A working CAPA program is essential to your business in order to remain compliant with the FDA. CAPA is not simply a way to stay compliant, but an efficient, well-run CAPA program can benefit your organization’s overall success.
Your CAPA program may seem like nothing more than some boxes to check and a pile of paperwork, but an effective CAPA program can improve your organization’s productivity and performance across the board.
At its core, a CAPA program is an essential component of any quality management system. Start making your CAPA program work for your organization, and it becomes a tool for constantly propelling your business toward improvement and success.
What is a CAPA Program?
A Corrective Action Preventative Action program (CAPA Program) is a way to address and correct problems in the workplace before they cause further damage. A CAPA program identifies an issue, finds the root cause of that issue, and outlines what action must be taken to avoid recurrence.
CAPA programs specifically identify, address, and prevent quality issues to boost overall product quality and employee safety. FDA inspectors and ISO auditors consider CAPA programs to be a critical regulatory requirement.
CAPA was first introduced by the FDA in 2006 as part of the Quality Systems Guidance, which formed the groundwork for the ICH Guideline Q10. CAPA is now part of the EU GMP Guide, outlining CAPA programs for pharmaceuticals.
CAPA identifies deviations from within the quality management system. This can be through sources like internal audits, customer feedback, and safety or security-related incidents. The process starts with immediate action that diffuses the situation, mitigating the risk of further damage. Defining the severity of the issue is vital here, as some cases result in ceasing production entirely.
Corrective action vs preventative action
Corrective action and preventive action are both necessary parts of the CAPA response. Some industries separate the two, while others view them as one process. Corrective action is all about reacting to whatever caused the nonconformance. This process can be divided into two steps:
Identifying the root cause: identifying what caused the problem to occur, and what might cause trigger recurrence. An important step here is to separate symptoms from causes to find the true root cause.
Taking action: taking quick action according to the PDCA (plan, do, check, act) approach.
Preventative action is a strategy designed to avoid recurrence, and thereby improve overall product quality and business performance.
Steps to the CAPA system
The regulations might look daunting in their native form, but establishing a CAPA program is pretty simple (especially with the right software on hand). Here are the basic steps you need to establish a compliant CAPA system:
Analyze the issue.
Investigate to determine the root cause.
Take action to fix the problems and prevent the issue from recurring.
Verify or validate the effectiveness of the corrective action, identifying any potential adverse effects and ensuring the desired result was achieved multiple times.
Make procedural changes for your entire organization.
Communicate the changes to all involved and make sure they are properly implemented.
Get management on the same page.
Document everything along the way.
What is the Purpose of CAPA?
The U.S. Food and Drug Administration (FDA) outlines the purpose of corrective and preventative action as collecting and analyzing information, identifying and investigating product and quality problems, and taking corrective and preventative action to avoid recurrence.
CAPA programs are used to address deviations in quality that have already been occurred in order to prevent them from happening in the future. They go beyond simply identifying issues by analyzing quality issues and identifying the potential effects of the deviations. CAPA acts as one element of a risk management program.
Benefits of a CAPA program
Although the most obvious benefit of a CAPA program is remaining compliant with the FDA, implementing an efficient CAPA program might benefit your organization in some unexpected ways.
For starters, you’ll likely experience fewer recalls. Minimizing nonconformance results in fewer accidents, better patient safety, less wasted materials, a reduction in reworks and repair costs, and even the minimization of warranty expenses.
The proactive nature of CAPA will prompt necessary design and engineering changes and lead to more efficient processes and procedures overall. Maintaining a CAPA program also means you’ll be constantly improving your organization’s quality management. All in all, meeting regulatory requirements can reduce overall costs and boost productivity and efficiency within your organization.
What are CAPA Requirements?
CAPA programs make up a subsystem that is housed in your overall quality management system and must adhere to requirements outlined by FDA 21 CFR 820.100, ISO 9001:2015, and ISO 13485:2016.
Acknowledging the differences between these regulations is helpful in understanding CAPA requirements.
ISO 9001 is the general quality management system standard. ISO 13485 evolved out of ISO 9001 and is specific to the medical device industry. ISO 13485 is the international standard, but it is voluntary and not a requirement for quality management systems. It also doesn’t identify any specific product, service, or business requirements.
While ISO 13485 is not law, adhering to these standards helps medical device companies meet other regulatory requirements.
FDA 21 CFR Part 820, however, is the law for medical device companies manufacturing and selling products in the United States. Most medical device companies try adhering to both ISO 13485 and FDA 21 CFR Part 820.
At the very least, here’s what your CAPA subsystems must include:
The ability to capture, review, approve, control, and retrieve established CAPA processes
The ability to capture and retrieve CAPA activities and results
A closed-loop process from workflow to sign-off that facilitates verification that actions are effective and don’t adversely affect the finished product.
A closed-loop process that ensures documentation of corrective and preventative action activities are established, defined, documented, complete, and implemented
The ability to capture, review, approve, control, and retrieve a CAPA procedure to determine when verification can be conducted in lieu of validation
It’s hard to visualize a CAPA system that adheres to the regulations without understanding what steps are necessary to meet them. Follow this checklist to ensure your CAPA process is FDA compliant:
Define your key terms. Make sure your team understands what a nonconforming product is, the difference between correction and prevention, etc.
Define all procedures necessary to meet CAPA program requirements.
Create a documented system of identifying and recording quality data.
Outline clear methods and procedures for inputting qualities issues into the CAPA system.
Create a schedule for regularly analyzing quality data to identify quality problems.
Collect post-distribution data like complaints, returned products, concessions, quality records, etc.
Regularly examine quality records for trending data, corrective actions, acceptance activities, etc for negative trends.
Create preventative measures to combat negative trends.
Capture in-conformance product data.
Implement statistical control techniques.
Make sure data is entered accurately.
Ensure your quality analysis utilizes statistical techniques like spreadsheets and pie charts as well as non-statistical techniques like quality review boards and committees.
Compare product and quality issues across all data sources to identify trends.
Make sure you fully understand the extent of the problem before acting on the issue.
Create procedures for conducting thorough failure investigations.
Create a system for determining if CAPA is necessary for a specific issue.
Create a rationale for not overextending corrective action.
Create a process for assessing the effectiveness of corrective and preventative actions.
Verify and validate actions.
Don’t overlook the application of design controls.
Submit relevant information regarding issues and actions for management review.
Communicate relevant information to all stakeholders.
Verification vs validation
Verification and validation are both effectiveness checks, but they aren’t interchangeable. The term verification describes all actions taken beforehand to ensure remediation occurs as anticipated. Validation is the process of going behind implementation to make sure the solution was effective.
Organizations sometimes want to skip over the verification phase and jump straight to implementation, but this can be a major waste of time. Verification identifies the likely outcome, pointing out any changes you might need to make before implementing your resolution. Proper verification leads to a less stressful validation process. You’ll have already identified a metric for success, and seeing whether or not you met that goal will help you identify what additional steps need to be taken.
CAPA Software Uses
When it comes to delivering quality products with as little nonconformance as possible, communication is key. Your CAPA program needs to be a place for your employees to collaborate across departments, remaining on the same page throughout the entire product lifecycle.
Corrective and preventative action software is a continuous improvement tool that takes care of the heavy lifting for you by collecting and analyzing data to identify issues with quality, processes, and equipment. CAPA software alerts organizations of any potential issues, helps your team identify the root cause of identified issues, and provides insight as to why the issue occurred and what corrective action can be taken to fix it.
Because corrective action software is often integrated into a larger quality management software, it draws data from the entire quality system and uses data like customer complaints, document management systems, and audit management systems.
Issue identification
Employees working the front lines can report potential issues right away. This rapid-action reporting gives supervisors and managers a head start on the investigation.
Root cause analysis
Root cause analysis is one of the most important corrective and preventive action software uses. This is what helps organizations get into the nitty-gritty of what actually caused the issue they’ve identified. It’s what informs the preventative action, too, as identifying the root cause is the only way to prevent the issue from recurring.
Root cause analysis takes error data from the CAPA program and guides your team through the process of creating plans for corrective action. Root cause analysis acts as your personal sleuth, analyzing when, where, and why an issue occurred and creating a plan for rapid correction.
Corrective action planning
CAPA software also helps teams create corrective action plans. When an audit reports an issue, you can use the corrective action software to define a corrective action plan that outlines all the steps your organization needs to take to correct the issue. CAPA software records any actions you take in preparation for follow-up audits.
Risk assessment
Risk assessment is another key use for CAPA software. Monitor everything from operational risks to risks in finance and human resources. When the corrective action software picks up risks, you’ll get a notification suggesting you take preventative action. You can even schedule risk assessments to run at whatever interval you choose.
Reporting
Reporting capabilities are central to any good CAPA software. Corrective and preventive action software simplifies the process of identifying defects and complaints in a standardized report template. CAPA software includes the following in the report:
A description of the issue
Action taken
Resolution
Resources and team members involved
Planned resolution date and actual resolution date
Ineffective reporting is one of the biggest challenges organizations face in complying with FDA cGMP requirements. Selecting a CAPA software solution with strong reporting capabilities will keep your organization ready for a potential audit.
Reporting features will also help your employees identify potential trends, giving you the chance to catch problems before they become serious.
Project management
Project management is an easily automated process using CAPA software. After your employees report an issue and you’re ready to take corrective action, CAPA software assigns tasks to employees across all the necessary departments, notifies individuals of what they need to do, and gives managers a place to monitor the process for smooth sailing supervision.
Automated reminders and notifications keep employees on their toes, and they have the software to turn to for support and collaboration if need be. Cloud-based access simplifies CAPA for global teams.
Impact measurement
To get the most out of CAPA programs, you need the ability to measure and communicate the impact of corrective actions across your teams. CAPA software gives teams the ability to measure and communicate the impact corrective actions have on factors like defect rates, customer satisfaction, and cost management.
Integrations
CAPA software can integrate with your other quality management systems. This helps your team automate the data entry process, resulting in quality data. By making the timeline visible across all departments, these integrations also help your team stay on top of what issues need to be solved and when.
Additional benefits to CAPA software integrations include:
Notifying staff members with action items and deadlines
Creating deviation reports and customer complaint forms linked to CAPA forms
Triggering updates to SOPs based on preventive or corrective actions
Tracking quality trends with closed-loop reporting
Forms
CAPA software uses automation to streamline quality management operations, making your job easier. Intuitive forms are part of this automation. They’re simple and easy for your employees to use. Related benefits include a cloud-based organization system, web-based template editors, guided form workflows, and a detailed drafting and approval process.
Linked quality processes
If you’re citing training as a potential cause for issues during your CAPA investigations, CAPA software can help you streamline and enforce standard operating procedures. This helps you avoid quality system failures by linking your CAPA program to your company-wide quality processes. Because CAPA software links the CAPA program to data and reporting, teams get a clearer understanding of what will boost quality improvement, trend analysis, and identify necessary updates to standard operating procedures.
Automated data entry from quality management systems reduces data quality issues.
CAPA software reduces quality issues by automatically entering data from quality management systems like:
Supplier management
Audits
Inspections
Complaints
Risk management
Design controls
Guided workflows
Noncompliance typically occurs when an organization doesn’t have the proper systems in place, or when employees aren’t aware of the systems. CAPA software solves this problem by providing guided workflows that show your organization how to resolve issues in time.
Full audit trail
Lastly, CAPA software offers peace of mind by creating a full audit trail. CAPA software takes care of record-keeping for you, collecting all the information necessary to avoid FDA noncompliance. Closed-loop systems go a step further, providing enough data for quality-improvement decisions.
Why use CAPA Software?
There are numerous uses for CAPA software, and the list continues to grow. The specific benefits realized through adopting CAPA software depends on the function of your program, but these four overarching benefits are universal.
Identify and resolve more issues
CAPA software facilitates an efficient CAPA program. When you make reporting issues easy for your employees, they’ll report and resolve more issues
Solve problems faster
CAPA software organizes the process into clear, easy-to-understand steps. Everyone on the team knows their part in the problem-solving process. This streamlined workflow helps employees solve problems faster.
Boost employee engagement
CAPA software gives every employee a role in the CAPA program. Rather than the process happening purely behind the scenes, team members are aware of their role and remain active in the CAPA process.
Align your team
Priorities differ across departments, but CAPA software combines these goals so that they support the overall company mission and do not interfere with each other. This increased communication boosts productivity by ensuring every department knows where their needs fall on the priority list of the organization.
When is CAPA Necessary?
In the case of nonconformance, you should institute a CAPA when you observe the same nonconformance problems more than once. This points to a systemic issue that needs addressing, rather than a fluke. This is especially true in cases where the same product or part is consistently failing inspection despite nonconformance procedures.
A single complaint isn’t enough to trigger a CAPA, but multiple complaints regarding the same issue that occur close together are a different story and should trigger a CAPA. However, a one-off complaint should definitely trigger a CAPA in the case of customer injury.
When it comes to audits, severe issues should automatically result in a CAPA. Less severe issues still warrant a CAPA when they occur multiple times.
Conclusion
You just got the rundown on what a CAPA program is, the benefits and requirements of a CAPA system, and all the ways you can use CAPA software to better your organization.
The key to a stellar CAPA program is understanding these benefits and communicating them to your team. When all of your departments are on the same page in terms of company priorities, quality management, and corrective and preventive action, production will run smoother. Customers will be happier.
Convey this to your employees, and watch the effect this change in perspective will have on their engagement rates. When even the employees identifying potential quality issues on the frontlines know the implications of their actions, they act as the foundation for a well-functioning CAPA program.
All you really need to do now is equip your team with the right CAPA software for the job.
FAQs
What is the purpose of a CAPA system?
CAPA is a subsystem of quality management designed to collect and analyze information related to quality issues, investigate those issues, and take the actions necessary to fix the issues and prevent them from occurring again.
What is a CAPA management system?
A CAPA management system is a corrective and preventative action system. It’s a part of an overall quality management system that identifies existing quality issues and creates an action plan for fixing those problems and preventing them from recurring. CAPA management systems improve a company’s overall product quality, safety, customer satisfaction, and compliance with FDA regulations.
How is a CAPA system implemented?
A CAPA system can be implemented following the PDCA cycle (plan, do, check, act). You start by gathering information on the necessary resources and requirements, acquiring tools like software, and distributing tasks to everyone involved.
Next, it’s time to develop your processes. Train your employees, create SOPs, and get straight on how the process will look in action.
In the check phase, it’s time to assess the effectiveness of your CAPA program.
Lastly, it’s time to implement your CAPA program by putting it in action. Continue assessing its effectiveness and efficiency and adjust as necessary.
What are CAPA requirements?
According to FDA regulations, CAPA programs must be able to capture, review, approve, control, and retrieve established CAPA processes, activities, and results in a closed-loop process. CAPA actions must be verified and validated, and everything must be thoroughly documented.
