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.
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.
The Problem Report Item uses the standard .
Traceability & Impact
A Problem Report Work Item must be traceable to either a Work Item or an Work Item and has an impact on a .
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:
|Problem Report type||Enum||A Problem Report has to be classify in the the following types:|
(as required by ->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 ->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 ->9.1c).
|Actual or potential adverse event(s)||Text||(as required by->188.8.131.52).|
|Deviation from specification||Text||(as required by->184.108.40.206).|
|Cause for reported problem||Text||(as required by->9.2a).|
|Actions taken to investigate the problem||Text||(as required by->9.2c).|
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.|
|Affects on safety||Text||(as required by->220.127.116.11/9.2b).|
|Trend analysis result||Text||(as required by->9.6).|
|Adverse trends that must be reversed have been detected||Enum (Yes/No)||(as required by->9.7).|
|Action taken to advice relevant parties||Text||(as required by->9.3).|
The following checklist must be filled out before evaluation can be finshed and the work item can be closed:
|No additional problems have been introduced||(as required by->9.7).|
|Has been analyzed for trends||(as required by->9.6).|
|Relevant parties must be adviced of the existence of the problem||(as required by->9.3).|
The following table shows the possible resolution values when the work item is closed:
|Needs Product Change||According to the results of the problem report, a product change is needed (as required by->18.104.22.168).|
|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