Biomedical Engineering Reference
In-Depth Information
In the case of a CAPA project, management appoints an
employee responsible for executing the CAPA, typically a
SME, and also stipulates the due date for the completion of
the CAPA project.
The project lead will fi rst review the documentation
associated with the just completed investigation as well as
the documentation of related CAPAs.
Second, the project lead will develop a template that will
facilitate the comparison of the currently existing program -
the object of the investigation, the RCA, and the CAPA -
with the desired (revised) program. The comparison can be
facilitated by casting the program and the proposed preventive
action into the framework of a program logic model.
8
Suppose that an observation was made for a cleaning and
sanitizing program. The levels of bioburden in controlled areas
was outside acceptable limits. The investigation found that the
specifi ed sanitizing solution was too weak. The proposed
remediation was to increase the concentration of the solution.
The elements of the CAPA are displayed in Table 2.7.
The program for cleaning and sanitizing of controlled
areas illustrates the role of CAPA (Figure 2.6). Under
Inputs
are included the input measures such as the cleanliness of
controlled areas as well as the determination of bioburden of
controlled areas. Other inputs include the various cleaning
and sanitizing materials (e.g., cleaning agents, sanitizing
agents, isopropyl alcohol, mops and mop buckets, cleaning
carts, etc.) The
Input Criteria
for these measures are visually
determined soiling of surfaces in the controlled area, and
environmental monitoring (EM) data indicating unacceptably
high levels of microbial contaminants. These criteria identify
the “gap,” mentioned earlier, that is the observation that
triggers intervention and remediation. The input criteria also
include the various approvals of the listed cleaning and
sanitizing materials.
