Biomedical Engineering Reference
In-Depth Information
lines suggested by the FDA and displayed in Table 1.5. The
manager will also stipulate a due date for the CAPA.
17
The quality audit observation will constitute the occasion
for the revision of an operational SOP insofar as the
remediation listed in the CAPA requires that revision. An
example of this kind of observation, investigation, and CAPA
would be an in-process quality observation of out of
specifi cation (OOS) levels of product variation. Management
would order an investigation and then call for CAPA. The
CAPA might propose that more specifi c directions were
needed in the charging procedure (e.g., a more defi ned
rate of addition of an ingredient) to minimize variation.
These directions would be added to the operational SOP,
either in the next routine biennial review or, more likely, by
way of a PDP.
18
As noted previously, a CAPA can call for all kinds of
remediation for a given audit observation - business process
redesign, risk mitigation, training intervention, organizational
development initiatives, etc. Some intervention involves the
revision of an operational SOP; for instance, business process
redesign typically must be captured in a revised procedure.
Other intervention does not; for instance, training
interventions and leadership development initiatives usually
do not require any change in an operational SOP. All
intervention should contribute to continuous improvement
of the GMP process.
This section has addressed the occasions for intervention
that are a result of an internal observation - an observation
of a discrepancy (or an opportunity for process improvement)
that an employee escalates to supervision, or an observation
made during a quality audit. In either case these may lead
to the revision of an SOP. The next section examines
occasions for remediation that are due to an external
observation.
