ABSTRACT
This chapter looks at some of the tools and techniques that can be used to carry out root cause analysis and examines how they can be used within the context of pharmaceutical process management. Brainstorming is a means by which collective experience is brought into the problem-solving process and is a way of generating large numbers of ideas rapidly. Problem-solving would first focus on factors other than temperature. The chapter provides an introduction to these tools and techniques and highlights the different facets of the toolbox rather than turn the reader into a master craftsman. Root cause analysis is an approach to problem-solving which leads to the identification of the true causes of a problem rather than addressing the obvious symptoms. A more quantitative approach to deciding which problem to address first can be obtained by using a Pareto chart, also known as the 80/20 rule.
