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Corrective and Preventive Actions
Corrective and Preventive Actions
Preventive Actions
(CAPA)
Dinesh TK
Corrective Actions
Theprocess of reacting to
an existing product
problem, customer
complaint or other
nonconformity and fixing it.
Preventive Actions
A process for detecting
potential problems or
nonconformance’s and
eliminating them.
Why CAPA?
Regulatory Requirements
• Both FDA and ISO require an active CAPA program
as an essential element of a quality system.
Customer Satisfaction
• The ability to correct existing problems or implement
controls to prevent potential problems is essential for
continued customer satisfaction
Good Business Practice
• Quality problems can have a significant financial
impact on a company.
CAPA Procedures
Implementing an effective and fully compliant
Corrective / Preventive action program is a
seven step process.
Each step must be thoroughly documented!
• Properly documented actions provide important historical
data for a continuous quality improvement plan and are
essential for any product that must meet the regulatory
requirements demanded by FDA and ISO.
CAPA Procedures
Seven Steps