SOP for Corrective Action and Preventive Action (CAPA)

OBJECTIVE

To provide instructions and assign responsibilities for initiating, requesting, implementing, and verifying the effectiveness of corrective and preventative actions (CAPA).

POLICY

• To lay down a procedure for applying to prevent and correct non-conformities related to resources, components, subassemblies, completed services, operational processes, and quality systems.
• CAPA focuses on the systematic investigation of discrepancies (failures and/or deviations) in an attempt to prevent their recurrence (for corrective action) or to prevent their occurrence (For preventive action).
• Resolution of identified quality issues
• Prevention of issue recurrence
• The system shall be applied for addressing nonconformance, and incidents and implementing quality systems. The same shall be applicable to all GMP operations and areas
• Documentation of all correction and preventive action activities.

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RESPONSIBILITY

G.M 

Q.A Manager 

Production Manager

Dept. Supervisors

PROCEDURE

Definitions:

Corrective Actions: 

• Corrective action is a term that encompasses the process of reacting to product problems, customer complaints or other nonconformities and fixing them. The process includes:

1. Reviewing and defining the problem or nonconformity.
2. Finding the cause of the problem.
3. Developing an action plan to correct the problem and prevent a recurrence.
4. Implementing the plan.
5. Evaluating the effectiveness of the correction.

• Corrective action is a reaction to a problem that has already occurred. It assumes that a nonconformance or problem exists and has been reported by either internal or external sources.
• The actions initiated are intended to: 

1. fix the problem and 
2. modify the quality system so that the process that caused it is monitored to prevent a reoccurrence. The documentation for a corrective action provides evidence that the problem was recognized, and corrected, and proper controls were installed to make sure that it does not happen again.

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Preventive Actions: 

• Preventive action is a process for detecting potential problems or nonconformances and eliminating them. The process includes:

1. Identify the potential problem or non-conformance.
2. Find the cause of the potential problem.
3. Develop a plan to prevent the occurrence.
4. Implement the plan.
5. Review the actions are taken and the effectiveness in preventing the problem.

• Preventive action is initiated to stop a potential problem from occurring.

CAPA Process:

To effectively manage the CAPA system and the associated documentation, the following process exists:

Identification

1. The initial step in the CAPA process is to clearly identify the potential problem(s).
2. This should include the source of information, a detailed explanation of the problem, and documentation of the available evidence that a problem exists.
3. Identification of recurring/critical/major problems from internal or external sources shall be carried out by Quality Assurance and forwarded to core team members.
4. The core team shall review the complete list of Market Complaints, Deviations, and OOS on a yearly basis and accordingly will take a decision for initiation of CAP
5. Each Market Compliant, OOS, and Deviation has Corrective and Preventive action mentioned in its format, however, to take it in CAPA format of this SOP, the Core Team will make the decision for a waiver in the initiation of CAPA.

Evaluation

1. Based on the decision by the core team CAPA will be initiated site QA. The details shall be captured.
2. The situation shall be evaluated along with the concerned person related to the problem to determine the need and level of action required.

Investigation

1. The core team to arrive at the root cause and will carry out a failure investigation.
2. A thorough investigation shall be carried out to arrive at the root cause. A comprehensive review of all circumstances related to the problem shall be considered. E.g. Equipment, Personnel, Design, Software, Materials, Procedures, Training, External factors and so on.
3. The necessary data and other information collected shall be used to determine the primary cause of the problem.
4. It is very important to distinguish between the observed symptoms of a problem and the fundamental (root) cause of the problem.
5. Approval of the concerned authority shall be sought on the proposed actions. Impact evaluation shall be done through a change control system.

Implementation

1. The core team shall ensure that the action plan that has been developed is executed and that all identified tasks and activities are completed. When implementation is over, the CAPA shall be considered as complete.
2. Approval of the concerned authority shall be sought on the CAPA report and the CAPA shall be closed.

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Effectiveness (Follow-up)

1. The core team shall verify the effectiveness of the CAPA. Duration of verification shall vary from case to case and depend upon the situation. To verify the effectiveness of CAPA, the core team shall ensure that.
2. The root cause of the problem has been solved. The actions taken had no other adverse effects. Adequate monitoring of the situation is in place.
3. CAPA tracking and effectiveness shall be evaluated periodically CAPA database bank with different color index/codes like Green represents Closed, Yellow represents Ongoing, Orange represents Open and Red represents Overdue. It will be maintained in a soft copy of an Excel file.

FREQUENCY

As and when required.

ANNEXURE

Corrective and Preventive Action Tracking Log

REVISION HISTORY

Nil

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