Risk priority number scores and criticality analysis are frequently used to quantify risks for users, designs, and processes. However, these traditional failure mode and effects analysis (FMEA) techniques often fail to fully document risks associated with contamination. To complement FMEA, consider borrowing a risk-management technique from the food industry.
For medical device manufacturers, and FDA/ISO-registered facilities, the integrity of quality systems is critical. Ensuring the quality system is suitable, efficient, and effective for business needs and customers is a key focus.