Biomedical Engineering Reference
In-Depth Information
standards and regulations. However, prior observations that
the location of the standard weight on the balance pan
affected weight data suggested that the calibration procedure
should be more carefully controlled. A target weight location
“
X
” was inscribed in the balance pan to better defi ne the
placement of the standard weight for calibration. This
change necessitated a revision to the calibration SOP used by
calibration technicians.
As the weighing procedure was reviewed, the following
revisions were indicated:
■
Requirements to use the specifi ed balance in the new
weighing facility for weighing of analytical standards;
■
New steps for correct operation of the protective shield
enclosure around the balance weighing pan;
■
Requirement to place sample to be weighed on the target
“
X
” location on the balance pan.
The revised procedures were drafted and critically reviewed
by a step-by-step real-world challenge.
This section discussed the review and revision of SOPs as
part of the implementation of a more general CAPA project.
It focused especially on the revision of the calibration SOP
and the critical review that was part of this revision. The
next section addresses the testing of the effi cacy of the CAPA
and the documentation of the results.
3.4.4 Testing and documenting the changes
As Gamal Amer has put it, a successful CAPA must “make
necessary changes to reduce risk or eliminate it.” Moreover,
it is necessary to “track and evaluate the actions taken to
ensure that no additional or different risk was introduced.”
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This calls for the testing of the effi cacy of the changes made,
