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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