What is CAPA? The CAPA quality process, in a nutshell, consists of the specific improvements a regulated organization makes to its processes to eliminate defects and non-conformities.
Effective CAPAs are the backbone of your quality management system , acting as the mechanism for fixing problems and optimizing your processes.
Let's dive in and take a look at everything you need to know about the CAPA process.
The CAPA acronym isn't unusual: the world of quality management is full of acronyms.
SOPs. NCRs. GxP. And CAPAs.
So what does 'CAPA' mean?
CAPA stands for 'corrective and preventive action'.
As the name suggests, CAPAs are about problem-solving. And it's a two-step process: when something goes wrong, a CAPA is executed to 'correct' the immediate issue, then to 'prevent' it reoccurring with a tweak or improvement that addresses the cause.
CAPA is defined as a systematic approach used in various regulated industries, including manufacturing, healthcare, and quality management, to identify, investigate, and address problems or non-conformities in products, processes and systems.
The purpose of CAPA is to rectify existing issues and prevent their recurrence in the future.
A CAPA system is therefore a crucial part of the modern quality management system, since quality in general is all about ensuring the integrity and quality of the products and services your company provides.
We can see how important this is when we consider that over half of the causes of a business failure can be attributed to internally generated problems that weren't properly addressed.
The Shewhart Cycle, more commonly known as Plan Do Check Act, is a classic quality management approach that enshrines CAPA procedures.
In this case, the 'check' and 'act' portions of the cycle are synonymous with CAPAs: systems and processes are checked, problems are found, then those problems are fixed with corrective and preventive actions.
What does a CAPA system look like in real life, then?
Remember, establishing CAPAs requires a commitment to quality and continuous improvement. It's an ongoing process that helps you identify and resolve issues proactively, ensuring that your business operates efficiently and delivers high-quality products or services.
And it's not always something businesses get right.
CAPA requirements for medical devices marketed in the United States are laid out in FDA 21 CFR 820.100(a) - and failure to instil proper CAPAs is a consistent leading cause for FDA audit failure and the sending of Form 483s as a slap on the wrist.
Analysis of FDA warning letter citations sent to drug companies between 2015 and 2023 reveals a similar pattern.
'Quality unit and investigations', 'complaints handling', 'process validation', and even 'cleaning validation & techniques', are all major recurring warning letter triggers which could have been avoided with robust CAPAs in place.
CAPAs and quality really go hand-in-hand. CAPA corrective actions and preventive actions, after all, are how your organization can eliminate quality weaknesses and ensure your products and services are optimized.
CAPAs are essential for maintaining high standards and ensuring continuous improvement, so you'll find them in any mature and effective quality management system.
The CAPA process typically involves several steps:
Your quality system should contain CAPA procedure documents to record how your organization intends to detect and react to defects and nonconformances. They should also lay out how each step will be executed and closed out to ensure CAPA success.
And because CAPAs are so critical for modern regulated businesses, it's important that you choose the right tools and systems to manage them efficiently.
Dedicated CAPA software can accelerate and automate your CAPA processes, providing bespoke workflows and analytical reports to help you keep up with your CAPA demands at scale.
A CAPA is required whenever a non-conformity or potential issue is identified that could impact your product quality, safety, or compliance.
CAPA 'triggers' can occur from routine inspections, audits, customer complaints, or internal reviews.
It's important that your business gets these observation mechanisms in place so defects and nonconformances don't go unnoticed and unaddressed.
To illustrate in more detail when a CAPA would be needed, let's consider a CAPA example in a drug manufacturing setting.
CAPA example kick-off: A batch of pharmaceutical product fails quality inspection due to a defect in its critical quality attributes (CQAs).
Corrective Action:
Preventive Action:
CAPAs are crucial for several reasons:
Understanding what CAPA is and its importance in quality management is essential for any organization committed to excellence.
By implementing effective CAPA processes, and even adopting CAPA and nonconformance management software, your organization can address existing issues, prevent future problems, and continuously improve your operational strength and maturity.
Whether in manufacturing, pharmaceuticals, or any other industry, CAPAs play a vital role in ensuring quality, compliance and customer satisfaction.
Lola is an ASQ Certified Medical Device Auditor with extensive experience working for large multinational corporations and start-ups across Europe and North America. She works closely with Qualio customers to implement and maintain their eQMS, helping them to achieve their quality goals and bring their product to market efficiently.
