Sunday, September 04, 2005

Risk Management

Okay, I just hit CNN again, and here's another one to think about.

I work for a pharmaceutical company. We export our API's and intermediates to the US as well. The American FDA requires us to follow certain guidelines in quality control and quality assurance. This is true, even for computer systems. In the past 10 years, a term called "Risk Based Approach" has been all the buzz in the industry. Meaning, whenever you verify a process for its quality, you assess its risk. How do you assess risk? You assume the worst possible case and plan for it. In our field that means, a computer system influences a production process in a way that the product gets adulterated and is delivered to customers, who then take it as part of a medication - and die. That's the worst case. We always assume that. We do it so that American (and, no mistake, European, Asian, African whatever) patients are safe. We (partly) do it, because American regulations ask us to do so.

Back to Katrina.

Homeland Security Secretary Michael Chertoff says "planners did not predict such a disaster ever could occur."

Read it again, it's juicy.

But there's more. Let me quote (without permission) from the CNN report:

[...] Also on Sunday, Placquemines Parish Sheriff Jeff Hingle referred back to Hurricane Betsy -- a Category 2 hurricane that struck in 1965 -- and said, "After Betsy these levees were designed for a Category 3."
He added, "These levees will not hold the water back."
But Chertoff seemed unaware of all the warnings. [...]
(http://edition.cnn.com/2005/US/09/03/katrina.chertoff/index.html)

So, for medications, there are worst cases. For possible terrorist attacks, there are worst cases (e.g. nuclear weapons imported into the US with malicious intent). Hell, they've got contingency plans for locust invasions!!

And they're trying to tell us, there was no prediction that such a disaster might occur? Even after Category 5 hurricanes have been spotted over and over again?

Come on!

Can they really be serious? Or is it all just part of the big charade they call "government"?

This (again, as so often) brings a line from an old Monthy Python song to my mind.

"Pray that there's intelligent life, somewhere up in space, cause there's bugger all down here on Earth!"

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