UFMEA - Use Failure Mode Effects Analysis

P

Phloogy

#1
#1
I'm familiar with PFMEAs and DFMEAs but not with UFMEAs. I have to do a Use FMEA for a medical device and I am unsure how to approach it. I've tried searching this site and others and I have not found much help.

The only definition I found was this:
User Failure Mode Effects Analysis (User FMEA). Marketing should lead the effort on User FMEA. The aim is to thoroughly review what can go wrong in use and what kind of misuses may be made.

Any advice on where to start? What are some potential failure modes? Any examples of one, or perhaps a completed line item?

Thanks!
 
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M

Marcelo

Inactive Registered Visitor
#2
#2
For use error and failures, you should probably use other better analysis techniques - HAZOP comes to mind. You can verify other in documents such as IEC 62366 or AAMI HE 75.

I really don?t know why people try to use FMEA for everything (and it?s not a comment specifically against you, just a general remark :p)
 
Y

yodon

Leader
Super Moderator
#3
#3
One of our clients required a uFMEA and it was relatively successful.

They have an orthopedic appliance. There's an external structure that ties into bones.

A couple of the use scenarios included:
* swimming with the appliance (biological hazards, hazards with the device failing due to water ingress, etc.)
* spilling a variety of liquids (Cokes, oils, juices, etc.) on the device
* bumping into things (device could bend / break, additional damage to the bones)


A good way to think of it would be "what if a kid got the device - what might they do?" :)

Good luck.
 
Q

QualityGuy50

#4
#4
We used the same format (as in the same Excel template) as the DFMEA and used the questions in Annex E of IEC 62366 as prompts for potential user failure modes.
 
mihzago

mihzago

Trusted Information Resource
#5
#5
one way to do it is to take your user manual and copy all functions and features into one column of a table or a spreadsheet, then similar to an FMEA, in the next column assess all possible ways that a user can mess something up (e.g. failure modes from a user perspective), and in another column list what are the potential effects of these actions. The describe how you plan to control these risks or provide a reference to another document that addresses them (e.g. risk assessment).

To prevent duplicate failure modes, any failures in hardware/software should be excluded from the scope and included in your dFMEA or another risk assessment activity.
 
K

kuyakut

Involved In Discussions
#6
#6
Phloogy said:
I'm familiar with PFMEAs and DFMEAs but not with UFMEAs. I have to do a Use FMEA for a medical device and I am unsure how to approach it. I've tried searching this site and others and I have not found much help.

The only definition I found was this:
User Failure Mode Effects Analysis (User FMEA). Marketing should lead the effort on User FMEA. The aim is to thoroughly review what can go wrong in use and what kind of misuses may be made.

Any advice on where to start? What are some potential failure modes? Any examples of one, or perhaps a completed line item?

Thanks!
Click to expand...
I think what you are looking for is a FMECA - Failure Mode Effect Criticality Analysis. This FMECA is for end user The rating for severity , occurence and detection is almost same as PFMEA.
What i usually do is use only 1 FMEA to cover both manufacturing and end user.
In the potential effect of failure , i have 2 column 1 is for manufacturing / assembly and the other is end user.
 
mihzago

mihzago

Trusted Information Resource
#7
#7
kuyakut said:
I think what you are looking for is a FMECA - Failure Mode Effect Criticality Analysis. This FMECA is for end user The rating for severity , occurence and detection is almost same as PFMEA.
What i usually do is use only 1 FMEA to cover both manufacturing and end user.
In the potential effect of failure , i have 2 column 1 is for manufacturing / assembly and the other is end user.
Click to expand...
That's actually not what FMECA is. FMEA and all of it's flavors with different prefixes e.g. d-design, p-process, u-usability, etc start the same way as FMECA. The only difference is at the end where you calculate each risk by typically multiplying probability x detectability x severity, then you rank the scores from highest to lowest, and decide which risks you are going to address (which is the criticality part). So in actuality almost everyone is performing an FMECA.
 
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