Corrective and Preventative Action
From Wikipedia, the free encyclopedia
Corrective and Preventive Action or Corrective and Preventative Action (CAPA) is a concept within Good Manufacturing Practice (GMP). CAPA focuses on the systematic investigation of discrepancies (failures and/or deviations) in an attempt to prevent their reoccurrence. To ensure that corrective and preventive actions are effective, the systematic investigation of the failure incidence is pivotal in identifying the corrective and preventative actions undertaken. CAPA is part of the overall Quality management system (QMS).
[edit] Concepts
- Remedial corrections of a problem which is identified.
- Root cause analysis combined with corrective action to help understand the cause of the deviation and potentially prevent recurrence of a similar problem.
- A preventive action to avert the recurrence of a similar potential problem.
A preventive action is to avert the occurrence of a similar potential problem.
[edit] See also
- Good Automated Manufacturing Practice (GAMP)
- Statistical process control
- Process capability
- Six Sigma
- Common cause and special cause
- Common Cause Variation
- Special Cause Variation
- Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme
- Validation (drug manufacture)
- EudraLex
