Biomedical Engineering Reference
In-Depth Information
range of approaches to the critical review of procedures, in
terms of increasing credibility of the review fi ndings, was
presented. Management must select among these approaches,
weighing the benefi ts of increasing credibility against the
costs of increasing rigor of the approach appropriate for the
level of risk of the procedure.
An illustrative problem involving a laboratory weighing
procedure was considered, including physical facilities that
might be implicated in the problem. This led to the development
and implementation of a CAPA project, including changes to
laboratory SOPs. FDA regulations for equipment calibration
and the associated SOPs were examined. The internal
calibration procedure was evaluated for consistency with
FDA requirements and technical quality. It was noted that the
laboratory weighing procedure must also be reviewed for
technical quality. Based on all of the above, the procedural
changes were implemented. Finally, the changes brought
about through the CAPA by comparative experimental testing
were evaluated, and the results were documented.
Critical review of procedures will prove useful in FDA
regulated industry. Whatever the origin of the proposal to
revise the procedure - whether it is the regularly scheduled
biennial revision of a life-cycle document, or a corrective
action in response to an investigation into non-conformance,
etc. - revision should add as much value as possible in terms
of the relative costs and benefi ts of the various approaches to
critical review. This cost/benefi t analysis must be informed
by a risk assessment of the change. Adding value to
procedures makes business sense. It also makes compliance
sense, because it affi rms that the document and its associated
real-world process are both in control. Employing one
of these approaches to the critical review of procedures
will surely contribute to process control in the lab or
manufacturing environment.
