Root Cause Analysis: How It Informs CAPA || Understanding Root Cause Analysis in the CAPA Process

RCA (Root Cause Analysis) and CAPA (Corrective and Preventive Action) are two different but related processes used to solve problems, especially in manufacturing and quality management. RCA is the systematic process of identifying the root cause or underlying reason for a problem, while CAPA is the structured approach that implements both corrective actions (to fix the immediate issue) and preventive actions (to stop it from happening again).
Root Cause Analysis (RCA)
What it is: A method for identifying the fundamental cause of an event or problem.
Purpose: To get to the bottom of why a problem occurred, not just what happened.
Examples: Using techniques like the "5 Whys" or Pareto Analysis to drill down to the origin of a quality defect, a safety incident, or an inefficiency.
Corrective and Preventive Action (CAPA)
What it is: A systematic process for documenting problems, investigating their root causes, and implementing actions to prevent their recurrence.
Purpose: To fix the current problem and prevent future occurrences.
Components: It has two parts:
Corrective Action: Actions taken to fix the immediate problem and its consequences.
Preventive Action: Actions taken to prevent the problem from happening again in the future.
Relationship to RCA: RCA is an essential first step within the CAPA process. It provides the necessary information about the root cause that then informs the development of effective corrective and preventive actions. what is rca and capa,
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