Critical
thinking is a key element of the new paradigm to keep our working standards
higher than the expectations. It is
essential towards successful management of growth & progress of an
organization.
Working
in a Healthcare industry is not a Piece of Cake. With time the expectations & working conditions
have changed significantly. We are
growing at a very fast pace. For
example, Indian pharmaceuticals market has grown at a Compound annual growth
rate (CAGR) of 17.46 per cent during
2005-16, with the market growth from US$ 6 billion in 2005 to US$ 36.7 billion
in 2016 and is expected to expand to US$ 55 billion by 2020.
Therefore,
regardless of the colossal potential growth, sustenance will be a big challenge
for everyone in view of the expectations by 2020. It doesn’t differ for a small scale &/or
a multinational company. Working with
the highest values is the demand of time.
Time requires us to work SMART rather than just working hard, and Smart
working requires Critical thinking.
What
exactly is this Critical thinking?
Thinking
with a RISK based approach. Different
guidelines have been published on Risk Management. For instance, ICH-Q9 provides a very good
model for Analysis & management of risk.
What these models want us to do? Are these not the tools, which make us to forcibly
think with critical brainstorming?
This
approach is certainly helpful in changing the mind-sets in industry. Thought process in the industry is changing,
absence of a Risk based or critical thinking has led us to the unpredictable
situations.
How
can we survive the growing expectations of industry and the Regulatory
agencies? The requirement is everything that we must do to ensure the Quality,
Safety & Efficacy of the product.
To
assure this we follow Quality Management systems & conduct Trainings. These provide us a very strong platform to effectively
address any deviations, failures, changes around us and protect the Quality,
Safety & Efficacy of the product. But,
“What if we come across similar deviations repeatedly, What if the Root cause of
OOS & Failures is same at most of the occasion?”. It is a direct or indirect indication of our ability
to critically think & act.
Critical
thinking means – Risk driven thinking
& analysis of the situation. Fact is that we all are, – RISK
Driven. But we need to understand the Application of Risk analysis. We know risk, but we need to decide, to
what level it needs to be analysed & addressed, to keep it to minimum.
I
always share with the people that, cGMP is
nothing but the application of common sense.
But it should now be spiced up
with a Critical risk based thought process.
Purpose
of me writing this blog is to instigate a Risk based Critical thinking in
whatever we do to make our lives a lot easier.
In
future, I shall be sharing some mind provoking thoughts and articles on
Technical matters.
Thanks
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