How to create a CAPA report that gets results

For SQEs, crafting an effective action plan is not the end of dealing with the corrective and preventive actions process. Once a problem is identified, analyzed, and addressed comes the time to create a thorough CAPA report outlining the details.

As a quality tool, the final objective of CAPA reports is continuous improvement. This is why the most impactful management reports go beyond documentation —they provide clear insights, actionable solutions, and measurable outcomes that lead to meaningful corrective and preventive actions, ensuring compliance and enhancing supplier performance.

In this guide, we explain what a CAPA report is and break down the essential elements that enable teams to track issues and power lasting solutions. 

What is a CAPA report?

A CAPA report is a document that formalizes the steps that a QA team has to perform to solve a quality issue, which the CAPA action plan outlines. It records relevant information encompassing the full process, from problem statement, root cause analysis, suggested corrective and preventive measures, execution timelines, and responsibilities assigned to people involved, all the way to effectiveness verification review and CAPA closure. 

CAPA reports are a critical component of broader QMS that provide a structured approach to adequately track issues, systematically address them and prevent their recurrence. And, since it’s required for regulatory purposes such as audits or inspections, CAPA reports are a vital part of upholding compliance with industry standards. 

Key elements of an effective CAPA report

Problem description

The first element of an effective CAPA report is a clear and thorough description of the nature and extent of the quality issue, supported by evidence and data. This serves to assess the severity of the problem and enables informed decision-making. 

A good problem description meets the following criteria:

• It clearly describes the problem as it currently exists and is easily understood
• It states the effect—what is wrong, when it happens, and where it is occurring, not why it is wrong or who is responsible
• It focuses on what is known, what is unknown, and what needs to be done
• It uses facts and is free of judgment
• It emphasizes the impact on the customer 

A well-written problem statement might look like this: 

The defect rate of product X is 10%, which exceeds the specification limit of 5% and results in customer dissatisfaction and increased rework costs. The desired outcome is to reduce the defect rate of product X to 5% or less.

Root Cause Analysis

Once the problem has been properly stated it is time to identify the underlying cause. In a CAPA report, this section describes the process and outcome of the investigation conducted to find the root cause of a quality issue. 

A root cause analysis goes beyond the surface level problem. Instead of talking about “human error”, for example, it delves into what could be triggering a team’s shortcomings: a training deficiency, lack of resources, or an undefined process.

It is fundamental to accurately identify the root of a problem, because a mistake here can lead to unnecessary waste of time and resources developing solutions to the wrong cause. 

Harness useful quality tools to identify the real cause of identified problems such as the 5 Whys method, the Fishbone Diagram, and the eight disciplines (8D) model. 

Corrective and preventive actions

Corrective and preventive actions are like two faces of the same QA coin. However, corrective actions focus on detection of defects, while preventive actions outline measures to avoid their recurrence. This means the key difference between the two is timing. 

Corrective actions list all the immediate adjustments that need to be taken to mitigate the issue or its effects, both in the short and long term. They clearly define the why, how, when, who, and where the problem will be solved.   

Preventive actions state the amendments required to fix systemic deficiencies that lead to the occurrence of quality issues. In other words, effective preventive actions are the roadmap on how to improve quality and eliminate problems before they happen.

Implementation plan and responsibilities

When solutions are decided, they can be implemented. This section of the CAPA report documents the execution and monitoring of corrective and preventive actions, in accordance with internal and industry quality standards. 

Therefore, it designates the required measures, responsibilities assigned, established deadlines, and resources needed to ensure effective implementation and completion.  

Verification and effectiveness review

Finally, changes must be monitored and evaluated by tracking issue development and studying the effectiveness of the corrective and preventive efforts through data collection and analysis. Maintaining meaningful change helps to ensure continuous improvement.

Making sure the issue has been successfully resolved requires periodical inspections to see if it’s required to refine the implemented measures. This also allows the team to promptly identify unforeseen issues that could develop as a result of the changes. 

If results are not satisfactory, teams need to trace back their steps and repeat the previous steps to effectively fix the problem and achieve compliance with quality standards.

Best practices for tracking and managing CAPA reports

Harnessing the benefits of a thorough CAPA report requires competent management and tracking throughout the process. Here are some recommendations that might help:

• Use digital tools to track issues: Implement a CAPA management system that allows real-time monitoring, document control, and automated workflows.
• Maintain a centralized management report: Track open CAPAs, overdue actions, and recurring trends in a single dashboard to enhance visibility and streamline decision-making.
• Automate reminders and status updates: Set up notifications for upcoming deadlines and overdue tasks to keep teams proactive and achieve timely resolution.
• Ensure comprehensive documentation: Use audit trails and change logs to maintain historical records for compliance and continuous improvement.
• Leverage data analytics: Identify patterns in CAPA trends to uncover systemic issues, refine processes, and enhance quality performance.

How Kiuey simplifies CAPA reporting and management

Make CAPA report management easier with Kiuey’s SCAR/CAPA Manager. With real-time tracking, audit trails, automated reports and collaborative issue resolution, this tool comes as one of the most comprehensive quality management software in the market.

Easily identify systemic issues through data collection and analysis, and create CAPA reports in seconds with our custom report builder.

Discover the future of quality management with Kiuey. Schedule a free demo and start saving time and money today.