Instrument development and data analysis validation

Topic:
 Definition of Validation
 Elements of validation
 Types of validation

The concept of validation was first
proposed by two Food and Drug
Administration (FDA) officials, Ted Byers
and Bud Loftus, in the mid 1970s in order
to improve the quality of
pharmaceuticals.[2]

Process validation is establishing
documented evidence which provides a
high degree of assurance that a specific
process will consistently produced a
product meeting its predetermined
specifications and quality characteristics.

Validation:
 Validation is the process confirming that
it meets the user`s requirements.
 Validation is the process of determining
whether a fully developed system
conforms to its requirements specification.

Equipment validation:
installation qualification (IQ)
Operational qualification (OQ)
Process validation:
Performance qualification (PQ)

This is the first step in validation.
This protocol (set of rules) insures that the
system and its components are installed
correctly and to the original manufacturer`s
specifications.

This step proceeds after the IQ has
performed
In the OQ test are performed on the critical
parameters of the system/process. These
are usually the independent and/or
manipulated variables associated with the
systems.

This is the third and final phase of
validation.
This phase test the ability of the test to
perform over long period of time within
tolerance deemed acceptable.
PQ is performed on the process/system as
a whole, individual components of the
system are not tested individually.

 Content related evidence
 Criterion related evidence
 construct related evidence
Are there approaches to test validation.

o Content validation includes any validity strategies
that focus on the content of the test.
o Determine the adequacy of the sampling of the
content
o The content validation process provides a rigorous
(exact) scientific structure to help assure that the
judgments made to plan and develop tests are
appropriate.

Content validation method focus on
content relevance
content representation
• Content relevance is the scope to which the tasks of
test or assessment are relevant to the target domain.
• Content representation refers to the extent to which the
test items proportional to the facets (aspects) of the
domain.

 Criterion validation is a strategy that
uses statistical techniques to demonstrate
that an examinee’s performance on a test
(his/her test score) is predictive of their
actual job performance as measured by
some criterion

A criterion-related validation study can
be either predictive of later behavior or a
concurrent measure of behavior or
knowledge. Predictive validity refers to the
"power" or usefulness of test scores to
predict future performance

 The process of determining the extent to
which the tests performance of related to
some other valuable measure of
performance.

 Construct validation refers to how well a test or
tool measures the construct that it was designed
to measure
Construct validity is “the degree to which a test
measures what it claims, or purports (intention),
to be measuring.” In the classical model
of validity, construct validity is one of three
main types of validity evidence, alongside
content validity and criterion validity.

Instrument development and data analysis validation

More Related Content

What's hot (19)

Viewers also liked (9)

Similar to Instrument development and data analysis validation (20)

Recently uploaded (20)

Instrument development and data analysis validation