DECISION THEORY

Decision Theory

Decision Theory

The report presents and discusses results from 27 statistical analyses exploring how organisational practices impact various manufacturing performance metrics for facilities producing Active Pharmaceutical Ingredients (API) and facilities producing Oral, Topical, or Injectables (OTI). Our statistical analyses focus on those factors correlated with cycle time, yield performance, deviation management outcomes, product unavailability, and process development along with analyses that identify factors corresponding to changes in each one of these metrics. Thus, statistical analyses provide insight into the managerial, technical and organisational practices that correspond with improving various manufacturing and deviation management performance metrics as well as to achieving high performance in these metrics. G

Given the large number of statistical analyses and the even larger number of variables used in these analyses, we present here a qualitative assessment of all findings. We identify five findings that are generally consistent across these analyses.

We first find that the extent and use of Information Technology (IT) almost universally corresponds to achieving superior manufacturing performance metrics. By IT, we mean those investments that enable manufacturers to electronically and automatically report deviations; track deviations by lot, by type of issue, and people assigned to resolving the deviation; and the central storing of data to facilitate problem solving. OTI facilities that scored highly with respect to these investments had lower cycle times, reduced batches failed over time, greater product availability, lower equipment deviations and reduced raw material and component deviations over time. API facilities that scored highly with respect to these investments had lower cycle time, higher yield, lower raw material deviations, lower equipment deviations, and reduced equipment and process deviations over time(Lind, 2006).

Second, the locus of decision rights within the organisation matters, especially with respect to deviation management, lot failure, lot review, and process validation. Generally speaking, the closer these decision rights ...