Capa

* What is CAPA? Corrective and Preventative Action (CAPA) is a system of quality procedures required to eliminate the causes of an existing nonconformity and to prevent recurrence of nonconforming product, processes, and other quality problems. * 4. Terminology * Nonconforming Material or Process (Discrepancy) - Any material or process that does not meet its required specifications or documented procedure. * Correction – Refers to repair, rework, or adjustment and relates to the disposition of an existing nonconformity. * Corrective Action - To identify and eliminate the causes of existing nonconforming product and other quality problems. * Preventive Action - To identify and eliminate the causes of potential nonconforming product and other quality problems. * 5. Seven Quality Subsystems

* 6. Components Of Corrective And Preventive Action (CAPA) * Collect and analyze data to identify nonconforming product and other quality problems * Investigate cause * Identify and implement corrective and preventive action * Verify or validate effectiveness * Communicate information about quality problems, changes made, outcomes, and trends to those persons directly responsible and to the staff in general * Forward information for management review * Work with staff and management to produce continuous quality improvement * 8. Quality Data Sources * * 9. CAPA Case Studies * Weak CA, Weak PA (Common) * Weak CA, Strong PA (Unusual) * Strong CA, Weak or Unlinked PA (Common) * Strong PA Linked to a Strong CA (Ideal) * . Case Study No. The company develops biopharmaceuticals The company has a CAPA program A review of existing internal and external audits reveal that: nonconformities are documented corrections are proposed (a temporary or permanent change, repair, rework, or scrap) corrections made are timely but the same nonconformities seem to reoccur over and over