1. FMEA – What’s the Worst That Could Happen? Eric Smathers, LSSBB

2. What’s the worst that can happen?
FMEA
What’s the worst that can happen?
TIPS: Work hard to keep your title short and easily readable; in general, short content is a best practice on Powerpoint slides. If you don’t have a subtitle, consider using the name of the presenter and/or the date of the presentation
IMPROVE: FMEA
How did this happen?

3. What is FMEA? Failure Modes and Effects Analysis
Disciplined approach to:
Identify potential & known failures
Identify causes & effects of failures
Establish risk factors
Make accountability clearer
Continuously improve
FMEA stands for Failure Modes and Effects Analysis. This step-by-step, disciplined approach to problem solving helps us to identify how a process can fail – potentially or actually. We look at all causes and the effects those causes have on the process and customers. It helps us to understand our risk – like the wet cat in this photo, there are always consequences when something goes wrong. No one wants to feel the wrath of an angry wet cat! Creating an FMEA makes accountability clearer to avoid failures or mistakes in the future. Finally, this tool helps us to continuously make improvements in our processes.

4. Create during Analysis Review during Improve and/or Control
When to use FMEA?
Improve a process or service
Analyze an actual failure
Design/redesign a process or service
The FMEA is created during the Problem Analysis phase. The solutions developed using the FMEA will be transferred to the Implementation Plan. As solutions are implemented and validation data collected, the team will come back to the FMEA to re-calculate the RPN to ensure there has been a reduction or elimination of possible failure in the selected process steps.
Create during Analysis
Review during Improve and/or Control

5. Who creates FMEA? A team made up of individuals:
Who know the system or process best
With a cross section of responsibilities, experiences, skills, perspectives
can have members who do not

6. How to create an FMEA Step 1 Map the process
Step 2 Analyze process steps
Step 3 Identify potential failures
Step 4 Describe effects of failure
Once the problem has been identified and scope determined, the team will map the process. Next you will analyze the process steps to identify where things can or did go wrong. What are all of the ways a process step can fail? Be as specific as you can. Details are good, but you don’t want to go so deep you lose sight of the problem.
Next you will describe the effects of the failure. Did the failure result in injury to a patient? Did the failure result in too much medication being administered?
What caused the failure? You can have more than one cause as well as more than one effect.
Next you want to look at what you currently have in place to help you detect a failure before it happens. A good example is your car. Years ago, you could get out of your car, lock it and walk away without knowing that you left your car lights on. The only way you knew was when you returned and the car wouldn’t start. Now, if you open your car door with your lights still on, what happens? Yes, your car makes a noise to alert you that your lights are on. That’s the type of signal we are looking for in this step.
At this point we will calculate how severe the effect is, how often the failure occurs and how easy it is for us to prevent or reduce the failure. These three numbers are multiplied to come up with a Risk Priority Number. We use a 1 – 10 scale with 10 being catastrophic. We want to work on failures that have a high RPN or are just do its.
The team will develop solutions and implement those solutions. At that point, we will reassess how well our solutions work by completing the FMEA again – hopefully with new scores.
Step 5 Determine causes
Step 6 Describe detection methods
Step 6 Calculate risk
Step 7 Take action
Step 8 Assess results

7. FMEA Worksheet
The FMEA worksheet. Click to talk through the major columns.

8. SEV (Severity of Effects)
Term
Rating Description
Rating
Critical
Affects patient, staff or visitor safety; catastrophic consequence. 10
Moderate
Failure could cause performance loss but may be overcome with modification to process. 7
Minor
Failure could cause minor performance loss but can be overcome with modification to process. 4
No effect
Failure would not be noticeable to patient and would not affect completion of process. 1

9. OCC (Occurrence Rating Scale)
Term
Rating Description
Rating
Frequent
* Likely to occur immediately or within short period of time. * Common or occurs frequently within defined time period. 10
Occasional
* Probably will occur. * May happen several times within defined time period. 7
Uncommon
* Possible to occur. * May happen sometime within defined time period. 4
Remote
* Unlikely to occur. * Doubtful but possible it may happen - usually past defined time period. 1

10. DET (Detection Rating Scale)
Term
Rating Description
Rating
Cannot detect failure
* No detection before it affects patient safety or process fails. * No control or warning of failure until it affects patient or process. 10
May detect failure
* Could detect prior to occurring. * Have a process step that will flag if a failure will occur. 7
May detect cause of failure
* Possible to occur. * May happen sometime within defined time period. 4
Can always detect errors
* Unlikely to occur. * Doubtful but possible it may happen -- usually past defined time period. 1

11. FMEA Worksheet Credit Card Printing FMEA Team Tom Jones
October 6, 2017
Card printed
incorrectly
Reissue card
Wrong info provided
Print Card
Visual 7 4 4
112
The FMEA worksheet. Click to talk through the major columns.
Reissue card
Wrong info entered
Visual 7 7 4
196

12. { Who uses FMEA? Patient Safety Military – created FMEA in 1950s
NASA – Apollo
Ford – Pinto
VA Hospital
Joint Commission
Institute for Healthcare Improvement
MUSC {
Patient Safety

13. Let’s make a pot of coffee!

14. Fill coffee pot with water Coffee too strong / weak
FMEA for making coffee
Step 1 Map the process
Step 2 Analyze process steps
Step 3 Identify potential failures
Step 4 Describe effects of failure
Make a pot of hot coffee
Fill coffee pot with water
Wrong amount of water
Coffee too strong / weak
S=7
RPN numbers come in at Step 6.
We could split the class into groups to complete a line or two of an FMEA for making coffee.
Step 5 Determine causes
Step 6 Describe detection methods
Step 7 Calculate risk
Step 8 Take action
Step 9 Assess results
Faded level marks
Visual inspection
7 * 4 * 4
Replace coffee pot
Make a new pot of coffee
O=4
D=4
RPN=112

15. FMEA Lovenox Injection1 2 3
Wash and dry your hands thoroughly
Have your patient sit or lie in a comfortable position and choose an area on the right or left side of the abdomen, at least 2 inches from the belly button
Clean the injection site with an alcohol swab and let dry. 4 5 6
Remove the needle cap by pulling it straight off the syringe and discard it in a sharps collector.
With your other hand, pinch an inch of the cleansed area to make a fold in the skin. Next, insert the full length of the needle straight down at a 90˚ angle – into the fold of skin
Press the plunger with your thumb until the syringe is empty. Then pull the needle straight out and release the skin fold. 7 8
FMEA Lovenox Injection
Point the needle down and away from yourself and others, and then push down on the plunger to activate the safety shield
Place the used syringe in the sharps collector

17. Scan the QR code with your smartphone
Give us your feedback
Scan the QR code with your smartphone

18. Next workshop is at 1:45 PM