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Focus on Product-Centric Quality Approach for Improved CAPA Processes

01 Aug 2023

Designing a product that serves its intended purpose is critical for medical device manufacturers, as it could have a great impact on a person’s health- for that matter even life. You can still manage your tasks if your internet modem is not working as it should be, but can you manage to breathe if your inhaler is insufficient to provide you the medication when you are already struggling to breathe. The worst scenario here could be a risk to your life, which is not acceptable at all.

Credit goes to the technology advancements, the medical industry has better and improved solutions to sustain lives and offer quality care like never before. When a nonconformance is identified in a medical device, it needs urgent attention. You need to investigate its root cause, resolve the issue as soon as possible, and most importantly, prevent its recurrence in the near future. You must have an effective CAPA process or CAPA management software to ensure timely correction or prevention of the product issues that may have frightening consequences.

Why CAPA is Significant for Compliance?

For medical device manufacturing companies, it is important to be compliant with FDA regulations. According to the FDA, it is important to maintain a closed loop of processes that focus on quality management, training, and audit if you want to introduce a new product in the market. Moreover, the product must adhere to ISO 13485 to reflect that you implement and maintain the quality systems on a regular basis. Keeping a balance of FDA and ISO standards ensure that the organization is following best practices for compliant and effective quality management processes.

It is quite challenging to meet the regulatory standards especially when you want to introduce a new product very quickly. Medical device companies need to manage Bill of Materials (BOM) that contain all the required details of the electrical, mechanical, and software components used in the product. In fact, they should track and manage all the important records including approved supplier list, the design history records, design master record, compliance information with regards to regulatory and environmental standards as all this information plays a key role in resolving quality issues through CAPA.

As per FDA title 21 CFR 820, it is imperative to establish CAPA processes for all the product companies, be it medical or any other. They must follow a closed-loop CAPA process to ensure quality and compliance.

How Closed-Loop CAPA Process Works?

The closed-loop CAPA process is generally conducted in two parts: Initiate and Update.

The initiation step of the CAPA process includes identification, documentation, and approval of the corrective and preventive action whereas the second part includes the implementation of the action plan and updating the impacted processes and systems.

Initiate Step

In the initial step, you need to deploy a cross-functional team to investigate the root cause of a problem identified in a nonconformance report, customer complaint, audit findings, or any other source of the quality issues.

Whether the issues are identified by the partners, customers, or employees, they are all recorded. The recorded information generally contains the description of the problem, risk severity of the problem, identification information of the product including product code and batch number, and other relevant information such as the operating environment.

After information recording, the analysis of the issues is done by the cross-functional team. The support team, quality team, and engineers may work collaboratively to resolve the problem effectively and replicate the solution for all the affected products. The process starts with the identification of root cause behind the problem, which is then documented and evaluated to identify the best action plans. The action plan may involve changes in the design process, suppliers, or in the manufacturing process.

The proposed action plan goes under review from the impacted departments for the final approval. On approval, the changes are also documented especially if it requires design changes. Then, the final action plan will address one or more elements mentioned in the list below:

  • Personnel training management (with an effective training management software)
  • Product designing
  • Manufacturing/Test documentation
  • Purchased products/services

Update Step

It is also referred to as a closed loop step wherein the processes from the identification of the problem to its resolution are taken care of. Since most of the CAPA processes involve more than one element in the product assembly and design, the CAPA management system eliminates the issues and ensures an easily traceable approach. This further allows all the impacted teams including manufacturing, design, and quality to review and collaborate for that particular product record and the resulting CAPA issues.

An effective closed-loop CAPA process is the one that can not only manage the initiation phase including identification, analysis, and root cause determination but also takes care of documentation of every step included in the implementations while linking CAPA records to their respective product records. This ensures that all the involved teams, including design, engineering, and manufacturing, have a clear understanding of the quality issues occurred so that they can also actively participate in the resolution of the problem. Such sort of connected approach with the CAPA processes is referred to as a product-centric quality management approach, which results in significant improvements in the entire CAPA process.

A Comprehensive Solution to Make Product-Centric Quality Approach for Improved CAPA Processes

Though closed-loop CAPA plays a significant role in resolving quality issues but implementing them manually and expecting the speed and accuracy won’t be justified in the modern technological era. You need to consider shifting to the technological solutions for the accuracy, speed, and precision required in the highly regulated industries like medical devices industry. One of the highly recommended solutions for closed loop CAPA management is Qualityze. It is a powerful and secure solution to help you manage all your CAPA tasks with complete flexibility, scalability, and security.

It’s an intuitive and easy to use software solution that comes with configurable workflows that ease the managing quality issues, maintaining the consistency in deliverables. Most importantly, it makes your organization ready with the proactive and reactive approach for resolving the issues without any delays. There are many other features to explore with Qualityze CAPA management solution like electronic signatures that ensure quality processes while meeting compliance.


Connecting the CAPA process with the product processes is the right thing to do for improving and saving lives especially in the highly regulated environments. It enables modern medical device manufacturers to drive more innovation by bringing impacted teams, product records, and all the quality processes together. This further ensures maximum traceability of the product lifecycle. Be sure that you are ready with the product centric QMS approach to comply with ISO, FDA, and other regulatory standards that will help medical device companies to deliver an improved range of products and make the world a better place.

Let’s focus on product-centric quality approach for improved CAPA processes with the technological solutions like Qualityze!



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