{"id":898,"date":"2015-01-05T12:00:03","date_gmt":"2015-01-05T20:00:03","guid":{"rendered":"https:\/\/blogs.plm.automation.siemens.com\/t5\/Polarion-Blog\/Morris-Medical-Monday-Work-Item-Types-34-SOUP-34\/ba-p\/380922"},"modified":"2026-03-26T05:32:19","modified_gmt":"2026-03-26T09:32:19","slug":"morris-medical-monday-work-item-types-soup","status":"publish","type":"post","link":"https:\/\/blogs.sw.siemens.com\/polarion\/morris-medical-monday-work-item-types-soup\/","title":{"rendered":"Morris Medical Monday: Work Item Types "SOUP""},"content":{"rendered":"

Welcome back to the first Morris Medical Monday article of the new year. I hope you had a great holiday season. For anyone who is new to our blog, this 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 SOUP<\/EM> Work Item.<\/p>\n


\n

Soup<\/H1>
\n

Description<\/H3>
\nA description of a s<\/STRONG>oftware c<\/STRONG>omponent of u<\/STRONG>nknown p<\/STRONG>rovenance (SOUP) used in the project, according to clause 3.29 of IEC 62304:2006. Any issue of this type must be linked to the software item that is implemented by the component.
\n

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

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

Traceability & Impact<\/SPAN><\/H3>
\nA SOUP Work Item must be traceable to a Software Item<\/SPAN> Work Item and a Architectural Design<\/SPAN> Work Item and has an impact on an Integration Test<\/SPAN> Work Item and a Hazardous Situation<\/SPAN> Work Item.
\nFor more information on traceability and impacts, see the Traceability wiki page<\/SPAN>.
\n

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

Special hyperlink roles<\/SPAN><\/H4>
\nA SOUP work item has special hyperlink roles to fulfill the requirements of IEC 62304. The following tables lists thos roles.
\n
\n
\n
\n
\n
\n
\n
\n
Hyperlink Role<\/TH>
\n		Description<\/TH>
\n<\/TR>
\n<\/THEAD>
\n
Published anomaly list<\/TD>
\n		URL of an anomaly list for the used SOUP component<\/TD>
\n<\/TR>
\n
SOUP manufacturer<\/TD>
\n		URL of the manufacturer’s homepage.<\/TD>
\n<\/TR>
\n
SOUP URL<\/TD>
\n		URL of additional information about the SOUP component.<\/TD>
\n<\/TR>
\n<\/TBODY>
\n<\/TABLE>
\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
\n
\n
Attribute Name<\/TH>
\n		Type<\/TH>
\n		Description<\/TH>
\n<\/TR>
\n<\/THEAD>
\n
SOUP title<\/STRONG><\/TD>
\n		Text<\/TD>
\n		(as required by IEC 62304:2006<\/SPAN>->8.1.2a).<\/TD>
\n<\/TR>
\n
SOUP manufacturer<\/STRONG><\/TD>
\n		Text<\/TD>
\n		(as required by IEC 62304:2006<\/SPAN>->8.1.2b).<\/TD>
\n<\/TR>
\n
SOUP designator<\/STRONG><\/TD>
\n		Text<\/TD>
\n		(as required by IEC 62304:2006<\/SPAN>->8.1.3c).<\/TD>
\n<\/TR>
\n
System hardware and software requirement [B,C]<\/STRONG><\/TD>
\n		Text<\/TD>
\n		Example: Processor type, storage type, system-software type,…(as required by IEC 62304:2006<\/SPAN>->5.3.3).<\/TD>
\n<\/TR>
\n
Functional and performance requirement [B,C]<\/STRONG><\/TD>
\n		Text<\/TD>
\n		(as required by IEC 62304:2006<\/SPAN>->5.3.4).<\/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
Ready For Use<\/STRONG><\/TD>
\n		The SOUP element has been evaluated and can be used in the product.<\/TD>
\n<\/TR>
\n
Obsolete<\/STRONG><\/TD>
\n		The SOUP element 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:<\/p>\n

http:\/\/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

Read how medical device company LifeWatch succeeds with Polarion:<\/EM>
\n\"Polarion<\/A><\/P>
\n <\/p>\n","protected":false},"excerpt":{"rendered":"

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