Many industries, from aerospace to medical device manufacturing, are required to show customers, auditors, or regulatory bodies that their measurement devices are acceptable for use. But how do you prove that?

One of my clients needed to show the Biomedical Advanced Research and Development Authority (BARDA) that a measurement device they were using to inspect incoming materials was acceptable as they transitioned from R&D into production. The goal was to produce a new medical device that met the “five nines” (99.999%) specification conformance goal of BARDA.

To achieve such high conformance rates, you need high-quality vendors. The client needed to move to a domestic supplier and show that they were capable of providing materials that would allow them to meet the five-nines requirement. This can be difficult to test, since the very device you are using to measure vendor specification conformance might be unreliable. Additionally, this device measured a number of different characteristics on parts with different shapes and materials.

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