Definition

Root Cause Analysis(RCS) is a method that is used to address a problem or non-conformance, in order to get to the “root cause” of the problem. It is used so we can correct or eliminate the cause and prevent the problem from recurring.

Key Attributes: ROOT CAUSE
• The causal or contributing factors that, if corrected, would prevent recurrence of the identified problem

• The “factor” that caused a problem or defect and should be permanently eliminated through process improvement

• The factor that sets in motion the cause and effect chain that creates a problem and is identified and eliminated

• The “true” reason that contributed to the creation of a problem, defect or nonconformance has been eliminated or controlled

Traditional Applications of Root Cause Analysis:
• Material Review Board
• CAPA Investigations
• Process Development
• Equipment Development
• OOS/OOT Investigations
• Customer Complaints
• Audit Observations

How do we do Root Cause Analysis?
Said simply, Root Cause Analysis is asking why the problem occurred and then continuing
to ask why that happened until we reach the fundamental process element that failed.

Approach of RCA