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CAPA
1
2
CAPA – CORRECTIVE & PREVENTIVE ACTION
3
CAPA – CORRECTIVE & PREVENTIVE ACTION
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
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
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
7
CAPA – CORRECTIVE & PREVENTIVE ACTION
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!
KIRANREDDY MUNNANGI
https://analyticalstudents.blogspot.com
https://www.slideshare.net/analyticalstudent/presentations

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Corrective & Preventive Action

  • 2. 2 CAPA – CORRECTIVE & PREVENTIVE ACTION
  • 3. 3 CAPA – CORRECTIVE & PREVENTIVE ACTION
  • 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
  • 7. 7 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!