QMS Consulting, Inc.

	CAPA (Corrective Action and Preventive Action) continues to be an area of emphasis during FDA Inspections and Notified Body audits. An effective CAPA system will enable your company to achieve its compliance and regulatory obligations and improve your ability to meet business goals.
	ESTABLISH ACTION LIMITS - define criteria - assess risk - prioritize	DEFINE THE PROBLEM - State the problem in measurable terms (how often, how much, where and when) - Emphasize the effects (risk) of the problem