Speaker: Slavko Jovanovic
There are many regulatory compliance costs out there. There are traceability and archiving requirements. Some of our customers have to store their as-built information or device history records for 10 to 20 years. From those records, they need information such as what is in the product, who touched the product, and who supplied the raw materials. There are Occupational Safety and Health Administration (OSHA) requirements for safety. There are International Organization for Standardization (ISO) requirements for quality control. There are International Traffic in Arms Regulations (ITAR) requirements for export control. These requirements say who is able to see what information, and you need to trace to see who has actually seen the information. There are special part-marking requirements for unique identification. All these requirements are very expensive to meet and that is why the costs are so high.
Organizations struggle with controlling those drivers because silo systems, un-integrated systems and paper systems simply are not sufficient to control these complexities. They lack the visibility and control to be effective. The best practice approach for reducing costs of regulatory compliance is to implement systems for safety and traceability as a natural extension of the manufacturing process. You want to implement these systems to reduce the burden to the user so it becomes automatic, and you want to use automation whenever possible. You need to reduce the cost by moving these regulatory requirements from the foreground to the background as a natural process of your manufacturing systems.