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How to Avoid CAPA-Related Pitfalls on Your Compliance Journey?

01 Aug 2023

When you are frequently reported about quality events, and many of them are recurring, it becomes difficult to prioritize them. You may find it challenging to decide which quality events require a detailed investigation. And you end up investing time and resources in the issues that may need minimal attention.  

Okay, so many quality managers say that resolving every issue is critical to achieve product quality, safety, reliability, and compliance. I agree, but is every issue worth the same level of priority?  

Probably, not! 

It is all about their risk severity. If you categorize risks based on severity, you can change the quality management game forever. What I am about to tell you through this post is you can avoid CAPAs piling over and can still achieve compliance excellence with some minor changes in the way you manage CAPAs. 

Quick Read: What is the best way to evaluate and categorize risks? 

As we advance, we look at the key steps to avoid CAPA overload. This makes our compliance journey smooth and more efficient than ever. Even if your compliance journey is different from those of regulated industries, you will still gain valuable insights on best practices to implement and improve the existing CAPA system in your organization. 

What is CAPA? 

CAPA (Corrective Action Preventive Action) is a method of determining and fixing the root cause of the problems. Furthermore, it examines other possible issues and future use and checks the conditions and solutions. 

Good Manufacturing Practice (GMP) and ISO 13485 include Corrective and Preventive Action concepts. Therefore, a CAPA investigates discrepancies methodically to avoid their repetition. 

CAPA is effective only if errors are identified, and their occurrences are continuously investigated. 

What is CAPA Overload? 

An organization or its employees can find themselves in a CAPA overload situation when they have too many CAPA issues in the pipeline and fail to deliver timely solutions for the nonconformances. As a result, your CAPA system don’t function properly despite knowing that these improvements will increase your company’s efficiency and competitiveness. 

How does CAPA Overload Impact the Compliance Journey? 

In the current regulated environment, corrective action/preventive action (CAPA) overload affects companies striving to stay compliant and sell high-quality products as rapidly as possible. Regulated companies spend a lot of time attempting to determine the causes of quality events like deviations and nonconformances in disorganized and inefficient ways. When companies rely on CAPA to resolve nearly all quality issues instead of taking a more strategic approach, they often result in “Death by CAPA.” 

CAPA overload is not the only issue, and there are many other pitfalls that organizations must avoid. So, let us get straight to those pitfalls.

9 CAPA Pitfalls You Should Avoid at All Costs 

1. Passing Every Single Issue Through CAPA System

It is a common scenario to witness companies funneling down all the reported events through their CAPA system. But this only leads to CAPA overload, as we discussed earlier. In addition, with the overburdened systems, you find it challenging to prioritize issues passed through the CAPA process and root cause analysis. You must understand some quality events can be fixed with minor corrections. For this, you must understand the risk threshold of the quality issues. If the risk severity is higher, you must pass such nonconformances through the CAPA system on priority. You can develop a risk matrix or choose a CAPA management system with an in-built risk matrix. It will be much easier and more efficient to deal with quality issues afterward.

Another common concern is that people are unaware and trained on the CAPA-related tools such as root cause analysis, investigation, and much more. This is because people are used to the reactive approach. They correct the quality issues with immediate corrections and then forget about it unless they get repetitive complaints about the same.  You must first identify the tools that best suit your organization’s requirements. Then, train your employees to ensure best practices are in place. Finally, you can integrate training management software with your quality system to ensure that your staff is regularly trained on industry-proven best practices. This will further build a culture of quality and compliance within the organization. 

3. Not Identifying the Root Cause Effectively

We have just discussed how people perceive the idea of resolving quality issues. They look for a quick fix or correction to eliminate the problem. But the harm of the quality issues goes beyond that. They can have severe consequences regarding brand reputation, customer trust, and compliance. Just having a system in place may not help. The focus should be on the process. It would be best if you standardize the processes so that your employees get used to them over time. As they say, “Practice drives perfection.” So, document every best practice and have your employees follow it regularly. You may hear what works and what doesn’t for your employees. This kind of involvement is what it takes to achieve excellence in every aspect. 

4. Not Having the Right People Involved in CAPA Process

Suppose you have everything in place, including process, documents, systems, training, and best practices, but you are still stuck with repetitive issues. Doesn’t that sound overwhelming? It obviously does!  You must be wondering what’s wrong now. And the answer is People.  Yes, you read that right! You might not be involving the right people in your CAPA processes. So, you must create a cross-functional team with a person with process insights, a decision-maker, an auditor, a person who can lead and implement change (if required for mitigating risks), and so on, depending on your objectives.  

Having the right people is key to success in every CAPA process. 

5. Lack of Verification Methods

All the action plans implemented during a CAPA process must be effective enough to mitigate the issue and prevent its recurrence in the future. The best way to do that is to keep track of the same problem for a period and report similar occurrences. Then, if you do not re-encounter the same issue, it would be considered a successful CAPA implementation. But the regulatory bodies require objective evidence for the same.You must train your teams on verification methods and sequentially document every activity. The manual systems may take a longer time. It would be best to have a cloud-based CAPA Management system to document every detail of the CAPA, including their effectiveness review. The CAPA records stored in the software database can also be presented as evidence of best practices to the regulatory bodies. 

6. Lack of Traceability

Whenever a quality issue is reported, the focus is on resolving them. This makes the organization overlook the opportunities to improve or implement preventive actions to avoid similar problems in the future. It could be due to a lack of traceability. It is common for organizations that are working with disconnected systems. The organizations need an integrated solution wherein they can track all the data in one place, analyze it, and make intelligent decisions. That’s where cloud-based solutions can help. Such solutions offer greater flexibility, traceability, and security. The next-generation CAPA solutions are what the evolving businesses need to handle CAPAs more effectively and efficiently than ever. 

7. Improper Documentation

Regulations are stringent regarding documentation: if you cannot provide proof that corrective steps have been taken, it is impossible to prove them. The auditors also review documentation. Creating a form that verifies documented efforts to completion is the most efficient way to ensure documentation compliance.  Using forms, you must provide information about the investigation, the root cause analysis, the containment or correction, and the corrective action. CAPA forms are commonly used in many organizations, which incorporate a “mandatory” section that prevents the person filling out the form from moving on until all the necessary information has been entered. You can use Forms Management Software to create and manage records efficiently. Therefore, it is essential to ensure that documentation is complete and that someone verifies it. 

8. Not Having a Culture of Continous Improvements

Making improvements is all about changing how we manage quality for products, processes, systems, and documentation. And change is something people resist pretty often. It could be due to any number of reasons. So, you must identify those reasons and make people understand how change can bring better results for everyone, including customers, organizations, and even themselves. First, you need to make your employees aware of the purpose and scope of change that will be implemented. Then you can use a change management system to implement changes systematically. 

9. Absence of Standardized Complaints Management System 

Monitoring customer complaints and satisfaction data can also prove to be invaluable when it comes to justifying CAPAs. Despite this, many organizations have a standardized complaints management system in place. The complaints management system helps you efficiently track the quality issues identified by the customer and resolve them on time. This will further help maintain customer trust and loyalty. 

The Bottom Line 

According to the industry experts, avoiding the common CAPA pitfalls can significantly improve the overall performance and efficiency of the organization. You can see a noticeable reduction in product recalls, nonconformances, audit findings, and customer complaints. Due to this, the costs of quality will also be reduced. Businesses that use CAPA as an effective tool to drive continuous improvements will be able to achieve quality, compliance, and operational excellence.  

So, implement an effective CAPA Management Software Solution like Qualityze today and experience the difference in how you manage quality issues and how you used to manufacture quality products. 

For more information on CAPA-related concerns, feel free to contact our customer success team at info@qualityze.com, or you can call us at 1-877-207-8616, and we will be right there for you.



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