ROOT CAUSE ANALYSIS (RCA) & CAPA Methods, Tools and Continuous Improvement
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Description
Root Cause Analysis is a systematic approach to investigating problems and identifying their underlying causes. CAPA is the structured process through which organizations correct identified problems, eliminate their causes and evaluate the effectiveness of implemented actions. Together, RCA and CAPA provide an essential foundation for continuous improvement. This textbook presents the principles, methods and practical applications of RCA and CAPA in a structured manner. It discusses basic quality control tools, advanced analytical techniques, risk assessment, process improvement, documentation, laboratory quality management and industrial case studies. Particular attention is given to pharmaceutical, food, chemical and testing laboratory environments, where process reliability, traceability and regulatory compliance are essential.