1. Failure Mode and Effects Analysis
System FMEA
Design FMEA
Process FMEA

2. Purpose
FMEA is a process designed to identify potential identify failure modes and to rate the severity of their effects.

3. Problem Solving Process
Requires problem identification before we proceed to a possible solution
We need to prioritize the problems so our energy is directed
We want to attack the problem upstream--root cause
Our countermeasure and action plans must be implemented

4. Recall: Quality Function Deployment
We begin at the end with a statement of needs and wants (standards etc.)
We ask what do we do to achieve these outcomes.
We then continue to ask about the elements of each sub-function we design
We then ask about the process of manufacture.

5. The Quality Matrix

6. Begin with the ultimate customer
Identify how the thing you deliver will be used.
Ask the client about the use so as to help identify needs and wants.
What are the subsystems we would put in place to meet these needs/wants?

7. Move backwards from the ultimate customer
Ask what process is required to reach the customer.
This process step is served by another supplier
Continue backwards--each in-process customer has an in-process supplier.

8. The Problems are Too Great and the Day is Short
We need to work on what we can put our hands around --not everything
The idea is to use a mechanism to prioritize the work.

9. Pareto Principle
An essential element of this process involves the Pareto Principle
80% of the occurrences of ill effects can be attributable to 20% of the causes
So, if we attack a few of the causes we can reduce the frequency of the problems in a substantial way.

10. Example
In the health care industry, over 80% ---I’m told 88%---of the charges come from under 20% of the carriers of insurance.
New advances in health care will likely use formats other than HMOs.

11. Pareto Chart Y-Axis The y-axis will be one of three quantities
Severity: S (of the effect)
Severity times Occurrence: S*O
RPN: Severity*Occurrence*Detection (Risk Priority Number)

12. Pareto Chart X Axis
Failure Modes
Obtained by brainstorm and or data

13. System FMEA
Before we design the products, we want to analyze the failure modes that can occur between subsystems and processes that are needed.

14. System Functions
What are the building blocks for the proposed operation?
How do these blocks--processes and subsystems--relate to each other?
Example: To generate light in a car we need a variety of subsystems to work.

15. Output of System FMEA The system failure mode prioritized by numbers
The specific functions that we need to monitor are identified.
A set of design actions to reduce the incidence of failures are put in place

16. What are the system functions here?
The battery operates the objects they are designed to power.
What do we need to do to make this happen? (specifically, we want to know the sub-systems needed to reach this point.):

17. Design FMEA
Before a product is released to manufacturing we need to analyze the potential failure modes in the product due to design deficiency
What functions/products do we need? Will the design work? Is it verified?
Actions: Revise specifications, change design simulation

18. Output of Design FMEA
Product failure modes and numbers that reflect their rank order
Critical characteristics that we want to study
Product design actions to reduce the frequency of failures and or Robust Design to reduce the effect of causes of failures

19. Process FMEA
The failure modes in production and the administrative processes that can be caused by process deficiencies
Our goal here is to connect the process with the outcomes and work in an EFFECTIVE way to reduce the failures.

20. FMEA Roadmap Potential failure mode ->
Effect (Determine Severity)->
Cause (determine Occurrence)->
Current Controls (Determine Detectability)
Determine Risk Numbers (S, O, RPN)
Actions Leading to Improvement

21. Roadmap

22. FMEA Development process

23. Process FMEA Template

24. What it looks like

25. Government regulation
Effects
Consider
Next user
Downstream users
Product operation
Safety
Government regulation
An effect of a failure is the consequence(s) of a failure mode that would be noticed or experienced at the next operation, at a subsequent operation, by a downstream user, or by the ultimate customer.

26. Customer probably will not notice the failure. Nuisance fault noticed
Hazardous failure. Safety related – sudden failure. Government regulation non-compliance. 10
Hazardous Effect
Potentially hazardous failure. Safety related but gradual failure. Subsequent process distruption 9
Very Serious Effect
Equipment damaged. System inoperable but safe. Very dissatisfied customer. 8
Serious Effect
Rework/repairs necessary. Performance severely affected but safe. Dissatisfied customer. Subsystem inoperable. 7
Major Effect
Performance degraded but safe. Discomfort. Repair required. Non-vital part nonfunctional. 6
Significant Effect
Moderate effect on performance. Customer dissatisfied. Nuisance repair required. Non-vital part non functional. 5
Moderate Effect
Minor effect on output or process performance. Slight deterioration. Chronic nuisance fault. 4
Minor Effect
Slight effect on output performance. Customer slightly annoyed. Nuisance fault obvious. 3
Slight Effect
Customer probably will not notice the failure. Nuisance fault noticed 2
Very Slight Effect
No effect on system or output performance or on subsequent processes 1
No effect
Severity is a rating corresponding to the seriousness of an effect of a potential failure mode.

29. Generic: Cause of Failure
Method
Equipment
Materials
People
Environment

30. Examples Failure Mode: Deposition too thick
Potential Cause: Air pressure peak too high

31. Failure Mode and Effect Analysis
Actions:
Revise Specifications
Change Design
Simulation
Design of Experiments
Revise Standard Operating
Procedures
Material Evaluation
Verification:
Risk Numbers Reduce
Additional Simulation
Additional D.V. “Builds”
Promotion Nonconforming or Variation Reduces
Fewer Returned Sales
Design Verification
Current Controls (SPC)
Failure mode
Severity
Occurrence
Product function
Process function & #
Design FMEA
Process FMEA

32. Control Plans: Idea
The plan is a record of how you intend to control the process.
It changes as we learn: called a living document
It should eliminate processes that were not effective and introduce process steps that are effective
It is essential that broad (cross-functional) input be used to create the plan

33. Team Include all major process leaders-cross-functional
Bring people from all levels
Make sure everyone is empowered

34. System Thinking Issues
Eliminate barriers between units, people and or departments-between design and manufacture, between purchasing and users etc.
Eliminate numerical goals, M.B.O., etc that cause people to tamper or use methods that take us away from our purpose
Institute a leadership that has us focused on the goal.

35. And also…. Drive out fear
Engage people in learning how to improve the system
and act on ideas...

36. Control Plan Includes:
A plan to control each process step: Connect to the flow chart
We only want to control “important” failure modes
The control plan should identify actions
We want actions for only the vital few failure modes

37. Categories of Measurements
Significant characteristics-dimensions of final product etc.
Critical Characteristics-features of the process that affect the SC values
The critical characteristics should be predictors of the significant characteristics

38. Key Measurement Features in Control Plan
For each step of the process we have the Significant Characteristics (SC)
Determined by the next in process customer
We have the Critical Characteristics (CC)
Determined by the process that gives rise to the SC

39. How are the SC and CC related?
Design of experiments is the tool we use to help us identify the connections between process parameters and significant characteristics
It is essential that we NOT look at features one-at-a-time with all else held constant.
Without a several factor study we can’t learn about interactions

40. First Step: Stability
Unless the characteristics we want to control exhibit stability, it is difficult to make improvement.
Operational definitions of stability should be described in the control plan.
The implementation of these rules with respect to the key features are described in the control plan too.

41. Connections
The Control Plan identifies failure modes with product characteristics (SC)
The Control Plan identifies causes with process parameters (CC)
The strength of the relationship is estimated by the team and portrayed in an input-output matrix

42. Input <-> Output Matrix
List the causes--particular process parameters CC-- as rows of the table
List the the failure modes as SC--significant characteristics as columns of the matrix.
Have the team identify the strength of the relationship as the matrix entry

43. One way to identify the few CC or SC for focus
For each SC we can determine the strength of the relationship with each CC (a 5 or ten point scale say.) Team creates a number.
We would add the strength measures for each CC across all SC to establish a priority rating for the Critical Characteristics.
We can do the same in the other direction to help focus on a few SC

44. Data Validation
The relationship between particular SC and CC --process parameters--must be validated.
The strength of the relationship and potentially complicated interactions needs to be studied.
Scatter diagrams are always preferred to correlation measures

45. Summary For each process step identify the key SC and CC.
Record results in the Control Plan
Obtain customer approval
Always look upstream for more effective control

46. Control Plan Categories
Pre launch
Process capability study
Prototype Control plan
Machine control plan
Ongoing
A living document to capture the current state of the plan--and history

47. Proactive Ideas Change design for elimination of the failure mode
Create a robust design so as to eliminate effect
The new design would be directed at the high severity and occurrence items in our Pareto Analysis

48. Reactive Plan
Add controls and inspection to improve our ability to detect the failure mode

49. General Strategy
Change design and or the process to prevent or reduce the frequency of occurrence of a few causes
Start with a reactive plan and continue the process of improvement by moving upstream in the process. Find process parameters that are excellent predictors of final significant characteristics--and control these.