Since fewer regulatory inspections were conducted in 2020 due to the ongoing COVID-19 pandemic, there were only half as many Form 483s issued to medical device companies for quality system failures. But that didn’t stop corrective action / preventive action (CAPA) from maintaining its perennial hold on the top spot as the most frequently cited quality issue, with 12.3% of 483s including CAPA mentions last year. (1)
The subsection of 21 CFR Part 820 most frequently noted on 483s issued last year was 820.100(a), the provision requiring the documentation of CAPA activities. In fact, 165 of the 197 times CAPA was mentioned was because device manufacturers failed to appropriately document their CAPA procedures.
The recurring trend of CAPA documentation shortcomings indicates that most device firms are taking adequate CAPA actions for the most part, yet they’re not putting in the work necessary to document CAPA-related activities at the level expected by the U.S. Food and Drug Administration (FDA).
Whether your company is struggling to adequately capture CAPA information or simply lacks a formal structure for documenting CAPA activities, there are five practical steps you can take to start simplifying and optimizing the processes involved in CAPA documentation. Abiding by the following practical measures will help any device company improve efficiencies and maintain compliance with regulatory documentation requirements.
It’s worth noting that some of these steps can be a heavy lift for many organizations, and not all of them need to be implemented simultaneously. Depending on your resources and most critical business needs, begin with the most manageable step and work toward completing all five.
For your documentation processes to be effective, you need tools that are up to the task of collecting and centralizing CAPA data. A system that digitally records all CAPA activities makes it simpler to generate comprehensive documentation. Digital CAPA solutions also streamline documentation processes by automating the routing, notification, delivery, escalation, and approval of CAPAs and related documents. Plus, documents are easier to search for and retrieve during audits and inspections when they’re centrally maintained within a digitized system.
Whether you develop such a system in house or purchase a commercially available software solution, it should be geared toward two primary functions:
Subsections 6 and 7 of 21 CFR 820.100 call for manufacturers to establish procedures for “ensuring that information related to quality problems or nonconforming product is disseminated to those directly responsible for assuring the quality of such product or the prevention of such problems, and submitting relevant information on identified quality problems, as well as corrective and preventive actions, for management review.” (2) An effective CAPA software solution should enable manufacturers to meet these requirements by providing functionality that allows them to generate reports based on validated CAPA document templates as well as the capability to forward those reports to the appropriate recipients.
Section 820.100(a)(1) also emphasizes that “appropriate statistical methodology shall be employed where necessary to detect recurring quality problems.” A CAPA solution with robust reporting and tracking tools will support this effort and help companies avoid the “misuse of statistics by manufacturers in an effort to minimize instead of address the problem” that far too frequently raises red flags for regulators. (3)
CAPA processes are commonly focused on manufacturing and quality issues, which usually means that other departments are in the dark until root cause investigation phases. This lack of information connectivity inevitably leads to inefficiency and siloed data. A digital platform that connects data across the product life cycle makes it simpler to keep every relevant department in the loop. Incidents that have the potential to escalate into a CAPA can be effectively tracked and appropriately handled when you have a system that provides visibility across all departments.
Extending the availability of CAPA-related information across all departments requires uniformity in all the processes involved. A commercially available software solution specifically designed for CAPA management should include preconfigured best practice forms and workflows that standardize CAPA processes and facilitate regulatory compliance.
A digital system that includes the capability to automatically launch a CAPA from another related process (such as a customer complaint or audit finding) further streamlines the entire CAPA process and lends to the accuracy and comprehensiveness of documentation. If the system’s connectivity allows for links to be maintained between forms, the overall process is more transparent, and all personnel involved can easily identify the action that triggered a CAPA. The ability to view the entire CAPA process from beginning to end makes it easier to gather data and provide complete and compliant documentation to auditors and regulatory inspectors.
Connected processes are the key to efficient and effective quality management. Before buying or building a CAPA solution, first ensure it will be capable of integrating with the quality activities that are essential to your operations, such as customer complaints, nonconformance management, training, change control, auditing, and other CAPA-adjacent processes. For example, an appropriately connected system should allow for a CAPA that results in a product design change to automatically invoke new training tasks after the change is approved. It’s also beneficial for the system to include functionality that automatically escalates a customer complaint that results in a CAPA when necessary. Having a deeper level of process integration helps keep quality groups and other functions on the same page, which makes tracking and documenting CAPA activities easier.
The five steps above will dramatically improve any medical device company’s CAPA documentation efforts, but they aren’t changes that can be made by flipping a switch. The best approach is to view CAPA documentation as an ongoing improvement effort. Each step can be broken down into smaller components that can be implemented systematically as your organization gets closer to a fully digitized and connected quality system that simplifies regulatory compliance.
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