Quality audits must occur on a regular basis, but you must be careful as to who is actually conducting these audits. It is not enough that the person is qualified to conduct the audit, but that person cannot also be responsible for the matters being audited. To avoid conflicts of interest, quality audits could be conducted by a qualified third party.

FDA Quality Audits

21 CFR 820.22 states: Quality audits shall be conducted by individuals who do not have direct responsibility for the matters being audited. 

A medical device company received this 483 observation: 

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

Specifically, your Vice President of Regulatory Affairs indicated that she is responsible for conducting all areas of your firm’s quality system audit, including the departments that she is directly responsible for.

Be sure that the person assigned to auditing is documented in your written procedures as well as the process for corrective action and re-auditing. These audits, and any necessary re-audit, should includes dates in your log.

For more details on this observation as well as other observations pertaining to Medical Device Manufacturers see Issue 1016 available today.  It features observations pertaining to Data Integrity on our rotating page 3 topic as well as Laboratory Controls and Manufacturing Controls.

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