Biomedical Engineering Reference
In-Depth Information
10. SPECIAL
INSTRUCTIONS:
Instructions to facilitate the preparation and
execution of the event (e.g., safety issues,
logistical requirements, pre-work, handouts,
etc.)
11. MEASURES of
EFFECTIVENESS:
The KTA (and answer sheet) or SDA should
be attached. The content of the KTA or
SDA is derived from the Behavioral
Objectives.
12. APPROVAL:
Includes dated signatures from:
■
Originator
■
Department Management and/or Business
Owner
■
Quality Unit
also in the list of Task Responsibilities within the SOP itself.
Unfortunately, these two lists of personnel do not always
coincide.
Precisely defi ning the training audience becomes critical
because those are the personnel who must be trained on the
training module associated with the new or revised SOP.
After a new or revised SOP has been approved, there is a
“training window” before the procedure goes into effect,
within which the impacted personnel can be trained on the
SOP. This window is typically a week or two in length. It is
critical that the training audience be defi ned before that
window opens - before the SOP is approved - so that all the
training will be completed before the effective date. Thus the
risk of untrained personnel “touching” the regulated product
will be minimized.
When the training module is in the Design phase, the
author of the module can provisionally prepare a Target
Audience List based on a review of the SOP Scope Statement
as well as the Task Responsibilities. When the Training
Outline is circulated for approval, the Target Audience List
