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June 13, 2013 at 2:00 PM
Ensuring you have properly characterized the problem and assembled the right team are crucial steps in the CAPA process. Miss a critical player or overlook an important aspect and it could result in failure creating an analysis "black hole" that could prove to be very costly before you realize what has happened.
The situation must be properly evaluated to determine a sense of urgency and then the level of action required. You need to document specifically why the problem is a concern and what the impact to the company and/or customers may be.
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