GoingToMeet

In order for an organization to satisfy the requirements for Design Control, no matter what Quality Management System (QMS) is being followed, there needs to be traceability from the Product Requirement specification through the verification and validation processes. The best way to establish and maintain this traceability is through the process of specification mapping. This process provides traceability from the highest level specifications down to the specification for components from both a "Top Down" and "Reverse" perspective. As an organization's design control system is audited, it is imperative that there be traceability from specifications to their test parameters during verification and validation, through the manufacturing, test and inspection processes and finally to the customer. This one hour session will define the process of specification mapping and provide the attendee with a well rounded methodology for implementing a program within their organization. Real life examples will be reviewed along with several different methods to approach specification mapping during the Design process.