
privilege of following the example of diverse organizations from various industries who have successfully taken
advantage of a quality policy in a very competitive environment here in the US and across the world. Quality is not a
simple gadget designed for large multinational companies, but it is a real strategy driving market expansion for
companies of all sizes. Here are the three major principles underlying a successful quality improvement process:
 Get the Board involved in strategizing Quality

 Create a Mindset of Quality throughout the organization
 Plan Quality as a continuous process
The Quality strategy is part of the Board’s responsibilities because of it takes all major functions of the
organization ( production, research, marketing, sales. supply chain, HR, administration. Etc.) to be able to deliver the
best level of customer satisfaction and maintain a consistent corporate image across departments and regions.
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The other reason for the Board to keep the oversight of Quality is its huge potential financial impact. On the positive
side, quality improvements generate multiple substantial benefits : customer satisfaction, increased market shares,
more effective processes, cost reductions, revenue and income increase . On the bad side , any quality issue can turn
fast into a major crisis for any organization , generating huge costs in litigation, products replacement , loss of
customers and image. A trend that is particularly true in this era of social media frenzy where an incident from a
remote village in India could be dramatically felt at the headquarters. That is why the board’s commitment is critical
in initiating and keeping a global view the Quality improvement process to make sure that :
 a comprehensive evaluation of quality risks ( positive or negative) is made globally

 Operational quality plans are consistent with strategic goals
 A powerful support is provided to the process for necessary resources ( financial, human, material )
 an efficient quality communication system is developed Top Down and Bottom Up
Creating a mindset of total quality is critical to mobilize the internal creativity and energy that feed the entire
continuous quality improvement process. Various resources can be used to achieve that goal such as :
communication, training, incentives. Everyone needs to be involved at each step of the supply chain with a focus on
:
 Purchasing quality parts ,goods or services while negotiating competitive prices and diversifying sources of
supply by including SMEs or local suppliers in international operations or projects ( helping them to upgrade
and to be associated to the project)
 Manufacturing/processing products in compliance with recognized norms and standards
 Offering seamless integration of sales/ after-sales to help consumers enjoy the full expected value of their
purchase on time
It is therefore critical to communicate internally and to set up incentives for the staff at all levels.
In a fast changing and global world, more than ever Quality is to be addressed as a continuous process of
improvement moving along continuous technological innovations and changing customers’ needs. It should
therefore be planned in a long-term perspective as other organization’s business strategies by:
 Setting out strategic and operational road-maps with SMART goals (Specific, Measurable, Attainable,
Relevant and Timely)
 Updating periodically quality criteria and goals according to the evolution of customers’ needs . Here is an
example of a changing quality need in the current throwaway society: the life expectancy of a refrigerator has
shrunk from 40-50 years in the sixties to 10-15 years nowadays and consumers are happy.
 Getting a quality certification is usually one of the steps in the quality road-map; local or international
certifications ( ISO or equivalent) are always beneficial in certain industries and business environments, but
certifications can be costly and are not always a requirement in many markets across the world;
Finally , choosing to invest in QUALITY is an achievable and winning strategy adding a powerful competitive
advantage that outweighs its cost. For the least organizations that value their responsibility to the community will
endeavor creating products that don’t put consumers safety or the environment at risk.
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Q. 4Write a short note on: (i) Quality Assurance (ii) Quality Control
Ans: Quality assurance (QA) is a way of preventing mistakes and defects in manufactured products and avoiding
problems when delivering products or services to customers; which ISO 9000 defines as "part of quality
management focused on providing confidence that quality requirements will be fulfilled".This defect prevention in
quality assurance differs subtly from defect detection and rejection in quality control and has been referred to as
a shift left since it focuses on quality earlier in the process (i.e., to the left of a linear process diagram reading left to
right).
The terms "quality assurance" and "quality control" are often used interchangeably to refer to ways of ensuring the
quality of a service or product. For instance, the term "assurance" is often used as follows: Implementation of
inspection and structured testing as a measure of quality assurance in a television set software project at Philips
Semiconductors is described. The term "control", however, is used to describe the fifth phase of the Define,
Measure, Analyze, Improve, Control (DMAIC) model. DMAIC is a data-driven quality strategy used
to improve processes.
Quality assurance comprises administrative and procedural activities implemented in a quality system so that
requirements and goals for a product, service or activity will be fulfilled.[3] It is the systematic measurement,
comparison with a standard, monitoring of processes and an associated feedback loop that confers error
prevention.[6] This can be contrasted with quality control, which is focused on process output.
Quality assurance includes two principles: "Fit for purpose" (the product should be suitable for the intended
purpose); and "right first time" (mistakes should be eliminated). QA includes management of the quality of raw
materials, assemblies, products and components, services related to production, and management, production
and inspection processes.[8] The two principles also manifest before the background of developing (engineering) a
novel technical product: The task of engineering is to make it work once, while the task of quality assurance is to
make it work all the time.
Historically, defining what suitable product or service quality means has been a more difficult process, determined in
many ways, from the subjective user-based approach that contains "the different weights that individuals normally
attach to quality characteristics," to the value-based approach which finds consumers linking quality to price and
making overall conclusions of quality based on such a relationship.
Quality control (QC) is a process through which a business seeks to ensure that product quality is maintained or
improved. Quality control requires the business to create an environment in which both management and employees
strive for perfection. This is done by training personnel, creating benchmarks for product quality and testing
products to check for statistically significant variations.
A major aspect of quality control is the establishment of well-defined controls. These controls help standardize both
production and reactions to quality issues. Limiting room for error by specifying which production activities are to
be completed by which personnel reduces the chance that employees will be involved in tasks for which they do not
have adequate training.
 Quality control (QC) is a process through which a business seeks to ensure that product quality is maintained
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or improved.
 Quality control involves testing of units and determining if they are within the specifications for the final
product.
 The quality control used in a business is highly dependent on the product or industry, and several techniques
exist for measuring quality.
Q. 5Explain TQM. Describe the key elements of Total Quality Management?.

Ans: TOTAL QUALITY MANAGEMENT (TQM)
Total Quality Management takes on an entire management system and is specifically focused on improving
customer satisfaction. TQM uses scientific methods for assessing quality, the cost of said quality, and also shifts
the focus to improving quality control in the future. TQM requires a wholistic approach where all functions,
process, departments, and employees at all levels are relied upon to ensure the principles of quality control are an
ever-present guiding light in every facet of operations.
Key elements
Ethics
Integrity
Trust
Training
Teamwork
Leadership
Recognition
Communication
Ethics:
Ethics is an element that is concerned with the understanding of the good and bad in any situation at the workplace.
It is a subject related to the organization as well as the individual. Ethics of an organization set up the business code
which outlines the guidelines that every employee is expected to follow. The individual ethics incorporate the rights
and wrongs.
Integrity:
Integrity is an element which refers to the morals, honesty, values, and sincerity of an individual in the organization.
It involves respecting fellow workers and the policies of the organization. This is one of the important characteristics
for which the customers expect.
Trust:
The by-product of ethical conduct and integrity is trust. The framework of Total Quality Management cannot be
built without trust. It stimulates complete participation of all members in the organization. It improves the
relationship among employees which helps in better decision making. It also promotes continuous improvement by
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individual risk-taking.
Training:
To be highly productive, employees must be trained. This responsibility falls solely on the supervisors who are
responsible for implementing Total Quality Management in their respective departments. Employees must be trained
under decision making, problem-solving, interpersonal skills, technical skills, and business economics. This is done
so that the employees can work effectively and produce efficient results.
Teamwork:
Teamwork is a crucial element of TQM. It helps the business to receive effective and efficient solutions to the
problems. Teams also provide a permanent improvement in process and operation. TQM organizations usually adopt
three types of teams. They are:
Quality improvement team: Also known as excellence teams whose purpose is to deal with the problems that recur
often. They are set up for 3 to 12 months.
Problem-solving team: These teams are set up to solve certain problems and also to identify the root cause of those
problems. They usually last from 1 week to 3 months.
Leadership:
Leadership is a quality trait of a person who provides an inspiring vision to the team and sets strategic directions to
be understood by all. This is one of the crucial elements which must be constructive, effective and positive.
Recognition:
This element involves the suggestions and achievements for the teams and the individuals including positive
feedback and encouragement. Every employee seeks recognition and it is the duty of the supervisor to detect and
recognize the contributors and motivate them. This increases self-esteem and boosts performance and morale in an
individual.
Communication:
Communication binds the organization together and is the core element of success. It is necessary to make sure that
all the levels of communication among the suppliers, member and the customers are kept open. The communication
among employees or the members of the organization is done in three ways. They are:
Downward communication: Downward communication is the central form of communication in any organization. It
is basically done through discussions and presentations.
Upward communication: Upward communication provides a platform to build trust amongst the employees and the
supervisors.
Sideways communication: This type of communication takes place among various departments. It allows dealing
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with customers and suppliers in a professional way and helps break down the barriers between the departments.
Q. 6 Explain the Deming management philosophy. Why has it been controversial?

Ans: Deming opined that by embracing certain principles of the management, organizations can improve the quality
of the product and concurrently reduce costs. Reduction of costs would include the reduction of waste production,
reducing staff attrition and litigation while simultaneously increasing customer loyalty. The key, in Deming’s
opinion, was to practice constant improvement and to imagine the manufacturing process as a seamless whole, rather
than as a system made up of incongruent parts.
In the 1970s, some of Deming's Japanese proponents summarized his philosophy in a two-part comparison:
Organizations should focus primarily on quality, which is defined by the equation ‘Quality = Results of work
efforts/total costs’. When this occurs, quality improves, and costs to fall suddenly and quickly from a high level or
position., over time.
When organizations' focus is primarily on costs, the costs will rise, but over time the quality drops.
The Deming Cycle
Also known as the Shewhart Cycle, the Deming Cycle, often called the PDCA, was a result of the need to link the
manufacture of products with the needs of the consumer along with focusing departmental resources in a collegial
effort to meet those needs.
The steps that the cycle follow are:

• Plan: Design a consumer research methodology that will inform business process components.
• Do: Implement the plan to measure its performance.
• Check: Check the measurements and report the findings to the decision-makers.
• Act/Adjust: Draw a conclusion on the changes that need to be made and implement them.
The 14 Points for Management

Deming’s other chief contribution came in the form of his 14 Points for Management, which consists of a set of
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guidelines for managers looking to transform business effectiveness.
1.Create constancy of purpose for improvement of product and service
2.Follow a new philosophy
3. Discontinue dependence on mass inspection
4. Cease the practices of awarding business on price tags.
5. Strive always to improve the production and service of the organization
6.Introduce new and modern methods of on-the-job training
7.Device modern methods of supervision
8.Let go of fear
9. Destroy barriers among the staff areas.
10. Dispose of the numerical goals created for the workforce.
11.Eradicate work standards and numerical quotas
12.Abolish the barriers that burden the workers
13.Device a vigorous education and training program
14.Cultivate top management that will strive toward these goals
Unit 2:
Short Answers: (2 Marks Each)
Q. 1 State 7QC tools?

Ans: The 7 quality tools were first conceptualized by Kaoru
Ishikawa, a professor of engineering at the University of Tokyo. They can be used for controlling and managing
quality in any organization.
The 7 basic quality tools are, essentially, graphical techniques used to identify & fix issues related to product or
process quality.
The 7 basic quality tools are as follows:
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1.Flow Chart
2.Histogram
3.Cause-and-Effect Diagram
4.Check Sheet
5.Scatter Diagram
6.Control Charts
7.Pareto Charts
Q. 2Explain measurement system analysis?

Ans: 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.
Before we dive further into MSA, we should review the definition of a measurement system and some of the
common sources of variation. A measurement system has been described as a system of related measures that
enables the quantification of particular characteristics. It can also include a collection of gages, fixtures, software
and personnel required to validate a particular unit of measure or make an assessment of the feature or
characteristic being measured. The sources of variation in a measurement process can include the following:
• Process – test method, specification
• Personnel – the operators, their skill level, training, etc.
• Tools / Equipment – gages, fixtures, test equipment used and their associated
calibration systems
• Items to be measured – the part or material samples measured, the sampling plan, etc. •Environmental factors –
temperature, humidity, etc.
Q. 3What do you mean by acceptance sampling pan?

Ans: Acceptance sampling is a statistical measure used in quality control. It allows a company to determine the
quality of a batch of products by selecting a specified number for testing. The quality of this designated sample will
be viewed as the quality level for the entire group of products.
A company cannot test every one of its products. There may simply be too high a volume or number of them to
inspect at a reasonable cost or within a reasonable time frame. Or effective testing might result in the destruction of
the product or making it unfit for sale in some way.
Acceptance sampling solves these problems by testing a representative sample of the product for defects. The
process involves first, determining the size of a product lot to be tested, then the number of products to be sampled,
and finally the number of defects acceptable within the sample batch.
Products are chosen at random for sampling. The procedure usually occurs at the manufacturing site—the plant or
factory—and just before the products are to be transported. This process allows a company to measure the quality
of a batch with a specified degree of statistical certainty without having to test every single unit. Based on the
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results—how many of the predetermined number of samples pass or fail the testing—the company decides whether
to accept or reject the entire lot. The statistical reliability of a sample is generally measured by a t-statistic, a type of
inferential statistic used to determine if there is a significant difference between two groups that share common
features.
A History of Acceptance Sampling
Acceptance sampling in its modern industrial form dates from the early 1940s. It was originally applied by the U.S.
military to the testing of bullets during World War II. The concept and methodology were developed by Harold Dodge,
a veteran of the Bell Laboratories quality assurance department, who was acting as a consultant to the Secretary of War.
While the bullets had to be tested, the need for speed was crucial, and Dodge reasoned that decisions about entire lots
could be made by samples picked at random. Along with Harry Romig and other Bell colleagues, he came up with a
precise sampling plan to be used as a standard, setting the sample size, the number of acceptable defects, and other
criteria.
Acceptance sampling procedures became common throughout World War II and afterward. However, as
Dodge himself noted in 1969, acceptance sampling is not the same as acceptance quality control.
Dependent on specific sampling plans, it applies to specific lots and is an immediate, short-term test—a
spot check, so to speak. In contrast, acceptance quality control applies in a broader, more long-term
sense for the entire product line; it functions as an integral part of a well-designed manufacturing
process and system.
Q. 4Explain the term hypothesis testing?

Ans: Hypothesis testing is an act in statistics whereby an analyst tests an assumption regarding a population parameter.
The methodology employed by the analyst depends on the nature of the data used and the reason for the analysis.
Hypothesis testing is used to assess the plausibility of a hypothesis by using sample data. Such data may come from a
larger population, or from a data-generating process. The word "population" will be used for both of these cases in the
following descriptions.
 Hypothesis testing is used to assess the plausibility of a hypothesis by using sample data.
 The test provides evidence concerning the plausibility of the hypothesis, given the data.
 Statistical analysts test a hypothesis by measuring and examining a random sample of the population being
analyzed.
Q. 5What does Regression mean in Process Quality Improvement?

Ans: Regression analysis is most associated with the analysis phase of the five-step Six Sigma method of DMAIC,
which stands for define, measure, analyze, improve and control. DMAIC allows organizations to optimize existing
processes and eliminate defects. Regression analysis is one of many tools of the Six Sigma analysis phase.
Regression analysis can also be used in Lean to find areas of waste. It allows for both making predictions based on data
and for measuring whether results align with what is expected when a variable in a process is changed.
Q. 6What is the role of process capability analysis?

Ans: 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.
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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.
STATGRAPHICS provides capability analyses for the following cases:
Probability Capability Indices
Cp stands for process capability, and is a simple measure of the capability of a process. It tells us how
much potential the system has of meeting both upper and lower specification limits. Its weak point is that,
in focusing on the data spread, it ignores the averages; so if the system being tested isn’t centered between
the specification limits it may (when used alone) give misleading impressions. The narrower the spread of
a systems output is, the greater the Cp value.
You can test how centered a system is by comparing Cp to Cpk. If a process is centered on its target,
these two will be equal. The larger the difference between Cpk and Cp the more off-center your process
is.
Cpk stands for process capability index and refers to the capability a particular process has of achieving output
within certain specifications. In manufacturing, it describes the ability of a manufacturer to produce a product
that meets the consumers expectations, within a tolerance zone. If Cpk is more than 1, the system has the
potential to perform as well as required.
Q. 1 Elaborate simple graphical and statistical techniques of seven basic tools of Quality?
Ans: The seven quality tools were originally developed by Japanese professor of engineering Kaoru Ishikawa. They
were implemented by Japan’s industrial training program during the country’s postwar period as it turned to statistical
quality control as a means of quality assurance. Their goal was to implement basic, user-friendly tools that workers
from various backgrounds with varied skill sets could implement without extensive training.
Today, these quality management tools are still considered the gold standard for troubleshooting a variety of quality
issues. They’re frequently implemented in conjunction with today’s most widely used process improvement
methodologies, including various phases of Six Sigma, TQM, continuous improvement processes, and Lean
management.
7 quality tools
1. Stratification
Stratification analysis is a quality assurance tool used to sort data, objects, and people into separate and distinct groups.
Separating your data using stratification can help you determine its meaning, revealing patterns that might not otherwise
be visible when it’s been lumped together.
Whether you’re looking at equipment, products, shifts, materials, or even days of the week, stratification analysis lets
you make sense of your data before, during, and after its collection.
To get the most out of the stratification process, consider which information about your data’s sources may affect the
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end results of your data analysis. Make sure to set up your data collection so that that information is included.
2. Histogram
Quality professionals are often tasked with analyzing and interpreting the behavior of different groups of data in an
effort to manage quality. This is where quality control tools like the histogram come into play.
The histogram can help you represent frequency distribution of data clearly and concisely amongst different groups of a
sample, allowing you to quickly and easily identify areas of improvement within your processes. With a structure
similar to a bar graph, each bar within a histogram represents a group, while the height of the bar represents the
frequency of data within that group.
Histograms are particularly helpful when breaking down the frequency of your data into categories such as age, days of
the week, physical measurements, or any other category that can be listed in chronological or numerical order.
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3. Check sheet (or tally sheet)

Check sheets can be used to collect quantitative or qualitative data. When used to collect quantitative data, they can be
called a tally sheet. A check sheet collects data in the form of check or tally marks that indicate how many times a
particular value has occurred, allowing you to quickly zero in on defects or errors within your process or product, defect
patterns, and even causes of specific defects.
With its simple setup and easy-to-read graphics, check sheets make it easy to record preliminary frequency distribution
data when measuring out processes. This particular graphic can be used as a preliminary data collection tool when
creating histograms, bar graphs, and other quality tools.
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4. Cause-and-effect diagram (also known as a fishbone or Ishikawa diagram)

Introduced by Kaoru Ishikawa, the fishbone diagram helps users identify the various factors (or causes) leading to an
effect, usually depicted as a problem to be solved. Named for its resemblance to a fishbone, this quality management
tool works by defining a quality-related problem on the right-hand side of the diagram, with individual root causes and
sub causes branching off to its left.
A fishbone diagram’s causes and subcauses are usually grouped into six main groups, including measurements,
materials, personnel, environment, methods, and machines. These categories can help you identify the probable source
of your problem while keeping your diagram structured and orderly.
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5. Pareto chart (80-20 rule)

As a quality control tool, the Pareto chart operates according to the 80-20 rule. This rule assumes that in any process,
80% of a process’s or system’s problems are caused by 20% of major factors, often referred to as the “vital few.” The
remaining 20% of problems are caused by 80% of minor factors.
A combination of a bar and line graph, the Pareto chart depicts individual values in descending order using bars, while
the cumulative total is represented by the line.
The goal of the Pareto chart is to highlight the relative importance of a variety of parameters, allowing you to identify
and focus your efforts on the factors with the biggest impact on a specific part of a process or system.
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6. Scatter diagram
Out of the seven quality tools, the scatter diagram is most useful in depicting the relationship between two variables,
which is ideal for quality assurance professionals trying to identify cause and effect relationships.
With dependent values on the diagram’s Y-axis and independent values on the X-axis, each dot represents a common
intersection point. When joined, these dots can highlight the relationship between the two variables. The stronger the
correlation in your diagram, the stronger the relationship between variables.
Scatter diagrams can prove useful as a quality control tool when used to define relationships between quality defects
and possible causes such as environment, activity, personnel, and other variables. Once the relationship between a
particular defect and its cause has been established, you can implement focused solutions with (hopefully) better
outcomes.
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7. Control chart (also called a Shewhart chart)

Named after Walter A. Shewhart, this quality improvement tool can help quality assurance professionals determine
whether or not a process is stable and predictable, making it easy for you to identify factors that might lead to variations
or defects.
Control charts use a central line to depict an average or mean, as well as an upper and lower line to depict upper and
lower control limits based on historical data. By comparing historical data to data collected from your current process,
you can determine whether your current process is controlled or affected by specific variations.
Using a control chart can save your organization time and money by predicting process performance, particularly in
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terms of what your customer or organization expects in your final product.
Q. 2 Explicate the term Analysis of Variance (ANOVA). What does the analysis of Variance reveal?
Ans: Analysis of variance (ANOVA) is a collection of statistical models and their associated
estimation procedures (such as the "variation" among and between groups) used to analyze
the differences among group means in a sample. ANOVA was developed by the statistician
Ronald Fisher. The ANOVA is based on the law of total variance, where the observed
variance in a particular variable is partitioned into components attributable to different
sources of variation. In its simplest form, ANOVA provides a statistical test of whether two
or more population means are equal, and therefore generalizes the t-test beyond two means.
Classes of models
Fixed-effects model.
The fixed-effects model (class I) of analysis of variance applies to situations in which the experimenter
applies one or more treatments to the subjects of the experiment to see whether the response variable
values change. This allows the experimenter to estimate the ranges of response variable values that the
treatment would generate in the population as a whole.
Random-effects models.
Random-effects model (class II) is used when the treatments are not fixed. This
occurs when the various factor levels are sampled from a larger population.
Because the levels themselves are random variables, some assumptions and the
method of contrasting the treatments (a multivariable generalization of simple
differences) differ from the fixed-effects model.
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Mixed-effects models.
A mixed-effects model (class III) contains experimental factors of both fixed and random-effects types, with
appropriately different interpretations and analysis for the two types.
Example: Teaching experiments could be performed by a college or university department to find a good
introductory textbook, with each text considered a treatment. The fixed-effects model would compare a list of
candidate texts. The random-effects model would determine whether important differences exist among a list of
randomly selected texts. The mixed-effects model would compare the (fixed) incumbent texts to randomly
selected alternatives.
Defining fixed and random effects has proven elusive, with competing definitions arguably leading
toward a linguistic quagmire.
Q. 3 What do you mean by Design of Experiments? When to use DOE?

Ans: Design of experiments (DOE) is defined as a branch of applied statistics that deals with planning, conducting,
analyzing, and interpreting controlled tests to evaluate the factors that control the value of a parameter or group of
parameters. DOE is a powerful data collection and analysis tool that can be used in a variety of experimental
situations.
It allows for multiple input factors to be manipulated, determining their effect on a desired output (response). By
manipulating multiple inputs at the same time, DOE can identify important interactions that may be missed when
experimenting with one factor at a time. All possible combinations can be investigated (full factorial) or only a portion
of the possible combinations (fractional factorial).
A strategically planned and executed experiment may provide a great deal of information about the effect
on a response variable due to one or more factors. Many experiments involve holding certain factors
constant and altering the levels of another variable. This "one factor at a time" (OFAT) approach to process
knowledge is, however, inefficient when compared with changing factor levels simultaneously. Many of
the current statistical approaches to designed experiments originate from the work of R. A. Fisher in the
early part of the 20th century. Fisher demonstrated how taking the time to seriously consider the design and
execution of an experiment before trying it helped avoid frequently encountered problems in analysis. Key
concepts in creating a designed experiment include blocking, randomization, and replication.
Blocking: When randomizing a factor is impossible or too costly, blocking lets you
restrict randomization by carrying out all of the trials with one setting of the factor and
then all the trials with the other setting.
Randomization: Refers to the order in which the trials of an experiment are performed.
A randomized sequence helps eliminate effects of unknown or uncontrolled variables.
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Replication: Repetition of a complete experimental treatment, including the setup.
When to use DOE:
Use DOE when more than one input factor is suspected of influencing an output. For
example, it may be desirable to understand the effect of temperature and pressure on the
strength of a glue bond.
DOE can also be used to confirm suspected input/output relationships and to develop a
predictive equation suitable for performing what-if analysis.
Q. 4 Explain Graphical tools for data representation?

🞂 Ans: Graphing the data can be utilized for both historical data already available and when
analyzing the data resulting from live data collection activities. Of course, you need to
pick the right graphical tool as there are a lot of different ways to plot your data. A number
of commonly used graphical tools will be covered here. However, note that if one graph
fails to reveal anything useful, try another one.
🞂 A long list of data is usually not practical for conveying information about a process. One
of the best ways to analyze problems in any process is to plot the data and see what it is
telling you. This is often recommended as a starting point in any data analysis during the
problem-solving process. A wide range of graphical tools are available which can generate
graphs quickly and easily such as Minitab and Microsoft Excel.
Different graphs can reveal different characteristics of your data such as the
central tendency, the dispersion and the general shape for the distribution.
Graphical Analysis allows to quickly learn about the nature of the process,
enables clarity of communication and provides focus for further analysis. It is an
important tool for understanding sources of variation in the data and thereby
helping to better understand the process and where root causes might be.
Conclusions drawn from the graphical analysis may require verification through
further advanced statistical techniques such as significance testing and
experimentation.
Q. 5 How process capability analysis finds out that the given process meets the sets of specification limits?
Ans: 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.
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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.
STATGRAPHICS provides capability analyses for the following cases:
 Probability Capability Indices

Cp stands for process capability, and is a simple measure of the capability of a process. It tells us how
much potential the system has of meeting both upper and lower specification limits. Its weak point is that,
in focusing on the data spread, it ignores the averages; so if the system being tested isn’t centered between
the specification limits it may (when used alone) give misleading impressions. The narrower the spread of
a systems output is, the greater the Cp value.
You can test how centered a system is by comparing Cp to Cpk. If a process is centered on its target,
these two will be equal. The larger the difference between Cpk and Cp the more off-center your process
is.
Cpk stands for process capability index and refers to the capability a particular process has of achieving output
within certain specifications. In manufacturing, it describes the ability of a manufacturer to produce a product
that meets the consumers expectations, within a tolerance zone. If Cpk is more than 1, the system has the
potential to perform as well as required.
The equation for Cpk is [minimum(mean – LSL, USL – mean)] / (0.5*NT), where NT stands for natural
tolerance, LSL for lower specification limit and USL for upper specification limit. Pp stands for process
performance. It is much the same as Cp, but unlike Cp it measures actual performance rather than potential.
Like Cp, it measures spread, and is subject to the same weaknesses.
>Ppk stands for process performance index. Like Pp, it measures actual performance rather than potential. A
Ppk of between 0 and 1 indicates that not all the processes outputs are meeting specifications. If Ppk is 1,
99.73% of your system’s output is within the specifications. The percentage 99.73% comes from the normal
distribution curve, where 99.73% of results fall within -3 and 3 standard deviations from the mean.
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• Smaller Ppkvalues indicate the deviation from specification is larger.

• Larger Ppkvalues indicate the deviation from specification is smaller.
These numbers, and a histogramrepresenting them, are usually produced in a process capability analysis report.
Q. 6 What is the importance of Hypothesis testing in Quality Management?

Ans:In modern manufacturing plants, people still seldom attach importance to hypothesis testing, which they believe is
merely a matter of theory. However, the application of hypothesis testing in quality management should be promoted.
Both parametric test (t-test and z-test) and nonparametric test (sign test and Wilcoxon rank-sum test) are appropriate for
use in a manufacturing environment.
Data collection establishes the foundation for appraising quality of a product or service. But without correct data
processing, it becomes challenging to make an objective conclusion. Sometimes, the observation is wrongly interpreted.
For instance, suppose that the fallout rate of samples drawn from two different groups is 15% and 10%, respectively. It
would be a partial judgment saying that one is better than the other. On this occasion, hypothesis testing is instrumental
in explanation of phenomena. Unfortunately, in many manufacturing facilities people tend to merely focus on
descriptive statistics such as arithmetic mean and range. Simply put, application of hypothesis testing is indispensable to
better understand quality data and provide guidance to production control. Cases of parametric test and nonparametric
test are presented below.
Definition of Terms
Hypothesis testing. This is the process of using statistics to determine the probability that a specific hypothesis is true.
Hypothesis testing is categorized as parametric test and nonparametric test. The parametric test includes z-test, t-test, f-
Test and x2 test. The nonparametric test includes sign test, Wilcoxon Rank-sum test, Kruskal-Wallis test and
permutation test.
Parametric test. In this test, samples are taken from a population with known distribution (normal distribution), and a
test of population parameters is executed.
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Nonparametric test. Also called distribution-free test, this test does not require the population to conform to a normal
distribution, nor do the popular parameters need to be statistically estimated.
Unit 3:
Q. 1Write some advantages of Benchmarking?

Ans:•To forecast industry trends - Because it requires the study of industry leaders, benchmarking can provide
numerous indicators on where a particular business might be headed, which ultimately may pave the way for the
organization to take a leadership position.
• To discover emerging technologies - The benchmarking process can help leaders uncover technologies that are
changing rapidly, newly developed, or state-of-the-art.
• To stimulate strategic planning - The type of information gathered during a benchmarking effort can assist an
organization in clarifying and shaping its vision of the future.
• To enhance goal setting - Knowing the best practices in your business can dramatically improve your ability to know
what goals are realistic and attainable.
• To maximize award-winning potential - Many prestigious award programs, such as the Malcolm Baldridge National
Quality Award Program, the federal government's President's Quality Award Program, and numerous state and local
awards recognize the importance of benchmarking and allocate a significant percentage of points to organizations that
practice it.
• To comply with Executive Order #12862, "Setting Customer Service Standards" - Benchmarking the customer
service performance of federal government agencies against the best in business is one of the eight action areas of this
Executive Order.
Q. 2Define PFMEA?
Ans: A Process Failure Mode Effects Analysis (PFMEA) is a structured analytical tool used by an organization,
business unit, or cross-functional team to identify and evaluate the potential failures of a process.
PFMEA helps to establish the impact of the failure, and identify and prioritize the action items with the goal of
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alleviating risk.
It is a living document that should be initiated prior to process of production and maintained through the life cycle of
the product.
Q. 3Define some characteristics of Quality Audit?

Ans: 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.
Q. 4What do mean by Quality Circle?

Ans: A quality circle or quality control circle is a group of workers who do the same or similar work, who meet
regularly to identify, analyze and solve work-related problems. It consists of minimum three and maximum twelve
members in number Quality circles are typically more formal groups.
Q. 5What is the role of QS 9000?
Ans: QS 9000 is a company level certification based on quality system requirements related specifically to the
automotive industry. These standards were developed by the larger automotive companies including Ford, General
Motors and DaimlerChrysler. This standard is obsolete and has been replaced by either ISO/TS 16949 or ISO 9001.
This certification was for organizations in the automotive supply chain.
Organizations that wanted to become certified to the current version of QS9000 would need to complete an application,
undergo a document review and certification audit. Once the certification was received, annual or regularly scheduled
audits would be conducted to verify continued compliance to the standard.

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Q. 1 Explain the term leadership for Decision making and Strategic planning Communications?
Q. 2 What do you mean by Quality Audit. Explain its procedure with the help of diagram?
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.
Q. 3 How International Standard ISO 9001 is important for Quality Management System.
Ans. ISO 9001 is defined as the international standard that specifies requirements for a quality management system
(QMS). Organizations use the standard to demonstrate the ability to consistently provide products and services that
meet customer and regulatory requirements.
It is the most popular standard in the ISO 9000 series and the only standard in the series to which organizations can
certify.
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ISO 9001 was first published in 1987 by the International Organization for Standardization (ISO), an international
agency composed of the national standards bodies of more than 160 countries. The current version of ISO 9001 was
released in September 2015.
HOW ISO9001 is important for Quality Management System
ISO 9001 helps organizations ensure their customers consistently receive high quality products and services, which in
turn bring many benefits, including satisfied customers, management, and employees.
Because ISO 9001 specifies the requirements for an effective quality management system, organizations find that using
the standard helps them:
• Organize a QMS
• Create satisfied customers, management, and employees
• Continually improve their processes
• Save costs
Q. 4 Explain DMAIC methodology. How it is similar to or different from the Deming cycle?
Ans. Define, measure, analyze, improve, and control (DMAIC) is a data-driven quality strategy used to improve
processes. The letters in the acronym represent the five phases that make up the process, including the tools to use to
complete those phases shown in Figure 1. It is an integral part of a Six Sigma initiative, but in general can be
implemented as a standalone quality improvement procedure or as part of other process improvement initiatives such
as lean.
THE DMAIC PROCESS

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1. Define the problem, improvement activity, opportunity for improvement, the project goals, and customer
(internal and external) requirements.
o Project charter to define the focus, scope, direction, and motivation for the improvement team
o Voice of the customer to understand feedback from current and future customers indicating offerings that
satisfy, delight, and dissatisfy them
o Value stream map to provide an overview of an entire process, starting and finishing at the customer, and
analyzing what is required to meet customer needs
2. Measure process performance.
o Process map for recording the activities performed as part of a process
o Capability analysis to assess the ability of a process to meet specifications
o Pareto chart to analyze the frequency of problems or causes
3. Analyze the process to determine root causes of variation and poor performance (defects).
o Root cause analysis (RCA) to uncover causes
o Failure mode and effects analysis (FMEA) for identifying possible product, service, and process failures
o Multi-vari chart to detect different types of variation within a process
4. Improve process performance by addressing and eliminating the root causes.
o Design of experiments (DOE) to solve problems from complex processes or systems where there are
many factors influencing the outcome and where it is impossible to isolate one factor or variable from
the others
o Kaizen event to introduce rapid change by focusing on a narrow project and using the ideas and
motivation of the people who do the work
5. Control the improved process and future process performance.
o Quality control plan to document what is needed to keep an improved process at its current level
o Statistical process control (SPC) for monitoring process behavior
o 5S to create a workplace suited for visual control
o Mistake proofing (poka-yoke) to make errors impossible or immediately detectable
Q. 5 What are the benefits of ISO certification? Explain ISO 14000 in detail?
Ans. ISO certification is proof from a third party that you comply with an ISO management standard. It can show your
key stakeholders that you have a well-run business that has structure, is stable and ready for growth – this can help with
applying for finance from your bank, impressing potential investors, or eventually selling.
To achieve ISO Certification, you have to prove that your business meets the requirements of the standard. Although
this sounds intimidating, a lot of the requirements are general good business practice and we will help you every step of
the way.
Once certified, we will help you to continually retain your certification. You will be able to contact us for advice
whenever you need it and our fees include on-going consultancy to help keep your systems on track for a painless re-
certification, year after year.
If you answer yes to all or some of the following questions, you should consider having your business certified:
 Would you like your business to be worth up to 20% more?
 Would you like to be more profitable?
 Are there areas within your business that could be more efficient?
 Would you benefit from reducing costs?
 Are your processes and procedures undocumented?
 Could improving customer satisfaction improve your turnover?
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 Do you find yourself (or your team) spending time fixing things rather than planning for a stronger future?
 Do different people do things in their own way?
 Does it take a while for new starters to become productive?
 Would your business benefit from improved staff engagement and heightened motivation?
ISO certification also offers other benefits, such as increased sales and reduced insurance premiums.
What Is ISO 14000?

ISO 14000 is a set of rules and standards created to help companies reduce industrial waste and environmental damage.
It’s a framework for better environmental impact management, but it’s not required. Companies can get ISO 14000
certified, but it’s an optional certification. The ISO 14000 series of standards was introduced in 1996 by
the International Organization for Standardization (ISO) and most recently revised in 2015 (ISO is not an acronym; it
derives from the ancient Greek word ísos, meaning equal or equivalent.)
 ISO 14000 is a set of rules and standards created to help companies address their environmental impact.
 This certification is optional for corporations, rather than mandatory;
 ISO 14000 is intended to be used to set and ultimately achieve environmentally-friendly business goals and
objectives.
 This type of certification can be used as a marketing tool for engaging environmentally conscious consumers
and may help firms reach mandatory environmental regulations.
Understanding ISO 14000

ISO 14000 is part of a series of standards that address certain aspects of environmental regulations. It’s meant to be a
step-by-step format for setting and then achieving environmentally-friendly objectives for business practices or
products. The purpose is to help companies manage processes while minimizing environmental effects, whereas
the ISO 9000 standards from 1987 were focused on the best management practices for quality assurance. The two can
be implemented concurrently.
Here are the key standards included in ISO 14000:

ISO 14001: Specification of Environmental Management Systems
ISO 14004: Guideline Standard
ISO 14010 – ISO 14015: Environmental Auditing and Related Activities
ISO 14020 – ISO 14024: Environmental Labeling
ISO 14031 and ISO 14032: Environmental Performance Evaluation
ISO 14040 – ISO 14043: Life Cycle Assessment
ISO 14050: Terms and Definitions
Q. 6 Briefly explain Lean and JIT Q Quality Philosophy? What are its Benefits and implementation?
Ans. Lean Management
A systematic approach to identifying and eliminating waste (non-value added activities) through continuous
improvement by flowing the product at the pull of the customer in pursuit of perfection.
Key Principals of Lean Thinking
 Value - what customers are willing to pay for;
 Value Stream – the sequence of processes to deliver value;
 Flow – organizing Value Stream to be continuous;
 Pulls – responding to downstream customer demand;
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 Perfection – relentless continuous improvement (culture);
Just-In-Time (JIT)
 Powerful strategy for improving operations
 Materials arrive where they are needed when they are needed
 Identifying problems and driving out waste reduces costs and variability and improves throughput
 Requires a meaningful buyer-supplier relationship
JIT Concepts
 Eliminate waste
 Remove variability
 Improve throughput
1. Eliminate Waste
 Waste is anything that does not add value from the customer point of view
 Storage, inspection, delay, waiting in queues, and defective products do not add value and are 100% waste
2. Remove Variability
 Variability is any deviation from the optimum process
 Lean systems require managers to reduce variability caused by both internal and external factors
 Inventory hides variability
 Less variability results in less waste
3. . Improve Throughput
 Push systems dump orders on the downstream stations regardless of the need
 By pulling material in small lots, inventory cushions are removed, exposing problems and emphasizing continual
improvement
 The time it takes to move an order from receipt to delivery is reduced.
Benefits of Lean Management System
 The lean manufacturing process provides a simple framework for defining a company’s purpose and
decision-making to reflect the needs of all stakeholders.
 “Lean” results in a highly engaged employee culture.
 Lean manufacturers can better navigate the competitive life cycle
Unit 4:
Q. 1What is the major difference between Process Quality and Product Quality?
Ans: Process quality is one of a number of contributors to product quality.
Product quality, as you might expect from the name, is the overall quality of the product in question: how well it
conforms to the product requirements, specifications, and ultimately customer expectations.
Process quality focuses on how well some part of the process of manufacturing that product, and getting it into the
customer’s hands, is working. The process being analyzed in a particular case may have a very broad scope, or it may
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focus in on minute details of a single step. For example, the precise temperature used when molding a component, or
the torque used when driving a specific screw.
When a product quality issue is identified, good practice is to perform a root cause analysis to narrow down on the
specific process steps that caused the issue, and then perform process experiments to develop and implement
a corrective action.
Quality Assurance and Quality Control are also processes in themselves that have quality parameters associated with
their design and implementation. For example, how many parts from a lot do you decide to sample, and how do you
select those parts, and which specific features do you inspect, and what do you do to react when a component quality
issue is identified. These process design decisions can result in, or avoid, quality escapes to the ultimate product quality.
Q. 2List some advantages of QFD?

Ans. 1. A systematic way of obtaining information and presenting it.
2. Shorter product development cycle.
3. Considerably reduced start-up costs.
4. Fewer engineering changes.
5. Reduced chance of overnights during design process.
6. An environment of team work.
7. Consensus decision.
8. Everything is preserved in writing.
9. It facilitates identification of the causes of customer complaints and makes it easier to takes prompt remedical action.
10. It is a useful tool for improving product Quality.
Q. 3Define the term product Quality?

Ans. 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.
The five main aspects of product quality are depicted and listed below:
Quality of design : The product must be designed as per the consumers' needs and high-quality standards.
Quality conformance : The finished products must conform (match) to the product design specifications.
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.
Safety: The finished product must be safe for use and/or handling. It must not harm consumers in any way.
Proper storage: The product must be packed and stored properly. Its quality must be maintained until its expiry date.
Q. 4What is the first step in performing Quality function Deployment?

Ans. QFD uses a series of matrices to document information collected and developed and represent the team’s plan for
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a product. The QFD methodology is based on a systems engineering approach consisting of the following general steps:
1. Derive top-level product requirements or technical characteristics from customer needs (Product Planning
Matrix).
2. Develop product concepts to satisfy these requirements.
3. Evaluate product concepts to select most optimum (Concept Selection Matrix).
4. Partition system concept or architecture into subsystems or assemblies and flow-down higher- level
requirements or technical characteristics to these subsystems or assemblies.
5. Derive lower-level product requirements (assembly or part characteristics) and specifications from
subsystem/assembly requirements (Assembly/Part Deployment Matrix).
6. For critical assemblies or parts, flow-down lower-level product requirements (assembly or part characteristics)
to process planning.
7. Determine manufacturing process steps to meet these assembly or part characteristics.
8. Based in these process steps, determine set-up requirements, process controls and quality controls to assure
achievement of these critical assembly or part characteristics.
Q. 5How does Taguchi method works?

Ans. The Taguchi method of quality control is an approach to engineering that emphasizes the roles of research and
development (R&D), product design and development in reducing the occurrence of defects and failures
in manufactured goods.
This method, developed by Japanese engineer and statistician Genichi Taguchi, considers design to be more important
than the manufacturing process in quality control, aiming to eliminate variances in production before they can occur.
KEY TAKEAWAYS
 In engineering, the Taguchi method of quality control focuses on design and development to create efficient,
reliable products.
 Its founder, Genichi Taguchi, considers design to be more important than the manufacturing process in quality
control, seeking to eliminate variances in production before they can occur.
 Companies such as Toyota, Ford, Boeing, and Xerox have adopted this method.
Understanding the Taguchi Method of Quality Control
The Taguchi method gauges quality as a calculation of loss to society associated with a product. In particular, loss in a
product is defined by variations and deviations in its function as well as detrimental side effects that result from the
product.
Loss from variation in function is a comparison of how much each unit of the product differs in the way it operates. The
greater that variance, the more significant the loss in function and quality. This could be represented as a monetary
figure denoting how usage has been impacted by defects in the product.
Example of the Taguchi Method of Quality Control
For instance, if the product is a precision drill that must consistently drill holes of an exact size in all materials it is used
on, part of its quality is determined by how much the units of the product differ from those standards. With the Taguchi
method of quality control, the focus is to use research and design to ensure that every unit of the product will closely
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match those design specifications and perform exactly as designed.
Q. 1 How can we improve the quality of the Product? Explain in detail.

Ans. Implement a Quality Management System (QMS)
While it is important to conceptualize, envision and create a roadmap for the product, these steps alone will not
determine the quality of the product by default. A quality management system (QMS) such as ISO 9001 is a set of
internal rules that will determine how a business will create and deliver their products or services.
Implementing a QMS will allow you to audit your processes yourself along with a certification body. Since a quality
management system is based on the 7 strict principles of quality, your customers will not have to audit your business
themselves. ISO 9001 is an internationally recognized standard that provides quality assurance, which is essential if you
are looking to increase the quality of your products.
By complying with the standard, you improve your business’s credibility and image but most importantly, you will
enhance customer satisfaction levels. One of the ISO 9001 requirements is to constantly improve customer satisfaction
by meeting customer needs. This, along with other requirements of the QMS, such as better process integration or
improving evidence for decision making, will condition you and your teammates to only strive for quality.
 Make Quality a Part of Your Company Culture

Implementing a QMS is important, but it is not enough to just appear compliant. These quality principles need to be
embedded firmly across your entire organization. The entire team needs to be on the same page when it comes to what
constitutes a quality product.
For some, it is a low-cost product while for others it is a cutting-edge solution. Regardless of what you agree on, have
your managers constantly reinforce the idea. This is how you will get everyone on board with your vision of quality.
To create products according to your quality specifications, management needs to let employees be part of the
development process. If an employee doesn’t feel like they have a say in a project, they will most likely ignore the need
to give you any feedback. And you need this feedback because your employees are directly connected to production.
Let employees speak freely on straying from the product roadmap or quality requirements.
You have to give your employees exactly the right amount of guidance during product development. If you
micromanage them too much, they will lose the capacity for creativity. If you are too loose, they will be unclear about
their authority to make independent decisions. Allow your employees to observe the business processes and organize
meetings where they suggest improvements.
 Perform Product and Market Testing

It is highly important to analyze and test your product prior to launch. Chances are you will need to fix errors, add
features and adjust the functionalities so the product meets the needs and requirements of consumers. You will need to
test the product through beta testing, as well as test how consumers react to it via market testing.
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Beta testing will allow you to meet the promised user experience and ensure all product components including quality
perform as initially intended. Product testing will also allow you to see how your product performs in the real world vs.
its performance in a controlled environment. You will test your product for usability, support, and marketing so you can
measure customer validation and enhance product quality accordingly.
Market research will help you understand the demand for and acceptance of your product, allowing you to achieve
higher accuracy during a full product launch. By performing market tests, you will be able to streamline distribution,
production, and support systems for your product. Additionally, you will be able to mitigate investment risks and make
changes to the marketing of the product as well as the product itself.
 Always Strive for Quality

The number of manufacturers and service providers is growing by the day. Standing out in such a competitive
environment can be extremely difficult. However, the majority of their products and services do not offer satisfying
levels of quality to their customers. By understanding product quality, you will be able to create more informed
decisions about how to develop your product from start to finish.
A lot of experts have different opinions on what constitutes quality. Remember to create a strategy, implement a QMS,
embed quality in your culture, and perform regular product and market tests. By doing all of this, you are well on your
way toward creating high-quality products that will delight your customers and keep them coming back for more.
Q. 2 What is the methodology use behind Quality Function Deployment (QFD)?

Ans. METHODOLOGY
In QFD, quality is a measure of customer satisfaction with a product or a service.
QFD is a structured method that uses the seven management and planning tools to identify and prioritize customers’
expectations quickly and effectively.
Beginning with the initial matrix, commonly termed the House of Quality (Figure 1), the QFD methodology focuses on
the most important product or service attributes or qualities. These are composed of customer wows,
wants, and musts. (See the Kano model of customer perception versus customer reality.)
Once you have prioritized the attributes and qualities, QFD deploys them to the appropriate organizational function for
action, as shown in Figure 2. Thus, QFD is the deployment of customer-driven qualities to the responsible functions of
an organization.
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Q. 3 Explain the term Robust Design in detail with the help of an example. Why Robust design is important?
Ans. A main cause of poor yield in manufacturing processes is the manufacturing variation. These manufacturing
variations include variation in temperature or humidity, variation in raw materials, and drift of process parameters.
These sources of noise / variation are the variables that are impossible or expensive to control.
The objective of the robust design [4] is to find the controllable process parameter settings for which noise or variation
has a minimal effect on the product's or process's functional characteristics. It is to be noted that the aim is not to find
the parameter settings for the uncontrollable noise variables, but the controllable design variables. To attain this
objective, the control parameters, also known as inner array variables, are systematically varied as stipulated by the
inner orthogonal array.
For each experiment of the inner array, a series of new experiments are conducted by varying the level settings of the
uncontrollable noise variables. The level combinations of noise variables are done using the outer orthogonal array.
The influence of noise on the performance characteristics can be found using the ratio [4] where S is the standard
deviation of the performance parameters for each inner array experiment and N is the total number of experiment in the
outer orthogonal array. This ratio indicates the functional variation due to noise. Using this result, it is possible to
predict which control parameter settings will make the process insensitive to noise.
However, when the functional characteristics are not affected by the external noises, there is no need to conduct the
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experiments using the outer orthogonal arrays. This is true in case of experiments which are conducted using the
computer simulation as the repeatability of a computer simulated experiments is very high.
Why Robust Design is important?
Over the last five years many leading companies have invested heavily in the Six Sigma approach aimed at reducing
waste during manufacturing and operations. These efforts have had great impact on the cost structure and hence on the
bottom line of those companies. Many of them have reached the maximum potential of the traditional Six Sigma
approach. What would be the engine for the next wave of productivity improvement?
Brenda Reichelderfer of ITT Industries reported on their benchmarking survey of many leading companies, “design
directly influences more than 70% of the product life cycle cost; companies with high product development
effectiveness have earnings three times the average earnings; and companies with high product development
effectiveness have revenue growth two times the average revenue growth.” She also observed, “40% of product
development costs are wasted!”
Q. 4 What are the benefits or advantages of Quality Function Deployment?

Ans. Major benefits of quality function deployment (QFD)
Quality Function Deployment (QFD)-House of Quality –is an effective Management tool to drive the design process
and production process with the main aim of satisfying the customer needs. The benefits of QFD are
1. A systematic way of obtaining information and presenting it.

2. Shorter product development cycle.
3. Considerably reduced start-up costs.
4. Fewer engineering changes.
5. Reduced chance of overnights during design process.
6. An environment of team work.
7. Consensus decision.
8. Everything is preserved in writing.
9. It facilitates identification of the causes of customer complaints and makes it easier to takes prompt remedical action.
10. It is a useful tool for improving product Quality.
11. It is a useful tool for competitive analysis of product quality.
12. It is stabilizes quality.
13. It cuts down on rejects and rework at the production site.
14. It decreases claims substantially.
15. Marketing benefits are obtained by identifying sales point.
Q. 5 How we can build a solid product Strategy to improve the product Quality?
Ans. Here’s a seven-point check-up to help you assess whether your product development process needs a little adjusting:
1. Size the opportunity, not the market
To create a solid understanding of your opportunity, look at the entire market through the lens of your customer to
determine the actual potential. For example, when financial services organizations started offering insurance products
directly, some decided that since everyone needed insurance, their market was as large as any other insurance
provider’s. But most of the insurance industry (approximately 60%) is serviced by brokers, therefore the opportunity lay
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with only 40% of the total market. And of that 40%, only a small percentage would be willing to buy directly from a
financial services provider.
By accurately sizing the opportunity, you can set proper expectations of what can be achieved. Then you can build a
realistic business case for whether this will be a large or small win.
2. Kill a few new ideas

Too many organizations carry all their new ideas through the development cycle when some should have been left
behind. This is often because commitments have been made, or because no one wants to be the bearer of bad news. But
carrying new ideas too far wastes resources and distracts the team’s efforts from focusing on the winners.
To avoid this, make sure you have comprehensive parameters against which to screen new product and service ideas.
Establish the elements that an idea must have to stay on the list. If an idea does not meet your revenue requirements, for
example, either cut it from the list or figure out how to rework it so that it can make more money.
Read: Hootsuite and the Art of Continual Product Improvement
3. Find the pain points

What is the actual purpose of your new product or service? What need does it solve? Some companies develop benefit
statements based on a new offering’s features instead of its actual benefits. Cloud computing services, for example, are
often touted as being a means of securely accessing information from anywhere, because that’s how cloud-based
computing functions. But what about the other less tangible advantages, like not having the downtime and expense of
fixing servers, or the hassle of Macs not being able to connect to PC-based servers? If you don’t thoroughly understand
your target group’s pain points, you can easily undersell the very real benefits of your service.
4. Price for customers

A lot of companies get tripped up in developing ˜cost plus’ pricing rather than true customer-based pricing. When
new products that required a substantial installation process were first launched in the communications industry—
Internet services, for example—most organizations sought to charge the customer for the full installation cost. This
reduced the number of potential new customers at a time when the service was just gaining awareness. By contrast, the
wireless industry understood this early on. It reduced the initial cost of a new phone to the customer by building the
hardware cost into the monthly fee.
Companies often use cost-based pricing in order to validate an acceptable ROI for the business case when they should
be developing pricing based on their customer’s cost threshold to ensure that price does not become a barrier to
purchase for people who truly want the product.
Read: How to Price for Profit
5. Get customers involved early

You can reality-proof your concepts by including your customer in the product development cycle—especially if you
do it well before you launch. Determine the phases in which you will reach out to your customers. Consider creating a
customer advisory panel, if you don’t already have one. And remember that regular touch-point meetings with a
customer feedback panel work both ways; not only do you improve your understanding of how they feel about your
product, you also build customer awareness of your offering before trying to sell them on it.
6. Dedicate a team to the job (and empower them to do great work)

A launch can easily be compromised if the responsibility for the success of a new service is spread among too many
individuals, or if there are no dedicated resources. But just making someone directly accountable is not enough. You
should look to empower that person so that they have authority and resources. Companies often function in a “business
as usual” when developing new offerings, when there should be additional resources allotted to the task.
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7. Consider life after launch
After most companies launch a new product or new service, the only people interacting with customers are the sales and
service teams. Not only should there be a detailed plan as to how this new product will be supported by the product
development team, but you should also have extensive training and education available internally to staff. It’s far better
when the development team and sales/support teams work in tandem. Your product development team might even seek
to involve sales and service teams earlier in the process, rather than just training them after the product is ready. This
will help get everyone thinking about the total customer experience: not just its initial marketing, but how the new
service will be supported and improved upon throughout its lifecycle.
Q. 6 Explicate Taguchi Method with the help of an example. What are the two basic stages of Taguchi design?
Ans. The Taguchi method of quality control is an approach to engineering that emphasizes the roles of research and
development (R&D), product design and development in reducing the occurrence of defects and failures
in manufactured goods.
This method, developed by Japanese engineer and statistician Genichi Taguchi, considers design to be more important
than the manufacturing process in quality control, aiming to eliminate variances in production before they can occur.
KEY TAKEAWAYS
 In engineering, the Taguchi method of quality control focuses on design and development to create efficient,
reliable products.
 Its founder, Genichi Taguchi, considers design to be more important than the manufacturing process in quality
control, seeking to eliminate variances in production before they can occur.
 Companies such as Toyota, Ford, Boeing, and Xerox have adopted this method.
Understanding the Taguchi Method of Quality Control
The Taguchi method gauges quality as a calculation of loss to society associated with a product. In particular, loss in a
product is defined by variations and deviations in its function as well as detrimental side effects that result from the
product.
Loss from variation in function is a comparison of how much each unit of the product differs in the way it operates. The
greater that variance, the more significant the loss in function and quality. This could be represented as a monetary
figure denoting how usage has been impacted by defects in the product.
Example of the Taguchi Method of Quality Control
For instance, if the product is a precision drill that must consistently drill holes of an exact size in all materials it is used
on, part of its quality is determined by how much the units of the product differ from those standards. With the Taguchi
method of quality control, the focus is to use research and design to ensure that every unit of the product will closely
match those design specifications and perform exactly as designed.
Special Considerations
Loss from detrimental side effects on society speaks to whether or not the design of the product could inherently lead to
an adverse impact. For example, if operating the precision drill could cause injury to the operator because of how it is
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designed, there is a loss of quality in the product.
Under the Taguchi method, work done during the design stage of creation would aim to minimize the possibility that
the drill would be crafted in a way that its use could cause injuries to the operator.
From a higher perspective, the Taguchi method would also strive to reduce the cost to society to use the product, such
as designing goods to be more efficient in their operation rather than generate waste. For instance, the drill could be
designed to minimize the need for regular maintenance.
History of the Taguchi Method of Quality Control
Genichi Taguchi, a Japanese engineer and statistician, began formulating the Taguchi method while developing a
telephone-switching system for Electrical Communication Laboratory, a Japanese company, in the 1950s. Using
statistics, he aimed to improve the quality of manufactured goods.
By the 1980s, Taguchi's ideas began gaining prominence in the Western world, leading him to become well-known in
the United States, having already enjoyed success in his native Japan. Big-name global companies such as Toyota
Motor Corp. (TM), Ford Motor Co. (F), Boeing Co. (BA) and Xerox Holdings Corp. (XRX) have adopted his methods.
Criticism of the Taguchi Method of Quality Control
Taguchi’s methods have not always been well received by Western statisticians. One of the biggest accusations against
his quality control methodology is that it is unnecessarily complicated. In fact, some skeptics even claim that a
doctorate in mathematics is required to understand it.
Unit 5:
Q. 1 Define lean six sigma approaches?

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Q. 2 Give some advantages of DFMEA?

Ans.
 Captures the collective knowledge of a team.
 Improves the quality, reliability, and safety of the process.
 Logical, structured process for identifying process areas of concern.
 Reduces process development time, cost.
 Documents and tracks risk reduction activities.
Q. 3 What do you mean by product reliability?
Ans. Reliability is defined as the probability that a product, system, or service will perform its intended function
adequately for a specified period of time, or will operate in a defined environment without failure.
Q. 4 What are the benefits of Six sigma Approaches?
ANS:
• Enables success in a world of intensified competition and declining margins
• Ensures quality necessary to satisfy increasingly demanding customers
• Provides means to become the best in the world
• Establishes standard language and approach across all functions and lines of business
• Helps develop next generation of leaders

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Q. 1 Briefly explain Design failure mode and effect analysis?
Ans. It was first used in rocket science. Initially, the rocket development process in the 1950’s did not go well. The
complexity and difficulty of the task resulted in many catastrophic failures. Root Cause Analysis (RCA) was used to
investigate these failures but had inconclusive results. Rocket failures are often explosive with no evidence of the
root cause remaining.
Design FMEA provided the rocket scientists with a platform to prevent failure. A similar platform is used today in
many industries to identify risks, take counter measures and prevent failures. DFMEA has had a profound impact,
improving safety and performance on products we use every day.
What is Design Failure Mode and Effects Analysis (DFMEA)

DFMEA is a methodical approach used for identifying potential risks introduced in a new or changed design of a
product/service.
The Design FMEA initially identifies design functions, failure modes and their effects on the customer with
corresponding severity ranking / danger of the effect. Then, causes and their mechanisms of the failure mode are
identified.
High probability causes, indicated by the occurrence ranking, may drive action to prevent or reduce the cause’s
impact on the failure mode.
Why Perform Design Failure Mode and Effects Analysis (DFMEA)

Risk is the substitute for failure on new / changed designs. It is a good practice to identify risks on a program as
early as possible. Early risk identification provides the greatest opportunity for verified mitigation prior to program
launch.
Risks are identified on designs, which if left unattended, could result in failure. The DFMEA is applied when:
• There is a new design with new content
• There is a current design with modifications, which also may include changes due to past failure
• There is a current design being used in a new environment or change in duty cycle (no physical change made
to design)
Q. 2 Describe lean six sigma approach to new product development?

Ans. Introduction to Design for Six Sigma (DFSS)
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.
What is Design for Six Sigma (DFSS)

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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.
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
Q. 3 How do you measure product Reliability. Why is product Reliability is important?

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Q. 4 How six sigma plays an important character in product Development?

Ans.What Is Six Sigma?
• Philosophy
• Vision
• Initiative
• Goal
• Method
• Tool
• A means to stretch our thinking with respect to quality.
Six Sigma Is Different From Past Quality Programs In That It…

• Changes businessmeasurements
• Changes the role offinance
• Monitors projects toclosure
• Sustains thegains
• Results in demonstrablesuccess
• Improvescompetitiveness
…and is bottom line-focused and led by executives.
Six Sigma Benefits.

• Enables success in a world of intensified competition and declining margins
• Ensures quality necessary to satisfy increasingly demanding customers
• Provides means to become the best in the world
• Establishes standard language and approach across all functions and lines of business
• Helps develop next generation of leaders
Results directly linked with business objectives.

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Premise of Six Sigma
• The basic premise of Six Sigma is that sources of variation can be:
- Identified
- Quantified
-Eliminated or controlled
• Focused on strategic or core processes
• Data driven
- Measurements focused on right things
Variation is the enemy!
What is 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
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expectations, shorten the time to market, provide a high level of initial product quality and succeed the first time.
Q. 5 What is the role of Product Reliability analysis in Design Failure?
Ans.
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Q. 6 What are the ten steps to conduct DFMEA (Design failure mode and effect analysis)?
Ans. Step 1 | Review the design
Use a blueprint or schematic of the design/product to identify each component and interface.
Reasons for the review:
 Help assure all team members are familiar with the product and its design.
 Identify each of the main components of the design and determine the function or functions of those components and
interfaces between them.
 Make sure you are studying all components defined in the scope of the DFMEA.
Use a print or schematic for the review.
 Add Reference Numbers to each component and interface.
Try out a prototype or sample.
 Invite a subject matter expert to answer questions.
 Document the function(s) of each component and interface.
Step 2 | Brainstorm potential failure modes

Review existing documentation and data for clues.
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Consider potential failure modes for each component and interface.
 A potential failure mode represents any manner in which the product component could fail to perform its intended
function or functions.
 Remember that many components will have more than one failure mode. Document each one. Do not leave out a
potential failure mode because it rarely happens. Don’t take shortcuts here; this is the time to be thorough.
Prepare for the brainstorming activity.
 Before you begin the brainstorming session, review documentation for clues about potential failure modes.
 Use customer complaints, warranty reports, and reports that identify things that have gone wrong, such as hold tag
reports, scrap, damage, and rework, as inputs for the brainstorming activity.
 Additionally, consider what may happen to the product under difficult usage conditions and how the product might fail
when it interacts with other products.
Step 3 | List potential effects of failure

There may be more than one effect for each failure.
The effect is related directly to the ability of that specific component to perform its intended function.
 An effect is the impact a failure could make should it occur.
 Some failures will have an effect on customers; others on the environment, the process the product will be made on,
and even the product itself.
The effect should be stated in terms meaningful to product performance. If the effects are defined in general terms, it will be
difficult to identify (and reduce) true potential risks.
Step 4 | Assign Severity rankings

The Severity ranking is based on the severity of the consequences of failure.
Assign a severity ranking to each effect that has been identified.
 The severity ranking is an estimate of how serious an effect would be should it occur.
 To determine the severity, consider the impact the effect would have on the customer, on downstream operations, or on
the employees operating the process.
The severity ranking is based on a relative scale ranging from 1 to 10.
 A “10” means the effect has a dangerously high severity leading to a hazard without warning.
 Conversely, a severity ranking of “1” means the severity is extremely low.
The severity ranking is based on the severity of the consequences of failure.
Step 5 | Assign Occurrence rankings

The Occurrence ranking is based on how frequently the cause of the failure is likely to occur.
We need to know the potential cause to determine the occurrence ranking because, just like the severity ranking is driven by the
effect, the occurrence ranking is a function of the cause.
 The occurrence ranking is based on the likelihood, or frequency, that the cause (or mechanism of failure) will occur.
 If we know the cause, we can better identify how frequently a specific mode of failure will occur.
The occurrence ranking scale, like the severity ranking, is on a relative scale from 1 to 10.
 An occurrence ranking of “10” means the failure mode occurrence is very high; it happens all of the time. Conversely,
a “1” means the probability of occurrence is remote.
 See FMEA Checklists and Forms for an example DFMEA Occurrence Ranking Scale.
Your organization may need to customize the occurrence ranking scale to apply to different levels or complexities of design. It
is difficult to use the same scale for a modular design, a complex design, and a custom design.
 Some organizations develop three different occurrence ranking options (time-based, event-based, and piece-based) and
select the option that applies to the design or product.
 See FMEA Checklists and Forms for an examples of Custom DFMEA Ranking Scales. (Examples of custom scales for
severity, occurrence, and detection rankings are included in this Resource Center.)
Step 6 | Assign Detection rankings

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Quality Management
The Detection ranking is based on the chances the failure will be detected prior to the customer finding it.
To assign detection rankings, consider the design or product-related controls already in place for each failure mode and then
assign a detection ranking to each control.
 Think of the detection ranking as an evaluation of the ability of the design controls to prevent or detect the mechanism
of failure.
 A detection ranking of “1” means the chance of detecting a failure is almost certain. Conversely, a “10” means the
detection of a failure or mechanism of failure is absolutely uncertain.
Prevention controls are always preferred over detection controls.
 Prevention controls prevent the cause or mechanism of failure or the failure mode itself from occurring; they generally
impact the frequency of occurrence. Prevention controls come in different forms and levels of effectiveness.
 Detection controls detect the cause, the mechanism of failure, or the failure mode itself after the failure has occurred
BUT before the product is released from the design stage.
To provide DFMEA teams with meaningful examples of Design Controls, consider adding examples tied to the Detection
Ranking scale for design related topics such as:
 Design Rules
 DFA/DFM (design for assembly and design for manufacturability) Issues
 Simulation and Verification Testing
Step 7 | Calculate the RPN

RPN = Severity x Occurrence x Detection.
 The RPN is the Risk Priority Number. The RPN gives us a relative risk ranking. The higher the RPN, the higher the
potential risk.
 The RPN is calculated by multiplying the three rankings together. Multiply the Severity Ranking times the Occurrence
Ranking times the Detection Ranking. Calculate the RPN for each failure mode and effect.
 Editorial Note: The current FMEA Manual from AIAG suggests only calculating the RPN for the highest effect
ranking for each failure mode. We do not agree with this suggestion; we believe that if this suggestion is followed, it
will be too easy to miss the need for further improvement on a specific failure mode.
Since each of the three relative ranking scales ranges from 1 to 10, the RPN will always be between 1 and 1000. The higher the
RPN, the higher the relative risk. The RPN gives us an excellent tool to prioritize focused improvement efforts.
Step 8 | Develop the action plan

Define who will do what by when.
Taking action means reducing the RPN.
 The RPN can be reduced by lowering any of the three rankings (severity, occurrence, or detection) individually or in
combination with one another.
 A reduction in the Severity Ranking for a DFMEA is often the most difficult to attain. It usually requires a design
change.
 Reduction in the Occurrence Ranking is accomplished by removing or controlling the potential causes or mechanisms
of failure.
 A reduction in the Detection Ranking is accomplished by adding or improving prevention or detection controls.
What is considered an acceptable RPN?
 The answer to that question depends on the organization.
 For example, an organization may decide any RPN above a maximum target of 200 presents an unacceptable risk and
must be reduced. If so, then an action plan identifying who will do what by when is needed.
There are many tools to aid the DFMEA team in reducing the relative risk of those failure modes requiring action.
The following recaps some of the most powerful action tools for DFMEAs.
DESIGN OF EXPERIMENTS (DOE)
 A family of powerful statistical improvement techniques that can identify the most critical variables in a design and the
optimal settings for those variables.
MISTAKE-PROOFING (POKA YOKE)
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Quality Management
Techniques that can make it impossible for a mistake to occur, reducing the Occurrence ranking to 1.
Especially important when the Severity ranking is 10.
DESIGN FOR ASSEMBLY AND DESIGN FOR MANUFACTURABILITY (DFA/DFM)
 Techniques that help simplify assembly and manufacturing by modularizing product sub-assemblies, reducing
components, and standardizing components.
SIMULATIONS
 Simulation approaches include pre-production prototypes, computer models, accelerated life tests, and value-
engineering analyses.
Step 9 | Take action

Implement the improvements identified by your DFMEA team.
 The Action Plan outlines what steps are needed to implement the solution, who will do them, and when they will be
completed.
 A simple solution will only need a Simple Action Plan while a complex solution needs more thorough planning and
documentation.
 Most Action Plans identified during a DFMEA will be of the simple “who, what, & when” category. Responsibilities
and target completion dates for specific actions to be taken are identified.
 Sometimes, the Action Plans can trigger a fairly large-scale project. If that happens, conventional project management
tools such as PERT Charts and Gantt Charts will be needed to keep the Action Plan on track.
Step 10 | Calculate the resulting RPN

Re-evaluate each of the potential failures once improvements have been made and determine their impact on the RPNs.
 This step in a DFMEA confirms the action plan had the desired results by calculating the resulting RPN.
 To recalculate the RPN, reassess the severity, occurrence, and detection rankings for the failure modes after the action
plan has been completed.

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ARYA COLLEGE OF ENGINEERING

Q. 2 Explain the concept of Quality on the basis of Quality Management?

 Produce goods or services that respond specifically to customer needs.

Q. 3How to do Quality Assurance?

Q. 4What are 4 types of Quality Control? Define them.

INTERNATIONAL STANDARDS ORGANIZATION QUALITY MANAGEMENT STANDARD

Q. 5Give formula to control Cost of Quality?

Q. 6State the views of different Quality Gurus?

Descriptive Answers: (6 to 15 Marks)

Components of quality management

CoQ = CoGQ + CoPQ

How to Measure Cost of Quality (COQ)

The Cost of Good Quality (CoGQ)

• Establishing Product Specifications

• New Product Development and Testing

• Development of a Quality Management System (QMS)

• Proper Employee Training

• Incoming Material Inspections

The Cost of Poor Quality (CoPQ)

Q. 3How can you say that” Quality as winning Strategy”. Elaborate.

 Get the Board involved in strategizing Quality

 a comprehensive evaluation of quality risks ( positive or negative) is made globally

Q. 5Explain TQM. Describe the key elements of Total Quality Management?.

Q. 6 Explain the Deming management philosophy. Why has it been controversial?

The steps that the cycle follow are:

The 14 Points for Management

1.Create constancy of purpose for improvement of product and service

2.Follow a new philosophy

3. Discontinue dependence on mass inspection

4. Cease the practices of awarding business on price tags.

5. Strive always to improve the production and service of the organization

6.Introduce new and modern methods of on-the-job training

7.Device modern methods of supervision

9. Destroy barriers among the staff areas.

10. Dispose of the numerical goals created for the workforce.

11.Eradicate work standards and numerical quotas

12.Abolish the barriers that burden the workers

13.Device a vigorous education and training program

14.Cultivate top management that will strive toward these goals

Q. 1 State 7QC tools?

Q. 2Explain measurement system analysis?

Q. 3What do you mean by acceptance sampling pan?

Q. 4Explain the term hypothesis testing?

Q. 5What does Regression mean in Process Quality Improvement?

Q. 6What is the role of process capability analysis?

3. Check sheet (or tally sheet)

4. Cause-and-effect diagram (also known as a fishbone or Ishikawa diagram)

5. Pareto chart (80-20 rule)

7. Control chart (also called a Shewhart chart)

Q. 3 What do you mean by Design of Experiments? When to use DOE?

Q. 4 Explain Graphical tools for data representation?

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

STATGRAPHICS provides capability analyses for the following cases:

 Probability Capability Indices

• Smaller Ppkvalues indicate the deviation from specification is larger.

Q. 6 What is the importance of Hypothesis testing in Quality Management?

Q. 1Write some advantages of Benchmarking?

Q. 3Define some characteristics of Quality Audit?

Q. 4What do mean by Quality Circle?

This certification was for organizations in the automotive supply chain.