When a deviation or nonconformance event involving a key metric occurs, all activities and actions taken in response to the deviation should be elevated. The root cause analysis investigation should be conducted as soon as is feasible and should involve multiple departments and levels of management within the organization. Corrective actions and preventive actions will likely be multi-faceted and should include retraining of all departments involved in the deviation. Because of this, corrective actions and preventive actions taken in response to a deviation involving key metrics will likely take longer to identify and implement.
An important step of the CAPA process involving a key metric is the follow up to verify the corrective and preventive actions. All actions taken in response to the deviation must be verified as fully implemented by management to ensure that the measures put in place remain effective.
In our next video in the CAPA series, we discuss impunity and disciplinary actions in CAPA programs.
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