IOQ Protocol for Strip Printer XXXX

Installation/Operational Qualification (IOQ) Protocol
for the Strip Printer XXXX
Document Version: 0
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DOCUMENT APPROVALS
Author's :
Your signature indicates that you have completed this document and that, to the best of your knowledge, it is accurate
and complete and it complies with existing XXX and regulatory requirements and adequately addresses the intended
purpose and scope.
This document requires the electronic approval of the following roles:
Subject Matter Expert:

Your signature indicates, as a subject matter expert of the named application, that you have reviewed this document and
agrees that it is accurate, complete, and contains the necessary degree of detail to accomplish the intended purpose.
System Custodian
Your signature indicates that you agree with this document, understand the areas of responsibility for your department,
that this document was prepared with your knowledge and approval, and that this document complies with current
Corporate/Local XXXXXX , Inc. policies, procedures and current Good Manufacturing practices as stated in this
document.
System Owner
Your signature indicates that you agree with this document, understand the areas of responsibility for your department,
that this document was prepared with your knowledge and approval, and that this document complies with current
Corporate/Local XXXXXX , Inc. policies, procedures and current Good Manufacturing practices as stated in this
document.
Quality Assurance
Your signature affirms awareness of this document and attests that the documentation and information contained herein
complies with current Corporate/ Local XXXXXX, Inc. policies, procedures, applicable regulatory, requirements and
current Good Manufacturing practices as stated in this document.
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TABLE OF CONTENTS
Page
INTRODUCTION...............................................................................................................................................4
PURPOSE 4
OBJECTIVE 4
SCOPE AND QUALIFICATION APPROACH RATIONALE.................................................................4
REFERENCES.....................................................................................................................................4
RESPONSIBILITIES ...........................................................................................................................5
METHODOLOGY.................................................................................................................................5
SYSTEM DESCRIPTION.....................................................................................................................8
2.0 INSTALLATION QUALIFICATION .............................................................................................................9
2.1 Documentation Verification Test....................................................................................................10
2.2 Equipment and Major Components Verification Test.....................................................................12
2.3 Serial Interface DIP-Switches Configuration Verification Test........................................................15
2.4 Utilities Verification Test.................................................................................................................21
2.5 Spare Parts List Verification Test...................................................................................................23
3.0 Installation Qualification Completion Verification ........................................................................................25
4.0 Operational QUALIFICATION ....................................................................................................................26
4.1 Standard Operating Procedures and Training Verification Test.....................................................27
4.2 Button/Switch/Lights Verification Test............................................................................................29
4.3 Power Loss and Recovery Verification Test...................................................................................32
4.4 Ticket Printer System Verification Test...........................................................................................34
5.0 QUALIFICATION DISPOSITION.................................................................................................................41
6.0 ATTACHMENTS.........................................................................................................................................42
Attachment No. 1: Discrepancy Log Form ...........................................................................................42
Attachment No. 2: Test or Reference Instruments List ......................................................43
Attachment No. 3: Signature Identification Log Sheet..........................................................................44
7.0 APPENDIX..................................................................................................................................................45
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INTRODUCTION
PURPOSE
The purpose of this Installation/Operational Qualification Protocol (IOQ) is to set forth the
objectives, methodology, procedures, and acceptance criteria necessary to qualify Strip Printer
XXXX. The purpose is also to assure that the equipment is installed, operates, and performs as
designed and in accordance to the manufacturer’s recommendations, XXXXXX, Inc. user
requirements and specifications, and cGMP’s requirements. .
OBJECTIVE
The objective of this qualification protocol is to verify and document that the Strip Printer XXXX has
been properly installed and operates in accordance to XXXXXX, Inc. specifications and cGMP’s
requirements under the authorization of Change Control XXXXXXX.
SCOPE AND QUALIFICATION APPROACH RATIONALE
This IOQ exercise will cover installation and operation of the Strip Printer XXXX following the
corporate Global Quality Standard (GQS), Common Quality Practice (CQP) and local procedures.
The Installation Qualification will verify the installed system components against design
specification and manufacturing requirements. The Operational Qualification will verify the
functional characteristics of the system and its components. System functionality will be tested and
challenged against process and design criteria. The Operational Qualification activities will
demonstrate that Strip Printer XXXX has the capability of printing weight of data. This protocol
covers the Installation and Operational Qualification activities for the Strip Printer XXXX.
REFERENCES
This Qualification Protocol was generated following and guided by current approved Standard Operating
XXXXX and XXXXXX
Table No. 1: Reference Documents
Document Type Title Approval Date Source
User
Requirements
Form
Design
Qualification
Report
Strip Printer
Manual
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1.0 INTRODUCTION (continued)

RESPONSIBILITIES
The responsibility for the qualification activities at XXX XXXXXX resides in the XXXXXXX. However,
other departments have some responsibility also for the activities related to qualification, depending
on their roles in regards to the Qualification Program. Roles and Responsibilities for the qualification
activities at XXX XXXXXX are contained in XXXXXXXXX
METHODOLOGY
All tests will be conducted following the procedures established in this Qualification Protocol. The results
obtained during the execution of the tests will be properly documented. Each step of the test procedures
will be initialed and dated as completed. Upon execution completion of each test, it must be indicated
whether the test acceptance criteria have been met or not, in the space provided.
Critical parameter measurements taken during the execution of the Qualification Protocol must be
performed using a calibrated instrument. Copy of the calibration certificate must be included in the
appendix section of this Qualification Protocol.
The Comments Section included in each Data Collection Form shall be used to describe any additional
information and/or reference data considered of importance during the qualification execution. All data
obtained and documented in the Qualification Protocol will be reviewed by a second person to assure
adequate documentation.
1.6.1 Discrepancy Reports

If any result obtained deviates from the acceptance criteria, it must be immediately communicated
to the involved XXX departments and documented in a Discrepancy Report Form, which remains
as part of XXXXXXX. The Discrepancy Report must be provided with a clear description of the
discrepancy/variation (including the IOQ Protocol test name and number), impact to the
qualification exercises, resulting investigation, resolution and/or applicable corrective action. All
discrepancy generated during the qualification exercises will be properly documented,
investigated and resolved.
1.6.2 Final Summary Report
Upon completion of the Protocol execution, a Final Summary Report must be generated and
approved. The Final Summary Report will consist of a discussion of the results obtained for the
different tests contained in the Qualification Protocol, an evaluation of these results against the
corresponding acceptance criteria, discussion of the discrepancies encountered during the
Qualification Protocol execution and their respective resolutions, and a conclusion in regards to
the final disposition of the executed Qualification Protocol. The Final Summary Report will be
circulated for approval to the assigned department personnel in Section 1.5 “Responsibilities” of
this document. Approval of the Final Summary Report will indicate that the executed Qualification
Protocol has been successfully completed and that any applicable discrepancy has been properly
resolved, and the associated data has been reviewed and approved as complete and accurate.
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1.6 METHODOLOGY (continued)
1.6.4 Data Collection
• Data collected and comments made while conducting the different tests contained in this
Qualification Protocol will be recorded on the appropriate data sheets.
• All entries should be recorded and dated legible following the SOP No. XXXXXXXX
• All data sheets should be signed and dated by the person recording the data and reviewed
by another person, who by signing affirms the accuracy and completeness of the data.
• Any space that is intentionally left in blank on any data sheet because it does not apply,
should be filled with “N/A”, initialized and dated.
• Any discrepancy to the Qualification Protocol procedure or out-of-specification result should
be documented in a Discrepancy Report Form and listed on the Discrepancy Log Form in
Attachment No.1.
• Summarize findings of any extraordinary conditions or special cases on the appropriate data
sheet entries.
• When more than one sheet of any test is required, replicate as many times as necessary but
uniquely identify each one.
• All entries should be verified by visual examination of the system. If visual examination is
not possible, use the Verification Procedures listed in Section 1.6.5, Table No. 2 “Codes and
Abbreviations” on the following page to specify how the entry was verified.
• Corrections to entries must be crossed out with a single line, explained, initialized and dated.
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1.6 METHODOLOGY (continued)
1.6.5 Codes and Abbreviations
The codes and abbreviations that are used throughout the Qualification Protocol are listed in the
following table (Table No.2), along with their meaning or definitions:
Table No. 2: Codes and Abbreviations
Verification
Description
Method
AUDIT Verification of the information in the documents
SPEC Specification from vendor and/or XXXXXX, Inc.
TEST Physical test that will be described under comments
Field Verified, Information Specified will be recorded as found during
VISUAL
field verification
PLATE Information obtained from nameplate, plate or sticker attached
Abbreviations Description
cGMP current Good Manufacturing Practices
C&Q Commissioning & Qualification
DEPT. Department
Doc Document
DQ Design Qualification
FLA Full Load Amperage
GDP Good Documentation Practices
Hz Hertz
ID Identification
IOQ, IQ/OQ Installation and Operational Qualification
Kg , KG, kg Kilograms
Lbs Pounds
Max. Maximum
N/A Not Applicable
N/Av Not Available
N/R Not Required
N/S Not Specified
NLT No Less Than
NMT No More Than
No. Number
QA Quality Assurance
RS232 Recommended Standard 232
S/N Serial Number
SOP Standard Operating Procedure
URF User Requirements Form
VAC Volts of Alternating Current
VDC Volts of Direct Current
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SYSTEM DESCRIPTION
1.7.1 General Description

The Strip Printer XXXX is a Epson Model TMU-220 compact printer which has the following
features:
• Drop-in auto loading of paper – Paper will thread automatically once it is inserted in the paper slot.
• Ribbon cassette – Snap-in endless loop cartridge
• Paper roll – Paper is friction fed.
• Power supply – Universal
• Near-end sensor – Will detect when the printer is low on paper.
• Paper-out sensor – Will detect when the printer is out of paper.
Figure 1: Epson Strip Printer TMU-220

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2.0 INSTALLATION QUALIFICATION
This section will provide documented evidence that the Strip Printer XXXX is installed in accordance to XXXXXX,
Inc. specifications and cGMP requirements. In addition, this section will verify that the necessary documentation
for the installation and maintenance of the equipment is correct and available.
The Installation Qualification consists of the following:
2.1. Documentation Verification Test

2.2. Equipment and Major Components Verification Test
2.3. Serial Interfaces DIP Switches Verification Test
2.4. Utilities Verification Test
2.5. Spare Parts List Verification Test
Note: The Strip Printer XXXX is a portable instrument that requires no particular service or
maintenance. Therefore, the Drawing Verification Test, Preventive Maintenance Program
(MXES) Verification Test, Material of Construction Verification Test, Instrument Calibration
Verification Test, and Lubricant Verification Test recommended by the SOP XXXXXXXX, do not
apply to this Qualification Protocol.
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2.0 INSTALLATION QUALIFICATION (continued)
2.1 Documentation Verification Test
Objective
The objective of this test is to verify that the necessary documentation (e.g. Manuals, Purchase
Orders, Change Control, Certifications, etc.) for the Strip Printer XXXX is available, correct, complete,
and properly identified.
Procedure
1. Fill out the information in the Data Collection Forms as applicable with the type of document
entered.
2. Include copy of documentation or document the location were it is stored in the Appendix
Section.
3. In case that the acceptance criteria are not met, develop and approve the corresponding
discrepancy report that applies to this section.
4. Use the “Comments” section to document any discrepancy variances or unexpected results.
5. Sign and Date the manual entries.
Reference
N/A
Acceptance Criteria
The documentation obtained must be in accordance with Strip Printer XXXX installed in XXXXXX,
Inc. XXXXX Plant. The documents must be properly identified, available, accurate and complete.
Copy of the related documentation must be included in the Appendix Section or if it is not possible,
the document location must be properly referenced in the protocol.
Summary of Results
Appendix No.: __________

Discrepancy: Yes/No __________
Discrepancy Report No.: __________
Acceptance Criteria Met: Yes/No __________
Initials/Date: ____________________
Reviewed by/Date ____________________
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2.1 Documentation Verification Test (continued) Page ___ of ___

DATA COLLECTION FORM
As Found Acceptance
Document Performed
Originator Title Criteria Met?
Approval Location By/Date
Revision Yes/No
Date
Documentation included in Appendix Number:______
Comments:
Reviewed By: Date:
Note: Make copies as deemed necessary

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2.2 Equipment and Major Components Verification Test
Objective
The objective of this exercise is to record in the protocol the actual identification information
pertaining to the Strip Printer XXXX being qualified and its major components. It is also an
objective of this test to verify if the system and its major components meet the required
specifications.
Procedure
1. Fill out the Data Collection Forms in the pages that follow with the required information
pertaining to the Strip Printer XXXX and its major components.
2. Include the verification method utilized to obtain the required information, using the
Verification Method Codes listed in Section 1.6.5, “Codes and Abbreviations”, of this IOQ
Protocol document.
3. Information specified, as “Field Verification” will be recorded as found during field
verification and/or execution.
5. Use the “Comments” Section in each table to document any discrepancies or unexpected
result.
6. Include the test reference documentation in the Appendix Section.
References
N/A
Acceptance Criteria
The required identification information pertaining to the Strip Printer XXXX and its major
components must be available and properly documented in the Data Collection Forms, as
applicable. The Actual Results must match the Specifications pre-established in the document.
Test supporting documents (if applicable) must be included in the Appendix section.
Summary of Results

Initials/Date: ____________________
Reviewed By/Date: ____________________
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2.0 INSTALLATION QUALIFICATION, (continued)
2.2 Equipment and Major Components Verification Test (continued)

Actual Results
Verification met Performed
Description Specifications Actual Results
Method specifications? By/Date
Yes/No
Equipment Name: Strip Printer XXXX
Model No. TMU-220
Serial No. Field
Location XXXXX
XXX Tag No. XXXX

Manufacturer
Epson
Information
Power 100-240 VAC / 50-60 Hz
Supporting Documentation included in Appendix No.:
Comments:
Reviewed By Date
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2.2 Equipment and Major Components Verification Test (continued)

Actual Results
Description Specifications Actual Results
Yes/No
Equipment Name: Strip Printer XXXX (continued)
Cartridge Black Ribbon Cassette
Paper Type: Roll

Connection interface cable
Cable
between printer and scale
RS232 serial communication
Interface
port
24 VDC Power Supply with

AC Adapter an input voltage of
110 / 220 VAC
Supporting Documentation included in Appendix No.:
Comments:
Reviewed By Date
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2.3 Serial Interface DIP-Switches Configuration Verification Test
Objective
The objective of this test is to verify and confirm that Serial Interface DIP-Switches settings are in
accordance to manufacturer specifications and actual equipment configuration to comply with
XXXXXX Inc. requirements.
Procedure
1. Verify and document the DIP-Switches settings according to the Data Collection Form.
Note: The numbers starting with 1 in the Data Collection Form are in the first set (DIP
Switch Set 1), and numbers starting with 2 are in the second set (DIP Switch set 2)
2. Sign and date the manual entries
References
TMU-220 Ticket Printer User’s Guide
Acceptance Criteria
The Ticket Printer Epson TMU-220, Serial Interface DIP-Switch setting must be in accordance with
manufacturer specifications as stated in the test data collection form.
Summary of Results

Initials/Date: ____________________
Reviewed By/Date: ____________________
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2.3 Serial Interface DIP-Switches Configurarion Verification Test (continued)

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Acceptance
Actual
DIP-Switch Set No. 1 Specification Criteria met? Verified By / Date
Results
(Yes/No)
1-1 OFF
1-2 OFF
1-3 ON
1-4 ON
1-5 ON
1-6 ON
1-7 OFF
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1-8 OFF
Comments:
Reviewed By Date
2.3 Serial Interface DIP-Switches Configurarion Verification Test (continued)

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Acceptance
Actual
DIP-Switch Set No. 2 Specification Criteria met? Verified By / Date
Results
(Yes/No)
2-1 OFF
2-2 OFF
2-3 OFF
2-4 FIELD
2-5 OFF
2-6 OFF
2-7 OFF
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2-8 OFF
Comments:
Reviewed By Date
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2.0 INSTALLATION QUALIFICATION; (continued)
2.4 Utilities Verification Test

Objective
The objective of this verification is to assure that the utilities required for the proper operation of the
Strip Printer XXXX are provided according to the equipment manufacturer and XXXXXX, Inc.
specifications.
Procedure
1. Fill out the information in the Data Collection Form, including the verification method used to
obtain the required information. For this purpose, use the Verification Method Codes listed in
Section 1.6.5, “Codes and Abbreviations”, of this protocol.
2. For pressure measurements used a calibrated instrument and include copy of the calibration
certifications in Appendix Section.
3. Sign and date the manual entries.
4. Sign and date the “Performed By:” section for each item in the table. After each table is
complete an authorized second person will review, sign and date, the “Reviewed By:” section
at the bottom of the page.
result.
References
N/A
Acceptance Criteria
The utilities required by the Strip Printer XXXX must be supplied within the equipment manufacturer
and XXXXXX, Inc specifications.
Summary of Results

Initials/Date: ____________________
Reviewed By/Date: ____________________
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2.4 Utilities Verification Test - Electrical (continued)

Strip Printer XXXX – Electrical Verification
Actual Results
Parameter Specifications Actual
(Yes/No)
Voltage
110 VAC ±10%
Requested
Amperage FIELD
Frequency 60 Hz ±5%
Additional information
Reference/ Test Instrument:
Electrical receptacle identification:
Circuit breaker location:
Performed By (Electrician): Date: License No.:
Calibration certificates are included in Appendix Number:
Comments:
Reviewed By Date
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2.5 Spare Parts List Verification Test
Objective
The objective of this exercise is to document all the spare parts needed to assure adequate
maintenance of the Strip Printer XXXX and to document the accessibility of any spare parts in the
plant.
Procedure
1. Fill out the information in the Data Collection Form.
2. Verify that an itemized spare parts list is available from the manufacturer to support the
operation of the equipment.
3. Include a copy of the spare parts list for the Weight Sorter System in the Appendix Section.
4. Sign and date the “Performed By:” section for each item in the table. After each table is
complete an authorized second person will review, sign and date, the “Reviewed By:” section at
the bottom of the page.
result.
References
SADE SP Technical Folder
Acceptance Criteria
There must be a recommended spare parts list available in the Plant for equipment operation
and/or maintenance. Copy of the recommended this spare parts list must be included in the
Appendix Section.
Summary of Results

Initials/Date: ____________________
Reviewed By/Date: ____________________
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2.5 Spare Part List Verification Test (continued)

Spare Parts List Acceptance

Verification Performed
Description Asset Number Available? Criteria
Method By / Date
Yes/No meet? (Y/N)
Copy of the Spare Part List (MXES) print-out) is included in Appendix _____
Comments:
Reviewed By: Date:

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3.0 INSTALLATION QUALIFICATION COMPLETION VERIFICATION
This section is to confirm that all sections contained in the Installation Qualification had been completed.
All Installation Qualification Sections Completed: Yes/No _________________

All Acceptance Criteria Met: Yes/No _________________
Proceed with the Operational Qualification Section: Yes/No _________________
Pending item after Installation Qualification execution: Yes/ No _________________
(if Yes, explain reason in Comments/Observations/Conclusions Section)
Comments/Observations/Conclusions:
Department Printed Name Signature Date

Protocol Reviewer or Designee:
(Designee Title:__________________)
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4.0 OPERATIONAL QUALIFICATION
The purpose of this section is to assure that the Strip Printer XXXX operates in accordance to the system
manufacturer recommendations, XXXXXX, Inc. specifications and cGMP’s requirements. IQ disposition approval
must be performed prior to start the execution of this section.
The Operational Qualification consists of the following:
4.1 Standard Operating Procedures and Training Verification Test
4.2 Button/Switch/Lights Verification Test
4.3 Power Loss and Recovery Verification Test
4.4 System Operation Verification Test

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4.0 OPERATIONAL QUALIFICATION (continued)

4.1 Standard Operating Procedures and Training Verification Test
Objective
The objective of this exercise is to assure that all the necessary procedures and training related to the
Strip Printer XXXX are available, correct and approved.
Procedure
2. Document and Review each procedure related to the Strip Printer XXXX
3. Include training records of the most current SOP revision on this section.
4. Include copy of procedure first and approval page and training evidence in the Appendix Section.
Reference
N/A
Acceptance Criteria
The necessary procedures must be correct, available and approved for the use of the Strip Printer XXXX.
Personnel related to the use of the procedures must be trained in the applicable SOP’s. Copy of the first
page and approval sections of the SOP’s with their corresponding training evidence must be included in
the Appendix Section.
Summary of Results
Initials/Date: ____________________
Reviewed by/Date ____________________

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4.1 Standard Operating Procedures and Training Verification Test (continued))

Page_____ of _____
Training As Found Approval Acceptance

Evidence Performed
Procedure Number Title Criteria Met?
included? By/Date
Date Version Yes/No
(Yes/No)
SOP(s) first and approval pages and training evidence (if applicable) are included in Appendix Number:
Note: Make copies of this sheet as deemed necessary.
Comments:
Reviewed By: Date:

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4.0 OPERATIONAL QUALIFICATION (Continued)
4.2 Button/Switch/Lights Verification Test

Objective
The objective of this test is to verify that all buttons, switches, and lights required for the operation
of the Strip Printer XXXX, operate in accordance with manufacturer and XXXXXX, Inc.
specifications, as applicable.
Procedure

2. Document the results and compare against the Specifications
Reference
N/A
Acceptance Criteria
All buttons, switches, and lights required for the operation of the Strip Printer XXXX must operate in
accordance with manufacturer and XXXXXX, Inc. specifications, as applicable
Summary of Results
Initials/Date: ____________________
Reviewed By/Date: ____________________

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4.2 Buttons/Switch/Lights Verification Test (continued)
Button / Actual results

Performed
Switch /Lights Step Procedure Expected Results Actual Result met expected
By/Date
Description results? (Y/N)
Printer was
Printer is energized and the __________.
Turn the power switch to the
1 green POWER light is
ON position. Green Power light
illuminated.
ON/OFF Power was _____________.
Switch Printer was
Printer is de-energized.and _________.
2 the green POWER light turns
OFF position Green Power light
off.
was _____________.
Paper __________
1 ON position. Press the Paper advance one line
one line.
“PAPER FEED” button once
FEED button
Press and hold down the Paper ________
2 Paper must feed continuously
“PAPER FEED” button continuously.
Comments:
Reviewed by: Date:

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4.2 Buttons/Switch/Lights Verification Test (continued)
Button / Actual results

Performed
Switch /Lights Step Procedure Expected Results Actual Result met expected
By/Date
Description results? (Y/N)

Red PAPER OUT
ON position. Press the Red PAPER OUT light is
1 light was
PAPER OUT “PAPER FEED” button until illuminated.
____________
Light the paper roll is near the end.
and
Red PAPER OUT
ERROR Light Red PAPER OUT and Red and Red ERROR
2 ON position with no paper in
ERROR light are illuminated. light were
the ticket printer.
_______________.
Comments:
Reviewed by: Date:

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4.3 Power Loss and Recovery Verification Test

Objective
The objective of this test is to verify the proper operation of the Strip Printer XXXX in a power loss
situation and upon power restoration..
Procedure

2. Document the results and compare against the Expected Results.
3. After each table is complete an authorized second person will review, sign and date, the
“Reviewed By:” section at the bottom of the page.
result.
Reference
N/A
Acceptance Criteria
The system operation must be in accordance with manufacturer specifications and expected
results for the test. In the event of a power loss, the printer must stop all current functions. The
machine must be capable to resume operation once the power is restored.
Summary of Results
Initials/Date: ____________________
Reviewed By/Date: ____________________

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4.3 Power Loss and Recovery Verification Test (continued)
Strip Printer XXXX

Actual Results met
Performed
Operation Procedure Test Expected Response Actual Results Expected
By/Date
Response? (Y/N)
Start Time: ______________
After power is lost, the system

During normal operation, After power is lost, the ____________ , and the process
interrupt the power supply system shuts off, and the
____________. Then, further
to the equipment. Wait at process stops. Then, no
Power Loss operation ____________ possible.
least 5 minutes and further operation should
and
restore the power supply be possible. After After restoring the power, the
Recovery
to the equipment. restoring the power, the
system ____________ able to start
Document the start and system must be able to
end time of the test. start operation. operation.
End Time: ______________
Comments:
Reviewed by: Date:

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4.4 Ticket Printer System Verification Test

Objective
The objective of this exercise is to verify the operation of the Ticket Printer XXXX interfacing with
the Epson Weighing terminal IND560 and also with the Epson Weighing Terminal LYNX by
simulating normal operating conditions
Procedure

2. Verify the Ticket Printer Epson TMU-220 operation by simulating a normal operating sequence.
Reference
1. TMU-220 Ticket Printer User’s Guide

2. IND560 Terminal User’s Guide
3. LYNX Terminal User’s Guide
Acceptance Criteria
The Ticket Printer Epson TMU-220 must interface with the Epson Weighing Terminal IND560 &
Epson Weighing Terminal LYNX and operate as specified in the expected response.
Summary of Results
Initials/Date: ____________________
Reviewed By/Date: ____________________

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4.4 Ticket Printer System Verification Test (continued)
Actual Results met
Verification with Expected Performed
Steps Test Procedure Expected Response Actual Results
Method Response? By/Date:
Yes/No
Epson Weighing Terminal IND560
The balance and the

Switch the digital scale and The balance and the printer
1 printer ____
the ticket Printer “ON”. energize.
energized.
The scale ________

2 Press Zero key “ ” in The scale resets to 0.000 kg.
to 0.000 kg
the digital scale screen.
The empty container weight

Empty Container
Place an empty container on is displayed on the digital
3 Displayed Weight:
the Digital Scale. scale indicator. Document
___________ kg
weight.
Display (at digital

The display (at digital scale
scale screen) ____
screen) is reset to 0.000 kg.
4 Press Tare key “ ”in to 0.000 kg and Net
and Net symbol appears in
the digital scale screen. symbol _______ in
screen.
the screen.
Comments:
Reviewed by: Date:

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Actual Results
met with
Performed
Steps Procedure Expected Response Actual Results Verification Method Expected
By/Date:
Response?
Yes/No
Epson Weighing Terminal IND560
The net weight is displayed

Net Weight Displayed:
on the digital scale
5 Fill the container.
indicator. Document
___________ kg
weight.
Gross Weight:
Insert a paper slip at _________
The Ticket Printer TMU-
Ticket Printer and press The Ticket Printer TMU-220
220 ______ gross weight,
6 prints gross weight, Tara Tara: _________
Tara and net weight
print key “ ” at the and net weight output data.
output data.
scale screen. Net Weight: _________
The weight data displayed The weight data
in the scale screen is displayed in the scale
identical to the printed data screen ____ identical to
Verify the printed data in the inserted ticket. The the printed data in the
7
in the inserted slip. date/hour is printed in the inserted ticket. The
inserted slip. date/hour ____ printed in
the inserted slip.
Comments:
Reviewed by: Date:

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Actual Results met
Yes/No
Epson Weighing Terminal 8530
The balance and the

1 printer ____
energized.
The scale ________

2 Press Zero key “ ” in The scale resets to 0.000 kg.
to 0.000 kg

Empty Container
3 Displayed Weight:
___________ kg
weight.
Display (at digital

scale screen) ____
4 to 0.000 kg and Net
Press Tare key “ ”in and Net symbol appears in
symbol _______ in
the digital scale screen. screen.
the screen.
Comments:
Reviewed by: Date:

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Actual Results
met with
Performed
By/Date:
Response?
Yes/No
Epson Weighing Terminal 8530

indicator. Document
___________ kg
weight.
Gross Weight:
Insert a paper slip at
_________
Ticket Printer and press The Ticket Printer TMU-
The Ticket Printer TMU-220
Tara and net weight
and net weight output data.
Enter key “ ” at output data.
Net Weight: _________
the scale screen.

Verify the printed data
7 in the inserted ticket. The the printed data in the
in the inserted slip.
date/hour is printed in the inserted ticket. The
the inserted slip.
Comments:
Reviewed by: Date:

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Actual Results met
Yes/No
Epson Weighing Terminal LYNX
The balance and the

1 printer ____
energized.
The scale ________

2 The scale resets to 0.000 kg.
Press Zero key “ ” in to 0.000 kg
Empty Container
3 Displayed Weight:
___________ kg
weight.
Display (at digital

scale screen) ____
4 to 0.000 kg and Net
Press Tare key “ ”in and Net symbol appears in
symbol _______ in
the digital scale screen. screen.
the screen.
Comments:
Reviewed by: Date:

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Actual Results
met with
Performed
By/Date:
Response?
Yes/No
Epson Weighing Terminal LYNX

indicator. Document
___________ kg
weight.
Gross Weight:
Insert a paper slip at
_________
Ticket Printer and press The Ticket Printer TMU-
The Ticket Printer TMU-220
Tara and net weight
and net weight output data.
Enter key “ ” at output data.
Net Weight: _________
the scale screen.
Verify the printed data in the inserted ticket. The the printed data in the
7
in the inserted slip. date/hour is printed in the inserted ticket. The
the inserted slip.
Comments:
Reviewed by: Date:

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5.0 QUALIFICATION DISPOSITION
Upon review of this executed IOQ Protocol including certifications and other records (where applicable), the C&Q
department is recommending that:
This Protocol has been completed. The Strip Printer XXXX is considered:
_____ Qualified
_____ Not Qualified
_____ Other (Explain in Comments, Observations, Conclusions)
Comments/Observations/Conclusions:
Business Area Printed Name Signature Date

Reviewer Section
Protocol Reviewer or Designee:
(Designee Title:__________________)
Management Approval Section

System Custodian or Designee:
(Designee Title:__________________)
System Owner or Designee

(Designee Title:_________________)
Quality Assurance Unit
(Designee Title:_______________)
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6.0 ATTACHMENTS
Page _____ of _____
Attachment No. 1: Discrepancy Log Form
Discrepancy
No. Qualification Protocol Section: Protocol Page Originated By/Date

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6.0 ATTACHMENTS (continued)
Attachment No. 2: Test or Reference Instruments List

Page ____ of ____
Record all test or reference instruments used during the execution of this qualification protocol.
Performed
Description Section Used Asset Number Calibration Date Calibration Due Date
By/Date
Calibration Certification are included in Appendix Number:
Comments:
Reviewed by: Date:

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6.0 ATTACHMENTS, (continued)
Attachment No. 3: Signature Identification Log Sheet

This log sheet is a record of each individual who signs or initials any page included in this qualification document.
Each person shall be identified by writing his/her name, initials, full signature, and department or company
represented. Anyone who signs or initials any location in this protocol (other than the approvals pages) shall fill in
the data requested below.
Print Name Signature Initials Department or

Company
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7.0 APPENDIX
Appendix Number Description

IOQ Protocol for Strip Printer XXXX

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Informasi Dokumen

Deskripsi Asli:

Judul Asli

Hak Cipta

Format Tersedia

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Format Tersedia

IOQ Protocol for Strip Printer XXXX

Diunggah oleh

Hak Cipta:

Format Tersedia

Installation/Operational Qualification (IOQ) Protocol

for the Strip Printer XXXX

This document requires the electronic approval of the following roles:

Subject Matter Expert:

SCOPE AND QUALIFICATION APPROACH RATIONALE

Document Type Title Approval Date Source

1.0 INTRODUCTION (continued)

1.6.1 Discrepancy Reports

1.6.2 Final Summary Report

1.0 INTRODUCTION (continued)

1.6.4 Data Collection

1.0 INTRODUCTION (continued)

1.0 INTRODUCTION (continued)

1.7.1 General Description

Figure 1: Epson Strip Printer TMU-220

2.0 INSTALLATION QUALIFICATION

The Installation Qualification consists of the following:

2.1. Documentation Verification Test

2.0 INSTALLATION QUALIFICATION (continued)

2.1 Documentation Verification Test

Appendix No.: __________

2.0 INSTALLATION QUALIFICATION (continued)

2.1 Documentation Verification Test (continued) Page ___ of ___

Documentation included in Appendix Number:______

Reviewed By: Date:

Note: Make copies as deemed necessary

2.0 INSTALLATION QUALIFICATION (continued)

2.2 Equipment and Major Components Verification Test

Appendix No.: __________

2.0 INSTALLATION QUALIFICATION, (continued)

2.2 Equipment and Major Components Verification Test (continued)

Equipment Name: Strip Printer XXXX

Model No. TMU-220

Serial No. Field

XXX Tag No. XXXX

Supporting Documentation included in Appendix No.:

2.0 INSTALLATION QUALIFICATION, (continued)

2.2 Equipment and Major Components Verification Test (continued)

Equipment Name: Strip Printer XXXX (continued)

Cartridge Black Ribbon Cassette

Paper Type: Roll

24 VDC Power Supply with

Supporting Documentation included in Appendix No.:

2.0 INSTALLATION QUALIFICATION (continued)

2. Sign and date the manual entries

Appendix No.: __________

2.0 INSTALLATION QUALIFICATION (continued)

2.3 Serial Interface DIP-Switches Configurarion Verification Test (continued)

DATA COLLECTION FORM

2.0 INSTALLATION QUALIFICATION (continued)

2.3 Serial Interface DIP-Switches Configurarion Verification Test (continued)

DATA COLLECTION FORM

2.0 INSTALLATION QUALIFICATION; (continued)

2.4 Utilities Verification Test

Appendix No.: __________

2.0 INSTALLATION QUALIFICATION, (continued)

2.4 Utilities Verification Test - Electrical (continued)

Strip Printer XXXX – Electrical Verification

Reference/ Test Instrument:

Electrical receptacle identification:

Circuit breaker location:

Performed By (Electrician): Date: License No.:

2.1 Documentation Verification Test (continued) Page _ of _