Chapter 22 : Biological Safety Program Management

Abstract:

A biological safety program management system, following the process identified by ISO 14001, is an organized and documented approach to managing biosafety issues within an organization. This chapter describes six key steps to an effective management system. Hazard identification requires the organization to identify, evaluate, and prioritize, in a systematic manner, the full set of biological hazards associated with its activities, products, and services. The biosafety program must have a system to keep its analysis of hazards up-to-date. All legal constraints imposed on an organization to control its biological materials should be identified. These include federal, state (or provincial), and local laws and regulations, permits, registrations, orders, and consent decrees. Establishing objectives and targets requires taking the program policy and the results from the significance criteria assessment and establishing more specific goals with regard to biosafety. Communication from nonregulatory external parties should be handled in a consistent and responsive manner. A biosafety manual is the most common means used to capture written information (paper or electronic) that describes core elements of the biosafety program. Corrective and preventive action provides the framework for identifying and correcting problems in the overall system, keeping the program on track relative to its goals and objectives, and for investigating and addressing any nonconformance with the defined biosafety program. Establishing a formalized, documented biosafety program management system is not an easy task, but the benefits are well established.