Biomedical Engineering Reference
In-Depth Information
procedure. If the SOP is unchanged, it will be diligently
executed during the remainder of its life-cycle. If problems of
execution occur, it will still be diligently executed until it is
appropriately changed.
Should problems of execution become apparent during the
life-cycle of the current version, there are two options. If the
problems are not critical (i.e., presenting neither business
risk nor quality risk), they can be documented by the business
owner (or management in any impacted area) and fi led for
the next routine review. An example of a non-critical problem
might be a change of name of an organizational unit that is
referenced in the SOP. If the problems are critical (i.e.,
posing a business risk or a threat to the SISPQ of the product),
a planned deviation protocol (PDP) can be prepared
according to the organization's change control procedure to
revise the current version. The PDP serves as a corrective
and preventive action to revise the SOP until the next
routine review. As soon as the PDP is implemented, the
SOP as revised will be diligently executed during the
remainder of its life-cycle.
The elements of the routine review of an SOP are displayed
in Table 1.3.
Once these steps have been completed, the SOP can be
subjected to a critical review, in light of the complexity and
criticality of the associated process. As the next chapter
explains, this critical review can take the form of a
management review, an SME review, or a step-by-step real-
world challenge. Finally, the SOP is approved and
implemented.
1.3.1 A different organizational approach
Some organizations take a different approach to the routine
review of operational SOPs. Consider the following: an
