Biomedical Engineering Reference
In-Depth Information
This chapter concludes by considering the place that the
critical review of procedures holds in a value-adding
approach to program design and management.
3.2 Overview of critical review
of SOPs
An SOP is a “process control;” it controls the execution of
a process. The SOP can address several kinds of process - a
person-to-machine process, a person-to-paper process, a
person-to-person process, or a combination of the three
processes.
1
The SOP is a controlled document, meaning it is subject to
change control. Any proposed changes to this document
(and the real-world process it refl ects) must be processed and
approved according to the applicable change control process,
as stated in the organization's change control procedure.
2
The proposed change request must indicate any impact the
changes will have on process, material, product, regulatory
fi ling, other good manufacturing practice (GMP) sites, etc.
The request must identify activities, responsible parties, time
frames and due dates, and deliverables comprising the
proposed changes.
Given the constancy of technological change - as well as
the frequency of non-conformances (unplanned deviations),
associated investigations, and CAPAs - procedures must be
revised. Revisions should be value-adding activities, but
often are not. When the revision does add value, it can
contribute to best practices in development or manufacturing.
When it does not add value, it is sometimes called “procedure
churn;” other times it is called “word-smithing.” From a
business standpoint, procedure churn is wasteful, hence
uneconomical. From a regulatory standpoint it also suggests
