CAPA, Root Cause Analysis & Problem Solving
CAPA, Root Cause Analysis & Problem Solving
Addressing Root Causes Rather Than Treating Symptoms
Recurring deviations, ineffective corrective actions, and poorly understood failure mechanisms are among the most significant challenges in quality management.
An effective CAPA process must go beyond documenting deviations. It should ensure that problems are appropriately investigated, root causes are systematically evaluated, and implemented actions are verified for effectiveness.
Avary Consulting supports companies in developing and optimizing structured Corrective and Preventive Action (CAPA) processes.
We consider applicable requirements under ISO 13485, the FDA QMSR, and, where relevant, pharmaceutical GMP regulations.
Our services include:
- Structured investigation of quality deviations
- Systematic root cause analysis
- Application of 5 Whys, Ishikawa diagrams, and appropriate statistical techniques
- Development of risk-based corrective actions
- Planning and evaluation of CAPA effectiveness checks
- Analysis of recurring deviations and quality trends
- Improvement of existing CAPA processes
Your Business Value: Sustainable defect prevention, more effective corrective actions, and a stronger culture of quality and regulatory compliance.