CORRECTIVE ACTION PREVENTIVE ACTION

The definition – Corrective action

• Exact definition from ISO 9001

• Corrective action is realizing and defining problems, determining their

causes, and taking appropriate measures to prevent their recurrence.

• The Corrective Action Process (CAP) then helps to document, create,

implement, and verify the actions taken
The definition – Preventive action
• Action to eliminate the cause of a potential nonconformity or other
potential undesirable situation
Scope
• Corrective Action and Preventive Action’ this tool is popularly known
as CAPA or 8D method in industries. The main purpose of using this
tool is to investigate the problem, implement corrective or preventive
action, and measure the effectiveness of corrective action to avoid
recurrence of the problem. It’s a systematic approach to solve the
problem. CAPA tool is not a problem-solving tool it acts as an
improvement tool also. CAPA is also known as 8D Problem solving
method
• Benefits of the Corrective Action & Preventive Action (CAPA) process.
• 1. Systematic way of solving a complex problem.
• 2. CAPA process helps to avoid the recurrence of the problem.
• 3. Prevention action of the CAPA process provides the opportunity to implement ‘preventive measures’ like mistake-
proofing in the manufacturing process or in mistake-proofing in the design itself.
• 4. CAPA tool is very effective to solve complex problems like product recall in the market.
• 5. Systematic root cause analysis in the CAPA process helps to detect flaws/gaps in the design or manufacturing process.
• 6. CAPA process involved cross-functional team involvement and the CAPA process also helps to maintain proper
documentation and record to solve a problem.
• 7. CAPA tool does not just cover the implementation of corrective action, it does cover the verification and validation of
corrective action and effectiveness check of corrective actions.
• 8. Corrective and preventive action of the CAPA phase can be implemented horizontally for other products and
processes.
• 9. CAPA tool also helps in soft or hard saving.
• 10. CAPA also helps to implement statistical process control to control non-conformity.
• 11. It’s a standard practice to determine CAPA outcome or status in the management review meeting. This process
ensures a track on ongoing and aging CAPA
Let’s understand the phases of CAPA.
Problem statement
Team Formation
Impact Assessment & Corrective / Containment Action:

1.Impact Assessment
2.Containment Action
3.Corrective Action
• Root Cause Analysis (Investigation
• Corrective Action
• Implement Corrective Action / Preventive Action
• Effectiveness Check
• Team Recognition & Closure
Root cause analysis

• In this phase, root cause analysis is conducted to determine the root cause of the non-conformance.
Various tools can be used for root cause analysis.
• 1. Pareto Analysis
• 2. 5 Why Analysis
• 3. Fishbone/Ishikawa Diagram
• 4. Control Plan
• 5. Scatter diagram
• 6. Check sheet
• 7. DOE (Design of Experiments)
• 8. Process flow diagram study
• 9. Brainstorming
• 10.Process Audit
• Root cause analysis is an important phase of the CAPA tool. If root cause analysis is failed, it will affect the
corrective action process and CAPA will not be helpful to stop the recurrence of defect/problem. For
solving a complex problem, the CAPA team can divide affected manufacturing process systems in
different components and use multiple problem-solving tools. This action will help team members to
execute root cause analysis effectively
Corrective action

• Correction:
• Action to eliminate detected non-conformity is known as a correction. After completion of impact
study and containment action, correction action must be initiated. Following correction actions
can be considered in CAPA,
• 1. Identification & Traceability
• 2. Rework
• 3. Replacing defective parts / components
• 4. Rejection
• 5. Re-testing after rework and Quality acceptance.
Corrective action
• Once we determine the root cause of the problem, the next step is to implement
corrective action. The success of corrective/preventive action depends on perfection in
root cause analysis. Corrective actions help to eliminate the root cause of the problem.
Based on the type of root cause, various corrective actions can be implemented.
• 1. Engineering Change Management – Process re-design, Product re-design (design
change)
• 2. Material change
• 3. Supplier change
• 4. Machine/tool replacement with a new tool
• 5. Change in the manufacturing process
• 6. Improvement in product and process quality control
• 7. Change in operator training
• 8. Implementation of Statistical Process Control.
• 9. Improve procedure, work-instructions
Preventive action

• These are :

• 1. Design mistake proofing

• 2. Process Mistake Proofing
• 3. Statistical Process Control
• 4. DFSS – Design for Six Sigma
• 5. Automation (eg. Robotic welding)
• 6. Automation in material handling, storage, and preservation.
• 7. Artificial intelligence
• 8. Design FMEA ( Failure Mode and Effects Analysis )
• 9. Process FMEA
• 10. System FMEA
• Preventive action prevents the occurrence of a non-conformity. In the long run, preventive
action serves as a cost-saving tool
Preventive actions
• There is no permanent preventive actions in reality
• There are always impact and response of the action taken
• Analysis of preventive action taken is required
• Effectiveness of the preventive actions taken shall be checked
• it depends on time, location, person to person, resources available and so on
• Preventive actions for one cause or failure or non conformance may not be same for kind of
problem but for another project / location / condition / circumstances