To CAPA or not to CAPA? That is the question…

CAPA – Corrective and Preventive Action

Within the medical device industry, if not carefully administered and messaged properly within the company, Corrective and Preventive Actions are often perceived by employees as “black eyes” on company performance. In these cases, the engineering teams perceive FDA corrective action as threats, punitive measures to force good FDA regulatory discipline and rigid process adherence.  Employees at these companies likely have been groomed to fear CAPAs. 

But are CAPAs really a black eye to be feared?

Not at all.

What is corrective action?

According to the FDA, “the purpose of the corrective and preventive action subsystem is to collect information, analyze information, identify and investigate product and quality problems, and take appropriate and effective corrective and/or preventive action to prevent their recurrence. Verifying or validating corrective and preventive actions, communicating corrective and preventive action activities to responsible people, providing relevant information for management review, and documenting these activities are essential in dealing effectively with product and quality problems, preventing their recurrence, and preventing or minimizing device failures. One of the most important quality system elements is the corrective and preventive action subsystem.”


At what point in the life cycle, should the Quality Manager start issuing a CAPA?

With one of Advantu’s clients, a major conflict erupted recently within the CAPA school of “scholars” over the issuance of its first corrective action.  The quality manager was against issuing its first CAPA, and one of the executives was in favor of it.  This is why companies adopt a QMS corrective and preventive action procedure.

Their device was just starting to turn the corner from the research phase to the iterative development and verification & validation phase.  In many organizations, Agile methodologies are employed with iterative cycles that blur the lines between R&D work and V&V work, thus complicating the evolution to increase the regulatory rigor of adhering to the company’s corrective and preventive action SOP  required by the FDA before the V&V effort is initiated.  Small start ups don’t always have the resources to apply the same FDA regulatory regimen during the research phase as they must do during the development and V&V phases, so determining when to initiate the corrective action process isn’t always clear-cut.

QMS corrective action preventative action

The issue of concern was regarding a sudden management change in direction over the use of the company’s SharePoint site for draft design documentation versus releasing the documents via the document control system as outlined by the QMS corrective and preventive action procedure.   The executive demanded that a corrective action be issued to get all draft documents under the Quality Management System control immediately, and the QMS manager argued that a corrective and preventive action was not appropriate without proper forewarning of the management change to employees.  He argued that the CAPA response would instill fear in the development teams and be perceived punitively. The conflict ultimately created a hostile situation in which the QMS manager resigned.

The perspective of each leader is valid.  The FDA looks favorably on companies who formally catch, acknowledge and take corrective and preventive action often; therefore, starting the CAPA process early in the lifecycle is a good practice.  But issuing a CAPA without fair warning to the impacted teams can quickly backfire and cause animosity. In this case, it undermined the trust and collaborative balance formerly at play.  Still, months later, the trust has not been rebuilt.  This is why your CAPA procedure, CAPA response and implementation must be carefully planned and executed.

To better understand the FDA’s document control requirements go to this site.

To better understand the FDA Corrective and Preventative requirements go to this site.

Better yet, contact Advantu’s sales team to see how we can help your company avoid these pitfalls, reduce churn, speed up the time to market, and make CAPA a positive experience for your company.


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