Welcome back to Morris Medical Monday: a weekly series for medical device development companies (and companies who are related to such companies), providing some useful information about Polarion solutions and Polarion extensions.
Today we will continue on the subject of Polarion's MedPack extension, and have a look into MedPack's Hazardous Situation Work Item.
Description of a hazardous situation according to chapter 7.1 of IEC 62304:2006. Any hazardous situation must have a link to the software item the hazardous situation springs from.
The Hazardous Situation Work Item uses the standard Evaluation Workflow.
Traceability & Impact
A Hazardous Situation Work Item must be traceable to either a Software System type Work Item, a Software Item type Work Item, a Software Unit type Work Item or a SOUP type Work Item. It has an impact on a Risk Control Measure type Work Item.
For more information on traceability and impacts, see the Traceability wiki page.
Work Item Attributes
The following custom fields must be filled out before evaluation can be requested:
Potential cause for hazardous situation [B,C]
(as required by IEC 62304:2006->7.1.2/7.1.4).
Specific software cause for hazardous situation [B,C]
(as required by IEC 62304:2006->7.3.3).
Sequence of events that lead to hazardous situation [B,C]
(as required by IEC 62304:2006->7.1.5).
The following custom fields must be filled out before evaluation can be finshed and the work item can be closed:
Person(s) to perform, performing or have performed a review.
Short summary of the review. Attachments should be used for additional information.
Last review date
Hidden field automatically set when review has been finshed. Intended to be used for sorting and statistical analysis.
The following checklist must be filled out before evaluation can be finshed and the work item can be closed:
The following table shows the possible resolution values when the work item is closed:
Needs Risk Control Measure
This hazardous situation requires a risk control measure.
No Risk Control Measure Needed
This hazardous situation does not require a risk control measure.
The work item entry has been discarded. No further attention is needed.