Hacking GMPs: Deliberate Attacks or Accidental Workarounds?

FEATURED ARTICLE in GXP LIFELINE JUNE, 2017

Abstract:

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”. It’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.

Who is Author, Vivian Bringslimark?

(c) HPIS Consulting, Inc.