Enhancing CAPA Through Continuous Improvement
PROACTIVE QUALITY MANAGEMENT FOR LIFE SCIENCES
In the life sciences industry, regulatory compliance is non-negotiable, and the pressure to manage quality effectively has never been greater. With 30-50% of FDA-483 citations stemming from CAPA deficiencies, organizations must adopt strategies that go beyond reactive problem-solving.
NPG’s DMAIC/CAPA integration offers a structured, data-driven approach to addressing these challenges. By embedding the define, measure, analyze, improve, and control (DMAIC) methodology into CAPA processes, businesses can move from resolving immediate issues to creating a culture of continuous improvement.
Key Benefits of a DMAIC/CAPA System:
- Root Cause Analysis: Proactively identify and mitigate systemic issues, preventing recurring non-conformities.
- Improved Compliance: Align CAPA processes with FDA and international regulatory requirements to reduce risks of citations.
- Long-Term Efficiency: Enhance organizational processes with Lean Six Sigma principles to drive sustained performance.
