Biomedical Engineering Reference
In-Depth Information
Table 1.3
The routine review of life-cycle documents
1.
Begin the routine review of life-cycle documents such as SOPs
by identifying the particular document that is due for versioning
up. In the case of biennial review, this involves tracking all SOPs
and provisionally tagging those that were implemented two years
ago.
2.
Accommodate the typical time involved in the document change
process. Suppose the amount of time needed to revise an
SOP is six weeks. This amount of time is added to the tracking
process, so the SOPs that are being tagged are those
implemented 25.5 months ago (rather than 24 months ago).
This ensures enough time for those SOPs to be revised within
their life-cycle.
3.
Identify the business owner/author of each of those tagged
SOPs.
4.
Query that business owner to assess the number and substance
of proposed revisions to the SOP that have been gathered over
the past two years. If those proposed revisions are neither
numerous nor substantial, prepare for a minor revision -
sometimes called an “update” - of the SOP. If the proposed
revisions are numerous and/or substantial, prepare for a full
revision of the SOP.
5.
Review the SOP and identify all impacted organizational units.
In the case of the proposed update, contact the impacted
units, indicate the assessment, and invite inputs to the update.
In the case of the full revision, contact the impacted units,
indicate the assessment, and propose a cross-functional
meeting.
6.
Prepare the draft document per the appropriate administrative
procedure. If it is only an update, submit for approval (see
item # 10 below).
7.
List the draft document in the document management schedule.
8.
If necessary, facilitate the cross-functional meeting and review
the draft document to ensure all impacted areas make their
inputs.
9.
Revise the draft document to address the comments raised in the
cross-functional meeting.
10.
Submit the document as revised to the management review
process.
