Focusing on symptoms instead of root causes locks teams into a corrective, rather than preventive, mindset. he philosopher George Santayana once wrote, “Those who fail to learn from the past are condemned to repeat it.” This is clearly seen in the way that some pharmaceutical manufacturers approach root cause analysis (RCA) and corrective action and preventive action (CAPA). Both RCA and CAPA are closely intertwined. For example, tracking and trending complaints allows companies to identify recurring problems that may not be caught during inspections on the manufacturing floor, says Kim Jackson, product manager at MasterControl, a vendor of quality management and CAPA software. It also allows them to determine the true severity of specific problems or failure modes, she says. Furthermore, CAPA effectiveness checks ensure that RCA investigations are sufficiently robust, says pharma quality consultant Ajay Pazhayattil. Both concepts are crucial for establishing continuous improvement and a true culture of quality, and achieving the goals established by International Council for Harmonization (ICH) Q 12. Click Here For Complete Article Text
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