The Laws of Thermodynamics don’t just apply to natural science. We see them every day, even in human interactions, in our daily battles against inertia and chaos, or as the geekier among us prefer to call it, entropy.
We don’t always win these battles, either within ourselves or our environments, but just making the effort ennobles our lives and our work.
An article soon to be published in the academic journal, Organization Science, examines entropy as it applies to pharmaceutical manufacturing—not its physical or chemical processes, but its “people”-oriented ones. Written by professors at the Universities of Illinois, Minnesota, and Ohio State, and based on analysis of FDA inspection data, the article hypothesizes that the entire foundation of drug manufacturing, adherence to well-documented routines (GMPs), will naturally decay to a state on chaos or entropy, unless “renewal” occurs regularly.
This renewal typically takes the form of an FDA inspection, or being acquired by a company with more stringent quality and operational codes.
Without going into the statistical methods and models used, the paper hypothesizes that the extent of failure to follow GMPs varies depending on facility or organization and the length of time since its last “renewal.”[pullquote]
In drug manufacturing, this slide into entropy occurs, the authors note, even though compliance to routines is legally required, even though FDA inspections will occur, and failure to comply can result in patient illness or worse. In fact, authors write, this slide is the rule rather than the exception.
Although this issue wasn’t studied in this particular report, one imagines that the degree of chaos can only increase when mission-critical operations are spread out among CMO’s, on and offshore. A law has just been proposed by Congress that would expand the old definition of “adulteration” to include the lack of a clearly articulated and implemented Quality Management Program.
Regulators serve as “entropy preventers,” but within any company, the only people who can prevent the inevitable slide into chaos, the researchers summarize, are senior managers who support internal renewal and reward processes that keep compliance in line.
Managers—such as those at one OTC pharma manufacturer who shall remain nameless and were nicknamed E-Z Pass—who chastise quality control staff for bringing up bad news and who focus on keeping the lines running at all costs only add to the overall entropy and increase the risk of tragedy occurring.
Authors noticed that the facilities with the best compliance records had senior managers who were engaged, who enforced routines as non-negotiable performance targets, even when faced with serious cost or delivery pressures, and who had internal renewal systems in place (i.e., internal compliance checks).
The authors acknowledge some limitations to their research and its conclusions, but the message is clear.
What they did not analyze was the impact of downsizing. Some of pharma’s recent decisions seem capricious—for instance, the gutting of well-established facilities in the U.K. and the construction of new ones in Ireland.
In California, unions are using hardball tactics to question one biopharma company’s basic rights to relocate and lay off staff, after the company had received tax and other incentives. Whatever its outcome, this move is unprecedented and represents an activism heretofore only seen in the IT and blue-collar work spheres.
Former pharma industry employee turned consultant Dan Hoffman asked some penetrating questions in an op-ed recently published on the Pharmalot blog: Has the downsizing trend left drug companies without the types of employees it needs?
“Many of the people remaining in operations deliberately choose not to ask big or important questions, lest their colleagues perceive any fundamental doubt as a threat. The truly adept manage to avoid taking a position on even the most mundane matters, lest someone else equate perceptive questions with disloyalty. Some even find it wise to feign ignorance of the various white elephants in various rooms.”
“If insight and experience can jeopardize earnings and raise liability exposure, the pharmas increasingly seek other qualities in their employees,” he goes on. “So, in the end, few people in senior and middle management want to make the sorts of changes pharma needs. Fewer still appear capable of doing so even if the inclination came upon them . . .”
Do the best lack all conviction at your facility? We doubt it, and we hope not. Write in and tell us how you are battling entropy and inertia. In the meantime, we promise to support you with information that can help you fight the good, and essential, fight.