Saturday, January 1, 2011

Fire Fighting Pharma


I am convinced that there is an element in some pharmaceutical companies that enjoys the adrenaline rush of a crisis. These are the people who descend upon problems and save the day through sheer grit and determination. They work late and weekends to pull the proverbial baby out of the fire.  They are known as having a “can do” attitude, and nothing gets in their way to get the job done. This is their life day-after-day. They receive great praise for their selfless commitment to the company by doing whatever it takes to fix a situation, and to (typically) muscle the batch of product out the door.

But have you ever noticed that they are the last people on earth who are interested in being involved in preventing the chaos in the first place? No, because they thrive on chaos. What’s worse is that these people get promoted further cementing the fire-fighting culture in place.

Meanwhile, there are the unsung heroes who go through their normal day changing batteries in the smoke detectors, checking to see that fire extinguishers have sufficient pressure, and generally making sure that the wiring meets code and that the circuits are not overloaded. In other words, devoting their attention to whatever will prevent a crisis.

How boring. There is no glory in that.

Has fire fighting become the norm? The chaotic environment is like Brownian movement where work is accomplished by the random collision of activities. To finish quicker—just turn up the heat on the already crazy atmosphere.

Prospective employees are screened on their ability to work in a chaotic, volatile environment where priorities shift daily and their planning horizon is barely a day ahead. They’re told they must possess the ability to “go with the flow” and multitask, and any personal projects or assignments will need to be done before or after normal working hours and on weekends. The politically correct term “nimble” is used to wrap the craziness in a progressive business buzzword.

Now…think about this from a patient’s perspective. Is this where you would want your life-saving drug manufactured?

I think not. There’s a regulatory expression for this: out of control.

Give me the boringly predictable—the consistent, sameness, no surprises, no daily fire alarms. But, for starters, that would take leadership with technical skills who know their way around the shop floor.

I have a vintage Coca-Cola advertisement that shows bottles of uniformly sized and filled bottles streaming off the line. The text reads: “Continuous Quality is Quality You Can Trust.” That is so true.

Predictability breeds confidence.
I wish you an operationally boring 2011.

John Snyder
The QA Pharm

The QA Pharm is a service of John Snyder & Company, Inc.

John Snyder & Company, Inc., provides consulting services to companies regulated by the Food and Drug Administration. We help our clients to build an effective Quality Management System to enable reliable supply of quality products to their patients. We also help our clients to develop corrective action plans to address regulatory compliance observations and communication strategies to protect against accelerated enforcement action.


Contact us at john@john-snyder.com.

No comments:

Post a Comment