Why Is There A Lack of Connection Between FDA Inspection Results and True Quality Outcomes?

Teresa Gorecki |

After decades in the pharma, device, and biologics industry working in new product development quality; manufacturing quality; market quality and post market surveillance; and quality systems my answer can be summed up in one word. Watermelon. yes, watermelon.

Why watermelon? Today’s drive to measure, measure, measure has yielded a culture of creating metrics that will be green. As green as the exterior of a ripe watermelon. Why? Measures and metrics are tied to performance which is tied to compensation, bonus, recognition and reward. But what color is the interior of the watermelon? Red.

Often the processes and outputs existing under the top line metrics are red, red, red. In some companies these “sub measures” have been created, monitored and reported. In some companies they are not.

The challenge in our industry is to create robust quality measures that are predictive and that monitor the quality of how we execute our key processes in clinical and product development, production and distribution. We must look for the reds and see them as sweet… just like the inside of the watermelon! Taken seriously those metrics will drive true improvement.

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