5. 5
Agenda Why does it always
seem we have plenty of
time to fix our
problems, but never
enough time to prevent
the problems by doing
it right the first time?
8. Failure Mode and Effects Analysis (FMEA) is an integral part
of product and process design activity. The FMEA process is
applicable in Design of Products, Processes and Services.
Failure Modes and Effects Analysis (FMEA) is commonly used
in a variety of industries for Risk Management, where simple
quantification of risk is insufficient.
9. FMEA (Failure Mode and Effects Analysis) software helps
organizations improve product quality by identifying the
sources and effects of risks and introducing control measures to
eliminate them. By implementing an FMEA tool early in the
product development process, organizations can systematically
identify risks at the functional, design, component, or process
level and implement risk controls to effectively address them.
10. This “type” of thinking has been around for
hundreds of years. It was first formalized in the aerospace
industry during the Apollo program in the 1963 .
1965 The military of the US started to apply
the FMEA technique.
1977 Ford Motor started to use FMEA.
11.
12. Severity: If a failure were to occur, what effect would that
failure have on the Product quality and on the patient (if any)?
Probability of occurrence: How likely is it for a particular
failure to occur?
Detectability: What mechanisms are in place (if any) to detect
a failure if it were to occur?
13.
14.
15.
16. It is an inseparable part of risk management and it supports the
continuous improvement. The main aim of the is detecting
effects and causes of failure modes that can affect the
reliability, the quality and not least the safety of products,
whether it is product, process, system or service analysis.
FMEA analysis involves teamwork, management support, and
deep knowledge of systems, products, processes, time and cost.
Therefore, to be successful, this technique should be fully
implemented quality management system both within the
process of both product development and processes. This will
enable companies to rationalize their activities and thus reduce
costs and increase efficiency.
17.
18. Six Sigma at many organizations simply means a
measure of quality that strives for near perfection. Six
Sigma is a disciplined, data-driven approach and
methodology for eliminating defects (driving toward
six standard deviations between the mean and the
nearest specification limit) in any process – from
manufacturing to transactional and from product to
service.
19.
20. A new way of doing business
Wise application of statistical tools within a structured
methodology
Repeated application of strategy to individual projects
Projects selected that will have a substantial impact on
the ‘bottom line’
21. Knowledge
Management
In some aspects of quality improvement, TQM and Six Sigma share the same philosophy of how to assist organizations to accomplish Total Quality.
22. Six Sigma
In some aspects of quality improvement, TQM and Six
Sigma share the same philosophy of how to assist
organizations to accomplish Total Quality. They both
emphasize the importance of top-management
support and leadership.
Both approaches make it clear that continuous quality
improvement is critical to long-term business success.
However, why has the popularity of TQM waned while
Six Sigma's popularity continues to grow in the past
decade?
25. Companies who have successfully adopted ‘Six Sigma’
strategies include:
26. GE “Service company” - examples
Approving a credit card application
Lending money
Answering a service call for an appliance
Underwriting an insurance policy
Developing software for a new product
27. • In 1995 GE mandated each employee to work towards
achieving 6 sigma
• The average process at GE was 3 sigma in 1995
• In 1997 the average reached 3.5 sigma
• GE’s goal was to reach 6 sigma by 2001
• Investments in 6 sigma training and projects reached 45MUS$
in 1998, profits increased by 1.2BUS$
General Electric
28. “At Motorola we use statistical methods daily
throughout all of our disciplines to manufacture an
wealth of data to derive real actions….
How has the use of statistical methods within
Motorola Six Sigma initiative.
Over the past decade we have reduced in-process
defects by over 300 fold, which has resulted in
cumulative manufacturing cost savings of over 11
billion dollars”*.
MOTOROLA
29. Barrier #1: Engineers and managers are not interested in
mathematical statistics
Barrier #2: Statisticians have problems communicating with
managers and engineers
Barrier #3: Non-statisticians experience “statistical nervousness”
which has to be minimized before learning can take place
Barrier # 4: Statistical methods need to be matched to
management style and organizational culture
Barriers to implementation
30. Focus of Six Sigma*
Accelerating fast come through performance
Significant financial results in 4-8 months
Ensuring Six Sigma is an extension of the Corporate
culture, not the program of the month
Results first, then culture change!
*Adapted from Zinkgraf (1999), Sigma Breakthrough
Technologies Inc., Austin, TX.
31. Six Sigma principles asserts
Continuous efforts to achieve stable and predictable process
results (reduce process variation) are of vital importance to
business success.
Manufacturing and business processes have characteristics that
can be measured, analyzed, controlled and improved.
Achieving sustained quality improvement requires commitment
from the entire organization, particularly from top-level
management.
32. Features that set Six Sigma apart from other quality
improvement initiatives include:
A clear focus on achieving measurable and
quantifiable financial returns from any Six Sigma
project.
An increased emphasis on strong and passionate
management leadership and support.
A clear commitment to making decisions on the basis
of verifiable data and statistical methods, rather than
assumptions and guesswork.
33. Applications Where Six Sigma Is
Better
Six Sigma initiatives are based on a preplanned project
charter that outlines the scale of a project, financial
targets, anticipated benefits and milestones. In
comparison, organizations that have implemented
TQM, work without fully knowing what the financial
gains might be. Six Sigma is based on DMAIC (Define-
Measure-Analyze-Improve-Control) that helps in
making precise measurements, identifying exact
problems, and providing solutions that can be
measured.
34. TQM vs. Six Sigma
TQM Six Sigma
A functional specialty within the
organization.
An infrastructure of dedicated change
agents. Focuses on cross-functional value
delivery streams rather than functional division
of labour.
Focuses on quality. Focuses on strategic goals and applies them to
cost, schedule and other key business metrics.
Motivated by quality idealism. Driven by tangible benefit far a major
stockholder group (customers, shareholders,
and employees).
Loosely monitors progress toward
goals.
Ensures that the investment produces the
expected return.
People are engaged in routine duties
(Planning, improvement, and control).
“Slack” resources are created to change key
business processes and the organization itself.
Emphasizes problem solving. Emphasizes breakthrough rates of
improvement.
Focuses on standard performance, e.g.
ISO 9000.
Focuses on world class performance, e.g., 3.4
PPM error rate.
Quality is a permanent, full-time job.
Career path is in the quality
profession.
Six Sigma job is temporary. Six Sigma is a
stepping-stone; career path leads elsewhere.
Provides a vast set of tools and
techniques with no clear framework
for using them effectively.
Provides a selected subset of tools and
techniques and a clearly defined framework for
using them to achieve results (DMAIC).
Goals are developed by quality
department based on quality criteria
and the assumption that what is good
for quality is good for the
organization.
Goals flow down from customers and senior
leadership's strategic objectives. Goals and
metrics are reviewed at the enterprise level to
assure that local sub-optimization does not
occur.
Developed by technical personnel. Developed by CEOs.
Focuses on long-term results.
Expected payoff is not well-defined.
Six Sigma looks for a mix of short-term and
long-term results, as dictated by business
demands.
35. Conclusion
Six sigma is also different from TQM in that it is fact based and data
driven, result oriented, providing quantifiable and measurable bottom-line
results, linked to strategy and related to customer requirements. It is
applicable to all common business processes such as administration, sales,
marketing and R & D.
Although many tools and techniques used in Six Sigma may appear similar
to TQM, they are often distinct as in Six Sigma; the focus is on the strategic
and systematic application of the tools on targeted projects at the appropriate
time. It is predicted that Six Sigma will outlast TQM as it has the potential of
achieving more than TQM.