Pre-Production Quality Tools

DFMEA / PFMEA and Validations

Dielectrics utilizes Design Failure Mode and Effects Analysis (DFMEA) and Process Failure Mode and Effects Analysis (PFMEA) to evaluate potential failures in the design and/or process and to identify actions intended to eliminate or reduce occurrence. This process is used as a proactive tool "before the event" in order to minimize the need for "after the fact" reactive measures.

We develop custom validation protocols which include IQ (Installation Qualification), OQ (Operational Qualification), PQ (Process Qualification) to validations in packaging, shipping, and sterilization.