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White Papers / Tech Papers

Beyond CAPA: Using Risk Assessment to Streamline your Quality System

Released By ETQ

CAPA has Become a Catchall.
With all the processes associated with managing a quality and compliance management system, Corrective Action and Preventive Action (CAPA) is a prominent feature. In many cases, if an event is found in the system, a CAPA is generated. No matter the scope or severity, CAPA is the ultimate catchall for events in the system.

The result—thousands upon thousands of CAPAs, with varying degrees of severity, assigned in the order they were created, like a pile of virtual papers stacking up on the QA manager’s inbox. This becomes a problem when the “critical” CAPAs (those events that have the most impact on the business as a whole),become lost in the pile, hidden among non-critical, immediately correctible events, and virtually invisible to the enterprise.

This paper describes a new risk-based methodology that will effectively reduce CAPAs as a whole. By employing this methodology, crucial CAPAs are extracted to determine the overall business impact, correct the problem, and implement the change throughout the enterprise.

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