1. FMEA
By Andy Klimes

2. Outline What is FMEA? History Benefits Applications Procedure
Sample Worksheet
Patient Safety Standards
Exercise
Summary
These items are the topics that the presentation will cover.

3. What is FMEA?
FMEA is an acronym that stands for Failure Modes and Effects 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. History of FMEA Created by the aerospace industry in the 1960s.
Ford began using FMEA in 1972.
Incorporated by the “Big Three” in 1988.
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.

5. 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.

6. Benefits cont. 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.

7. 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.

8. 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.

9. Procedure cont. 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.

10. 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).

11. 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

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

13. FMEA for Patient Safety Standards
Darryl S. Rich, Pharm. D., M.B.A.,
FASHP, advocates using FMEA in the pharmacy industry
Annually select at least one high-risk process
Medication use
Restraint use
Darryl Rich suggests selecting at least one high-risk process each year for a proactive assessment. He criteria for selection is based on risks identified as being most frequent by the Surveyor Development and Management Joint Commission.
Medication use and restraint use are two examples. Other examples are: operative and other procedures, use of blood, seclusion as part of care, and resuscitation.

14. Patient Safety Standards
Medication Use Processes
Selection
Procurement
Ordering
Transcribing
Preparing
Dispensing
Administration
Monitoring
Conduct a FMEA
1. Rich outlines the different processes used with prescribing medications.
2. Rich calls upon the medical community to conduct an FMEA to determine where failures may occur during the medication use process.

15. Patient Safety Standards
Flow Chart Requirement
Determine which steps can fail
Physician
Order completion
Transcription
Look-alike drug
Determine effects of the failures
A flow chart of the process needs to be constructed in great detail.
The pharmacists need to look at the possibilities of failure. Besides the above, there can also be writing and Non-formulary drug prescribed.
Pharmacists must then determine what the effects of the failures can be. Examples are: wrong drug, wrong dose, incomplete order, writing is illegible so the order cannot be filled, etc.

16. Patient Safety Standards
Assign a rank for each effect:
Occurrence of Failure
Severity of Failure
Probability of Failure
Compute the Risk Probability number
Find the root cause of the most critical effects
The rank for each effect will be 1 through 10 for occurrence, severity, and probability.

17. Patient Safety Standards
Rich is advocating the use of FMEA to:
Enhance patient satisfaction
Prevent potential hazardous drug interaction
Prevent incorrect dosages from being administered to patients

18. Exercise You are the owner of a lawn mowing service.
Use FMEA to analyze the failure modes associated with mowing a lawn.
Before the exercise, the presenter may what to develop a simple FMEA worksheet such as the example given previously. This will provide the group viewing the presentation to fill out the form. This exercise is designed to let the class or group determine how they would rank each failure. There is no right or wrong answers, but the reasons for how they rank each failure during the exercise should be discussed.

19. Exercise cont.
Brainstorm for possible failures that can occur while mowing a lawn
Determine the effects of the failure
Assign rankings to each failure
Determine the RPN
For the presenter, possible failures are: Dull blade, height not set right, run out of gas, run out of oil, wheels may be loose, blade may be loose, grass bagger not set correctly, grass bagger clogs up quickly, safety shut-off bar not working correctly, grass is too wet, and hazards such as rocks, twigs, or toys in the lawn.
Have the group determine the effects of the failures and assign rankings for severity, occurrence, and detection. Severity must also include a class: catastrophic, critical, marginal, or negligible.

20. Exercise cont.
List the current controls over the process of lawn mowing
List the recommended actions to reduce severity, detection, and occurrence
Assign responsibility and completion dates for each action
Examples of current controls could be: checking oil and fuel before every use, sharpening the blade on a set schedule, checking the bagger to make sure that it is seated correctly, etc.

21. Exercise cont. List actions taken
After actions have been taken, estimate the new rankings and calculate the new RPN
On the FMEA worksheet, list actions taken and then calculate a new RPN.

22. 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

23. References
Crow, Kenneth. Failure Modes and Effects Analysis (FMEA). DRM Associates: <
FMECA.COM. Kentic, LLC: <

24. References Cont.
Foster, S. Thomas. Managing Quality: An Integrative Approach. Upper Saddle River, New Jersey: Prentice Hall, 2001.
Rich, Darryl S. Complying with the FMEA Requirements of the New Patient Safety Standard. JCAHO: <