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This document is a validation plan and report for a long medical drill project. It details 4 tests to test the machine, mechanical installation, surface finish, and reliability of the drill. Each test lists acceptance criteria and responsibilities. The validation report shows the tests were completed successfully, with tight fitting and low runout for the machine and installation, visually accepted surface finish, and no vibration or damage during reliability testing. All tests passed criteria within the planned timeframes and sample sizes.
This document is a validation plan and report for a long medical drill project. It details 4 tests to test the machine, mechanical installation, surface finish, and reliability of the drill. Each test lists acceptance criteria and responsibilities. The validation report shows the tests were completed successfully, with tight fitting and low runout for the machine and installation, visually accepted surface finish, and no vibration or damage during reliability testing. All tests passed criteria within the planned timeframes and sample sizes.
This document is a validation plan and report for a long medical drill project. It details 4 tests to test the machine, mechanical installation, surface finish, and reliability of the drill. Each test lists acceptance criteria and responsibilities. The validation report shows the tests were completed successfully, with tight fitting and low runout for the machine and installation, visually accepted surface finish, and no vibration or damage during reliability testing. All tests passed criteria within the planned timeframes and sample sizes.
7/24/2019 Green = test passed Project Description Long medical drill - Straits Malaysia Report Date 7/24/2019 Amber = test Plan Author Chayoot Pungpak uncovered error Red = test failed Validation Plan Validation Report Test Name Procedure Acceptence criteria Responsibility Duration Test Start Test Bundle File Pass / Sample Size Sample Size Actual Results Test # (hrs) Complete Fail Machine Testing Both flutes are formed on the tool Grinding 2 flutes with wheel clearance No interference with the collet adaptor Gerald Tan 2 24-Jul-19 24-Jul-19 2 Pass without any interference Geometry after the grinding is close to the 0.3 4 um Grind 3.2mm X 343mm brad point Run all grinding operations to achieve the 1 customer's drawing. Maximum runout of 5 Gerald Tan 2 24-Jul-19 24-Jul-19 2 Pass tip threaded guide pin required shapr stated in the drawing. um No interference, not difficult to insert the 0.03 Insert the tool into the workholding Gerald Tan 2 24-Jul-19 24-Jul-19 2 Pass tool Mounting Integral PCA SPRG Adaptor B32/45 WITH 70MM Spacer to FX the head Tight fit and visually accepted with rigidity Gerald Tan 1 0.1 24-Jul-19 24-Jul-19 1 Pass stock Enough force to clamp tool with no tool 0.03 Clamping force sliding out from the collet after apply some Gerald Tan 2 24-Jul-19 24-Jul-19 2 Pass force to the tool 2 Mechanical installation Able to tighten the workholding to the Tightening all screws headstock without any special tool Gerald Tan 1 0.1 24-Jul-19 24-Jul-19 1 Pass required. Set runout on spacer, collet adaptor and tool Set-up time is not over 45 minute Gerald Tan 1 24-Jul-19 24-Jul-19 1 0.5 Pass 0.8 blank and check using a dial guage. Runout maximum of 4 um Gerald Tan 2 24-Jul-19 24-Jul-19 2 2 um Pass No visual interferance with the pop-up Installation pop-up steady Gerald Tan 1 0.3 24-Jul-19 24-Jul-19 1 Pass steady 3 Surface Finish Visual inspection of the surface finish Visually accepted surface condition Gerald Tan 2 1 24-Jul-19 24-Jul-19 2 No unappealing surface finish Pass 4 No vibration or damage to the A-Axis and No vibration, the workhold still Run a-axis forward and backward 360 degree remain rigid Reliability the workholding remain intact to the Gerald Tan 1 5 25-Jul-19 25-Jul-19 1 and stop for 1 second. Repeat for 5 hours headstock Total 6.3