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Viraj D replied to the topic Discussion Topic: Verification vs. Validation in the forum The Design History File 8 years, 6 months ago
By process, I am assuming you mean any standard operating procedures and policies created by the Quality department. These processes are considered higher level documents, which explain how to perform a Design Validation Process, Product Risk Management Plan, Design Verification Procedure, etc. Specifically for a design verification procedure, it details the steps on creating a protocol, routing the document to a technical authority to review and then to a QA for pre-approval. Next, the protocol is executed, and a report & discussion is conducted to analyze the results, which then gets post approved. This process for a verification, needs its own “V&V” in a way because the process must make sense and be correct for engineers to follow. Each SOP, is essentially dry ran to make sure each step is detailed enough to make sense, so when a new hire enters the company they can refer to the company’s SOPs and understand the different processes.