IOQ Protocol- Strip Printer

Installation/Operational Qualification (IOQ) Protocol for the Strip Printer XXXX

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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 CustodianYour 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 OwnerYour 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 AssuranceYour 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 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

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.............................................................................................................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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1.0 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 manufacturer’s recommendations, XXXXXX, Inc. user requirements and specifications, and cGMP’s 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 cGMP’s 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 Title Approval Date Source

User Requirements

Form

Design Qualification

Report

Strip Printer Manual


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1.0 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 METHODOLOGYAll 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 AbbreviationsThe 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

Description

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

VISUALField Verified, Information Specified will be recorded as found during 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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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:

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

Originator Title

As Found Document Location

Acceptance Criteria Met?

Yes/No

Performed By/DateApproval

DateRevision

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)


Description Specifications Actual ResultsVerification

Method

Actual Results met

specifications? Yes/No

Performed By/Date

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


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2.2 Equipment and Major Components Verification Test (continued)


Description Specifications Actual ResultsVerification

Method

Actual Results met

specifications? Yes/No

Performed By/Date

Equipment Name: Strip Printer XXXX (continued)

Cartridge Black Ribbon Cassette

Paper Type: Roll

CableConnection interface cable between printer and scale

InterfaceRS232 serial communication

port

AC Adapter24 VDC Power Supply with

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

ReferencesTMU-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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DIP-Switch Set No. 1 SpecificationActual

Results

Acceptance Criteria met?

(Yes/No)Verified By / Date

1-1 OFF

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 Date


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



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DIP-Switch Set No. 2 SpecificationActual Results

Acceptance Criteria met?

(Yes/No)Verified By / Date

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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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.

Procedure1. 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.



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

ParameterSpecification

sActual

Verification Method

Actual Results met

specifications? (Yes/No)

Performed By/Date

Voltage Requested

110 VAC ±10%

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.



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)


Description Asset NumberSpare Parts List

Available? Yes/No

Verification Method

Acceptance Criteria

meet? (Y/N)

Performed By / Date

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 _____


Procedure Number Title

Training Evidence included? (Yes/No)

As Found Approval Acceptance Criteria Met?

Yes/No

Performed By/Date

Date Version

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


1. 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 / Switch /Lights

DescriptionStep Procedure Expected Results Actual Result

Actual results met expected results? (Y/N)

Performed By/Date

ON/OFF Power Switch

1Turn the power switch to the ON position.

Printer is energized and the green POWER light is illuminated.

Printer was __________.

Green Power light was _____________.

2Turn the power switch to the OFF position

Printer is de-energized.and the green POWER light turns off.

Printer was _________.

Green Power light was _____________.

FEED button

1Turn the power switch to the ON position. Press the “PAPER FEED” button once

Paper advance one linePaper __________ one line.

2Press and hold down the “PAPER FEED” button

Paper must feed continuously

Paper ________ continuously.

Comments:

Reviewed by: Date:


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4.2 Buttons/Switch/Lights Verification Test (continued)


Button / Switch /Lights

DescriptionStep Procedure Expected Results Actual Result

Actual results met expected results? (Y/N)

Performed By/Date

PAPER OUT Light

and

ERROR Light

1

Turn the power switch to the 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 ____________

2Turn the power switch to the 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 _______________.

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.




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

Operation Procedure Test Expected Response Actual ResultsActual Results met

Expected Response? (Y/N)

Performed By/Date

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.

Start Time: ______________

After power is lost, the system

____________ , and the process

____________. Then, further

operation ____________ possible.

After restoring the power, the

system ____________ able to start

operation.

End Time: ______________

Comments:

Reviewed by: Date:


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4.4 Ticket Printer System Verification Test

ObjectiveThe 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)


Steps Test Procedure Expected Response Actual ResultsVerification

Method

Actual Results met with Expected

Response? Yes/No

Performed By/Date:

Epson Weighing Terminal IND560

1Switch the digital scale and the ticket Printer “ON”.

The balance and the printer energize.

The balance and the printer ____ energized.

2 Press Zero key “ ” in the digital scale screen.

The scale resets to 0.000 kg.The scale ________ to 0.000 kg

3Place an empty container on the Digital Scale.

The empty container weight is displayed on the digital scale indicator. Document weight.

Empty Container Displayed Weight: ___________ kg

4 Press Tare key “ ”in the digital scale screen.

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.

Comments:

Reviewed by: Date:


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Steps Procedure Expected Response Actual Results Verification Method


Response? Yes/No

Performed By/Date:

Epson Weighing Terminal IND560

5 Fill the container.

The net weight is displayed on the digital scale indicator. Document weight.

Net Weight Displayed:

___________ kg

6

Insert a paper slip at Ticket Printer and press

print key “ ” at the scale screen.

The Ticket Printer TMU-220 prints gross weight, Tara and net weight output data.

The Ticket Printer TMU-220 ______ gross weight, Tara and net weight output data.

Gross Weight: _________

Tara: _________

Net Weight: _________

7Verify the printed data in the inserted slip.

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.

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:


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Method


Response? Yes/No

Performed By/Date:

Epson Weighing Terminal 8530




2 Press Zero key “ ” in the digital scale screen.





4Press Tare key “ ”in the digital scale screen.



Comments:

Reviewed by: Date:


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Response? Yes/No

Performed By/Date:

Epson Weighing Terminal 8530




___________ kg

6


Enter key “ ” at the scale screen.




Tara: _________





Comments:

Reviewed by: Date:


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Method


Response? Yes/No

Performed By/Date:

Epson Weighing Terminal LYNX




2Press Zero key “ ” in the digital scale screen.





4Press Tare key “ ”in the digital scale screen.



Comments:

Reviewed by: Date:


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Response? Yes/No

Performed By/Date:

Epson Weighing Terminal LYNX




___________ kg

6


Enter key “ ” at the scale screen.




Tara: _________





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:_______________)

Page _____ of _____


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6.0 ATTACHMENTS

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.

Description Section Used Asset Number Calibration Date Calibration Due DatePerformed

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