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.
A specific CQA was out of specification
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 out of specification. We’re talking either API concentration, impurities, appearance or any other. We’re going to keep that detail for ourselves for the sake of confidentiality.
It was challenging: the product wasn't making it to the commercial phase as the control strategy was not ensuring a consistent quality profile. To make things worse, PC had already invested a large amount of time and money investigating the root cause(s) for this behavior, an investment that yielded few results.
Finding the Root Cause
When ValGenesis 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 performing a gap assessment to the process and its control strategy. We have facilitated sessions to map out and characterize the risks. For that we used a set of Digital Risk Management tools such as ValGenesis 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 historical process data, we structured and performed a comprehensive analysis, and put together a risk analysis that identified the failures in the control strategy and created an action plan with preventive and corrective actions to mitigate the identified new risks.
Beyond Fixing the Problem
Besides the implementation of a standardized root cause investigation workflow, we have 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.