The 4 Phases of CAPA Maturity

CAPA Overview

Corrective Actions

A corrective action refers to any step taken to eliminate the cause of an existing problem to prevent its recurrence. They are reactions to nonconformities, complaints, or similar types of events. The process for “fixing” these issues typically includes:

• Reviewing and defining the problem or nonconformity.
• Identifying the cause of the problem.
• Developing an action plan to correct the problem and prevent a recurrence.
• Implementing the plan.
• Evaluating the effectiveness of the correction.

Preventive Actions

Preventive actions are steps taken to neutralize the potential causes of nonconformities. The activities involved are aimed at detecting potential problems or nonconformances and eliminating them. A preventive action process generally entails:

• Identifying the potential problem or nonconformance.
• Finding the cause of the potential problem.
• Developing a plan to prevent the occurrence.
• Implementing the plan.
• Reviewing the actions taken and their effectiveness in preventing the problem.

The combined efforts of identifying, correcting, and preventing problems are the backbone of every quality management system (QMS).

In addition to the U.S. Food and Drug Administration (FDA), other international regulatory bodies also require documented evidence that CAPAs have been conducted. However, there is a universal understanding in regulated life sciences environments worldwide that CAPA is necessary for more than just compliance.

An effective CAPA process helps ensure product quality and safety. When implemented properly, a company’s CAPA management program will not only enhance product quality and safety but will drive continuous improvement efforts and increase customer satisfaction as well.

Fulfilling Regulatory Requirements

• FDA

  CAPA requirements for medical device companies are specified in the 21 CFR Part 820.100 standard, which states “each manufacturer shall establish and maintain procedures for implementing corrective and preventive action.” Medical device companies have an additional incentive to properly conduct and document CAPAs: under quality system inspection technique (QSIT), an FDA inspection will always include an inspection of a company’s CAPA system. For pharmaceutical companies, FDA requirements related to CAPA are set forth in the current good manufacturing practice (CGMP) guidelines outlined in 21 CFR Parts 210 and 211.

• ISO

  Most companies doing business in regulated environments, especially general manufacturers, adhere to the International Organization for Standardization (ISO) international quality standards to help them compete in the global market. The ISO 9001 series – the most widely used quality standard worldwide – calls for the implementation and documentation of CAPA. The most current version of the standard, ISO 9001:2015, covers the impact of CAPA activities on the measurement, analysis, and improvement of the overall QMS.

• ICH

  The International Conference on Harmonization (ICH) E6 consolidated guidance for good clinical practice (GCP), which the FDA has adopted, requires that there should be a CAPA plan and implementation for the incidence of quality issues. This includes investigations into how widespread the problems are, correction of the problems, and corresponding efforts to help prevent their recurrence.

Improving Product Quality

Even more important than being a regulatory requirement, an effective CAPA process should have a direct and measurable impact on improving product quality. An effective corrective action process accounts for all the potential sources of a quality issue and provides a feedback mechanism to prevent it from recurring. An effective preventive action process minimizes the number of quality deviations that occur in the first place. Taken together these two processes should reduce product returns, recalls, scrap, and warranty claims.

The 4 Phases of CAPA Maturity

The CAPA tools and procedures used in quality event management processes are the primary factors that determine the success or failure of the overarching QMS. Most companies follow an evolutionary path in developing the correct set of procedures and tools required to maintain an effective CAPA system. Companies doing business in regulatory environments often start with a paper-based system because it offers familiarity and a seemingly low start-up cost. Next, it’s common for a company to move to a hybrid paper/electronic system with the aim of making their paper-based system more efficient. The next step is to either create a custom application that is completely digital or purchase commercially available, purpose-built CAPA management software. The following is an examination of the common pitfalls and potential benefits of each type of solution.

1. The Paper Approach

Many organizations rely on a completely paper-based CAPA process because it has three primary advantages over electronic systems:

• The initial implementation cost is low.
• All participants in the process are familiar with paper.
• Paper processes are very flexible and can be customized to meet almost any CAPA activity.

Despite its apparent flexibility and affordability, the initial low cost of a paper-based system is quickly outweighed by the ongoing costs required to manually maintain it effectively. Most of these costs are hidden. In fact, unless the necessary analysis is performed to quantify them, the true cost is unknown. A few of these costs and issues include:

• Extensive cross-departmental follow-up is required to determine statuses and ensure CAPAs progress.
• The CAPA process lacks control and therefore is difficult to formalize and execute consistently.
• Reporting and analysis is very labor intensive.
• Mistakes and incomplete fields are common when forms are completed.
• The costs, inefficiencies, and environmental impacts of using paper mount over time.
• Determining the bottlenecks in the process is difficult due to the lack of overall transparency.
• Retrieval of documents during audits and inspections is a time-intensive and inefficient process.
• Lack of buy-in and accountability from employees due to lack of management visibility.

In some cases, the use of paper-based systems has contributed to FDA violations. For example, the FDA recently cited a pharmaceutical manufacturing company for multiple instances of CAPA system inadequacies and its use of loose sheets of paper for tracking CGMP documentation, all of which stemmed from using a paper-based system.

2. The Hybrid Approach

A paper/electronic hybrid solution combines the flexibility of paper-based forms with some degree of electronic tracking and reporting capabilities. The digitized functionalities of a hybrid solution usually range from a simple spreadsheet used to track certain data subsets on CAPA forms to a database application that enables electronic entry of CAPA data.

Like a paper system, a hybrid solution usually has relatively low start-up costs. Unlike a paper system, however, a hybrid solution becomes less flexible and requires more resources to manage the more it gets spread across disparate systems. Also, hybrid systems only resolve a few of the inherent issues paper- based systems have, so most of the hidden costs of CAPA management remain.

A hybrid solution can reduce the labor required to report and analyze corrective action data. Depending on how sophisticated the system is, it may also help reduce issues surrounding incomplete or inaccurate forms. However, this type of solution rarely resolves the extensive follow-up challenges and buy-in and accountability problems that inevitably accompany novel CAPA processes. This is mainly due to such systems’ inability to electronically distribute and track CAPA-related tasks.

3. The Fully Digitized Approach

When CAPAs prove too complex to manage with disparate systems and disconnected data and teams, companies either build a custom application or, more commonly, purchase a solution from a software vendor. Purpose-built CAPA tracking software can enable a company to overcome many of the challenges of maintaining an effective CAPA system, and there are a variety of software products available that offer varying capabilities to organizations of all sizes. As the market has matured, more solutions have arisen to meet companies’ specific needs.

If you are considering investing in or developing a CAPA software solution, here are some of the key capabilities you can’t afford to overlook:

• Automated Distribution of Tasks:

  The system should automate all CAPA-related tasks and documentation-processes, including routing, follow-up, escalation, and approval. This greatly improves efficiency and facilitates buy-in and accountability for individual participants in the process. A fully digitized system allows managers to see where the bottlenecks are in the process because they have access to real-time data.

• Built-in Reporting and Analytics:

  The solution you choose should include robust reporting and analytic capabilities. It should provide the adequate functionality to enable responsible personnel to report on every aspect of the data tracked by the system. Robust visualizations and charting features should also be included to enable users to easily trend and tell relevant stories with quality data. analysis, and improvement of the overall QMS.

• Electronic Signature Manifestations:

  Signatures should be automatically appended to each document that include the signer’s printed name, date, time, and meaning of the electronic signature. This feature is especially vital for ISO-certified organizations endeavoring to promote good business practices by displaying approval statuses at a glance when users view records.

• Audit Trails:

  The system should have a secure, time-stamped audit trail of all changes made to any record that should be accessible to the appropriate users and departments. This information should be automatically captured and digitally secured.

• Email Notifications:

  The system should incorporate real-time notifications to alert users of specific CAPA-related tasks they need to complete. Turnaround times for corrective actions are dramatically reduced when tasks are escalated when appropriate and the appropriate users are promptly notified of pending assignments.

• Strong Security:

  The solution should provide for system access to be individually tailored to each user. Tools should be included that allow system administrators to easily group together users with the same security rights. In addition, automatic time-out options, minimum password settings, intruder login detection, and SSL (secure sockets layer) for secure communication should be standard features.

• Cloud-Based System:

  Seek a cloud-based solution that allows authorized personnel from all site locations to access and enter CAPA-related data into a single repository. CAPA solutions that are not accessible via a cloud-based system keep quality data in departmental silos. When data is siloed, it makes it much more difficult to identify systemic problems and maintain information and communication consistency across functional teams. Additionally, the total cost of ownership of a cloud-based system is much less than that of an on-premise system since cloud solutions don’t require hardware expenses, are less expensive to maintain, and allow user licenses to be tailored to the size of the organization.

• Mobile Accessibility:

  Users should be able to access CAPA information and perform tasks from any location using a tablet or smartphone. Mobile access grants users greater flexibility and helps boost overall productivity and efficiency.

In general, best-of-breed software solutions do a fantastic job of overcoming many of the challenges of maintaining an effective CAPA system. However, most standalone software tools have drawbacks that may prevent an organization from gaining all the benefits they could with a fully digitized system. Such shortcomings may include:

• Inflexibility:

  Most commercially available solutions require conformance to the software’s forms and processes instead of allowing the organization the flexibility to generate forms suited to their particular business needs and processes. Additionally, many CAPA software solutions lack the capability to extend the application to effectively control other sources of quality incidents, such as nonconforming materials, rework documentation, returned goods authorizations, etc.

• Lack of Connectivity:

  Most electronic solutions do not tie quality processes together or allow for data to be connected and synchronized across different enterprise systems. Ideally, a company should be able to “close the loop” and have a completely documented flow from the initial nonconformance to the ensuing corrective actions, documented changes, trainings, and all the way through to verification.

4. The Intelligent Approach

A solution that digitizes CAPA processes and data does not necessarily ensure that those processes and data are more efficient or effectively connected with other quality processes. An intelligent software solution that integrates CAPA and its correlated data and processes (i.e., document management, nonconformance management, training control, change control, audit management, etc.) within a unified platform allows companies to streamline and effectively manage CAPAs from beginning to end. If your organization needs an intelligent, integrated solution to form the basis of a holistic approach to CAPA management, you should look for the following innovative characteristics:

• Closed-Loop CAPA Process:

  A reliable closed-loop process can ensure effective and rapid disposition of CAPAs. With a closed-loop process, managers can oversee all CAPA-related activities, better avoid errors and omissions, and maintain a complete, compliant, and traceable audit trail. Truly intelligent solutions feature workflows that guide users through the entire CAPA process, from root cause investigation through the implementation of corrective actions.

• Best Practice Forms:

  Intelligent solutions should include best practice forms that can be used as is or configured to meet your organization’s unique processes and business requirements.

• Detailed Trend and Quality Event Analysis:

  A robust solution should include quality event analysis tools that help you detect trends. Such tools should incorporate automated notifications that alert decision-makers when predetermined thresholds are reached or if a trend is identified.

• Automatic Revision Control:

  When only the most current version of a document is available, users won’t make the mistake of using obsolete or unapproved documents.

• Seamless Training Integration:

  Whenever an important change occurs as the result of a CAPA (in product designs or work instructions, for instance), the system should automatically invoke training tasks upon approval of the change.

• Real-Time Visibility:

  Decision-makers who have visibility into how CAPA processes are functioning in real time can see where connections exist between quality events, thus allowing them to make better decisions and bigger contributions to quality improvement efforts.

As QMS software tools increasingly incorporate innovative technologies like artificial intelligence (AI), the life sciences industry will see a revolution in CAPA management. AI-enabled solutions will get smarter, faster, and more accurate the longer they are in operation. Eventually, these applications will be able to detect, investigate, and resolve a CAPA with little or no human involvement. As you search for a solution capable of fulfilling your current CAPA management requirements, be sure the system you choose can accommodate emerging technologies so your CAPA handling practices will be well positioned to keep pace as quality management tools and techniques evolve.