INSPECTION

Whether component parts are made in Dynaroll's own temperature-controlled machine shop or by an outside vendor, inspection standards are agreed beforehand with the customer according to each application. Inspection criteria for in-process and final inspection are developed from the design and validation steps and are controlled under ISO 9001-2000.

Documentation standards meet ISO 9001-2000 and FDA-critical requirements. In particular, Dynaroll has developed an advanced DHR (Device History Record) system for critical applications. Complete manufacturing and service records for a mechanism are accessed from a bar-code serial number, as well as top-down/ bottom-up component traceability.