This is a happy story. But it’s also confidential in some parts, which is why we changed names and a few details. But don’t worry, it’s quite faithful to what happened.
The CQA was off.
Our story starts somewhere in central Europe. Our main character is a large pharmaceutical company with several sites spread over the continent. We’ll call it PC (as in, Pharma Company).
PC was trying to bring a product to market, but things weren’t looking great.
One of their Critical Quality Attributes (CQAs) was off. We’re talking either pH, concentration, foreign particles, appearance or any other. We’re going to keep that detail for ourselves for the sake of anonymity.
It was tough: the product wasn’t making it to the commercial phase. To make things worse, PC had already invested a large amount of time and money searching the solution, an investment that yielded few results.
Finding the Root Cause.
When 4TE entered the project, there was already a lot of frustration and resources invested.
The question was: how were we going to succeed where so many others had failed?
We started by evaluating the gaps in the process. We facilitated sessions with their teams to map out and understand the risks. For that we used a set of Digital Risk Management tools such as iRISK™.
And we succeeded!
Well, we have been successful thus far in every End-to-End Root Cause Analysis we performed so it wasn’t entirely surprising, but still it was very gratifying.
In a nutshell, we gathered all the process data, we processed it, and put together a risk analysis that identified the failures in the control strategy.
Beyond fixing the problem.
Then we proposed a set of Corrective and Preventive Actions. And more than that, we proposed a set of digital tools that strengthened PC’s Quality Risk Management Program.
If this is a topic that interests you, we recommend you check our recent post: QRM over Lifecycle Management.