FMEA

Failure Mode & Effects

Analysis

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Introduction to FMEA

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 Takata Air Bag Recall

Year: 2008 and

counting
Cost: $24 billion
(2016 estimate)

 The largest recall in U.S. auto safety history.

 The issue: The inflators can explode and eject a shrapnel-like
material that has been linked to at least 20 deaths.

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What is FMEA?
 FMEA stands for Failure Mode & Effects Analysis

 FMEA is 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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Types of FMEAs

TYPES OF
FMEAs

Design FMEA Process FMEA

(DFMEA) (PFMEA)

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Design FMEA (DFMEA)
 Design FMEA (DFMEA) explores the possibility of product
malfunctions, reduced product life, and safety and regulatory
concerns derived from:
• Material properties
• Geometry
• Tolerances
• Interfaces with other components and/or systems
• Engineering noise: environments, user profile, degradation and
systems interactions

 Example: Air Bag (excessive air bag inflator force)

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Process FMEA (PFMEA)
 Process FMEA (PFMEA) discovers failure that impacts product
quality, reduced reliability of the process, customer dissatisfaction,
and safety or environmental hazards derived from:
• Human factors
• Methods followed while processing
• Materials used
• Machines utilized
• Measurement systems impact on acceptance
• Environment factors on process performance
 Example: Air Bag Assembly Process (operator may not install air
bag properly on assembly line such that it may not engage during
impact)

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 The FMEA Form
Example of a Process FMEA Form

FMEA Form
Process Name: Prepared by: Page: of
Process Owner: FMEA Date (Orig.) Rev.

OCCURRENCE (O)

DECTECTION (D)

OCCURRENCE

DECTECTION
SEVERITY (S)
Responsibility

SEVERITY
Process Step/ Potential Potential Failure Potential Current Actions & Target

RPN

RPN
Actions Taken
Input Failure Mode Effects Causes Controls Recommended Completion
Date

How often does the cause of

How severe is the effect on

What are the

How well can you detect

the failure mode occur?

cause or failure mode?

actions for
What controls eliminating or What are the
the customer?

What causes and procedures Who is

S x O x D
What is the What can go reducing the completed
What is the impact on the process exist that either responsible for
process step or key wrong with the occurrence of the actions taken
the customer or key step or key prevent or the action?
input under process step or cause, or with the
output variables? input to go detect the cause When should it
investigation? key input? improving recalculated
wrong? of the failure be completed?
detection of the RPN?
mode? cause or failure
mode?

0 0
0 0
0 0
0 0
0 0

Improvement Post-improvement
Initial development of the FMEA
activities activities

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 ?
What is the
difference
between
FMEA &
RCA © Operational Excellence Consulting. All rights reserved. 9
FMEA vs. RCA

FMEA RCA

FMEA is a structured Root Cause Analysis

way to identify and (RCA) is a structured
address potential way to address problems
problems, or failures and or failures after they
their resulting effects on occur. Uses common
the system or process tools such as 5 Whys
before an adverse event and Cause & Effect
occurs. Diagram.

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When to Use 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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 2
FMEA Definitions, Scoring
System & Calculations

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Definitions

1. Failure Mode: (Specific loss of a function) is a concise

description of how a part, system, or manufacturing
process may potentially fail to perform its functions.

2. Failure Effect: A description of the consequence or

ramification of a system or part failure. A typical failure
mode may have several effects.

3. Severity Rating: (Seriousness of the Effect) Severity

is the numerical rating of the impact on customers.

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Definitions

4. Failure Causes: A description of the design or process

deficiency (global cause or root level cause) that
results in the failure mode.

5. Occurrence Rating: Is an estimate number of

frequencies or cumulative number of failures (based on
experience) that will occur for a given cause over the
intended “life of the design”.

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Definitions

6. Failure Controls: The mechanisms, methods, tests,

procedures, or controls that we have in place to
PREVENT the Cause of the Failure Mode or DETECT
the Failure Mode or Cause should it occur.

7. Detection Rating: A numerical rating of the probability

that a given set of controls WILL DISCOVER a specific
Cause of Failure Mode to prevent bad parts leaving the
facility or getting to the ultimate customer.

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Definitions

8. Risk Priority Number (RPN): Is the product of

Severity (S), Occurrence (O), and Detection (D).

Risk = RPN = S x O x D
9. Action Plan: A sequence of steps that must be
implemented in order to eliminate or reduce the
occurrence of the cause, or improving detection of the
cause or failure mode.

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Severity, Occurrence and Detection

Severity Occurrence Detection

Importance of the Frequency with The ability of the

effect on customer which a given cause current control
requirements. occurs and scheme to detect
creates failure (then prevent) a
modes (obtain from given cause (may
past data if be difficult to
possible). estimate early in
process
operations).

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Scoring System
 There are a wide variety of scoring systems – both
quantitative or qualitative

 Two common 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

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Scoring System

Severity
1 Not Severe Very Severe 10

Occurrence
1 Not Likely Very Likely 10

Detection
1 Easy to Detect Not Easy to Detect 10

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Scoring System – Severity (S)
Severity Guidelines
Score
AIAG Six Sigma

10 Hazardous without warning Injure a customer or employee

Bad

9 Hazardous with warning Be illegal

8 Very high Render product or service unfit for use

7 High Cause extreme customer dissatisfaction

6 Moderate Result in partial malfunction

Cause a loss of performance which is likely to

5 Low
result in a complaint

4 Very low Cause minor performance loss

Cause a minor nuisance but can be overcome

3 Minor
with no performance loss
Be unnoticed and have only minor effect on
Good

2 Very minor
performance

1 None Be unnoticed and not affect the performance

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Scoring System – Occurrence (O)
Occurrence Guidelines
Score
AIAG Six Sigma

10 Very high: Persistent failures, Ppk < 0.55 More than once a day > 30%
Bad

9 Very high: Persistent failures, Ppk >= 0.55 Once every 3-4 days < 30%

8 High: Frequent failures, Ppk >= 0.78 Once a week < 5%

7 High: Frequent failures, Ppk >= 0.86 Once per month < 1%

6 Moderate: Occasional failure, Ppk >= 0.94 Once every 3 months < 0.03%

Moderate: Occasional failures, Ppk >=

5 Once every 6 months < 1 per 10,000
1.00
Moderate: Occasional failures, Ppk >=
4 Once per year < 6 per 100,000
1.10

3 Low: Relatively few failures, Ppk >= 1.20 Once every 1-3 years < 6 per million
Good

2 Low: Relatively few failures, Ppk >= 1.30 Once every 3-6 years < 3 per 10 million

1 Remote: Failure is unlikely, Ppk >= 1.67 Once every 6-100 years < 2 per billion

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Scoring System – Detection (D)
Detection Guidelines
Score
AIAG Six Sigma
Almost impossible: Absolute certainty and no
10 Defect undetectable
detection
Bad

9 Very remote: Controls will probably not detect Units sporadically checked for defects

Remote: Controls have poor chance of

8 Units are systematically sampled and inspected
detection
Very low: Controls have poor chance of
7 All units are manually inspected
detection
Manual inspection with mistake-proofing
6 Low: Controls may detect
modifications

5 Moderate: Controls may detect SPC and manual inspection

Moderately high: Controls have a good SPC with immediate reaction to out-of-control
4
chance to detect conditions
SPC with 100% inspection surrounding out-of-
3 High: Controls have a good chance to detect
control conditions
Good

2 Very high: Controls almost certain to detect 100% automatic inspections

Defect is obvious and can be kept from reaching

1 Almost certain: Controls certain to detect
customer

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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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