When companies jump too quickly to declare a corrective and preventive action is needed, "death by CAPA" occurs.
For companies, bad things can come in all shapes and sizes. When something goes wrong, it could possibly lead to the company's demise. Because of the serious consequences that can occur, taking quick action to correct problems is a necessity, but is also important not to overreact.
For companies operating under the auspices FDA, when something goes wrong, such as a nonconformance, customer complaint or deviation, it's called a quality event. If one of these occurs, a corrective action and preventive action (CAPA) process is required to resolve and mitigate the impact of the quality event.
The most frequently cited reason for issuing a 483 warning letter to medical device companies is a failure to adequately establish procedures for CAPA.
CAPAs are an essential element to any FDA-regulated company's system as stipulated in 21 CFR Part 820.100, which states, "each manufacturer shall establish and maintain procedures for implementing corrective and preventive action." But it is not only FDA that requires it; most regulated companies, especially general manufacturers, adhere to ISO international quality standards. The ISO 9001 series is the most widely used set of quality standards worldwide. It calls for the implementation and documentation of CAPA. The International Conference on Harmonization (ICH) E6 GCP Consolidated Guidance, which FDA has adopted, requires that when quality issues arise, there should be a CAPA plan and implementation. This includes the investigation of how widespread the problems are, the correction of the problems, and the efforts to be taken to help prevent the issues from reoccurring.
There is no doubt that CAPAs are serious business, and in fact, if a CAPA is opened, it is required that the CAPA be resolved and closed. Companies can get into hot water if they have too many open CAPAs. When companies jump too quickly to declare a CAPA is needed, "death by CAPA" occurs. When this happens, companies find themselves drowning in excess paperwork and lacking adequate resources to deal with the extra work. To avoid this, it's important to be able to distinguish whether an issue or incident is CAPA worthy. For example, if a company identifies a nonconformity and it immediately corrects the issue, it can continue to monitor and measure the issue. However, if the issue is discovered due to a complaint, a corrective action should be taken. Not every quality event needs to launch a CAPA.
The following are ways to determine whether companies should take the step of launching a CAPA due to a quality event:
- Understand that corrections do not necessarily mean corrective actions. FDA advises that companies look at investigating events that are proportionate with the risk that's contained within a particular event. For example, if the event produces a low-impact result and it does not occur very often, the company should have a way within the system to perform a correction that does not require all the investigative work a CAPA would require.
- Filter the feeders. Implement risk-based gateways to help determine the events that require the most attention. In other words, events should be filtered and prioritized according to size, scope, and severity. The higher the risk, the more likely a CAPA would need to be initiated. If safety and effectiveness of a device is in question, escalation to CAPA should always be considered.
- Get to the root of the problem. The new standard, ISO 13485:2015, places more emphasis on root cause analysis. Root-cause investigations enable companies to focus on the source of the problem, not just the symptom. Proper investigations can help determine how systemic or localized the issue is and enable a faster, more effective resolution.
Even with the best intentions of improving, unless following these pathways, a company can be easily overwhelmed by dozens of unresolved CAPAs.
As the medical device product manager at MasterControl, Alex Butler is focused on developing solutions that help medical device companies increase efficiencies, ensure compliance and speed time to market. Before joining MasterControl in 2014, Butler worked as a product development manager for Opal Orthodontics, a division of Ultradent Products Inc., where he helped launch several Class II medical devices, including the Opal Espirit Class II Corrector.
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