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 Process tools

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 Benefits
 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

3
 Application Examples
 Manufacturing: A manager is responsible for moving a
manufacturing operation to a new facility. He/she 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 being designed could fail so that robustness can be built
into the product.
 Software: A software engineer wants to think of possible problems
a software product could fail when scaled up to large databases.
This is a core issue for the Internet.

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 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

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 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 (likely contractual)
 FMEA may be required by an applicable
Quality Management System Standard (possibly ISO)

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 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 (design FMEA) or current
control plan (process FMEA)

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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 defined,
but before specific hardware is selected or released to
manufacturing

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 Examples

History of FMEA
 First used in the 1960’s in the Aerospace industry during
the Apollo missions
 In 1974, the Navy developed MIL-STD-1629 regarding
the use of FMEA
 In the late 1970’s, 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 Identify causes of the Prioritize Determine and

and their effects failure modes assess actions
10 and controls
 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
after they are implemented

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 Team Input
Required

FMEA: A Team Tool

 A team approach is necessary.
 Team should be led by the Process Owner who is the
responsible manufacturing engineer or technical person, or
other similar individual familiar with FMEA.
 The following should be considered for team members:
– Design Engineers – Operators
– Process Engineers – Reliability
– Materials Suppliers – Suppliers
– Customers

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

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 Analyzing
Severity, Occurrence, Failure &
Effects

and Detection
 Severity
 Importance of the effect on customer requirements

 Occurrence
 Frequency with which a given cause occurs and
creates failure modes (obtain from past data if possible)

 Detection
 The ability of the current control scheme to detect
(then prevent) a given cause (may be difficult to estimate early
in process operations).

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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 may allow 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 = Easy to Detect, 10 = Not easy 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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 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 Process tools such as
C&E Matrix and Process Map.

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 Description of FMEA Worksheet
Protection:The spreadsheets are not protected or locked.

System Potential FMEA Number

Subsystem Failure Mode and Effects Analysis Prepared By
Component (Design FMEA) FMEA Date
Design Lead Key Date Revision Date
Core Team Page of

Action Results
Potential
P Responsibilit

New RPN
New Sev
New Occ
New Det
Potential Potential S Cause(s)/ Current D R Recommend
Item / r y & Target Actions
Failure Effect(s) e Mechanism Design e P ed
Function o Completion Taken
Mode(s) of Failure v (s) of Controls t N Action(s)
b Date
Failure

8 8 1 64

Write down each failure Response Plans and Tracking

mode and potential
consequence(s) of that
Risk Priority Number - The combined weighting
Severity - On a scale of 1- of Severity, Likelihood, and Detectability.
10, rate the Severity of RPN = Sev X Occ X Det
each failure (10= most
severe). See Severity

Likelihood - Write down Detectability - Examine the current

the potential cause(s), and
on a scale of 1-10, rate the
Likelihood of each failure
(10= most likely). See
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design, then, on a scale of 1-10,
rate the Detectability of each failure
(10 = least detectable). See
Detectability sheet.
 Detection Likelihood of DETECTION by Design Control Ranking PROBABILITY of Failure Failure Prob Ranking
Absolute Design control cannot detect potential cause/mechanism
10
Uncertainty and subsequent failure mode
Very High: Failure is almost inevitable >1 in 2 10
Very Remote Very remote chance the design control will detect potential 9
cause/mechanism and subsequent failure mode
1 in 3 9
Remote Remote chance the design control will detect potential 8
cause/mechanism and subsequent failure mode
High: Repeated failures 1 in 8 8
Very Low Very low chance the design control will detect potential 7
cause/mechanism and subsequent failure mode
1 in 20 7
Low Low chance the design control will detect potential 6 Moderate: Occasional failures 1 in 80 6
cause/mechanism and subsequent failure mode
Moderate Moderate chance the design control will detect potential 5 1 in 400 5
cause/mechanism and subsequent failure mode
Moderately High Moderately High chance the design control will detect 4 1 in 2,000 4
potential cause/mechanism and subsequent failure mode
High High chance the design control will detect potential 3 Low: Relatively few failures 1 in 15,000 3
cause/mechanism and subsequent failure mode
Very High Very high chance the design control will detect potential 2 1 in 150,000 2
cause/mechanism and subsequent failure mode
Almost Certain Design control will detect potential cause/mechanism and 1 Remote: Failure is unlikely <1 in 1,500,000 1
subsequent failure mode

Effect SEVERITY of Effect Ranking

Hazardous without Very high severity ranking when a potential failure mode 10
warning affects safe system operation without warning
Hazardous with Very high severity ranking when a potential failure mode 9
warning affects safe system operation with warning
Very High System inoperable with destructive failure without 8
compromising safety
High System inoperable with equipment damage 7
Moderate System inoperable with minor damage 6
Low System inoperable without damage 5
Very Low System operable with significant degradation of performance 4
Minor System operable with some degradation of performance 3
Very Minor System operable with minimal interference 2
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None No effect 1
 FAILURE MODE AND EFFECTS ANALYSIS

Item: Responsibility: FMEA number: 123456

Model: Prepared by: Page : 1 of 1
Core Team: FMEA Date (Orig): Rev: 1

Action Results
O D
Potential Potential S Potential Cause(s)/ c Current e R Responsibility and
Process Recommended S O D R
Failure Effect(s) of e Mechanism(s) of c Process t P Target
Function Action(s) Actions Taken e c e P
Mode Failure v Failure u Controls e N Completion Date
v c t N
r c

23
Drilling - A drill bit enters the work piece
axially and cuts a blind hole or a through hole
with a diameter equal to that of the tool. A drill
bit is a multi-point tool and typically has a
pointed end. A twist drill is the most commonly
used, but other types of drill bits, such as a
center drill, spot drill, or tap drill can be used to
start a hole that will be completed by another
operation

The operator drills a blind hole through the work piece. Chances that
he might drill through the table are high (hole being too deep).

• Design a Failure Mode Effect and Analysis (FMEA) for this

process. Process function (i.e. Blind hole) and Potential failure (i.e.
24 Hole too deep/Not deep enough)
 FAILURE MODE AND EFFECTS ANALYSIS

Item: Drill Hole

√ Responsibility: √
Student Name FMEA number: 123456 √
Model:
Core Team:
Current
√ Prepared by: Student Name
J. Doe (Engineering), J. Smith (Production), Student Name (Quality)
Page :
FMEA Date (Orig):
1 of 1
2017/01/01 Rev: 1

Action Results
O D
Potential Potential S Potential Cause(s)/ c Current e R Responsibility and
Process Recommended
Failure Effect(s) of e Mechanism(s) of c Process t P Target S O D R
Function Action(s)
Mode Failure v Failure u Controls e N Completion Date Actions Taken e c e P
r c v c t N

Break
Hole too through Improper machine Operator training
√
Drill Blind Hole
deep √ √
bottom of
7
√ set up
√ √
3
√
and instructions
3
√
63
√
0

plate
Hole not Incomplete
5
Improper machine
3
Operator training
3 45 √ √0
deep thread set up and instructions
√
Install Tool √ √ √5 √1
5 Broken Drill 5 None 9 225 J. Doe 2008/03/01 5 25
Detectors

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