Frequently Asked Questions: CAPA
What is corrective and preventive action (CAPA)?
Corrective and preventive action, commonly called CAPA, is a methodical system used by businesses and manufacturers to identify the source of actual or potential problems and their root causes, determine solutions for problems, implement solutions and document each step to ensure a problem does not occur in the future.
What is the difference between corrective action and preventive action?
Despite CAPA often being used as a catch-all term to refer to the overall process, corrective actions and preventive actions occur at different stages of a product’s lifecycle. Still, they are generally addressed in the same way.
Corrective Actions are the steps taken to identify and eliminate the cause of a nonconformity that has already occurred.
Preventive Actions are the steps taken to find and rectify the cause of a potential nonconformity to prevent it from occurring.
Nonconformity, also called nonconformance, is when a product or service deviates from a specification, standard or expectation so that the end result does not meet requirements.
What is the CAPA process?
The CAPA process can be very involved depending on your business and/or the nonconformity it is addressing. In high-level general terms, the CAPA process involves:
- Identifying and describing the problem or nonconformance
- Taking any immediate actions necessary
- Investigating the root cause of the nonconformance
- Creating an action plan to address the root cause
- Implementing and then assessing the plan
- Communicating the new process
It is important to document each step of the CAPA process for review and future improvement purposes.
What is root cause analysis?
Root cause analysis (RCA) refers to efforts undertaken to identify the real cause of a nonconformance or quality problem. Popular root cause analysis models include Five Whys, Fishbone Diagrams, Failure Mode and Effects Analyses (FEMA), and Pareto Charts.
What are FDA and ISO CAPA requirements?
FDA 21 CFR 820 calls for regulated organizations to establish and maintain procedures for implementing corrective and preventive actions. Companies must be able to demonstrate a well-thought-out process, including methods for data analysis, root cause analysis, verification or validation of corrective or preventive actions, implementation of changes, keeping a record of changes in methods and procedures, and communicating relevant changes to management and others directly responsible for ensuring quality of the product.
ISO and GMP share CAPA standards with the FDA, however, documentation of the problem and how it was fixed is the only actual requirement.
Ultimately, companies need to be able to demonstrate to auditors that their quality system can effectively identify problems quickly and implement effective corrective and preventive actions.
Why should I use QT9 QMS for my CAPA processes?
QT9 QMS has 25+ interconnected modules that come standard, including a CAPA module that connects with other key applications, including audits, risk management, customer complaints, deviations and supplier management. It’s cloud-based platform allows you to keep track of corrective actions and synchronize records with anyone, anywhere.
QT9’s QMS software is a highly rated, affordable, easy-to-use quality management system that excels at all of the processes that go into providing high-quality goods and services that are FDA and ISO compliant.
With QT9 QMS you get unlimited scalability and traceability at a great price, so you can bring quality products and services to market in the most efficient way.
