{"id":1010,"date":"2014-10-27T18:01:36","date_gmt":"2014-10-28T01:01:36","guid":{"rendered":"https:\/\/blogs.plm.automation.siemens.com\/t5\/Polarion-Blog\/Morris-Medical-Monday-Work-Item-type-39-Hazardous-Situation-39\/ba-p\/380913"},"modified":"2026-03-26T05:33:40","modified_gmt":"2026-03-26T09:33:40","slug":"morris-medical-monday-work-item-type-hazardous-situation-in-polarion-medpack","status":"publish","type":"post","link":"https:\/\/blogs.sw.siemens.com\/polarion\/morris-medical-monday-work-item-type-hazardous-situation-in-polarion-medpack\/","title":{"rendered":"Morris Medical Monday: Work Item type 'Hazardous Situation' in Polarion MedPack"},"content":{"rendered":"

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<\/A> and Polarion extensions<\/A>.<\/p>\n

Today we will continue on the subject of Polarion’s MedPack extension<\/A>, and have a look into MedPack’s Hazardous Situation Work Item.<\/p>\n


\n

Hazardous Situation<\/H1>
\n

Description<\/H3>
\nDescription 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.
\n

Workflow Steps<\/SPAN><\/H3>
\nThe Hazardous Situation Work Item uses the standard Evaluation Workflow<\/SPAN>.<\/p>\n

\"EvaluationWorkflow_Overview\"<\/A>
\n

Traceability & Impact<\/SPAN><\/H3>
\nA Hazardous Situation Work Item must be traceable to either a Software System<\/SPAN> type Work Item, a Software Item<\/SPAN> type Work Item, a Software Unit<\/SPAN> type Work Item or a SOUP<\/SPAN> type Work Item. It has an impact on a Risk Control Measure<\/SPAN> type Work Item.
\nFor more information on traceability and impacts, see the Traceability wiki page<\/SPAN>.
\n

Attributes<\/SPAN><\/H3>
\n

Work Item Attributes<\/SPAN><\/H4>
\nThe following custom fields must be filled out before evaluation can be requested:
\n
\n
\n
\n
\n
\n
\n
\n
Attribute Name<\/TH>
\n		Type<\/TH>
\n		Description<\/TH>
\n<\/TR>
\n<\/THEAD>
\n
Potential cause for hazardous situation [B,C]<\/STRONG><\/TD>
\n		Text<\/TD>
\n		(as required by IEC 62304:2006<\/SPAN>->7.1.2\/7.1.4).<\/TD>
\n<\/TR>
\n
Specific software cause for hazardous situation [B,C]<\/STRONG><\/TD>
\n		Text<\/TD>
\n		(as required by IEC 62304:2006<\/SPAN>->7.3.3).<\/TD>
\n<\/TR>
\n
Sequence of events that lead to hazardous situation [B,C]<\/STRONG><\/TD>
\n		Text<\/TD>
\n		(as required by IEC 62304:2006<\/SPAN>->7.1.5).<\/TD>
\n<\/TR>
\n<\/TBODY>
\n<\/TABLE>
\n

Evaluation Attributes<\/SPAN><\/H4>
\nThe following custom fields must be filled out before evaluation can be finshed and the work item can be closed:
\n
\n
\n
\n
\n
\n
\n
\n
Attribute Name<\/TH>
\n		Type<\/TH>
\n		Description<\/TH>
\n<\/TR>
\n<\/THEAD>
\n
Reviewer<\/STRONG><\/TD>
\n		Text<\/TD>
\n		Person(s) to perform, performing or have performed a review.<\/TD>
\n<\/TR>
\n
Review summary<\/STRONG><\/TD>
\n		Text<\/TD>
\n		Short summary of the review. Attachments should be used for additional information.<\/TD>
\n<\/TR>
\n
Last review date<\/STRONG><\/TD>
\n		Date<\/TD>
\n		Hidden field automatically set when review has been finshed. Intended to be used for sorting and statistical analysis.<\/TD>
\n<\/TR>
\n<\/TBODY>
\n<\/TABLE>
\n

Evaluation Checklist<\/SPAN><\/H4>
\nThe following checklist must be filled out before evaluation can be finshed and the work item can be closed:
\n
\n
\n
\n
Checklist entry<\/TH>
\n		Description<\/TH>
\n<\/TR>
\n<\/THEAD>
\n<\/TABLE>
\n

Possible Resolutions<\/SPAN><\/H4>
\nThe following table shows the possible resolution values when the work item is closed:
\n
\n
\n
\n
\n
\n
\n
\n
Resolution Name<\/TH>
\n		Description<\/TH>
\n<\/TR>
\n<\/THEAD>
\n
Needs Risk Control Measure<\/STRONG><\/TD>
\n		This hazardous situation requires a risk control measure.<\/TD>
\n<\/TR>
\n
No Risk Control Measure Needed<\/STRONG><\/TD>
\n		This hazardous situation does not require a risk control measure.<\/TD>
\n<\/TR>
\n
Discarded<\/STRONG><\/TD>
\n		The work item entry has been discarded. No further attention is needed.<\/TD>
\n<\/TR>
\n<\/TBODY>
\n<\/TABLE>
\n <\/p>\n

For more information about Polarion’s MedPack visit our Extension Portal using following link:
\nhttp:\/\/extensions.polarion.com\/extensions\/31-polarion-alm-medpack-iec-62304<\/A>. I hope you liked this article and you will visit our Blog again when there is another Morris Medical Monday <\/B>article.<\/p>\n


\n

YOU MAY ALSO BE INTERESTED IN:<\/P>
\n

\"Polarion<\/A><\/P>
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Polarion Customer Success Story: LifeWatch<\/A><\/P>
\n <\/p>\n","protected":false},"excerpt":{"rendered":"

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