The analysis of hazard is a routine subconscious process inherent to all sentient creatures. Subconscious risk assessment has likely evolved as a part of survival strategy; performed on a continuous basis to preserve and sustain the quality of existence. Understanding hazards and the evaluation of any potential harm are fundamental processes facilitating swift decision-making permitting the continuance of our state of health and survival. It should therefore be of no surprise that the concept of risk assessment is favored in the management of hazards and risk to product quality in pharmaceutical manufacture-assuring patient safety. In contrast to the swift, systematic, and inherent assessment of risk routinely performed by all sentient organisms, the wide spread implementation of rigorous risk assessment in pharmaceutical manufacture has been slow, fraught with interpretive difficulty and cumbersome. As with any newly pioneered process its gradual evolution is in addressing these shortfalls.