Maik W. Jornitz, President, G-CON Manufacturing LLC
Past experiences have shown that too often product quality is based on sole reliance of vendor certifications, statements and promises. To diminish such reliance new technologies started to be implemented, like process analytical technologies (PAT), process controls, automation etc. often once again overexerted as the solution to all problems. Activities that supposedly result in higher product quality due to better process controls. Process equipment received as much new up-grades and moved into single-use technologies, once again with the promise of enhanced production safety and product quality. Technology advances, which are embraceable, but only when one has a full understanding of them. If understanding is pushed to the side, due to its time consumption or a “push the button” mentality is created, risks and corrective action timelines are elevated. Only understanding will allow an immediate response when something unforeseen happens or an adverse activity has proceeded.