Lynn D. Torbeck

No plant manager wants to hear the words, "Your process is out-of-control." The process was probably designed, developed, nursed, nurtured, fine-tuned, tested, and coddled until it met the definition of a validated process (1). Now, someone who was never involved in process development declares it is as OOC. Not a welcome message and it begs the question, "out-of-control for what?" Modifiers and definitions are needed.

There are several ways that the process can be described as OOC. There could be equipment failures or changes in the raw materials used. The process could be financially OOC (i.e., losing money), or out-of-regulatory-control with cGMP violations. Perhaps the operators are creating excessive deviations and confusion by not following the standard operating procedures because of a dysfunctional work culture; managerial malfeasance has resulted in the demise of several companies in the past. If we say it is OOC, we are obligated to specify how.

This event precipitates a cascade of activity as described in the OOS guidance. This has been discussed extensively for years and is well understood by the industry.