What are the most common mistakes when implementing corrective actions from an audit or inspection?

Описание к видео What are the most common mistakes when implementing corrective actions from an audit or inspection?

There is a requirement for taking corrective action without undue delay for any internal audit finding, but what are the 6 most common mistakes when implementing those corrective actions?

1. Failure to initiate containment, corrections, or corrective actions (or all 3).
2. Forgetting to reference the source of the CAPA.
3. Inadequate investigation of the quality issue to identify the root cause.
4. Creating a corrective action plan that is not risk-based.
5. Failure to complete the CAPA before the next audit.
6. Failure to complete an effectiveness check before the next audit.

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The general topic for October is quality auditing. The topic for November will be CAPAs. The topic for December will be supply-chain management. We also will have a bonus live streaming video next week on the topic of the new FDA eSTAR guidance.

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