1. Identification - clearly define the problem
2. Evaluation - appraise the magnitude and potensial impact
3. Investigation - make a plan to research the problem

Continue from Complete Procedure of CAPA for Pharmaceutical Industry (Part I)

4 - Analysis - perform a thorough assessment
The investigation procedure is used to conduct the investigation into the cause of the problem. The goal of this analysis is primarily to determine the root cause of the problem described, but any contributing causes are also identified.

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

•The results of the data collection are documented and organized.
Data may come from a variety of sources: testing results and/or a review of records, processes, service information, design controls, operations, and any other information that may lead to a determination of the fundamental cause of the problem.The data collected is organized into a useable form.The resulting documentation should 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.

•Everything related to the problem must be identified, but the primary goal must be to find the root cause.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.

• Problem Analysis form
A sample “Problem Analysis” form is included. This form is optional but is intended to be used for recording information related to the analysis of the problem. The form can be used as a collection point for the information discovered during the analysis and any supporting data or documentation can be attached.

5 - Action Plan - create a list of required tasks

Using the results from the analysis, the best method(s) for correcting the situation (or preventing a future occurrence) is determined and act ion plan developed. All of the tasks required to correct the problem and prevent a recurrence are identified and incorporated into an action plan.
The plan includes changes that must be made and assigns responsibility for the tasks. The action plan should also identify the person or persons responsible for completing each task.

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

• Document or Specification Changes
Needed changes to documents, processes, procedures, or other system modifications should 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.

• Process, Procedure, or System changes
If any changes to processes, procedures, or systems must be made they are described. Enough detail should be included so that it is clearly understood what must be done. The expected outcome of these changes should also be explained.

• Employee 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 affected.

• Action Plan form
A sample “Action Plan” form is included. This should provide a set of written procedures that detail all of the actions that must be done to resolve the problem and prevent it from recurring. This includes corrective and preventive activities, document changes, training, etc. The person or persons responsible and an expected completion date should also be entered on the form.

6 - Implementation - execute the action plan
The corrective / preventive action plan that has been created is now implemented. All of the required tasks listed and described in the action plan are initiated, completed, and documented.

• Implementation Summary
All of the activities that have been completed as required in the “Action Plan” should be listed and summarized. This section should contain a complete record of the actions thatwere taken to correct the problem and assure that it will not recur. This includes changes, preventive measures, process controls, training, etc.

• Documentation
All documents or other specifications that have been modified are listed. Typically the documentation would be attached to a final printed report of this CAPA action. This will facilitate verification of the changes for the follow up.

7 - 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 actions taken.

•Key questions
Have all of 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 that that the actions taken have not had any additional adverse effect on the product or service?

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

•Validation results
A validation of the action is done. This must document that:

o The root cause of the problem has been solved,
o Any resulting secondary situations have been corrected,
o Proper controls have been established to prevent a future occurrence,
o The actions taken had no other adverse effects.
o Adequate monitoring of the situation is in place.


When the Follow Up has been finished, the CAPA is complete. It should be dated, and signed by appropriate, authorized personnel.