FMEA

FMEA
Failure Modes Effect Analysis

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
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/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.
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
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
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)
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

8
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
9
A Closer Look
The FMEA Form
Identify failure modes and their effects
10
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 after they are implemented
11
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 Process Engineers Materials Suppliers Customers
12
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
13
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
14
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
15
Severity, Occurrence, and Detection
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
16
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)
17
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
18
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
19
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
20

FMEA

Uploaded by

Copyright:

Available Formats

FMEA

Uploaded by

Document Information

Original Description:

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

FMEA

Uploaded by

Copyright:

Available Formats

What are the steps involved in conducting an FMEA?

What are the steps involved in conducting an FMEA?

What are some examples of where FMEAs are commonly used?

What are some examples of where FMEAs are commonly used?

FMEA

Failure Modes Effect Analysis

To learn how to link the FMEA to other

Whats In It for Me?

most impact our customers

What Can Go Wrong?

What Is A Failure Mode?

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

may cause downstream operations to fail

Things that could go wrong

When to Conduct an FMEA

are being designed

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

The FMEA Form

Identify failure modes and their effects

Identify causes of the failure modes and controls

Determine and assess actions

processes after they are implemented

Team Input Required

FMEA: A Team Tool

Team should be led by the Process Owner who is

Operators Reliability Suppliers

3. Identify potential causes of each failure mode

4. List current controls for each cause

FMEA Procedure (Cont.)

FMEA Inputs and Outputs

Severity, Occurrence, and Detection

Analyzing Failure & Effects

Assigning Rating Weights

Assigning Rating Weights

Calculating a Composite Score

Risk Priority Number (RPN)

and detection scores.

tools such as C&E Matrix

You might also like