1. Purpose and scope
Validation shows that the process as designed works as built. It is not enough for an automotive customer that prototypes or engineering lots passed; the parts that will be approved must come from the production process, run with production equipment, tooling, test programs, people, materials and instructions, at a rate that shows the process holds together under real conditions. That production trial is often called a significant production run or a run at rate, and customers may specify how it is run.
Several kinds of evidence come out of the trial. Measurement system studies show that every gauge, metrology tool and tester in the control plan is good enough for the decisions made with it. Initial capability studies show how well the process meets each special characteristic. Qualification, run on parts from the production process, shows the part meets its stress test plan, such as AEC-Q100 for integrated circuits. Packaging is evaluated under handling and shipment conditions.
The stage closes when the production control plan is approved and the team, with management, signs off quality planning. That sign-off is the internal statement that the approval package can be built on solid evidence.
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