Topics: Quality, Management, Root cause analysis Pages: 2 (464 words) Published: January 11, 2013
*  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 again...
Continue Reading

Please join StudyMode to read the full document

You May Also Find These Documents Helpful

  • Robert Capa Essay
  • Robert Capa Essay
  • Robert Capa- Photojournalism Essay
  • Capa Report Essay

Become a StudyMode Member

Sign Up - It's Free