Machine Validation Format

Machine Validation Plan
Project: High Speed Placement SMD System Installation - China

Part Numbers/ Products that will use this equipment: Various
Equipment/Process to be Process/Product ECN Number:Various
Validated
XPF-L N/A
Date Required: 11/1/2016
Project Manager(s): Jamie Dobravec / Alfred Sham
Team Member(s): Matthew Wong, Michael Yip, Franky Tang, Lina Yan
This form is used to approve new equipment for product. This form is provided as a base to
describe “what” and “how” of the validation. Sections may be added at the discretion of the project
manager or engineer.
1. Introduction................................................................................................................................2
1.1. Objective ............................................................................................................................2
1.2. Reference Documents .......................................................................................................2
2. Validation Plan ..........................................................................................................................2
2.1. Installation Qualification Plan.............................................................................................2
2.2. Operational Qualification Plan ...........................................................................................2
2.3. Performance Validation/Qualification Plan.........................................................................2
3. Results.......................................................................................................................................3
3.1. Installation Qualification Results ........................................................................................3
3.2. Operational Qualification Results.....................................................................................11
3.3. Performance Qualification Results...................................................................................14
4. Conclusion................................................................................................................... ............16
ENG FORM #325 Page 1 of 16

File name: ENG#325.DOC
Created: 8-19-11, K. Hansen
Equipment Validation Plan/Results
1. Introduction
A new FUJI XPF-L High Speed SMC Placement System System machine has been
purchased to assist in the production of the various PCBA’s at Grayhill’s Shenzhen facility.
This plan will aid in the proper installation and validation of the new equipment.
1.1. Objective
Receive, install, and qualify the new placement machine for use in all China PCBA
assembly.
1.2. Reference Documents

- FUJI XPF-L Installation Documentation
- FUJI XPF-L Operator Manual
- FUJI XPF-L Technical Manual
2. Validation Plan
2.1. Installation Qualification Plan

The machine was delivered to the Shenzhen, China facility on 2016.08.29. An
electrician wired the machine before Grayhill’s installation team arrives on
2016.09.01. The electricity run to the breaker box next to the machine will able to
produce 200 VAC, 3 phase, 50-60Hz power. Operating conditions will be between
20 and 30C.
2.2. Operational Qualification Plan

After the machine is completely installed, all specifications located in the user
manual will be verified. All potential profiles will be run to ensure each profile is
operational within the program and the wave solder machine. The FUJI XPF-L
System machine will be added to eMaint for preventative maintenance.
2.3. Performance Validation/Qualification Plan
A representative sample PCBA will be processed through the placement equipment.

Nominal settings to ensure a good process will be used. After placement of the
components, location of components to nominal will be measured on a minimum
sample of 32 pieces. Cpk values should be in the acceptable range (>1.33) for the
process.

3. Results
3.1. Installation Qualification Results

Verify Environmental requirements:
20 – 30C
30 – 80% Humidity
60 – 80 Decibals
In front of the machine Rear of machine
Ensure floor is capable of holding 1500kg and level level

Ensure space is capable of supporting System
Length Depth Height
1500mm 1607.5mm 1419.5mm
The environment is clean

Verify power is available for 200V, 50 or 60 Hz, 3 Phase 30 AMPS
Input voltage: 198V
Verify a pneumatic supply of clean, non lubricated air which

should maintain :
Air supply 0.5MPa

Verify data transmission wire correct connection (network)

Verify the PCB handling I/F transmitting signal connection
Verify the MFU materials plate bracket installation.

Verify the height of MFU, adjust the height of the MFU: 23 mm
Verify material fixed station installation

Machine preparation transit brackrts and screws removal

Verify emergency Stop buttons function

3.2. Operational Qualification Results
Operational testing will qualify system hardware and software functionality
Verify the following:
Placement capability: 25000 components/hr

Placement tact time: 0.144 seconds/component
Placement Accuracy:Chips ±0.050mm
Leaded parts ±0.040mm
Conveyor loading time:1.8 sec
Verify the Nozzles fit correctly and tape feeder handles reel size

Verify width capability as follows:
Board Specifications
Metric
Width (XPF-L) Min 50*50mm
Max 457*356mm
Verify XPF-L I/O diagnostic capability

Verify XPF-L the placement accuracy test
Training
The following associates have been properly trained.
_Franky tang
_Pen Huihua
_Wang guangquan

3.3. Performance Qualification Results
Ran one representative PCBA order of 88 pieces through all processing following the pick
and place operation. Placement of the components on the PCBA’s were visually inspected
with no abnormalities. Assemblies using these PCBA’s were built and tested with no
electrical issues.
CpK data collected for location of components.

FUJI XPF-L chip shooter X-Direction CPK:1.57

FUJI XPF-L chip shooter Y-Direction CPK:2.20
Verified the placement and quality following reflow.

4. Conclusion
Following installation of the new XPF-L high speed placement machine, all functions of the
were found to be normal and production utilizing this equipment was found to be without
error.
Approvals
VP – Global October 17, 2016 Date

Quality
Project
October 17, 2016 Date
Manager
Operations
October 17, 2016 Date
BUL/VP

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Machine Validation Plan

Project: High Speed Placement SMD System Installation - China

ENG FORM #325 Page 1 of 16

1.2. Reference Documents

2.1. Installation Qualification Plan

2.2. Operational Qualification Plan

2.3. Performance Validation/Qualification Plan

A representative sample PCBA will be processed through the placement equipment.

ENG FORM #325 Page 2 of 16

3.1. Installation Qualification Results

In front of the machine Rear of machine

Ensure floor is capable of holding 1500kg and level level

ENG FORM #325 Page 3 of 16

Length Depth Height

1500mm 1607.5mm 1419.5mm

The environment is clean

ENG FORM #325 Page 4 of 16

Verify power is available for 200V, 50 or 60 Hz, 3 Phase 30 AMPS

Input voltage: 198V

Verify a pneumatic supply of clean, non lubricated air which

Air supply 0.5MPa

ENG FORM #325 Page 5 of 16

Verify data transmission wire correct connection (network)

ENG FORM #325 Page 6 of 16

Verify the MFU materials plate bracket installation.

ENG FORM #325 Page 7 of 16

Verify the height of MFU, adjust the height of the MFU: 23 mm

Verify material fixed station installation

ENG FORM #325 Page 8 of 16

ENG FORM #325 Page 9 of 16

ENG FORM #325 Page 10 of 16

Verify the following:

Placement capability: 25000 components/hr

ENG FORM #325 Page 11 of 16

Verify XPF-L I/O diagnostic capability

ENG FORM #325 Page 12 of 16

ENG FORM #325 Page 13 of 16

3.3. Performance Qualification Results

CpK data collected for location of components.

ENG FORM #325 Page 14 of 16

FUJI XPF-L chip shooter Y-Direction CPK:2.20

Verified the placement and quality following reflow.

ENG FORM #325 Page 15 of 16

VP – Global October 17, 2016 Date

ENG FORM #325 Page 16 of 16

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