Creators Fear Industry May Shy Away From Speedy Risk-Based CAPA Initiative

After five years of development, a program to help devicemakers improve and accelerate their corrective and preventive action (CAPA) programs is ready to implement but its creators worry the industry will not be ready to adopt the model.

The #MakeCAPACool program, a collaboration between the FDA and the Medical Device Innovation Consortium (MDIC), can help devicemakers implement CAPAs 80 percent faster, according to a panel presentation Tuesday at MDIC’s Case for Quality Collaborative Community (CfQcc) Summit.

In its pilot stage, the program saw 60 percent of CAPAs closed in 60 days compared with the average of more than 400 days. Companies participating in the pilot reported an 80 percent reduction in time required to implement improvements. And CAPA timelines from investigation to closure were reduced by 50 percent with preventive actions 100 percent successful. The framework also allowed companies to find problems earlier.

Another sign of success: 32 audits took place during the pilot with no findings.

Read MDIC’s 57-page white paper on the program here.

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