VAL-IQ-0164-P PCBA Depanalization Maestro 2M Rev1 29 Nov 2016 Gabriel

Equipment Installation Qualification
Protocol
Protocol Number : VAL-IQ-E-0164/P Revision : A
Title : PCBA Depenalization Maestro 2M No. of Pages : 1 of 20
Revision History
S/N Reason for Change Effective Date Revision Originator

1. Initial Release 1 Fathur
Department Head Management Rep./ Effective Date

(Name / Signature / Date) Div. QA Manager (to be filled up by DCC)
(Name / Signature / Date)
F-MP-04-51 Rev. D Form Effective Date: 19-Apr-2016

Form Originator: Wahyudi
Protocol Number : VAL-IQ-E-0164/P Revision: A
PCBA Depenalization Maestro 2M
Equipment Installation Qualification Protocol
This document describes the Installation Qualification Protocol for the PCBA
Depenalization Maestro 2M.
GENERAL INFORMATION
Equipment Name: Model Number:
PCBA Depenalization MAESTRO-2M
Serial Number: Qualified as Mobile?
001956 M17 N/A Yes X No
Equipment Source: Software:
Developed In-house N/A Developed In-house N/A
Bought from vendor X Bought from vendor N/A
Not Applicable X
Hybrid Equipment N/A
Description of Intended Use:
The intended use of this document is to provide the Installation Qualification Protocol
for PCBA Depenalization Maestro 2M Main Plant Batam.
Mobile Equipment Justification:
PCBA Depenalization Maestro 2M is stand- alone and located at fix location and is
not mobile.

Signature Approval Matrix
This Equipment Installation Qualification Protocol must be reviewed and approved by

all individuals listed below or their authorized representatives.
TITLE NAME SIGNATURE DATE
Engineer Fathur
Director of Sivakumar
Engineering Thanupillai
Director of Sivakumar
Operational Thanupillai
Director of Quality Gabriel Lye Huat Ng
Review and approve by customer:
TITLE NAME SIGNATURE DATE
Spacelabs Supplyier
Sophie Yang
Chain Engineer
This document, with authorizing signatures, must be collected, maintained and

controlled per established Document Control Procedures.

INTRODUCTION / PURPOSE
The purpose of this Installation Qualification (IQ) protocol is to verify and ensure
that the PCBA Depenalization Maestro 2M is installed in accordance with OSIE
criteria and specifications. This equipment was designed and developed by Cab
Produkttechnik GmbH & Co KG Germany. This document also defines the
qualification requirements and the acceptance criteria required to ensure that the
PCBA Separator MAESTRO 2M is installed properly. This work will be
accomplished by verifying the proper installation of the PCBA Depenalization
Maestro 2M appropriately documenting the results.
SCOPE
The scope of this IQ protocol is limited to the PCBA Depenalization Maestro 2M
which is located at Back End Manual Insert 3.
DEFINITIONS
Term Definition
Establishing by objective evidence that all key aspects of the process equipment and
Installation
ancillary system installation adhere to the manufacturers approved specifications and
Qualification (IQ)
that the recommendations of the supplier of the equipment are suitably considered.
Master Validation A document that defines responsibilities and outlines the methods involved in the
Plan (MVP) qualification and validation of a specific process or group of processes.
Operational Establishing by objective evidence process control limits and action levels which result in
Qualification (OQ) product that meets all predetermined requirements.
Performance Establishing by objective evidence that the process, under anticipated conditions,
Qualification (PQ) consistently produces a product which meets all predetermined requirements.
Establishing by objective evidence that a process consistently products a result or
Process Validation
product meeting its predetermined requirements.
A document stating how a validation will be conducted, including test parameters,
Process Validation
product characteristics, manufacturing equipment, and decision points on what
Protocol
constitutes acceptable test results.
Confirmation by examination and provision of objective evidence that the specified
Verification
requirements have been fulfilled.

EQUIPMENT DESCRIPTION AND FUNCTION
The PCBA Depenalization Maestro 2M is stand- alone equipment and

does not require compress air supply. The lower blade of the PCBA
Depenalization Maestro 2M is motor driven.
PCBA Depenalization Maestro 2M specification as per the table stated

below,
Decription Specification
Dimention H x D x W 330 X 620 X 195 mm
Separating Length Up to 300 mm
PCBA Thickness 0.8 ~ 3.2 mm
Separating Principle Circular Blades
Maximum cut thickness 0.8 mm
The PCBA Depenalization Maestro 2M consists of the following major

components,
Machine Component Operation

Top Circular blade FR4 PCBA Separator Station
Upper safety guide PCBA Separator Station
Bottom circular blade PCBA Separator Station
Lower safety guide PCBA Separator Station
Scale plate and Knob PCBA Separator Station
Top circular shaft PCBA Separator Station

The PCBA Depenalization Maestro 2M is intended exclusively for

separating pre scored PCBA, The PCBA panel is feed manually between the
circular blades and to separate the PCBA panel into individual PCBA.
The PCBA Depenalization Maestro 2M has a safety operation where the

clearance between the upper guide 1 and the lower guide 2 is adjusted to
ensure that the PCBA is only feed through the PCBA Depenalization
Maestro 2M in the pre-scored groove The PCBA can be smoothly moved
forwards but cant move to the sideways.

The PCBA Depenalization Maestro 2M is placed on the production area at the

manufacturing facility located at Back End process (PCBA Separator Station) next to
Manual Insert area.

RESPONSIBILITY
The following matrix details the responsibilities for the Installation Qualification of
the PCBA Depenalization Maestro 2M.
Engineering/ Process/Test
Quality Assurance
Production
Task
Develop protocol N/A N/A X
Review and approve protocol X N/A X
Develop manuals for machines N/A N/A X
Develop and revise preventive maintenance and

N/A N/A X
calibration procedures and requirements.
Develop and revise equipment set up SOPs N/A N/A X
Execute protocol N/A N/A X
Write final report N/A N/A X
Review and approve protocol and report X X X
REFERENCES
The following regulatory, guidance, documents and standard operating
procedures (SOPs) will be required for the protocol.
Document or SOP
Document
Number
Process Validation SOP WI-MP-08-10
Equipment Calibration QP-04-12
Preventive Maintenance QP-04-13
Instruction manual Maestro 2M

ENVIRONMENT REQUIREMENT
The environmental requirements for this machine to operate as reference to
Temperature and Humidity Control procedure WI-MP05-87 as listed below:
Result
Environment Requirement Actual Result Pass Initial/Date
/Fail
Temperature
10 to 35 C
(Operation)
Humidity 10 to 85 % RH
Comments:
Signature below (Verified by :) indicates data entered is accurate and complete.
Verified by: Date:
PERSONNEL PERFORMING VALIDATION

All OSIE personnel executing or witnessing this protocol must be identified in the
table below, before executing any portion of this protocol.
Signature Sheet
Print Name Signature Initials Job Title / Affiliation
Comments:
Signature below (Verified by:) indicates data entered is accurate and complete.
Verified by: Date:

PERSONNEL TRAINING VERIFICATION

All OSIE personnel executing or witnessing this protocol must be trained and
identified in the table below, before executing any portion of this protocol.
Training shall include protocol training and applicable procedures/work
instructions necessary for proper execution of this protocol
Signature Sheet
Training
subject
Print Name Signature Job Title / Affiliation
(Protocol or
Procedure)
Comments:

Verified by: Date:
CALIBRATED TEST INSTRUMENTS

Calibrated Test instruments used in the execution of this protocol must be within
calibration at the time of use, and be traceable to National Institute of Standards
and Technology (NIST) or equivalent.
Cal. Cert
Equipment
Calibration Cal. Due Attached
Instrument Description ID / Serial
Date Date (Appendix
No.
no.)
FLUKE 87 V
True RMS Multi Meter
Digital Caliper
Comments:

Verified by: Date:

Title : PCBA Depenalization Maestro 2M
No. of Pages : 11 of 20
INSTALLATION QUALIFICATION TESTING
Equipment Identification and Vendor Documentation

Method
a) Record Equipment details and availability of associated documentation.
b) Confirm that all required documentation is correct, complete and current location recorded.
c) Include a layout of the location of the equipment
Acceptance Criteria
a) Table completed with required information
b) Pass recorded in all steps.
c) Layout of the location of the equipment is available
Additional Manual Pass

Equipment Type Serial No. Cal Due Cal Ref: Initial Date
Details Available / Fail
PCBA
MAESTRO 2M Cab 001956 M17
Depanalization
Comments:

Verified by: Date:

Equipment Installation & Electrical Check

Method
a) With equipment electrically isolated from main supply, inspect electrical components i.e. security and condition of base units & cabling.
Acceptance Criteria
a) Table completed with required information.

b) Pass recorded in all steps.
Pass / Fail or
Test Requirements Actual Condition Initial Date
N/A
Is the space sufficient ?

Space sufficient (refer to the dimension)
Yes:_______ / No: _______
Is the earth cable connected ?

Protective earth ground cable are connected
Yes:_______ / No: _______
Is the power loss tested ?

Power Loss testing (Refer to section 13.0)
Yes:_______ / No: _______
Note: Power loss testing is targeted at verifying the proper response of individual components and subsystems to an unexpected loss of power, such as during
a storm or equivalent event for the intent of power loss testing, is to demonstrate the equipment returns to operation in a manner that is consistent with the
operating requirements of the system, including appropriate equipment/system alarms and messages
Comments:


Verified by: Date:
Utility Connection Verification

Method
a) Using previously identified calibrated instruments, measure utility supplies at Utility / Equipment connections
b) Power up & run the equipment to confirm correct operation (Ref: Machine user manual)
Acceptance Criteria
a) Electrical supply meets requirements, and Equipment powers up ready for operator use. Upon loss and restoration of utility the equipment will respond as expected. When
the utility is restored, the equipment/system will retain all critical parameters or settings and return to a pre-defined state or in the event where parameters change,
procedures are in place to address recovery of operational parameters.
b) Required details are completed, and a Pass recorded in all steps.
Requirement Expected Results Equipment Identification Actual Result (v) Pass / Fail Initial Date
Electrical supply 220 10 Volt AC
Comments:

Verified by: Date:
INSTALLATION QUALIFICATION CHECKLIST

Method
a) Verify Equipment requirements and conditions.
Acceptance Criteria
a) Table completed with required information
b) PASS recorded in all step.
Pass /
Step Test Requirements Actual Condition (Details) Initial Date
Fail
Is PM Schedule established?
1 Planned Preventative Maintenance Schedule established. Yes:______ / No:_______
PM schedule and report attached in Appendix:______________
Is it the spare part available?

2 Spare parts list available.
Yes:______ / No:_______
All special ESD control requirements have been Is it special ESD control has been established?
4
established. Yes:______ / No:_______
Verify the instrument chassis is connected to an electrical Is it the machine connected to ground?
5
protective earth ground. Yes:______ / No:_______
Comments:


Verified by: Date:
POWER LOSS CHALLENGING
Step Instruction Expected Result Actual Result Pass / Fail Initial DatE
A power source of electric is normaL
Showing the lamp indicator ON 0 Is it the lamp indicator ON and 0 position?

Plug in cable power and switch ON PCBA
position as standby operation. Yes:______ / No:_______
Depanelization Maestro 2M.
1
The machine have an incoming Is it an incoming voltage 220 10 Volt AC?
Check incoming Electricity supply voltage.
power supply 22010 Volt AC. Yes:______ / No:_______
Is it the lamp indicator ON and 1 position?

Showing the lamp indicator ON 1
Yes:______ / No:_______
position.
2 Push ON the motor button.
Are the bottom blade turning ?
The bottom blade motor is turning
Yes:______ / No:_______
Switch OFF 220 10 Volt AC for PCBA Showing electric power lamp Is it electricity power lamp indicator OFF?
3
Depanelization Maestro 2M. indicator red colour is light OFF Yes:______ / No:_______

During machine continue run suddenly a power source of electric switched OFF
The machine have an incoming Is it an incoming voltage 0 Volt AC?

1 Check incoming Electricity supply voltage.
electricity supply 0 Volt AC. Yes:______ / No:_______

Switch ON PCBA Depanelization Maestro Is it the lamp indicator ON and 0 position?
2 as standby operation.
2M. Yes:______ / No:_______
Is it the lamp indicator ON and 1 position?

Yes:______ / No:_______
position.
3 Push ON the motor button.
Are the bottom blade turning ?
The bottom blade motor is turn ON
Yes:______ / No:_______
Comments:
Signature below (Verified by:) indicates data entered is accurate and complete

Verified by: Date:

DEVIATIONS
List deviation forms issued in execution of this protocol.
Deviation
Description Appendix Initials Date
No.
Signature below (Verified by:) indicates data entered is accurate and complete.
Verified by: Date:

ACCEPTANCE CRITERIA
IQ Acceptance Criteria:
Approval of IQ protocol.
Successful completion of verification of each section in this

protocol with required information recorded and each pass all inspection
items.
No deviation or all deviations with justification and mitigation, the

deviation do not impact on Validity of Validation.
APPENDICES
List all supporting documentation used during the execution of this qualification.
Protocol
Appendix No of
Description Section Date Added
No Pages
Reference

Verified by: Date:

DEVIATION REPORT FORM

Originator Name Date
Report No. Test No. Step No.
Detailed description of deviation
Deviation Investigation Result and initial Impact Assessment (Attach supporting evidence as required)
Minor - Major -
A Minor issue with no significant potential to impact the A Major issue that has significant potential to impact
result of the Qualification. subsequent steps of the Qualification.
Qualification may proceed prior to resolution of Deviation Qualification not to proceed until Deviation is resolved
Corrective action taken (Attach supporting evidence as required)
Documentation Enter details below of required changes in Documentation
Deviation Close Out and Approval
Deviation Resolved (Y/N) ____ Adverse impact on Validity of Validation (Y/N) ____
Approvers
Title Name Signature Date

VAL-IQ-0164-P PCBA Depanalization Maestro 2M Rev1 29 Nov 2016 Gabriel

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Equipment Installation Qualification

S/N Reason for Change Effective Date Revision Originator

Department Head Management Rep./ Effective Date

F-MP-04-51 Rev. D Form Effective Date: 19-Apr-2016

PCBA Depenalization Maestro 2M

Equipment Installation Qualification Protocol

Equipment Name: Model Number:

PCBA Depenalization MAESTRO-2M

Serial Number: Qualified as Mobile?

001956 M17 N/A Yes X No

Equipment Source: Software:

Developed In-house N/A Developed In-house N/A

Bought from vendor X Bought from vendor N/A

Description of Intended Use:

Mobile Equipment Justification:

F-MP-04-51 Rev. D Form Effective Date: 19-Apr-2016

Signature Approval Matrix

This Equipment Installation Qualification Protocol must be reviewed and approved by

TITLE NAME SIGNATURE DATE

Director of Quality Gabriel Lye Huat Ng

Review and approve by customer:

TITLE NAME SIGNATURE DATE

This document, with authorizing signatures, must be collected, maintained and

F-MP-04-51 Rev. D Form Effective Date: 19-Apr-2016

F-MP-04-51 Rev. D Form Effective Date: 19-Apr-2016

EQUIPMENT DESCRIPTION AND FUNCTION

The PCBA Depenalization Maestro 2M is stand- alone equipment and

PCBA Depenalization Maestro 2M specification as per the table stated

The PCBA Depenalization Maestro 2M consists of the following major

Machine Component Operation

F-MP-04-51 Rev. D Form Effective Date: 19-Apr-2016

The PCBA Depenalization Maestro 2M is intended exclusively for

The PCBA Depenalization Maestro 2M has a safety operation where the

F-MP-04-51 Rev. D Form Effective Date: 19-Apr-2016

The PCBA Depenalization Maestro 2M is placed on the production area at the

F-MP-04-51 Rev. D Form Effective Date: 19-Apr-2016

Develop protocol N/A N/A X

Review and approve protocol X N/A X

Develop manuals for machines N/A N/A X

Develop and revise preventive maintenance and

Execute protocol N/A N/A X

Write final report N/A N/A X

Review and approve protocol and report X X X

Process Validation SOP WI-MP-08-10

Equipment Calibration QP-04-12

Preventive Maintenance QP-04-13

Instruction manual Maestro 2M

F-MP-04-51 Rev. D Form Effective Date: 19-Apr-2016

Signature below (Verified by :) indicates data entered is accurate and complete.

Verified by: Date:

PERSONNEL PERFORMING VALIDATION

F-MP-04-51 Rev. D Form Effective Date: 19-Apr-2016

PERSONNEL TRAINING VERIFICATION

Signature below (Verified by :) indicates data entered is accurate and complete.

CALIBRATED TEST INSTRUMENTS

Signature below (Verified by :) indicates data entered is accurate and complete.

F-MP-04-51 Rev. D Form Effective Date: 19-Apr-2016

INSTALLATION QUALIFICATION TESTING

Equipment Identification and Vendor Documentation

Additional Manual Pass

Signature below (Verified by :) indicates data entered is accurate and complete.

F-MP-04-51 Rev. D Form Effective Date: 19-Apr-2016

Equipment Installation & Electrical Check

a) Table completed with required information.