Risk management historical development

Taking into account all marketing and development failures, cost calculations demonstrate that companies have to develop more blockbuster products with annual sales over US 1 billion if they are to maintain historical rates of returns to shareholders, or they must cut significantly the development costs. Thus, the focus of management is increasingly on the high costs of Phase III programmes, and there is a need to reduce risks and costs in Phase III by ... 

Animals are treated routinely with antibiotics to prevent, treat, or control disease. Even under the best conditions of agricultural management, crowding and stress can lead to disease. While historically there have also been non-therapeutic uses of antibiotics, typically as production tools to improve endpoints such as feed efficiency and weight gain, there is a call to diminish these uses worldwide, and concern for the development of resistance to antibiotics used in human medicine as a result of their use in animal agriculture has led to international efforts to evaluate that risk. The results of the therapeutic uses are healthy animals that contribute to a healthful and plentiful food supply. 

Historically, employees in the company would have focused on who would require the service, who would pay the costs, what the impact of a failure to solve the problem would be, if the customer would appreciate the effort, and so on—all risks associated with taking this action. But RBL was implementing total quality management (TQM). Within this context, the decision to lead development of a solution was easy. Since customer satisfaction was important, RBL offered to solve the problem and believed that its superior processes were capable of managing the execution. 

During the concept phase, historical data and technical forecasts are developed as a base for a system hazard analysis. A Preliminary Hazard Analysis (PHA) is conducted during this phase. At the gross level, a Risk Analysis (RA) is performed to ascertain the need for hazard control and to develop system-safety criteria. Safety management will be doing the initial work on the System Safety Program Plan (SSPP). Three basic questions must be answered by the time the concept phase is completed ... 

---