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Lean-Insight.comLean Six Sigma Training

Part 16

Training Location: Bangalore / Bengaluru

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Failure Modes and Effects Analysis (FMEA)First developed in the 1950’sApplied by NASA in the 1960’s for the space programFord 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

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Initial Assessment Actions and HistoryActions Taken

SEV

OCC

DET

RPN

What are the actions for reducing the occurrence, or improving detection, or for identifying the root cause if it is unknown? Should have 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.

Wha

t is

the

new

se

verit

y?

Wha

t is

the

new

pro

cess

ca

pabi

lity?

Are

the

dete

ctio

n lim

its

impr

oved

?

Reco

mkp

ute

RPN

aft

er

actio

ns a

re c

ompl

ete.

0

0

0

0

0

0

Action Results

RecommendedAction(s)

Responsibility and

Completion Date

The highest value process steps from the 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.

How

Sev

ere

is th

e ef

fect

to

the

cuso

tmer

?

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.

How

ofte

n do

es th

e ca

use

or fa

ilure

mod

e oc

cur?

What are the existing controls and procedures (inspection and test) that either prevent failure mode from occurring or detect the failure should it occur? Should include an SOP number.

How

wel

l can

you

det

ect

caus

e or

FM

?

SEV

x OCC

x D

ET

0

0

0

0

0

0

RPN

Potential Cause(s)/Mechanism(s) of Failure

OCC

Current Process Controls

DET

Process Function Potential Failure Mode Potential Effects

of Failure

SEV

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.

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FMEA Examples

Documentation ExampleThe 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 ExampleA 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.

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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.

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Noble Institute of Quality Certification – NIQC

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 Stakeholders2. Understand their power over the organization and influence3. Determine their level of support4. Recognize the nature of their resistance5. Learn how to address their needs and fears6. Enlist the help of your influential allies7. Develop an action plan

Stakeholder Analysis

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Stakeholder AnalysisWHAT 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 startStakeholder 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 orAble 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 decisionPeople who have influence over whether implementation proceeds or notPeople who are affected by the project outcome

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Who Are Your Stakeholders?

• Some possible examples:• External customers• Internal customers• Suppliers• Champion• Process Owner• Project team resources• Affected departments• Process workers • Support personnel

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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

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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

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Six Sigma (DMAIC) Define Measure Analyze Improve ControlDesign for Six Sigma (DFSS) Define Measure Analyze Design Verify

SCORE fits with Six Sigma methods

SCORE is a means to accelerate improvements.

ImprovingWorker productivityWorker involvement

Create savings inTimeSpace

Output

Reducing Lead times

WIPScrap

DefectsRework

Very Similar to• Workout

Effective in• Service• Manufacturing• Transactional processes

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SCORE is all about speed to complete

Removes “Red Tape” barriers Blasts through business politics Focuses on

Business prioritiesProgressCooperationImproving 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

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If you are looking for Lean Six Sigma training in Bangalore / Bengaluru along with certification visit: http://lean-insight.com/six-sigma-training-bangalore/