An Initial Demonstration of Capability must include which elements?

• A. Only instrument calibration
• B. All sample preparation and analytical steps contained in the method
• C. Only data analysis steps
• D. Only instrument setup steps

Answer: (B)

An initial demonstration of capability tests the full workflow described in the method, from how the sample is prepared through the analytical steps to how the data are processed and reported. This matters because capability isn’t proven by inspecting pieces in isolation; it’s shown only when the lab can execute the entire method as written under routine conditions. Therefore, including all sample preparation and analytical steps contained in the method ensures the demonstration reflects real-world performance and confirms that the method can be applied reliably to produce valid results. While instrument setup, calibration, and data analysis are important, they are part of the complete method run, and focusing on just one aspect would miss potential issues in other parts of the workflow.