Biomedical Engineering Reference
In-Depth Information
the importance of the task; when and where to perform the
activity; and the expected results of correct performance and
the potential results of incorrect performance. Highlight
critical safety points for each task (as needed); also highlight
key cGMP points for each task (as needed). Then
invite questions or concerns. It perhaps goes without saying
that training and development peers should hold their
questions and concerns for a post-session debriefi ng. It can
be quite disruptive if the peers raise questions while the
trainees are present. On the one hand, the trainees can
be confused by the different “spins” on the training
material. Moreover, the exchange between training and
development peers can suggest that there is dissention within
the training unit.
10.6.5 Step 5: Demonstrate each task
(as needed)
This step is particularly important in SOJT sessions. Also in
SOJT sessions, allow the trainee to practice; record the
trainee's progress through the sequence of tasks. It is
important to track trainee progress on an explicitly non-
GMP progress form. Since trainee progress will only be on
part of the module - representing part of a SOP - that
progress cannot be recorded on a controlled (GMP) form.
The non-GMP progress form can be discarded after the
module is completed, after the session is duly recorded on a
controlled training tracking form.
While the trainees are progressing through the sequence of
tasks, provide assistance as needed - while the trainee
prepares for independent performance (for SOJT), and while
the trainee prepares for an assessment (for a classroom
module).
