Biomedical Engineering Reference
In-Depth Information
Because SOPs must be and are constantly revised in a
controlled fashion, it will prove useful to identify the various
kinds of events and situations that may call for the revision
of procedures. Neither an event nor a situation automatically
calls for intervention; these must be labeled as “events or
situations of interest” by an appropriate administrative
procedure.
There are two fundamental kinds of occasions for revision:
routine review of life-cycle documents and revision due to
observations of a non-conformance, etc. In turn, there are
fi ve main kinds of observations - those that follow from
escalated events, from internal audits, from regulatory (FDA)
inspections, from AEs, and from customer quality complaints.
These fi ve kinds of observations correspond to the fi ve
stakeholder groups identifi ed previously, and are displayed
in Table 1.2.
A complex decision process lies between observation and
intervention. Any one of the fi ve kinds of observations may
bring about an investigation. An observation is typically
escalated, triaged, and may or may not become a record of
interest in the organization's quality management system
(QMS). It is the QMS record that may or may not become
the basis of an investigation and RCA. The record can also
become part of a set of similar records that can be tracked
Table 1.2
Correspondence between roles and observations
Major Roles
Kinds of Observations
Operational staff and supervisors
Escalated events
Quality unit auditors
Internal audits
Regulatory investigators
Form 483 observations
Healthcare providers
Adverse events
Patients
Customer quality complaints
