Biomedical Engineering Reference
In-Depth Information
that a process is not in control. In order to ensure that the
revision adds value (i.e., adds content that is needed and no
more), the SOP should be critically reviewed.
The critical review of an SOP ensures that the process
addressed in the procedure, as written and executed, will
attain the outcome the organization wants. The critical
review of a revised procedure ensures that the proposed
changes will add value to the process. Addressing “validation
of both the process and process controls,” FDA defi nes
validation as follows: “Process validation is establishing
documented evidence which provides a high degree of
assurance that a specifi c process will consistently produce a
product meeting its pre-determined specifi cations and quality
characteristics.”
3
Various approaches to validation can then
be ranked in terms of the “degree of assurance,” or credibility
of the resulting evidence. The same is the case for the critical
review of procedures.
Take a drafted SOP, whether a newly written procedure or
a revision of a current one. Critical review of the SOP consists
of one or more of the following approaches, listed in terms
of increasing credibility of the resulting evidence:
■
management review during the SOP approval process;
■
expert review by subject matter experts (SMEs) or others;
■
step-by-step real-world challenge;
■
experimental design study.
Management review
is the vetting of the procedure as it goes
through the several iterations of the document change
process. The management of each department that will be
impacted by the revisions has the opportunity to review the
draft, suggest changes, and sign off on the document.
Everything in management review will routinely be captured
in the document change process.
