CAPA Decision
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Flowchart to assist in evaluating nonconformance to be elevated to a CAPA ( Corrective Action Preventive Action). FDA requires from their regulated industry to eliminate or reduce risk to the public. In the high risk industry such as Pharmaceuticals and Medical Devices any major nonconformance or customer complaints must be evaluated and if necessary investigated to identify the root cause, place an effective solution to eliminate or reduce risk for the public.
CAPA Decision
- 1. Production Nonconformance Customer Complaint Is it a New Risk? High Health Risk? N High Compliance Risk? N High Frequency (Trend) N N Business Risk exceeds $100,000? Stop N Evaluate the Risk Y Is it a known Cause? Y Y Y Y Was this CAPA investigated ? Y Decide the Action Required, and Document Justification Initiate a CAPA N Investigate the Root Cause Identify Potential Solution N Is a Correction required? Complete the necessary Correction Y Select Effective Solutions Implement the Selected Solutions Evaluate Solution Effectivness Was the Solution Effective? Y N N Y Is this CAPA Still Open? N Y CAPA DECISION