Using CAPA to Improve the Health of Your Business

Build a CAPA-conscious work environment

Published: Monday, February 13, 2023 - 12:02

A company’s quality management system should have a formal, effective, and efficient corrective action and preventive action (CAPA) program so management can stay informed and correct existing business problems. The data output and corrective actions from a CAPA program can help prevent recurring problems and prevent new ones, giving management key indicators of what is going wrong and where to change the organization.

Per ISO 9000:2015—“Quality management systems—Fundamentals and vocabulary,” the following definitions are provided for correction, corrective action, and preventive action:
• A correction is an action to eliminate a detected nonconformity (examples include rework, scrap, reprocess, reject, or upgrade).
• A corrective action is an action executed to eliminate the cause of a detected nonconformity and to prevent the recurrence.
• A preventive action is taken to prevent occurrence or prevent it from happening in the first place.

There’s a distinction between correction and corrective action, according to the ISO standards.

Some industries require a CAPA process. For instance, medical device manufacturers are required by the U.S. Food and Drug Administration (FDA) and ISO 13485 to address both corrective and preventive actions. But CAPA can be implemented in any business to achieve excellence. The ability to correct existing problems or implement controls to prevent potential problems is essential for continued customer satisfaction and an efficient business. Therefore, it’s important that businesses use CAPA to clearly recognize issues, how they were resolved, and how to prevent them before they occur.

Using CAPA to accelerate business

A CAPA program should be a closed-loop process that provides meaningful data to support continuous improvements for all business units, which is critical to a company’s survival. The data should always be meaningful and useful to management and other investigative teams to make sound business decisions. Collecting data without taking action to improve a company’s problems is wasteful; therefore, data should be captured, analyzed, and targeted for corrective or preventive action.  

It’s important to select the right data-gathering tools and have good techniques, as well as a process by which the data will be analyzed and actions taken. The CAPA process should employ alert systems to manage critical failures that affect customer satisfaction.

CAPA as a core business process

The CAPA process is a company’s defense against systematic issues and potential complaints. Therefore, it should be recognized as a core business process. Investing in a robust CAPA process for a business will be less costly than dealing with downstream failures.

An organization’s business processes and procedures should reflect a “CAPA-conscious” work environment where leaders are responsible for ensuring that company policies and procedures are robust and implemented, employees are empowered to solve problems, and a feedback loop of best practices is established.

Figure 1: CAPA is central to a business and a core process. Inputs can come from a complaint system, production, facilities and equipment controls, logistics, and any business unit of interest.

CAPA records demonstrate issues in product or service processes, from concept to postmarket monitoring. They provide insight about how a company treats an issue’s criticality, effectiveness, and maintenance, and how a company upholds its business models. CAPA documentation should always identify why something has (or may) go wrong and what has been done to make sure it doesn’t happen again. Therefore, properly documented investigations and their actions are key to understanding the important historical state of a business’s health. 

Create a risk management culture

Involving all employees in a CAPA program actively creates a culture of problem solving, continuous improvement, lessons learned, and risk management as a central part of the workplace. It promotes smarter issue resolution and customer satisfaction. It drives quality, employee behavior, and response to problems. Understanding and exercising root cause analysis (RCA) enhances a team’s ability to identify flaws and issues in a business and is a part of the continuous improvement cycle within the company that leads to better products and process.

The following actions are typically part of an effective CAPA system:
• Establish and practice a closed-loop process companywide.
• Assign appropriate organizational responsibilities for carrying out the process.
• Ensure that issues are identified, corrected, eliminated, or prevented.
• Establish well-defined and robust processes, procedures, and best practices.
• Qualify corrective action tools as fit-for-use for the problem-solving process.

Final thoughts

CAPA has numerous benefits for businesses, including higher productivity, efficiency, quality output, consistency, and customer satisfaction. Using a quality management system is a vital part of any CAPA implementation. Employees should have a place to document and share issues, work on root cause analysis, and issue closures in a secure location that is accessible to all.

Every corrective and preventive action must involve an investment of resources. CAPA investments will vary depending on the scenario. This requires careful consideration about corrective measures and their costs. Sometimes the investment is small, while at other times it might require significant resources and training. An organization’s culture should practice evaluating the return on investment (ROI) from using a CAPA program.

Mainstream businesses can adapt the CAPA best practices of medical device manufacturers to create a method for improving their processes. With the increase of advanced technologies, customer experiences are now more individual and require greater judgement and problem-solving analysis. Companies benefit when their processes can adapt to changing business demands. As part of that, CAPA allows issues to be documented, tracked, mitigated, and resolved. This allows businesses to get ahead of recurring issues and avoid losing profits.

About The Authors

Alonso Diaz

Alonso Diaz is director of quality at Taimei Technologies. He specializes in pharmaceutical and medical device compliance, auditing, quality assurance, validation, and artificial intelligence. Diaz has 25 years of cGMP experience in the biotechnology, pharmaceutical, medical device, and information technology areas. He has been a leader and influencer in compliance working for major health care companies such as Amgen, Medimmune, Applera, Abbott, and IBM. He holds bachelor’s degrees in chemistry and microbiology from New Mexico State University, and brings a unique blend of science, big pharma, medical device, and business acumen to the life science industry.

Maria Dibari

Maria Dibari is director of quality at Full Spectrum Software. A graduate of State University of New York-New Paltz, she has a master’s degree in molecular biology and more than 18 years’ experience in medical device R&D and manufacturing, pharmaceutical manufacturing, and health software application development. She is a quality expert in management development and the application of regulations such as 21 CFR Part 11, ensuring that business entities meet laws, regulations, guidelines, and best practices that govern the healthcare industry. She provides regulatory and industry guidance and consultation to executive leadership on strategy around quality, compliance, and product labeling. In 2021, she was awarded a first patent in artificial intelligence around improving patient outcomes.