In the world of medical device manufacturing, mistakes on the plant floor can have dire consequences. That’s why meeting FDA requirements such as 21 CFR Part 820, 21 CFR Part 11 and ISO 13485 are so critical.
Bottom line: Manufacturers today are facing the global challenges of staying in step with increasingly complex customer requirements while accelerating product development and reducing costs. Excelling on these three dimensions is going to require an entirely new level of Manufacturing Execution Systems (MES), Manufacturing Intelligence and analytics performance.
Gartner predicts that algorithms will have a galvanizing effect across and within enterprises and implies this will extend to value chains, defining the future of business from an interconnection and relationship standpoint.
To fully capitalize on these opportunities and perform at the speed customers expect, many of these aerospace manufacturers need to move forward with the current generation of MES applications and tools.
You can have all the fancy tools, all the simulation that shows how products could be assembled, but if your shop floor isn't working efficiently, if they don't have the right tool to build the product, those other fancy options bring you no value.
The greatest supply chain challenges A&D manufacturers face include ensuring sufficient supplier capacity meet demand (43%), supplier performance in terms of risk, reliability and quality (43%) and flexibility and responsiveness to changes in demand or product mix (40%).
The highest-performing Manufacturing Execution Systems (MES) reduce the chaotic clutter of paperwork by delivering greater accuracy, precision and quality of online work instructions, while scaling processes across all production centers anytime, anywhere.
From the initial supplier quality qualifications, audits and sourcing requirements to production and maintenance, repair and overhaul (MRO), all aspects of jet production are predicated on quality management.