7 Steps to a Comprehensive CAPA

Introduction: Biopharmaceutical companies whose products are subject to regulatory requirements, a corrective action/preventive action (CAPA) process is needed to address and mitigate the impact of quality events such as deviations, incidents, complaints and non-conformances.

In recent times USFDA and other agencies issued many 483s/warning letters on CAPA management, most common reasons are inadequate process, ineffective action plans, and lack of compliance. It may be due to lack of proper training and understanding to the staff to perform corrective actions or have no access to tools and strategies that requires for effective CAPA process.

Read this article on "7 Steps to a Comprehensive CAPA" to effectively address quality events at your organization.

1. Identification and recording the problem.

The first step to implement an effective CAPA is to clearly define the actual problem, quality issue, nonconformity, or incident. It is important to accurately and completely describe the situation as it currently exists. This should include the source of the information for the quality event, a detailed explanation of the problem, and any available evidence of the problem’s existence.

2. Evaluation of Risk and Impact

To evaluate the extent of the risk and its potential impact on the operations requires a detailed and sufficient written description of the issue. There are five key activities involved in the evaluation phase.

• ?Document Evidence: List the specific information available that demonstrates the problem exists.
• Determine Action: The problem explained in the “Identification” step must be evaluated to determine the need for action and potential impact of the problem.
• Forecast Potential Impact: Include possible repercussions the problem may have on product quality, safety, reliability, costs, function, and customer satisfaction.
• Assess Risk: The level of risk associated with the problem may affect subsequent actions that are taken. Serious risks to the product quality and patient safety must be assigned a high priority and require immediate remedial action.
• Take Remedial Action: Based on the outcome of the impact and risk evaluations, the actions or expedite actions taken and the resources required should be documented. This documentation will become part of the “Action Implementation” and “Follow-Up” steps of the CAPA.

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3. Investigate the Problem.

For investigations to be effective, follow below listed four investigation fundamentals.

• Gain Organizational Commitment: Empower employees to solve a variety of problems.
• ?Integrate Root Cause Analysis into Quality System: ?All business functions must be aligned to achieve desired result. When alignment is lacking, personnel tend to revert to familiar, ineffective methods.
• Train Key Personnel in Root Cause Analysis: Teach the right RCA skills to those who need and will use them.
• Provide Reinforcement and Appropriate Tools: Equip key employees who have been trained on RCA with tools that enable them to conduct investigations and implement corrective actions.

4. Analyse and determine the cause.

The primary goal of this phase is to determine the root cause of the problem by identifying contributing and secondary causes to the problem. While there are many formal methods that can be used to perform root cause analyses, 5 Whys and Ishikawa/Fishbone Diagram are most commonly used.

5. Creation of an effective Action Plan.

Using the results from the analysis, the optimal method for correcting the situation and preventing a recurrence should be determined and an action plan developed. The plan should include the following tasks and identify the individuals responsible for completing each:

• Actions to be completed.
• Document or specification changes
• Process, procedure, or system changes
• Employee training
• Monitors/controls

6. Implementation of the Action Plan.

To ensure the CAPA implementation is comprehensive, maintain the following:

• Implementation Summary: should include a list and summary of all the activities that were completed as outlined in the action plan step.
• Supplementary Documentation: List all documents or other specifications that have been modified. This documentation is typically attached to a final report on the CAPA action, which facilitates the verification of the changes in the next “Follow-up” step.

7. Follow-up and verification.

Auditor performing effectiveness check must verify:

• Have all the objectives of this CAPA been met?
• Have all the recommended changes been completed and verified?
• Have appropriate communications and training been implemented?
• Are the actions implemented had any adverse effects on the product or service?

Conclusion: You must agree that documenting CAPA process from identifying the quality event to closure, and effectiveness verification is important for all companies, but absolutely critical for the Organizations subject to regulatory scrutiny. Following the seven steps outlined above should result in a complete, well documented investigation that facilitates compliance to FDA and ISO regulatory requirements and contribute towards improved product quality and patient safety.