July 6, 2004

Robert C. Menson, PhD

For manufacturers and users of in vitro diagnostics (IVDs), the process of risk management has a more urgent and direct objective than for many other industries practicing some form of risk evaluation. That’s because in the medical professions, and specifically the clinical laboratory, risk management, design control, and hazard analysis are integral components in reducing medical errors and enhancing patient safety

Traditional engineering analytic methodology is now being employed not only in manufacturing processes, but in clinical settings as well, with significant success. Analytic methodologies such as Failure Mode and Effects Analysis (FMEA) and Fault Tree Analysis (FTA) can be very effective in improving patient care and reducing health care costs. Software facilitation of both FMEA and RCA can greatly assist managers by offering the advantages of automation, standardization and lower training costs, while enhancing data collection and record keeping. This improves patient safety and reduces costs in healthcare delivery, through the optimization of processes and systems.

Join us as Robert Menson, PhD, principal of Menson & Associates, Inc. (Newport, R.I.), answers your questions concerning risk management in the clinical laboratory and shows how industrial risk-management tools can offer a disciplined environment for proactive decision making to

• continuously assess potential process failures (risks)
• determine which risks are important to deal with
• implement strategies to deal with those risks