Biomedical Engineering Reference
In-Depth Information
1.4.2 Quality audit observation
Any organization whose processes are “in control” will have
a QA unit that is responsible for approving or rejecting
the procedures, protocols, and specifi cations that impact the
SISPQ of the product.
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That unit must monitor the
organization's compliance with these operational SOPs,
which entails responsibility for quality audits and “reaudits
of defi ciencies.”
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A quality auditor, at the conclusion of the audit, will
document audit fi ndings (i.e., observations) and report these
to the manager of the unit that was audited. The manager
will identify a responsible person to undertake or oversee
whatever investigation and RCA is required. In the real
world of limited resources, Lee Vanden Heuvel and Christine
Robinson point out that an investigation must balance the
costs of the effort against the expected benefi t of identifying
the root cause.
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Typically, an investigation includes the following main
steps:
■
Identify the problem;
■
Evaluate the information, assess risk, take immediate
remedial action;
■
Investigate and assign responsibility;
■
Analyze and document the root cause.
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FDA also stipulates that when an investigation is called for
under 21 CFR 211.192 and is not conducted, “the written
record shall include the reason that an investigation was
found not to be necessary and the name of the responsible
person making such a determination.”
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When the
investigation is complete, the responsible person will then
prepare a CAPA plan to address the observations, along the
