Biomedical Engineering Reference
In-Depth Information
Figure 4.2
Actions and responsibilities
decision points and potential controls. Implement this
fl owchart. Then use mock audits or test runs to assess
the controls and the business fl ow. Refi ne and test
again . . . Finally, write and wordsmith the detail behind
the fl owchart.
3
How will the content of the fl owchart be assembled? There
are several options - employee behavior can be directly
observed, critical incidents can be reviewed (a case-study
approach), questionnaires can be developed (and, if so,
can be distributed to various employees), subject matter
experts (SMEs) can be interviewed, etc. An illustrative
fl owchart for a Notice of Event (NoE) is shown in Figure 4.3a
and deviation investigation process is shown in Figure 4.3b.
The risk levels for the illustrative event range from 1 = highest
to 3 = lowest.
Once the fl owchart has been fi nalized, and approved by
management, it can be translated into the documentary form
of the SOP. Many times, this translation will amount to the
discursive writing out of the process map captured in Visio.
Any time the documentary form deviates from the process
map, the latter will prevail.
Approvals
is the third section of the procedure, allowing
each employee who must approve the procedure to do so
(Figure 4.4).
