Tuesday, September 16, 2014

If You Need a Burning Platform to Justify Change, You Must Like Firefighting

Often times pharma has a split personality. One personality loathes firefighting, and the other personality needs a burning platform to justify doing anything that requires spending money.

Go figure.

This becomes evident in our industry when some companies cannot part with a pittance of their multi-billion dollar profit to establish or ensure that an effective and sustainable Quality Management System (QMS) is in place--along with suitable facilities for intended use and sufficient staff levels.

This is really obvious when such companies are at the heart of the devastating drug shortage problem. The burning platform appears in the form of regulatory enforcement action, disgorgement and penalty fines, consumer stakeholder lawsuits, loss of goodwill from patient advocate groups, and a drop in stock price.

A burning platform you want? A burning platform you get.

But what about the patient? 

The patient deserves better. No company can claim to put the patient first without solidly and confidently knowing that an effective QMS is in place, in use, and providing the data-driven evidence that you are operating in a state of control. 

But that is way too boring. 

It is much more exciting to emerge victorious from the daily firefights. The person who rescues the baby will always get more recognition than the schmuck who goes around changing the batteries twice a year in the smoke detectors.

So the next time you hear someone say that there is no burning platform to motivate spending the money, investing the capital, or authorizing the project, tell them it is too late when the platform is on fire. Make the business case that the QMS and other worthwhile quality / compliance projects are an investment in ensuring a reliable supply of quality products to desperately needy patients. 

You will always spend more money at the most inconvenient time and under the most impossible timelines when you have to react to a crisis. Smart companies know how to anticipate a problem; not react when the damage is done.

Waiting for the platform to burn ends up scorching the patient.


The QA Pharm

The QA Pharm is a publication 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.


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