Biomedical Engineering Reference
In-Depth Information
1.4.1 Management notifi cation
The fi rst kind of observation is made by an employee who is
not necessarily (or even usually) an auditor. This is an internal
observation of an event or situation that may constitute a
business risk or quality risk. This can be an observation of
either an exceptional event or a routine activity.
Any organization whose processes are “in control” will
have an administrative SOP, call it “Management
Notifi cation,” that requires an employee to inform
supervision of any event or situation that may impact the
SISPQ of the product or constitute a business risk. FDA
stipulates that it is the “person responsible for supervising”
who must provide assurance of the SISPQ of the regulated
product.
10
And supervisory personnel and management can
only provide that assurance if they are notifi ed of threats to
the SISPQ of the product in a timely fashion. Management
must be informed within a specifi ed time frame so that
appropriate action can be taken (Table 1.4).
The employee's observation will prompt one or more of
the following responses from the manager. First, the manager
may triage and dismiss the event as insignifi cant. Second, the
Table 1.4
Fields in typical Notice of Event form
1.
Title of this event
2.
Name of employee who observed this
3.
Associated Quality Management System (QMS) tracking number(s)
4.
Department where event was observed
5.
Shift when event was observed
6.
Date of discovery
7.
Date of event occurrence (if known)
8.
Employee involved in event
9.
Other personnel involved
10.
Symptom (problem type)
11.
Attached fi les
