In the medical device industry, validating new test systems is crucial to ensure that test results are reproducible and reliable. Once a system has been validated, replacing it with a newer system requires proving that the reproducibility and reliability of the new system are comparable to the existing one. This robust comparison can reveal interesting and unexpected insights into the original system.
In this presentation, we discuss the validation of our new test system, which integrates two existing systems. The integration aimed to enhance efficiency and time in testing.
To ensure the new system met standards, we conducted a gage study to compare its precision and tolerance (P/T ratio) with the existing system. Acceptance criteria, based on AIAG MSA guidelines, were established to ensure rigorous evaluation.
During validation, we improved the gage P/T ratio from over 40% to an acceptable 10%-20% in the new system and following AIAG MSA guidelines. This proved the new system's reliability and showed optimization areas in the system.
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