{"id":854,"date":"2014-11-10T19:36:25","date_gmt":"2014-11-11T03:36:25","guid":{"rendered":"https:\/\/blogs.plm.automation.siemens.com\/t5\/Polarion-Blog\/Morris-Medical-Monday-Work-Item-Type-34-Problem-Report-34\/ba-p\/380915"},"modified":"2026-03-26T05:32:01","modified_gmt":"2026-03-26T09:32:01","slug":"morris-medical-monday-work-item-type-problem-report","status":"publish","type":"post","link":"https:\/\/blogs.sw.siemens.com\/polarion\/morris-medical-monday-work-item-type-problem-report\/","title":{"rendered":"Morris Medical Monday: Work Item Type "Problem Report""},"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 Problem Report Work Item.<\/p>\n


\n

Problem Report<\/H1>
\n

Description<\/H3>
\nA problem report describing an anomaly found during an integration or system test according to clause 9.1 of IEC 62304:2006. Any issue of this type must be linked to the source anomaly and the resulting change request, if there is any.
\n

Workflow Steps<\/SPAN><\/H3>
\nThe Problem Report Item uses the standard Feedback Workflow<\/SPAN>.<\/p>\n

\"FeedbackWorkflow_Overview\"<\/A>
\n

Traceability & Impact<\/SPAN><\/H3>
\nA Problem Report Work Item must be traceable to either a Anomaly<\/SPAN> Work Item or an Feedback<\/SPAN> Work Item and has an impact on a Change Request<\/SPAN>.
\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
\n
\n
\n
\n
Attribute Name<\/TH>
\n		Type<\/TH>
\n		Description<\/TH>
\n<\/TR>
\n<\/THEAD>
\n
Problem Report type<\/STRONG><\/TD>
\n		Enum<\/TD>
\n		A Problem Report has to be classify in the the following types:
\n– Corrective
\n– Preventive
\n– Adaptive
\n(as required by IEC 62304:2006<\/SPAN>->9.1a).<\/TD>
\n<\/TR>
\n
Problem Report scope<\/STRONG><\/TD>
\n		Text<\/TD>
\n		Problem Report scope examples:
\n– Size of change
\n– Number of device models affected
\n– Supported accessories affected
\n– Resources involved
\n– Time to change
\n(as required by IEC 62304:2006<\/SPAN>->9.1b).<\/TD>
\n<\/TR>
\n
Problem Report criticality<\/STRONG><\/TD>
\n		Enum<\/TD>
\n		A Problem Report has to be classify in the the following criticalities:
\n– Effect on performance
\n– Effect on safety
\n– Effect on security
\n(as required by IEC 62304:2006<\/SPAN>->9.1c).<\/TD>
\n<\/TR>
\n
Actual or potential adverse event(s)<\/STRONG><\/TD>
\n		Text<\/TD>
\n		(as required by IEC 62304:2006<\/SPAN>->6.2.1.2).<\/TD>
\n<\/TR>
\n
Deviation from specification<\/STRONG><\/TD>
\n		Text<\/TD>
\n		(as required by IEC 62304:2006<\/SPAN>->6.2.1.2).<\/TD>
\n<\/TR>
\n
Cause for reported problem<\/STRONG><\/TD>
\n		Text<\/TD>
\n		(as required by IEC 62304:2006<\/SPAN>->9.2a).<\/TD>
\n<\/TR>
\n
Actions taken to investigate the problem<\/STRONG><\/TD>
\n		Text<\/TD>
\n		(as required by IEC 62304:2006<\/SPAN>->9.2c).<\/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
\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
Affects on safety<\/STRONG><\/TD>
\n		Text<\/TD>
\n		(as required by IEC 62304:2006<\/SPAN>->6.2.1.3\/9.2b).<\/TD>
\n<\/TR>
\n
Trend analysis result<\/STRONG><\/TD>
\n		Text<\/TD>
\n		(as required by IEC 62304:2006<\/SPAN>->9.6).<\/TD>
\n<\/TR>
\n
Adverse trends that must be reversed have been detected<\/STRONG><\/TD>
\n		Enum (Yes\/No)<\/TD>
\n		(as required by IEC 62304:2006<\/SPAN>->9.7).<\/TD>
\n<\/TR>
\n
Action taken to advice relevant parties<\/STRONG><\/TD>
\n		Text<\/TD>
\n		(as required by IEC 62304:2006<\/SPAN>->9.3).<\/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
\n
\n
\n
\n
Checklist entry<\/TH>
\n		Description<\/TH>
\n<\/TR>
\n<\/THEAD>
\n
No additional problems have been introduced<\/STRONG><\/TD>
\n		(as required by IEC 62304:2006<\/SPAN>->9.7).<\/TD>
\n<\/TR>
\n
Has been analyzed for trends<\/STRONG><\/TD>
\n		(as required by IEC 62304:2006<\/SPAN>->9.6).<\/TD>
\n<\/TR>
\n
Relevant parties must be adviced of the existence of the problem<\/STRONG><\/TD>
\n		(as required by IEC 62304:2006<\/SPAN>->9.3).<\/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
Needs Product Change<\/STRONG><\/TD>
\n		According to the results of the problem report, a product change is needed (as required by IEC 62304:2006<\/SPAN>->6.2.1.3).<\/TD>
\n<\/TR>
\n
No Product Change Needed<\/STRONG><\/TD>
\n		According to the results of the problem report, no product change is 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>
\n

<\/H3>
\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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