Total Quality Management , its framework ,

Its impact & Obstacles

What is Total Quality Management (TQM)?

Total quality management are the act, art or manner of handling, controlling & directing for an organization
to maintain long-term success through procedure of raising degree of excellence of products or services.
Some Key elements of TQM like        
. Customer focus                       
·        Strategic systematic approach
·        Process centered
·        Fact based decision making
·        Employee engagement
·        Integrated system
·        Communication
. Continual improvement       

   

Pillars of total quality management

·        Customers-orientation (both internal and external)
·        Never-ending improvement
·        Statistical control of business processes
·        Preventive maintenance
·        Participative management
·        Ongoing preventive action
·        Cross-functional management
·        Product, Process & systematic approach
·        Organization
·        Leadership
·        Commitment
o  commitment to continuous improvement,
o  commitment of top management
·      Synergistic relationships.
 What is quality culture?
Quality culture is an environment where team members genuinely care about the quality of their
works and make decisions based a set of group values that guide how improvements are made to
everyday working practices and consequent outputs.
 How TQM has impacted quality culture: -
The area total quality management has evolved
1.     From “product orientation” to “customer requirement orientation”.
2.     Prioritize equal of service & cost through standardization with proper transparent distribution.
3.     It insists on “long term decision making” rather “short-term decision”.
4.     TQM emphasize on “prevention of occurring defects” over “detection of defects”.
5.     Focus & give importance on removing error from “system” rather from “operation” by focusing on
preventive action.
6.     TQM impart responsibility distribution for “all members of organization” rather “quality control
department” through individual leadership concept demonstration, awareness & communication
7.     Problem solving through “team work” not only by “managers” through engagement.
8.     Role of manager change from “planning, assign, control & enforce” to “delegation, coach, facilitate &
mentoring”
9.    TQM focused procurement not only through “price basis” but also with “life cycle cost & partnership
building”.
 What are the obstacles of total quality management implementation?
1.     Lack of management commitment: - senior management demonstration & adequate resource
allocation, view quality program as quick fix.
2.     Improper planning: - lack of formalize strategic plan for change
3.     Lack of continuous training and education: - awareness of companywide definition of quality
4.     Incompatible organizational structure and isolated individuals and departments: - poor
interorganizational communication
5.     Ineffective measurement techniques and lack of access to data and results.

6.     Lack of customer focus: - paying inadequate attention to internal and external customers
7.     Inadequate use of empowerment and teamwork
8.     Inability to change organizational culture: - Politics and turf issues
9.     Failure to continually improve
QUALITY FRAME WORK:
BENCHMARKING
Benchmarking is defined as the process of measuring products, services, and processes against those of
organizations known to be leaders in one or more aspects of their operations. Benchmarking provides
necessary insights to help you understand how your organization compares with similar organizations, even
if they are in a different business or have a different group of customers.
Benchmarking can also help organizations identify areas, systems, or processes for improvements—either
incremental (continuous) improvements or dramatic (business process re-engineering) improvements.
 Incremental Quality Improvement vs Benchmarking Breakthroughs
Benchmarking has been classified into two distinct categories: technical and competitive. The House of
Quality matrix and Gantt charts are often used to plot the benchmarking evaluation.
 Technical benchmarking
 Competitive benchmarking
 Benchmarking procedure
 Benchmarking example
 Benchmarking studies
 Benchmarking resources
TECHNICAL BENCHMARKING
Technical benchmarking is performed by design staff to determine the capabilities of products or services,
especially in comparison to the products or services of leading competitors. For example, on a scale of one
to four, four being best, how do designers rank the properties of your organization’s products or services? If
you cannot obtain hard data, the design efforts may be insufficient, and products or services may be
inadequate to be competitive.
COMPETITIVE BENCHMARKING
Competitive benchmarking compares how well (or poorly) an organization is doing with respect to the
leading competition, especially with respect to critically important attributes, functions, or values associated
with the organization’s products or services. For example, on a scale of one to four, four being best, how do
customers rank your organization’s products or services compared to those of the leading competition? If
you cannot obtain hard data, marketing efforts may be misdirected and design efforts misguided. 
BENCHMARKING PROCEDURE
Considerations
 Before an organization can achieve the full benefits of benchmarking, its own processes must be clearly
understood and under control.
 Benchmarking studies require significant investments of manpower and time, so management must
champion the process all the way through, including being ready and willing to make changes based on
what is learned.
 Too broad a scope dooms the project to failure. A subject that is not critical to the organization’s success
won’t return enough benefits to make the study worthwhile.
 Inadequate resources can also doom a benchmarking study by underestimating the effort involved or
inadequate planning. The better you prepare, the more efficient your study will be.
Plan
1. Define a tightly focused subject of the benchmarking study. Choose an issue critical to the organization’s
success.
2. Form a cross-functional team. During Step 1 and 2, management’s goals and support for the study must be
firmly established.
3. Study your own process. Know how the work is done and measurements of the output.
4. Identify partner organizations that may have best practices.
Collect
5. Collect information directly from partner organizations. Collect both process descriptions and numeric
data, using questionnaires, telephone interviews, and/or site visits.
Analyze
6. Compare the collected data, both numeric and descriptive.
7. Determine gaps between your performance measurements and those of your partners.
8. Determine the differences in practices that cause the gaps.
Adapt
9. Develop goals for your organization’s process.
10. Develop action plans to achieve those goals.
11. Implement and monitor plans.
BENCHMARKING EXAMPLE
Carleton University’s department of housing began a project to improve the process by which students apply
for and are assigned housing. This project had three main goals:
1. Reduce residence vacancy rates to below 1%
2. Improve student satisfaction levels
3. Make the best possible use of employee time and effort
The department chose benchmarking as the basis for the improvement project after realizing that other
universities already had better processes Carleton could learn from and quickly implement without needing
to re-engineer the process from scratch.
The cross-functional team started by mapping the existing residence application process to establish a
baseline, focusing attention on the process used by new first-year students (left side, Figure 1).

Figure 1: Main Process Steps Before and After Benchmarking

The project team then conducted focus groups with students living in residence, asking them to describe
their expectations of the assignment service process, their perceptions of the services they actually received,
and any gaps between the two.
The team also reviewed websites of housing offices at 24 international universities, followed by a telephone
survey of 12 of these to find out more about their systems. The team then conducted site visits to four
universities seen as leaders in dealing with residence applications to learn about their current processes and
discuss the relative advantages and disadvantages of each one.
 The team presented its benchmarking report to management, describing the best practices seen at other
universities and making specific recommendations for adapting them for Carleton (right side, Figure 1).
Carleton implemented many of the recommended changes and is seeing the benefits (Figure 2).

Figure 2: Benchmarking Average Vacancy Rates for Residences

Why is benchmarking important?

The goal of your business should be to grow, improve processes, increase quality, decrease costs, and earn
more money. Benchmarking is one of many tools you can use as part of any continuous improvement model
used within your organization.
Consistent benchmarking can help you:
 Improve processes and procedures.
 Gauge the effectiveness of past performance.
 Give you a better idea of how the competition operates, which will help you to identify best practices to
increase performance.
 Increase efficiency and lower costs, making your business more profitable.
 Improve quality and customer satisfaction.
Types of benchmarking
There are many different types of benchmarking that fall into three primary categories: internal, competitive,
and strategic.
Internal benchmarking
If other teams or organizations within your company have established best practices in processes similar to
yours, internal benchmarking involves analyzing what they are doing so you can find areas where you can
improve and be more efficient.
For example, you could compare the performance of one warehousing and shipping site against another
warehousing and shipping site. The site with superior performance simply needs to share their processes and
procedures so that the entire company benefits from increased performance. 
Competitive benchmarking
This type of benchmarking is a comparison of products, services, processes, and methods of your direct
competitors. This type gives you insight into your position within your industry and what you may need to
do to increase productivity.
For example, you can compare the customer satisfaction of a competitor’s product to yours. If your
competitor is getting better customer reviews, you need to analyze what the difference is and figure out how
to improve the quality of your product. 
Strategic benchmarking
Use this type of benchmarking when you need to look beyond your own industry to identify world-class
performance and best practices so you can look for ways to adapt their methods to your procedures and
processes.
For example, seeing a need to improve performance, Southwest Airlines turned to NASCAR to analyze how
pit crews are able to service race cars so quickly. They realized that it all depends on each pit crew
member’s ability to perform clearly defined tasks within specific time intervals—12 to 16 seconds if all four
tires need to be changed and the car needs to be fueled. As a result, Southwest Airlines changed and
streamlined processes for gate maintenance, plane cleaning, and passenger boarding.
8 steps in the benchmarking process
1. Select a subject to benchmark
Executives and other senior management should be involved in deciding which processes are critical to the
company’s success. The processes should then be prioritized based on which metrics are most important to
all stakeholders. After prioritizing, select and define the measures you want to collect.
2. Decide which organizations or companies you want to benchmark
Determine if you are going to benchmark processes within your own company, a competitor, or a company
outside of your industry.
It may be hard to collect all the data you want if you benchmark a direct competitor. So you should select
several different organizations to study in order to get the data you need. Gather information from several
sources to get the most detailed information about the organization you select to study.
3. Document your current processes
Map out your current processes so you can identify areas that need improvement and more easily compare
against the chosen organization.
The road to improvement starts with a better understanding of where you're at now.
Document your as-is processes
4. Collect and analyze data
This step is important—but it can prove difficult when you are trying to gather data from a competitor
because a lot of that information may be confidential. Gather information through research, interviews,
casual conversations with contacts from the other companies, and with formal interviews or questionnaires.
You can also collect secondary information from websites, reports, marketing materials, and news articles.
However, secondary information may not be as reliable.
After you have collected enough data, get all stakeholders together to analyze the data. 
5. Measure your performance against the data you’ve collected
Look at the data you’ve collected side by side with the metrics you gathered from your analysis of your own
processes. You may want to layer your performance metrics on top of your process diagrams or map out
your competitor’s processes to more easily see where you’re falling behind.
As you analyze the comparisons, try to identify what causes the gaps in your process. For example, do you
have enough people and are they sufficiently trained to perform assigned tasks? Brainstorm ideas to
effectively and efficiently fill those gaps.
6. Create a plan
Create a plan to implement changes that you have identified as being the best to close performance gaps.
Implementation requires total buy-in from the top down. Your plan must include clearly defined goals and
should be written with the company’s culture in mind to help minimize any pushback you may get from
employees.
7. Implement the changes
Closely monitor the changes and employee performance. If new processes are not running smoothly as
expected, identify areas that need to be tweaked. Make sure all employees understand their jobs, are well
trained, and have the expertise to complete their assigned tasks.
Document all processes and make sure all employees have access to documentation and instructions so that
all are on the same page working toward the same goal. 
Consider these 7 fundamental change management models as you implement new processes.
8. Repeat the process
After successfully implementing a new process, it’s time to find other ways to improve. Review the new
processes you’ve implemented and see if there are any changes that need to be made. If everything is
running smoothly, look to other areas or more ambitious projects that you may want to benchmark and start
the process again.
When you correctly implement and follow the continuous practice of benchmarking, your company will
grow, and you will keep up with (or even surpass) your competitors. Get started now by understanding your
as-is processes.
Quality Function Deployment (QFD)
Introduction to Quality Function Deployment (QFD)
The average consumer today has a multitude of options available to select from for similar products and
services. Most consumers make their selection based upon a general perception of quality or value.
Consumers typically want “the most bang for their buck”. In order to remain competitive, organizations
must determine what is driving the consumer’s perception of value or quality in a product or service. They
must define which characteristics of the products such as reliability, styling or performance form the
customer’s perception of quality and value. Many successful organizations gather and integrate the Voice of
the Customer (VOC) into the design and manufacture of their products. They actively design quality and
customer perceived value into their products and services. These companies are utilizing a structured
process to define their customer’s wants and needs and transforming them into specific product designs and
process plans to produce products that satisfy the customer’s needs. The process or tool they are using is
called Quality Function Deployment (QFD).
What is Quality Function Deployment (QFD)
Quality Function Deployment (QFD) is a process and set of tools used to effectively define customer
requirements and convert them into detailed engineering specifications and plans to produce the products
that fulfill those requirements. QFD is used to translate customer requirements (or VOC) into measureable
design targets and drive them from the assembly level down through the sub-assembly, component and
production process levels. QFD methodology provides a defined set of matrices utilized to facilitate this
progression.
QFD was first developed in Japan by Yoji Akao in the late 1960s while working for Mitsubishi’s shipyard.
It was later adopted by other companies including Toyota and its supply chain. In the early 1980s, QFD was
introduced in the United States mainly by the big three automotive companies and a few electronics
manufacturers. Acceptance and growth of the use of QFD in the US was initially rather slow but has since
gained popularity and is currently being used in manufacturing, healthcare and service organizations.
Why Implement Quality Function Deployment (QFD)
Effective communication is one of the most important and impactful aspects of any organization’s success.
QFD methodology effectively communicates customer needs to multiple business operations throughout the
organization including design, quality, manufacturing, production, marketing and sales. This effective
communication of the Voice of the Customer allows the entire organization to work together and produce
products with high levels of customer perceived value. There are several additional benefits to using
Quality Function Deployment:
 Customer Focused: QFD methodology places the emphasis on the wants and needs of the customer,
not on what the company may believe the customer wants. The Voice of the Customer is translated
into technical design specifications. During the QFD process, design specifications are driven down
from machine level to system, sub-system and component level requirements. Finally, the design
specifications are controlled throughout the production and assembly processes to assure the
customer needs are met.
 VOC Competitor Analysis: The QFD “House of Quality” tool allows for direct comparison of how
your design or product stacks up to the competition in meeting the VOC. This quick analysis can be
beneficial in making design decisions that could place you ahead of the pack.
 Shorter Development Time and Lower Cost: QFD reduces the likelihood of late design changes by
focusing on product features and improvements based on customer requirements. Effective QFD
methodology prevents valuable project time and resources from being wasted on development of
non-value added features or functions.
 Structure and Documentation: QFD provides a structured method and tools for recording decisions
made and lessons learned during the product development process. This knowledge base can serve as
a historical record that can be utilized to aid future projects.
Companies must bring new and improved products to market that meet the customer’s actual wants and
needs while reducing development time. QFD methodology is for organizations committed to listening to
the Voice of the Customer and meeting their needs.
How to Implement Quality Function Deployment (QFD)
The Quality Function Deployment methodology is a 4-phase process that encompasses activities throughout
the product development cycle.  A series of matrices are utilized at each phase to translate the Voice of the
Customer to design requirements for each system, sub-system and component. The four phases of QFD are:
1. Product Definition: The Product Definition Phase begins with collection of VOC and translating the
customer wants and needs into product specifications. It may also involve a competitive analysis to
 evaluate how effectively the competitor’s product fulfills the customer wants and needs. The initial
design concept is based on the particular product performance requirements and specifications.
2. Product Development: During the Product Development Phase, the critical parts and assemblies are
identified. The critical product characteristics are cascaded down and translated to critical or key part
and assembly characteristics or specifications. The functional requirements or specifications are then
defined for each functional level.
3. Process Development: During the Process Development Phase, the manufacturing and assembly
processes are designed based on product and component specifications. The process flow is
developed and the critical process characteristics are identified.
4. Process Quality Control: Prior to production launch, the QFD process identifies critical part and
process characteristics. Process parameters are determined and appropriate process controls are
developed and implemented. In addition, any inspection and test specifications are developed. Full
production begins upon completion of process capability studies during the pilot build.
Effective use of QFD requires team participation and discipline inherent in the practice of QFD, which has
proven to be an excellent team-building experience.
Level 1 QFD
The House of Quality is an effective tool used to translate the customer wants and needs into product or
service design characteristics utilizing a relationship matrix. It is usually the first matrix used in the QFD
process. The House of Quality demonstrates the relationship between the customer wants or “Whats” and
the design parameters or “Hows”. The matrix is data intensive and allows the team to capture a large
amount of information in one place. The matrix earned the name “House of Quality” due to its structure
resembling that of a house. A cross-functional team possessing thorough knowledge of the product, the
Voice of the Customer and the company’s capabilities, should complete the matrix. The different sections
of the matrix and a brief description of each are listed below:
 “Whats”: This is usually the first section to be completed. This column is where the VOC, or the
wants and needs, of the customer are listed.
 Importance Factor: The team should rate each of the functions based on their level of importance to
the customer. In many cases, a scale of 1 to 5 is used with 5 representing the highest level of
importance.
 “Hows” or Ceiling: Contains the design features and technical requirements the product will need to
align with the VOC.
 Body or Main Room: Within the main body or room of the house of quality the “Hows” are ranked
according to their correlation or effectiveness of fulfilling each of the “Whats”. The ranking system
used is a set of symbols indicating either a strong, moderate or a weak correlation. A blank box
would represent no correlation or influence on meeting the “What”, or customer requirement. Each
of the symbols represents a numerical value of 0, 1, 3 or 9.
 Roof: This matrix is used to indicate how the design requirements interact with each other. The
interrelationships are ratings that range from a strong positive interaction (++) to a strong negative
interaction (–) with a blank box indicating no interrelationship.
 Competitor Comparison: This section visualizes a comparison of the competitor’s product in regards
to fulfilling the “Whats”. In many cases, a scale of 1 to 5 is used for the ranking, with 5 representing
the highest level of customer satisfaction. This section should be completed using direct feedback
from customer surveys or other means of data collection.
 Relative Importance: This section contains the results of calculating the total of the sums of each
column when multiplied by the importance factor. The numerical values are represented as discrete
numbers or percentages of the total. The data is useful for ranking each of the “Hows” and
determining where to allocate the most resources.
 Lower Level / Foundation: This section lists more specific target values for technical specifications
relating to the “Hows” used to satisfy VOC.
Upon completion of the House of Quality, the technical requirements derived from the VOC can then be
deployed to the appropriate teams within the organization and populated into the Level 2 QFDs for more
detailed analysis. This is the first step in driving the VOC throughout the product or process design process.
Level 2 QFD
The Level 2 QFD matrix is a used during the Design Development Phase. Using the Level 2 QFD, the team
can discover which of the assemblies, systems, sub-systems and components have the most impact on
meeting the product design requirements and identify key design characteristics. The information produced
from performing a Level 2 QFD is often used as a direct input to the Design Failure Mode and Effects
Analysis (DFMEA) process. Level 2 QFDs may be developed at the following levels:
 System Level: The technical specifications and functional requirements or “Hows” identified and
prioritized within The House of Quality become the “Whats” for the system level QFD. They are
then evaluated according to which of the systems or assemblies they impact. Any systems deemed
critical would then progress to a sub-system QFD.
 Sub-system Level: The requirements cascaded down from the system level are re-defined to align
with how the sub-system contributes to the system meeting its functional requirements. This
information then becomes the “Whats” for the QFD and the components and other possible “Hows”
are listed and ranked to determine the critical components. The components deemed critical would
then require progression to a component level QFD.
 Component Level: The component level QFD is extremely helpful in identifying the key and critical
characteristics or features that can be detailed on the drawings. The key or critical characteristics
then flow down into the Level 3 QFD activities for use in designing the process. For purchased
components, this information is valuable for communicating key and critical characteristics to
suppliers during sourcing negotiations and as an input to the Production Part Approval Process
(PPAP) submission.
Level 3 QFD
The Level 3 QFD is used during the Process Development Phase where we examine which of the processes
or process steps have any correlation to meeting the component or part specifications. In the Level 3 QFD
matrix, the “Whats” are the component part technical specifications and the “Hows” are the manufacturing
processes or process steps involved in producing the part. The matrix highlights which of the processes or
process steps have the most impact on meeting the part specifications. This information allows the
production and quality teams to focus on the Critical to Quality (CTQ) processes, which flow down into the
Level 4 QFD for further examination.
Level 4 QFD
The Level 4 QFD is not utilized as often as the previous three. Within the Level 4 QFD matrix, the team
should list all the critical processes or process characteristics in the “Whats” column on the left and then
determine the “Hows” for assuring quality parts are produced and list them across the top of the matrix.
Through ranking of the interactions of the “Whats” and the “Hows”, the team can determine which controls
could be most useful and develop quality targets for each. This information may also be used for creating
Work Instructions, Inspection Sheets or as an input to Control Plans.
The purpose of Quality Function Deployment is not to replace an organization’s existing design process but
rather support and improve an organization’s design process. QFD methodology is a systemic, proven
means of embedding the Voice of the Customer into both the design and production process. QFD is a
method of ensuring customer requirements are accurately translated into relevant technical specifications
from product definition to product design, process development and implementation. The fact is that every
business, organization and industry has customers. Meeting the customer’s needs is critical to success. 
Implementing QFD methodology can enable you to drive the voice of your customers throughout your
processes to increase your ability to satisfy or even excite your customers.
 QFD + House of Quality Example
T P M ( T O T A L P R O D U C T I V E MA I N T EN A N C E )
WHAT IS TPM?
TPM (Total Productive Maintenance) is a holistic approach to equipment maintenance that strives to
achieve perfect production:

 No Breakdowns
 No Small Stops or Slow Running
 No Defects

In addition it values a safe working environment:

 No Accidents

TPM emphasizes proactive and preventative maintenance to maximize the operational efficiency of
equipment. It blurs the distinction between the roles of production and maintenance by placing a
strong emphasis on empowering operators to help maintain their equipment.
The implementation of a TPM program creates a shared responsibility for equipment that
encourages greater involvement by plant floor workers. In the right environment this can be very
effective in improving productivity (increasing up time, reducing cycle times, and eliminating
defects).
TRADITIONAL TPM PILLARS
The traditional approach to TPM was developed in the 1960s and consists of 5S as a foundation and
eight supporting activities (sometimes referred to as pillars).
 The traditional TPM model consists of a 5S foundation (Sort, Set in Order, Shine, Standardize, and Sustain)
and eight supporting pillars.
The 5S Foundation
The goal of 5S is to create a work environment that is clean and well-organized . It consists of five
elements:

 Sort: eliminate anything that is not truly needed in the work area

 Straighten: organize the remaining items
 Shine: clean and inspect the work area
 Standardize: create standards for performing the above three activities
 Sustain: ensure the standards are regularly applied
It should be reasonably intuitive how 5S creates a foundation for well-running equipment. For
example, in a clean and well-organized work environment, tools and parts are much easier to find,
and it is much easier to spot emerging issues such as fluid leaks, material spills, metal shavings
from unexpected wear, hairline cracks in mechanisms, etc.
The Eight TPM Pillars
The eight pillars of TPM are mostly focused on proactive and preventative techniques for improving
equipment reliability.
Pillar What Is It? How Does It Help?

Autonomous Places responsibility  Gives operators greater “ownership” of their

Maintenance for routine equipment.
maintenance, such as  Increases operators’ knowledge of their equipment.
cleaning, lubricating,  Ensures equipment is well-cleaned and lubricated.
and inspection, in the  Identifies emergent issues before they become
hands of operators. failures.
 Frees maintenance personnel for higher-level tasks.
Planned Schedules maintenance  Significantly reduces instances of unplanned stop
Maintenance tasks based on time.
predicted and/or  Enables most maintenance to be planned for times
measured failure rates. when equipment is not scheduled for production.
 Reduces inventory through better control of wear-
prone and failure-prone parts.
Quality Design error detection  Specifically targets quality issues with improvement
Maintenance and prevention into projects focused on removing root sources of defects.
production processes.  Reduces number of defects.
 Pillar What Is It? How Does It Help?

Apply Root Cause  Reduces cost by catching defects early (it is

Analysis to eliminate expensive and unreliable to find defects through
recurring sources of inspection).
quality defects.
Focused Have small groups of  Recurring problems are identified and resolved by
Improvement employees work cross-functional teams.
together proactively to  Combines the collective talents of a company to
achieve regular, create an engine for continuous improvement.
incremental
improvements in
equipment operation.
Early Directs practical  New equipment reaches planned performance levels
Equipment knowledge and much faster due to fewer startup issues.
Management understanding of  Maintenance is simpler and more robust due to
manufacturing practical review and employee involvement prior to
equipment gained installation.
through TPM towards
improving the design
of new equipment.
Training and Fill in knowledge gaps  Operators develop skills to routinely maintain
Education necessary to achieve equipment and identify emerging problems.
TPM goals. Applies to  Maintenance personnel learn techniques for proactive
operators, maintenance and preventative maintenance.
personnel and  Managers are trained on TPM principles as well as on
managers. employee coaching and development.

Safety, Health, Maintain a safe and  Eliminates potential health and safety risks, resulting
Environment healthy working in a safer workplace.
environment.  Specifically targets the goal of an accident-free
workplace.
TPM in Apply TPM techniques  Extends TPM benefits beyond the plant floor by
Administration to administrative addressing waste in administrative functions.
functions.  Supports production through improved administrative
operations (e.g., order processing, procurement, and
scheduling).
FMEA – Failure Mode & Effects Analysis –
Introduction to Failure Mode and Effects Analysis (FMEA)
There are numerous high-profile examples of product recalls resulting from poorly designed products
and/or processes. These failures are debated in the public forum with manufacturers, service providers and
suppliers being depicted as incapable of providing a safe product. Failure Mode and Effects Analysis, or
FMEA, is a methodology aimed at allowing organizations to anticipate failure during the design stage by
identifying all of the possible failures in a design or manufacturing process.
Developed in the 1950s, FMEA was one of the earliest structured reliability improvement methods. Today
it is still a highly effective method of lowering the possibility of failure.
What is Failure Mode and Effects Analysis (FMEA)
Failure Mode and Effects Analysis (FMEA) is a structured approach to discovering potential failures that
may exist within the design of a product or process.
Failure modes are the ways in which a process can fail. Effects are the ways that these failures can lead to
waste, defects or harmful outcomes for the customer. Failure Mode and Effects Analysis is designed to
identify, prioritize and limit these failure modes.
FMEA is not a substitute for good engineering. Rather, it enhances good engineering by applying the
knowledge and experience of a Cross Functional Team (CFT) to review the design progress of a product or
process by assessing its risk of failure.
There are two broad categories of FMEA, Design FMEA (DFMEA) and Process FMEA (PFMEA).
Design FMEA
Design FMEA (DFMEA) explores the possibility of product malfunctions, reduced product life, and safety
and regulatory concerns derived from:
 Material Properties
 Geometry
 Tolerances
 Interfaces with other components and/or systems
 Engineering Noise: environments, user profile, degradation, systems interactions
Process FMEA
Process FMEA (PFMEA) discovers failure that impacts product quality, reduced reliability of the process,
customer dissatisfaction, and safety or environmental hazards derived from:
 Human Factors
 Methods followed while processing
 Materials used
 Machines utilized
 Measurement systems impact on acceptance
 Environment Factors on process performance

Design FMEA Worksheet

Process FMEA Worksheet
Why Perform Failure Mode and Effects Analysis (FMEA)
Historically, the sooner a failure is discovered, the less it will cost. If a failure is discovered late in product
development or launch, the impact is exponentially more devastating.
FMEA is one of many tools used to discover failure at its earliest possible point in product or process
design. Discovering a failure early in Product Development (PD) using FMEA provides the benefits of:
 Multiple choices for Mitigating the Risk
 Higher capability of Verification and Validation of changes
 Collaboration between design of the product and process
 Improved Design for Manufacturing and Assembly (DFM/A)
 Lower cost solutions
 Legacy, Tribal Knowledge, and Standard Work utilization
Ultimately, this methodology is effective at identifying and correcting process failures early on so that you
can avoid the nasty consequences of poor performance.

Late Failure Mode Discovery

Early Failure Mode Discovery
When to Perform Failure Mode and Effects Analysis (FMEA)
There are several times at which it makes sense to perform a Failure Mode and Effects Analysis:
 When you are designing a new product, process or service
 When you are planning on performing an existing process in a different way
 When you have a quality improvement goal for a specific process
 When you need to understand and improve the failures of a process
In addition, it is advisable to perform an FMEA occasionally throughout the lifetime of a process. Quality
and reliability must be consistently examined and improved for optimal results.
How to Perform Failure Mode and Effects Analysis (FMEA)
FMEA is performed in seven steps, with key activities at each step. The steps are separated to assure that
only the appropriate team members for each step are required to be present. The FMEA approach used by
Quality-One has been developed to avoid typical pitfalls which make the analysis slow and ineffective. The
Quality-One Three Path Model allows for prioritization of activity and efficient use of team time.
There are Seven Steps to Developing an FMEA:
1. FMEA Pre-Work and Assemble the FMEA Team
2. Path 1 Development (Requirements through Severity Ranking)
3. Path 2 Development (Potential Causes and Prevention Controls through Occurrence Ranking)
4. Path 3 Development (Testing and Detection Controls through Detection Ranking)
5. Action Priority & Assignment
6. Actions Taken / Design Review
7. Re-ranking RPN & Closure
The Steps for conducting FMEA are as follows:
1. FMEA Pre-Work and Assembly of the FMEA Team
Pre-work involves the collection and creation of key documents. FMEA works smoothly through the
development phases when an investigation of past failures and preparatory documents is performed from its
onset. Preparatory documents may include:
 Failure Mode Avoidance (FMA) Past Failure
o Eight Disciplines of Problem Solving (8D)
 Boundary/Block Diagram (For the DFMEA)
  Parameter Diagram (For the DFMEA)
 Process Flow Diagram (For the PFMEA)
 Characteristics Matrix (For the PFMEA)
A pre-work Checklist is recommended for an efficient FMEA event. Checklist items may include:
 Requirements to be included
 Design and / or Process Assumptions
 Preliminary Bill of Material / Components
 Known causes from surrogate products
 Potential causes from interfaces
 Potential causes from design choices
 Potential causes from noises and environments
 Family or Baseline FMEA (Historical FMEA)
 Past Test and Control Methods used on similar products
2. Path 1 Development- (Requirements through Severity Ranking)
Path 1 consists of inserting the functions, failure modes, effects of failure and Severity rankings. The pre-
work documents assist in this task by taking information previously captured to populate the first few
columns (depending on the worksheet selected) of the FMEA.
 Functions should be written in verb-noun context. Each function must have an associated
measurable. Functions may include:
o Wants, needs and desires translated
o Specifications of a design
o Government regulations
o Program-specific requirements
o Characteristics of product to be analyzed
o Desired process outputs
 Failure Modes are written as anti-functions or anti-requirements in five potential ways:
o Full function failure
o Partial / degraded function failure
o Intermittent function failure
o Over function failure
o Unintended function failure
 Effects are the results of failure, where each individual effect is given a Severity ranking. Actions are
considered at this stage if the Severity is 9 or 10
o Recommended Actions may be considered that impact the product or process design
addressing Failure Modes on High Severity Rankings (Safety and Regulatory)
3. Path 2 Development – (Potential Causes and Prevention Controls through Occurrence Ranking)
Causes are selected from the design / process inputs or past failures and placed in the Cause column when
applicable to a specific failure mode. The columns completed in Path 2 are:
 Potential Causes / Mechanisms of Failure
 Current Prevention Controls (i.e. standard work, previously successful designs, etc.)
 Occurrence Rankings for each cause
 Classification of Special Characteristics, if indicated
 Actions are developed to address high risk Severity and Occurrence combinations, defined in the
Quality-One Criticality Matrix
4. Path 3 Development- (Testing and Detection Controls through Detection Ranking)
Path 3 Development involves the addition of Detection Controls that verify that the design meets
requirements (for Design FMEA) or cause and/or failure mode, if undetected, may reach a customer (for
Process FMEA).
 The columns completed in Path 3 are:
o Detection Controls
o Detection Ranking
 Actions are determined to improve the controls if they are insufficient to the Risks determined in
Paths 1 and 2. Recommended Actions should address weakness in the testing and/or control strategy.
  Review and updates of the Design Verification Plan and Report (DVP&R) or Control Plans are
also possible outcomes of Path 3.
5. Action Priority & Assignment
The Actions that were previously determined in Paths 1, 2 or 3 are assigned a Risk Priority Number (RPN)
for action follow-up.
RPN is calculated by multiplying the Severity, Occurrence and Detection Rankings for each potential
failure / effect, cause and control combination. Actions should not be determined based on an RPN
threshold value. This is done commonly and is a practice that leads to poor team behavior. The columns
completed are:
 Review Recommended Actions and assign RPN for additional follow-up
 Assign Actions to appropriate personnel
 Assign action due dates
6. Actions Taken / Design Review
FMEA Actions are closed when counter measures have been taken and are successful at reducing risk. The
purpose of an FMEA is to discover and mitigate risk. FMEAs which do not find risk are considered to be
weak and non-value added. Effort of the team did not produce improvement and therefore time was wasted
in the analysis.
7. Re-Ranking RPN and Closure
After successful confirmation of Risk Mitigation Actions, the Core Team or Team Leader will re-rank the
appropriate ranking value (Severity, Occurrence or Detection). The new rankings will be multiplied to
attain the new RPN. The original RPN is compared to the revised RPN and the relative improvement to the
design or process has been confirmed. Columns completed in Step 7:
 Re-ranked Severity
 Re-ranked Occurrence
 Re-ranked Detection
 Re-ranked RPN
 Generate new Actions, repeating Step 5, until risk has been mitigated
 Comparison of initial RPN and revised RPN
FMEA Document Analysis
Deciding when to take an action on the FMEA has historically been determined by RPN thresholds.
Quality-One does not recommend the use of RPN thresholds for setting action targets. Such targets are
believed to negatively change team behavior because teams select the lowest numbers to get below the
threshold and not actual risk, requiring mitigation.
The analysis of an FMEA should include multiple level considerations, including:
 Severity of 9 / 10 or Safety and Regulatory alone (Failure Mode Actions)
 Criticality combinations for Severity and Occurrence (Cause Actions)
 Detection Controls (Test and Control Plan Actions)
 RPN Pareto
When completed, Actions move the risk from its current position in the Quality-One FMEA Criticality
Matrix to a lower risk position.
RPN Action Priority
When risk is determined to be unacceptable, Quality-One recommends a priority of action to be applied as
follows:
1. Error Proofing (Eliminate Failure Mode or Address Cause)
o Failure Mode (Only Severity of 9 or 10)
o Causes with High Occurrence
2. Improve Potential Process Capability
o Increase Tolerance (Tolerance Design)
o Reduce Variation of the Process (Statistical Process Control and Process Capability)
3. Improve Controls
o Mistake Proofing of the tooling or process
o Improve the inspection / evaluation techniques
FMEA Relationship to Problem Solving
The Failure Modes in a FMEA are equivalent to the Problem Statement or Problem Description in Problem
Solving. Causes in a FMEA are equivalent to potential root causes in Problem Solving. Effects of failure in
a FMEA are Problem Symptoms in Problem Solving. More examples of this relationship are:
 The problem statements and descriptions are linked between both documents. Problem solving
methods are completed faster by utilizing easy to locate, pre-brainstormed information from an
FMEA.
 Possible causes in an FMEA are immediately used to jump start Fishbone or Ishikawa diagrams.
Brainstorming information that is already known is not a good use of time or resources.
 Data collected from problem solving is placed into an FMEA for future planning of new products or
process quality. This allows an FMEA to consider actual failures, categorized as failure modes and
causes, making the FMEA more effective and complete.
 The design or process controls in an FMEA are used in verifying the root cause and Permanent
Corrective Action (PCA).
 The FMEA and Problem Solving reconcile each failure and cause by cross documenting failure
modes, problem statements and possible causes.
FMEA Example
This FMEA Example has one item with a progression through multiple recommended Actions. With each
instance, the revised RPN has improved. The final RPN of 10 indicates the issue has been mitigated
successfully. The new state should be captured as Standard Work.