The Knob That Changed Everything
This quote brings to mind a time when we had to update a very old piece of equipment. It was a machine that filled foil pouches with dry powder. The machine wasn't automated; it mostly ran on mechanical settings. The key control was a stainless-steel knob. The knob had no markings, and neither did the base around it. It was likely set the last time the machine was serviced and had been running that way ever since.
Our challenge was to describe this knob setting in our validation protocol. So, we made etch marks on the knob and the base. We then figured out how many full and partial turns were needed to get the knob back to that position. This information was added to the protocol and the procedure. Now, the process validation can refer to a specific setting.
Don't underestimate the small details; they can make or break your validation process. Ready to turn the knob towards better compliance? Let's talk.
About Brayearst Validation Consulting
Brayearst Validation Consulting leverages Six Sigma methodologies to provide targeted validation services for the life sciences industry. We specialize in process, cleaning, software, and analytical test method validation, ensuring compliance with FDA requirements while optimizing operations for efficiency and quality. Our team combines technical expertise with a deep understanding of regulatory standards to deliver process-driven validation documents that withstand rigorous auditor scrutiny. From strategy development to study execution, we empower our clients to achieve operational excellence and bring high-quality products to the market with confidence.
