Page 196 - Safety Risk Management for Medical Devices

CHAPTER 20

Risk Assessment and Control Table

Abstract
Every risk management process typically brings the results of the hazards analyses, risk estimations,
and risk evaluation into a table. This is usually a large table and is called by many names. Examples:
risk matrix, risk table, risk chart, product risk assessment, and risk analysis chart. The RACT tells the
story of how each System Hazard manifests itself, what causes it, how exposure to that Hazard hap-
pens, and what Harms could ensue. The RACT also captures the Risk Control option analysis. That is,
it shows what Risk Control options were considered and implemented. Additionally, the RACT com-
putes the risks, both individual risks and overall System risk.
Keywords: Risk Assessment and Control Table; Risk Control option analysis; risk evaluation; RACT;
residual risks

Every risk management process typically brings the results of the hazards analyses, risk
estimations, and risk evaluation into a table. This is usually a large table and is called by
many names. Examples: risk matrix, risk table, risk chart, product risk assessment, and
risk analysis chart. The BXM method calls this table the Risk Assessment and Control
Table (RACT). You can find a template for the RACT in Appendix B—Templates.
The RACT is a tool of risk management that integrates the results of all the
analyses performed at lower levels of the System and enables the computation of resid-
ual risks for the System. The RACT tells the story of how each System Hazard mani-
fests itself, what causes it, how exposure to that Hazard happens, and what Harms
could ensue. The RACT also captures the Risk Control option analysis. That is, it
shows what Risk Control options were considered and implemented. Additionally,
the RACT computes the risks, both individual risks and overall System risk. The
RACT can also evaluate the risks by comparing the computed risks against the risk
acceptability criteria.
The BXM RACT template that is provided in Appendix B - Templates, does
not show a pre-/post risk. Only the final risks of the medical device are shown.
The reasons for this are:

1. The final risks of the device are what matter to the patient, and what is used to
evaluate the benefit risk ratio of the device.
2. Manageability of the RACT size. RACTs are typically huge tables and span multi-
ple pages. Page management and reading of a larger RACT is more difficult.

Safety Risk Management for Medical Devices r 2018 Elsevier Ltd.
DOI: https://doi.org/10.1016/B978-0-12-813098-8.00020-9 All rights reserved. 175