ABSTRACT
Process management relies on statistics to assist shop-floor personnel when they encounter unexpected events and situations. Closely related to statistics is the concept of decision boundaries. Decision boundaries define the edges of process performance on either side of the point of central tendency of the data set. One of the unintended consequences of moving away from principle-based process design, as described by the Artisan Model, is the reliance on statistics to determine the priority and strategy of process management and subsequent improvement programmes. However, in the pharmaceutical industry an added legal and regulatory burden of intent must be considered. It is intent that makes mutual understanding and knowledge critical for the successful use of statistics. Intent includes both scientific veracity and evidence of safety and efficacy. Data rationalization through the use of statistics can often have negative effects on the ability to manage a process within the intent of the law.
