According to Nancy Singer and Mark Lagunowich in their informative MD+DI article entitled “Getting Your CAPA House in Order,” CAPA (Corrective and Preventative Action) remains one of the top FDA 483 citations year after year, due typically to “either inadequate processes or inconsistent adherence to processes,” they write. “This includes failing to define which issues should or should not be elevated to CAPA status, insufficiently documenting the data required by FDA to adequately assess the CAPA’s effectiveness, or relying on outmoded systems to collect and analyze the data and demonstrate that the firm is operating in a state of control.”
CAPA is a response to a nonconformance event that should be designed to prevent that nonconformance event from happening in the future. Root cause needs to be identified and corrected; too often companies look for a quick, easy fix that will satisfy FDA observers at the time (worker training is a common one) but ultimately is not the actual cause of the problem.
It is important not to take CAPA lightly—CAPA is linked to other data the FDA monitors such as complaint files, acceptance activities, audits, reports of corrections and reports, and medical device reporting. More often than not, sloppy or cursory CAPA responses will result in a 483 or warning letter.
Nobody wants increased scrutiny from the FDA, or a reputation for cutting corners on quality—which will certainly happen with repeat CAPA offenses.
The first step for dealing with CAPA wisely is establishing a company-wide standard operating procedure (SOP) that is comprehensive, detailed, written out, and distributed to staff. This document should include CAPA regulations, definitions, and step-by-step procedures for taking corrective or preventative action. If you don’t feel this SOP document can be written with confidence in-house, hire a consultant or purchase an SOP module online from a qualified firm or consultant.
Singer and Lagunowich indicate the following elements should be provided to the FDA for any CAPA response:
- A structure for directing current and future activities (SOP)
- A tool for forward and backward traceability
- The history explaining how the company complied with the requirements to correct a nonconformity and employed reasonable measures to limit the risk to its consumers of being exposed to unsafe or ineffective products
“When documenting CAPAs, it is critical to articulate the timeline for when the incidents occurred, and when each of the appropriate steps was taken to resolve them,” they state. “Volume and error reports are some of the most elementary components of a quality system. These should always be evaluated as part of the CAPA process. Companies should include as much detail about the steps taken through the process so that FDA is left with little question about when the incident occurred, when and how it was corrected, and how quickly the loop was closed.”
Paper-based CAPA systems can be slow, inefficient, and may result in missing paperwork or documents—none of which inspire confidence in FDA auditors. Invest in a high-quality CAPA documentation system that captures incidents and responses in real time.
“Once a CAPA is initiated, companies can then centrally manage and automate the processes of resolving it across any number of sites, setting user access privileges as necessary and setting up e-mail alerts to ensure the right personnel take the required action efficiently and effectively,” say Singer and Lagunowich. “Finally, and perhaps most importantly, as many such systems feature templates configured in an FDA-ready format, quality management systems prove especially adept when it comes time to extract data from the system to track and trend across departments and demonstrate compliance to third parties.”
The FDA recently conducted a survey of 229 medical device makers to see how they are dealing with CAPA investigations. Interesting observations include:
- Sixty-three percent of companies have increased reporting to senior management
in the past two years to improve CAPA performance
- Companies using individuals to conduct CAPA investigations—as opposed to
teams—are twice as likely to have investigations lingering more than 120 days
- Increasing senior-level oversight of complex CAPAs results in a ten percent
improvement in closing investigations quickly
- Companies using a standard approach to CAPA investigations are twice as likely
to report an increasing workload compared to those using a risk-based approach
Finally, when a CAPA issue is identified and resolved, don’t hide it—share it with company employees to build CAPA awareness and a mindset toward best practices and continual improvement.