It includes the identification, documentation and elimination of a root cause of a nonconformity or problem to prevent the problem from happening again. The 5 Whys is a simple but powerful tool to help determine the root cause of a problem by repeatedly asking why something occurred in various ways until the cause is identified.Ĭorrective Action is the immediate action taken in response to a problem that has already occurred or which has been identified.
CORRECTIVE ACTION PREVENTIVE ACTION TRIAL
The Therapeutic Goods Association’s (TGA) ICH Guideline for Good Clinical Practice (GCP) and the National Health and Medical Research Council (NHMRC): Reporting of Serious Breaches of Good Clinical Practice (GCP) or the Protocol for Trials Involving Therapeutic Goods require the clinical trial Sponsor-Investigator to perform a thorough analysis and implement a Corrective and Preventive Action (CAPA) plan if a serious breach takes place.Ĭorrective Action is reactive, while Preventive Action is proactive and although they both use similar procedures, they are not always used together. Documenting that the Corrective and Preventive Actions has resolved the issue(s).Documenting that the Corrective and Preventive Actions were carried out.Identifying actions to prevent the recurrence of the issue (Corrective Action) and identifying actions to prevent a problem from occurring (Preventive Action).Identifying the root cause of the issue.It also prevents the study data from being compromised. A CAPA plan is crucial to a clinical trial as it helps keep trial participants safe and protects their rights. CAPA (Corrective and Preventive Action) is a quality system plan which aims to resolve compliance issues and to prevent any further recurrences.
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