Certified Quality Engineer (CQE) Exam 2025 – 400 Free Practice Questions to Pass the Exam

The method used to determine whether a process functions properly for its intended use is validation. Validation is a critical step in quality management that ensures a process, system, or product is capable of consistently producing results that meet predetermined specifications and requirements. It involves a thorough assessment of the process to verify whether it aligns with the intended use and can operate effectively in the real-world environment.

During validation, various approaches such as testing, analysis of data, and operational assessments are carried out. The goal is to confirm that the process will perform its intended function reliably, which is essential for quality assurance and customer satisfaction.

In contrast, while capacity is important for understanding the full potential of a process, it does not directly assess whether the process serves its intended purpose. Inspection involves examining outputs to determine adherence to specifications but does not encompass the broader aspect of whether the process meets overall effectiveness. Design review focuses on evaluating the design phase, ensuring that the specifications and requirements are being met from a design perspective, but it does not assess operational functionality in its intended use. Therefore, validation stands out as the most comprehensive method for determining process effectiveness in relation to its intended application.