It’s no secret that Food and Drug Administration (FDA) inspectors hone in on a medical device company’s corrective and preventive action (CAPA) program during an inspection. But a leading CAPA consultant says many companies may have overreacted and made things unnecessarily difficult for themselves.
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“Audits we’ve worked on often come after the FDA has found CAPA deficiencies [at a company],” says John DiMaria, product market manager at BSI Group America Inc.
Irony No. 1. DiMaria says it’s usually not a problem of a company doing too little. “They take a ‘better safe than sorry’ approach,” where they label almost any anomaly as a problem that triggers their CAPA machinery,” he says. In other words, they are doing too much. “They launch into a 10-step procedure that requires management sign-off” and a whole lot of other time-consuming activities.
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Comments
A System is a System is a System
There's no such a thing as minor mistakes in any system: any mistake, any failure is a system failure. All too often we meet with CAPAs' root cause analyses that end up with a "human error" root cause. Is the "human" a part of the system, or not? When a system is robust enough, it does provide for the individuals who make up to it not to make mistakes - but it's the system that has to be made fail-safe, not the individuals. Read Nagarjuna, please, his "Elimination of Mistakes", there are lessons to be learned from him.
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