Root Cause Analysis A Step by Step Guide
Root Cause Analysis A Step by Step Guide
Root Cause Analysis (RCA) is a structured approach to identify and address the underlying causes of problems or issues. It
helps prevent similar problems from happening again by addressing the root cause, not just the symptoms.
QA Compliance Team
Understanding the Problem
What Where When
Clearly define the problem Determine the location or context Establish the timeframe of the
statement. What is the issue or where the problem occurred. problem. When did it happen? Was
event that occurred? Where was the issue? it a one-time event or a recurring
issue?
Gathering Data
Interviews Documents
Conduct interviews with Review relevant documents,
relevant stakeholders to records, and reports to gain
gather their perspectives. insights.
Observations
Observe the process or system in question to identify potential
contributing factors.
Analyzing the Data
2 People
3 Processes
4 Environment
5 Materials
Brainstorming
1 Group Discussion
Engage in a collaborative brainstorming session to generate
a wider range of potential causes.
2 Open Mind
Encourage participants to think outside the box and consider
unconventional possibilities.
5 Whys
1 What was the initial problem?
Propose Solutions
Develop specific actions to address the root cause.
Evaluate Solutions
Assess the feasibility, effectiveness, and cost of each
proposed solution.
Implementing and
Monitoring
1 Execute the Corrective Actions
Put the chosen solutions into practice.
2 Monitor Progress
Observe how effectively the solutions are working.
3 Adapt as Necessary
Refine the plan based on the monitoring results.
Benefits of RCA
Root cause analysis (RCA) offers significant benefits in problem-
solving and decision-making.
1 2
Key Insights Next Steps
Summarize the key findings from the RCA process. Outline the follow-up actions and recommendations.