Quality Core Tools I
Week – 6: APQP - Product and Process
Validation Phase & Feedback, Assessment and
Corrective Actions Phase
A.
Validation vs. Verification- Intro Material
Prepared By: Prof. Rafat Tahboosh
A. Validation vs. Verification – Intro Material
Lesson Outline
1.
Product Verification
2.
Product Validation
3.
Validation vs. Verification and Examples
Lesson Objectives
1. Define the validation and the verification activities along with
their differences and applications
2
1. Product Verification

Product Verification is a confirmation, through the provision of
objective evidence, that specified requirements have been
fulfilled (ISO 9000, 2015).

The objective evidence needed for a verification can be the
result of an inspection
or of other forms of determination
such as performing alternative calculations or reviewing
documents.
3
1. Product Verification 2
The activities carried
out for verification
are sometimes called
a qualification
process
The word “Verified”
is used to designate
the corresponding
status.
4
2. Product Validation

Product validation is a confirmation, through the
provision
of
objective
evidence,
that
the
requirements for a specific intended use or
application have been fulfilled (ISO 9000, 2015).

The objective evidence needed for a validation is
the result of a test or other form of determination
such as performing alternative calculations or
reviewing documents.
5
2. Product Verification

The word “validated” is used to designate the
corresponding status.

The use conditions for validation can be real or
simulated.
6
3. Verification vs. Validation and Examples

Some of the known verification methods are:

Inspection

Testing

Demonstration

Analysis

Example: Q.C activities of a pharmaceutical drug to confirm the assay and
other material components
7
3. Verification vs. Validation and Examples 2

Validation Methods:

Different methods to confirm for a specific intended use or application of
a product have been fulfilled.

Examples:

The testing trial of a drug on mouse

The testing of a drug or vaccine on volunteers
8
3. Verification vs. Validation Examples
17 Minutes
9
3. Verification Vs. Validation Audio Quiz
(Non-graded)

Based on the Validation and Verification (V&V) video/audio, please answer the
following questions:
(1)
What is Verification?
(2)
What is Validation?
(3)
Summarize the main difference between validation and verification?
(4)
Provide one example from the audio for a validation and verification activity?
(5)
Based on the definitions of (V&V), what do you think about UAT (User Acceptance
Testing)? Is it Verification or Validation?
15 Min.
10
References

Audiopedia. (2014, August 1). Verification and Validation [Video]. YouTube.
https://www.youtube.com/watch?v=vfw2R9BS46w

Ulrich, Karl T., Eppinger, Steve D., and Yang, Maria C., Product Design and Development. 6th
ed., McGraw-Hill Education, 2016.

ISO. (2015). ISO 9000:2015 Quality management systems - Fundamentals and vocabulary
11
THANK YOU
12