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 Risk Control Measure Work Item type.

Risk Control Measure

Description

Description of a risk control measure according to chapter 7.2 of IEC 62304:2006. A risk control measure have a traceability link to the hazardous situation it mimic as well as a link from the software requirement that springs from it.

Workflow Steps

The Risk Control Measure Work Item uses the standard Full Workflow.

Traceability & Impact

A Risk Control Measure Work Item must be traceable to a Hazardous Situation 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 verification can be requested:

Attribute Name	Type	Description
Measure is implemented in software	Enum (Yes/No)	(as required by IEC 62304:2006->7.2.2a).
Affects software safety classification	Enum (Yes/No)	(as required by IEC 62304:2006->7.2.2b).
Safety principle used	Enum (see below)	Safety principal used to reduce risk (according to the Medical Device Directive 93/42/EEC, Annex I “Essential Requirements”, Section 2)

Possible values for “Safety principle used” enumeration

Name	Description
Inherently safe design	The risk is eliminated or reduced as far as possible by design and construction.
Protection measures	Protection measures (including alarms if necessary) in relation to risks are implemented, but the risk is not eliminated.
User information	Users are informed of the residual risks due to any shortcomings of the protection measures adopted.

Verification/Evaluation Attributes

The following custom fields must be filled out before verification/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
Risk control measure has been implemented	(as required by IEC 62304:2006->7.3.1).
New sequences of events have been analyzed	New sequences of events that could result in a hazardous situation have been analyzed (as required by IEC 62304:2006->7.3.2).

Possible Resolutions

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

Resolution Name	Description
Approved	The risk control measure has been approved and needs to be implemented.
Not Approved	The risk control measure has not been approved. No further action is needed.
Obsolete	The risk control measure 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.

---