Biomedical Engineering Reference
In-Depth Information
under-resourced case may require rework, and the over-
resourced case may require cost recovery.
The sequencing of tasks may go awry without an SOP - a
task that must precede a task may be omitted, or a task
that depends upon another task may be performed too
soon. Either of these could threaten the integrity of the
entire regulated process.
In the absence of an SOP, personnel may be confused
about who is responsible for each task. Tasks may not be
successfully performed if there is no one responsible for
them, or if two or more employees are responsible for
them.
Without an SOP there are no standards to defi ne the
satisfactory task completion.
SOPs are not set in stone, once and forever. Business process
and regulatory requirements for using SOPs incorporate the
necessity of revising procedures. The revision process
provides an opening for continuous improvement insofar as
the changes represent improvement. FDA predicate rules call
for not only “written procedures” that “shall be followed,”
but the predicate rules also stipulate “written procedures,
including any changes.” 7
There are several aspects to this issue of “changes.” First,
an SOP is a controlled document, so any change in the
associated process must be documented in conformity with
the organization's change control process. Second, the FDA
predicate rules stipulate that the GMPs must be “current”
(i.e., cGMPs), so that changes in the associated process or
practices must be captured in the procedure in a timely
fashion. Third, technological change is ubiquitous in the life
science industry, so there will always be the necessity of
revising SOPs as an aspect of business process as well as a
regulatory requirement.
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