PROCESS VALIDATION

Process validation means the whole range of procedures and tests in order to demonstrate that a process is able to reproduce a product in a repeatable way being compliant to quality specifications.

GB Soluzioni is able to help companies during the three main validation phases:

• Specifications definition
• Measurement tools assessment
• Validation

Below you can see the typical V model used in our process validation.

The tools used during the validation are the statistic ones like DOE, Anova, Gauge R&R (in order to understand if the gauges are suitable for what we want to measure). The process validation allows to understand where to improve the production and which corrective actions are needed. A validated process is compliant to the certification organisms requirements and has a low scrap rate.

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