21 CFR 820.100(a)(2)

Each manufacturer shall establish and maintain procedures for implementing corrective and preventive action. The procedures shall include requirements for:


(2) Investigating the cause of nonconformities relating to product, processes, and the quality system.





CAPA Investigation Phase

The CAPA Investigation Phase requires comprehensive Root Cause Analysis (RCA) of any issue / signal judged significant, and resulting in one or mores CAPAs during the Analyze Phase. The goal is to identify the causes of undesired outcomes; e.g. behaviors, actions or conditions that must be corrected to prevent recurrence. The analysis must consider quality systems and processes. The issues are often multi-dimensional and caused by a combination of root causes.  To be effective, the analysis must go beyond the symptoms of the issue or problem and identify all potential root causes.


This detailed analysis can take many forms.  The most commonly used analysis models include:


  • Fault Tree
  • Failure Mode Effect Analysis
  • 5 Why's
  • Cause and Event Factors / Fishbone
  • Is / Is Not method
  • Change Analysis
  • Pareto Charts
  • Tree Diagrams.


The ExtraView Difference


ExtraView Enterprise is well suited to lead your analysts through your preferred Root Cause Analysis method(s).  More importantly, it captures the critical output of that process; i.e. causal factors which leads to the Identification Phase.



Example Screens from Customer Implementations


  • Reporting & ChartingLeverage reports and charting to analyze trends & identify root causes
  • 5 WhysCompletely Configurable Screens
  • ChartingDraw pie, line, bar, stacked-bar, area charts
  • Root Cause AnalysisThoroughly investigate issues
  • Fully Configurable WorkflowDesign the screens the way you want to work



Learn About Other CAPA Phases

Select any of the puzzle pieces below to learn more about how ExtraView Enterprise meets your business requirements in that specific CAPA area.  For a synopsis of ExtraView’s role in the entire CAPA process, see the ExtraView CAPA Functionality Matrix.