Featured Product
This Week in Quality Digest Live
Health Care Features
Etienne Nichols
How to give yourself a little more space when things happen
Chris Bush
Penalties for noncompliance can be steep, so it’s essential to understand what’s required
Jennifer Chu
Findings point to faster way to find bacteria in food, water, and clinical samples
Smaller, less expensive, and portable MRI systems promise to expand healthcare delivery
Lindsey Walker
A CMMS provides better asset management, streamlined risk assessments, and improved emergency preparedness

More Features

Health Care News
Showcasing the latest in digital transformation for validation professionals in life sciences
An expansion of its medical-device cybersecurity solution as independent services to all health systems
Purchase combines goals and complementary capabilities
Better compliance, outbreak forecasting, and prediction of pathogens such as listeria or salmonella
Links ZEISS research and capabilities in automated, high-resolution 3D imaging and analysis
Creates one of the most comprehensive regulatory SaaS platforms for the industry
Resistant to high-pressure environments, and their 3/8-in. diameter size fits tight spaces
Easy, reliable leak testing with methylene blue
New medical product from Canon’s Video Sensing Division

More News

The QA Pharm

Health Care

If You Need a Burning Platform to Justify Change...

You must really like firefighting

Published: Tuesday, October 7, 2014 - 13:34

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

Go figure.

This becomes evident in our industry when some companies can’t part with a pittance of their billion-dollar profits to establish or ensure that an effective and sustainable quality management system (QMS) is in place—along with suitable facilities and sufficient staff levels. It’s really obvious when they’re at the heart of a devastating drug shortage problem.

The burning platform appears in the form of regulatory enforcement actions, 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 confidently knowing that a QMS is in place, it’s effective, and providing the data-driven evidence that you are operating in a state of control.

But that’s way too boring. It is far more exciting to emerge victorious from the daily firefights. The person who rescues the baby from a house fire will always get more recognition than the schmuck who goes around changing the batteries in the smoke detectors twice a year.

So the next time you hear someone say that there is no burning need to spend the money, invest the capital, or authorize the project, tell them it’s too late when the platform is already on fire. Make the case that a QMS and other quality/compliance projects are worthy investments to ensure 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 is too late for the patient.

Change the batteries.

First published Sept. 16, 2014, on The QA Pharm.


About The Author

The QA Pharm’s picture

The QA Pharm

The QA Pharm is a service of John Snyder & Co. Inc., provider of consulting services to FDA-regulated companies to build quality management systems and develop corrective actions that address regulatory compliance observations and communication strategies to protect against enforcement action. John E. Snyder worked at the lab bench, on the management board, and as an observer of the pharmaceutical industry for more than 30 years. His posts on The QA Pharm blog are straight talk about the challenges faced by company management and internal quality professionals. Synder is the author of Murder for Diversion (Jacob Blake Pharma Mystery Series Book 1).