Just Get Er Done – Get the Audit Observation Closed Already

HPISC. Resource Library

Content Area: Cause Analysis – Human Error

Item: Get Er Done Impact Story

Impact Story – Just Get Er Done

This impact story is about assuming that all you need to do is capture knowledge from Subject Matter Experts to upgrade operators’ skill sets.
The request was to design and implement a training and qualification program.
The problem was the client could not defend the effectiveness of their training “program” during an extensive FDA inspection.



Take Aways:

  • Brief explanation of the Human Performance Improvement Method in Use.
  • Learn what the biggest challenges were and what wasn’t working for this company.

Typical Requester:
This article appeals to a CAPA investigators who are charged with expediting audit observations to full closure and those QS specialists who are responsible for conducting effectiveness checks.

How Used: Requesters want to leverage the lessons learned and advise their management not to fall into the same predicament.



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