Monday, 23 November 2009

Gxp audits

When meeting with auditors, a technician should remain calm but mentally alert. A technician must remember that he or she knows what is done in a process/test etc, and how it is done. Though the tendency is to direct auditors toward paperwork and procedures, if they aren't familiar with one's particular plant or site in general, they may well like to get a feel for how tasks are actually performed.

It's very important for a technician to not allow day to day tasks to fluster themselves, and display poor courtesy toward an auditor. I've come across rushed and almost rude with auditors in the past, which sets a bad mood and paves the way for more findings. Such lessons are quickly learnt.

A technician is not an expert, despite training and education he or she might have. The answer to a why question is little more than 'because it works' in the mind of the technician. More advanced questioning beyond the what and how should be referred to those paid to live and breathe such experience and knowledge.

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