1. F.M.E.A (Failure Mode and Effect Analysis)
Chapter 14
Ronette Braithwaite
Tom Plotner

2. GOALS F.M.E.A. Reliability Block Diagrams What is it? Why is it used?
How it is used.
Reliability
Why it is important.
Block Diagrams

3. How are we going to accomplish the goals?
Implement quality!

4. Survey

5. WHAT IS F.M.E.A??
FMEA is an analytical technique that combines the technology and experience of people in identifying foreseeable failure modes of a product or process and planning for its elimination .
FMEA can be explained as a group of activities intended to:
Recognize and evaluate the potential failure of a product or process and its effects
Identify actions that could eliminate or reduce the chance of potential failures
Document the process

6. Cont.
FMEA attempts to detect the potential product-related failure modes
FMEA uses occurrence and detection probability criteria in conjunction with severity criteria to develop risk prioritization numbers for prioritization of corrective action considerations
FMEA is a team effort which the engineer has to involve the assembly, manufacturing, materials, quality, service, supplier, and the next customer (internal or external)

7. Benefits of FMEA
Improves the quality, reliability, and safety of products / services / machinery and processes
Improves company image and competitiveness
Increases customer satisfaction
Reduces product development timing and cost / support integrated product development
Documents and tracks action taken to reduce risk
Reduces potential for Warranty concerns
Integrates with Design for Manufacturing & Assembly techniques

8. Several types of F.M.E.A: design FMEA, process FMEA, equipment FMEA, maintenance FMEA, concept FMEA, service FMEA, system FMEA, environmental FMEA, and others.
Design FMEA
Identifies known and foreseeable failure modes
Establishes priorities based on expected failures and the severity of those failures
Reduces development time and the cost of manufacturing process
Process FMEA
Identifies potential failure modes prior to operation of the process
Helps to establish priorities according to the relative impact on the internal or external customer
Helps to identify potential manufacturing or assembly causes in order to establish controls for occurrence reduction and detection

9. Reliability Reliability defined:
The probability of a product to perform as expected for a certain period of time, under the given operating conditions, and at a given set for product performance characteristics.

10. Why is reliability important?
Reputation
Customer Satisfaction
Warranty Costs
Repeat Business
Cost Analysis
Customer Requirements
Competitive Advantage

11. What is the difference between Quality and Reliability?

12. TAKE A BREAK!!!!
Come back in about minutes

13. Block Diagram Is a simple, specialized, high-level type of flowchart.
Provides a quick and uncomplicated overview of a process.
Is used to design new processes or to simplify and understand existing processes.
Is a starting point for process improvement.

14. Simple Block Diagram

15. Complex Block Diagram
CELL PHONE

16. ACTIVITY

17. 4 Stages of FMEA Specifying Possibilities Quantifying Risk
Functions
Possible Failure Modes
Root Causes
Effects
Detection/Prevention
Quantifying Risk
Probability of Cause
Severity of Effect
Effectiveness of Control to Prevent Cause
Risk Priority Number
Correcting High Risk Causes
Prioritizing Work
Detailing Action
Assigning Action Responsibility
Check Points on Completion
Re-evaluation of Risk
a. Recalculation of Risk Priority Number

18. Design FMEA
View Handout

19. Failure Mode And Effect Analysis (Design FMEA)
FMEA Number______________ Page___________of__________ Item ____________ Design Responsibility___________Prepared By _______________ Mode Number/Year________Key Date__________FMEA Date (Orig.)____(Rev.)____ Core Team______________________________________________________________

20. List the functions of the item
Item/ Function
Potential
Failure
Mode
Effect(s) of S C L A
Causes(s)/
Mechanism(s) O
Current
Design
Controls D R P N
List the functions of the item
Function should be written in verb-noun context
Each function must be measurable
Example
Must hold an extra large coffee (16 oz)
Heat transmission of less than xx deg

21. Failure modes should be described in technical terms
Item/ Function
Potential
Failure
Mode
Effect(s) of S C L A
Causes(s)/
Mechanism(s) O
Current
Design
Controls D R P N
Failure modes should be described in technical terms
Avoid to many details
Example
Does not hold 16 oz.
Transmits heat too quickly

22. Effects must be listed from the customers point of view
Item/ Function
Potential
Failure
Mode
Effect(s) of S C L A
Causes(s)/
Mechanism(s) O
Current
Design
Controls D R P N
Effects must be listed from the customers point of view
Also state whether the failure will impact personal safety or break any product regulations
Many effects may exist for each failure mode
Example
Insufficient quantity of coffee
Must fill too often
Injury to person - burn

23. Insufficient quantity of coffee – severity 5 Must fill too often
Item/ Function
Potential
Failure
Mode
Effect(s) of S C L A
Causes(s)/
Mechanism(s) O
Current
Design
Controls D R P N
View severity chart
The severity applies only to the effect of the failure, not the potential failure mode
If a severity of 9 or 10 is selected an action should be considered before continuing
Example
Insufficient quantity of coffee – severity 5
Must fill too often
Injury to person (burn) – severity 10

24. Item/ Function
Potential
Failure
Mode S C L A
Causes(s)/
Mechanism(s) of O
Current
Design
Controls D R P N
Classify any special product characteristics for components, subsystems, or systems that may require additional process controls.

25. Must be listed completely and consciously
Item/ Function
Potential
Failure
Mode
Effect(s) of S C L A
Causes(s)/
Mechanism(s) O
Current
Design
Controls D R P N
Must be listed completely and consciously
There is usually more than one cause of failure for each failure mode
Causes must be identified for a failure mode, not an individual effect
Example
Insulation material too thick
Inside cup sized incorrectly
Insufficient insulation

26. Insulation material too thick – occurrence 5
Item/ Function
Potential
Failure
Mode
Effect(s) of S C L A
Causes(s)/
Mechanism(s) O
Current
Design
Controls D R P N
View occurrence chart
Occurrence is based on the chance that one of the specific causes/mechanisms will occur
Each cause must be rated on the probability of occurrences as it contributes to each failure mode
Example
Insulation material too thick – occurrence 5
Inside cup sized incorrectly – occurrence 2
Insufficient insulation – occurrence 5

27. Three types of design controls
Item/ Function
Potential
Failure
Mode
Effect(s) of S C L A
Causes(s)/
Mechanism(s) O
Current
Design
Controls D R P N
The activities that assure the design sufficiency for the failure mode or mechanism are listed
Activities may include prevention measures, design validation, and design verification
Three types of design controls
Prevent the cause/mechanism or failure mode effect from occurring or reduce the rate of occurrence
Detect the cause/mechanism and lead to corrective actions
Detect only the failure mode

28. The first type is the preferred method to use
Item/ Function
Potential
Failure
Mode
Effect(s) of S C L A
Causes(s)/
Mechanism(s) O
Current
Design
Controls D R P N
The first type is the preferred method to use
Example
Engineering specifications – preventive control
Historical data – preventive control
Functional testing – detective control

29. Detection is the value assigned to each of the detective controls
Item/ Function
Potential
Failure
Mode
Effect(s) of S C L A
Causes(s)/
Mechanism(s) O
Current
Design
Controls D R P N
View detection chart
Detection is the value assigned to each of the detective controls
Example
Engineering specifications – no detection value
Historical data – no detection value
Functional testing – detection 3

30. Values for the RPN can range from 1 to 1000
Item/ Function
Potential
Failure
Mode
Effect(s) of S C L A
Causes(s)/
Mechanism(s) O
Current
Design
Controls D R P N
RPN = (S) x (O) x (D)
Values for the RPN can range from 1 to 1000
RPN is used to rank the various concerns on the document
Example
Insufficient quantity of coffee – severity 5, Inside cup sized incorrectly – occurrence 2, Functional testing – detection 3
S= 5 O= 2 D= 3 RPN= 30
Injury to person (burn) – severity 10, Insufficient insulation – occurrence 5, Functional testing – detection 3
S= 10 O= 5 D= 3 RPN= 150

31. Recommended
Actions
Responsibility
and
Target
Completion
Dates
Action
Results
Taken S E V O C D T R P N
Recommended actions should be focused on design, and directed toward justifying the cause of failure mode, or eliminating the failure mode
Always begin with the concern with the greatest RPN and working in descending order

32. Recommended
Actions
Responsibility
and
Target
Completion
Dates
Action
Results
Taken S E V O C D T R P N
All recommended actions must have a person assigned responsibility for completion of the action
There must be a completion date accompanying each recommended completion

33. Recalculate and record the resulting RPN
Recommended
Actions
Responsibility
and
Target
Completion
Dates
Action
Results
Taken S E V O C D T R P N
A brief description of the actual action and its effective date should be entered
Re-estimate the resulting severity, occurrence, and detection rankings after the corrective actions have been identified
Recalculate and record the resulting RPN

34. Process FMEA

35. ACTIVITY

36. QUIZ

37. Occurrence numbers tell:
How bad a failure is
The likelihood of completing the FMEA
The chance of detecting a failure
The probability of a failure

38. FMEA stands for _________ Mode and Effects Analysis
Founded
Failure
Function
Fart

39. RPN development is the reason FMEAs are performed
True
False

40. Reliability is important to external and internal customers?
True
False

41. There are only two types of FMEAs – Design and Process
True
False

42. Design FMEA should always begin with:
Risk priority number
FMEA team
Block diagram
Failure rate

43. Is FMEA a team effort?
True
False

44. Does an organization need to implement FMEA to achieve quality?
True
False

45. Design FMEA should always start with a _________.
FMEA Team
FMEA evaluation
Block diagram
Quality function deployment

46. Are you comfortable in conducting your own FMEA document ?
TRUE