Gravity and Quality Assurance

March 9, 2016 by Eric Good, Ph.D Director, Compliance Services 

On the Blog: ProPharma Group Director of Compliance Services, Eric Good, Ph.D, discusses the internal pressures facing Quality professionals in our industry.

As we’ve now moved on from another cold winter month, I was captivated recently thinking about Quality Assurance and our collective responsibilities. All kinds of things come to mind; Deviations, OOS, Complaints, Product Disposition and FDA Inspections. And certainly, don’t forget about other stressors like Metrics reporting, Product Approvals, Field Alerts and the like. As Regulated-Industry professionals, we all have tremendous responsibilities as part of our job descriptions. While we may all not “touch the product” or be “customer facing” in the end, it’s all about patient safety.

The fundamentals of patient safety are hard to remember when internal forces are pressing Quality to “ship it”, “release it”, or “get it out the door”. Knowing the business forces that drive our operations and the push for higher patient safety had me thinking and asking myself a question that other may have as well, “As a Quality professional, have I failed in some regard or another…?” I realize it’s a pretty broad question, but let me ask the question a little more pointedly, “As a QA professional, have you ever felt like a loser?” Did you ever miss a calculation? Was there ever a Field Alert, Recall, or Enforcement action taken for product YOU released? Hopefully not, but maybe. Here is what caused me to reflect so heavily during the month of January. In 1986, I was in a small town Colorado classroom watching the live feed of the Shuttle Challenger explosion. An epic tragedy.

What struck me in the years to follow was the investigation into the disaster, root cause analysis and after-action reporting that NASA conducted. Another figure stood out in the investigation. Roger Boisjoly was a booster rocket engineer for NASA contractor Morton Thiokol. Boisjoly predicted the failure due to the cold, ambient temperatures at the time of launch. He was overruled by management. The experience both haunted and inspired Boisjoly in the decades that followed the disaster. Although feeling like a failure he used the experience to speak to others as a means of healing. Since the Challenger explosion, Boisjoly has spoken to many groups about the pressure of ethical decision making. Credit is certainly due to a brave man with many sleepless nights.

There are some slight parallels when Quality Assurance professionals feel the gravity of Product Disposition and, ultimately, patient safety. We too have management pressures. We too have many data points and analyses to consider. The organization most likely puts the ultimate and ethical decision for release or rejection of product with the Quality Assurance Leader. Is this keeping you up at night?  ProPharma Group understands the pressure of those gravitational forces, and is here to help.


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