(470d) Analysis and Interpretation of a Process Risk Assessment
AIChE Annual Meeting
2014
2014 AIChE Annual Meeting
Process Development Division
Reducing Risk during Technology Transfer
Wednesday, November 19, 2014 - 10:00am to 10:30am
A case study will be presented on a late stage quality risk assessment carried out on a manufacturing process using Failure Mode and Effects Analysis (FMEA). The case study will focus on demonstrating methods and techniques that can be used to analyze the results of a risk assessment to extract the most learnings and value from the exercise. In particular, categorization of risk reduction actions and data visualization are leveraged to better understand the current risk associated with a process and determine the level of risk that may need to be accepted moving forwards. The outcome is a comprehensive framework for making process changes geared towards reducing risk on scale up.