21 CFR 820 - 820.22 Quality audit

Original text

Expert opinion

Each manufacturer shall establish procedures for quality audits and conduct such audits to assure that the quality system is in compliance with the established quality system requirements and to determine the effectiveness of the quality system. Quality audits shall be conducted by individuals who do not have direct responsibility for the matters being audited. Corrective action(s), including a reaudit of deficient matters, shall be taken when necessary. A report of the results of each quality audit, and reaudit(s) where taken, shall be made and such reports shall be reviewed by management having responsibility for the matters audited. The dates and results of quality audits and reaudits shall be documented.

For manufacturers of medical devices, the QSR demands that procedures are established (in writing) for audits. The audits must be conducted to assure that the quality system is effective in compliance with the QSR.

The QSR demands an unbiased auditor for internal audits, which is not involved in the audited matter. This allows to have external auditors used for internal audits.

Any conducted internal audit must be summarized in an audit report. In case of deviations, appropriate actions should be defined potentially in corrective and preventive (CAPA) measures. CAPA measures shoul dbe reaudited for implementation and effectiveness.

Management, as being resposible, must be informed on audits and potential actions derived thereof. It is recommended to implement an audit database to log each audit including derived tasks, task owner, due date, reaudit measures and effectiveness checks.

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