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 Reviews
Along with traceability, the need to review all deliverables (see IEC 62304:3006->3.6) is one of the main requirements of IEC 62304. By reviewing all concepts and outputs it can be proved that decisions have been thoroughly reflected and possible consequences have been considered. Therefore, it is one of the most important factors for quality and patient and user safety, which is the main focus of IEC 62304.
Review Requirements of IEC 62304:2006
The picture below shows the review requirements for the deliverables of IEC 62304:2006 in the white part of the boxes, which themselves represent the deliverables. The clause of the standard requiring the activity is given in brackets. MedPack represents most of these deliverables with Work Items, some with dedicated wiki pages.
How MedPack implements reviews
Reviews are implemented by the work item's workflows and attributes. For any work item, there are three kinds of custom fields that contribute to reviews:
These attribute types have to be filled out before some workflow transitions are possible (see picture below).
Work item attributes
These attributes are specific information to the work item type that are required by the standard (the description of the custom fields contains information about the clause requiring the information). The content of these fields contains information to be reviewed, so all custom fields of this kind have to be filled out before a review, which is either a evaluation or a verification, can be requested. It is the duty of the developer the work item is assigned to to provide this information.
After a review has been requested, it is the duty of the reviewer to perform this review. By design of the workflow, all necessary information should be available at that time. The reviewer has to fill out the custom fields grouped as "Evaluation/Verification attributes". All work item have at least the following attributes:
The Reviewer attribute has to be filled out with the name(s) of the reviewer(s) for that work item. The Review Summary should contain a brief description of the result of the summary. If additional information has to be provided, it should be added as an attachment. The Review date attributes is hidden and automatically set when the review is closed. Having the date of the last review as a custom fields helps sorting and filtering attributes in the table view by date of review. Some work items provide additional fields specific for the work item.
All custom fields grouped as evaluation/verification attributes have to be filled out before a review can be finished and the work item can be closed.
In addition to the evaluation/verification attributes described above, work items might have boolean attributes grouped as a "Evaluation/Verification checklist". This checklist is used as a reminder of things to remember required by the standard. Additionally, the reviewer confirms that he or she has thought about or done the things described in the list.
Every entry in the evaluation/verification checklist have to be checked as "done" before a review can be finished and the work item can be closed.
For more information about Polarion's MedPack visit our Extension Portal using following link:
http://extensions.polarion.com/extensions/31-polarion-alm-medpack-iec-62304I hope you liked this article and you will visit our Blog again when there is another Morris Medical Monday article.