Biomedical Engineering Reference
In-Depth Information
Moreover, in the example, this approach to the routine
review of life-cycle documents contradicted the organization's
change control procedure. That procedure stipulated that for
proposed changes to be implemented, an operational SOP
had to be appropriately requested, processed, and approved.
A proposed change request had to indicate any impact the
changes would have on process, material, product, regulatory
fi lings, etc. The request also had to identify activities,
responsible parties, deliverables, and time frames and due
dates, comprising the proposed changes. Pending the
approval of the change request, the current version of an
operational SOP was to be executed diligently. There is no
easy way to harmonize such contradictory SOPs as the SOP
Revision Cycle procedure and the change control procedure.
This section has addressed the requirements for the routine
review and controlled change of life-cycle documents such as
an operational SOP. An alternate approach to routine review
is discussed; however, it was found that the alternate
approach posed the threat of FDA inspectional observations.
The next section of this chapter examines the occasions for
remediation that are due to an internally-based observation.
Some of these implicate the revision of an SOP; others do
not.
1.4 Intervention due to
internal observation
There are two major occasions for remediation because of an
internally-based observation that may require the revision of
an operational SOP. The fi rst is an observation made by an
employee that requires notifi cation to management of a
business risk or quality risk. The second is an observation
made by an auditor during an internal quality audit.
