Page 240 - Safety Risk Management for Medical Devices
P. 240
CHAPTER 30
Risk Management Process Metrics
Abstract
Process metrics are interesting to many businesses, and the risk management process is no excep-
tion. But how does one measure the performance of a risk management process?
Keywords: Process metrics; risk management process
Process metrics are interesting to many businesses, and the risk management process is
no exception. But how does one measure the performance of a risk management
process?
If a project was successful, met its objectives, had no questions/findings from the
Regulatory bodies, and the product is performing safely in the market, is that a sign
that the risk management process was successful? Or, could it be just good luck? The
problem with measuring risk management is that when risk management is successful,
the product gets approved smoothly and no one gets injured. No drama at all!
So, how do we go about measuring the effectiveness and success of a risk manage-
ment process? What do we measure? How do we measure it? And, if we were able to
measure “it,” what is considered good, and what’s bad? What is the criteria for
goodness?
There is currently no consensus on how to measure the goodness of a risk
management process. But in the subsections below, we offer three options for
consideration.
30.1 COMPARISON WITH HISTORICAL PROJECTS
If a company has produced and commercialized a significant number of medical
products, and has collected data about each product on how smoothly the product
was approved, and whether it was the subject of any field corrective actions, then the
company could potentially create a benchmark from a composite of the performance
of the previous products. With this benchmark, risk management process on a new
product could be measured.
The problem with this method is that it is a lagging indicator. It can only indicate
whether the risk management for a project met expectations, perhaps years after all is
said and done.
Safety Risk Management for Medical Devices r 2018 Elsevier Ltd.
DOI: https://doi.org/10.1016/B978-0-12-813098-8.00030-1 All rights reserved. 219
