PFMEA


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AcronymDefinition
PFMEAPotential Failure Mode and Effects Analysis
PFMEAProcess Failure Mode and Effects Analysis
References in periodicals archive ?
Whilst the enhanced form of PFMEA proved effective, the method was still limited for in-depth determination of 'root cause'; as apparent from the high mix of failure permutations observed.
Study conducted with 150 automotive companies shows that the highest number of surveyed companies see PFMEA as additional administrative work which wastes a lot of time, and gives back less benefits [5].
Most PFMEAs are conducted using a highly structured PFMEA form or "template.
During its PFMEA, a potential failure mode--the possibility for an assembler to miss one or two ball bearings in the assembly process--was identified.
There are number of methods to evaluate and improve process reliability, for instance, PFMEA, FTA, RBD, however in this paper the question of the process reliability will be evaluated from the aspect of production process variability.
It also employs Six Sigma and Kaizen practices, surpassing cGMP guidelines for process control, IP protection, CAPA (Corrective and Preventative Actions), PFMEA (Process Modes Effects Analysis), DFM (Design for Manufacturability), product traceability and government regulatory compliance.
All our facihties are fully certified ISO 13485 and ISO 9001, providing Dynamic Control Plans, PFMEA Data, First Article Inspection, Device History Records, Process Validation.
Some of the more common requirements include PFMEA (Process Failure Mode Effects Analysis), control plans, MSA (measurement systems analysis) studies and capability studies.
All our facilities are fully certified ISO 13485 and ISO 9001, providing Dynamic Control Plans, PFMEA Data, First Article Inspection, Device History Records, Process Validation.
This fully certified ISO 9001, ISO13485 and FDA registered facility provides; Dynamic Control Plans, PFMEA Data, First Article Inspection, Device History Records, Process Validation and Statistical Process Control.