Analyze Opportunity Part 1

Failure Modes Effect Analysis

(FMEA)

Learning Objectives
To understand the use of Failure Modes Effect

Analysis (FMEA)
To learn the steps to developing FMEAs To summarize the different types of FMEAs

To learn how to link the FMEA to other Black

Belt tools
To perform an exercise to actually perform

an FMEA

Whats In It for Me?

Allows us to identify areas of our process that

most impact our customers

Helps us identify how our process is most likely to

fail
Points to process failures that are most difficult to

detect

Application Examples
Manufacturing: A manager is responsible for moving a

manufacturing operation to a new facility. He wants to be sure the move goes as smoothly as possible and that there are no surprises.
Design: A design engineer wants to think of all the

possible ways a product he is designing could fail so that he can build robustness into the product.

What Can Go Wrong?

What Is A Failure Mode?

A Failure Mode is:
The way in which the component, subassembly,

product, input, or process could fail to perform its intended function

Failure modes may be the result of upstream operations or

may cause downstream operations to fail

Things that could go wrong

Evaluate Failure Modes and Effects

FMEA
Failure Mode Gas will not shut off Specific Cause Spring broke preventing valve from closing Likeliness of Failure Explosion resulting in 3 property damage and/ or serious injury Effect of Failure Detectability Severity of Risk of Failure Failure Priority 5 10 150

Likeliness of Failure: 1-10 with 10 representing most likely Detectability of Failure: 1-10 with 10 representing most difficult Severity of Failure: 1-10 with 10 representing most severe Risk Priority = (Likeliness of Failure) X (Detectability of Failure) X
(Severity of Failure)

What
Failure Modes & Effects Analysis is a methodology to evaluate

failure modes and their effects in designs and in processes.

FMEA
Why Methodology that facilitates process improvement Identifies and eliminates concerns early in the development of a process or design Improve internal and external customer satisfaction Focuses on prevention FMEA may be a customer requirement FMEA may be required by an applicable Quality System Standard

Implementing FMEA

FMEA
How Team identifies potential failure modes for design functions or process requirements
They assign severity to the effect of this failure mode They assign frequency of occurrence to the potential

cause of failure and likelihood of detection

Team calculates a Risk Priority Number by

multiplying severity times frequency of occurrence times likelihood of detection Team uses ranking to focus process improvement efforts
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Exercise Link

FMEA Form

Blank FMEA form in Virtual Coach Exercises Chapter 3.4 - FMEA Form.xls

FMEA
A structured approach to:
Identifying the ways in which a product or process

can fail Estimating risk associated with specific causes Prioritizing the actions that should be taken to reduce risk Evaluating design validation plan (product) or current control plan (process)

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When to Conduct an FMEA

Early in the process improvement investigation When new systems, products, and processes

are being designed

When existing designs or processes are being

changed
When carry-over designs are used in new

applications
After system, product, or process functions are
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defined, but before specific hardware is selected or released to manufacturing

Examples

History of FMEA
First used in the 1960s in the Aerospace

industry during the Apollo missions In 1974, the Navy developed MIL-STD-1629 regarding the use of FMEA In the late 1970s, the automotive industry was driven by liability costs to use FMEA Later, the automotive industry saw the advantages of using this tool to reduce risks related to poor quality

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A Closer Look

The FMEA Form

Identify failure modes and their effects

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Identify causes of the failure modes and controls

Prioritize

Determine and assess actions

Specialized Uses

Types of FMEAs
Design
Analyzes product design before release to

production, with a focus on product function Analyzes systems and subsystems in early concept and design stages
Process
Used to analyze manufacturing and assembly

processes

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Team Input Required

FMEA: A Team Tool

A team approach is necessary.

Team should be led by the Black Belt, a

responsible manufacturing engineer or technical person, or other similar individual familiar with FMEA. The following should be considered for team members:
Design Engineers Process Engineers Materials Suppliers Customers
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Operators Reliability Suppliers

Process Steps

FMEA Procedure
1. For each process input (start with high value inputs), determine the ways in which the input can go wrong (failure mode) 2. For each failure mode, determine effects
Select a severity level for each effect

3. Identify potential causes of each failure mode

Select an occurrence level for each cause

4. List current controls for each cause

Select a detection level for each cause

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Process Steps

FMEA Procedure (Cont.)

5. Calculate the Risk Priority Number (RPN) 6. Develop recommended actions, assign responsible persons, and take actions
Give priority to high RPNs MUST look at severities rated a 10

7. Assign the predicted severity, occurrence, and detection levels and compare RPNs

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Information Flow

FMEA Inputs and Outputs

Inputs Brainstorming C&E Matrix Process Map Process History Procedures Knowledge Experience Outputs List of actions to prevent causes or detect failure modes History of actions taken

FMEA

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Failure Effects Relationship

Failure Modes and Effects

The relationship between failure modes and effects

is not always 1 to 1.

Failure Mode 1 Failure Mode 2 Failure Mode 1

Effect 1 Effect 2 Effect 1 Effect 1

Failure Mode 2
Failure Mode 1
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Effect 2

Severity, Occurrence, and Detection

Often cant do anything about this

Analyzing Failure & Effects

Severity Importance of the effect on customer requirements Occurrence Frequency with which a given cause occurs and creates failure modes Detection The ability of the current control scheme to detect or prevent a given cause

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Assigning Rating Weights

Rating Scales
There are a wide variety of scoring anchors,

both quantitative or qualitative Two types of scales are 1-5 or 1-10 The 1-5 scale makes it easier for the teams to decide on scores The 1-10 scale allows for better precision in estimates and a wide variation in scores (most common)

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Assigning Rating Weights

Rating Scales
Severity
1 = Not Severe, 10 = Very Severe

Occurrence
1 = Not Likely, 10 = Very Likely

Detection
1 = Likely to Detect, 10 = Not Likely to Detect

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Calculating a Composite Score

Risk Priority Number (RPN)

RPN is the product of the severity, occurrence,

and detection scores.

Severity

X Occurrence X

Detection

RPN

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Lets Try Using FMEA

FMEA Example
We will conduct an FMEA on the truck stop

example we used to create a C&E Matrix A Black Belt wants to improve customer satisfaction with the coffee served at the truck stop The process map and completed C&E matrix follow

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Process Map

Truck Stop Coffee Process Map

Inputs
Hot Water Soap Scrubber
Clean Carafe Cold Water Measuring Mark Full Carafe Clean Carafe

Outputs
Cleaned Carafe Dirty Water Wet Scrubber
Full Carafe

Inputs
Customer Order Size Specification Complete Order Hot Coffee Cup Filled Cup Customer Cream Sugar Amount Desired Complete Order Money Receive Coffee Order Pour Coffee into Cup

Outputs
Complete Order

Fill Carafe w/Water

Filled Cup

Pour Water into Maker Place Filter in Maker Put Coffee in Filter

Filled Maker Empty Carafe Maker w/Filter Maker w/Filter & Coffee Operating Maker Heat Brewed Coffee Hot Coffee

Filter Maker w/Filter Fresh Coffee Dosing Scoop Maker w/Filter & Coffee Brewing Coffee

Offer Cream & Sugar

Customer Reply Amount Specified Complete Order

Complete Transaction

Turn Maker On

Make Change Temperature Taste Strength Smile Happy Customer

Coffee Delivery

Say Thank You

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Select Temperature Setting

C&E Matrix

Truck Stop Coffee C&E Matrix

Temp of Coffee 8 Process Step ----- Process input ----Taste 10 Strength 6 Process Outputs Importance --------- Total --------0 36 144 16 36 144 34 120 6 52 132 24 0 0 0 0 0 0 0 0 0 0 0 0 --------- Correlation of Input to Output --------0 0 0 0 0 3 9 0 3 3 1 0 3 9 1 3 9 1 3 0 1 9 1 0 1 9 1 1 9 0 3 1 3 3 1 0

Clean Carafe Fill Carafe with Water Pour Water into Maker Place Filter in Maker Put Coffee in Filter Turn Maker On Select Temperature Setting Receive Coffee Order Pour Coffee into Cup Offer Cream & Sugar Complete Transaction Say Thank You

We will focus on one of the two steps with the highest scores

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Determine Failure Modes

Step 1: For Each Input, Determine the Potential Failure Modes

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Identify Effects and Severity

Step 2: For Each Failure Mode, Identify Effects and Assign Severity

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Identify Failure Causes and Score

Step 3: Identify Potential Causes of Each Failure Mode and Assign Score

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Identify Controls and Score

Step 4: List Current Controls for Each Cause and Assign Score

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RPNs

Step 5: Calculate RPNs

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Identify Actions and Responsibilities

Step 6: Develop Recommended Actions, Assign Responsible Persons, and Take Actions

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Compare RPNs

Step 7: Assign the Predicted Severity, Occurrence, and Detection Levels and Compare RPNs

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Team Exercise

Exercise
Meet together in the same teams as you did

during the Process Mapping and C&E Matrix exercises

Create an FMEA for a process (project

subject)
Limit the FMEA to the top 3 inputs or steps

(for the sake of time)

Return and report results to the group
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Be sure to discuss lessons learned as part of

Key Points

Summary
An FMEA: Identifies the ways in which a product or process can fail Estimates the risk associated with specific causes Prioritizes the actions that should be taken to reduce risk FMEA is a team tool There are two different types of FMEAs: Design Process Inputs to the FMEA include several other Black Belt

tools

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