Certified Pharmaceutical GMP Professional Practice

What is the final step in root cause analysis?

1. Defining the problem

2. Implementing the risk reduction plan and monitoring effectiveness

3. Collecting data and evidence

4. Assessing employee performance

The correct answer is: Implementing the risk reduction plan and monitoring effectiveness

The final step in root cause analysis is to implement the risk reduction plan and monitor its effectiveness. This step is crucial as it ensures that the actions taken to address the identified root causes are not only executed but also evaluated for their effectiveness in preventing recurrence of the issue. This monitoring phase allows for adjustments and improvements to be made to the plan if necessary, thereby ensuring that the solutions are both practical and impactful. Implementing the risk reduction plan provides an opportunity to apply learned lessons from the analysis process and reinforces a culture of continuous improvement within the organization. By closely monitoring effectiveness, organizations can confirm whether the corrective actions are producing the desired outcomes or if further measures are needed, closing the loop on the entire root cause analysis process. This step emphasizes the importance of ongoing evaluation in maintaining compliance and ensuring product quality within a GMP environment.