The short and simple answer is this – Process Validation is a means of demonstrating to a statistically valid level that a process, when followed rigorously, delivers results consistent to a predetermined set of requirements. In pharmaceutical manufacturing and volume production of any kind a solid, clean, validation of a process is needed to haveContinue reading “What is Process Validation?”
Tag Archives: Lean Manufacturing
5th S – Sustain (Shitsuke)
Consistency is a problem. Not just in engineering, but universally – finding ways to do something the same way every time is tricky. Trying to get a group to accomplish this feat is even trickier. It takes weeks of practice to get a marching band to look – and sound – as polished as theyContinue reading “5th S – Sustain (Shitsuke)”
Important tools – 5S
Where did 5S come from? What is the purpose? Why is this not taught in college? It’s fun researching the roots of 5S. Some websites suggest the core fundamentals are traced back to Italy in the 1500’s. That aside, the structured practice of the five elements – Seiri, Seiton, Seiso, Seiketsu, Shitsuke – reportedly cameContinue reading “Important tools – 5S”
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