Table 1.

Common audit findings and corrective actions.

Audit finding	Potential corrective actions
Lack of reagent bridging SOP	Develop SOP for parallel testing to ensure that all reagents used in kits perform equivalently across rounds
Lack of/inconsistent assay training	Develop SOP for training new employees and employees that have taken an extended absence Develop training matrix stating required SOPs
No internal competency testing	Develop program to assess each operator's ability to perform an assay
Lack of equipment SOPs	Develop common practices for using equipment, calibration schedules and preventative maintenance