Certified Pharmaceutical GMP Professional Practice

What is the first step in conducting root cause analysis?

1. Collecting data and evidence

2. Identifying all contributing events

3. Defining the problem

4. Designing risk reduction strategies

The correct answer is: Defining the problem

Defining the problem is the essential first step in conducting root cause analysis. This initial step sets the foundation for the entire process by clarifying what exactly the issue is that needs to be addressed. A well-defined problem statement helps focus the analysis, guiding the investigation to ensure that all relevant factors are considered. It enables the team to determine the scope of the analysis, clarifying any ambiguities and ensuring that all stakeholders share a common understanding of the issue. Once the problem is clearly defined, it becomes easier to collect data and evidence, identify contributing events, and ultimately design strategies for risk reduction. Clarifying the specific problem narrows down the context within which data is gathered and analyzed, making the subsequent steps of the root cause analysis more effective and targeted.