{"id":964,"date":"2014-11-24T19:11:40","date_gmt":"2014-11-25T03:11:40","guid":{"rendered":"https:\/\/blogs.plm.automation.siemens.com\/t5\/Polarion-Blog\/Morris-Medical-Monday-Work-Item-Type-34-Software-Item-34\/ba-p\/380917"},"modified":"2026-03-26T05:33:15","modified_gmt":"2026-03-26T09:33:15","slug":"morris-medical-monday-work-item-type-software-item","status":"publish","type":"post","link":"https:\/\/blogs.sw.siemens.com\/polarion\/morris-medical-monday-work-item-type-software-item\/","title":{"rendered":"Morris Medical Monday: Work Item Type "Software Item""},"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 Software Item<\/EM> type Work Item.<\/p>\n


\n

Software Item<\/H1>
\n

Description<\/H3>
\nA description of a software item according to clause 3.25 of IEC 62304:2006. Any issue of this type must be linked to the parent software system(s) and the child software unit(s). In the case that this item is a SOUP, a link to the SOUP issue must be provided as well. See the note in clause 3.25 for further information about software decomposition.
\n

Workflow Steps<\/SPAN><\/H3>
\nThe Software Item Item uses the standard Verification Workflow<\/SPAN>.<\/p>\n

\"VerificationWorkflow_Overview\"<\/A>
\n

Traceability & Impact<\/SPAN><\/H3>
\nA Software Item Work Item must be traceable to a Software System<\/SPAN> Work Item, to a Architectural Design<\/SPAN> or to another Software Item<\/SPAN> Work Item and has an impact on a Integration Test<\/SPAN> Work Item and to a Hazardous Situation<\/SPAN>Work Item. It can also has an impact to a SOUP<\/SPAN> Work Item, to a Software Unit<\/SPAN> Work Item or to another Software Item<\/SPAN> 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 verification 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
Software Safety Class<\/STRONG><\/TD>
\n		Enum (A,B,C,Inherit)<\/TD>
\n		A Software System have to classified in one of the following Software Safety Classes:
\n– Software Safety Class A (No injury or damage to health is possible)
\n– Software Safety Class B (Non-serious injury is possible)
\n– Software Safety Class C (Death or serious injury is possible)
\n– Inherit (Software Item inherit software safety class from linked Software System or Software Item)
\n(as required by IEC 62304:2006<\/SPAN>->4.3).<\/TD>
\n<\/TR>
\n
Rationale for classification other than ‘inherited’<\/STRONG><\/TD>
\n		Text<\/TD>
\n		It has to declare a reason, if a Software Item has another software safety class as ‘inherit’.
\n(as required by IEC 62304:2006<\/SPAN>->4.3d)<\/TD>
\n<\/TR>
\n
Segregation to other items concerning risk control [C]<\/STRONG><\/TD>
\n		Text<\/TD>
\n		A effectively segregation to other Software Items concerning risk control.
\n(as required by IEC 62304:2006<\/SPAN>->5.3.5)<\/TD>
\n<\/TR>
\n<\/TBODY>
\n<\/TABLE>
\n

Verification Attributes<\/SPAN><\/H4>
\nThe following custom fields must be filled out before verification 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

Verification Checklist<\/SPAN><\/H4>
\nThe following checklist must be filled out before verification can be finshed and the work item can be closed:
\n
\n
\n
\n
\n
\n
\n
\n
\n
\n
Checklist entry<\/TH>
\n		Description<\/TH>
\n<\/TR>
\n<\/THEAD>
\n
Incorrect or incomplete specification of functionality has been taken into account<\/STRONG><\/TD>
\n		Identify potential causes of contribution to a hazardous situation
\n(as required by IEC 62304:2006<\/SPAN>->7.1.2a)<\/TD>
\n<\/TR>
\n
Software defects in the identified software item functionality has been taken into account<\/STRONG><\/TD>
\n		Identify potential causes of contribution to a hazardous situation
\n(as required by IEC 62304:2006<\/SPAN>->7.1.2b)<\/TD>
\n<\/TR>
\n
Failure or unexpected results from SOUP has been taken into account<\/STRONG><\/TD>
\n		Identify potential causes of contribution to a hazardous situation
\n(as required by IEC 62304:2006<\/SPAN>->7.1.2c)<\/TD>
\n<\/TR>
\n
Hardware failures or other software defects that could result in unpredictable software operation has been taken into account<\/STRONG><\/TD>
\n		Identify potential causes of contribution to a hazardous situation
\n(as required by IEC 62304:2006<\/SPAN>->7.1.2d)<\/TD>
\n<\/TR>
\n
Reasonably foreseeable misuse has been taken into account<\/STRONG><\/TD>
\n		Identify potential causes of contribution to a hazardous situation
\n(as required by IEC 62304:2006<\/SPAN>->7.1.2e)<\/TD>
\n<\/TR>
\n<\/TBODY>
\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
Implemented<\/STRONG><\/TD>
\n		The software item has been implemented.<\/TD>
\n<\/TR>
\n
Obsolete<\/STRONG><\/TD>
\n		The software item has become obsolete and is no longer needed.<\/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>
\nFor 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

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