Golmenafohon Installation and Operational Qualification Protocol (IQ/0Q) and Computer System 2020-052-CSVIG0Q Validation (CSV) for Machine Safety Risk Consumer Products Company Reduction and Epson Robotic Arms Upgrade Haina, DR in FFS1, GCC-094336 and GCC-095076 Page 1 of 48 Installation and Operational Qualification Protocol (l1Q/OQ) and Computer System Validation (CSV) for Machine Safety Risk Reduction and Epson Robotic Arms Upgrade in FFS1 GCC-094336 and GCC-095076 2020-052-CSV-IQO0Q (12/08/2020)Installation and Operational Qualification Protocol (IQ/0Q) and Computer System 2020-052-CSVIG0Q Validation (CSV) for Machine Safety Risk Consumer Products Company Reduction and Epson Robotic Arms Upgrade Haina, DR in FFS1, GCC-094336 and GCC-095076 Page 2 of 48 Table of Content 1 APPROVAL. 4 2 PURPOSE 5 3 SCOPE 5 3.1 Hardware Changes 5 3.2 Software Changes 5 3.3 Guards and Electrical Safety Structure: 6 4 REFERENCE DOCUMENTS, 8 5 SYSTEM DESCRIPTION 7 6 ROLES AND RESPONSABILITIES 8 7 TEST PREREQUISITES 8 8 INSTALLATION QUALIFICATION TEST FORMS. 8 8.1 EQUIPMENT INFORMATION (MAJOR COMPONENTS LIST). 8 8.2 CALIBRATION (N/A), 8 83 ENVIRONMENTAL VERIFICATION 8 84 HARDWARE CONFIGURATION (NIA). 8 &5 WIRING, CABLING AND FUSING VERIFICATION 8 86 GROUNDING VERIFICATION. 8 87 INPUTIOUTPUT VERIFICATION (N/A) 9 88 SOFTWARE ARCHIVING, VERSION AND BACK-UP VERIFICATION 9 89 DIAGNOSTICS FOR STRUCTURAL VERIFICATION OF SOFTWARE a) 8.10 UTILITIES VERIFICATION eB 8.17 ELECTROMAGNETIC AND RADIOFREQUENCY INTERFERENCE VERIFICATION TEST.. 9 8.12 | DOCUMENTATION VERIFICATION 8 8.19 ATTACHMENTS GENERATED IN THE I 8 8.14 INSTALLATION VERIFICATION CHECKLIST 10 9 OPERATION QUALIFICATION TEST FORMS .. 10 1 SCREEN VERIFICATION. 10 @.2 CONTROL, SWITCHES AND INDICATORS VERIFICATION (N/A) 10 @.3 POWER LOSS VERIFICATION neniesnniinineninninnniiniinninninminianinninninannninnnniaiinnnnmnannen TO 9.4 BOUNDARY CONDITION VERIFICATION TEST 10 9.8 _ EMERGENCY STOPS VERIFICATION TEST. 10Gohbmena{olmwon Installation and Operational Qualification Protocol (IQ/0Q) and Computer System 2020-052-CSV-IQ0Q Validation (CSV) for Machine Safety Risk Consumer Products Company Reduction and Epson Robotic Arms Upgrade Haina, DR FFS1, GCC-094336 and GCC-095076 Page 3 of 48 916 ALARMS VERIFICATION. 10 9.7 PROCESS VARIABLES vosnssnsnnsinninninnienininienneninnnninanineuininuneninnsieninesinmnieninn 1 9.8 COMMUNICATION LOSS VERIFICATION (NIA) sussinssnunnineninnuneninesieninunsinunnninnaeninesinmniesinnn TO 9.9 SECURITY VERIFICATION TEST (N/A) "1 9.10 SYSTEM NORMAL OPERATIONAL SEQUENCE (N/A) 14 9.11 BACKUPIRESTORE AND ARCHIVING PROCESS TEST (N/A), 14 9.12 _ STANDARD OPERATION PROCEDURE (SOP) VERIFICATION (N/A) 14 9.42. ATTACHMENTS GENERATED IN THE 0. 14 10 _ INSTALLATION QUALIFICATION SECTION... 2 10.1 EQUIPMENT INFORMATION (MAJOR COMPONENTS LIST) 12 10.2 _ ENVIRONMENTAL VERIFICATION 14 10.3 WIRING, CABLING AND FUSING VERIFICATION 6 10.4 GROUNDING VERIFICATION. 18 10.8 SOFTWARE ARCHIVING, VERSION AND BACK-UP VERIFICATION 20 10.6 DIAGNOSTIC FOR STRUCTURAL VERIFICATION OF SOFTWARE. 22 10.7 UTILITIES VERIFICATION 24 10.8 ELECTROMAGNETIC AND RADIOFREQUENCY INTERFERENCE VERIFICATION TEST. 26 10.8 DOCUMENTATION VERIFICATION wuesiuasininmininininininniniinnsninnisninninnnnnnnnsannnsnnsinn 2 10.10 ATTACHMENTS GENERATED IN THE 1 3t 10.11 INSTALLATION QUALIFICATION APPROVAL, 32 11 OPERATIONAL QUALIFICATION TEST FORMS. 33 11.1. SCREEN VERIFICATION 33 11.2 POWER LOSS VERIFICATION 36 11.8 BOUNDARY CONDITION VERIFICATION TEST 39 11.4 EMERGENCY STOPS VERIFICATION. isnsnsninninnsnininisnanninisinnniniinninnnnsminnninninanonansinndl 11.8 ALARMS VERIFICATION 43 11.6 PROCESS VARIABLES 45 11.7 ATTACHMENTS GENERATED DURING 0@ ar 12 TRAINING SHEET. 48Installation and Operational Qualification Protocol (IQ/0Q) and Computer System 2020-052-CSVIG0Q Validation (CSV) for Machine Safety Risk Consumer Products Company Reduction and Epson Robotic Arms Upgrade Haina, DR in FFS1, GCC-094336 and GCC-095076 Page 4 of 48 1 APPROVAL Signatures that appear in this Protocol indicate understanding, acceptance and approval of the approver. All changes to the approved Protocol will be submitted to the approval authority for a re-approval process. The signature of an individual in this document indicates that the individual has reviewed, understood and approved only the sections of the specific document for its functional area. This means that the content of the document {including objective evidence / supporting data) comply with the requirements of the functional area of the person in Question according to his knowledge, 1.41 Originator NAME DEPARTMENT SIGNATURE DATE ‘Abel Andujar ME Abel Andujar ~ 1.2 Final Approval WANE DEPARTMENT SIGNATURE VALENTIN MATOS — Valentin Matos Validation R tat /alidation Representative ESPINAL Estefany Mercedes Manufacturing Representative Javier Betancourt JAVIER HUMBERTO BETANCOURT PEREZ Engineering Representative Emelin Ramirez Quality Assurance RepresentativeGohbmena{olmwon Installation and Operational Qualification Protocol (IQ/0Q) and Computer System 2020-052-CSVIG0Q Validation (CSV) for Machine Safety Risk Consumer Products Company Reduction and Epson Robotic Arms Upgrade 2 Haina, DR FFS1, GCC-094336 and GCC-095076 Page 5 of 48 PURPOSE ‘The objective of this Installation and Operational Qualification (I@/0Q) and Computer System Validation (CSV) is to verify and document the installation of the Upgraded Electrical Safety Risk Reduction System and Robotic Epson ‘Arms Upgrade, both in Form Fill and Seal (FFS1) machine, demonstrating with documented evidence that these changes have been properly executed in accordance with Johnson & Johnson Consumer Products Company (J&JCPC), Haina, Dominican Republic facilities requirements. Electrical Safety System for Form Fill and Seal (FFS1) machine, is being upgraded in order to meet the requirements of a Class 3 Safety System as defined in GCC-094336 (Machine Safety Risk Reduction FFS1). Robotic Epson Arms is being upgraded to replace the current version as it is outdated on the market and no parts are provided by the supplier as defined in GCC-095076. 3 SCOPE 34 3.2 This protocol will cover the Installation and Operational Qualification (IQOQ) and Computer Systems Validation (CSV) activities at the following elements: Hardware Changes ‘The EPSON Robot Hardware system consists of two main components: Manipulator and Controller. 3.1.1 Manipulator ‘The new EPSON Robot will use the manipulator model RG10-651ST73, which has a payload capacity of 10Kg. The Z axis has the capacity of 180mm for Up / Down movement in the main axis of the manipulator. Overall, with the new Epson Robot RG10-651ST73 manipulator, the robot will have an increased movement ‘on the Up/Down Z axis, and an improvement in payload capacity compared to earlier versions. 3.1.2 Controller The new EPSON Robot Controller RC700-A communicates to the new HMI (High Performance O| Touchscreens HGxG-series, IDEC) via an Ethernet / IP connection. The new Robot Controller has a 32 bits Micro Processor as CPU, and two positioning control: PTP (Point-To -Point control) and CP (Continuous Path control). Software Changes 3.2.1. Programming Language and Software ‘The new Programming language version and Robot control software is EPSON RC +7.0 (a multi-taking robot language).Installation and Operational Qualification Protocol (IQ/0Q) and Computer System 2020-052-CSVIG0Q Validation (CSV) for Machine Safety Risk Consumer Products Company Reduction and Epson Robotic Arms Upgrade Haina, DR in FFS1, GCC-094336 and GCC-095076 Page 6 of a8 3.3 Guards and Electrical Safety Structure * Guards and Electrical Safety structure, in compliance with Machine Safety Standard ISO 13849-1 and ISO 12100, as defined in GCC-095076 (Machine Safety Risk Reduction FFS1), including safety relays, wiring and redundant guard interlocks, and does not affect other equipment, equipment functionalities, critical process parameters, product specifications or environmental conditions. Changes are limited to the Upgraded Electrical Safety Risk Reduction System and Robotic Epson Arms Upgrade: in FFS1, as defined in GCC-094336 and GCC-095076 and don't affect other stations in the equipment. This protocol includes tests according to specifications, equipment manufacturer and Johnson & Johnson Haina, DR requirements. 4 REFERENCE DOCUMENTS Document Number | Revision Title GCC-094336 NIA | Machine Safety Risk Reduction FFSt Gcc-095076 NIA | Robotic Epson Arms Upgrade SOP32010 39 | Requerimiento De Validacién Para La Faciidad De DR FM.011639, 2 | HOJADE INSPECCION DE VALIDAGION (DATOS POR ATRIBUTO) S0P33004 33 | Procedimiento De Mantenimiento FM-009334 2 | Reporte de Desviacién o incidente sopotete 4 | Prossdiniento para Contry Ejecucion de Vallaciones o Pruebas en JJ ‘SOP35000 103 | Operacién De Handpacking De Hilo Dental sop-08z23 11 | Procedmienio De Vaidacén De Sistemas Computazados Para La sop 008aa 7 | brosemento de Valdacion de Facidadesy Uldades paras planta de SoP.015502 2 | Evaluacién de EHS en el disefio y manejo de cambios FM.016410 3___| Requisitos de EHS en cambios a faciidades y/o ullidades SOP-012108 15___| Proceso de Etiquetado aulomatico en FFS y Blister 10 SOP-001783 54 | Procedimiento Operacién de las Méquinas Form, Fill and Seal 1,2 y 3Gohbmena{olmwon Installation and Operational Qualification Protocol (IQ/0Q) and Computer System 2020-082-C8V-IQ0Q Validation (CSV) for Machine Safety Risk Consumer Products Company Reduction and Epson Robotic Arms Upgrade Haina, DR FFS1, GCC-094336 and GCC-095076 Page 7 of 48 SYSTEM DESCRIPTION ‘The FFS1 Line is composed of a Flex Link conveyor which performs the function of transporting the manual assembled dispensers through a sensor that triggers the lot number printer and inspects the lot number by a camera that is located next to the lot printing device to detect the presence of the printed lot number in the bottom of the dispenser. Dispensers with non-printed lot numbers are rejected and sent to a rejection bin. If the rejection cannot be confirmed by the lat number reject verification sensor the infeed conveyor will be stopped. After this the conveyor moves forward the dispensers through a sensor that verifies if the product contains a dental floss coil, a rejection system will be activated if the sensor detects that the dispenser is empty, and it will be sent to a rejection bin. ifthe rejection cannot be confirmed by the empty dispenser reject verification sensor the infeed conveyor will be stopped. Once empty dispenser is verified, the conveyor moves on the dispenser to the Automatic Labeling Stand-Alone System. After that, unit will enter into the modular Label Inspection and Rejection System, where a camera located at the Top of the equipment verifies dispenser correct position, front label presence and label 2D code correct number. Dispensers without front labels are rejected and sent to a rejection bin and Dispensers with the wrong front label 2D code will stop the Module and the Labeler conveyor immediately to allow the operator to verify the Unit. Concurrently, a camera located at the Bottom of the equipment verifies instructional label presence and label code correct number (when required by product configuration). Dispensers without instructional labels are rejected and sent to a rejection bin and Dispensers with the wrong instructional label code will stop the Module and Labeler conveyor immediately to allow the operator to verify the unit, Form Fill and Seal #1 can be selected to run bulk product or blister packaged product: For Blister packaged product, a conveyor moves the dispenser to the FFS station, where an EPSON Robot Arms picks six dental floss WIP units (filed and labeled dispenser) and places them into formed blisters in a slidericonveyor, and then FFS station packs the units into individual blister packs. Once the units in blister are processed in the FFS station, they are transported through a conveyor to the packing station PFM-FFS#1. When the product reaches the bag area, they are separated in groups of six units, the groups are wrapped in a transparent plastic sleeve and sealed at the ends by a heated vertical roller and a horizontal jaw to ensure a proper packaging, ‘Then the bag is cut by an integrated blade into the mechanism, These bags are transported to the final packaging section where they are manually packed in boxes. The boxes are sealed, labeled and placed on pallets for shipment. For bulk product final stage, the dispenser is transferred into a cardboard box or plastic tote bin through a detachable chute after the hand packaging and labeling process. vanseraror) (oocmme non Ematy Labeler 7955 ‘inchs of vi Inspection Dispenser instructor Sparen) Sytem station {060/055 Label Vision ‘system Inspection/Rejection Modulestation Figure 1 Form Fill and Seal Lines Process FlowInstallation and Operational Qualification Protocol (IQ/OQ) and Computer System Validation (CSV) for Machine Safety Risk Consumer Products Company Reduction and Epson Robotic Arms Upgrade Haina, DR in FFS1, GCC-094336 and GCC-095076 Page 8 of 48 2020-052-CSV-IQ0Q 6 ROLES AND RESPONSABILITIES Activity Responsible Person Role (Function) Preparation and execulion of the Protocol | A. Andujar Validation Representative Calibration and preventive maintenance F Gonzalez Maintenance Supervisor or Manager Manufacturing Process E. Mercedes Manufacturing Manager or designee Engineering Activities J Betancourt Engineering Manager or designee Final Report Preparation ‘A Andujar Validation Representative 7 TEST PREREQUISITES 7.1 GCC-094336 (Machine Safety Risk Reduction FFS1) in execution phase. 7.2 GCC-095076 (Robotic Epson Arms Upgrade) in execution phase. 7.3 System components schematics or P&ID's. 7.4 Standard Operation procedures draft versions, application and device reference manuals. 8 INSTALLATION QUALIFICATION TEST FORMS 8.1 EQUIPMENT INFORMATION (MAJOR COMPONENTS LIST) To identify the contro! system hardware, its auxiliary components (i. peripheral devices) and verity that the installation was performed according to manufacturer and/or supplier recommendations. 8.2 CALIBRATION (N/A) Not applicable. Project is limited to the Electrical Safety System and Epson Robot Arms Upgrade; system calibration is not affected by the change. 8.3. ENVIRONMENTAL VERIFICATION To verify that the environmental conditions at the FFS #1 control system locations meet the equipment specifications 8.4 HARDWARE CONFIGURATION (N/A) Not applicable. This test is not required since the PLC and power supply models are different and do not use OIP Control System, do not have any dipswitches, rotary switches or jumpers.Installation and Operational Qualification Protocol (IQ/0Q) and Computer System 2020-052-CSVIG0Q Validation (CSV) for Machine Safety Risk Consumer Products Company Reduction and Epson Robotic Arms Upgrade Haina, DR in FFS1, GCC-094336 and GCC-095076 Page 9 of 48 8.5 WIRING, CABLING AND FUSING VERIFICATION Verify that the equipment complies with the required electrical connections specifications and that the correct tools, were used to perform the test. Verify that the wiring, cabling and fusing for the system under qualification, except any that is self-contained as supplied by the equipment manufacturer, agrees with the approved as-built electrical ‘schematics included in the documentation package. 8.6 GROUNDING VERIFICATION To verify that control system devices that require grounding are grounded according to the manufacturer specifications and in compliance with NEC and/or equivalent guidelines. 8.7 INPUT/OUTPUT VERIFICATION (N/A) Not Applicable. Project is limited to Electrical Safety System and Epson Robot Arms Upgrade: Actual Input/output Connection is not affected by this change. 8.€ SOFTWARE ARCHIVING, VERSION AND BACK-UP VERIFICATION To verify all file names, version and vendor/programmer of the software required for the operation of the control System. &.£ DIAGNOSTICS FOR STRUCTURAL VERIFICATION OF SOFTWARE ‘The objective of this procedure is to examine the source code of the Software for clarity, consistency of annotation, modularity, consistency of structure, and dead or redundant code, 8.10 UTILITIES VERIFICATION ‘The objective of this verification is to ensure that for each utilty required for the system, all he “as-found” conditions comply with the specifications, and that the utilities required for this system are installed as specified by the manufacturer. 8.11 ELECTROMAGNETIC AND RADIOFREQUENCY INTERFERENCE VERIFICATION TEST Verify and document the effect of Electromagnetic and Radiofrequency waves’ interference. 8.12 DOCUMENTATION VERIFICATION To document all engineering-related information available for the system such as Spare Parts List, Installation P&ID's/Vendor Drawings on file, Manuals and Standard Operating Procedures. 8.13 ATTACHMENTS GENERATED IN THE 1 List the attachments Generated in the IQ that contains supporting documentation to the validationInstallation and Operational Qualification Protocol (IQ/0Q) and Computer System 2020-052-CSVIG0Q Validation (CSV) for Machine Safety Risk Consumer Products Company Reduction and Epson Robotic Arms Upgrade Haina, DR in FFS1, GCC-094336 and GCC-095076 Page 10 of 48 8.14 INSTALLATION VERIFICATION CHECKLIST Verify that the installation is performed according to the requirements and specifications of J&J, that all installations and connections have been made as expected, Add as many questions as necessary for proper installation verification OPERATION QUALIFICATION TEST FORMS For each system or component, document the actual condition in the provided form. If specification is not available, document the available or actual information during the qualification in the provided specification or requisite space such as “Available Information’ and proceed to document the “As Found” conditions. 9.1 SCREEN VERIFICATION Test the menu system functions specified in the column device of the provided Data Sheet. Compare the system actual response with the response described under the Expected Response Column Test the menu system functions specified in the column device of the provided Data Sheet. 9.2 CONTROL, SWITCHES AND INDICATORS VERIFICATION (N/A) ‘This test is not applicable. Test the software controls conditions is not affected by this change. 9.3 POWER LOSS VERIFICATION Test the power failure conditions to verify if the equipment will perform a power off and recovery sequence in an established and safe way. 9.4 BOUNDARY CONDITION VERIFICATION TEST ‘The objective of this test is to verify the ability of the System to allow the user to select cycle parameters within the defined valid range by using the operator interface keyboard 9.5 EMERGENCY STOPS VERIFICATION TEST Perform an evaluation of all the controls and devices that render the equipment safe to perform the task according to the J&J requirements and specifications. 9.6 ALARMS VERIFICATION Verify that the alarms operate adequately. 9.7 PROCESS VARIABLES Challenge and document the system normal operation 9.8 COMMUNICATION LOSS VERIFICATION (N/A) Not Applicable. This testis not required since the line does not have an access point or physically installed computer,Installation and Operational Qualification Protocol (IQ/0Q) and Computer System 2020-052-CSVIG0Q Validation (CSV) for Machine Safety Risk Consumer Products Company Reduction and Epson Robotic Arms Upgrade Haina, DR in FFS1, GCC-094336 and GCC-095076 Page 11 of 48 9.9 SECURITY VERIFICATION TEST (N/A) Not Applicable, This test is not required since the HMI does not have access level rights. 9.10 SYSTEM NORMAL OPERATIONAL SEQUENCE (N/A) Not applicable. This test will be covered on the Process Variables test. 9.11 BACKUP/RESTORE AND ARCHIVING PROCESS TEST (N/A) Not applicable. This element is being covered under section 8.8 (Sofware Archiving, Version and Back-Up Verification). 9.12 STANDARD OPERATION PROCEDURE (SOP) VERIFICATION (N/A) Not Applicable. This test will be covered on the section 8.12 (Documentation Verification test) in the IQ Section. 9.13 ATTACHMENTS GENERATED IN THE OQ List the attachments Generated in the OQ that contains supporting documentation to the validation.10 Gohbmena{olmwon Installation and Operational Qualification Protocol (IQ/OQ) and Computer System 2020-052-CSV-IQ0Q Validation (CSV) for Machine Safety Risk Consumer Products Company Reduction and Epson Robotic Arms Upgrade Haina, DR INSTALLATION QUALIFICATION SECTION 10.1 EQUIPMENT INFORMATION (MAJOR COMPONENTS LIST) Make copies as necessary Objecti FFS1, GCC-094336 and GCC-095076 Page 12 of 48 Page of To identity the control system hardware, its auxiliary components (i.e. peripheral devices) and verify that the installation was performed according to manufacturer and/or supplier recommendations. Procedure/Testing Instructions: The equipment's documented in this test are: Major components: a set of devices that can be ctitical or not, that work together to perform a function, Example: Wax Pumping Station, which is made up of level sensors, servo drive, servo motors, heaters, etc., which work together to impregnate the thread with wax. Critical devices: device, module, component or system whose failure could endanger the safety of staff, have directly or indirectly impact to qualityifunction of the product and/or the functionality of the equipment, therefore, itis essential to the operations of J&. Note: serial numbers of equipment’s/devices will be documented as reference only. References Required: Equipment Manuals (If applicable) Acceptance Criteria: The main equipment components are installed as per manufacturer and/or supplier recommendations, and correctly identified Results Verification/Conclusions: Yes/No” Performed by/Date Acceptance Criteria Me *Note: Identify Deviation number if answer is NO: Comments/Observations:Installation and Operational Qualification Protocol (IQ/0Q) and Computer System 2020-052-CSVIG0Q Validation (CSV) for Machine Safety Risk Consumer Products Company Reduction and Epson Robotic Arms Upgrade Haina, DR in FFS1, GCC-094336 and GCC-095076 Page 13 of 48 10.1.1. MAJOR COMPONENTS LIST RESULT Make copies as necessary, Page of Machine Performed By! Date Description/Function ‘Component DEquipment Device EquipmentDevice ID Manufacturer Model Serial Number Location Performed By/ Description/Function Field Ver et ication ‘Component DEquipment Device EquipmentiDevice ID Manufacturer Model Serial Number Location Reviewed by: Date:Gohmronafolmwon Installation and Operational Qualification Protocol (IQ/0Q) and Computer System 2020-052-CSV-IQ0Q Validation (CSV) for Machine Safety Risk Consumer Products Company Reduction and Epson Robotic Arms Upgrade Haina, OR FFS1, GCC-094336 and GCC-095076 Page 14 of 48 10.2 ENVIRONMENTAL VERIFICATION Make copies as necessary. Page of Objective: To verify that the environmental conditions at the FFS #1 control system location meets the equipment specifications. Procedure/Testing Instructions: Using a calibrated temperature and relative humidity chart recorder, take one (1) continuous measure over a period of 24 hours inside the FFS #1 control panel. Compare actual maximum and minimum readings against the manufacturer specified limits provided on the data sheet. Attach recorder charts. References Required: Equipment manuals (If applicable) Acceptance Criteria: The environmental conditions comply with the specifications, Results Verification/Conclusions: Yes/No* Performed by/Date Acceptance Criteria Met: **Note: Identify Deviation number if answer is NO: Comments/Observations:Golmeonafohwon Installation and Operational Qu: ication Protocol (IQ/0Q) and Computer System 2020-052-CSV-IQ0Q Validation (CSV) for Machine Safety Risk Consumer Products Company Reduction and Epson Robotic Arms Upgrade Haina, OR in FFS1, GCC-094336 and GCC-095076 Page 15 of 48 10.21 ENVIRONMENTAL VERIFICATION RESULTS, Make copies as necessary Page of Machine Epson Robot Manipulator ‘As Found as Manufacturer Limits Actual Read category janufacturer Limit \ctual Reading cur poe Minimum | Maximum | Minimum | Maximum | Specification aa (Yes/No) Equipment 7 40°C Temperature SC (ANF) | roger) Equipment Relative | 10% non- | 80% non- Humidity condensing | condensing Epson Robot Controller 7 As Found as Manufacturer Limits Actual Readi em lanufacturer Lim eee por Performed By! sen Minimum | Maximum Maximum | Specification oe (Yes/No) Equipment oc (ater 40°C Temperature SCI) | coger) Equipment Relative | 20%non- | 80% non- Humidity condensing | condensing Comments: Reviewed by: Date:Gohmronafolmwon Installation and Operational Qualification Protocol (IQ/0Q) and Computer System Validation (CSV) for Machine Safety Risk Consumer Products Company Reduction and Epson Robotic Arms Upgrade Haina, OR in FFS1, GCC-094336 and GCC-095076 Page 16 of 48 2020-052-CSV-IQ0Q 10.3. WIRING, CABLING AND FUSING VERIFICATION Make copies as necessary. Page of Objective: Verify that the wiring, cabling and fusing for the system under qualification, except any that is self-contained as, supplied by the equipment manufacturer, is according to the approved as-built electrical schematics included in the documentation package. Procedure/Testing Instructions: Obtain a copy of the as-built electrical schematics for the system under qualification. Test for proper connection, tagging, and identification of each terminal against manufacturer specifications or industry standards (e.g. IEEE, NEC). Test for specified circult fuses. References Required: Equipment Manuals and Drawings (if applicable) Acceptance Criteria Al installed wiring; cabling and fusing for the system comply with the manufacturer specifications and are as per approved as-built electrical schematics. Results Verification/Conclusions: Yes/No* Performed by/Date Acceptance Criteria Me! "Note: Identify Deviation number if answer is NO: Comments/Observations:Golmeonafohwon Installation and Operational Qu: ication Protocol (IQ/0Q) and Computer System 2020-052-CSV-IQ0Q Validation (CSV) for Machine Safety Risk Consumer Products Company Reduction and Epson Robotic Arms Upgrade Haina, OR in FFS1, GCC-094336 and GCC-095076 Page 17 of 48 10.3.1 WIRING, CABLING AND FUSING VERIFICATION RESULTS Make copies as necessary. Page: of ___ Machine: Electrical Schematic as Rev. | Wires Properly | Wires Properly Number «| Connected (YIN)? | Tagged (YIN)? Performed by: Date: Reviewed by: Date:Gohmronafolmwon Installation and Operational Qu: ication Protocol (IQ/0Q) and Computer System 2020-052-CSV-IQ0Q Validation (CSV) for Machine Safety Risk Consumer Products Company Reduction and Epson Robotic Arms Upgrade Haina, OR in FFS1, GCC-094336 and GCC-095076 Page 18 of 48 10.4 GROUNDING VERIFICATION Make copies as necossary. Page ___of Objective: To verify that control system devices that require grounding are grounded according to the manufacturer specifications and in compliance with NEC andior equivalent guidelines. Procedure/Testing Instructions: Verify that when applicable, devices are grounded according to manufacturer specifications References Required: Equipment Manuals (if applicable) Acceptance Criteria: All installed equipment's are properly grounded and comply with the manufacturer specifications and in compliance with NEC and equivalent guidelines. Results Verifi “ion/Conclusions: Yes/No” Performed by/Date Acceptance Criteria Met: *Note: Identify Deviation number if answer is NO: Comments/Observations:Golmeonafohwon Installation and Operational Qu: ication Protocol (IQ/0Q) and Computer System 2020-052-CSV-IQ0Q Validation (CSV) for Machine Safety Risk Consumer Products Company Reduction and Epson Robotic Arms Upgrade Haina, OR in FFS1, GCC-094336 and GCC-095076 Page 19 of 48 10.4.1. GROUNDING VERIFICATION RESULTS Make copies as necessary Page of Machine: Expected Item Range (Example) <10 Measured | Ground Values | Pass/Fail <19 <19 <19 <19 <10 <10 <10 <19 <10 <10 <19 <19 <18 <12 <12 <18 <18 IDEC HMI must display a With the Epson Robot Arm is 41 | running, turn OFF its electrical Power. ‘communication error message, The FFS #1 stops its cycle 2 _| Verity ifthe FFS1 stops. operation, but it remains energized, Epson Robat Arm is energized. Wait at least 60 seconds and Epson Robot's program was 3 | tum back ON the electical | not affected by power loss power for the Epson Robot | condition Arm, ® IDEC HMI must display its previous story stalus message. Epson Robot Arm activated and fctoring Trough —Zaoranshy Hl sanleyaetaun 4. | recelne pean Rebat Amand f° DECHMI Mus delay att the FFSt |e The FFS #1 working on its cycle Epeon Robot ne tintonng. butt sonar Through Zahoransky HMI, energized. 5 | croc te Epon Rahsaan |® DECHM musty asian > The FFS #1 stops its cycle operation, but it remains energized, [Epson Robot Arm activated and functioning. Through Zahoransky HMI, Epson Robot's program was 6 | reactivate the Epson Robot] not affected by disabled ‘Arm and the FFS1. condition. IDEC HMI must display a status message Performed by: Date: Reviewed by: Date:Golmeonafohwon Installation and Operational Qu: ication Protocol (IQ/0Q) and Computer System 2020-052-CSV-IQ0Q Validation (CSV) for Machine Safety Risk Consumer Products Company Reduction and Epson Robotic Arms Upgrade Haina, OR in FFS1, GCC-094336 and GCC-095076 Page 38 of 48 41.2.2 POWER LOSS VERIFICATION RESULTS Form Fill and Seal #1 (FFS #1) ‘Specifications andlor Step Instructions Actual Condition Requirement With the FFS #1 in normal fF FFS #1 is stopped and ‘operation, simulate a power | de-energized. loss condition by switching } Epson Robot Arm 1 | the contro! system panel | stopped, but it remains ONIOFF switch to the OFF | energized. position and wait atleast 60 |e IDEC HMI must shut seconds, off. Tho FFST is energized. Zahoransky HMI must Set_back control panel | display a status 2 | ONIOFF switch to the ON| message. position. le IDEC HMI must display its previous story status message. Epson Robot Arm activated and Through Zahoransky HMI, | funetioning. 3. | active the Epson Robot Arm | IDEC HMI must display and the FFS1 a status message ls The FFS1 working on its cycle operation Performed by: Date Reviewed by: Date.Gohmronafolmwon Installation and Operational Qualification Protocol (IQ/0Q) and Computer System 2020-052-CSV-IQ0Q Validation (CSV) for Machine Safety Risk Consumer Products Company Reduction and Epson Robotic Arms Upgrade Haina, OR FFS1, GCC-094336 and GCC-095076 Page 39 of 48 11.3. BOUNDARY CONDITION VERIFICATION TEST Objective: The objective of this testis to verify the ability of the System to allow the user to select cycle parameters within the defined valid range by using the operator interface keyboard. Procedur Use the keyboard to test the high and low limits for each modifiable parameter listed on the following pages andior the system specification. Verify that the defined limits cannot be exceeded. The type of values entered are the high limit +1, +.9 or +1, low limit -1, -1, negative values, decimals limit values and within range values. Record any error messages. Settings not specified will be documented as they exist. Detailed test procedure and test, ‘equipment used during execution will be recorded in comments section. Specifications should be obtained from the manufacturer or other acceptable source prior to executing this test. References Required: Equipment Manuals Acceptance Criteria: The System does not allow selection of input outside the specified range and allows selection of inputs within the specified range as outlined on the following page(s) andior in the system specifications, Results Verification/Conclusions Yes/ No* Performed by/Date Acceptance Criteria Met: *Note: Identify Deviation number if answer Is NO: Comments/Observations:‘Consumer Products Company Installation and Operational Qui ication Protocol (IQ/0Q) and Computer System Validation (CSV) for Machine Safety Risk Reduction and Epson Robotic Arms Upgrade 2020-052-CSV-IQ0Q Page 40 of 48, Haina, DR in FFS1, GCC-094336 and GCC-095076 41.3.4 BOUNDARY CONDITION VERIFICATION RESULTS Make copies as necessary. Page___of. Specified at Actual | Values | Criteria Process Paramater_ | Seif Input Values raat acest | Met? Within Range [Out ofRange]| YesiNo | YesiNo [Yes | No 650 mm to ‘Stroke (X axis) 650 mm 650, 318, 650 -651,651 “850 mm fo Stroke (Y axis) 's0 mmo | “e50, 430, 650 | _-651.851 7180 mm fo ‘Stroke (2 axis) 180mm |-180-125, 180) 481,181 -360 deg to Rotation (Spin Angle) 360 deg -360, -162, 360] -361,361 Performed by: Date Reviewed by: DateGohmronafolmwon Installation and Operational Qu: ication Protocol (IQ/0Q) and Computer System 2020-052-CSV-IQ0Q Validation (CSV) for Machine Safety Risk Consumer Products Company Reduction and Epson Robotic Arms Upgrade Haina, OR in FFS1, GCC-094336 and GCC-095076 Page 41 of 48 11.4 EMERGENCY STOPS VERIFICATION Make copies as necessary. Page of Objective To challenge the security features provided by the unit under qualification. Examples: E-stops, Door guards ete. Procedure/Testing Instructions Follow the instructions detailed on the Action column of the provided Data Sheet. Compare the system actual response with the response described under the Expected Response column. If the actual response does not match the expected, record the actual response and initiate an exceptional condition report. Otherwise, fill the Actual Response column with As Expected. References Required Equipment Manual (If applicable) Acceptance Criteria The system enforces designed logical security schemes as specified Results Verification/Conclusions: Yes/No* Performed by/Date Acceptance Criteria Me! “Note: Identify Deviation number if answer is NO, Comments/Observations:Golmeonafohwon Installation and Operational Qu: ication Protocol (IQ/0Q) and Computer System 2020-052-CSV-IQ0Q Validation (CSV) for Machine Safety Risk Consumer Products Company Reduction and Epson Robotic Arms Upgrade Haina, OR in FFS1, GCC-094336 and GCC-095076 Page 42 of 48 11.4.1 EMERGENCY STOPS VERIFICATION RESULTS Make copies as necessary Page ___of ‘Specification and/or Requirement . Equipment stops Alarm) Performed By/ Step | __ Instructions Pass Pass Date Test result Tost result Yes | No Yes [__No |Push Emergency Stop |The equipment |Zahoransky HMI 1 [Button at the Control. |stops and shuts off must display an Panel immediately. |Alarm Message. Comments: Reviewed by: Date:Gohmronafolmwon Installation and Operational Qualification 2020-052-CSV-IQ0Q Protocol (IQ/0Q) and Computer System Validation (CSV) for Machine Safety Risk Consumer Products Company Reduction and Epson Robotic Arms Upgrade Haina, OR FFS1, GCC-094336 and GCC-095076 Page 43 of 48 14.5 ALARMS VERIFICATION Make copies as necessary. Page of ___ Objective: To challenge the control system configured alarms. Procedure/Testing Instructions: For each of the alarms listed, simulate the condition(s) by any of the following methods: ‘A— Device disconnection B— Set point modification C— Other Verify that the alarm condition is logged into the Alarms Summary screen. Reset the alarm condition and verify that the reset event was logged into the Alarms Summary screen. If the actual response does not match the expected results, record the actual response and initiate a discrepancy report. Otherwise, fill the Actual Response column. with “As Expected” References Required: Equipment Manuals (if applicable) Acceptance Criteri The control system process configured alarms as specified by the manufacturer. Results Verification/Conclusions: Yes/No™ Performed by/Date Acceptance Criteria Met: “Note: Identify Deviation number if answer is NO., Comments/Observations:Golmeonafohwon Installation and Operational Qualification Protocol (IQ/0Q) and Computer System 2020-052-CSV-IQ0Q Validation (CSV) for Machine Safety Risk Consumer Products Company Reduction and Epson Robotic Arms Upgrade Haina, OR in FFS1, GCC-094336 and GCC-095076 Page 44 of 48 11.5.1 ALARMS VERIFICATION RESULTS. Ne ‘Alarm au Aiheccroe, | AlarmReset | Pass | Fail 7 Cortando Formate Medium z Correndo Formato Large 3 Corriendo Formato Family a Parada De Emergencia Acivada x [x __| Zahoransky HMI 5 Guarda f1 Abierta (Robot, x x Zaharansky HMI 5 Guarda 2 Rotvada (Banner) x x Zahoransiy HW 7_[-Giardadas De Conveyor #3 YI0 Fa x x Zahoransiy A @_|__ Mezcla De Producto (Clame Al Ga) x x Zahoransky HMI [Nivel De Wip (Verfique €1 Conveyor) x x 70 Conveyor Esta Apagado x X Zahoransky HMI “1 | Falla De Desplazamiento De PaPWVenaue | x ahoraneky HM PP) % Falla De Clindro De PEP x Zaharansky FN 3 Robot Desactvado x Zahoransky HMI 74_| Problema En Gortador (Lame ATMecanico) | __X x Zahoransky HMI 75_|___ Maquina Parada Por El Operador x x Zahoransky Nl 76 Robot Esta Apagado x x Zahoransiy HN 7 Magazine Vacio x x Zahoransiy HN 78 Ta Bare De Banner Esta Abajo x x Zahoransiy HMI 79 | __Liave De Calidad insertada (Oa) x Zahoransky HMI 20 Fala Do Wip Consecutvas [x [x Zahoransky HMI zi Maquina En Modo RobovSider x Zaharansky HMI a Pulso de fala de diverter x x Zahoransiy HN Z| Fala del lector de codigo de barras x x Zahoransiy Hl 24 Falla de moter de gripper ha ~ Zahoransky HMI Z5_| Fates consecutvas de ormade sirbanner |X x Zahoransiy HW 26 | Tranque de wip (no estan legando altope) |X x Zahoransky HMI 27_|_ Falla de aimentacion de wip constants x Zahoransky HMI 3e-[ Revo oss seve vortia vaorsncny a —X Zanoransky FN Performed by: Date: Reviewed by: Date: ‘Comments:Gohmronafolmwon Installation and Operational Qualification Protocol (IQ/0Q) and Computer System 2020-052-CSV-IQ0Q Validation (CSV) for Machine Safety Risk Consumer Products Company Reduction and Epson Robotic Arms Upgrade Haina, OR FFS1, GCC-094336 and GCC-095076 Page 45 of 48 14.6 PROCESS VARIABLES Objective: The test will focus on challenging the next elements: 1) FFS #1 process sequence and response when operated at current worst-case conditions (higher operational speed, achieved when stations times are set to the lower limit), to verify and validate that its process parameters were not affected by the implementation of the Machine Safety Risk Reduction and EPSON Robotic Arms Upgrade in FFS #4 2). Verify that implementation of the EPSON Robot Arm does not have an adverse effect on FFS1 machine overall performance (as measured by OEE). Procedure: Parameters eee Low Nominal High Blowing Time 550 (Ms) Set Point Set Point Sealing Time 750 (vs) SetPoint, Set Point Cooling Time 750 (Ms) Set Point Set Point Table #1 -Medium Parameters Configuration Parameters: ge Low Nominal High Blowing Time 500 (vs) Set Point Set Point Sealing Time 750 (vs) SetPoint Set Point Cooling Time 750 (ws) Set Point Set Point Table #2 -Large Parameters Configuration Parameters: a Low Nominal High Blowing Time 500 (vs) Set Point Set Point Sealing Time 750 (Ms) set Point set Point Cooling Time 750 (Ms) Set Point, Set Point Table #3 -Family Parameters Configuration Note: Parameters related to operation time will be set to the low limit. All other parameters will be set at thelr nominal value.Golmeonafohwon Installation and Operational Qu: ication Protocol (IQ/0Q) and Computer System 2020-052-CSV-IQ0Q Validation (CSV) for Machine Safety Risk Consumer Products Company Reduction and Epson Robotic Arms Upgrade Haina, OR in FFS1, GCC-094336 and GCC-095076 Page 46 of 48 11.6.1 Process Attributes and Acceptance Criteria The Form Fill and Seal Line #1 (FFS #1) will produce units using extreme (low) time-related parameters for product codes 220921703 (representing Medium size), 529626701 (representing Large Size) and 200923413 (representing Family Size). Process Overall Performance evaluation will be executed according to the following table for each run Run] Product Dispenser] punsie | Reduired | Observed | Pass/Fail Number | Code rectuct Nene Size ‘OEE OEE ‘J&J REACH DENTAL 1 | 220821703} FLOSS MINT WAXED | Medium | 30 min/1800 55 YD units (approx.) LISTERINE CM XWIDE, 2 | 529626701 WAX FLSS Large Somirts00, o10% 45YDCA96267 Pr ‘J&J REACH DENTAL 3 | 200923413] FLOSSMINTWAXED | Family | S0min/tt00 200YD units (approx.) Additionally, machine behavior will be observed and normal operation situations (stops, scrap causes) shalllbe identified as not occurring in an excessive manner. Stoppages occurring in an excessive manner will result in a reduced OEE for the run. a oT Functioning Expected FFS Message Alarm: h ‘Stopped Message Pass Fail Conditions Response Yes/No. ‘Yes/No Yes/No Reset fomeameyorend | Pocand Place crowed | No No ey wo Salen ap Samsara and Pace] . TP ararsty Failure not executed x Ne ¥ HMI Pick and Paco Zahorany WiP overLevel | £¥20uted vel | Yay Yes No HM slam Bick and Pace Zaharaty Gorweyor wit wp | PRand Pace [5 wo ves | hora Performed By/Date Rovowed Biba YeaTno™ Paformed byDate Acceptance Criteria Met: *Note: Identify Deviation number if answer is NO. Comments/Observations:Installation and Operational Qui ication Protocol (IQ/0Q) and Computer System Validation (CSV) for Machine Safety Risk 2020-052-CSV-IQ0Q Consumer Products Company Reduction and Epson Robotic Arms Upgrade Haina, OR in FFS1, GCC-094336 and GCC-095076 Page 47 of 48 11.7. ATTACHMENTS GENERATED DURING 0 Make copies as necessary. Page of List the attachments generated in the OQ containing supporting documentation to the validation. Attachment # Description Performed by: Date: Reviewed by: Date:Golmeonafohwon Installation and Operational Qualification Protocol (IQ/0Q) and Computer System Validation (CSV) for Machine Safety Risk Reduction and Epson Robotic Arms Upgrade 2020-052-CSV-IQ0Q Consumer Products Company Haina, OR in FFS1, GCC-094336 and GCC-095076 Page 48 of 48 12. TRAINING SHEET Page of Make copies as necessary. The following persons were trained in this protocol prior to the protocol execution. All personnel involved in the execution, review andior verification of any documentation pertaining this protocol, must be trained in this form. For example: Quality Associates, Lead Operators, Operators, Manufacturing Inspectors, Mechanics, Group Leaders, etc. Name Department Position Signature Date Performed by: Date: