1. FMEA

2. Outline What is FMEA? History Timing Benefits Applications
Stages of FMEA
FMEA Team
Procedure (RPN=S*O*D)
Summary
These items are the topics that the presentation will cover.

3. What is FMEA? FMEA stands for Failure Mode and Effect Analysis
Methodology of FMEA:
Identify the potential failure of a system and its effects
Assess the failures to determine actions that would eliminate the chance of occurrence
Document the potential failures
FMEA is a methodology used to:
1. Identify the possible failures that a component can have on a system.
2. Assess how these failures could affect the system.
3. Document the possible failures and the potential effects they could have on the system.

4. What is FMEA
FMEA is a systematic way of assuring that every conceivable potential failure of a design/process has been considered.

5. History of FMEA Created by the aerospace industry in the 1960s.
Ford began using FMEA in 1972.
Automotive Industry Action Group and American Society for Quality Control copyright standards in 1993.
Ford began using FMEA in 1972 to analyze their engineering designs.
Chrysler, Ford, and GM developed QS9000, an automotive equivalent to ISO9000. Design and process FMEAs were a standard for compliance with the QS9000
The AIAG and ASQC presented an FMEA manual that was approved by the Big Three automakers in 1993.

6. Timing Integral part of the early design evaluation
During the design phase
Preliminary design or layout
Design improvement programmes
Perriodically updated

7. What are the Benefits? Improvements in: Safety Quality Reliability
FMEA is a preventative action. Predefined problems can help with:
Safety- Potential safety problems with a product or service can be defined and rectified before an incident can occur.
Quality- Identifying potential failures and the possible means of fixing these can help reduce quality costs that may have occurred if the problems weren’t identified until implementation of the system.
Reliability- Consumers will be able to rely on a product or service if they do not encounter failures during use.

8. Benefits What other potential benefits can be identified?
Company image
User satisfaction
Lower development costs
Presence of a historical record
The presenter will ask the group to brainstorm ideas for benefits other than those listed on the previous slide.
Other examples the presenter can give:
If failures are identified before implementation, the company will have less field failures and therefore be seen as having a desirable product or service.
The user will have an increased level of satisfaction due to the lack of failures that had already been identified and rectified before implementation.
Development costs are lower. It is much easier to fix a predetermined failure than to find a failure well into the development process that may cause a setback in development time and the time it will take to get a knew product or service to the user.
A historical record of these identified failures and proposed actions will exist for future use. When developing the next system, whether it be a product or service, the designers will have a framework for future FMEA.

9. Applications Concept Design Process Service Equipment FMEA is used in:
Concept – FMEA is used to analyze a system when it is first conceived.
Design – FMEA is used to analyze a product before it is put into production.
Process-FMEA is used by companies to analyze manufacturing processes and the potential failures that might occur during production.
Service – FMEA focuses on the service industry and focuses on potential failures based on industry practices before bring this service to the customer.
Equipment – A company will use FMEA to determine failures of equipment or software before they purchase them for use.

10. 4 Stages of FMEA 1. Specifying Possibilities (ROOT CAUSES/ EFFECTS)
2. Quantifying Risk ( SEVERITY, OCCURENCE, DETECTION= RPN)
3. Correcting High Risk Causes (DETAILING ACTION/ASSIGNING RESPONSIBILITIES)
4. Re-Evaluation of Risk (RE- CALCULATIING OF RPN)

11. FMEA Team It is a team effort RESPONSIBILITIES
Determining the meeting time and place
Communicating
Coordinating
Corrective Action/Assignments
Follow up
Participation from all
Keeping the records/files/documents
Keeping the process moving

12. FMEA Procedure Assign a label to each system component
Describe the functions of each part
Identify potential failures for each function
Each component must be labeled so none of them will be overlooked.
Develop a block diagram that shows the components or steps and indicate how they are related.
List the failures that may occurr with each function. This is the failure mode.

13. Procedure Determine the effects of the failures
Estimate the severity of the failure
Estimate the probability of occurrence
Determine what the ultimate effect of the failure will be . Examples are: product or process fails to function, the user is injured, physical defects occur, color is wrong, etc. Anything that would cause the product or process to be undesirable to the user or consumer.
Estimate which failure would be the most severe. Failures that could cause human injury would be the most severe. Rank these 1 through 10. One being lease severe and 10 being most severe.
Weight the probability of the occurrence on a scale of one to ten. One being least likely and ten being most likely to occur.

14. Procedure cont. Determine the likelihood of detecting the failure
Determine which risks take priority
Address the highest risks
Assign a Risk Priority Number
Update the FMEA as action is taken
Based on the current controls of the company, determine the likelihood that a failure would be detected. Rank them from one to 10. One being least likely to detect, 10 being most likely to detect.
Decide which risks take the highest priority. This can be determined from the previous factors. A combination of the severity, probability, and the likelihood of detection should determine which risks would take priority.
Assign responsibility of the highest risks and set a completion date.
Update the FMEA as action is taken. Once a failure mode has been neutralized, determine the next highest risk. Also an update will be needed if there is a change in the product or service that could produce new failure modes.
The risks are assigned a Risk Priority Number. This is equal to (Severity Rank)*(Probability Rank)*(Detection Rank).

15. FMEA Flow Chart Assign a label to each process or system component
List the function of each component
List potential failure modes
Describe effects of the failures
Determine failure severity
Determine probability of failure
Determine detection rate of failure
Assign RPN
Take action to reduce the highest risk

16. SEVERITY
Severity is an assessment of the seriousness of the effect and refers directly to the potential failure mode being studied

17. OCCURENCE
The occurrence is the assessment of the probability that the specific cause of the failure mode will occur

18. DETECTION
This is an assessment of the probability that the proposed process controls will detect a potential cause of failure or a process weakness

19. Ranking for SEVERITY Rank Effect 1 None 2 Very Minor 3 Minor
4 Very Low
5 Low
6 Moderate
7 High
8 Very High
9 Hazard with Warning
10 Hazard without Warning

20. Ranking of OCCURENCE Rank Evaluated Failure Rates 1 1 in 1,500,000

21. Ranking of DETECTION Rank Detection 1 Almost Certain 2 Very High
4 Moderately High
5 Moderate
6 Low
7 Very Low
8 Remote
9 Very Remote
10 Almost Impossible

22. RPN (RISK PRIORITY NUMBER)
RPN = SEVERITY*OCCURENCE*DETECTION (S*O*D)
Value Ranges from 1 to 1000, 1 being the smallest possible risk.

23. FMEA Worksheet
This is an example of an FMEA form. The heading vary from company to company.

24. Summary
FMEA is a procedure designed to identify and prevent potential failures
Provides cost savings and quality enhancing benefits
Should be used for all business aspects in both manufacturing and services

25. THANK YOU