March 15, 2017

VALIDATION What’s your level?

Validation shouldn’t slow you down

AIM provides three levels of validation. These segments allow you to quickly reference the degree of validation that you need, and implement it as needed. This gives your team back valuable time to focus on design and construction.

LEVEL ONE
SIM – AIM’s standard scientific injection molding workbook
N=1 100%  layout
N = 30 shot capabilty (nominal process)

LEVEL TWO
SIM- AIM’s standard scientific injection molding workbook
N=3 100%  layout
High/Low – 30 shot tool capability study
One 1-hour PQ run – 30 shot Cpk study provided
Injection Molding  – process cycle card created
APQP document package (control plan)

LEVEL THREE

SIM- AIM’s standard scientific injection molding workbook
N=3 100%  layout
3-Way DOE (3 factor, 2 repeats, 5 shot subgroup, 25 runs = 125 shots)
OQ – 30 shot each high/low capability study
Three 4-hour PQ runs – 30 shot Cpk study provided for each run
Injection Molding  – process cycle card created
APQP document package (process flow diagram, PFMEA, control plan)

 

 

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