BME 302 Final Exam | Includes definitions, Exam Elaborations Plus Questions and Answers
Requirement
[Definition] *** customer need which must be met
Specification
[Definition] *** technical description of how a given requirement will be satisfied.
Quality
[Definition] *** the totality of features and characteristics of a product or service that
bears on its ability to satisfy stated or implied needs.
Quality System
[Definition] *** organizational structure, responsibilities, procedures, processes, and
resources for implementing quality management.
Verification
[Definition] *** confirmation by examination and provision of evidence that specified
requirements have been fulfilled.
Validation
[Definition] *** confirmation by examination and provision of objective evidence that
the particular requirements for a specific intended use can be consistently fulfilled.
What question do you ask to see if a device is Verified? *** "Does the device meet
specifications?"
What question do you ask to see if a device is Validated? *** "Does the specification
satisfy the requirement and meet the user's need?"
, User Needs inform the _____ _____.
[2 Words] *** design inputs
What questions do you ask at the User Needs step? *** - Who are your users?
- What do your users want you to design?
- What are the overarching design goals?
Design Input - Constraint
[Definition] *** a limit or restriction on the design's behaviors or attributes.
Design Input - Function
[Definition] *** a specific thing a designed device or system is expected to do.
Design Input - Specification
[Definition] *** a scale on which the achievement of a design's functions can be
measured.
What happens in the Design Process step? *** You consider multiple design options
that could meet the specified constraints and specifications.
What questions do you ask at the Design Process step? *** - How well do the design
options fit within the constraints of the design problem?
- How well might these design options perform in reality? Will they meet the
specifications?
What is the purpose of the Design Output step? *** Informs how you fabricate the
device for testing.
Requirement
[Definition] *** customer need which must be met
Specification
[Definition] *** technical description of how a given requirement will be satisfied.
Quality
[Definition] *** the totality of features and characteristics of a product or service that
bears on its ability to satisfy stated or implied needs.
Quality System
[Definition] *** organizational structure, responsibilities, procedures, processes, and
resources for implementing quality management.
Verification
[Definition] *** confirmation by examination and provision of evidence that specified
requirements have been fulfilled.
Validation
[Definition] *** confirmation by examination and provision of objective evidence that
the particular requirements for a specific intended use can be consistently fulfilled.
What question do you ask to see if a device is Verified? *** "Does the device meet
specifications?"
What question do you ask to see if a device is Validated? *** "Does the specification
satisfy the requirement and meet the user's need?"
, User Needs inform the _____ _____.
[2 Words] *** design inputs
What questions do you ask at the User Needs step? *** - Who are your users?
- What do your users want you to design?
- What are the overarching design goals?
Design Input - Constraint
[Definition] *** a limit or restriction on the design's behaviors or attributes.
Design Input - Function
[Definition] *** a specific thing a designed device or system is expected to do.
Design Input - Specification
[Definition] *** a scale on which the achievement of a design's functions can be
measured.
What happens in the Design Process step? *** You consider multiple design options
that could meet the specified constraints and specifications.
What questions do you ask at the Design Process step? *** - How well do the design
options fit within the constraints of the design problem?
- How well might these design options perform in reality? Will they meet the
specifications?
What is the purpose of the Design Output step? *** Informs how you fabricate the
device for testing.
