Gap Assessment and Remediation

•     Quality Management System improvement and compliance
•     Retrospective DHF construction
•     Business process and Quality System evaluation
•     Audit preparation

Case Studies

Performed CAPA system assessment, leading to improved process that removed ambiguity and inconsistency in decision making and prioritization. Mentored CAPA owners in root cause analysis and DMAIC-based project execution.

Results: Eliminated extensive CAPA backlog. Achieved full compliance with QMS procedures.

Conducted deep-dive assessment of acquired company’s quality system and product DHF for in-process PMA submission. Led prioritized remediation effort encompassing all design control elements. 

Results: Contained cost and regulatory risk for subsequent 18 months, resulting in PMA approval.