We frequently ask or hear others ask that question. Root cause analysis  (RCA) is an old subject and is familiar to many people. You might assume quality professionals would have a clear understanding of this technique.

For everyone involved, FDA inspections are time-consuming and labor-intensive processes, but they needn?t be frustrating or mysterious if a company has prepared properly. The most important preparation is complying with the pertinent laws and regulations, including developing safe and effective products and implementing an effective quality system.

When FDA inspects a device facility, it is natural for the staff to be concerned and more than apprehensive. This is to be expected when the outcome can result in loss of stock value, income or personal advancement. However, when an auditor arrives, the reaction is the same.