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Knowledge and Risk

Buddha said: "it is difficult to be thorough in learning and exhaustive in investigation".

He was referring, of course, to the arduous path of spiritual growth, but it is interesting to have these words resonate when contemplating on the Learning and Investigation we do all the time, in Science and Technology....


Happy September 1st to all schoolchildren and their parents!

The infinite continuum of Knowledge Management and Risk Management are elegantly presented in this ISPE publication and the associated Good Practice Guide.


Knowledge is becoming abundant at an exponential pace.


Science and Technology are producing enormous amounts of knowledge, to the point we must step up our knowledge management practices if we want to stay on top of it.


Risk was always there, but as we gain more knowledge we can better assess it: how likely it is to occur, what would be the impact, and most importantly- how to prevent it in the future (and at what cost)?


The more you know, the better you can manage your risks- so simple... so true....


We oftentimes lose opportunities to be thorough in learning, because it is difficult.

Learning in Pharmaceutical Development is not different- the experiments we run cost Millions and sometimes take many years to conclude- like Clinical trials and Manufacturing Process development. The enormous amounts of data they generate are oftentimes noisy and difficult to interpret (correctly). It is for our limited capacities as individuals, that we become experts in specific niches, creating “knowledge silos” which are very hard for others in the team to peek into, not to mention individuals can one day decide to leave….


Companies must draw a line and make just the right amount of investment in learning, because resources are limited by definition, and thoroughness can cost the life of a project. So Knowledge Management is becoming a must-have.


For the same reasons it is difficult to be exhaustive in Investigation.


When risks materialize (and they do)- we focus on the immediate Drama and oftentimes must move on soon after, never fully ceasing the opportunity to identify the root cause that emerged.


Having an investigation conclude with “Human error” is the single most depressing outcome, because human errors are the most obvious to notice, and the most difficult to prevent. But if we look deeper, and find the REAL root cause that enabled the human to make the error in the first place, this is when our investigation was thorough, and we have grown out of this crisis smarter.


So the infinite cycle of learning and investigation goes on over the generations, and in spite of all constraints, Humanity grows along with it…


https://ispe.org/pharmaceutical-engineering/ispeak/exploring-risk-knowledge-infinity-cycle-rki-cycle-across-product.

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