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0:00
Hello everyone, this
is Jyoti Baweja.
I'm a toxicologist, a certified Good
Laboratory Practice Professional
from India with
an experience of
around 23 years.
I'm a GLP Consultant,
Auditor as well as a Trainer on
OECD series on
principles of GLP.
I'm also a member of the
Society of Quality
Assurance, United States.
Today I will be talking about
a very crucial topic which is
Implementing a Risk-Based Approach in Good
Laboratory Practice Quality Assurance Program.
0:36
Let's start with the agenda
for today's session.
It will be all about
the three Ws and
one H approach for
risk management and
quality assurance program.
To begin with, what is risk?
What is risk management?
Why do we need to implement
a risk based approach in
quality assurance program?
Who is responsible for
implementing this approach?
Lastly, how are we actually
going to implement it?
Which means, what should
be the entire process
for the implementation
of a risk-based approach
in a quality assurance program?
1:12
What is risk? According to
OECD document number 23,
risk may be defined as
a combination of the
probability of issues or
problems occurring, the
ability to detect them,
and the impact these
risks may have on
the integrity and quality
of data generated,
and on the overall GLP
compliance of the test facility,
the studies conducted
and the systems used.
The keywords here, which we need
to remember, are probability,
detectability, and impact.
By probability, we mean
what is the likelihood
that a particular activity
or process might go wrong?
Now, it can be determined
by considering
the implemented controls
at the test facility,
the personal knowledge, and
the experience of the
activity or process.
Next, we have detectability.
Detectability here
means how likely
is it that any issue or
problem will be detected?
In this case, it is
important to remember that
the detection must occur
before the consequence
of the risk,
or before the failure
state actually occurs.
The third keyword here
is impact or severity.
Which means how severe
will the consequences be,
if that particular risk,
issue, or problem occurs?
