IOQ Protocol- Strip Printer
-
Upload
sandra-i-rodriguez-marcial -
Category
Documents
-
view
185 -
download
1
Transcript of IOQ Protocol- Strip Printer
Installation/Operational Qualification (IOQ) Protocol for the Strip Printer XXXX
Document Version: 0
Installation/Operational Qualification (IOQ) Protocol for the Strip Printer XXXX
Version
0
Page
2 of 45
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.
Installation/Operational Qualification (IOQ) Protocol for the Strip Printer XXXX
Version
0
Page
3 of 45
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
Installation/Operational Qualification (IOQ) Protocol for the Strip Printer XXXX
Version
0
Page
4 of 45
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
Installation/Operational Qualification (IOQ) Protocol for the Strip Printer XXXX
Version
0
Page
5 of 45
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.
Installation/Operational Qualification (IOQ) Protocol for the Strip Printer XXXX
Version
0
Page
6 of 45
1.0 INTRODUCTION (continued)
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.
Installation/Operational Qualification (IOQ) Protocol for the Strip Printer XXXX
Version
0
Page
7 of 45
1.0 INTRODUCTION (continued)
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
Installation/Operational Qualification (IOQ) Protocol for the Strip Printer XXXX
Version
0
Page
8 of 45
1.0 INTRODUCTION (continued)
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
Installation/Operational Qualification (IOQ) Protocol for the Strip Printer XXXX
Version
0
Page
9 of 45
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.
Installation/Operational Qualification (IOQ) Protocol for the Strip Printer XXXX
Version
0
Page
10 of 45
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 ____________________
Installation/Operational Qualification (IOQ) Protocol for the Strip Printer XXXX
Version
0
Page
11 of 45
2.0 INSTALLATION QUALIFICATION (continued)
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
Installation/Operational Qualification (IOQ) Protocol for the Strip Printer XXXX
Version
0
Page
12 of 45
2.0 INSTALLATION QUALIFICATION (continued)
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 Appendix Section.
7. In case that the acceptance criteria are not met, develop and approve the corresponding discrepancy report that applies to this 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
Appendix No.: __________
Discrepancy: Yes/No __________
Discrepancy Report No.: __________
Acceptance Criteria Met: Yes/No __________
Initials/Date: ____________________
Reviewed By/Date: ____________________
Installation/Operational Qualification (IOQ) Protocol for the Strip Printer XXXX
Version
0
Page
13 of 45
2.0 INSTALLATION QUALIFICATION, (continued)
2.2 Equipment and Major Components Verification Test (continued)
DATA COLLECTION FORM
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
Installation/Operational Qualification (IOQ) Protocol for the Strip Printer XXXX
Version
0
Page
14 of 45
2.0 INSTALLATION QUALIFICATION, (continued)
2.2 Equipment and Major Components Verification Test (continued)
DATA COLLECTION FORM
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
Installation/Operational Qualification (IOQ) Protocol for the Strip Printer XXXX
Version
0
Page
15 of 45
2.0 INSTALLATION QUALIFICATION (continued)
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
Appendix No.: __________
Discrepancy: Yes/No __________
Discrepancy Report No.: __________
Acceptance Criteria Met: Yes/No __________
Initials/Date: ____________________
Reviewed By/Date: ____________________
Installation/Operational Qualification (IOQ) Protocol for the Strip Printer XXXX
Version
0
Page
16 of 45
2.0 INSTALLATION QUALIFICATION (continued)
2.3 Serial Interface DIP-Switches Configurarion Verification Test (continued)
DATA COLLECTION FORM
Installation/Operational Qualification (IOQ) Protocol for the Strip Printer XXXX
Version
0
Page
17 of 45
DATA COLLECTION FORM
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
Installation/Operational Qualification (IOQ) Protocol for the Strip Printer XXXX
Version
0
Page
18 of 45
Comments:
Reviewed By Date
2.0 INSTALLATION QUALIFICATION (continued)
2.3 Serial Interface DIP-Switches Configurarion Verification Test (continued)
DATA COLLECTION FORM
Installation/Operational Qualification (IOQ) Protocol for the Strip Printer XXXX
Version
0
Page
19 of 45
DATA COLLECTION FORM
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
Installation/Operational Qualification (IOQ) Protocol for the Strip Printer XXXX
Version
0
Page
20 of 45
Comments:
Reviewed By Date
Installation/Operational Qualification (IOQ) Protocol for the Strip Printer XXXX
Version
0
Page
21 of 45
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.
5. Use the “Comments” Section in each table to document any discrepancies or unexpected result.
6. Sign and Date the manual entries.
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 __________
Discrepancy Report No.: __________
Acceptance Criteria Met: Yes/No __________
Initials/Date: ____________________
Reviewed By/Date: ____________________
Installation/Operational Qualification (IOQ) Protocol for the Strip Printer XXXX
Version
0
Page
22 of 45
2.0 INSTALLATION QUALIFICATION, (continued)
2.4 Utilities Verification Test - Electrical (continued)
DATA COLLECTION FORM
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
Installation/Operational Qualification (IOQ) Protocol for the Strip Printer XXXX
Version
0
Page
23 of 45
2.0 INSTALLATION QUALIFICATION; (continued)
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.
5. Use the “Comments” Section in each table to document any discrepancies or unexpected result.
6. Sign and Date the manual entries.
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 __________
Discrepancy Report No.: __________
Acceptance Criteria Met: Yes/No __________
Initials/Date: ____________________
Reviewed By/Date: ____________________
Installation/Operational Qualification (IOQ) Protocol for the Strip Printer XXXX
Version
0
Page
24 of 45
2.0 INSTALLATION QUALIFICATION; (continued)
2.5 Spare Part List Verification Test (continued)
DATA COLLECTION FORM
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:
Installation/Operational Qualification (IOQ) Protocol for the Strip Printer XXXX
Version
0
Page
25 of 45
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:__________________)
Installation/Operational Qualification (IOQ) Protocol for the Strip Printer XXXX
Version
0
Page
26 of 45
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
Installation/Operational Qualification (IOQ) Protocol for the Strip Printer XXXX
Version
0
Page
27 of 45
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
1. Fill out the information in the Data Collection Form.
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.
5. Sign and Date the manual entries.
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
Appendix No.: __________
Discrepancy: Yes/No __________
Discrepancy Report No.: __________
Acceptance Criteria Met: Yes/No __________
Initials/Date: ____________________
Reviewed by/Date ____________________
Installation/Operational Qualification (IOQ) Protocol for the Strip Printer XXXX
Version
0
Page
28 of 45
4.0 INSTALLATION QUALIFICATION (continued)
4.1 Standard Operating Procedures and Training Verification Test (continued))Page_____ of _____
DATA COLLECTION FORM
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:
Installation/Operational Qualification (IOQ) Protocol for the Strip Printer XXXX
Version
0
Page
29 of 45
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. 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 discrepancy report that applies to this section.
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 __________
Discrepancy Report No.: __________
Acceptance Criteria Met: Yes/No __________
Initials/Date: ____________________
Reviewed By/Date: ____________________
Installation/Operational Qualification (IOQ) Protocol for the Strip Printer XXXX
Version
0
Page
30 of 45
4.0 OPERATIONAL QUALIFICATION (Continued)
4.2 Buttons/Switch/Lights Verification Test (continued)
DATA COLLECTION FORM
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:
Installation/Operational Qualification (IOQ) Protocol for the Strip Printer XXXX
Version
0
Page
31 of 45
4.0 OPERATIONAL QUALIFICATION (Continued)
4.2 Buttons/Switch/Lights Verification Test (continued)
DATA COLLECTION FORM
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:
Installation/Operational Qualification (IOQ) Protocol for the Strip Printer XXXX
Version
0
Page
32 of 45
4.0 OPERATIONAL QUALIFICATION (Continued)
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
1. Fill out the information in the Data Collection Form.
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.
4. Use the “Comments” Section in each table to document any discrepancies or unexpected result.
5. In case that the acceptance criteria are not met, develop and approve the corresponding discrepancy report that applies to this section.
6. Sign and Date the manual entries.
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 __________
Discrepancy Report No.: __________
Acceptance Criteria Met: Yes/No __________
Initials/Date: ____________________
Reviewed By/Date: ____________________
Installation/Operational Qualification (IOQ) Protocol for the Strip Printer XXXX
Version
0
Page
33 of 45
4.0 OPERATIONAL QUALIFICATION (Continued)
4.3 Power Loss and Recovery Verification Test (continued)
DATA COLLECTION FORM
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:
Installation/Operational Qualification (IOQ) Protocol for the Strip Printer XXXX
Version
0
Page
34 of 45
4.0 OPERATIONAL QUALIFICATION (Continued)
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
1. Fill out the information in the Data Collection Form.
2. Verify the Ticket Printer Epson TMU-220 operation by simulating a normal operating sequence.
3. Sign and Date the manual entries.
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
Appendix No.: __________
Discrepancy: Yes/No __________
Discrepancy Report No.: __________
Acceptance Criteria Met: Yes/No __________
Initials/Date: ____________________
Reviewed By/Date: ____________________
Installation/Operational Qualification (IOQ) Protocol for the Strip Printer XXXX
Version
0
Page
35 of 45
4.0 OPERATIONAL QUALIFICATION (Continued)
4.4 Ticket Printer System Verification Test (continued)
DATA COLLECTION FORM
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:
Installation/Operational Qualification (IOQ) Protocol for the Strip Printer XXXX
Version
0
Page
36 of 45
4.0 OPERATIONAL QUALIFICATION (continued)
4.4 Ticket Printer System Verification Test (continued)
DATA COLLECTION FORM
Steps Procedure Expected Response Actual Results Verification Method
Actual Results met with Expected
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:
Installation/Operational Qualification (IOQ) Protocol for the Strip Printer XXXX
Version
0
Page
37 of 45
4.0 OPERATIONAL QUALIFICATION (Continued)
4.4 Ticket Printer System Verification Test (continued)
DATA COLLECTION FORM
Steps Test Procedure Expected Response Actual ResultsVerification
Method
Actual Results met with Expected
Response? Yes/No
Performed By/Date:
Epson Weighing Terminal 8530
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
4Press 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:
Installation/Operational Qualification (IOQ) Protocol for the Strip Printer XXXX
Version
0
Page
38 of 45
4.0 OPERATIONAL QUALIFICATION (continued)
4.4 Ticket Printer System Verification Test (continued)
DATA COLLECTION FORM
Steps Procedure Expected Response Actual Results Verification Method
Actual Results met with Expected
Response? Yes/No
Performed By/Date:
Epson Weighing Terminal 8530
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
Enter 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:
Installation/Operational Qualification (IOQ) Protocol for the Strip Printer XXXX
Version
0
Page
39 of 45
4.0 OPERATIONAL QUALIFICATION (Continued)
4.4 Ticket Printer System Verification Test (continued)
DATA COLLECTION FORM
Steps Test Procedure Expected Response Actual ResultsVerification
Method
Actual Results met with Expected
Response? Yes/No
Performed By/Date:
Epson Weighing Terminal LYNX
1Switch the digital scale and the ticket Printer “ON”.
The balance and the printer energize.
The balance and the printer ____ energized.
2Press 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
4Press 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:
Installation/Operational Qualification (IOQ) Protocol for the Strip Printer XXXX
Version
0
Page
40 of 45
4.0 OPERATIONAL QUALIFICATION (continued)
4.4 Ticket Printer System Verification Test (continued)
DATA COLLECTION FORM
Steps Procedure Expected Response Actual Results Verification Method
Actual Results met with Expected
Response? Yes/No
Performed By/Date:
Epson Weighing Terminal LYNX
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
Enter 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:
Installation/Operational Qualification (IOQ) Protocol for the Strip Printer XXXX
Version
0
Page
41 of 45
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 _____
Installation/Operational Qualification (IOQ) Protocol for the Strip Printer XXXX
Version
0
Page
42 of 45
6.0 ATTACHMENTS
Attachment No. 1: Discrepancy Log Form
Note: Make copies of this sheet as deemed necessary.
Discrepancy No. Qualification Protocol Section: Protocol Page Originated By/Date
Installation/Operational Qualification (IOQ) Protocol for the Strip Printer XXXX
Version
0
Page
43 of 45
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:
Note: Make copies of this sheet as deemed necessary.
Installation/Operational Qualification (IOQ) Protocol for the Strip Printer XXXX
Version
0
Page
44 of 45
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
Installation/Operational Qualification (IOQ) Protocol for the Strip Printer XXXX
Version
0
Page
45 of 45
7.0 APPENDIX
Appendix Number Description