Are you conducting your internal audits properly?

A company recently received this 483 observation:

…..Individuals who conduct quality audits have direct responsibility for the matters being audited.

Specifically, my review of the firm’s 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.”

For more observations pertaining to medical devices, see Issue 1043 available today.  It also has observations pertaining to lab controls, manufacturing controls, and APIs.

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