But a leading certified body says many companies may have overreacted and made things unnecessarily difficult for themselves.
“Audits we’ve researched show the FDA has found CAPA deficiencies” at a company, says John DiMaria, Product Market Manager at BSI Group America Inc.
Irony: DiMaria says it’s usually not a a problem of a company doing too little. “They take a ‘better safe than sorry’ approach” where they label almost any anomaly a problem that triggers their CAPA machinery. In other words, they are doing too much. “They launch into a ten-step procedure that requires management sign-off” and a whole lot of other time-consuming activities.
Irony #2: By labeling too many small problems as potentially big CAPA issues, medical device companies often overwhelm themselves and “struggle” to give enough attention to the “preventive” part of CAPA. Medical device companies try to deal with so many “CAPAs” that they end up being sloppy with some, e.g., not closing the loop on an investigation. It’s not company chicanery; it’s honest overload. But try telling that to an FDA inspector.
Full disclosure: We may have helped contribute to that overreaction with our numerous blogs emphasizing FDA’s fixation on CAPA. Warning letter stats clearly show an FDA focus on CAPA. However, DiMaria delivers a helpful reminder: Don’t throw a full-blown CAPA investigation at a minor, one-off mistake.
Instead, he advises medical device companies to have a strong investigative process up front. “If something small happens, say human error, you should have the data in place to show it doesn’t warrant a corrective action,” DiMaria notes.
“Understand the magnitude of the problem,” DiMaria adds. “Sometimes it’s not a system problem at all.
Think of it as eating right and getting enough exercise, rather than calling a surgeon every time you’ve got a minor ache.