From policy documents to product and part specifications, ineffective document control practices have the potential to wreak havoc on a company. Problems include:
• Receiving parts or products built to an out-of-date specification.
• Quality or safety incidents arising from lack of awareness or poor training.
• Scrambling during audits to come up with required process or specification documents.
It seems like one of the smaller details, but having a Document Control system integrated with your FDA compliance program is essential to keeping everything straight. Effective document control ensures you can do what you say, and say what you do.