VALIDATION MASTER PLAN FOR VALUE PLASTICS FACILITY MOVE DOCUMENT NUMBER: 1034722 EFFECTIVE DATE: 09 FEB 2015 LOCATION: FT COLLINS/LOVELAND AUTHOR: Jodi Raus PAGE REV 1 of 9 B ANY COPY MADE FROM THE ELECTRONIC VERSION SHALL BE CONSIDERED AN UNCONTROLLED COPY.. 4.1 In-Scope 4.1.1 Injection Molding Machines moved to new facility 4.1.2 Injection Molding Machine monitoring software 4.1.3 Injection Mold Tooling moved to new facility PRINTED HARDCOPIES ARE FOR REFERENCE USE ONLY VALIDATION MASTER PLAN FOR VALUE PLASTICS FACILITY MOVE DOCUMENT NUMBER: 1034722 EFFECTIVE DATE: 09 FEB 2015 LOCATION: FT COLLINS/LOVELAND AUTHOR: Jodi Raus PAGE REV 2 of 9 B ANY COPY MADE FROM THE ELECTRONIC VERSION SHALL BE CONSIDERED AN UNCONTROLLED COPY.. DEFINITIONS 5.0 CMM – contact measuring machine CNC – computer numeric control EDM – electric discharge machining IMM – injection molding machine IQ – installation qualification OQ – operational qualification PPP – product preparation and packaging PQ – process qualification ACCEPTANCE CRITERIA 6.0 6.1 Product – The first run of parts produced in an IMM post facility move must pass all quality checks per our standard processes.. REFERENCES 10.1 Project Schedule A project schedule has been completed for the facility move: • • • • • • • • 10.2 Release VMP Validation Plans created/ IQ/OQ/PQ checklists finalized Validation Plans approved (Primary Equipment) Facility/commissioning plan complete Begin Moving Injection Molding Machines Last set of IMMs moved • Validation tags attached • Execute IQ/OQ/PQ • Complete Validation report Release VMP Summary report Obtain ISO 13485 certification February 2015 (Complete) April 2015 (Complete) July 2015 (Complete) July 2015 (Complete) July 2015 (In process) September 2015 (Planned) October 2015 (Planned) October 2015 (Planned) Applicable Reference Documents, Regulations, and Procedures All SOPs required have been listed in prior sections of this VMP..
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