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2. 2
Failure Modes and Effects Analysis (FMEA)
First developed in the 1950’s
Applied by NASA in the 1960’s for the space program
Ford Motor Company was the first North American company
to widely implement the use of FMEAs
The FMEA reduces risk of failure, a barrier to acceptance of change.
A tool to help manage the risk of change
The point of this brainstorming tool is to identify potential change risks and provide
focus on the significant few from the insignificant many.
The FMEA form, in addition to identifying the critical risks, serves as a vehicle for
generating future improvement actions.
FMEA’s have been used at the macro and micro level of process change. They are
perhaps most commonly known for their use to reduce risk with the design of new
products.
FMEA
Lean-Insight.com
3. 3
Initial Assessment Actions and History
Actions Taken
S
E
V
O
C
C
D
E
T
R
P
N
What are the actions for
reducing the occurrence, or
improving detection, or for
identifying the root cause if it
is unknown? Shouldhave
actions only on high RPN's or
easy fixes.
Who is
responsible for
the
recommended
action?
List the completed actions
that are included in the
recalculated RPN.
Include the implementation
date for any changes.
Whatisthenew
severity?
Whatisthenewprocess
capability?
Arethedetectionlimits
improved?
RecomkputeRPNafter
actionsarecomplete.
0
0
0
0
0
0
Action Results
Recommended
Action(s)
Responsibility
and
Completion
Date
The highest value
process steps
fromthe C&E
matrix.
In what ways might the
process potentially fail to
meet the process
requirements and/or design
intent?
What is the effect of each
failure mode on the outputs
and/or customer requirements?
The customer could be the next
operation, subsequent
operations, another division or
the end user.
HowSevereistheeffect
tothecusotmer?
How can the failure occur?
Describe in terms of something
that can be corrected or
controlled. Be specific. Try
identify the causes that directly
impacts the failure mode, i.e., root
causes.
Howoftendoesthe
causeorfailuremode
occur?
What are the existing controls and
procedures (inspection and test) that
either prevent failure mode from
occurring or detect the failure should
it occur? Shouldinclude an SOP
number.
Howwellcanyoudetect
causeorFM?
SEVxOCCxDET
0
0
0
0
0
0
R
P
N
Potential Cause(s)/
Mechanism(s) of Failure
O
C
C
Current
Process
Controls
D
E
T
Process
Function
Potential Failure Mode
Potential Effects
of Failure
S
E
V
Parts of the FMEA Form
The first section of the FMEA form, “initial assessment”, is used to evaluate initial
conditions of the process.
After completing the initial assessment, the team then generates a list of actions
to reduce the occurrence or increase the detection.
Lean-Insight.com
4. 4
FMEA Examples
Documentation Example
The Human Resources Department for a particular organization maintains “official” files for
all personnel. Included is personal data, benefits, current organizational status, and
performance evaluation packages. Many within the organization query HR for the info
contained in those files. A SCORE team is applying Lean techniques to reduce the query
response time. They use FMEA to identify risks with the changes they have planned.
Service Time Example
A Customer Service Department for a particular organization handles all customer inquiries.
A SCORE team has been formed to improve the timeliness of completing those inquiries.
They have created an improvement plan. Before implementing that plan, they conduct an
FMEA to surface potential problems.
In the following examples, a single line from the FMEA is used as an illustration for
each of the above examples.
Lean-Insight.com
5. 5
Process FMEA -- Terminology
FMEA: A systematic analysis of a process used to identify potential failures and to prevent their
occurrence.
Potential Failure mode: The manner in which the process could potentially fail to meet the
process requirements.
Potential Failure Effect: The effects of the failure mode on the customer.
Severity: An assessment of the seriousness of a failure mode. Severity applies to the effects only.
Cause: How the failure could occur, described in terms of something that can be corrected or
controlled.
Occurrence: The likelihood that a specific failure mode is projected to occur.
Detection: The effectiveness of current process controls to identify the failure mode (or the
failure effect) prior to occurring, prior to release to production, or prior to shipment to the
customer.
RPN -- Risk Priority Number: The product of Severity, Occurrence & Detection.
Lean-Insight.com
6. Noble Institute of Quality Certification – NIQC
6
Who are the stakeholders associated with your process?
What is important to them?
How do you get their support?
We must plan.
Steps:
1. Identify Stakeholders
2. Understand their power over the organization and influence
3. Determine their level of support
4. Recognize the nature of their resistance
5. Learn how to address their needs and fears
6. Enlist the help of your influential allies
7. Develop an action plan
Stakeholder Analysis
7. 7
Stakeholder Analysis
WHAT is a Stakeholder Analysis?
A method to identify and understand your project’s stakeholders
WHY is it important?
Without support and acceptance of key stakeholders, the probability of project success is greatly reduced
WHEN should it be used?
Early in the project (Define Phase) to ensure a good start
Stakeholder support should be monitored and managed throughout the project
WHO should conduct it?
The project leader, with input from the team
A stakeholder is any individual or group with an interest in the outcome of a project, either
as a result of being:
Affected by the project or
Able to influence the project
The effect on or by the stakeholder can be positive or negative.
There are three main types of stakeholder:
Person who is responsible for the final decision
People who have influence over whether implementation proceeds or not
People who are affected by the project outcome
Lean-Insight.com
8. 8
Who Are Your Stakeholders?
• Some possible examples:
• External customers
• Internal customers
• Suppliers
• Champion
• Process Owner
• Project team resources
• Affected departments
• Process workers
• Support personnel
Lean-Insight.com
9. 9
There is confusion as to how to plan and conduct kaizen events.
SCORE provides the needed method.
The SCORE method can be planned and progress tracked, similar to the benefits of
DMAIC.
SCORE ’s meaning:- SCORE relates to sports where the objective is to score points.
Each SCORE needs to be celebrated.
Like a good sports team, you will want to SCORE often. It takes a team effort.
Look for many quick SCORE s.
SCORE can also be related to music, where the score is the plan for the music.
SCORE provides a method so that participants can act in harmony.
SCORE
“If you’re not keeping score , you’re only practicing.”
Vince Lombardi
Lean-Insight.com
10. 10
Select the process to be worked on.
Clarify the problem statement and project objective. Measure historical data
to quantify the current capability.
Organize the team members and train them on methods and scope of
project. Ready the work place and interfaces such as suppliers, customers,
and facilities people.
Run the event (observe, brainstorm improvements, select improvements,
test, implement).
Evaluate the results, standardize the new procedure, and define future work.
The Acronym of SCORE
Lean-Insight.com
11. 11
Six Sigma (DMAIC) Define Measure Analyze Improve Control
Design for Six Sigma (DFSS) Define Measure Analyze Design Verify
SCORE fits with Six Sigma methods
SCORE is a means to accelerate
improvements.
Improving
Worker productivity
Worker involvement
Create savings in
Time
Space
Output
Reducing
Lead times
WIP
Scrap
Defects
Rework
Very Similar to
• Workout
Effective in
• Service
• Manufacturing
• Transactional processes
Lean-Insight.com
12. 12
SCORE is all about speed to complete
Removes “Red Tape” barriers
Blasts through business politics
Focuses on
Business priorities
Progress
Cooperation
Improving communications
SCORE savings potential
Reduced cycle time
Increased productivity
Reduction in floor space needed
Higher quality
Less overtime
Faster service to customers
Improved profits
Improved moral
Improved communication
between management and
workers
Respect for each other
Lean-Insight.com
13. 13
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