Page 223 - Safety Risk Management for Medical Devices

202 Safety Risk Management for Medical Devices

and the subsequent sequence of events that lead into the Hazard is captured in the
RACT. Similarly, the traceability between each Hazard and the evaluation of the risks
associated with that Hazard can be captured in the RACT.
The assessment of acceptability of the residual risks must also be documented. In
the BXM method this traceability is also captured in the RACT.
As design, implementation, testing, and risk management activities continue, it is
crucial that the integrity of traceability links be maintained. Without this diligence, it
is easy for the links to become inaccurate. The use of automation tools can help with
this endeavor. Many requirements management tools enable creation of entities, e.g.,
requirements, Risk Controls, or test cases, and to link such entities within the tool.
This is very convenient for up-to-the-minute viewing and reporting of link maps.
Moreover, the tools can flag links as suspicious, if one or the other end of the link is
modified. The engineers can then review the contents of both ends of a link and ver-
ify whether the link is still valid.
For devices of even moderate complexity the traceability analysis report would be
a large document. For this reason, it is not recommended that the traceability analysis
report be included in the Risk Management Report (RMR), as it could make the
RMR too large and unwieldy. Instead, it is better to include a summary of the trace-
ability analysis report in the RMR, and make a reference to the traceability analysis
report, as one of the elements of the Risk Management File (RMF).