QbDVision Blog

Last week, we saw how capturing uncertainty and detectability risk brings clarity and dimension while assessing risk when used appropriately. This week, we will look at the practical aspects of process risk assessments from a different lens: that of the people executing or using these tools.

Last week we explored how the concepts we’ve been discussing in our series line up with FMEA/FMECA methodologies. This week, we’ll explore the two impostors, uncertainty and detectability risk, a little bit further.

Last week we discussed how to use the concepts of ISO 14971 to create a generalized framework for risk management that works across pharma and is compatible with (and leverages the best parts from) medical devices. This week, we’re going to take that one step further. We will explore how these concepts line up with FMEA/FMECA methodologies.

Last week we defined a common structure and terms for process risk assessments. This was the first article in a series intended to rationalize and standardize the risk assessment discussion to communicate strategies that provide consistency, objectivity, and risk understanding.

This blog post series is intended to rationalize and standardize the risk assessment discussion to communicate strategies that provide consistency, objectivity, and risk understanding. Over the next few weeks, we’ll be sharing strategies and approaches that explain how to manage these situations.