Biomedical Engineering Reference
In-Depth Information
TABLE 13.1 Change Control Screening Criteria
Type of Change
Alternate Documentation System
Changes that do not impact a CGMP system
Maintenance work order
Changes that occur during commissioning,
before completion of the initial system
installation qualification (IQ)
Final IQ; ECR
Change that are allowed per established
operating procedures (PM, calibration, etc.)
Equipment use log, maintenance
work order, calibration record, PM
record, ECR, etc.
request is then reviewed and the reviewer may request more information from
the initiator.
The reviewer also performs an initial risk evaluation to screen out any change
requests that do not need to be handled through this formal system. This step
adds value, as handling changes through the formal change control system may
consume more resources than handling them by other means.
Changes can be screened out from the formal change control system for two
basic reasons (Table 13.1). First, changes that do not impact product quality or
regulatory compliance, such as changes to non-GMP areas (such as nonprocess-
ing areas, maintenance shop, and certain plant utilities such as electricity) are
out of scope . Second, changes that are specifically allowed per approved stan-
dard operating procedures (SOPs) can also be eliminated, provided that these
SOPs were developed using QRM concepts. One example is the calibration and
preventive maintenance (PM) system. Established calibration procedures allow
adjustment of the sensor, provided it was not outside of the preestablished toler-
ance. Maintenance procedures typically allow replacement of normal wear items
using approved spares, and documentation may be performed through the mainte-
nance work order system and equipment log books. A further example is change
that occurs before the installation qualification of a system. As long as the user
requirements specifications (URSs) have not changed, it may be acceptable to
document these changes through the engineering change request (ECR) system,
if the company SOPs permit. Table 13.1 shows the kinds of changes that might
be processed outside of a formal change control system via procedural (SOP)
controls.
Change requests that pass the screening criteria are then reviewed by a cross-
functional change review team. The team performs a detailed review of the
change request, supporting documentation (including any existing risk assess-
ments), and especially the proposed change implementation plan, to assure that
all considerations have been made to protect patient safety by maintaining prod-
uct quality and regulatory compliance. The change review team members (which
typically include representatives from the owning department, quality assurance
(QA), quality control, operations, engineering, technical support, and regulatory
affairs) look at the change request from their individual areas of expertise to
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