Like many industry phrases, “traceability” can mean different things to different stakeholders. Our definition takes into account its current and future phases in a global context. Our goal with this white paper is to give you a thorough understanding of traceability’s importance as a manufacturing strategy that touches every aspect of production.
Medical devices range from complex, life-saving pieces of equipment like pacemakers to fairly simple tools like surgical clamps and scalpels. Many of the simpler instruments are sold in kits, and yet there’s really no one-size-fits-all kit composition that satisfies the needs of all care providers.
Production line automation helps ensure that the system can respond immediately to changes in requirements without requiring human intervention. A good traceability system is also a must, since the increase in variables from flexibility necessitates more diligent tracking and error-proofing.
The manufacture of biological materials and biopharmaceuticals for use in research and drug development often involves sudden shifts in demand as a company’s customers pivot to new research focuses and clinical trials. The resulting product diversification and quick changeover requires manufacturers to implement more flexibility into their existing systems.
To reduce the costs and effort of product changeover, manufacturers rely heavily on strategies like modularity, reconfigurability and automation. Modular systems make it possible to easily boost production of certain items and lower the production of others in response to changing demand.
Medical laboratories are increasingly using large, automated testing machines to support diagnostic decisions. Although the machines are typically one-size-fits-all devices that perform commonly ordered test panels, the supply of reagents and the process of prepping samples for the tests requires flexibility.
The larger and more heavily automated the laboratory, the more the process of prepping test samples resembles flexible manufacturing. By checking cap color on test tubes and other key information about a sample, vision systems support quality control requirements in a flexible environment.