A formal document employed to address deviations from established standards, procedures, or requirements. It outlines the identified problem, its potential cause, and the actions planned or taken to prevent recurrence. For instance, if a manufacturing process consistently produces defective parts, this document initiates an investigation and implementation of solutions to eliminate the root cause of the defects.
This mechanism is vital for continuous improvement, ensuring adherence to quality standards, and minimizing risks. Historically, its roots lie in quality management systems and have evolved to become a core component of regulatory compliance across various industries. Its proactive nature contributes to operational efficiency, cost reduction, and enhanced stakeholder confidence by preventing future issues.