ABSTRACT
Establishing a timely root cause of process problems is at the heart of process management. Cause and effect is the pathway to effective root-cause analysis. The productive capacity of pharmaceutical companies exceeds the market demand for the finished drug product. Frequent laboratory OOS investigation is one of the most certain signals of a process out of control and testing product into compliance. The ability to effectively implement the process lies in the ability to understand the cause and effect of the quality control system. The ideas of cause and effect, as with the other process management tools, are fundamentally common sense. From the Artisan Model viewpoint, cause and effect should be readily obvious at the critical decision point. Deviations from process design will result in an accurate and timely cause and effect signal. For process management to be successful, theoretical foundations must be solid and experienced understanding must be used as a counterpoint of strategic discussion.
