QA Compliance Projects as a 3-Ring Circus

I find the typical approach to managing massive pharma compliance projects quite fascinating, particularly when it comes to problems that require a fundamental makeover. It reminds me of a three-ring circus.

In the middle ring, management immediately starts to tackle the problem by doing what it does best: establishing layers of bureaucracy. The multiple layers of overseers with increased distance between the operation and the executive suite, which guarantees senior management complete insulation of from reality. No one knows who makes final decisions, and project teams are left befuddled at best.

Then, in the left ring, come along the project managers who are foisted into the process to do what they do best: thinking the work is just like the last capital project or new product launch. Teams are left scratching their heads when asked by project managers to estimate how long each detail will take to complete–without resources. When teams uncover a new compliance problem, they are told it is out of scope and not in the timeline. Teams are serially called to explain their situation to each level of overseers whose technical understanding does not exceed beyond the colors of red, yellow and green project scorecards.

Convinced that teams are floundering, into the right ring come the Operations Excellence gurus, to do what they do best: bring in the brown paper and 3M sticky notes to lead a Kaizen event to deliver results in five days. Proud of their non-pharma experience, they rescue the project for the sake of the “customer.” Teams pinch themselves to wake up from the surreal experience where not once are mentioned regulations, guidance documents, industry standards, the root cause of the problem–or resources.

Like a three ring circus, something captures your attention everywhere you look. Activity abounds: planning the impossible; reporting the predictable; explaining the obvious. Lives are filled with administration giving the illusion that real work is getting done.

What is needed?

Leadership is needed, not bureaucratic oversight.
Quality system architects are needed, not work breakdown schedulers.
Degreed and experienced scientists, process engineers and technologists are needed, not faux quality practitioners.

But, that’s just me.

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republished and adapted with permission from The QA Pharm

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