As I was re-reading MHRA’s GXP guide for data integrity several weeks ago, the concept of “right environment” outlined in section 5 caused me to pause and think; and I have been pondering the significance of this idea ever since.
I have always had the belief that Quality Culture and Data Integrity are intrinsically connected; one cannot exist without the other. With that said, how can we facilitate this connection, essentially making it “doable” in real life? I think MHRA provides an important part of the solution with their idea of “right environment”.
Most of the historical terminology in this space has focused on the idea of “Quality Culture”. But what does this actually mean, and how can we achieve whatever it is in large organizations?
[NOTE: The author of this article, Peter Baker, was previously named FDA Investigator of the Year for his work uncovering serious breaches in data integrity. Learn more about his inspection history here!]
During my time as an investigator, I found the companies with strong Quality Units took a long-term approach to corrective actions.
Let’s consider for a moment a real-life example we are all familiar with in the GMP world. Big-time corrective actions (e.g. complex CAPAs) are not realistically achieved through massive organizational changes rolled out the day before the due date, but rather through incremental smaller actions based on realistic timelines. This is well understood in companies with mature quality systems based on decades of trial and error.
During my time as an investigator, I found the companies with strong Quality Units took a long-term approach to corrective actions. For example, I found that the most effective data integrity programs were rolled out incrementally with a risk-based approach based on the universal reality of limited resources – essentially doing the best we can with what we have.
Implementing Corrective Actions
Implementing immediate corrective actions in high-risk areas, followed by regular re-evaluations and the rolling out of additional controls on a periodic basis were found to be, in my experience, highly effective.
I found that companies who failed to implement incremental corrective actions based on employee- and/or product-focused concepts were prone to breaches in data integrity.
This approach avoids overwhelming employees with hundreds of actions (not properly ranked by risk to product quality) to be completed by the unrealistic due date. The end result of such a front-loaded approach is a flat tire, and often a significant quality system breakdown due to employees feeling immense pressure to achieve unrealistic timelines.
As an investigator, I found that companies who failed to implement incremental corrective actions based on employee- and/or product-focused concepts were prone to breaches in data integrity. In my experience, once a certain level of management pressure is exerted on front-line employees, shortcut actions begin to manifest themselves outside of the quality system, making them rather difficult to detect through normal means, and can spread quickly and effectively throughout the company.
The Regulator’s Guide
Have you facilitated the “right environment” for success and data integrity assurance by implementing small scale realistic improvements for the people and processes directly within your control?
As we progress now into a future where the regulator begins to evaluate the maturity of our Quality Culture, signaled through recent data integrity guidance, we should reflect on lessons already learned: namely, is this same concept of incremental realistic achievements in our quest to address complex CAPAs not also true for big-time organizational changes such as Quality Culture improvement initiatives? Based on MHRA’s own experience as a regulator, it appears that they have found this to be true and have provided several simple real-world examples for us to follow.
Take a moment to reflect on the people and processes you are responsible for: have you facilitated the “right environment” for success and data integrity assurance by implementing small scale realistic improvements for the people and processes directly within your control? If not, MHRA provides some simple solutions in section 5 of their guidance that can be considered!
[NOTE: Get insight on one of the most renowned FDA Investigator’s enforcement actions. Download Peter Baker’s InspectorProfile here!]
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