Manage Your CAPAs Effectively with a Cloud-Based CAPA System
Every company must master CAPA management system to achieve commercial success by maintaining a proactive quality mindset that regulators demand.
The ISO 13485:2016 standard, the MHRA guidance, and FDA 21 CFR 820.100 cover the requirements for CAPA management in the world of highly regulated medical devices.
CAPA Management Software - what does it mean?
CAPA refers to two separate requirements for documented 'Corrective Action' and 'Preventative Action' procedures in your Quality Management System. This plan should outline how your company identifies, corrects, and prevents future non-conformities in its processes and products.
As a quick overview, let's compare FDA and ISO 13485 definitions of CAPA.
The FDA defines CAPA in 21 CFR Part 820.100. Corrective action and preventive action:
Manufacturers must establish and maintain corrective and preventive action procedures. Therefore, it is necessary to include requirements such as:
- Identifying the existing and potential causes of nonconforming products, both internal and external audits, quality records, complaints, returned products, and other quality data. A quality problem that occurs repeatedly must be detected using appropriate statistical methods;
- Analyzing the causes and consequences of nonconformities relating to products, processes, and quality systems;
- Determining what actions must be taken to correct nonconforming products and prevent future problems;
- Evaluating the effectiveness of the preventive or corrective actions to reduce the chances of adverse effects on the finished products;
- Implementing and recording quality improvement methods and procedures;
- Informing the responsible parties for maintaining the quality of a product or preventing problems about quality problems or nonconforming products; and
- Informing management of identified quality problems and preventive and corrective actions.
A record of all the activities and the results should be kept under this section.
FDA QSIT explains the purpose of CAPA as follows:
"Corrective Action Preventive Action is concerned with gathering information, analyzing data, identifying problems with quality and products, and taking appropriate and effective measures to prevent recurrences of those problems." To resolve product issues effectively and minimize device failures, verifying and validating corrective and preventive actions, communicating them to responsible people, presenting relevant information to management for review, and documenting them. The corrective and preventive action subsystem is one of the essential quality system elements."
ISO 13485:2016 addresses CAPA in two separate clauses: 8.5.2 Corrective Actions and 8.5.3 Preventive Actions.
Corrective action
Corrective action must be taken within a reasonable time frame to prevent the recurrence of nonconformities. Corrective actions shall be proportionate to the impact of nonconformities.
Preventive action
Preventive actions must be proportionate to the effects of potential nonconformities so that they can be avoided.
CAPA: 5 Problems You Need to Know
The following reasons explain why CAPA has problems:
It lacks cross-functionality
Being reactive instead of proactive
Underuse vs. overuse
Insufficient root cause analysis
CAPA lacks a clear definition
CAPA Management Software: 7 Steps to Success
Here are seven steps to building a CAPA process that works:
Determine the problem
Assess the problem
Identify and investigate the failure
Root cause analysis
Develop a resolution plan
Putt the plan into action
Monitor and follow-up
How to make your CAPA process as effective and efficient as possible?
Medical Device companies can benefit greatly from the use of cloud-based CAPA management systems, which can streamline and automate processes that are so crucial to the safety of their products and, as a result, to their success.
An effective CAPA management software system like Qualityze will digitize these processes, automate workflows, provide notification and reporting tools, keeping relevant stakeholders informed throughout investigations and follow-up activities. It also enables you to document and record every part of your CAPA management software process in a way that is auditable in the future and reduces the risk of errors and liabilities. The system has exceptional in-built capabilities such as Notifications, Alerts, Risk Matrix, Email Approval, Digital Signature validation, and much more.
If you want to discover more functionalities of Qualityze CAPA Management Software, it would be best to request a free demo.
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