Let’s go through the seven steps of a CAPA implementation process.

Identification

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Evaluation

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Investigation

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Analysis

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Action Plan

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Implementation

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Follow up

1. Identification :

Problem identification is the first step and plays a vital role in the success of the ongoing CAPA process. It includes identifying all the product and quality problems that require corrective actions. It also provides identification of sources used to classify issues such as complaints, returned product records, quality audits, installation reports, Out of specification, deviation and non-conforming products.

2. Evaluation :

In this stage, the problem is evaluated for further decision-making.

The problem is analyzed to determine its nature and whether it requires a CAPA or not ? It also considers its impact on other processes and its effect on the output.

It also analyzes the severity of the problem.

For example, suppose a lack of safety is identified on the machine during an audit. In that case, it can be evaluated for different severity levels and how it impacts the machine operation and operator safety.

3. Investigation :

In this step, the problem is investigated for further planning.

The typical investigation includes objectives, i.e., deliverables, Procedures delivering the intent of the action, and Personnel for conducting the investigation. The root cause should be documented for better understanding and implementation.

For example, a team leader’s responsibilities can include authorization to use departmental resources and interviewing the concerned personnel to fully understand the problem.

4. Analysis :

This step identifies and establishes the root cause of the problem by investigating the available data. The required information must be accurately depicted and preserved to reflect the actual cause of the problem.

For example, if a misprint is detected on any pharmaceutical product, the analysis would focus on answering the following questions:

• What are the contributing factors to the problem?
• Is the printing system reliable?
• Or is the operator capable enough to qualify for system operation?

5. Action Plan :

This step’s success depends on the success of the preceding steps.

It is a series of steps required to implement corrective and preventive actions.

For example, it might include employee training if the CAPA team concludes that the cause of the problem was the inability of the personnel to use the system.

6. Implementation :

It is about how the action plan is implemented, devised in the previous stage.

It includes detailed information about the action plan, desired outcomes, settings, steps, and observation. The final action plan must be thoroughly documented for record purposes.

For example, if the training plan is the action plan, implementation of the training could include devising training contents, arranging training resources, instructor, and so on.

7. Follow Up :

After the team executes the CAPA activity, they must follow up.

It helps to measure the effectiveness of the Corrective and Preventive actions and improves the remedial measures.

After this stage, the CAPA activity is finally concluded with a detailed CAPA report.

For example, the training plan is the suggested solution. In that case, follow-up could include assessing the participant’s capabilities, whether more training is required or not and marking participants as pass or fail.

Using QMS software with a built-in training management software solution you can assure efficient, well-documented, and compliant training management. you can ensure that all employees receive the correct training based on their functional roles.

For more details can read https://pharmaceuticalupdates.com/2020/04/15/corrective-action-and-preventive-action-capa/

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