Kellia N Hicks

FDA auditor Kellia N. Hicks often emphasizes process controls, procedures for complaint handling, and employee training. She is meticulous in ensuring that sufficient controls are established for process variability and she pays close attention to the establishment of quality control units. Her history shows a keen interest in the implementation of aseptic procedures, adequacy of design controls, and vigorous review of discrepancies. She has also been known to stress the importance of adequate laboratory control procedures, design controls and statistical techniques for process capability.

Hicks is rigorous on process control and design controls. She strongly advocates for the establishment of robust procedures for handling complaints and thorough review of discrepancies. Employee training is another aspect that she scrutinizes heavily.