(R20MED4296) Total Engineering Quality Management

UNIT II - PRODUCT DESIGN AND ANALYSIS (9 hours) Basic Design Concepts and TQM
– Design Assurance – Design Validation – Failure Mode Effect Analysis – Fault Tree Analysis
– Design for Robustness – Value Analysis
Basic Design Concepts:
Design concepts are fundamental principles and guidelines that govern the creation of products,
systems, or processes. These concepts ensure that designs are effective, efficient, and user-
friendly. Some basic design concepts include:
a. Functionality: Design should prioritize fulfilling the intended purpose or function of the
product or system. It involves understanding user needs and requirements and designing
solutions that effectively address them.
b. Usability: Design should focus on creating products that are easy to use, intuitive, and user-
friendly. This involves considerations such as user interface design, ergonomics, and
accessibility to ensure that the product can be used efficiently by its intended users.
c. Aesthetics: Aesthetics play a significant role in design, influencing user perception and
satisfaction. Designers consider factors such as visual appeal, form, color, and texture to create
products that are visually appealing and emotionally engaging.
d. Sustainability: Sustainable design involves considering environmental and social impacts
throughout the design process. Designers strive to minimize resource consumption, reduce
waste, and create products that are environmentally friendly and socially responsible.
e. Cost-effectiveness: Design should balance performance and quality with cost
considerations. Designers seek to optimize the use of resources, minimize production costs,
and create products that offer value to customers while remaining affordable and competitive
in the market.
f. Innovation: Design encourages creativity and innovation to generate new ideas and
solutions. Designers explore unconventional approaches, technologies, and materials to create
products that push the boundaries of what is possible and meet emerging needs and trends.
1. Total Quality Management (TQM):
Total Quality Management (TQM) is a management philosophy and approach that aims to
achieve continuous improvement in quality and performance across all aspects of an
organization. TQM emphasizes the involvement of all employees, from top management to
frontline workers, in the pursuit of quality excellence. Key principles of TQM include:
a. Customer Focus: TQM places a strong emphasis on understanding and meeting customer
needs and expectations. Organizations strive to deliver products and services that consistently
meet or exceed customer requirements.
b. Continuous Improvement: TQM promotes a culture of continuous improvement, where
processes, systems, and practices are continuously reviewed, evaluated, and refined to enhance
quality, efficiency, and effectiveness.
c. Employee Involvement: TQM recognizes the importance of involving employees at all
levels in quality improvement efforts. Employees are encouraged to contribute ideas, identify
problems, and participate in decision-making processes to drive organizational improvement.
d. Process Approach: TQM adopts a systematic approach to quality management, focusing on
improving processes and systems rather than just addressing individual issues or defects. By
optimizing processes, organizations can achieve better outcomes and greater efficiency.
e. Data-Driven Decision Making: TQM relies on data and evidence to inform decision-
making and problem-solving. Organizations collect and analyze data related to quality metrics,
customer feedback, and process performance to identify areas for improvement and make
informed decisions.
f. Supplier Relationships: TQM recognizes the importance of strong relationships with
suppliers and partners. Organizations collaborate closely with suppliers to ensure the quality
and reliability of inputs, foster innovation, and drive mutual success.
g. Leadership Commitment: TQM requires strong leadership commitment and support to
foster a culture of quality and continuous improvement throughout the organization. Leaders
set the vision, establish clear goals and expectations, and provide the necessary resources and
support to enable TQM initiatives to succeed.
By embracing basic design concepts and principles of Total Quality Management,
organizations can create products and systems that are not only functional and aesthetically
pleasing but also of high quality, reliability, and value to customers. TQM provides a
framework for organizations to continuously improve processes, enhance customer
satisfaction, and achieve long-term success in a competitive marketplace.
Product design
Product design is the process of creating new products or improving existing ones to meet the
needs and desires of consumers. It encompasses a range of activities, including
conceptualization, planning, development, and refinement, aimed at translating ideas into
tangible products that fulfill specific purposes and objectives.
Key aspects of product design include:
1. Identifying User Needs: Understanding the needs, preferences, and behaviors of users
is fundamental to effective product design. Designers conduct market research, user
surveys, and user testing to gain insights into user requirements and expectations.
2. Conceptualization and Ideation: Product design begins with generating ideas and
concepts for new products or improvements to existing ones. Designers brainstorm,
sketch, and prototype concepts to explore different possibilities and refine their vision.
3. Functional Design: Product design involves defining the functionality and features of
the product to ensure that it performs its intended purpose effectively. Designers
consider factors such as usability, ergonomics, performance, and reliability in designing
functional prototypes and mockups.
4. Aesthetic Design: Aesthetic considerations play a significant role in product design,
influencing consumer perception and appeal. Designers focus on creating products that
 are visually appealing, emotionally engaging, and aligned with brand identity and
values.
5. Materials and Manufacturing Processes: Product designers select appropriate
materials and manufacturing processes based on functional requirements, cost
considerations, and environmental considerations. They consider factors such as
material properties, durability, sustainability, and manufacturability in choosing
materials and production methods.
6. Prototyping and Testing: Prototyping is an essential step in product design, allowing
designers to validate concepts, test functionality, and gather feedback from users.
Prototypes may range from rough sketches and 3D models to functional prototypes and
pre-production samples.
7. Iterative Design Process: Product design is often an iterative process, involving
multiple rounds of refinement and iteration based on feedback, testing results, and
design evaluations. Designers continuously iterate on designs to improve performance,
usability, and user experience.
8. Collaboration and Communication: Product design often involves collaboration
between multidisciplinary teams, including designers, engineers, marketers, and
stakeholders. Effective communication and collaboration are essential for aligning
goals, sharing ideas, and coordinating efforts throughout the design process.

Product design presents several challenges that designers and design teams must navigate to
create successful and innovative products. Some of the key challenges include:
1. Understanding User Needs: Identifying and understanding the diverse needs and
preferences of users can be challenging, especially in markets with varying
demographics, cultural backgrounds, and usage contexts. Designers must conduct
thorough user research and employ techniques such as user personas and journey
mapping to gain insights into user requirements.
2. Balancing Functionality and Aesthetics: Achieving a balance between functionality
and aesthetics can be challenging, particularly when design requirements and aesthetic
preferences may conflict. Designers must prioritize usability and functionality while
also considering the visual appeal and emotional engagement of the product.
3. Incorporating Emerging Technologies: Rapid advancements in technology present
both opportunities and challenges for product design. Integrating emerging
technologies such as artificial intelligence, augmented reality, and Internet of Things
(IoT) into product designs requires staying abreast of technological trends and
understanding their implications for user experience and product performance.
4. Sustainability and Environmental Impact: Designing products that are
environmentally sustainable and have minimal ecological footprints is a growing
concern in the design industry. Designers must consider factors such as material
selection, energy efficiency, recyclability, and end-of-life disposal when designing
products to minimize environmental impact.
 5. Manufacturability and Cost Constraints: Designing products that are
manufacturable at scale and within budgetary constraints can be challenging. Designers
must consider factors such as production processes, material costs, labor costs, and
supply chain logistics when making design decisions to ensure that products can be
produced efficiently and cost-effectively.
6. User Experience and Accessibility: Creating products that provide exceptional user
experiences and are accessible to users with diverse abilities and needs requires careful
consideration of usability principles, interaction design, and accessibility standards.
Designers must prioritize inclusivity and user-centered design practices to ensure that
products are intuitive, usable, and accessible to all users.
7. Regulatory Compliance and Standards: Ensuring that products comply with
regulatory requirements and industry standards is essential for market acceptance and
consumer safety. Designers must stay informed about relevant regulations, standards,
and certification requirements and incorporate compliance considerations into the
design process from the outset.
8. Managing Design Complexity and Iteration: Product design often involves
managing complexity and navigating through multiple design iterations. Designers
must effectively manage project timelines, scope changes, and stakeholder expectations
while maintaining design integrity and quality throughout the iterative design process.

Design assurance
Design assurance refers to the process of ensuring that a product or system meets its intended
design requirements, specifications, and standards throughout the design and development
lifecycle. It involves implementing quality assurance practices, design controls, and
verification and validation activities to mitigate risks, address potential issues, and achieve
design integrity and reliability. Design assurance is essential for ensuring that products are safe,
effective, and compliant with regulatory requirements.
Design assurance is a comprehensive approach to ensuring the integrity, reliability, and quality
of product designs throughout the development lifecycle. By implementing robust design
controls, risk management practices, verification and validation activities, and quality
assurance measures, organizations can mitigate risks, enhance product quality, and achieve
regulatory compliance in the design and development of safe, effective, and reliable products.
Key aspects of design assurance include:
1. Design Controls: Design controls are a set of procedures and processes implemented
to manage the design and development of products. They include defining design
inputs, establishing design outputs, documenting design changes, and conducting
design reviews throughout the product lifecycle. Design controls help ensure that the
design process is well-defined, controlled, and documented to meet regulatory
requirements and quality standards.
2. Risk Management: Risk management is an integral part of design assurance, involving
the identification, assessment, and mitigation of risks associated with the product
 design and development process. Design assurance teams conduct risk assessments to
identify potential hazards, assess the severity and likelihood of harm, and implement
risk mitigation measures to reduce or eliminate risks to an acceptable level.
3. Verification and Validation (V&V): Verification and validation are critical activities
in design assurance, aimed at confirming that the product design meets specified
requirements and performs as intended. Verification involves checking that the design
outputs meet the design inputs and comply with relevant standards and regulations.
Validation involves evaluating the product's performance and effectiveness in real-
world conditions to ensure that it meets user needs and expectations.
4. Quality Assurance (QA): Quality assurance encompasses the processes, procedures,
and activities implemented to ensure that products meet specified quality standards and
requirements. QA practices include establishing quality objectives, conducting audits
and inspections, implementing quality control measures, and monitoring and analyzing
quality metrics throughout the design and development process.
5. Compliance and Regulatory Requirements: Design assurance involves ensuring that
products comply with applicable regulatory requirements, standards, and guidelines
governing product design and development. Design assurance teams stay informed
about regulatory changes, obtain necessary certifications and approvals, and ensure that
products meet safety, performance, and labeling requirements to gain market approval
and maintain regulatory compliance.
6. Documentation and Traceability: Design assurance requires thorough documentation
and traceability of design activities, decisions, and changes throughout the product
lifecycle. Documentation includes design specifications, drawings, test protocols, risk
management files, and regulatory submissions, ensuring transparency, accountability,
and traceability of design-related activities and decisions.
7. Continuous Improvement: Design assurance involves a commitment to continuous
improvement, where design processes, practices, and outcomes are regularly evaluated,
reviewed, and optimized to enhance efficiency, effectiveness, and quality. Design
assurance teams seek opportunities to learn from past experiences, address recurring
issues, and implement best practices to drive continuous improvement in product design
and development.
DESIGN VALIDATION:
Design validation is the process of evaluating and confirming that a product or system meets
its intended use, user needs, and specified requirements. It verifies that the product design is
effective, reliable, and capable of performing its intended functions in real-world conditions.
Design validation is typically conducted after the product has been manufactured or assembled,
using representative samples or prototypes.
The steps involved in design validation include:
1. Define Validation Criteria: Establish clear criteria and objectives for design validation
based on user needs, product specifications, regulatory requirements, and stakeholder
expectations. Define key performance indicators (KPIs), acceptance criteria, and test
protocols to guide the validation process.
 2. Plan Validation Activities: Develop a validation plan outlining the scope, objectives,
methods, resources, and timeline for conducting validation activities. Identify the
validation tests, experiments, simulations, and analyses required to evaluate the
product's performance and functionality.
3. Select Validation Methods: Choose appropriate validation methods and techniques
based on the nature of the product, the complexity of its design, and the available
resources. Common validation methods include testing, simulation, analysis, user trials,
field studies, and expert evaluations.
4. Perform Validation Testing: Execute the validation plan by conducting the identified
validation tests and activities according to the established protocols and procedures.
Use validated test methods, calibrated equipment, and standardized procedures to
ensure consistency, accuracy, and reliability of the test results.
5. Collect Data and Observations: Record and collect data, observations, and
measurements obtained during the validation testing process. Document relevant
information such as test conditions, test results, deviations, anomalies, and observations
to facilitate analysis and decision-making.
6. Analyze Validation Results: Analyze the validation data and results to assess whether
the product meets the defined validation criteria and performance requirements.
Compare the observed performance against the expected outcomes, acceptance criteria,
and regulatory standards to identify any discrepancies or areas for improvement.
7. Document Validation Findings: Document the validation findings, conclusions, and
recommendations in a validation report or documentation. Clearly summarize the
validation results, including any deviations, failures, or non-conformities observed
during testing, along with proposed corrective actions and follow-up activities.
8. Address Non-Conformities: If any non-conformities or deficiencies are identified
during validation testing, take appropriate corrective and preventive actions to address
the root causes and mitigate potential risks. Implement design changes, process
improvements, or corrective measures as necessary to resolve issues and ensure
compliance with validation criteria.
9. Review and Approval: Review the validation report and findings with relevant
stakeholders, including design engineers, quality assurance personnel, regulatory
authorities, and customer representatives. Obtain approval and sign-off on the
validation results before proceeding to production or product release.
10. Continuous Improvement: Use the insights gained from the validation process to
inform future design iterations, product enhancements, and process improvements.
Incorporate lessons learned, feedback from validation testing, and emerging best
practices to drive continuous improvement in product design and validation practices.
By following these steps, organizations can effectively validate product designs, verify their
performance, and ensure that they meet user requirements, regulatory standards, and quality
expectations before market release. Design validation plays a critical role in mitigating risks,
enhancing product reliability, and delivering products that meet customer needs and
expectations.
FAILURE MODE AND EFFECT ANALYSIS (FMEA)
Also called as design failure mode and effects analysis (DFMEA).
Customers are placing increasing demands on companies for high quality reliable products.
The increasing capabilities and functionality of many products are making it more difficult for
manufacturers to maintain quality and reliability. Traditionally, reliability has been achieved
through extensive testing and the use of techniques such as probabilistic reliability modeling.
These are techniques done in the late stages of development. The challenge is to design in
quality and reliability early in the development cycle.
Failure modes and effects analysis (FMEA) is a step-by-step approach for identifying all
possible failures in a design, a manufacturing or assembly process or a product or service.
Failures are any errors or defects, especially ones that affect the customer and can be potential
or actual. “Effects analysis” refers to studying the consequences of those failures.
Begun in the 1940s by the US military, FMEA was further developed by the aerospace and
automotive industries. Several industries maintain formal FMEA.
FMEA is a methodology for analysing potential reliability problems early in the development
cycle where it is easier to take actions to overcome these issues, thereby enhancing reliability
through design.
FMEA is used to identify potential failure modes, determine their effects on the operation of
the product and identify actions to mitigate the failures. A crucial step is anticipating what
might go wrong with a product. While anticipating every failure mode is not possible, the
development team should formulate as extensive a list of potential failure modes as possible.
Th e early and consistent use of FMEAs in the design process allows the engineer to design out
failures and produce reliable, safe and customer pleasing products. FMEAs also capture
historical information for use in future product improvement.
Failures are prioritized according to how serious their consequences are, how frequently they
occur and how easily they can be detected. The purpose of the FMEA is to take action to
eliminate or reduce failures, starting with the highest-priority ones.
FMEA also documents current knowledge and actions about the risks of failures for use in
continuous improvement. FMEA is used during design to prevent failures. It is also
subsequently used for control, both before and during the ongoing operation of the process.
Ideally, FMEA begins during the earliest conceptual stages of design and continues throughout
the life of the product or service.
When to Use FMEA?
FMEA can be used:
• When a process, product or service is being designed or re-designed aft er quality function
deployment.
• When an existing process, product or service is being applied in a new way.
• Before developing control plans for a new or modified process.
• When improvement goals are planned for an existing process, product or service.
• When analysing failures of an existing process, product or service.
• Periodically throughout the life of the process, product or service.
Types of FMEAs
There are several types of FMEAs. Some are used more often than others. FMEA should
always be done whenever failures mean potential harm or injury to the user of the end item
being designed. The diff erent types of FMEA are:
• System—focuses on global system functions
• Design—focuses on components and subsystems
• Process—focuses on manufacturing and assembly processes
• Service—focuses on service functions
• Software—focuses on software functions

FMEA—Procedure
The process for conducting an FMEA is straightforward. The basic steps are outlined below:
1. Describe the product/process and its function: An understanding of the product or process
under consideration has to be clearly articulated. Th is understanding simplifies the process of
analysis by helping the engineer identify those product/process uses that fall within the
intended function and the ones that fall outside. It is important to consider both intentional and
unintentional uses since product failure often ends in litigation, which can be costly and time
consuming.
2. Create a block diagram of the product or process: A block diagram of the product/process
should be developed. This diagram shows major components or process steps as blocks
connected by lines that indicate how the components or steps are related.
3. Complete the header on the FMEA form worksheet: FMEA table headers vary since they
are supposed to be customized according to the requirements of the companies using them.
Generally, the header requires information such as product/process/system name,
component/step name, product designer or process engineer, name of the person who prepared
the FMEA form, FMEA date, revision level (letter or number) and revision date. These
headings must be modified as needed.
4. Enumerate the items (components, functions, steps, etc.) that make up the product or
process:
Table 14.1 shows a simplified FMEA sheet.The items that make up the product or process must
be listed.

5. Identify all potential failure modes associated with the product or process: A failure mode
is defined as the manner in which a component, subsystem, system, process, etc. could
potentially fail to meet the design intent. Examples of potential failure modes include corrosion,
hydrogen embitterment, electrical short or open, torque fatigue, deformation and cracking.
6. List down each failure mode using its technical term: A failure mode in one component
can serve as the cause of a failure mode in another component. Each failure should be listed in
technical terms. Failure modes should be listed for functions of each component or process
step. At this point the failure mode should be identified whether or not the failure is likely to
occur.
7. Describe the effects of each of the failure modes listed and assess the severity of each: For
each failure mode identified in Column 2, a corresponding effect (or effects) must be identified
and listed in Column 3 of the FMEA table. A failure effect is defined as the result of a failure
mode in the function of
the product/process as perceived by the customer. Examples of failure effects include injury to
the user, inoperability of the product or process, improper appearance of the product or process,
degraded performance
and noise. A numerical ranking must be established for the severity of the effect. A common
industry standard scale (1 to 10) uses 1 to represent “no effects” and 10 to indicate “very
severe” with failures affecting system operation and safety without warning. Column 4 of the
FMEA table is used for the severity rating (SEV) of the failure mode.
8. Identify the possible cause(s) for each failure mode: A failure cause is defi ned as a design
weakness that may result in a failure. The potential causes for each failure mode should be
identified and documented. The causes should be listed in technical terms and not in terms of
symptoms. Potential causes are listed in Column 5 and examples include improper torque
applied, improper operating conditions, contamination, erroneous algorithms, improper
alignment, excessive loading and excessive voltage.
9. Quantify the probability of occurrence (probability factor or PF) of each of the failure
mode causes: Every failure cause must be quantified and will be assigned a number (PF), which
indicates how likely that cause has the probability of occurring. A common industry standard
scale uses 1 to represent “not likely” and 10 to indicate “inevitable.” PF values for each of the
failure causes are indicated in Column 6 of the FMEA table.
10. Identify all existing controls (current controls) that contribute to the prevention of the
occurrence of each of these failure mode causes: Current controls (design or process) are the
mechanisms that prevent the cause of the failure mode from occurring or which detect the
failure before it reaches the customer. The engineer should now identify testing, analysis,
monitoring and other techniques that can or have been used on the same or similar
products/processes to detect failures.
Each of these controls should be assessed to determine how well it is expected to identify or
detect failure modes. Each of the controls must be listed in Column 7 of the FMEA table. Aft
er a new product or process has been in use, previously undetected or unidentified failure modes
may appear. The FMEA should then be updated and plans must be made to address those
failures to eliminate them from the product/process.
11. Determine the ability of each control in preventing or detecting the failure mode or its
cause:
Detection is an assessment of the likelihood that the current controls (design and process) will
detect the cause of the failure mode or the failure mode itself, thus preventing it from reaching
the customer. As usual, a number must be assigned to indicate the detection effectiveness
(DET) of each control.
DET numbers are shown in Column 8 of the FMEA table.
12. Calculate risk priority numbers (RPN): The risk priority number is a mathematical product
of the numerical severity, probability and detection ratings:
RPN = (Severity) × (Probability) × (Detection) = SEV × PF × DET
The RPN that is listed in Column 8 of the FMEA table is used to prioritize items required for
additional quality planning or action.
13. Determine recommended action(s) to address potential failures that have a high RPN: A
high RPN needs immediate attention since it indicates that the failure mode can result in an
enormous negative effect, its failure cause has a high likelihood of occurring and there are
insufficient controls to catch it. Action items must be defi ned to address failure modes that
have high RPNs.
These actions could include specific inspection, testing or quality procedures, selection of
different components or materials, de-rating, limiting environmental stresses or operating
range, redesign of the item to avoid the failure mode, monitoring mechanisms, performing
preventative maintenance and inclusion of back-up systems or redundancy. Column 10 of the
FMEA table is used to list applicable action items.
14. Implement the defi ned actions: Assign responsibility and a target completion date for
these actions. Th is makes responsibility clear-cut and facilitates tracking. The responsible
owner and target completion dates must be indicated in column 11 of the FMEA table.
15. Review the results of the actions taken and reassess the RPNs: Aft er the defi ned actions
have been taken, re-assess the severity, probability and detection and review the revised RPNs.
The new RPN should help the engineer decide if more actions are needed or if the actions are
sufficient. Columns 13, 14, 15 and 16 of the FMEA table are used to indicate the new SEV,
PF, DET and RPN, respectively.
16. Keep the FMEA table updated: Update the FMEA as the design or process changes, the
assessment changes or new information cause the SEV, PF or DET to change.
Benefits of FMEA
FMEA is designed to assist the engineer improve the quality and reliability of design. FMEA
provides
the engineer several benefits when used properly. These benefits include:
• Improve product/process reliability and quality
• Increase customer satisfaction
• Early identification and elimination of potential product/process failure modes
• Prioritize product/process deficiencies
• Capture engineering/organization knowledge
• Emphasizes problem prevention
• Documents risk and actions taken to reduce risk
• Provides focus for improved testing and development
• Minimizes late changes and associated cost
• Catalyst for teamwork and idea exchange between functions
Fault Tree Analysis
Fault Tree Analysis (FTA), sometimes called cause and effect tree analysis, is a method to
describe combinations of conditions or events that can lead to a failure. In effect, it is a way to
drill down and identify causes associated with failures and is a good complement to DFMEA.
It is particularly useful for identifying failures that occur only as a result of multiple events
occurring simultaneously. A cause and effect tree is composed of conditions or events
connected by “and” gates and “or” gates as shown in Figure. An effect with an “and” gate
occurs only if all of the causes below it occur; an effect with an “or” gate occurs whenever any
of the causes occur.
The primary steps involved in conducting a Fault Tree Analysis (FTA) typically include:
1. Define the Top Event: The first step in FTA is to define the top event, which represents
the undesired outcome or failure mode that is of interest to the analysis. The top event
could be a system failure, equipment malfunction, safety hazard, or any other adverse
event that needs to be prevented or mitigated.
2. Identify Basic Events: Identify and list the basic events that could potentially
contribute to the occurrence of the top event. Basic events represent the individual
failure modes, component malfunctions, human errors, environmental factors, or other
conditions that may lead to the occurrence of the top event.
3. Construct the Fault Tree Diagram: Create a fault tree diagram using graphical
symbols and logic gates to represent the logical relationships between the top event and
its contributing basic events. The fault tree diagram visually depicts the causal
relationships and dependencies among different events, illustrating how combinations
of basic events can lead to the occurrence of the top event.
4. Define Logic Gates: Use logic gates such as AND, OR, and NOT gates to define the
logical relationships between the basic events and the top event within the fault tree
diagram. Each logic gate represents a specific combination of events and conditions
that can lead to the occurrence or non-occurrence of the top event.
5. Assign Probabilities and Failure Rates: Assign probabilities or failure rates to the
basic events within the fault tree diagram based on available data, historical records,
expert judgment, or engineering analysis. Probabilistic information helps quantify the
likelihood of different failure scenarios and assess the overall risk associated with the
top event.
6. Perform Analysis and Evaluation: Analyze the fault tree diagram to evaluate the
potential paths or combinations of events that could lead to the occurrence of the top
event. Assess the criticality and importance of different basic events and combinations
thereof in contributing to the top event.
7. Calculate Top Event Probability: Calculate the overall probability of the top event
occurring based on the logical combinations and probabilities assigned to the basic
events within the fault tree diagram. The top event probability provides an estimate of
the likelihood of the undesired outcome or failure mode under consideration.
8. Identify Critical Paths and Weaknesses: Identify critical paths, minimal cut sets, or
key failure modes within the fault tree diagram that have the highest probability of
contributing to the occurrence of the top event. Identify potential weaknesses,
vulnerabilities, or failure modes that require mitigation or corrective actions to reduce
the risk of the top event.
9. Develop Risk Mitigation Strategies: Develop risk mitigation strategies, preventive
measures, or control measures to address the identified weaknesses, reduce the
likelihood of critical events, and improve the reliability, safety, and performance of the
system or process under analysis.
 10. Document Findings and Recommendations: Document the findings, results, and
recommendations derived from the Fault Tree Analysis process in a formal report or
documentation. Communicate the analysis outcomes, risk assessment findings, and
recommended actions to relevant stakeholders, decision-makers, and subject matter
experts.
11. Review and Update: Periodically review and update the Fault Tree Analysis to
incorporate new information, changes in the system or process, lessons learned from
previous experiences, and emerging risks or trends. Continuous improvement and
iterative refinement of the FTA process help enhance risk management effectiveness
and ensure ongoing compliance with quality and safety standards.
Design for robustness
Design for robustness is a concept in product design that emphasizes creating products that are
resilient and reliable under a variety of operating conditions, environmental factors, and user
behaviors.
Robust design refers to designing goods and services that are insensitive to variation in
manufacturing processes and when consumers use them. Robust design is facilitated by design
of experiments (see Chapter 6) to identify optimal levels for nominal dimensions and other
tools to minimize failures, reduce defects during the manufacturing process, facilitate assembly
and disassembly (for both the manufacturer and the customer), and improve reliability.
In a celebrated case, Ina Tile Company, a Japanese ceramic tile manufacturer, had purchased a
$2 million kiln from West Germany in 1953.24 Tiles were stacked inside the kiln and baked.
Tiles toward the outside of the stack tended to have a different average size and more variation
in dimensions than those further inside the stack. The obvious cause was the uneven
temperatures inside the kiln. Temperature was an uncontrollable factor. To try to eliminate the
effects of temperature would require redesign of the kiln itself, a very costly alternative. A
group of engineers, chemists, and others who were familiar with the manufacturing process
brainstormed and identified seven major controllable variables that could affect the tile
dimensions:
1. Limestone content
2. Fineness of additive
3. Content of agalmatolite
4. Type of agalmatolite
5. Raw material quantity
6. Content of waste return
7. Content of feldspar
The group designed and conducted an experiment using these factors. The experiment showed
that the first factor, the limestone content, was the most significant factor; the other factors had
smaller effects. By increasing the limestone content from 1 percent to 5 percent and choosing
better levels for other factors, the percentage of size defects was reduced from 30 percent to
less than 1 percent. Limestone was the cheapest material in the tile. In addition, the experiment
revealed that a smaller amount of agalmatolite, the most expensive material in the tile, could
be used without adversely affecting the tile dimension.
This created a robust design that was insensitive to the uneven temperatures in the kiln, and
was a breakthrough in the ceramic tile industry
The need and significance of design for robustness in product design are multifaceted and can
be understood from several perspectives:
1. Enhanced Reliability and Durability: Designing products for robustness helps
improve their reliability and durability, ensuring that they can withstand the rigors of
real-world usage over time. By considering factors such as material selection,
component strength, and manufacturing processes, designers can create products that
are less prone to failure and require fewer repairs or replacements, thereby enhancing
customer satisfaction and reducing lifecycle costs.
2. Increased Performance Consistency: Robust product designs exhibit consistent
performance across a range of operating conditions and environments. By accounting
for variations in input parameters, environmental factors, and user interactions during
the design process, designers can minimize performance variability and ensure that
products deliver reliable and predictable outcomes under diverse scenarios. This
consistency contributes to user confidence and trust in the product's capabilities.
3. Improved User Experience: Designing products for robustness enhances the overall
user experience by minimizing disruptions, errors, and inconvenience associated with
product failures or malfunctions. Robust products are more forgiving of user errors,
environmental extremes, and unforeseen challenges, providing users with greater
confidence, satisfaction, and peace of mind in their interactions with the product.
4. Mitigation of Risk and Liability: Robust product designs help mitigate risks and
liabilities associated with product failures, recalls, and safety incidents. By identifying
and addressing potential failure modes, weak points, and vulnerabilities during the
design phase, designers can proactively reduce the likelihood of product-related
accidents, injuries, and liabilities, thereby protecting both users and manufacturers from
legal, financial, and reputational consequences.
5. Adaptability to Changing Conditions: Robust products are designed to adapt and
evolve in response to changing market dynamics, technological advancements, and user
needs. By building flexibility, modularity, and scalability into the product architecture,
designers can future-proof products against obsolescence, accommodate emerging
trends, and facilitate seamless integration with complementary technologies and
ecosystems, thereby extending the product's lifecycle and relevance in the marketplace.
6. Competitive Advantage and Brand Differentiation: Designing products for
robustness can confer a competitive advantage and serve as a key differentiator for
brands in crowded markets. Robust products are perceived as high-quality, dependable,
and trustworthy by consumers, leading to increased brand loyalty, positive word-of-
mouth, and repeat purchases. By prioritizing robustness in product design, companies
can strengthen their market position, build brand equity, and gain a competitive edge
over rivals.

VALUE ANALYSIS/VALUE ENGINEERING

Value is a personal perspective of one’s willingness to pay for the performance delivered by a
product, process or project. Good value is achieved when the required performance can be
accurately defined and delivered at the lowest lifecycle cost.
What Is Value Engineering?
It is an undisputed fact that the gap between the price and the cost of production, i.e. the profit
margin should be widened as far as possible for the sustained growth of an organization.
Value engineering (VE), also known as value analysis, is a systematic and function-based
approach to improving the value of products, projects or processes. VE involves a team of
people following a structured process. The process helps team members communicate across
boundaries, understand different perspectives, innovate and analyse.
What Does Value Engineering Do?
VE improves value. On highway projects, improvements to value might include reducing the
lifecycle cost of an interchange, enhancing safety in a design or reducing impacts to the public
by shortening the duration of a construction project.
VE uses a combination of creative and analytical techniques to identify alternative ways to
achieve objectives. The use of function analysis differentiates VE from other problem-solving
approaches.
VE focuses on delivering the product or service at the best price by incorporating those value
characteristics deemed most important by the customer.
Value analysis can be used to understand the details of specific situations and to focus on key
areas for innovation. It can be used in reverse (called value engineering) to identify specific
solutions to detailed problems.
Identifying Priorities of VE
First, the main business goals have to be summarized broadly with regard to:
•The company’s vision for business improvement
• An understanding of its products or services from the customer’s perspective
• Analysis [identification] of its main customer and market segments
• An assessment of competition
• Objectives for growth, profitability, customer and employee satisfaction
A prioritized list of challenges facing the business is developed on the basis of these elements.
These priorities are then evolved into projects suitable for the VE process. The VE “job plan”
is then applied to the individual projects based on the order of their priorities. A “job plan”
typically consists of the following phases:
Planning phase: During this phase, emphasis is on the objectives to be achieved, composition
of the project study team, information on which to base the study and detailed planning.
Information phase: In this phase, the detailed information requirements for the project are
identified and distributed among team members. Th is ensures that adequate data is available
to the VE team.
Analysis phase: During the analysis phase, the VE team structures the information and applies
techniques
to analyse the problem.
Creative phase: During the creative phase, the teams undergo structured “brainstorming” to
generate
ideas, which are again combined or developed further.
Evaluation phase: Also termed team design, this phase comprises a series of processes to
evaluate the best ideas generated during the creative phase. The ideas are prioritized in terms
of cost, time and practicality. Those that meet most of the customer requirements at the lowest
lifecycle cost are selected.
Reporting phase: Here, the new initiatives developed are formally presented to senior
management as business cases along with alternatives and appropriate financial cases wherever
investment is required.
Implementation phase: The selected proposals are implemented and new approaches brought
into practice in this phase.
Follow-up phase: Systematic follow-up procedures must be put in place in order to ensure that
all the benefits of the VE project are achieved.
Although VE practices vary from business to business, the above phases must be implemented
to obtain full benefits.

Value Analysis and Value Engineering (VAVE)

VAVE is a generic name given to the techniques of value analysis and VE. Although it is
believed that VAVE can be applied to all spheres of activities of an organization, the difficulties
faced in the application phase have to be realised. Looking into the Aristotelian classification
of the seven types of values, we realise that except in the case of economic value, all others are
highly subjective and fully individual oriented rather than group or society oriented. The seven
classes of values propounded by Aristotle are:
1. Economic value
2. Political value
3. Social value
4. Aesthetic value
5. Ethical value
6. Religious value
7. Judicial value
The Economic Value
Alternative products or services can be found so as to serve the required function at a much
lower cost within a given framework and conditions. The economic value of a product or
service can be broadly divided into six basic values:
(a) Usage value: A product has usage value to the extent that the money spent justifies the
usefulness of the product or service. Th is can be related to the specific functional requirement.
For example, a James Clip in place of a tie pin.
(b) Exchange value: A product has exchange value to the extent that the additional amount
paid guarantees the resale or exchange at any point of time. Though the item is never exchanged
in most cases,
this factor helps by way of insurance against crises. An example of this is the purchase of a
particular brand of scooter by paying three to four thousand rupees more than its face value.
We also k now that most people buying that particular brand never really sell it off . However,
they are sure that if necessary they will be able to sell the brand more easily when compared to
other brands. It is perhaps the feeling of safety that forces one to spend the extra amount.
(c) Esteem value: A product has esteem value to the extent that it meets ego needs. This is a
very difficult item to assess. Hence, the main aim is to eliminate it as it does not contribute
anything towards the satisfactory performance of the function. The concept of appearance
engineering is picking up fast nowadays. For example, packaging a medicine in a nice package
will not encourage the buyer to purchase it unless it has been prescribed by the doctor. In this
case, packaging should aim at only preserving the medicine and nothing more. On the other
hand, a consumer good can be packaged in an appealing manner as it would definitely add to
the decision-making process of the buyer. Government sponsored and highly subsidized items
such as bio-gas stoves, gasifiers, etc. need not be made more expensive by way of esteem
features as they are supposed to be just functional products.
(d) Cost value: A product has cost value to the extent that the expense to produce the item or
service has already been incurred.
(e) Place value: A product has place value when it has a specific value in a certain place and
does not have the same value in another place. A glass of water in a desert is an ideal example
for this.
( f) Time value: A product has time value when it loses its value aft er a certain period of time
has elapsed. For example, transfusing blood to a patient during an operation.
How to Use VAVE?
• Identify and prioritize functions.
• Identify the item to be analysed and the customers for whom it is produced.
• List the basic functions (the things for which the customer is paying). Note that there are
usually very few basic functions.
• Identify the secondary functions by asking, “How is this achieved?” or “What other functions
support the basic functions?”
• Determine the relative importance of each function, preferably by asking a representative
sample of customers (who will always surprise you with what they prefer).
• Analyse contributing functions.
• Find the components of the item being analysed that are used to provide the key functions.
Again, the question, “How” can come in very useful here.
• Measure the cost of each component as accurately as possible, including all material and
production costs.
• Seek improvements.
• Eliminate or reduce the cost of components that add little value, especially high-cost
components.
• Enhance the value added by components that contribute significantly to functions that are
particularly important to customers.
Understanding Value Engineering
Managers across various industries constantly face the challenge of survival and growth in
today’s dynamic and competitive business environments. The biggest challenge they face is,
“How to improve performance on a continual basis to ensure survival and profitable
development?”
For years, companies across the world have been looking for methods to improve and grow
successfully. VE is a powerful technique that when applied on a systematic basis helps users
achieve best performance and improve business by cutting costs and improving performances.
Also known as value management or value analysis, VE is a function-oriented, systematic,
team- approach to reduce costs and simultaneously add value to a product or service.
VE is a framework within which proven methods are systematically employed to identify better
value for products and services. Although the key disciplines are not new, it is the way they
are integrated and deployed that makes the approach effective. The VE methodology includes
multi- disciplined teamwork, function analysis, implementation, financial reporting,
communication techniques and lifecycle costs.
VE is recognized as an efficient way to achieve greater profits, enhanced customer satisfaction
and improved quality. The concept has been successfully applied for many years to businesses
across various government and service industries. The scope of its application is vast. VE has
been applied for cost reduction in purchasing, overall reduction in cost of products and to
minimize costs in the early stages of product development. It has also been applied to
assembling and machining processes, packaging, transportation and distribution, construction,
healthcare and environmental engineering.
Value analysis begins with functional analysis. A function is defi ned as the characteristics that
products/services possess to make them work and sell. In VE, the various functions of a product
are first listed accurately based on their priority.
Take the case of a washing machine. The functions to be performed in the order of priority can
be listed as—remove dirt, extract water, rinse contents and drain the same. Similarly, in the
case of an automobile, various parts perform various functions. The VE project can be broken
into sub-projects for various sub-assemblies to facilitate better results. The VE methodology
takes the cost of a product or service and allocates it to each function being performed to
determine the cost of each function. In conducting value studies, functions are classified as
either basic or secondary.
Basic functions: These are essential for the product to perform well and sell. In simple terms,
they refer to the primary utilitarian characteristic of a product or service to fulfill a user
requirement.
Secondary functions: These functions indicate quality, dependability, performance,
convenience, attractiveness and other features required beyond those needed to satisfy the
minimum requirements specified by the user (basic function).
Functional analysis helps to detect whether minor functions are responsible for a major part of
the total cost or vice versa. Moreover, it enables detection of relatively expensive but
unimportant parts of
a product or aspects of a service.
Benefits of VE
VE can integrate both value-for-money and quality initiatives under a common framework.
The longterm benefits of this approach include:
• Best-of-class performance
• Enhanced quality
• Greater employee involvement and better morale
Best-of-class performance: VE not only brings about improvements in function, performance
and quality, but also results in improved business processes and reduced project lead times. It
facilitates growth of companies even in highly competitive markets. VE provides a framework
with which businesses can either close the gap between them and the best in class or maintain
the competitive edge where they are currently leading.
Enhanced quality: The quality of products, services, projects and business processes are a
function of cost, time and performance. By systematically focusing on these aspects, VE
provides a structured approach to enhance quality.
Greater employee involvement and better morale: VE stimulates an improved working culture
by motivating employees to contribute to their business environment through team-based
workshops. It encourages suggestions and feedback not only from employees, but also from
customers and suppliers. Thus, it helps sustain competitiveness.