However, as with many regulatory requirements today, the interpretation of how to validate a process can be quite overwhelming.
In fact, there are entire books written about the subject. A simple and basic definition for process validation is: Establishing, through documented evidence, a high degree of assurance that a specific process will consistently produce a product that meets its predetermined specifications.
Is it possible that a customer, an auditor, a quality representative, a process technician and a design engineer would all agree that the process has demonstrated a high enough degree of assurance? Many times, a company or an industry will set a statistical standard for the amount of variation allowed in a process.
Simply put, when this requirement is met, a high enough level of assurance is reached.
To understand rules related to injection molding part design Injection Molding Design Guidelines Clicking on failed rule displays failure incidence, Reason for failure and settings for defined rule.
To display how it looks I have added results to Word file and stored it for display Please CLICK HERE to see the results.
2) MS Excel - The report can also be generated in Ms Excel format.
It analyzes the in depth part geometry and does not depend just on native CAD model. After completion of analysis, it shows Rules Failed depicted by 'Cross' sign and rules passed by 'Tick' size.
DFMPro has it's unique rule based engine which is easy to configure and work with.