For Medical Devices Five Steps to Simplifying CAPA Documentation Processes Five steps that can help medical device companies simplify CAPA documentation processes. In light of the record number of medical device recalls in 2006 and the FDA’s recent urging to device manufacturers to double-check all systems related to corrective and preventive actions (CAPA), the importance of proper CAPA documentation, tracking, and verification has never been a more relevant topic in the medical device industry. In fact, the most frequently cited CAPA subsection of 21 CFR Part 820 on FDA 483 forms in 2006 was 820.100(b), the subsection requiring the documentation of CAPA activities. 1 There are several schools of thought regarding the correlation between the changing trends in CAPA documentation and the increase in device recalls. Some believe recall increases are being driven by better CAPA practices. Tim Ulatowski, director of CDRH’s Office of Compliance, was quoted in the February 2007 “Silver Sheet” as saying, “(W)hen you get increases in recalls it’s because maybe companies are doing some of the right things, too, in terms of corrective and preventive actions.” 2 Others believe the reason is likely related to increased regulation enforcement. “I think medical device companies are a little gun shy with the ramp up in enforcement at FDA, so they are more diligent in reporting complaints and quicker to initiate a voluntary recall,” said Matthew M. Lowe, product manager, medical device expert with MasterControl Inc. “Device companies have seen more injunctions in the past year than they have for a long time, so there is a general feeling in the industry that they are being monitored more closely than in the past.” Whatever the reason may be, the general trend in the industry appears to be that most medical device firms are taking adequate CAPA actions but are just not making efforts to document CAPA activities to the extent the FDA expects. The key to CAPA, therefore, is found in the FDA’s perspective: It’s not enough to just say that you do it, you have to document it, too. CAPA actions taken must be thoroughly documented for regulatory purposes. The flip side of this CAPA coin is that there are other companies that do not believe their products are subject to device regulation. It is only when the FDA comes knocking that they realize they are obligated to comply with regulatory requirements and must have the quality system regulation (QSR) elements in place. Wherever your device company may be positioned on the CAPA spectrum, there are five steps that can simplify and streamline the processes involved with CAPA documentation. Adopting these fundamental measures will help device companies improve compliance with regulatory documentation requirements and avoid product recalls. 1. Automate CAPA Documentation Processes to Increase Efficiency Any tool that facilitates the collection and centralization of data generated through CAPA investigations will contribute to the effectiveness and ultimate success of the CAPA process as a whole. Implementing an electronic CAPA solution will simplify the overall CAPA documentation process by automating the routing, notification, delivery, escalation, and approval of CAPAs and any related documentation. An automated system not only saves resources and manpower, but it facilitates compliance by streamlining CAPA processes and providing better tracking of all CAPA activities, resulting in thorough documentation that is easier to generate. The main purpose of the CAPA software system should be its capacity to securely store documentation and report on the data generated through investigation processes. It is much easier to identify harmful trends when data from CAPAs can be effortlessly retrieved and analyzed. Whether it is an electronic system developed in-house or a proven out-of-the- box software solution, an effective automated CAPA system simplifies documentation efforts and makes search and retrieval of documents easier during inspections and audits. 2. Streamline Reporting/Tracking/Verification Capabilities An effective CAPA solution should provide the ability to track the implementation phase of CAPAs and verify the efficacy of actions taken. Verification can be dramatically simplified through the use of a proven CAPA software solution in that all quality events can be electronically tracked and users can report on events with greater ease. For instance, if a device company has a specific part that is failing in a particular way, an automated CAPA system permits users to track complaints without difficulty following the implementation of a corrective action. Verification that the failure has been rectified is automatically provided by the system. Advanced analytics, reporting, and tracking capabilities are integral components of any automated CAPA system. A CAPA system that has the capability to electronically track all routing information and data entered into a form allows all departments to view the CAPA process, identify bottlenecks, and understand the sequence of events during processing. With a comprehensive system, the revision or approval history of all CAPA- related documents should be easy to review and the documents should be viewable by status (i.e. “in process” or “complete”) or by history. If the system allows CAPAs to be summarized in multiple levels (such as product, department, root cause, etc.) then the paper trail of CAPA documentation is easier to follow. 21 CFR 820.100 (6-7) mandates that manufacturer’s 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.” 3 In support of these requirements, an effective CAPA software solution should be able to generate reports based on validated templates and forward those reports to appropriate recipients. An effectual electronic CAPA system should also allow recipient receipt and review activities to be fully documented and readily tracked. The FDA has emphasized that appropriate statistical tools must be employed when it is necessary to utilize statistical methodology. An all-inclusive CAPA solution with robust reporting and tracking tools can support this effort and help medical device companies avoid “the misuse of statistics by manufacturers in an effort to minimize instead of address the problem.” 4 3. Connected CAPA: Provide All Departments with Easy Access to CAPA Processes Because CAPAs tend to be centered heavily on manufacturing and quality, other departments are typically kept out of the loop until later phases when teams are investigating a root cause. A CAPA system that connects all departments allows effective tracking of all incidents that could potentially escalate into a CAPA and provides a view of those incidents across departments. A secure, Web-based CAPA system can connect employees, suppliers, contractors, and any other parties involved in a corrective action. If the automated system allows customers, vendors, and others outside the company to electronically submit forms that could generate a CAPA (such as customer complaints or product issue reports) the ability to track and document CAPA activities is vastly improved. 4. Integrate CAPA with All Quality Processes A connected CAPA solution should have the capability to seamlessly integrate with other quality processes (change control, training, customer complaints, audit, nonconformance, etc.), the result being a more efficient and effective system. For example, a CAPA that causes a change in product design or function could automatically invoke new training tasks after the change is approved. Or a customer complaint that results in a CAPA could be automatically escalated by a connected, automated system. Such process integration keeps all quality groups on the same page, making it easier to track and subsequently document CAPA actions. 5. Develop Standard CAPA Protocols If a CAPA program is to be extended across all departments, the basic CAPA processes involved must be uniform. Some commercial off-the-shelf (COTS) CAPA management software solutions include pre-configured best practice forms and workflows that can be used as is or that may be customized to suit a device company’s specific needs. Configurable CAPA forms simplify the process of initiating a CAPA by only requiring completion of fields related to data entry and by limiting users’ views to only relevant information. A system that includes the capability to automatically launch a CAPA from another process (such as a customer complaint or audit finding) further streamlines the CAPA process and provides more thorough and accurate documentation. If the system can manage and maintain the links between the forms, all parties involved can easily identify the action that triggered a CAPA and review the completed process. When all relevant groups are able to view the entire CAPA process from start to finish, it is much easier for companies to gather data and provide thorough documentation to inspectors and auditors. Implementation of these five measures will have a perceptible impact on a medical device company’s capacity to improve CAPA documentation efforts, but these are not changes that can be made overnight. The best way to start is to view each step as an ongoing process in a state of continual progression as the company strives for better CAPA documentation, regulatory compliance and product quality. 1. “FDA Urges Device Manufacturers to Double-Check Their CAPA Systems” from the June 2007 issue of “The Silver Sheet.” http://www.medicaldevicestoday.com /2007/07/fda-urges-devic.html 2. “Device Recalls Reach New High In 2006 As FDA Works On Postmarket Issues,” from the February 2007 issue of “The Silver Sheet.” http://www.medical devicestoday.com/2007/02/february_2007_i.html 3. Federal Register, 61 FR:52601, October 7, 1996 [online]: www.fda.gov /cdrh/fr1007ap.pdf. 4. Federal Register, 61 FR:52601, October 7, 1996 [online]: www.fda.gov /cdrh/fr1007ap.pdf.