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 Problem Report Work Item.

Problem Report

Description

A 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.

Workflow Steps

The Problem Report Item uses the standard Feedback Workflow.

Traceability & Impact

A Problem Report Work Item must be traceable to either a Anomaly Work Item or an Feedback Work Item and has an impact on a Change Request.
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
Problem Report type	Enum	A Problem Report has to be classify in the the following types: – Corrective – Preventive – Adaptive (as required by IEC 62304:2006->9.1a).
Problem Report scope	Text	Problem Report scope examples: – Size of change – Number of device models affected – Supported accessories affected – Resources involved – Time to change (as required by IEC 62304:2006->9.1b).
Problem Report criticality	Enum	A Problem Report has to be classify in the the following criticalities: – Effect on performance – Effect on safety – Effect on security (as required by IEC 62304:2006->9.1c).
Actual or potential adverse event(s)	Text	(as required by IEC 62304:2006->6.2.1.2).
Deviation from specification	Text	(as required by IEC 62304:2006->6.2.1.2).
Cause for reported problem	Text	(as required by IEC 62304:2006->9.2a).
Actions taken to investigate the problem	Text	(as required by IEC 62304:2006->9.2c).

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.
Affects on safety	Text	(as required by IEC 62304:2006->6.2.1.3/9.2b).
Trend analysis result	Text	(as required by IEC 62304:2006->9.6).
Adverse trends that must be reversed have been detected	Enum (Yes/No)	(as required by IEC 62304:2006->9.7).
Action taken to advice relevant parties	Text	(as required by IEC 62304:2006->9.3).

Evaluation Checklist

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

Checklist entry	Description
No additional problems have been introduced	(as required by IEC 62304:2006->9.7).
Has been analyzed for trends	(as required by IEC 62304:2006->9.6).
Relevant parties must be adviced of the existence of the problem	(as required by IEC 62304:2006->9.3).

Possible Resolutions

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

Resolution Name	Description
Needs Product Change	According to the results of the problem report, a product change is needed (as required by IEC 62304:2006->6.2.1.3).
No Product Change Needed	According to the results of the problem report, no product change is 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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