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FMEA Day 1 of 3

Total questions: 10

Worksheet time: 5mins

Name
Class
Date
1.
What is an FMEA
a)
A structured, statistical approach to study how multiple input variables affect output variables.
b)
A written plan describing the method of validation, including production equipment, how validation will be conducted, and pre-determined acceptance criteria.
c)
A single-fault failure analysis technique to systemically identify potential failure modes, their cuases, and effect on system performance
d)
A comprehensive analysis of a project or business idea to determine if it is practical, viable, and likely to succeed.
2.
What is the purpose of a Design FMEA?
a)
To identify possible errors in the interaction between the product and the product's users.
b)
To identify failures in the manufacturing process.
c)
To comply with regulations
d)
To identify design flaws.
3.
What is the purpose of a Use FMEA?
a)
To identify possible errors in the interaction between the product and the product's users.
b)
To identify design flaws.
c)
To identify failures in the manufacturing process.
d)
To comply with regulations
4.
What is the purpose of a Process FMEA?
a)
To identify design flaws.
b)
To identify failures in the manufacturing process.
c)
To identify possible errors in the interaction between the product and the product's users.
d)
To comply with regulations
5.
FMEA are:
a)
Point-in-time documents
b)
Living documents
6.
What are the two sections of an FMEA:
a)
Design and Use
b)
Planning and Cleanup
c)
Top and Bottom
d)
Initial Risk Assessment and Residual Risk Assessment
7.
When should we start FMEAs
a)
As soon as we have enough information
b)
At the very end of the design process, after validation
8.
Who should participate in the FMEA analysis
a)
The lead project engineer should complete the FMEA by themselves.
b)
All the engineers on your team
c)
As many functions as are needed for the scope and type of FMEA
d)
The FMEA facilitator by themselves.
9.
Severity scoring of FMEAs is separated into Safety Impacting and Non-Safety Impacting
a)
True
b)
False
10.
Structure of the FMEA must be decided at the end of the FMEA analsysis
a)
True
b)
False