Product-related quality issues are the most sensitive: they affect customer trust, can lead to costly product returns, and attract increased regulatory scrutiny<\/b>.<\/p>\n
When quality issues arise, the process that takes center stage is called CAPA<\/strong> – Corrective Action, Preventive Action. In other industries, CAPA may also be referred to as corrective actions, root cause analysis (RCA), incident management, or problem management.<\/p>\n The objective of CAPA is simple: address the immediate issue (corrective action) and implement measures to prevent recurrence (preventive action). While the goal<\/em> may be straightforward, your quality systems and processes are often complex – investigations and resolutions can take time, involve multiple stakeholders, rely on excessive and hard-to-analyze data, and suffer from poorly documented decisions. The most complicated problems are often those that weren’t addressed early enough.<\/p>\n To avoid this, companies must regularly review their CAPA and quality processes to ensure people, procedures and information are in place and ready to be deployed if a product recall becomes necessary. Assessing your CAPA process before major problems arise can help you:<\/p>\n\n
When reviewing your CAPA and quality process, focus on these key elements:<\/h2>\n