Biomedical Engineering Reference
In-Depth Information
If there is a correction to a log entry, the erroneous entry
will be struck out with a single line using a black (or blue)
ink pen, the correction will be entered, and initialed and
dated. The cleaning and sanitizing logs for each room will be
reviewed by the supervisor of the cleaning and sanitizing
staff according to the review schedule. After determining
that the logs are complete and correct, the supervisor will
countersign and date. The logs countersigned by supervision
will be reviewed by quality control (QC) staff. After
determining that the logs are complete and correct, the QC
staff member will countersign and date. The completed,
countersigned and dated logs will be retained by the
maintenance department.
According to FDA regulations, it is the supervisors who
must perform assigned functions in such a manner as to
provide assurance that the regulated product has the SISPQ
that it purports or is represented to possess. The CFR
indicates that non-supervisory personnel, by contrast, must
simply perform assigned functions. Thus the personnel
responsible for the effi cacy of the cleaning and sanitizing
activities are supervisors, not operators.
8
Cleanliness of facilities and equipment is typically
determined by visual inspection.
9
Visual cleanliness is defi ned
as the absence of visible residue. Factors that can impact the
perception of visual cleanliness include the observer's
distance from the surface, the viewing angle, light intensity,
the color of the residue and the surface color, human
differences in eyesight, etc.
10
The adequacy of the cleaning
program should be investigated, should visual inspection
indicate residue remaining after cleaning.
Environmental monitoring (EM) data indicate the quality
of the sanitizing activities. Each air and surface sample must
be evaluated by comparison to the established alert or action
levels. This comparison as well as monitoring schedules,
