RAPS Twin Cities Chapter: Root Cause Investigation for CAPA

As defined by Wikipedia, “Corrective and preventative actions (CAPA) are improvements to an organization's processes taken to eliminate causes of non-conformities or other undesirable situations.” In the medical device and pharmaceutical industries, CAPA is often required as part of the quality management system. Root Cause Investigation for CAPA is a proven methodology ideal for investigating any performance change. Some of the most common examples include change in the performance of a product (tangible or intangible), machine or equipment, work process or system (physical or virtual) or escalated consumer complaints.

Based upon 40+ years’ experience, Root Cause Investigation for CAPA integrates problem solving techniques from Total Quality Management (TQM), Six Sigma, Kaizen, DMAIC (define, measure, analyze, improve, control), as well as other techniques to identify:

• Technical root cause(s):  the change(s) that occurred
• Systemic root cause(s): system failures that allowed the change(s) to occur
• Corrective and/or preventive actions: restore performance to previous levels
• Control plan: prevent recurrence

This program is coordinated by the RAPS Twin Cities Chapter and is intended to encourage knowledge sharing and community development. Breakfast will be provided. RAC holders may claim three RAC recertification credits.