Risk Assessment: Why FMEA Fails [Download]
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?
Please share!
Here’s a followup article to this Problem.