Building a Quality Management System in a Core Facility: A Genomics Core Case Study.

Core facilities are key resources supporting the academic research enterprise, providing access to innovative and essential technologies and expertise. Given the constraints placed on core facilities as recharge centers and the ever-changing research environment, an important competitive differentiator that can support rigorous and reproducible approaches in core labs is the implementation of a quality management system (QMS). This paper describes a systematic approach to building a QMS in a genomics core facility at the University of North Carolina School of Medicine. This model is based on principles of the International Organization for Standardization 9001 system with initiatives focused on process mapping, training (communication, customer service, performance management, development of standard operating procedures, and quality audits), root cause analysis, visual control boards, mock quality audits, and continuous improvement through metrics tracking and "voice of the customer" exercises. The goal of this paper is to share practical step-by-step recommendations and outcomes of this core facility QMS that are generally applicable to academic core facilities, regardless of technical focus. Application of these good laboratory practice principles will foster "competitiveness through compliance" and promote outstanding interdisciplinary research between academic cores and their nonacademic pharmaceutical and federal research partners. Additionally, implementation of the QMS qualified this core to apply for federally funded contracts, thereby diversifying its types of projects and sources of revenue.