Thursday 17 September 2015

Hacking GMPs: Deliberate Attacks or Accidental Workarounds?

ads

Can't find the right lid for the barrel?  You might find 
a different lid that almost fits and use duct tape. But if 
you do, chances are you'll be hacking your GMPs.
by Vivian Bringslimark
President & Owner
HPIS Consulting, Inc.



The subtitle tells it all.  Most employees don’t come to work with the intention to cause harm, fail or make mistakes intentionally.  Yet mistakes, errors, and failures happen.  According to Sidney Dekker, author of The Field Guide to Understanding Human Error, “mismatches between written guidance and operational practice always exist”.  I’s due to “the amount of increasingly tight constraints of procedures” (p.8).  There have been some occasions where following a procedure could have caused a deviation if it weren’t for an astute technician who questioned the “GMP” rule.   Talk about a GMP dilemma, “always follow the SOP” but don’t create a deviation either.  Alas, we have a classic example of a white hat hacker.
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