Fork in the Road


Excepting in the presence of active research in a pure science, the applications of the science tend to drop into a deadly rut of unthinking routine, incapable of progress beyond a limited range predetermined by accomplishments of pure science, and are in constant danger of falling into the hands of people who do not really understand the tools that they are working with and who are out of touch with those that do…

Harold Hotelling, Memorandum to the Government of India, 24 February 1940

That is the predicament I found myself in.

I was hired to support the company’s efforts to validate their processes in preparation for registering their manufacturing facility with the FDA. The FDA defines process validation as:

…establishing by objective evidence that a process consistently produces a result or product meeting its predetermined specifications.

— 21CFR820.3(z)(1)

While the definition is succinct, process validation is not a trivial task. And, contrary to the belief of management that is not literate in the quality system regulations or the subject of quality assurance, it is certainly not something you can “whip out”. It requires an understanding of the process in question – its key inputs and the key attributes of its output – coupled with an understanding of statistical principles such as the design of experiments (DOE) and analysis of variance (ANOVA) necessary to generate the objective evidence that will establish for the company and the FDA that the “process consistently produces a result meeting its predetermined specifications”. And, it also helps to have a proper plan that allows management to identify and allocate the resources required to successfully meet its objectives. At a minimum, a basic project plan should include a detailed checklist of actions items with clearly defined owners and due dates.

But, when management does not understand or trivializes these requirements, it makes decisions that endanger the best interests of the company. Unnecessary risk is assumed. Resources are wasted. Workers are put in a chaotic situation that is the primary source of much of their frustration and fear. So it should not be a surprise when “new” action items “pop up” in crunch time; when there is confusion around the ownership of a task, or when deadlines are missed and missed again causing tensions to flare. And, while these gaffes in project management might be overcome through working harder (translated as management by proclamation – “because I said so” – and long hours), there is no hope to compensate for poorly designed experiments with insufficiently identified process parameters through brute force. Without the right data there is no way to show the process’s capability or even that it is in statistical control.

So there it is – a fork in the road. A choice that we are all confronted with more often than we would like: follow the whack-a-mole tactics of a management team without a strategy or as Dr. Hotelling put it “people who do not really understand the tools that they are working with and who are out of touch with those that do”, or make a swift exit to focus on developing your personal knowledge and skills while searching for a better opportunity. As scary as it seems, the latter choice will always lead to a better outcome. At least that has been my experience.

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