Who is this for?
Owner - completing the effectiveness assessment
How to do it
When the Execution phase has been approved, the CAPA moves to Pending Effectiveness Check. If Assess effectiveness is enabled for the CAPA type, an effectiveness check task is scheduled within the configured due period (for example 30 days) and becomes available. If it is not enabled, the CAPA is completed on closure.
In this step the CAPA Owner verifies whether the corrective and preventive actions were effective. The effectiveness assessment is mandatory and cannot be bypassed.
From My Work, open the effectiveness check task and select Effectiveness Check.
Answer Was the CAPA effective? and record the effectiveness assessment, then select Submit Evaluation.
Enter the justification and select Submit. In Action Confirmation, select Approve and Sign and enter your account credentials.
The Effectiveness Check.
Effectiveness Check
Field name | Description | Note |
Was the CAPA effective? | Yes or No. |
|
Effectiveness assessment | The effectiveness of the corrective and preventive actions, recorded in detail. | Part of the permanent CAPA record. |
Justification | The justification recorded when submitting the evaluation. | An electronic signature is required to submit. |
When the CAPA is effective, it becomes Effective.
When it is not effective, see Reopening the CAPA if not effective.
❗Effectiveness is a distinct, evidence-based conclusion. A verification that the actions actually prevented recurrence. This is not a repeat of the approval already given in Execution. Base the answer on objective evidence gathered over the due period (for example recurrence data or monitoring results) and record the justification. A 'Yes' without evidence is exactly what an assessor probes.
❗To remain compliant, ensure that some form of effectiveness check is performed even if the system setting based check is disabled. This could be in the form of a Quality Document linked to the CAPA.
💡Tip: Set the effectiveness due period to a window that can actually show whether recurrence stopped. Set this too short and you are risking signing off before there is anything to measure.