SOP for Corrective and Preventive Action Procedure (CAPA)

This document details the procedure of Corrective Action & Preventive Action. It is the policy of Pharmaceuticals Limited that a written procedure shall be followed to provide a guideline for identification, evaluation & implementation of the corrective Action & Preventive Actions for reacting to an existing product, problem, customer complaint, or other non-conformity and fixing it. 

This procedure is to be applied at the time for identification, assessment, and implementation of the Corrective Action & Preventive action for detecting potential problems or non-conformances and eliminating them to prevent recurrences.

RESPONSIBILITY

Persons along with their responsibilities are given below:

 

 

 5.0 DEFINITION

5.0.1 Corrective Action: The process of reacting to an existing product, problem, customer, complaint, or other nonconformity and fixing it.

5.0.2 Preventive Action:   A Process for detecting potential problems or non-conformance and eliminating them.

5.1 CAPA Procedure

5.1.1 DOCUMENTATION OF THE CAPA

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 & ISO.

5.1.2 CAPA PROCEDURE

Seven steps shall be followed to implement the corrective & preventive actions.

Identification:               Clearly define the Problems.

Evaluation:                  Appraise the magnitude and impact.

Investigation:               Make a plan to research the problem.

Analysis:                      Perform a thorough assessment.

Action plan:                 Create a list of the required tasks.

Implementation:          Execute the action plan

Follow-up:                   Verify and assess the effectiveness.

5.1.3 Identification of CAPA

The initial step in the process is to clearly define the problem or potential problem.

This shall include. The source of the information, A detailed explanation of the problem, and documentation of the available evidence that a problem exists. The Source of the information: the specific source of the information shall be documented; there may be possible sources.

Service requests

Internal Quality Audits

Trend Data

Process monitoring

Customer complaints

Staff observations

QA inspections

Risk analysis

This information is important for the investigation and action plan, but also useful for effectiveness evaluation and communicating the resolution of the problem.

Explanation of the Problems:   A description of the problem is written that is concise but complete. The Description must contain enough information so that the specific problem can be easily understood.

Evidence: - List the specific information, documents, or data available that demonstrates that the problem does exist.   This information will be very important during the investigation into the problem.

5.14 Evaluation:  Appraise the magnitude and impact

The situation shall be evaluated to determine both the need for action and then, the level of action required.

 An evaluation shall include:

The potential impact of the problem.

Risk to the company or customers.

Remedial action that may be required.

Evaluation (Potential Impact)

Shall be determined and documented specifically why the problem is a concern and what the impact to the company and our customers may be. Concerns may include costs, function product Quality, safety, reliability, and/ or customer satisfaction.

Evaluation (Risk)

Based on the result of the impact evaluation, the seriousness of the problem is assessed.  The level of the risk that is associated with the problem will affect the actions that are taken and the priority assigned to the situation.

 Evaluation (Remedial Actions)

 The potential impact and risk assessment shall indicate a need for some immediate action to remedy the situation until a permanent solution can be implemented. In some cases, the remedial action may be adequate. If so, the CAPA can then be closed, after documenting the rationale for this decision and completing an appropriate follow-up. 

5.15 Investigation:- A plan shall be made to research the problem.

 A written procedure for doing an investigation into the problem shall be created.

 This procedure shall include:

 The objectives for the action

 An investigation strategy

 Assignment of responsibility and required resources

 Investigation (Objective)

The objective is a statement of the desired outcome (s) of the corrective or preventive action. The action shall be complete when all aspects of the objects have been met and verified.

Investigation (Strategy)

A set of specific instructions for determining the contributing and root causes of the problem shall be written. This procedure directs a comprehensive review of all circumstances related to the problem and must be considered.

Equipment - Materials

Personnel - Procedures

Design - Training

Software - External factors.

Investigation (Assign Responsibility and Resources)-  It is important to assign someone the responsibility for each aspect of the investigation. Any additional resources (Financial, equipment, etc) shall be identified and documented.

5.16 Analysis: The investigation procedure is used to conduct the investigation into the cause of the problem. Every possible cause shall be identified and appropriate data collected. The results of the data collection shall be documented and organized. Everything related to the problem must be identified, but the primary goal must be to find the root cause.

Possible causes/Data collection

An A-list of all possible causes shall be created which then form the basis for collecting relevant information, test data, etc. The necessary data and other information shall be collected that will be used to determine the primary cause of the problem.

 5.17 Results:- Data may come from a variety of sources, testing results, and/ or a review of records, processes, and service information, design controls, operations, and other information that may lead to a determination of the fundamental cause of the problem.

The Data collected shall be organized into a usable form.

The resulting documentation shall address all of the possible causes previously determined. This information is used to determine the root cause of the problem. The effectiveness of the analysis will depend on the Quality and thoroughness of the information available.       

5.18 Root cause analysis:- Use the data to complete a Root cause analysis. This involves finding the actual cause of the problem rather than simply dealing with the symptoms. Finding the primary cause is essential for determining appropriate corrective and or/ preventive actions.

5.19 Action Plan: A list of required tasks shall be prepared Using the results from the analysis, the best method (S) for correcting the situation   (or preventing a future occurrence) shall be determined. All of the tasks required to correct the problem and prevent a recurrence shall identify and incorporated into an action plan. The plan includes changes that must be made and assigns responsibility for the tasks.

5.20 Actions to be completed: all activities and tasks shall be listed that must be accomplished to correct the existing problem eliminate potential problems and prevent a recurrence. It is very important to identify all actions necessary to address everything that contributed to or resulted from the situation.

5.21 Changes: Needed changes to documents, processes, procedures or other system modifications shall be described. Enough detail must be included so it is clearly understood what must be done and what the outcome of the changes should be.

5.22 Training: Employee training is an essential part of any change that is made and should be made part of the action plan. To be effective, all modifications and changes made must be communicated to all persons, departments, suppliers, etc. that were or will be effective.

5.23 Implementation: Execute the action plan. The Action plan that has been developed shall be executed and all identified tasks and activities completed. The actions that were taken are summarized and all modifications to documents, processes, etc. shall be listed.

5.24 Follow-up: verify and assess the effectiveness. One of the most fundamental steps in the CAPA process is completing an evaluation of the actions that were taken.  This evaluation must not only verify the successful completion of the identified tasks but also assess the appropriateness and effectiveness of the action taken.

5.25 Verification Results: Have all the objectives been met? (Did the actions correct or prevent the problem with assurances that the same situation will not happen again?)

Have all recommended changes been completed and verified?

Has training and appropriate communications been implemented to assure that all relevant employees understand the situation and the changes that have been made?

Has an investigation demonstrated the actions were taken?

Has an investigation demonstrated that the actions taken have not had any additional adverse effect on the product or service?

Make sure that appropriate information has been recorded that provides proof that all actions have been completed successfully.

5.26 Validation Results: A validation of the action is done. This must document that

The root cause of the problem has been solved,

Any resulting secondary situations have been corrected,

Proper controls have been established to prevent a future occurrence,

The actions taken had no other adverse effects.

Adequate monitoring of the situation is in place.

5.27 CAPA Completion:  When the follow-up has been finished, the CAPA is complete. It shall be dated and signed by appropriate, authorized personnel (Production, Quality Control, Regulatory Affairs, Process & Development & Quality Assurance) 

ANNEXURE -I

CORRECTIVE & PREVENTIVE ACTION REQUEST

1.0       Date of Request:                                   

2.0       Name of Department:

3.0       CAPA PROCEDURE:

ANNEXURE-II

Corrective & Preventive Action Remedial action required

Date:

Name of Department:                  

3.0   Root causes:   

4.0    Action Plan:                           

5.0    Follow-up:                                 

Approved by

Quality Assurance Manager

ANNEXURE -III

Corrective & Preventive Action Investigation Procedure

Date:

2.0       Investigation Objective:    

3.0       Investigation Strategy:

 4.0      Investigation was done by:

5.0      Investigation Analysis mentioning:

            Possible causes/ Data collection

6.0      Result of Investigation: