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.

Change Request

Description

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.

Workflow Steps

The Change Reques Item uses the standard Feedback Workflow.

Traceability & Impact

A Change Reques Item must be traceable to a Problem Report Work Item and has an impact on a Software Requirement Work Item.
For more information on traceability and impacts, see the Traceability wiki page.

Attributes

Work Item Attributes

The following custom fields must be filled out before evaluation can be requested:

Attribute Name	Type	Description
Effect on the organisation [B,C]	Text	All effects on the organisation have to be analyzed. (as required by IEC 62304:2006->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 IEC 62304:2006->6.2.3)
User must be informed	Enum (Yes/No)	Decision whether the user must be informed. (as required by IEC 62304:2006->6.2.5).
Action taken to inform users	Text	(as required by IEC 62304:2006->6.2.5).
Have additional potential causes been introduced contributing to hazardous situation?	Enum (Yes/No)	(as required by IEC 62304:2006->7.4.1a)
Are additional software risk control measures required?	Enum (Yes/No)	(as required by IEC 62304:2006->7.4.1b)
Does the change interfere with existing risk control measures?	Enum (Yes/No)	(as required by IEC 62304:2006->7.4.2)

Evaluation Attributes

The following custom fields must be filled out before evaluation can be finshed and the work item can be closed:

Attribute Name	Type	Description
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.

Evaluation Checklist

The following checklist must be filled out before evaluation can be finshed and the work item can be closed:

Checklist entry	Description

Possible Resolutions

The following table shows the possible resolution values when the work item is closed:

Resolution Name	Description
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.

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