Is your CAPA management system effective enough to get you to the root cause of the problem and eliminate it to avoid reoccurrences? If not, consider switching to ISO 9001 quality management software that allows you to plan, do, check, and act iteratively to ensure continual improvement of the processes and products. 

CAPA is triggered by certain situations such as non-conformances or deviations customer complaints and unfavourable trends. Not all deviation or nonconformance require a CAPA. A single misstep in the CAPA can result in higher costs, process delays and inefficient use of the organization’s resources. Uncompleted CAPA can be a serious compliance and that’s why here’s the detailed guide to follow- 

What is CAPA?

Corrective and preventive action is a process taken to eliminate the causes of non-conformities and other undesirable situations. It is a set of actions required for GMP compliance to resolve an issue that must be addressed. Since corrective actions are essential, they consist of two parts: 1. Identify the problem and take immediate action, and 2. Discover the root cause to ensure this issue does not happen again in the future.

The CAPA management system allows you to resolve quality issues from their root. Moreover, you can take a proactive approach rather than a reactive one in your organization. Forget about product recalls and rework repeatedly, and you will be more effective in dealing with quality issues.

What are CAPA ISO 9001 requirements?

CAPA, or corrective and preventive action, can also consist of non-conformances, deviations, out-of-specs, and complaints. It requires to review of the corrective action taken and its effectiveness. The CAPA quality system is a part of ISO 9001 requirement compliance and it is an important part of quality management practices if a company ever expects to reach its goal of zero defects.

On the other hand, quality-focused management is a collection of core beliefs, principles, values and rules that are widely accepted as fundamental truths. This can be used as a foundation guide in an organization performance improvement is achieved by analyzing and understanding the customer requirements which are incorporated and measured in the industry objectives.

A well-defined compliant CAPA process enables firms to unleash the power of continuous improvement without repeating the same defects. CAPA is known as the immune system of the quality management process. CAPA management enables the organization to effectively control CAPA processes while monitoring and tracking all ongoing activities. CAPA management system helps streamline, standardize and automate the implementation of copper process across your organization.

The International Organization for Standardization (ISO) is a non-governmental organization dedicated to developing International standards. These standards are created with contributions from national standards organizations and member countries. ISO has published more than 25,000 standards across various areas of technology and manufacturing. It operates through over 800 technical committees and sub-committees responsible for standard development. 

ISO 9001 is a widely recognized standard for Quality Management Systems (QMS). It helps organizations consistently deliver products and services that meet customer requirements and enhance satisfaction. ISO 9001 certification is considered the gold standard for product quality which is why manufacturing companies strive to achieve it. 

What is a Quality-focused Approach? 

By applying in quality-focused approach, consistent and predictable results are achieved more effectively and efficiently when activities are understood and managed as interconnected processes within a cohesive system. Decisions driven by data analysis and evaluation are more likely to result in desired results and improvements. 

The core focus of quality is to meet the requirements of customers and satisfy the needs of other key stakeholders. Achieving sustained success is possible when an organization constantly gains and retains the trust of customers along with all external or internal interested parties. 

The organization must establish a system to provide and support goods and services that fulfil customer needs and expectations. It is important to measure and monitor customer satisfaction to determine the needs and expectations of targeted consumers. 

7 Steps in the CAPA Plan

The CAPA process involves analyzing correcting and preventing issues. It outlines procedures to solve the issue and also analyses the cause of the problem to prevent its recurrence. 

1. Identify and record the problem– The first step is identifying the issue. Identify and record the actual problem including a detailed description of the issue and any supporting evidence. 
2. Evaluate risk and impact– Determine and analyse the root cause of the incident. Evaluate the problem to assess its impact. Including possible impact on cost product quality safety and reliability.
3. Establish a procedure for investigating the problem– Write a procedure for investigating the problem including an objective, investigative steps, a timeline, responsible parties and required resources.
4. Analyze the problem & determine its cause– Inspect and analyze the issues to determine how and why happened and appropriate corrective actions are identified and implemented. 
5. Create an Action Plan– Use the analysis to create an action plan to resolve the issue and prevent it from reoccurring. The effectiveness of the corrective actions taken is reviewed and evaluated. 
6. Implement Corrective/Preventive Action– Now execute the action plan as the incident is resolved and the documentation is completed.
7. Verify Effectiveness– Once the action plan is complete, verify how effective it was in solving the issue and make any necessary changes to the CAPA process.

These steps showcase impactful and beneficial change within the organization. It is important to highlight that the CAPA framework decision process has been reinforced through extensive piloting in real-world production over a long period. The understanding that consistent, successful application of a model depends on an organizations ability to determine a meaningful threshold for action and adequately distinguish risk levels as well as the organization’s capability to identify and evaluate trends in signals that indicate process quality.

Moreover, with the faster pace of improvement companies are spending more time on problem-solving and initiating preventive actions. Therefore, seeing smaller portfolios of open and ageing corrective actions and increased focus on potential clients impacting events. The framework acknowledges that there is a benefit in promoting a problem-solving culture understanding the lower-risk issues investigated in as much detail as higher-risk issues. 

Conclusion 

A CAPA quality system is essential in some formats for a complete quality management program. Without a CAPA process, focusing on quality improvement efforts may not improve customer satisfaction. Both FDA and ISO require an active CAPA program as an essential element of a quality system. The CAPA system is one of the best ways to find, fix and eliminate defects from the process. By following these comprehensive guide outlined in this article will provide a complete well-documented CAPA action that will meet regulatory requirements and can significantly improve the quality process in an organization.

Keep an eye for more news & updates on Ssense!