1. Failure Modes Effects Analysis (FMEA)
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Continuous Improvement - FMEA

2. Objectives Discuss what FMEA is for Review how to use FMEA
Address steps involved in constructing an FMEA
Using FMEA for risk assessment
Continuous Improvement - FMEA

3. What is FMEA?
FMEA: Failure Modes Effects Analysis. A proactive, preventative evaluation.
What does it do?
Helps to evaluate how a process or design can fail
Helps to quantify risk factors assisting in prioritizing current or future potential projects
Can act as a forum for process or design improvements and preventative actions
Assists in identifying weaknesses in current control plan
May lead to reduction in manufacturing costs to improved design or set-up processes
Continuous Improvement - FMEA

4. Some Sources of Risk? Total Risk Potential Safety Hazards
Poor control plans & SOP’s
Unclear Customer Expectations
Vague Workmanship Standards
Raw Material Variation
Total Risk
Machine Reliability/Poor Process Capability
Poorly developed Specification Limits
Measurement Variation (On- Floor and QC)
The FMEA seeks to attack and identify RISKS through an RPN number.
D. H. Stamatis, FMEA:FMEA from Theory to Practice, Quality Press, 1995
Continuous Improvement - FMEA

5. Types of FMEA?
PFMEA --- Process or Potential Failure Modes Effects Analysis. May be used where a process needs to be evaluated for potential failures. May be a manufacturing or transactional process
DFMEA --- Design Failure Modes Effects Analysis. Generally used in Research/Development where designs are analyzed for potential weaknesses
SFMEA --- System Failure Modes Effects Analysis. Used to evaluate system issues that cross corporate functions
Continuous Improvement - FMEA

6. Process Mapping / Brown Paper Initial Capability Study
Where Can FMEA Fit In?
Process Mapping / Brown Paper
X-Y Matrix
Initial Capability Study
FMEA
Continuous Improvement - FMEA

7. When Do I Do an FMEA?
They can begin as soon as a project is selected for a certain process, system or design
First one usually started no later than Measure Phase, or beginning of the Analysis Phase
FMEA document is a dynamic document
Should be revised as improvements or changes made to a process
Also done in the Control Phase of the project for use as a Control Plan.
Continuous Improvement - FMEA

8. Who Does an FMEA?
This is a team process. Team sizes may vary, but recommended size is approximately 5-7 members.
Depending upon the type of FMEA being done, members may come from:
Research and Design Engineers
Manufacturing Supervisors, Manufacturing Engineers, Manufacturing Operators (very important members)
Quality Department Members
Sales
Marketing
Testing or Validation Department
Human Resources
Maintenance
Supplier
Continuous Improvement - FMEA

9. How to Do an FMEA
1. For each Process Input, determine the ways in which the input can fail (these are failure modes)
2. For each failure mode associated with the inputs, determine effects
3. Identify potential causes of each failure mode
4. List the current controls for each cause
5. Define or adapt definitions of Severity, Occurrence and Detection appropriate to what is being evaluated
6. Assign Severity, Occurrence and Detection ratings to each cause
7. Calculate RPN (spreadsheet does it automatically)
8. Determine recommended actions to reduce high RPN’s
9. Take appropriate actions and document
10. Update FMEA documents as appropriate
11. Recalculate RPN’s
Continuous Improvement - FMEA

10. FMEA Document
Continuous Improvement - FMEA

11. Sales creates quote/orders
FMEA: Step 1
Process Function (or step) --- Refers to the function of a process or step within a process. A manufacturing example might be “Drilling Holes,” and a transactional example, “Create Sales Orders.”
Sales creates quote/orders
Continuous Improvement - FMEA

12. Sales creates quote/order
FMEA: Step 1 (cont’d)
Failure Mode --- the way a process input may fail. Can be associated with a defect (in manufacturing) or a process input within a transactional process. A manufacturing example would be: “Wrong Hole Size” or a transactional example being, “Incorrect Information.”
Sales creates quote/order
Incorrect info
Continuous Improvement - FMEA

13. FMEA: Step 2
Effect --- The impact on process or customer requirements. This impact or result may be on a downstream process, the system, design or end-user customer. A manufacturing example may be, “Parts scrapped” and a transactional example could be, “Wrong person gets benefits”:
Sales creates quote/order
Incorrect info
Customer does not receive product
Customer receives incorrect product
Order cancelled
Continuous Improvement - FMEA

14. FMEA: Step 3 Cause --- Source of the failure mode.
Sales creates quote/order
Incorrect info
Customer does not receive product
Customer gave wrong info
Customer gave wrong info
Type/operator
Customer receives incorrect product
Customer changes mind
Part deviation
Continuous Improvement - FMEA

15. FMEA: Step 4
Current Process Controls --- Methods/devices in place to prevent or detect failure modes or causes. Prevention consists of mistake-proofing, automated controls and set-up verifications. Controls consists of audits, checklists, Inspection, laboratory testing, training, SOP’s, preventive maintenance, etc.
Customer gave wrong info
Repeat/verify info with customer (shipping vs billing address)
Quality review by random sampling
Continuous Improvement - FMEA

16. FMEA Step 5: Severity
Addresses how severe the failure mode and effect is to the customer. Also may address safety concerns. See below:
Effect
Criteria: Severity of Effect Defined
Ranking
Hazardous:
Without
Warning
GRAVE SAFETY concern/ violation, Possible Injury/ Death to customer or employee 10
With Warning
Major Safety/ / Health/ Environmental concern and/ or may be illegal 9
Very High
Render the product or service unfit for use 8
High
Cause extreme Customer dissatisfaction . 7
Moderate
Result in partial malfunction, major customer dissatisfaction i 6
Low
Cause a loss of performance likely to result in a complaint 5
Very Low
Cause minor performance loss 4
Minor
Cause a minor nuisance, can be overcome with no loss 3
Very Minor
Be unnoticed, minor effect on performance 2
None
Be unnoticed and not effect performance. 1
Also refer to the AIAG guidebook: Potential Failure Mode and Effects Analysis (FMEA), Reference Manual,
1995. Page 35. Chrysler Corporation, Ford Motor Company, General Motors Corporation.
Continuous Improvement - FMEA

17. Guidelines for Failure Possible Failure Rates
FMEA Step 5: Occurrence
Addresses the frequency the failure mode occurs. See below:
Guidelines for Failure
Possible Failure Rates
Probability
Ranking
Very High: Failure is almost inevitable
More than one per day
> 30% 10
Once every 3 to 4 days
£ 30% 9
High: Generally associated with processes similar to previous processes that have often failed.
Once per week
£ 5% 8
£ 1%
Once per Month 7
£ .03%
Moderate: Generally associated with processes similar to previous processes that have experienced occasional failures but not in major proportions :
Once every 3 months 6
Once every 6 months
£ 1 per 10,000 5 ,
Once a year 4 .
£ 6 per 10,000
Low: Isolated failures associated with similar processes.
Once every 1 – 3 years
£ 6 per million 3
Very Low: Only isolated failures associated with almost identical processes
Once every 3 – 6 years
£ 3 per 10 million 2
Remote: Failure is highly unlikely. No failures ever associated with almost identical processes.
Once every 6 – 50 years
£ 2 per billion 1
* Also refer to the AIAG guidebook Potential Failure Mode and Effects Analysis (FMEA), Reference Manual, Page 39. Chrysler Corporation, Ford Motor Company, General Motors Corporation.
Continuous Improvement - FMEA

18. FMEA Step 5: Detection
Addresses the ability of methods or systems in place to detect the failure if it occurs. See guidelines below:
Criteria:
Detection
Ranking
Almost Impossible
Defect caused by failure is not detectable. 10
Very Remote
Occasional units are checked for defects. 9
Remote
Units are systematically sampled and inspected. 8
Very Low
All units are manually inspected. 7
Low
Manual inspections with mistake-proofing. 6
Moderate
Process is monitored (SPC) and manually inspected. 5
Moderately High
SPC utilized with immediate reaction to
out-of-control (OOC) condition. 4
High
SPC (above) with 100% inspection (for OOC condition). 3
Very High
All units are automatically inspected/ tested/ verified. 2
Almost Certain
Defect is obvious and kept from affecting Customer. 1
* Also refer to AIAG guidebook Potential Failure Mode and Effects Analysis (FMEA), Reference Manual, Page 39. Chrysler Corporation, Ford Motor Company, General Motors Corporation.
Continuous Improvement - FMEA

19. FMEA Step 5: Additional Information
One thing that will save a lot of time is if the Black Belt defines the scales and definitions previous to the FMEA meeting
Scales do not have to be They may also be 1, 3, 7, 10 or similar scale
Additional characteristics may be factored into the RPN. For example, one Black Belt added an “Impact” characteristic. The intent was to quantify the impact to the process
Continuous Improvement - FMEA

20. FMEA: Step 6
We could put the following scores for the information we had below:
Customer does not receive product
Repeat/verify info with customer (shipping vs billing address) 4
Customer gave wrong info 2 2 4
Quality review by random sampling
Customer gave wrong info 2 4 4
Repeat/verify info with customer (shipping vs billing address)
Type/operator 3 2
Severity will continue all the way down for the issue on the left…
Continuous Improvement - FMEA

21. Let’s Look at Each Characteristic
FMEA: Step 7
Risk Priority Number (RPN) --- The risk priority number allows the team to quantify various failure modes to assist in prioritizing the team’s improvement efforts. The RPN is the product of:
Severity x Occurrence x Detection
The value of each of these characteristics is determined by the team.
The higher the RPN, the higher priority the potential failure mode becomes. Prevention becomes the focus of the team
Let’s Look at Each Characteristic
Continuous Improvement - FMEA

22. FMEA: Step 7
We could put the following scores for the information we had below:
We Get An RPN =4X2X2= 16
Customer does not receive product 4
Customer gave wrong info 2
Repeat/verify info with customer (shipping vs billing address) 2 16 4
Quality review by random sampling
Customer gave wrong info 2 4 32 4 3
Repeat/verify info with customer (shipping vs billing address)
Type/operator 2 24
Continuous Improvement - FMEA

23. Causes of Failure (X’s)
FMEA: Before Actions 12 2
Repeat/verify info with customer (shipping vs billing address) 3
Operator error 8
Customer gave wrong info (credit card)
Order delayed 16
Wrong address 4
Order not deliverable 60 5
Pre-production report
Part has EOL/leadtime increased
Order cancelled 1
Call customer
Part deviation
Verify order with customer
Customer changes mind
Customer receives incorrect product 48
Quality review by random sampling
Type/operator 24 32
Customer gave wrong info
Customer does not receive product
Incorrect info
Sales creates quote/order
RPN D E T
Current
Controls O C
Causes of Failure (X’s)
S E V
Failure
Effects
Failure Mode
Process Function
Continuous Improvement - FMEA

24. FMEA: Step 8
Recommended Actions --- Actions that are decided on by the team that will eliminate, reduce the impact or prevent the failure mode from occurring.
Customer gave wrong info 2
Quality review by random sampling 4 32
Confirm Customer Requirement before issue order
Continuous Improvement - FMEA

25. FMEA: Step 9
Responsible Person & Target Date --- Actions have a much better rate of completion when they are assigned a person with an expected date of completion. Once completed, update the FMEA form and fill out the “Taken Action” field.
R. Day 12-Dec-02
Customer gave wrong info 2
Quality review by random sampling 4
Confirm Customer Requirement before issue order 32
Continuous Improvement - FMEA

26. FMEA: Step 10 and 11 10. Update FMEA documents as appropriate
11. Re-assign the re-assign Severity, Occurrence and Detection ratings. Then Recalculate RPN’s
Quality review by random sampling 32
Confirm Customer Requirement before issue order
R. Day 12-Dec-02 4
As recommend Actions 4 1 2 8
Re-score each line and then recalculate.
Continuous Improvement - FMEA

27. In Class Exercise Break into your designated groups.
Use the XY matrix created during the last module.
Using the methodology you have learned today, create a preliminary FMEA for two steps from the in-class project.
You have 30 minutes for this exercise.
Be prepared to report your results to the class.
Continuous Improvement - FMEA

28. Failure Modes Effects Analysis (FMEA)
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Continuous Improvement - FMEA