FW: [Histonet] Help!

[Owen, Michael P]

From: Owen, Michael P 
Sent: Friday, May 12, 2006 3:35 PM
To: 'Histo Lady'
Subject: RE: [Histonet] Help!

Dear Histo Lady,

The best approach to take is to apply CAPA testing to the situation.
Determine the problem, create a corrective action then implement preventive
action.

My colleagues target CAPA files for critical reviews in biomedical firms
during inspections as most members of this list know. Sadly, my colleagues
are slow to applying this concept to their own work. :o)

The employee may not be the problem, instead you may have a system that
needs adjustment to work smarter and not harder.

Good luck in your investigation.


Michael P. Owen, Regulatory Microbiologist
U.S. FDA Pacific Regional Lab Northwest
22201 23rd Drive SE  Bothell, WA 98021-4421
Phone: 425-483-4865     E-Mail: michael.owen <@t> fda.hhs.gov