4. 4
Correction
• Reaction to a
problem to
provide
immediate
remedy to save
situation.
• No guarantee on
fixing the cause
of the problem
Corrective Action
• Eliminates the
cause of the
nonconformity
and prevents
repetition
Preventive Action
• This prevents
potential
occurrences
CAPA – CORRECTIVE & PREVENTIVE ACTION
5. 5
CAPA – CORRECTIVE & PREVENTIVE ACTION
taking a medicine
for symptomatic
relief from fever
Identifying the
actual reason for
fever (viral/
bacterial
infection) and
treating the
infection
maintaining
proper hygiene
and a healthy
lifestyle to build
up resistance to
infections
infection
6. 6
Corrective Action:
Investigating the sink, drain, and supply system, learning that blockage at U traps and replaced the
utrap, and confirming that nothing leaks
Preventive Action:
An example of this process would be checking the other U Traps, another sinks for existing problems
and asking if any parts should be replaced now before they fail.
Correction or Immediate Action:
An example of this process is mopping up water and adding a bucket under the leak or temporary
patch up.
CAPA – CORRECTIVE & PREVENTIVE ACTION
8. 8
CAPA – CORRECTIVE & PREVENTIVE ACTION
Verify
Effectiveness
Identify problem
Assess impact
Quality / Regulatory
/ Management
Notification
Investigation
Process?
Complete
Investigation
Determine Root
Cause
Proposed
Corrective /
Preventive Actions
Plan effectiveness
Assess changes
Ensure no impact
to product quality
Consensus from
SMEs
Approval
Implement
Actions
Verify
completed
Inform
stakeholders
Measure to ensure
problem has been
resolved
Monitor to ensure
it is not re-
occurring
Implement
Actions
Review &
Approve Plan
Investigate,
Root Cause,
Action Plan
Identify &
Triage
Change ControlMetrics and Reporting
CAPA is much more than just “corrective actions” and “preventive actions”.
Any opportunity to improve quality in your organization is a CAPA!