The U.S. Food and Drug Administration, as well as other regulatory agencies view Corrective and Preventive Action (CAPA) as the central component that influences all control segments. This includes design, production and process controls. It also encompasses documents change controls, material controls, facility and equipment controls. The worst thing that can happen is a sudden surge of customer complaints regarding a defective product although you had done everything right since the beginning. Maintaining quality consistently is of utmost priority.
Corrective and preventive action (CAPA) issues continue to be one of top Form 483 observational discoveries by the FDA, during audits. Commonly, CAPA fails because of the structure and direction of the procedures and not the endeavors of those dealing with the CAPA. A poor paper-based CAPA procedure won’t improve results even with an electronic-based CAPA framework. Regularly, associations do not completely record the CAPA stages and confound confirmation of execution and check of implantation exercise.
This article may help you to gather relevant information on the 10 most effective phases of CAPA by the governing regulatory authorities.
A good CAPA process consists of 10 distinct phases, as shown in the figure below.
IDENTIFICATION AND INITIATION OF CAPA ISSUES
The issue of identification and CAPA initiation stage requires reporting the issue to start the CAPA procedure.
An issue is identified when somebody observes a nonconformance or deformity in a product or during the making of the product. This should be described in as much detail as possible, including who, what, when, where, why, and how many.
Here are some questions that could be used to collect the details of the issue:
- Describe what is included. Is it a product, equipment or a process that is having a problem?
- Describe what happened and what should have happened?
- In what room or specialty unit did the issue arise?
- Clarity on when the occasion occurred. At what time or on what day was the issue found?
EVALUATE THE RISK INVOLVED IN THE ISSUE
A risk analysis should be performed based upon severity to patient/user/business/compliance risk. The results of the risk analysis should drive the CAPA process.
Our main objective in this phase is to decide:
- If the issue requires a CAPA plan to resolve, or
- If forbearing to a milder strategy is appropriate.
This choice is best made by evaluating the severity, harm and complexity of the problem. This analysis will decide if a basic or minimal change can keep the issue under control or if we need to evaluate and implement additional steps.
CORRECTION OR IMMEDIATE ACTION
Correction/Immediate Action should be completed as soon as possible to stop further production and distribution of defective products. The organization should survey related processes and products to rule out any further extensive issues. In case of product-related issues, a field correction and/or recall may be required. Correction activities are an effort undertaken to diminish the impact within a short period.
Correction activities can include:
- Reworking, and
INVESTIGATE THE ROOT CAUSE
In this phase, the goal is to investigate the issue and determine its root cause. The root cause is the source of the identified problems or risks, and it’s a crucial bit of information in the battle to prevent their occurrence or reoccurrence.
A proper investigation is necessary before we can raise a flag. Even if the cause and effect give off an impression of being self-evident we should not jump to any definite conclusion. Several methods/tools for performing investigations can and must determine the root cause of a problem.
Here are a few of the most common ones:
- The 5 whys
- Fishbone diagrams
SOLIDIFY ROOT CAUSE ANALYSIS
An effective CAPA process depends on your team’s ability to understand the definitive cause of each issue you encounter. So, a well-defined root cause analysis process is essential to a CAPA system’s effectiveness. Corrective and preventive actions cannot be effective without understanding the original reason for the problem.
The aim of root cause analysis is not only to solve the problem on hand; it is to understand why the issue occurred so the precise actions can be taken to prevent that problem from reoccurring. A root cause needs to be specific, and it also needs to be something that can be corrected with action.
CORRECTIVE/PREVENTIVE ACTION PLAN TO RESOLVE THE ISSUE
The objective is to utilize the data assembled from the above stages to build up a roadmap to resolve the issue and eliminate the root cause. Corrective and preventive actions are viewed as long-term solutions to resolve or eliminate the cause of a potential nonconformity.
There are two categories of actions to fix an incident: a corrective action or a preventive action.
Corrective actions are put in place to resolve the incident of non-compliance.
Preventive action is a form of risk management—it seeks to prevent the occurrence of a problem in the future by gauging the potential for nonconformity.
IMPLEMENT CORRECTIVE ACTIONS
The next two stages are tied in with implementing your Action plan, regardless of whether that comprises corrective activities, preventive activities or both.
In case you’re hoping to implement corrective actions, you would have first previously recognized fundamental issues tormenting your company, service or product. Corrective actions are a reactionary measure which is a significant advance in amending and containing an incident.
Corrective actions need to be prompt. An Employee Disciplinary Action Form should be kept at hand if any alerts or other disciplinary activities are required. Whatever corrective actions you make, do them quickly and accurately. Remember that they may not be a lasting answer to the immediate issue.
IMPLEMENT PREVENTIVE ACTIONS
Preventive activities are forecast based. The proactive approach tries to foresee the screen potential dangers before they grow into major, conceivably hurtful issues.
Normal preventive activities include:
- Reviewing or evaluating suppliers
- Identifying issues predominant in contenders
- Monitoring and breaking down negative trends
- Implementing alerts
- Conducting risk analysis
- Conducting customary performance surveys
- Establishing training programs
- Developing disaster recovery plans
- Implementing calibration control programs
VERIFICATION OF EFFECTIVENESS OF ACTION
The next phase of your system is examining and reporting the effectiveness of the corrective or preventive actions you’ve implemented.
This effectiveness check is the most significant phase as it assurance the activity isn’t just appropriate. It is effective to resolve the issue and prevent it from re-occurrence (or repeating). There are numerous approaches to give an account of the effectiveness check, contingent upon the measures you decided to execute.
Trend analysis of human error, testing errors and deviations both before and after you implemented the corrective action can help to determine if it’s working.
Surprise audits are another great option for efficiency checks. The audit will ensure that all machinery, people and processes are acting according to the prescribed corrective action.
CHANGE IMPLEMENTATION AND COMMUNICATION
Additionally, track the effectiveness of the plan itself. After its first live run, ask the question: was it straight forward to follow? Even better, hold training on the draft variant of your CAPA methodology and utilize the criticism or problem areas identified to update the strategy and resolve troublesome, confounding or dubious capacities.
This contribution won’t just ensure those included get a sense of proprietorship, it will also empower them with the tools to carry out the system right from the first time around.
This is the last Phase of a CAPA procedure. A CAPA should be closed, once the check of effectiveness has been successfully completed. On an off-chance that a CAPA was found ineffective, then recommend opening another CAPA, and refer the first CAPA to re-evaluate the incident.