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 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.
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.
Work Item Attributes
The following custom fields must be filled out before verification can be requested:
Measure is implemented in software
(as required by IEC 62304:2006->7.2.2a).
Affects software safety classification
(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
Inherently safe design
The risk is eliminated or reduced as far as possible by design and construction.
Protection measures (including alarms if necessary) in relation to risks are implemented, but the risk is not eliminated.
Users are informed of the residual risks due to any shortcomings of the protection measures adopted.
The following custom fields must be filled out before verification/evaluation can be finshed and the work item can be closed:
Person(s) to perform, performing or have performed a review.
Short summary of the review. Attachments should be used for additional information.
Last review 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:
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).
The following table shows the possible resolution values when the work item is closed:
The risk control measure has been approved and needs to be implemented.
The risk control measure has not been approved. No further action is needed.
The risk control measure has become obsolete and is no longer needed.
The work item entry has been discarded. No further attention is needed.