Biomedical Engineering Reference
In-Depth Information
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34R
The role of critical review in the
revision of procedures
Abstract:
This chapter addresses changes to processes and
the revision of standard operating procedures (SOPs).
Emphasis is put on the necessity of SOP revisions. An
illustrative problem is presented - an example of a
laboratory weighing procedure and the development of a
corrective action and preventive action (CAPA) project.
Procedural changes in the example are evaluated and
reviewed for regulatory compliance. The management of
change depending upon risk assessment is considered.
Key words:
calibration, CAPA plan, change management,
complexity, critical review, criticality, real-world challenge,
risk assessment.
3.1 Introduction
Given the ubiquitous changes in technology, procedures
must be appropriately revised. The key word here is
“appropriate.” Revisions - the “versioning up” - of a
standard operating procedure (SOP) that adds value to a
procedure can contribute to best practices. Revisions that
34R
