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.
For most medical products, at least one series of validations are performed. These an range from DV (Design Validation) / OQ (Operational Qualification) / PQ (Process Qualification) to validations in packaging, shipping, and sterilization. |
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MSA
Dielectrics
conducts Measurement System Analysis (MSA) to ensure that measurement
system variation is understood and that the systems are repeatable and
reproducible.
PPAP
Production
Part Approval Process (PPAP) is followed at Dielectrics to demonstrate
that customer design and specification requirements are understood and
that the process has the ability to meet the requirements.
CP
Dielectrics develops Control Plans (CP) to maintain a common understanding of what is necessary to ensure that the product meets customer satisfaction requirements.