Biomedical Engineering Reference
In-Depth Information
of exceptional practices. Thus routine practices can be taken
as a baseline for the exceptional practices that are addressed
in the remainder of this chapter. The third section addresses
the two kinds of internally-based observations that can
initiate an intervention and thereby the revision of SOPs:
employee notifi cation to supervision and quality (internal)
audits. The fourth section discusses the three types of
externally-based observations that may initiate an
intervention and thereby the revision of a SOP: regulatory
inspections, adverse event (AE) reporting, and customer
quality complaints.
1.2 Procedures and change
Controlled documents such as SOPs, batch records,
manufacturing orders, packaging orders, etc. provide
guidance for performing tasks. For brevity's sake, all
these controlled documents are referred to herein as
“procedures” or “SOPs.” The procedure identifi es the tasks,
the environmental and organizational setting for task
performance, the resources that make up the prerequisites
to each task, the sequencing of the tasks within a given
process, the personnel responsible for completing the tasks,
and the standards that defi ne the satisfactory completion of
the tasks. As David Peterson states:
The purpose of an SOP is straightforward: to ensure
that essential job tasks are performed correctly,
consistently, and in conformance with internally
approved procedures. Clearly, employees' correct,
consistent performance of essential job tasks is as much
a business and quality issue as it is a regulatory
requirement.
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