How you did the investigation, RC and CAPA?

Question

Accepted Answer

I conducted investigations, root cause analysis (RCA), and corrective and preventive actions (CAPA) by following a systematic approach.

I started by gathering all relevant information and data related to the issue.
I conducted interviews with involved parties to gather their perspectives and insights.
I analyzed the data and information to identify potential root causes.
I used tools such as fishbone diagrams, 5 Whys, or Pareto analysis to determine the most probable root cause.
Once the root cause was identified, I developed and implemented appropriate corrective and preventive actions.
I ensured that the CAPA plan was communicated to all relevant stakeholders and that they understood their roles and responsibilities.
I monitored the effectiveness of the implemented actions and made adjustments if necessary.
I documented the entire investigation process, including the RCA and CAPA, for future reference and audit purposes.

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