1. Failure Modes and Effects Analysis (FMEA)

2. Description
Failure modes and effects analysis (FMEA) is a step-by-step approach
for identifying all possible failures in a design, a manufacturing or
assembly process, or a product or service.
“Failure modes” means the ways, or modes, in which something might
fail. Failures are any errors or defects, especially ones that affect the
customer, and can be potential or actual.
“Effects analysis” refers to studying the consequences of those failures.

3. History
FMEA was formally introduced in the late 1940s for military usage
by the US Armed Forces.
Later it was used for aerospace/rocket development to avoid errors
in small sample sizes of costly rocket technology.
In the late 1970s the Ford Motor Company introduced FMEA to the
automotive industry for safety and regulatory consideration after the
Pinto affair. They also used it to improve production and design.

4. Types of FMEA's System - focuses on global system functions
Design - focuses on components and subsystems
Process - focuses on manufacturing and assembly processes
Service - focuses on service functions
Software - focuses on software functions

5. FMEA Procedure
Assemble a cross-functional team of people with diverse knowledge
about the Design, process, product or service and customer needs.
Create a Block Diagram of the product or process. A block diagram of the
product/process should be developed. This diagram shows major
components or process steps as blocks connected together by lines that
indicate how the components or steps are related.

6. Fill in the identifying information at the top of your FMEA form.

7. Use the diagram prepared above to begin listing items or functions
Use the diagram prepared above to begin listing items or functions. If items are
components, list them in a logical manner under their subsystem/assembly based on
the block diagram.
Identify Failure Modes. A failure mode is defined as the manner in which a
component, subsystem, system, process, etc. could potentially fail to meet the design
intent. Examples of potential failure modes include:
Corrosion
Hydrogen embrittlement
Electrical Short or Open
Torque Fatigue
Deformation
Cracking

8. For each failure mode, identify all the consequences on the system,
related systems, process, related processes, product, service,
customer or regulations.
Determine how serious each effect is. This is the severity rating, or
Severity is usually rated on a scale from 1 to 10, where 1 is insignificant
and 10 is catastrophic. Examples of failure effects include:
Injury to the user
Inoperability of the product or process
Improper appearance of the product or process
Degraded performance
Noise 8

9. For each failure mode, determine all the potential root causes
For each failure mode, determine all the potential root causes. List all
possible causes for each failure mode on the FMEA form.
For each cause, determine the occurrence rating, or O. This rating
estimates the probability of failure occurring for that reason during the
lifetime of your scope. Occurrence is usually rated on a scale from 1 to 10.
For each cause, identify current process controls. These are tests,
procedures or mechanisms that you now have in place to keep failures
from reaching the customer.

10. Determine the likelihood of Detection
Determine the likelihood of Detection. Detection is an assessment of the
likelihood that the Current Controls (design and process) will detect the
Cause of the Failure Mode or the Failure Mode itself, thus preventing it
from reaching the Customer.
Review Risk Priority Numbers (RPN). The Risk Priority Number is a
mathematical product of the numerical Severity, Probability, and
Detection ratings:
         RPN = (Severity) x (Probability) x (Detection)

11. Identify recommended actions. These actions may be design or process
changes to lower severity or occurrence. They may be additional
controls to improve detection. Also note who is responsible for the
actions and target completion dates.
Update the FMEA as the design or process changes, the assessment
changes or new information becomes known.

12. Design-FMEA DFMEAs should be conducted: On all new products.
DFMEAs should be conducted throughout the design cycle, beginning in the concept stage.
Revise the DFMEA in the preliminary design stage, revise again in the prototype stage, and finalize the DFMEA in the final design stage.
Whenever a change is to be made to a product.
On existing products.

13. Design-FMEA

14. Design-FMEA

15. DFMEA- Procedure 1: Review the Design Reasons for the review:
Help assure all team members are familiar with the product and its design.
Identify each of the main components of the design and determine the function or functions of those components and interfaces between them.
Use a print or schematic for the review.
Add Reference Numbers to each component and interface.
Try out a prototype or sample.
Invite a subject matter expert to answer questions.

16. 2. Brainstorm Potential Failure Modes
Consider potential failure modes for each component and interface.
A potential failure mode represents any manner in which the product component could fail to perform its intended function or functions.
Prepare for the brainstorming activity.
Before you begin the brainstorming session, review documentation for clues about potential failure modes.
Use customer complaints, warranty reports, and reports that identify things that have gone wrong, such as hold tag reports, scrap, damage, and rework, as inputs for the brainstorming activity.

17. 3. List Potential Effects of Failure
An effect is the impact a failure could make should it occur.
Some failures will have an effect on customers; others on the environment, the process the product will be made on, and even the product itself.
4. Assign Severity Rankings
The severity ranking is based on a relative scale ranging from 1 to 10.
A “10” means the effect has a dangerously high severity leading to a hazard without warning.

18. 5. Assign Occurrence Rankings
The occurrence ranking is based on the likelihood, or frequency, that the cause (or mechanism of failure) will occur.
If we know the cause, we can better identify how frequently a specific mode of failure will occur.
6. Assign Detection Rankings
Think of the detection ranking as an evaluation of the ability of the
design controls to prevent or detect the mechanism of failure.

19. 8. Develop the Action Plan
7. Calculate the RPN
The RPN is the Risk Priority Number. The RPN gives us a relative risk ranking. The higher the RPN, the higher the potential risk.
8. Develop the Action Plan
A reduction in the Severity Ranking for a DFMEA is often the most difficult to attain. It usually requires a design change.
There are many tools to aid the DFMEA team in reducing the relative risk of those failure modes requiring action
Mistake-Proofing (Poka Yoke)
Techniques that can make it impossible for a mistake to occur, reducing the Occurrence ranking to 1.

20. Simulations 9. Take Action
Design for Assembly and Design for Manufacturability (DFA/DFM)
Techniques that help simplify assembly and manufacturing by modularizing product sub-assemblies, reducing components, and standardizing components.
Simulations
Simulation approaches include pre-production prototypes, computer models, accelerated life tests, and value-engineering analyses.
9. Take Action
The Action Plan outlines what steps are needed to implement the solution, who will do them, and when they will be completed.
Most Action Plans identified during a DFMEA will be of the simple “who, what, & when” category. Responsibilities and target completion dates for specific actions to be taken are identified

21. 10. Recalculate the Resulting RPN
This step in a DFMEA confirms the action plan had the desired results by calculating the resulting RPN.
To recalculate the RPN, reassess the severity, occurrence, and detection rankings for the failure modes after the action plan has been completed.

22. Design-FMEA