Zillery Fortner, Product Advisor, QA/RA Life Sciences, Sparta Systems, a Honeywell company04.01.22
The fourth industrial revolution has resulted in fast-paced technology and innovations taking the life sciences industry by storm. This is where Quality 4.0 was derived. The goal of Quality 4.0 is to use a predictive mindset that does not replace traditional methods. Rather, it harmonizes people, culture, technology, and processes to help reach organizational goals. The result of this is less burdensome systems that instead can be used as powerful, proactive tools to help shape quality within an organization.
Implementing a holistic corrective and preventive action (CAPA) system is one of the most effective ways a medical device manufacturer can minimize risk, improve quality, and effectively manage cost. An effective CAPA system will increase product quality and safety while ensuring customer satisfaction and helping to meet regulatory compliance.
By following the guidelines outlined below, organizations can create a holistic, predictive and proactive CAPA system to foster improvements continuously.
What’s in a Successful CAPA Process?
A successful CAPA process will decrease product risk, improve the overall quality of the product, ensure compliance, and increase customer satisfaction by uncovering trends, providing preventive measures, and streamlining workflows.
These issues are addressed with new or revised processes to minimize them and ensure they are corrected elsewhere where the same conditions exist. This allows organizations to anticipate future problems and save enormous time and resources.
CAPA management is viewed as an efficient way of tackling quality issues during the manufacturing process. However, challenges arise when organizations lack an effective closed-loop CAPA management process. For example, many firms still use manual tools like spreadsheets and paper-based systems to track their CAPA issues and efforts. This proves to be inefficient, error-prone, and hinders visibility into the process.
Corrective (Reactive) Action vs. Preventive (Proactive) Action
What is the difference between corrective and preventive action? A corrective action is the measure(s) taken to find a root cause and to stop the problem from happening. The corrective action is not “the fix” or a long-term solution.
Preventive action happens once the issue is solved, and is the need to prevent it from happening in the future. It involves cross-functional teams and takes a continuous improvement approach to prevent recurrence.
Over time, using a holistic approach ensures the quality system will not be static. It will continue to evolve and meet new challenges and requirements.
The Benefits of an Automated, Holistic CAPA System
Organizations implementing an automated CAPA solution will be better positioned to manage all quality processes in a centralized system. This results in improved visibility, efficiency, and other key benefits, including:
An effective CAPA system will help to reduce costs that would otherwise go toward supporting quality initiatives in other departments in the organization. Implementing a closed-loop CAPA management system is essential for reducing quality issues and improving the overall cost of quality.
Organizations should create, document, and review the automated, holistic CAPA system. During this step, the organization should set clear policies on the CAPA process, document those processes, and staff should be trained according to their job matrix. It’s essential to ensure the CAPA system is centralized and controlled, consolidating operations and eliminating overlap between departments. Organizations will also need to have an effective method for tracking all incidents and events, ensuring visibility, and providing a single source of the truth.
It’s also important to set a robust foundation for an effective CAPA process. Inadequate CAPA procedures continue to be the most common FDA inspection observations. A strong CAPA process embedded into the lifecycle process is key. This provides companies with an organized method for identifying all concerns, solving them, and preventing recurrence.
Having an efficient CAPA process in place is essential for a successful QMS. Both ISO and the FDA provide the CAPA framework, but it is the organization’s responsibility to determine and maintain a systematic and practical system.
Follow these basic steps for a successful CAPA process:
When there is confusion over understanding when a CAPA should be open, organizations will have less time to spend on problem-solving and making improvements. Using a closed-loop CAPA system that follows the Plan, Do, Check, Act process reduces cost and increases customer satisfaction.
Continuous improvement is an effort to continually improve products, processes, and services. Organizations should ensure the following are part of the CAPA continuous improvement process:
CAPA continues to be a widely-used and effective process for ensuring product quality and safety. It’s critical in manufacturing operations—an effective CAPA process will ensure any quality events are addressed quickly and effectively and prevent the recurrence of these events.
By following these guidelines, organizations can empower the CAPA process and use it as a continuous improvement method to drive product quality and patient safety.
An automated, holistic CAPA system is the most efficient system to achieve this. It will result in a minimal drain on an organization’s time and resources and transform the formerly burdensome CAPA system into a powerful and proactive tool.
Doing so provides organizations with the capability to anticipate future quality events and maintain business now and in the future.
Zillery A. Fortner is the Product Advisor, QA/RA Life Sciences at Sparta Systems, a Honeywell company. She earned a bachelor’s degree in health science from South University. Fortner has 20 years of experience in the medical device arena related to quality assurance, regulatory affairs, and JACHO. She served 10 years in the military as a certified surgical technician. Fortner is an active member of ASQ and AAMI.
Implementing a holistic corrective and preventive action (CAPA) system is one of the most effective ways a medical device manufacturer can minimize risk, improve quality, and effectively manage cost. An effective CAPA system will increase product quality and safety while ensuring customer satisfaction and helping to meet regulatory compliance.
By following the guidelines outlined below, organizations can create a holistic, predictive and proactive CAPA system to foster improvements continuously.
What’s in a Successful CAPA Process?
A successful CAPA process will decrease product risk, improve the overall quality of the product, ensure compliance, and increase customer satisfaction by uncovering trends, providing preventive measures, and streamlining workflows.
These issues are addressed with new or revised processes to minimize them and ensure they are corrected elsewhere where the same conditions exist. This allows organizations to anticipate future problems and save enormous time and resources.
CAPA management is viewed as an efficient way of tackling quality issues during the manufacturing process. However, challenges arise when organizations lack an effective closed-loop CAPA management process. For example, many firms still use manual tools like spreadsheets and paper-based systems to track their CAPA issues and efforts. This proves to be inefficient, error-prone, and hinders visibility into the process.
Corrective (Reactive) Action vs. Preventive (Proactive) Action
What is the difference between corrective and preventive action? A corrective action is the measure(s) taken to find a root cause and to stop the problem from happening. The corrective action is not “the fix” or a long-term solution.
Preventive action happens once the issue is solved, and is the need to prevent it from happening in the future. It involves cross-functional teams and takes a continuous improvement approach to prevent recurrence.
Over time, using a holistic approach ensures the quality system will not be static. It will continue to evolve and meet new challenges and requirements.
The Benefits of an Automated, Holistic CAPA System
Organizations implementing an automated CAPA solution will be better positioned to manage all quality processes in a centralized system. This results in improved visibility, efficiency, and other key benefits, including:
- Streamlined CAPA process: Managing CAPAs in a centralized database improves visibility and efficiency. It enables automatic routing, notifications, and escalations that help eliminate time-consuming manual processes and protect an organization’s reputation by adequately addressing quality and safety issues. Ultimately, it provides the tools needed to recognize the need for and initiate CAPAs.
- Ability to respond to quality events faster: Organizations can reduce reaction time on quality and safety issues by using an automated CAPA solution. They can also lower operations and production costs and the likelihood of repeat incidents. These digital systems also provide seamless traceability to related quality processes, such as change control and training.
- Meeting regulatory compliance: An automated CAPA system helps organizations comply with 21 CFR Part 11, including the entire audit trail and electronic signature functionality. It also demonstrates to regulatory agencies that proper corrective actions have been taken.
An effective CAPA system will help to reduce costs that would otherwise go toward supporting quality initiatives in other departments in the organization. Implementing a closed-loop CAPA management system is essential for reducing quality issues and improving the overall cost of quality.
Organizations should create, document, and review the automated, holistic CAPA system. During this step, the organization should set clear policies on the CAPA process, document those processes, and staff should be trained according to their job matrix. It’s essential to ensure the CAPA system is centralized and controlled, consolidating operations and eliminating overlap between departments. Organizations will also need to have an effective method for tracking all incidents and events, ensuring visibility, and providing a single source of the truth.
It’s also important to set a robust foundation for an effective CAPA process. Inadequate CAPA procedures continue to be the most common FDA inspection observations. A strong CAPA process embedded into the lifecycle process is key. This provides companies with an organized method for identifying all concerns, solving them, and preventing recurrence.
Having an efficient CAPA process in place is essential for a successful QMS. Both ISO and the FDA provide the CAPA framework, but it is the organization’s responsibility to determine and maintain a systematic and practical system.
Follow these basic steps for a successful CAPA process:
- Intake of issue: Provide the basic concept or potential issue. These issues can come from either internal or external sources.
- Notification requests for CAPA review: A vital component of the CAPA process includes reviewing the quantity and severity of the event to find out if a CAPA is necessary. This could involve a recurring event or impact on product design and performance.
- Risk review: Look at historical data to determine attributes, frequency, and impact and qualify the risk and its impact.
- Accept or reject the CAPA request: If a CAPA is not required, it can be moved to a nonconformance or complaint. If the CAPA was initiated, the right people must be notified.
- Determine CAPA team: A cross-functional team should be used if the CAPA is high-risk. In the event of a low-risk CAPA, areas that are directly affected would be involved.
- Identify any immediate actions required: A cross-functional team should be used if the CAPA is high-risk. If the CAPA is low-risk, directly affected areas should be involved.
- Analyze data and investigate the cause: This can be completed by using standard root cause analysis tools, such as flowcharts, Failure Mode and Effects Analysis (FMEA), and scatter diagrams.
- Implementation of actions (changes): Prediction-based actions help prevent or monitor an event before it escalates. This includes reviewing suppliers, risk analysis, disaster recovery plans, and internal audits.
- Disseminate information: The management team must be notified of all actions.
- Verification and effectiveness: This ensures the actions have resolved any issue and stopped recurrence.
- Closure: The CAPA is submitted for review and closure during this stage.
When there is confusion over understanding when a CAPA should be open, organizations will have less time to spend on problem-solving and making improvements. Using a closed-loop CAPA system that follows the Plan, Do, Check, Act process reduces cost and increases customer satisfaction.
Continuous improvement is an effort to continually improve products, processes, and services. Organizations should ensure the following are part of the CAPA continuous improvement process:
- Cross-functional review of the root cause and agreement of actions
- A strong culture of quality that prioritizes improvement and growth
- Involving the correct stakeholders
- Using the CAPA system for gains and not just flaws
- Dissemination of CAPA outcome, which includes risk remediation, procedure, or process changes, documented training with appropriate staff members, and training effectiveness
- Retooling where appropriate
- Modifying responsibilities
CAPA continues to be a widely-used and effective process for ensuring product quality and safety. It’s critical in manufacturing operations—an effective CAPA process will ensure any quality events are addressed quickly and effectively and prevent the recurrence of these events.
By following these guidelines, organizations can empower the CAPA process and use it as a continuous improvement method to drive product quality and patient safety.
An automated, holistic CAPA system is the most efficient system to achieve this. It will result in a minimal drain on an organization’s time and resources and transform the formerly burdensome CAPA system into a powerful and proactive tool.
Doing so provides organizations with the capability to anticipate future quality events and maintain business now and in the future.
Zillery A. Fortner is the Product Advisor, QA/RA Life Sciences at Sparta Systems, a Honeywell company. She earned a bachelor’s degree in health science from South University. Fortner has 20 years of experience in the medical device arena related to quality assurance, regulatory affairs, and JACHO. She served 10 years in the military as a certified surgical technician. Fortner is an active member of ASQ and AAMI.
