Asking all stakeholders to identify potential risks is quite important. As said before, different stakeholders from different parts of the stream offer varying perspectives of the industry. While it’s important to include all potential stakeholders from the start, it is also very important to continue the conversation about risk throughout the life of the project. Just because a FMECA (pFMECA,dFMECA, etc) is done at a certain point does not mean that every single risk has been taken into account. It is completely possible for a risk to slip through, and often times it is that which turns into a non-conformance or CAPA. Therefore in order to mitigate this, continuing conversations about risk is important in order to capture the full breadth of it. A time this happened was in a design change project to change the on label shelf life of a product. The main risks were thought to have been determined, however when we continued to talk about the project, more and more risks were identified. The biggest one was identified only more recently: reducing the on label shelf life may trigger the risk of having a massive recall of product that has the old shelf life on it (this is major!). It was only because we were continuing the conversation on risk that we were able to identify this. Had we not done so, it may have been identified at a time where it would hurt us a lot more.