WorksheetsFMEA training, Day 2 of 2
Total questions: 11
Worksheet time: 8mins
Name
Class
Date
1.
What is the "Local Effect" in an FMEA?
a)
The impact of the failure mode on the end user, donor/patient or product as a result of the failure.
b)
Describes the way in which the item (system/sub-system/component) could fail to perform its desired function (design intent or performance requirements)
c)
The immediate resulting event that occurred within the same subsystem or adjacent item/process step/task as a direct result of the failure mode.
d)
What the item is intended to do in a successful state. It is the primary purpose or design intent, usually written to a given standard of performance or requirement.
2.
What is the "Final Effect/Harm" in an FMEA?
a)
Specific reason for the failure, preferably found by asking “why” until the root cause is determined.
b)
The user task that is individually analyzed in that record
c)
The immediate resulting event that occurred within the same subsystem or adjacent item/process step/task as a direct result of the failure mode.
d)
The impact of the failure mode on the end user, donor/patient or product as a result of the failure.
3.
True or False: Records that have patient impact will have Severity from the Hazard Analysis
a)
True
b)
False
4.
Which selection of Safety Impact will result in the Severity score automatically populated from the Hazard Analysis (HA)?
a)
Safety Impact of "yes"
b)
Safety Impact of "No"
c)
Safety Impact of "Maybe"
d)
Safety Impact of "Unknown"
5.
The Severity score is based on which column in the PFMEA
a)
FMEA ID
b)
Potential Effects
c)
Item
d)
Function
6.
What does "O Failure" mean?
a)
Outstanding Failure
b)
Occurrence of the Failure ranking
c)
Other Failure
d)
Operation Failure
7.
The Occurrence score is based on which column in the FMEA?
a)
Local Effect
b)
Safety Impact?
c)
Residual FPN
d)
Failure Mode
8.
How is the Failure Priority Number (FPN) for a dFMEA calculated?
a)
O Failure x Severity
b)
Item x Severity
c)
Residual FPN / 3
d)
1/1000
9.
True or False: Risk Controls can change the severity of the effect?
a)
True
b)
False
10.
Which of the following risk controls should be prioritized the highest (we should pick this risk control first, if possible)?
a)
Inherently safe design and manufacture
b)
Information or safety notice
c)
Disclosure of Potential Harm
d)
Protective measures in the product
11.
True or False: the uFMEA does not need to be linked to the Hazard Analysis
a)
True
b)
False
100 %
