Sunday, December 11, 2011

Quality management process

Vesta is a quality management process in the medical development field. they specialize mostly in product development.

there are 3 main parts to the Vesta process. process validation, lean six sigma, and analytics and reporting.

all vesta systems are designed to support compliance. they are ISO registered and FDA compliant.

process validation begins with pre-production. some of the tools used are reviewing design attributes, establishing process parameters, tooling validation, prototyping, testing and inspection.

Vesta incorporates Lean Six Sigma quality management principles at every level of their operation to verify that quality standards are being met, and to identify areas in need of improvement.

they conduct Gauge Reproducibility and Repeatability Studies. And they run validation includes a first article inspection report, qualification data collection and statistical analysis. they continually analyze the results and use them as guides for refinement of the process.

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