I just returned from IFPAC 2014 and will begin sharing some presentations with presenters’ consent, starting with mine. In the previous article I shared a typical scenario that a Risk Assessment facilitator may face.
If you tried a FMEA-based risk assessment for QbD, you will be familiar with the following story. Picture yourself and 4 scientists starting a meeting in a conference room at 4pm…
The 3 main reasons why FMEA-based approach is challenging is as below:
As discussed in the previous post, the 3 main reasons why FMEA is not the best way to conduct risk assessment for the R&D team.
1. Most attributes come out as “critical because FMEA’s Risk calculation is biased towards occurrence
2. Inappropriate ordinal scale
3. Mediocre Control Strategy
I began sharing these points at the IFPAC 2014 conference and received numerous “I’ve-been-there” nods and questions during the presentation. Many asked for the presentation file so here it is. In the upcoming posts, I will reveal the details, tips and a tool to conduct Risk Assessments for QbD with minimal resistance that will result in a better control strategy.
You can also download the Powerpoint File via Google Docs or Slideshare.
What is your best practice for Risk Assessment in the context of QbD?