Biomedical Engineering Reference
In-Depth Information
so as to enable that person to perform the assigned functions.
As the process and procedures change, the impacted
employees must be trained in a timely fashion. Hence the
critical issues of timing attending the rollout of a fi nalized
training module.
13.3 The typical organizational
response
In many cases, an organization will realize that it must take
further steps to ensure that employees are trained on the
relevant SOPs before they touch the regulated product.
Sometimes this is a result of a deviation investigation or an
audit observation. Other times it may be the result of cost
considerations, seeking to reduce rework and reprocessing,
or because of compliance concerns. In any case, a typical
response is to develop a new SOP that calls upon supervision
to check the employee's training status. We will refer to such
a controlled document as a “Task Assignment Procedure.”
Such a procedure might require that the supervisor ensures
all necessary training and qualifi cation requirements have
been completed and documented prior to permitting an
employee to work independently. This check is typically
performed by looking at the employee's training record in
the validated tracking system or LMS during task scheduling.
If employees have been trained on all the procedures listed in
their curricula, the supervisor can make the task assignments.
What if the supervisor makes a mistake in checking the
training records? What if the supervisor is not diligent, or
overlooks a particular employee, or misses a page of the
training record? Referring again to the Red Cross example,
where the employee was not trained before touching the
product, the Red Cross concluded that “the Education
