Capa

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*  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
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* 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 again...
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