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What do you think is the value in the FMEA process?

Failure Mode Effects Analysis (FMEA) is an assessment tool that prospectively

looks to identify and eliminate concerns early in the development of a process or

design. The FMEA process consists of 5 steps: 1) Define the topic, 2) Assemble a

team, 3) Graphically describe the process, 4) Conduct hazard analysis and 5) Define

actions and outcome measures. (Shaqdan et al, 2014). FMEA however is not designed

to eliminate problems.

One of the benefits of FMEA is that it enables early identification of single failure

points and system interface problems that can impact safety. A simple yet very

effective example of how FMEA can help identify single failure points in a pharmacy is

the one listed below. When thinking about how medications are laid out in a pharmacy

it is important to think about look alike sound alike medications and what impact they

may have if dispensed incorrectly. For example, this picture displays 2 very different

medications; tramadol and trazadone

The medications are both made by TEVA, have the same coloring scheme and both

come as 50mg tablets.

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1) Define the topic:

Preventing picking errors of lookalike sound alike medications in similar packaging

on the pharmacy shelves

2) Assemble a team:

Pharmacy manager, Pharmacy Technician

3) Graphically describe the process:

Current process (high level)

Rx for Tramadol Rx typed for Rx label for Go to pharmacy Dispense

50mg comes in Tramadol 50mg Tramadol 50mg shelf to select Tramadol
printed Tramadol

New process (high level)

Rx for Tramadol Rx typed for Rx label for Go to pharmacy Caution stickers

50mg comes in Tramadol 50mg Tramadol 50mg shelf to select and different
printed Tramadol colored dividers
separate
tramadol from
other
medications

Caution and
dividers alert
Dispense
technician to be
Tramadol
cautious when
selecting
medications

4) Conduct hazard analysis:

Dispensing the wrong medication tramadol (used for pain) and trazadone (used for

sleep) could result in potentially serious consequences.

5) Define actions and outcome measures

Use ‘caution’ verbiage in bright caution colors and dividers to separate medications

(ideally in a different color to regular dividers to differentiate and bring attention to

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medications with different colored dividers, we use blue), consider using different

shelf locations.

Use a quality assurance tool to measure picking errors and re-address is any

errors occur.

I don’t see any unnecessary steps in the FMEA process but I do see issues

where it may be subject to bias, lack of experience and incomplete analysis methods.

For example, the team selected may not have the necessary skill set or experience to

complete a FMEA assessment for example the rank scores used in FMEA are

subjectively generated (in particular severity (S), occurrence (O) and detection (D).

Error detection is composed of two components; containment (prevention of error

reaching the patient) and controls (prevention of error from being created). Most FMEA

assessments focus on the containment portion, if we review the example above

containment would be when a pharmacist is verifying that a prescription is dispensed

correctly notices that a prescription for tramadol was filled with trazadone and has a

quick discussion to let everyone know to be careful when picking look alike or sound
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alike medications whilst control would be having processes that prevent the error in the

first place for example, signage, different dividers, located on different shelves so the

error does not happen. It is important to break down detection into its two components

for a more complete analysis.

References
Flaig, J. (2015, June 15). Rethinking Failure Mode and Effects Analysis. Retrieved from

https://www.qualitydigest.com/inside/statistics-column/062415-rethinking-failure-

mode-and-effects-analysis.html#

Griffin, P. M., Nembhard, H. B., DeFlitch, C., Bastian, N. D., Kang, H., & Muñoz, D. A.

(2016). Healthcare systems engineering. Hoboken, NJ: John Wiley & Sons.

Shaqdan, K., Aran, S., Besheli, L. D., & Abujudeh, H. (2014). Root-Cause Analysis and

Health Failure Mode and Effect Analysis: Two Leading Techniques in Health

Care Quality Assessment. Journal of the American College of Radiology, 11(6),

572-579.