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 Change Request Work Item.
A change request resulting from either a risk control measure or a problem report, according to clause 9.2 of the IEC 62304:2006. Any issue of this type must be linked to the risk control measure or the problem report it springs from and to the software requirement following the request.
The Change Reques Item uses the standard .
Traceability & Impact
A Change Reques Item must be traceable to a Work Item and has an impact on a Work Item.
For more information on traceability and impacts, see the .
Work Item Attributes
The following custom fields must be filled out before evaluation can be requested:
|Effect on the organisation [B,C]||Text||All effects on the organisation have to be analyzed.|
(as required by ->6.2.3)
|Effect on released software products and systems [B,C]||Text||All effects on released software products and system have to be analyzed.|
(as required by ->6.2.3)
|User must be informed||Enum (Yes/No)||Decision whether the user must be informed.|
(as required by ->6.2.5).
|Action taken to inform users||Text||(as required by->6.2.5).|
|Have additional potential causes been introduced contributing to hazardous situation?||Enum (Yes/No)||(as required by->7.4.1a)|
|Are additional software risk control measures required?||Enum (Yes/No)||(as required by->7.4.1b)|
|Does the change interfere with existing risk control measures?||Enum (Yes/No)||(as required by->7.4.2)|
The following custom fields must be filled out before evaluation can be finshed and the work item can be closed:
|Reviewer||Text||Person(s) to perform, performing or have performed a review.|
|Review summary||Text||Short summary of the review. Attachments should be used for additional information.|
|Last review date||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:
|Approved||The change request has been approved and needs to be implemented.|
|Not Approved||The change request has not been approved. No further action is needed.|
|Obsolete||The change request has become obsolete and is no longer needed.|
|Discarded||The work item entry has been discarded. No further attention is needed.|
For more information about Polarion’s MedPack visit our Extension Portal using following link:
http://extensions.polarion.com/extensions/31-polarion-alm-medpack-iec-62304. I hope you liked this article and you will visit our Blog again when there is another Morris Medical Monday article.