A company recently received this 483 observation regarding internal audits:
ā¦..Individuals who conduct quality audits have direct responsibility for the matters being audited.
Specifically, my review of the firmās internal audit schedule revealed the individual conducting the quality audits were auditing Quality System areas they were responsible for.
According to 21 CFR 820.22 – Quality Audits …”Quality Audits shall be conducted by individuals who do not have direct responsibility for the matters being audited.”
In other words, the individual responsible for the system cannot be the same individual that is conducting the internal audit.
According to the FDA’s report an “internal audit procedure should be developed and documented to ensure that the planned audit schedule takes
into account the relative risks of the various quality system activities, the results of previous audits and corrective actions, and the need to audit the complete system.” Part of this procedure should include team assignment. While the manager responsible for audited area should to take timely action to resolve audit findings, they cannot be the same individual who is conducting the audit.
For more observationsĀ pertaining to medical devices, seeĀ Issue 1043Ā available today.Ā It also has observations pertaining to lab controls, manufacturing controls, and APIs.
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