Biomedical Engineering Reference
In-Depth Information
warranted, the complaint moves to the quality lab or other
location where more tests are conducted and evaluations
made. Finally, the fi ndings and recommendations of the
investigation are reported, routed through the approval
process and fi nalized, and the fi le is closed. Insofar as the
remediation following from the investigation includes the
revision of an operational SOP, the customer quality
complaint initiates the chain of events that lead to the
revision.
1.6 Conclusion
This chapter has considered the occasions that lead to re-
engineering of GMP processes and, under certain conditions,
the revision of SOPs. Five groups of stakeholders in the
sphere of FDA-regulated industry are identifi ed. Particular
kinds of observations that can occasion intervention tend to
be associated with each of these stakeholders. While there is
some overlap between them, escalated events tend to be
associated with employees, internal audits with auditors,
Form 483 observations with regulatory investigators, AEs
with health care providers, and customer quality complaints
with patients.
The observations initiate an investigation and remediation
process that varies in emphasis but that has an underlying
logic. An observation is typically escalated, triaged, and can
become a record of interest in the organization's QMS. That
record can become the basis of an investigation and RCA. It
can also become part of a set of records of similar events that
are tracked and trended, and investigated further. When the
investigation is concluded, remediation can be proposed in
the form of CAPA. The remediation is approved and enacted,
and may include the revision of an SOP. Thus the initial
