Strip Printer IOQ

Installation/Operational Qualification (IOQ) Protocol
for the Strip Printer XXXX
Document Version: 0

DOCUMENT
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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
1.0
2.0
INTRODUCTION.................................................................................................................................. 4
1.1
PURPOSE.................................................................................................................................. 4
1.2
OBJECTIVE................................................................................................................................ 4
1.3
SCOPE AND QUALIFICATION APPROACH RATIONALE.........................................................4
1.4
REFERENCES........................................................................................................................... 4
1.5
RESPONSIBILITIES................................................................................................................... 5
1.6
METHODOLOGY....................................................................................................................... 5
1.7
SYSTEM DESCRIPTION........................................................................................................... 8
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.............................................................................................................. 18
2.5
Spare Parts List Verification Test................................................................................................ 20
3.0
INSTALLATION QUALIFICATION COMPLETION VERIFICATION......................................................22
4.0
OPERATIONAL QUALIFICATION........................................................................................................ 23
4.1
Standard Operating Procedures and Training Verification Test..................................................24
4.2
Button/Switch/Lights Verification Test.........................................................................................26
4.3
Power Loss and Recovery Verification Test................................................................................29
4.4
Ticket Printer System Verification Test........................................................................................31
5.0
QUALIFICATION DISPOSITION.......................................................................................................... 36
6.0
ATTACHMENTS................................................................................................................................... 37
Attachment No. 1: Discrepancy Log Form............................................................................................37
Attachment No. 2: Test or Reference Instruments List.........................................................................38
Attachment No. 3: Signature Identification Log Sheet..........................................................................39
7.0
APPENDIX........................................................................................................................................... 40

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INTRODUCTION
1.1
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 manufacturers recommendations, XXXXXX, Inc. user
requirements and specifications, and cGMPs requirements. .
1.2
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 cGMPs
requirements under the authorization of Change Control XXXXXXX.
1.3
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.
1.4
REFERENCES
This Qualification Protocol was generated following and guided by current approved Standard Operating
XXXXX and XXXXXX
Table No. 1: Reference Documents
Document Type
User
Requirements
Form
Design
Qualification
Report
Strip Printer
Manual
Title
Approval Date
Source

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INTRODUCTION (continued)
1.5
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
1.6
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
Method
AUDIT
SPEC
TEST
VISUAL
PLATE
Abbreviations
cGMP
C&Q
DEPT.
Doc
DQ
FLA
GDP
Hz
ID
IOQ, IQ/OQ
Kg , KG, kg
Lbs
Max.
N/A
N/Av
N/R
N/S
NLT
NMT
No.
QA
RS232
S/N
SOP
URF
VAC
VDC
Description
Verification of the information in the documents
Specification from vendor and/or XXXXXX, Inc.
Physical test that will be described under comments
Field Verified, Information Specified will be recorded as found during
field verification
Information obtained from nameplate, plate or sticker attached
Description
current Good Manufacturing Practices
Commissioning & Qualification
Department
Document
Design Qualification
Full Load Amperage
Good Documentation Practices
Hertz
Identification
Installation and Operational Qualification
Kilograms
Pounds
Maximum
Not Applicable
Not Available
Not Required
Not Specified
No Less Than
No More Than
Number
Quality Assurance
Recommended Standard 232
Serial Number
Standard Operating Procedure
User Requirements Form
Volts of Alternating Current
Volts of Direct Current

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1.1
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:
Note:
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

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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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.
2.
3.
4.
5.
Fill out the information in the Data Collection Forms as applicable with the type of document
entered.
Include copy of documentation or document the location were it is stored in the Appendix
Section.
In case that the acceptance criteria are not met, develop and approve the corresponding
discrepancy report that applies to this section.
Use the Comments section to document any discrepancy variances or unexpected results.
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
Originator
Title
Approval
Date
Revision
Document
Location
Acceptance
Criteria Met?
Yes/No
Documentation included in Appendix Number:______

Comments:
Reviewed By:
Note: Make copies as deemed necessary
Date:
Performed
By/Date

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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.
4. Sign and Date the manual entries.
5. Use the Comments Section in each table to document any discrepancies or unexpected
result.
6. Include the test reference documentation in the Section 10.0 - Appendix Section.
7. In case that the acceptance criteria are not met, develop and approve the corresponding
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 Aappendix section.
Summary of Results
Appendix No.:
__________
Discrepancy: Yes/No
__________
__________
__________
Initials/Date:
____________________
Reviewed By/Date:
____________________

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INSTALLATION QUALIFICATION, (continued)

2.2
Equipment and Major Components Verification Test (continued)

Description
Specifications
Actual Results
Verification
Method
Actual Results
met
specifications?
Yes/No
Equipment Name: Strip Printer XXXX

Model No.
TMU-220
Serial No.
Field
Location
XXXXX
XXX Tag No.
XXXX
Manufacturer
Information
Epson
Power
100-240 VAC / 50-60 Hz

Supporting Documentation included in Appendix No.:
Comments:
Reviewed By
Date
Performed
By/Date

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2.2
Equipment and Major Components Verification Test (continued)

Description
Specifications
Actual Results
Verification
Method
Actual Results
met
specifications?
Yes/No
Equipment Name: Strip Printer XXXX (continued)

Cartridge
Black Ribbon Cassette
Paper
Type: Roll
Cable
Connection interface cable

between printer and scale
Interface
AC Adapter
RS232 serial communication

port
24 VDC Power Supply with
an input voltage of
110 / 220 VAC
Supporting Documentation included in Appendix No.:
Comments:
Reviewed By
Date
Performed
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 Users 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
Appendix No.:
__________
Discrepancy: Yes/No
__________
__________
__________
Initials/Date:
____________________
Reviewed By/Date:
____________________

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INSTALLATION QUALIFICATION (continued)QUALIFICATION (continued)

2.3
Serial Interface DIP-Switches Configurarion Verification Test (continued)
2.0
2.8
System Instrumentation Verification Test (continued)

Page _____ of _____DATA COLLECTION FORM

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2.8

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NIST Standards? (Yes/No)
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Calibration Certification is included in Appendix Number: ___________
Note: Make copies of this sheet as deemed necessary.
Comme
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D
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e:
Review
ed By:
DIP-Switch Set No. 1
Specification
1-1
OFF
Actual
Results
Acceptance
Criteria met?
(Yes/No)
Verified By / Date

1-2
OFF
1-3
ON
1-4
ON
1-5
ON
1-6
ON
1-7
OFF
1-8
OFF
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Comments:
Reviewed By
2.0
Date
INSTALLATION QUALIFICATION (continued)QUALIFICATION (continued)

2.3
Serial Interface DIP-Switches Configurarion Verification Test (continued)
2.0
2.8

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using NIST Standards?
(Yes/No)
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Calibration Certification is included in Appendix Number: ___________
Comm
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Review
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D
at
e:

DIP-Switch Set No. 2
Specification
2-1
OFF
2-2
OFF
2-3
OFF
2-4
FIELD
2-5
OFF
2-6
OFF
2-7
OFF
2-8
OFF
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Actual
Results
Acceptance
Criteria met?
(Yes/No)
Comments:
Reviewed By
Date
Verified By / Date

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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
Appendix No.:
__________
Discrepancy: Yes/No
__________
__________
__________
Initials/Date:
____________________
Reviewed By/Date:
____________________

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2.4
Utilities Verification Test - Electrical (continued)

Strip Printer XXXX Electrical Verification
Parameter
Specifications
Voltage
Requested
110 VAC 10%
Amperage
FIELD
Frequency
60 Hz 5%
Verification
Method
Actual
Actual Results
met
specifications?
(Yes/No)
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
Performed
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
Appendix No.:
__________
Discrepancy: Yes/No
__________
__________
__________
Initials/Date:
____________________
Reviewed By/Date:
____________________

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2.5
Spare Part List Verification Test (continued)

Description
Asset Number
Spare Parts List

Available?
Yes/No
Verification
Method
Acceptance
Criteria
meet? (Y/N)
Copy of the Spare Part List (MXES) print-out) is included in Appendix _____
Comments:
Reviewed By:
Date:
Performed
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
Protocol Reviewer or Designee:
(Designee Title:__________________)
Printed Name
Signature
Date

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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 cGMPs 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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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 SOPs. Copy of the first
page and approval sections of the SOPs with their corresponding training evidence must be included in
the Appendix Section.
Summary of Results
Appendix No.:
__________
Discrepancy: Yes/No
__________
__________
__________
Initials/Date:
____________________
Reviewed by/Date
____________________

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

Page_____ of _____
Procedure Number
Title
Training
Evidence
included?
(Yes/No)
As Found Approval
Date
Version
SOP(s) first and approval pages and training evidence (if applicable) are included in Appendix Number:
Comments:
Reviewed By:
Date:
Acceptance
Criteria Met?
Yes/No
Performed
By/Date

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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
1.
Fill out the information in the Data Collection Form.
1.
Document the results and compare against the Specifications
2.
Sign and Date the manual entries.
3.
In case that the acceptance criteria are not met, develop and approve the corresponding
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
Appendix No.:
__________
Discrepancy: Yes/No
__________
__________
__________
Initials/Date:
____________________
Reviewed By/Date:
____________________

4.0
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4.2
Buttons/Switch/Lights Verification Test (continued)

Button /
Switch /Lights Step
Description
Procedure
Expected Results
Actual Result
Printer was
__________.
Turn the power switch to the

ON position.
Printer is energized and the

green POWER light is
illuminated.

OFF position
Printer was
Printer is de-energized.and
_________.
the green POWER light turns
Green Power light
off.
was _____________.

ON position. Press the
PAPER FEED button once
Paper advance one line
Paper __________
one line.
Press and hold down the

PAPER FEED button
Paper must feed continuously
Paper ________
continuously.
ON/OFF Power
Switch
FEED button
Green Power light

was _____________.
Comments:
Reviewed by:
Date:
Actual results
met expected
results? (Y/N)
Performed
By/Date

4.0
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4.2
Buttons/Switch/Lights Verification Test (continued)

Button /
Switch /Lights Step
Description
PAPER OUT
Light
Procedure
Expected Results
Actual Result

ON position. Press the
PAPER FEED button until
the paper roll is near the end.
Red PAPER OUT light is

illuminated.
Red PAPER OUT

light was
____________

ON position with no paper in
the ticket printer.
Red PAPER OUT and Red

ERROR light are illuminated.
Red PAPER OUT

and Red ERROR
light were
_______________.
and
ERROR Light
Comments:
Reviewed by:
Date:
Actual results
met expected
results? (Y/N)
Performed
By/Date

4.0
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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.
5. In case that the acceptance criteria are not met, develop and approve the corresponding
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
Appendix No.:
__________
Discrepancy: Yes/No
__________
__________
__________
Initials/Date:
____________________
Reviewed By/Date:
____________________

4.0
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4.3
Power Loss and Recovery Verification Test (continued)

Strip Printer XXXX
Operation
Procedure Test
Expected Response
Actual Results
Actual Results met

Expected
Response? (Y/N)
Start Time: ______________

After power is lost, the system
Power Loss
and
Recovery
During normal operation,

interrupt the power supply
to the equipment. Wait at
least 5 minutes and
restore the power supply
to the equipment.
Document the start and
end time of the test.
After power is lost, the

system shuts off, and the
process stops. Then, no
further operation should
be possible. After
restoring the power, the
system must be able to
start operation.
____________ , and the process

____________. Then, further
operation ____________ possible.
After restoring the power, the
system ____________ able to start
operation.
End Time: ______________
Comments:
Reviewed by:
Date:
Performed
By/Date

4.0
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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 Users Guide
2. IND560 Terminal Users Guide

3. LYNX Terminal Users 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
Appendix No.:
__________
Discrepancy: Yes/No
__________
__________
__________
Initials/Date:
____________________
Reviewed By/Date:
____________________

4.0
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4.4
Ticket Printer System Verification Test (continued)

Steps
Test Procedure
Expected Response
Actual Results
Verification
Method
Actual Results met

with Expected
Response?
Yes/No
Epson Weighing Terminal IND560

1
Switch the digital scale and

the ticket Printer ON.
The balance and the printer

energize.
The balance and the

printer ____
energized.
Press Zero key

in
the digital scale screen.
The scale resets to 0.000 kg.
The scale ________

to 0.000 kg
The empty container weight

is displayed on the digital
scale indicator. Document
weight.
Empty Container
Displayed Weight:
___________ kg
The display (at digital scale

screen) is reset to 0.000 kg.
and Net symbol appears in
screen.
Display (at digital

scale screen) ____
to 0.000 kg and Net
symbol _______ in
the screen.
Place an empty container on

the Digital Scale.
Press Tare key

in
Comments:
Reviewed by:
Date:
Performed
By/Date:

4.0
Version
Page
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4.4

Steps
Procedure
Expected Response
Actual Results
Verification Method
Actual Results
met with
Expected
Response?
Yes/No
Epson Weighing Terminal IND560
Fill the container.
Insert a paper slip at

Ticket Printer and press
6
print key
scale screen.
at the
Verify the printed data

in the inserted slip.
The net weight is displayed

on the digital scale
indicator. Document
weight.
The Ticket Printer TMU-220

prints gross weight, Tara
and net weight output data.
The weight data displayed
in the scale screen is
identical to the printed data
in the inserted ticket. The
date/hour is printed in the
inserted slip.
Net Weight Displayed:

___________ kg
The Ticket Printer TMU220 ______ gross weight,

Tara and net weight
output data.
Gross Weight:
_________
Tara: _________
Net Weight: _________
The weight data

displayed in the scale
screen ____ identical to
the printed data in the
inserted ticket. The
date/hour ____ printed in
the inserted slip.
Comments:
Reviewed by:
Date:
Performed
By/Date:

4.0
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4.4

Steps
Test Procedure
Expected Response
Actual Results
Verification
Method
Actual Results met

with Expected
Response?
Yes/No
Epson Weighing Terminal 8530

1


energize.
The balance and the

printer ____
energized.
Press Zero key

in
The scale ________

to 0.000 kg

weight.
Empty Container
Displayed Weight:
___________ kg

screen.
Display (at digital

scale screen) ____
to 0.000 kg and Net
symbol _______ in
the screen.

the Digital Scale.
Press Tare key

in
Comments:
Reviewed by:
Date:
Performed
By/Date:

4.0
Version
Page
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4.4

Steps
Procedure
Expected Response
Actual Results
Verification Method
Actual Results
met with
Expected
Response?
Yes/No
Epson Weighing Terminal 8530
Fill the container.

6
Enter key
at
the scale screen.


indicator. Document
weight.


inserted slip.

___________ kg

Tara and net weight
output data.
Gross Weight:
_________
Tara: _________
The weight data

the inserted slip.
Comments:
Reviewed by:
Date:
Performed
By/Date:

4.0
Version
Page
41 of 47

4.4

Steps
Test Procedure
Expected Response
Actual Results
Verification
Method
Actual Results met

with Expected
Response?
Yes/No
Epson Weighing Terminal LYNX

1

Press Zero key

in
the Digital Scale.
Press Tare key

in

energize.
The balance and the

printer ____
energized.
The scale ________

to 0.000 kg

weight.
Empty Container
Displayed Weight:
___________ kg

screen.
Display (at digital

scale screen) ____
to 0.000 kg and Net
symbol _______ in
the screen.
Comments:
Reviewed by:
Date:
Performed
By/Date:

4.0
Version
Page
42 of 47

4.4

Steps
Procedure
Expected Response
Actual Results
Verification Method
Actual Results
met with
Expected
Response?
Yes/No
Epson Weighing Terminal LYNX
Fill the container.

6
Enter key
at
the scale screen.


indicator. Document
weight.


inserted slip.

___________ kg

Tara and net weight
output data.
Gross Weight:
_________
Tara: _________
The weight data

the inserted slip.
Comments:
Reviewed by:
Date:
Performed
By/Date:

Version
Page
43 of 47
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
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:_______________)
Signature
Date

Version
Page
44 of 47
6.0 ATTACHMENTS
Page _____ of _____
Attachment No. 1: Discrepancy Log Form
Discrepancy
No.
Qualification Protocol Section:
Protocol Page
Originated By/Date

6.0
Version
Page
45 of 47
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.
Description
Section Used
Asset Number
Calibration Date
Calibration Due Date
Calibration Certification are included in Appendix Number:

Comments:
Reviewed by:
Date:
Performed
By/Date

6.0
Version
Page
46 of 47
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

Version
Page
47 of 47
7.0 APPENDIX
Appendix Number
Description

Strip Printer IOQ

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Installation/Operational Qualification (IOQ) Protocol

for the Strip Printer XXXX

Installation/Operational Qualification (IOQ) Protocol

Installation/Operational Qualification (IOQ) Protocol

SCOPE AND QUALIFICATION APPROACH RATIONALE.........................................................4

Documentation Verification Test.................................................................................................10

Equipment and Major Components Verification Test..................................................................12

Serial Interface DIP-Switches Configuration Verification Test.....................................................15

Utilities Verification Test.............................................................................................................. 18

Spare Parts List Verification Test................................................................................................ 20

INSTALLATION QUALIFICATION COMPLETION VERIFICATION......................................................22

Standard Operating Procedures and Training Verification Test..................................................24

Button/Switch/Lights Verification Test.........................................................................................26

Power Loss and Recovery Verification Test................................................................................29

Ticket Printer System Verification Test........................................................................................31

Installation/Operational Qualification (IOQ) Protocol

SCOPE AND QUALIFICATION APPROACH RATIONALE

Installation/Operational Qualification (IOQ) Protocol

Final Summary Report

Installation/Operational Qualification (IOQ) Protocol

Any discrepancy to the Qualification Protocol procedure or out-of-specification result should

Installation/Operational Qualification (IOQ) Protocol

Installation/Operational Qualification (IOQ) Protocol

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

Installation/Operational Qualification (IOQ) Protocol

2.0 INSTALLATION QUALIFICATION

Documentation Verification Test

Equipment and Major Components Verification Test

Serial Interfaces DIP Switches Verification Test

Utilities Verification Test

Spare Parts List Verification Test

Installation/Operational Qualification (IOQ) Protocol

INSTALLATION QUALIFICATION (continued)

Documentation Verification Test

Discrepancy Report No.:

Acceptance Criteria Met: Yes/No

Installation/Operational Qualification (IOQ) Protocol

INSTALLATION QUALIFICATION (continued)

Documentation Verification Test (continued)

Page ___ of ___

DATA COLLECTION FORM

Documentation included in Appendix Number:______

Installation/Operational Qualification (IOQ) Protocol

INSTALLATION QUALIFICATION (continued)

Equipment and Major Components Verification Test

Discrepancy Report No.:

Acceptance Criteria Met: Yes/No

Installation/Operational Qualification (IOQ) Protocol

INSTALLATION QUALIFICATION, (continued)

Equipment and Major Components Verification Test (continued)

Equipment Name: Strip Printer XXXX

XXX Tag No.

100-240 VAC / 50-60 Hz

Installation/Operational Qualification (IOQ) Protocol

INSTALLATION QUALIFICATION, (continued)

Equipment and Major Components Verification Test (continued)

Equipment Name: Strip Printer XXXX (continued)

Black Ribbon Cassette

Page _ of _