Abstract
The chapter reviews corrective action and preventive action (CAPA) for the pharmaceutical industry. It discusses different approaches to completing a CAPA, using as few as five to as many as nine steps. Most of the chapter discusses and demonstrates the use of various quality tools and techniques that can be used to complete the CAPA process. The tools discussed include brainstorming, check sheets, root cause analysis (RCA), Pareto chart, flowchart, histogram, cause-and-effect diagram, scatter diagram, run chart, control chart, Kepner–Tregoe problem analysis, nominal group technique (NGT), 5 WHYs, failure mode and effects analysis (FMEA), decision matrix, process capability, and descriptive statistics.
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