Occurrence of problems in any business have impact on the financial conditions of a company. Therefore every Pharmaceutical Industry is focusing on troubleshooting problems, identifying and preventing them. This not only have significant impact on improvement of the industry but also provide customer satisfaction. As per FDA and ISO it is evident to document the details of each and every incident during the manufacturing of a product which provides historical data that is essential for the continuous quality improvement plan and meeting the regulatory requirements. Many fundamental tools has been established, Corrective and Preventive Action (CAPA) being one of them is utilized in every quality system.
The main aim of implementing this tool is to provide a step by step analysis of a problem, well documenting the investigation and finding a solution that will satisfy the regulatory requirements and also form a basis for an effective continuous improvement plan. Corrective and Preventive Action both have almost similar stages however there is slight difference in both the aspects which is vital to be known before performing and documenting each. Corrective action is taken to eliminate the cause of a detected non- conformity and to prevent it’s re occurrence. Through it the non-conformity is tackled, corrected and controlled in such a way that it does to happen again. Preventive action is to prevent the occurrence of non-conformity beforehand by providing adequate monitoring and control that restrain the non-conformity to happen. Through this the effective quality system is developed in such a way that it anticipates, identify and eliminated the problems.
CAPA is a seven step procedure which is outlined as follows:
1) Identification of the Problem: Whenever a non- conformity appears it is important to go through some questions like where, what, why, how it happened. This will help to generate a clear identification of the problem as it will be reflected in the symptoms.
2) Evaluation of the Problem: This is done to have information that how deep is the problem and how much level of action is required. It is done in three steps:
a) To analyse potential impact of the problem.
b) Assessment of the risk (level of risk is evaluated which in turn define the actions to be taken)
c) Remedial Action (based on the level of risk immediate remedial actions are taken till a permanent solution of problem is obtained)
3) Investigation of Problem: The data is gathered for analysis which form the basis for the investigation process. The data may be collected for batch records, any complaints associated, through service records etc. An investigation procedure is developed in such a way that have a defined objective and have all the instructions for conducting an investigation.
4) Analysis of Problem: Through investigation process root cause of the problem is described. In this all the possible causes and information available is evaluated. At this stage the symptoms of a problem and the fundamental (root) cause of the problem is distinguished.
5) Action Plan: An action plan is set up after determining the root cause which involve what will be done, who will do it, how it will be done and where it is going to be done. The plan should include: actions to be completed, document changes, process, procedure or system changes, employee training, action plan form ( written procedures that will define step by step resolving of problem and preventing it’s recurrence).
6) Implementation of Plan: After creation of action plan it must be implemented as described and documented clearly.
7) Follow up of Plan: Once the plan has been implemented it is essential to follow up the actions taken which could be done by verification of the results, effectiveness of the actions taken.