Framework for continuous improvement - Quality Assurance - page 4

. . . Investigation AIR 1517 dated 21 June 2007 was
opened because HEPA fi lters in the fi lling suite failed
routine recertifi cation. The investigation found metal
particles embedded in several of the HEPA fi lters.
However, no route [ sic ] cause was determined for the
source of the metal contamination found in these
fi lters. 1

■ FDA MAUDE AE Report on Genzyme Biosurgery's
Synvisc Injection dated 4 August 2008: “The [health care
provider] assessed the relationship of the events - swelling
both knees and right knee effusion - to synvisc as probable.
He assessed the relationship of the event - allergic reaction
to synvisc - as likely.” 2
■ McNeil Consumer Healthcare recalled bottles of Tylenol
eight-hour caplets after some consumers complained of a
musty or moldy odor in the product. 3

The outcome of an investigation can be followed by the
development and execution of corrective actions and
preventive actions (CAPA). The logic of this investigative
and revising process may be more or less explicit in
the various regulated industries, but the underlying logic is
the same.
Briefl y put, a CAPA can identify several kinds of
remediation for a given observation. Some remediation
implicates the revision of a standard operation procedure
(SOP); other remediation does not. This chapter focuses on
the range of intervention and remediation, giving special
attention to those that lead to the revision of procedures.
Following an initial section of this chapter that addresses
the function of SOPs and the revision of life-cycle documents,
the second section discusses the routine review of procedures.
This set of routine practices should be juxtaposed to the set

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