1. Failure Mode & Effect Analysis (FMEA)
Training Presentation

2. Presentation Objectives
Understand FMEA concepts and learn when to use them
Learn how to identify failure modes in processes and design
Know how to organize, plan and run an FMEA project

3. What is FMEA?
A tool used to identify and evaluate failure modes in a process or design, and help determine the causes of those failures
Designed to prioritize potential failures based on risk
Designed to reduce the chances of failure by driving actions for improvement
Presents only the failure modes and does not solve problems on its own

4. Types of FMEA Design FMEA – Primary focus is product
Process FMEA – Primary focus is the process
Equipment/Machine FMEA – Primary focus is equipment

5. FMEA Process Map

6. When to use FMEA New process development New product development
Changes in man, machine, method, materials or environment

7. FMEA Success Factors A team approach is imperative Accurate data
Background knowledge of the process
Experienced personnel

8. FMEA Toolbox Large, open meeting room
Large table and wall space with marker boards
Paper and post-it notes, note pads
Tape for paper and sketches on walls
Marker pens
Snacks/drinks

9. Process Analysis
Find and review existing process maps, SIPOC analysis, Value Stream Maps, etc.
Team must fully understand the how, when and why of each process involved (What is the point of the process?)
Walk through the entire process, step-by-step
Encourage questions
Uncover data and hidden process steps

10. What is the point? example

11. What is the point? example
What is the point (purpose/objective) of a key?
How can it be clearly defined – ask for suggestions
(Suggestion) “It is a tool to open doors”: It is designed to do this when doors are locked for the safety and security of the contents
This is only one suggestion and may be different than someone else’s – how close is it to other suggestions?

12. What is a Failure?
The condition or fact of not achieving the desired result or outcome; insufficient or non-performing
Note: Evaluate processes and understand the point for each process step

13. What is a Failure Mode?
The manner in which a process, equipment or machine can potentially fail.
A description of the potential opportunity for non-conformance at a specific point in time
Such as – premature operation; failure to operate at a prescribed time; operational failure; or resultant failure (as from a bad set-up)

14. Failure Mode Considerations
How could process steps or pieces of equipment fail their intended functions?
Why could a component, document or service be rejected at this particular operation?
Voice of the Customer (VOC): What would the customer consider acceptable/unacceptable?

15. Examples of failure modes (think 8 wastes)
Incorrect information
Out of round
Deformation
Undersized
Cracks
Late/early
Dirty
Incomplete
Under-performing
Missing
Scratched
Ripped
Dented
Unreadable

16. What is Effect? To determine effect, consider impact on customer
Customer could be: end user, subsequent operation or downstream process or document
There can be more than one effect for each failure mode
Think about difference in perspective between each type of customer: Internal –vs- external

17. Severity in FMEA
Severity is the level of significance of the effect of the potential failure mode
Severity applies to the effect only

18. Severity Ranking

19. Potential cause of failure
Be specific in describing failure – no ambiguity
Ex. The key does not work –vs- The key is worn down and chipped on two teeth
List all potential causes in terms of how something could be corrected
Find the root cause using analysis tools: C&E, Brainstorming, 5Y’s, etc.

20. Causes of Process Failure examples
Wrong components
Missing components
Processing the wrong part or document
Fatigue
Poor control procedures
Wrong tools or fixtures; not set-up properly

21. Occurrence in FMEA
Is the frequency a specific failure Cause is likely to arise
Review similar processes or products and the failure modes associated with them
If similar items not available, use the FMEA Team to assess the items subjectively and then develop guidelines

22. Occurrence Ranking

23. Current Controls Existing Process Controls in place which would:
(Type 1) Prevent the cause or failure mode from occurring, or reduce the rate of occurrence
(Type 2) Detect the cause & lead to corrective action
(Type 3) Detect the failure mode
Poke Yoke, SPC or post process evaluation

24. Examples of Process Controls
Jigs and fixtures
Light curtains and sensors
Bar coding with integrated software
Training matrix
Work Instructions and procedures
Order/Job sheets
Databases

25. Detection in FMEA
Is the assessment of the likelihood of finding the Failure Mode before
The failure occurs
The next downstream process
Leaving the factory/facility

26. Detection Ranking

27. Risk Priority Number (RPN)
RPN = Severity x Occurrence x Detection
The output of an FMEA is the RPN
The RPN is calculated based on information from
The potential failure modes;
Their effects & causes; &
The current ability of the process to detect the failures before they reach the customer
Is calculated as the product of three quantitative ratings, each one related to the effects, causes and controls
The RPN’s are then sorted & actions are recommended for the top issues

28. Take Action!
When
An effect of Failure has a Severity of 8 or higher
The product of Severity & Occurrence is high
When the RPN is high
> 75 or whatever your business decides
The RPN is calculated for the entire process or design first
Failure Modes with the highest RPN = Highest Priority!

29. Suggested Actions Minimize Severity through
Design modifications or Process modifications
Reduce the likelihood of Occurrence by
Design or process improvement
Improve Detection
Poor action but may be necessary

30. Actions for Improvement
Identify the high RPN’s
Determine what to do to achieve an improvement
Implement the improvement action
Recalculate the RPN

31. Improvement Actions are Visible
Should be ‘SMART’
Specific
Measurable
Achievable
Relevant
Time bound

32. Use the FMEA template
Follow this link for the template: