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1.    Title Page   Installation and Functional Verification Protocol For Hot Detergent and Hot PUW Generation and Distribution System AuthorAuthor’s Title / Position   Document NumberRevision NumberRevision Date      2.    Approvals Page Prepared By: ________________________      Date:   ____________                         Validation Engineer Approved By:            ________________________      Date:   ____________                         Validation Manager Your signature attests that you have reviewed this document and it complies with relevant validation policies & procedures Approved By:            ________________________      Date:   ____________                         Engineering Your signature attests that……(align with ‘Responsibilities’ Protocol Section-10) Approved By:            ________________________      Date:   ____________                         QA Your signature attests that……(align with ‘Responsibilities’ Protocol Section-10) Approved By:            ________________________      Date:   ____________                         etc. Your signature attests that……(align with ‘Responsibilities’ Protocol Section-10)   3.    Document Revision History RevisionDate of IssueReason for revision updateA12 Jan 2012Issued for review014 Mar 2012Issued for approval and use               4.    Table of Contents Title Page  1Approvals Page     3Document Revision History          4Table of Contents  5Protocol Objective 7System Description           7Scope         9System Impact Assessment……………………………………………………………………. 9Component Impact Assessment……………………………………………………………… 9Summary Table – Operational Critical Components……………………………….. 10P&ID Scope………………………………………………………………………………………. 13Reference Documentation 15Definitions/ Glossary        16Responsibilities / Subject Matter Experts 17Installation Verification Testing Procedures        18P&ID Walkdown Testing Procedure…………………………………………………….. 18Equipment Installation Verification Procedure………………………………………. 20Instrument Installation Verification Procedure………………………………………. 22 Piping Installation Verification Procedure……………………………………………. 24Calibration Program Verification…………………………………………………………. 25Preventative Maintenance Program Verification……………………………………. 25Draft SOP Verification……………………………………………………………………….. 25Test-Instrument Calibration Verification………………………………………………. 25Progression Approval to Proceed to Functional Verification       26Operational-Critical-Instrument Calibration Verification Form……………….. 27Functional Verification Testing Procedures         29Hot Detergent System – Level Control…………………………………………………. 30Hot Detergent System – Flow Control………………………………………………….. 31Hot Detergent System – Temperature Control……………………………………….. 33Hot Detergent System – Detergent Dosing Control………………………………… 35Hot PUW System – Level Control……………………………………………………….. 37Hot PUW System – Flow Control………………………………………………………… 37Hot PUW System – Temperature Control……………………………………………… 37Approved SOP Verification…………………………………………………………………. 38Protocol Quality Procedures         38Signature Log…………………………………………………………………………………….. 38Deviation Procedure…………………………………………………………………………… 39Change Control Procedure…………………………………………………………………… 39IOQ Protocol Summary Report    39List of Appendices 40Appendix A – Protocol Signature Log…………………………………………………… 41Appendix B – Installation Verification GMP checksheets……………………….. 43P&ID Walkdown Installation Verification………………………………………….. 43Equipment Installation Verification……………………………………………………. 44Instrument Installation Verification……………………………………………………. 55Piping Installation Verification………………………………………………………….. 66Calibration Program Verification………………………………………………………. 71Preventative Maintenance Program Verification………………………………….. 73Draft SOP Verification…………………………………………………………………….. 74Test-Instrument Calibration Verification…………………………………………….. 75Appendix C:…………………………………………………………. OQ GMP check-sheets.. 76Hot Detergent System – Level Control……………………………………………….. 76Hot Detergent System – Flow Control………………………………………………… 79Hot Detergent System – Temperature Control…………………………………….. 83Hot Detergent System – Detergent Dosing Control……………………………… 86Hot PUW System – Level Control……………………………………………………… 89Hot PUW System – Flow Control……………………………………………………… 91Hot PUW System – Temperature Control…………………………………………… 95Approved SOP Verification………………………………………………………………. 98Appendix D:………………………………………………………………………. Deviation log.. 99Appendix E:……………………………………………………………………. Deviation Form.. 100Appendix F:…………………………………………………………….. Change Control Log.. 106Appendix G:…………………………………………………………… Change Control Form.. 107Appendix H:…………………………………………….. Component Impact Assessment.. 111Appendix I:……………………………………………………………….. Traceability Matrix.. 116   5.    Protocol Objective The objective of this protocol is to provide testing evidence that will prove that the ‘Hot Detergent and Hot PUW Generation and Distribution’ system is fit for its intended use. Testing will incorporate both installation verification and functional verification test. 6.    System Description Prepare a summary ‘System Description’. Suggestions include drawing a process flow / block diagram; listing critical operational features; and, describing the major equipment components in the context of their installation and functional features.                                                                       7.        7.    Scope 7.1.         System Impact Assessment The ‘Hot Detergent and Hot PUW Generation and Distribution’ is considered a ‘direct impact’ system because:                           7.2.           7.3.         Component Impact Assessment The Component Impact Assessment will drive the scope of the installation and functional verifications. Product contact plus operational critical components must be included in the installation verifications. The operationally critical components will drive the functionality testing.   7.4.         Summary Table – Operational Critical Components #*Operational Critical Component**Additional components in the loop (if applicable)Rationale1   2   3   4   5   6   7   8   9   10   11   12   13   14   15   16   17   18   19   20   21   22   23   24   25   26   27   28   29   30    7.5.             7.6.         P&ID Scope In Protocol Section-7.4 include a copy/scan of the P&ID and either draw a ‘scope bubble’ or yellow-highlight the ‘in-scope’ components.                                                                                           7.7.             8.    Reference Documentation Document #Document DescriptionDocument Location##.####.##.#P&IDEngineering Library##.####.##.#Instrument ListEngineering Library##.####.##.#Equipment ListEngineering Library##.####.##.#E&I DrawingsEngineering Library##.####.##.#Line ListEngineering Library##.####.##.#Commissioning ProtocolEngineering Library##.####.##.#Site VMPQA Library##.####.##.#URSQA Library##.####.##.#System Impact AssessmentQA Library##.####.##.#Validation PlanQA Library##.####.##.#FRSEngineering Library##.####.##.#Validation SOPQA Library##.####.##.#Change Control SOPQA Library##.####.##.#Deviation ProcedureQA Library##.####.##.#Training SOPQA Library##.####.##.#Site documentation policyQA Library##.####.##.#Site GlossaryQA Library 9.        9.    Definitions/ Glossary AcronymDefinitionE&IElectrical & InstrumentationFRSFunctional Requirement SpecificationIQInstallation QualificationOQOperational QualificationP&IDPiping & Instrumentation DiagramSMESubject Matter Expert.SOPStandard Operating ProcedureURSUser Requirement SpecificationVMPValidation Master Plan           10.      Responsibilities / Subject Matter Experts ValidationPrepare ProtocolDepartmental Review & Approval of ProtocolExecute Protocol, including dotting i’s & crossing t’sCo-Ordinate input from other responsible departmentsDocument DeviationsPrepare Report Quality Assuranceetc. Quality controletc. Manufacturingetc. Engineeringetc. Maintenance/ Calibrationsetc. HR / Trainingetc. EHSetc.   11.      Installation Verification Testing Procedures   11.1.     P&ID Walkdown Testing Procedure 1. Description of Test The objective of the test is to verify all direct impact components are installed and orientated correctly as per the functional illustration on the P&ID. 2. Linkage to Requirements Challenged Confirm correct installation and orientation of direct impact components as per the P&ID schematic illustration. 3. Acceptance Criteria All direct impact components are functionally installed and orientated correctly as per the P&ID specification. 4. Prerequisites and/or Assumptions All commissioning activities are complete and commissioning punch-list items are closed out.All testers shall be trained and educated in the test method listed in section-5 below: it is crucial to the success of the testing effort that the testing process be well understood by all participants. 5. Test Method On a blank copy of the P&ID draw in the direct-impact system boundary in black-inkWalk down the P&ID and using a yellow-highlighter confirm each component is correctly installed and orientated as represented on the P&IDConfirm all component tag numbers are correctConfirm all lines are correctly labelledConfirm all lines where applicable are correctly insulatedEnsure all flow direction components are orientated correctlyEnsure all instruments indicators are orientated correctly so as operators can readily view them in the fieldEnsure all commissioning filters are installed in filter-housingsOn the P&ID any additions shall be drawn in using blue-ink, any deletions shall be crossed-out using red ink, comments shall be inserted using green-ink, and sign and date any entries on the P&ID using black-ink 6. Expected Results and Actual results In the IQ GMP test-sheet(s) overleaf, reach a conclusion as to whether each test step has been successfully completed by transcribing bold text from the ‘Expected Results’ column into the corresponding ‘Actual Results’ field.Assess each step listed and determine whether the step has passed or failed.The person performing the test should be identified and the date the testing was performed should be recorded.At the bottom of the test script a validation peer (other than the person performing the test) shall review the script post execution.Quality Assurance (QA) shall approve the completed test.  Validation Peer Review        Print Name Signature Date  11.2.     Equipment Installation Verification Procedure 1. Description of Test The objective of the test is twofold: To verify that all direct impact equipment components are of the correct specification as per the detailed mechanical data sheetsTo verify that all direct impact equipment components are installed and configured correctly as per the functional illustration on the P&ID. 2. Linkage to Requirements Challenged Confirm correct installation and primary specifications of direct impact equipment components as detailed in the P&ID and URS. 3. Acceptance Criteria All direct impact components are of the correct specification, are functionally installed and configured as per the P&ID, the vendor handover documentation is complete, and appropriate material certification is available. 4. Prerequisites and/or Assumptions All commissioning activities are complete and commissioning punch-list items are closed out.All testers shall be trained and educated in the test method listed in section-5 below: it is crucial to the success of the testing effort that the testing process be well understood by all participants. 5. Test Method On the equipment IQ GMP test sheets confirm the equipment description and critical design features. Inspect the installed equipment item in the field and while referencing the vendor’s documentation package verify specification conformance.Confirm that the vendor handover package is in place and contains correct material certificates.In the field visually confirm the following:Equipment item is installed as per P&ID, is securely fitted and is free from damageNameplate is securely fitted, clearly legible and its details conform to the design specificationAll process and utility connections, and instrumentation are connected up to the correct nozzles/flanges, as per P&ID 6. Expected Results and Actual results In the equipment IQ verification forms, reach a conclusion as to whether each test step has been successfully completed by transcribing bold text from the ‘Expected Results’ column into the corresponding ‘Actual Results’ field where appropriate.Assess each step listed and determine whether the step has passed or failed.The person performing the test should be identified and the date the testing was performed should be recorded.At the bottom of the test script a validation peer (other than the person performing the test) shall review the script post execution.Quality Assurance (QA) shall approve the completed test. Validation Peer Review      Print Name Signature Date 11.3.     Instrument Installation Verification Procedure 1. Description of Test The objective of the test is twofold: To verify that all direct impact instruments are of the correct specification as per the detailed instrument data sheetsTo verify that all direct impact instruments components are installed and configured correctly as per the functional illustration on the P&ID. 2. Linkage to Requirements Challenged URS refers to major P&ID components. The system P&ID details all necessary process instrumentation: confirm correct installation and specification of direct impact instrument components. 3. Acceptance Criteria All direct impact instruments are of the correct specification, are functionally installed and configured as per the P&ID, the vendor handover documentation is complete, and appropriate material, calibration and loop-check certification is available. 4. Prerequisites and/or Assumptions All commissioning activities are complete and commissioning punch-list items are closed out.All testers shall be trained and educated in the test method listed in section-5 below: it is crucial to the success of the testing effort that the testing process be well understood by all participants. 5. Test Method On Part-1 of the instrument GMP test sheets confirm the instrument description and critical design features. Inspect the installed instrument item in the field and while referencing the vendor’s documentation package verify conformance:ManufacturerCalibrated RangeMOCLoop CheckedOn Part-2 of the instrument GMP test sheets confirm that the appropriate vendor documentation is available in accordance with the following:Vendor handover package is in placeMaterial Certification is available for wetted partsCalibration Certification is availableLoop Checksheet is available (Yes/No)In the field visually confirm, on Part-3 of the instrument GMP test sheets confirm, the following:Instrument item is installed as per P&ID, is securely fitted and is free from damageInstrument and cabling is correctly tagged and details conform to the design specificationInstrument orientated correctly and is accessible for calibration and maintenance 6. Expected Results and Actual results In the instrument verification forms, reach a conclusion as to whether each test step has been successfully completed by transcribing bold text from the ‘Expected Results’ column into the corresponding ‘Actual Results’ field where appropriate.Assess each step listed and determine whether the step has passed or failed.The person performing the test should be identified and the date the testing was performed should be recorded.At the bottom of the test script a validation peer (other than the person performing the test) shall review the script post execution.Quality Assurance (QA) shall approve the completed test. Validation Peer Review      Print Name Signature Date 11.4.      Piping Installation Verification Procedure 1. Description of Test The objective of the test is to verify all direct impact pipes are installed and orientated correctly as per the functional illustration on the P&ID and piping Isometrics. 2. Linkage to Requirements Challenged Confirm correct installation and orientation of direct impact piping as per the P&ID schematic illustration and piping isometrics. 3. Acceptance Criteria All direct impact components are functionally installed and orientated correctly as per the P&ID’s and isometrics’ specifications. 4. Prerequisites and/or Assumptions All commissioning activities are complete and commissioning punch-list items are closed out.All testers shall be trained and educated in the test method listed in section-5 below: it is crucial to the success of the testing effort that the testing process be well understood by all participants. 5. Test Method Pre-populate the piping verification with the Tag # and material-of-construction (MOC) details.In the field enter the details of the weld log for every each pipe Tag #.Confirm the Weld Log is complete, as the Weld Log collates material-of-construction certificates and weld inspection certificates.In the field record the details of the Pressure Test Pack for every each pipe Tag #.Confirm the Pressure Test is complete verifying the absence of leaksIn the field enter the details of the Construction Dossier for every each pipe Tag #.Confirm all slopes have been checked and verified as correct from the Construction Dossier. 6. Expected Results and Actual results In the IQ GMP test-sheet(s) overleaf, reach a conclusion as to whether each test step has been successfully completed by transcribing bold text from the ‘Expected Results’ column into the corresponding ‘Actual Results’ field.Assess each step listed and determine whether the step has passed or failed.The person performing the test should be identified and the date the testing was performed should be recorded.At the bottom of the test script a validation peer (other than the person performing the test) shall review the script post execution.Quality Assurance (QA) shall approve the completed test.     Validation Peer Review      Print Name Signature Date   11.5.     Calibration Program Verification During installation verification we need to verify that instruments are in the calibration system. Here summarize a ‘Calibration Program Verification’ procedure that complements the form in Protocol Section-16.2.5. 11.6.     Preventative Maintenance Program Verification During IQ, we need to verify that instruments are in the Preventative Maintenance system. Here summarize a ‘Preventative Maintenance Program Verification’ procedure that complements the form in Protocol Section-16.2.6. 11.7.     Draft SOP Verification Prior to proceeding to functional verification, we need to ensure the required SOPs are in-draft. Propose a list of necessary standard operating procedures for the ‘Hot Detergent and Hot PUW Generation and Distribution’ system and enter the equivalent details into the form in Protocol Section-16.2.7. Ensure the details in the list of draft SOPs aligns with Protocol Section-13.8 ‘Approved SOP Verification’ and its associated form in Protocol Section-16.3.8. 11.8.     Test-Instrument Calibration Verification Suggest a list of test instruments that may be required for the testing phase. Enter the equivalent details into the form in Protocol Section-16.2.8   12.      Progression Approval to Proceed to Functional Verification The signatories below verify the following: That the installation verification testing phase is sufficiently complete and permission is given to progress to the functional verification testing phase.All critical deviations from the installation verification testing phase have been closed out, or a change control initiated in its place.All critical items are installed.All operational critical instruments will remain in a calibrated state during the functional verification testing phase. Prepared By: ________________________      Date:   ____________                         Validation Engineer Approved By:            ________________________      Date:   ____________                         Validation Manager Your signature attests that you have reviewed this document and it complies with relevant validation policies & procedures Approved By:            ________________________      Date:   ____________                         Engineering Your signature attests that……(align with ‘Responsibilities’ Protocol Section-2) Approved By:            ________________________      Date:   ____________                         QA Your signature attests that……(align with ‘Responsibilities’ Protocol Section-2) Approved By:            ________________________      Date:   ____________                         etc. Your signature attests that……(align with ‘Responsibilities’ Protocol Section-2)   12.1.     Operational-Critical-Instrument Calibration Verification Form Page _ __ of _ __ Operational-Critical-Instrument Calibration Verification Form Critical instruments associated with the system will remain in a calibrated state during the anticipated OQ execution timeframe? (Yes/No)Verified By / Date                                        Comments:  Reviewed By: Validation Date: Approved By: (QA) Date:  Page _ __ of _ __ Operational-Critical-Instrument Calibration Verification Form Critical instruments associated with the system will remain in a calibrated state during the anticipated OQ execution timeframe? (Yes/No)Verified By / Date                                        Comments:  Reviewed By: Validation Date: Approved By: (QA) Date:    13.      Functional Verification Testing Procedures 13.3.1        Hot Detergent System – Level Control 13.3.2        Hot Detergent System – Flow Control 13.3.3        Hot Detergent System – Temperature Control 13.3.4        Hot Detergent System – Detergent Dosing Control 13.3.5        Hot PUW System – Level Control 13.3.6        Hot PUW System – Flow Control 13.3.7        Hot PUW System – Temperature Control 13.3.8        Approved SOP Verification 13.1.     Hot Detergent System – Level Control 1. Short description of the test The objective of this test is to confirm that the Hot Detergent Tank is filled and maintained to a level of 5775 litres +/-5% from the 25°C PUW1 water loop. 2. Linkage to the requirements challenged URS Section 3.3: The system shall have the facility to maintain the level in the Hot Detergent Tank at 5775 litres +/-5%. Operationally Critical Component(s): Hydrostatic Pressure Type level transmitter LT-002Low level Switch (tuning fork type) LS-004High Level Switch (tuning fork type) LS-006 3. Acceptance criteria for the test The level measurement LT-002 shall read 5775 litres +/-5% before, during and after the maximum instantaneous detergent drawdown. 4. Prerequisites and or assumptions All commissioning activities are complete and commissioning punch-list items are closed out.All testers shall be trained and educated in the test method listed in section-5 below: it is crucial to the success of the testing effort that the testing process be well understood by all participants.Level transmitter LT-002 is currently within calibration 5. Specific Test Steps The Hot Detergent Tank is fed directly from the 25°C PUW1 water loop.At time = 0 (t0-min) confirm the level in the Detergent Tank.Note the level in the tank every 5-minutes until it reaches 5775 litres +/-5%. The filling of the tank should stop automatically at this level.Open the drain valve at the bottom of the tank and flow the water to drain. The tank should automatically start filling again from the 25°C PUW1 water loop and maintain a level of 5775 litres +/-5%.Note the level in the tank every 5-minutes for 30-minutes.Close the drain valve and the level in the tank should maintain 5775 litres +/-5% for a further 30-minutes with no further drawdown.In the table provided confirm the level in the Hot Detergent Tank by recording the value at successive 5-minute intervals, noting the time for each measurementPrint out the readings of level in the tank (LT-002) from the computer control system during the test period and append to this test section. 6. Expected results and Actual results In the check-sheets in Appendix-C1, reach a conclusion as to whether each test step has been successfully completed by transcribing bold text from the ‘Expected Results’ column into the corresponding ‘Actual Results’ field.Assess each step listed and determine whether the step has passed or failed.The person performing the test should be identified and the date the testing was performed should be recorded.At the bottom of the test script a validation peer (other than the person performing the test) shall review the script post execution.Quality Assurance (QA) shall approve the completed test. Validation Peer Review      Print Name Signature Date 13.2.     Hot Detergent System – Flow Control 1. Short description of the test The objective of this test is to confirm that the flow rate of the Hot Detergent transfer loop is maintained between 3,000 litres/hr +/-5% and 25,000 litres/hr +/-5%, before, during and after the transfer of water from the Hot Detergent Tank into reactors RE-119 and RE-140 (which are both to be filled at the same time at a rate of 11,000 litres/hr each). 2. Linkage to the requirements challenged The system shall be capable of achieving and maintaining a maximum outward flowrate of the loop to reactors RE-119 and RE-140 of 25,000 litres/hr +/-5%The system shall be capable of achieving and maintaining a minimum return flowrate of the loop to the Hot Detergent tank of 3,000 litres/hr +/-5% when filling the two reactors RE-119 and RE-140 at a rate of 11,000 litres/hr.The maximum number of simultaneous users being washed by the CIP system shall be two.            Operationally Critical Component(s): Magnetic Flow Transmitter FT-002Magnetic Flow Transmitter FT-004Hydrostatic Pressure Type level transmitter LT-002Hydrostatic Pressure Type level transmitter LT-119Hydrostatic Pressure Type level transmitter LT-140 3. Acceptance criteria for the test The online flow measurement FT-002 (on the outward flow loop) shall read 25,000 litres/hr +/-5% before, during and after the maximum transfer flowrate into RE-119 and RE-140.The online flow measurement FT-004 (on the return loop) shall read 3,000 litres/hr +/-5% to before, during and after the maximum transfer flowrate into RE-119 and RE-140. 4. Prerequites and or assumptions All commissioning activities are complete and commissioning punch-list items are closed out.All testers shall be trained and educated in the test method listed in section-5 below: it is crucial to the success of the testing effort that the testing process be well understood by all participants.Flow transmitters FT-002 and FT-004 and level transmitters LT-002, LT-119 and LT-140 are currently within calibration 5. Specific Test Steps Check the Hot Detergent Tank is filled to a level of 5775 litres +/-5% from the 25°C PUW1 water loop, noting the level reading on LT-002Start the Hot Detergent Pump circulating.Confirm the initial flow reading of FT-002 and FT-004 at time = 0 (t0-min) and note the flow every 5-minutes for 30-minutes.Open the transfer valves to RE-119 and RE-140 and transfer 5,500 litres into each vessel (this will take approximately 30-minutes), noting the level on LT-119 and LT-140Note the flow reading on FT-002 and FT-004 every 5-minutes during the transfer.Note the level in the Hot Detergent Tank maintains 5775 litres +/-5% (LT-002) during the transferAfter transferring 5,500 litres into both RE-119 and Re-140 stop the transfer and maintain the CIP skid in normal recirculation operation mode for a further 30-minutes with no further drawdown.In the table provided confirm the level in the Hot Detergent Tank (LT-002) and the flowrate readings of FT-002 and FT-004 by recording the value at successive 5-minute intervals, noting the time for each measurement.In the same table also record the values for level in reactor RE-119 and reactor RE-140 from level-transmitters LT-119 and LT-140.Print out the readings of FT-002, FT-004, LT-119 and LT-140 from the computer control system during the test period and append to this test section. 6. Expected results and Actual results In the check-sheets in Appendix-C1, reach a conclusion as to whether each test step has been successfully completed by transcribing bold text from the ‘Expected Results’ column into the corresponding ‘Actual Results’ field.Assess each step listed and determine whether the step has passed or failed.The person performing the test should be identified and the date the testing was performed should be recorded.At the bottom of the test script a validation peer (other than the person performing the test) shall review the script post execution.Quality Assurance (QA) shall approve the completed test. Validation Peer Review      Print Name Signature Date 13.3.     Hot Detergent System – Temperature Control 1. Short description of the test The objective of this test is to confirm that the supply temperature of Hot Detergent is maintained at80°C±5°C, before, during and after maximum instantaneous detergent drawdown when the two biggest users (reactors RE-119 and RE-140) are being be charged simultaneously. 2. Linkage to the requirements challenged The Hot Detergent supply temperature shall be maintained by a closed loop control system, which modulates steam flow to the heat exchanger.The control system shall be capable of controlling the supply temperature to within +/-5°C of the setpoint (80°C±5°C). Operationally Critical Component(s): Bimetalic Temperature Indicator TI-0083 wire RTD Temperature transmitter TT-0023 wire RTD Temperature transmitter TT-004Magnetic Flow Transmitter FT-002Magnetic Flow Transmitter FT-004Hydrostatic Pressure Type level transmitter LT-002Hydrostatic Pressure Type level transmitter LT-119Hydrostatic Pressure Type level transmitter LT-140 3. Acceptance criteria for the test The online temperature measurements TT-002 (on the outward loop) & TT004 (on the return loop) reads 80°C±5°C before, during and after the maximum instantaneous detergent drawdown to fill RE-119 and RE-140. 4. Prerequites and or assumptions All commissioning activities are complete and commissioning punch-list items are closed out.All testers shall be trained and educated in the test method listed in section-5 below: it is crucial to the success of the testing effort that the testing process be well understood by all participants.Temperature transmitters TT-002 & TT-004, flow transmitters FT-002 and FT-004, level transmitters LT-002, LT-119 and LT-140 are currently within calibration 5. Specific Test Steps Check the Hot Detergent Tank is filled to a level of 5775 litres +/-5% from the 25°C PUW1 water loop, noting the level reading on LT-002Start the Hot Detergent Pump circulating and confirm the initial flow reading of FT-002 and FT-004 are 25,000 litres/hrNote the initial temperature of TT-002 and TT-004 at time = 0 (t0-min) and commence heating the recirculating water to up 80°C±5°C noting the temperature readings every 5-minutes.Maintain the temperature at 80°C±5°C for 30-minutes on the recirculation loop.Open the transfer valves to RE-119 and RE-140 and transfer 5,500 litres into each vessel (this will take approximately 30-minutes), noting the level on LT-119 and LT-140Note the flow reading on FT-002 and FT-004 and the level reading in the Hot Detergent Tank (LT-002) every 5-minutes during the transfer.Note the temperature of TT-002 and TT-004 during the transfer. It should maintain 80°C±5°CAfter transferring 5,500 litres into both RE-119 and RE-140 stop the transfer and maintain the CIP skid in normal recirculation operation mode for a further 30-minutes with no further drawdown.In the table provided confirm the temperature of TT-002 and TT-004, and in the reactors (LT-119 and LT-140) and the flowrate readings of FT-002 and FT-004 by recording the value at successive 5-minute intervals, noting the time for each measurement.Print out the readings of TT-002, TT-004, FT-002, FT-004, LT-119 and LT-140 from the computer control system during the test period and append to this test section. 6. Expected results and Actual results In the check-sheets in Appendix-C1, reach a conclusion as to whether each test step has been successfully completed by transcribing bold text from the ‘Expected Results’ column into the corresponding ‘Actual Results’ field.Assess each step listed and determine whether the step has passed or failed.The person performing the test should be identified and the date the testing was performed should be recorded.At the bottom of the test script a validation peer (other than the person performing the test) shall review the script post execution.Quality Assurance (QA) shall approve the completed test. Validation Peer Review      Print Name Signature Date 13.4.     Hot Detergent System – Detergent Dosing Control 1. Short description of the test At 80°C±5°C, 2% ± 0.05% detergent concentration is equivalent to 500 μScm-1 ± 0.25 μScm-1. The objective of this test is to confirm that the supply detergent concentration, at a temperature of 80°C±5°C, is maintained at 500 μScm-1 ± 0.25 μScm-1, before, during and after maximum instantaneous detergent drawdown when the two biggest users (reactors RE-119 and RE-140) are being be charged simultaneously. 2. Linkage to the requirements challenged URS Section 3.5: The system shall have the facility to automatically dose STERIS 100 detergent to the required concentration (2% ± 0.05%)Online conductivity measurement shall be provided to verify the detergent concentration Operationally Critical Component(s): Conductivity transmitter CT-0013 wire RTD Temperature transmitter TT-0023 wire RTD Temperature transmitter TT-004Magnetic Flow Transmitter FT-002Magnetic Flow Transmitter FT-004Hydrostatic Pressure Type level transmitter LT-002Hydrostatic Pressure Type level transmitter LT-119Hydrostatic Pressure Type level transmitter LT-140 3. Acceptance criteria for the test At 80°C±5°C, the online conductivity measurement CT-001 read 500 μScm-1 ± 0.25 μScm-1 before, during and after the maximum instantaneous detergent drawdown. 4. Prerequisites and or assumptions All commissioning activities are complete and commissioning punch-list items are closed out.All testers shall be trained and educated in the test method listed in section-5 below: it is crucial to the success of the testing effort that the testing process be well understood by all participants.Conductivity transmitter CT-001, temperature transmitters TT-002 & TT-004, flow transmitters FT-002 and FT-004, level transmitters LT-002, LT-119 and LT-140 are currently within calibration 5. Specific Test Steps Check the Hot Detergent Tank is filled to a level of 5775 litres +/-5% with PUW water loop (noting the level reading on LT-002)Start up the hot detergent recirculation system. Give the system time to warm up until it is recirculating this water at 80°C±5°C  (noting the temperature readings on TT-002 and TT-004) at a flow of 25,000 litres/hr (noting the flow readings on FT-002 and FT-004)Start introducing detergent into the recirculation system at time = 0 (t0-min) and note the conductivity measurement of the recirculating water every 5-minutes for the next 30 minutes. The concentration of detergent in the water is measured by its conductivity using CT-001 until it reaches a level of 500 μScm-1 ± 0.25 μScm-1 (equivalent to a detergent concentration of 2% ± 0.05%).Maintain the conductivity of the recirculation loop at 500 μScm-1 ± 0.25 μScm-1 at a temperature of 80°C±5°C and a flow of 25,000 litres/hr. Open the transfer valves to RE-119 and RE-140 and transfer 5,500 litres into each vessel (this will take approximately 30-minutes), noting the level on LT-119 and LT-140Note the conductivity readings (CT-001) for the recirculation loop every 5-minutes during the transfer, in addition to the temperature (80°C±5°C) and the flow (25,000 litres/hr) and the level of Hot Detergent Tank.After transferring 5,500 litres into both RE-119 and RE-140 stop the transfer and maintain the CIP skid in normal recirculation operation mode for a further 30-minutes with no further drawdown.In the table provided confirm the conductivity of CT-001, the temperature of TT-002 and TT-004, and in the reactors (LT-119 and LT-140) and the flowrate readings of FT-002 and FT-004 by recording the value at successive 5-minute intervals, noting the time for each measurement.Print out the readings of CT-001, TT-002, TT-004, FT-002, FT-004, LT-119 and LT-140 from the computer control system during the test period and append to this test section. 6. Expected results and Actual results In the check-sheets in Appendix-C1, reach a conclusion as to whether each test step has been successfully completed by transcribing bold text from the ‘Expected Results’ column into the corresponding ‘Actual Results’ field.Assess each step listed and determine whether the step has passed or failed.The person performing the test should be identified and the date the testing was performed should be recorded.At the bottom of the test script a validation peer (other than the person performing the test) shall review the script post execution.Quality Assurance (QA) shall approve the completed test.  Validation Peer Review      Print Name Signature Date 13.5.     Hot PUW System – Level Control 1. Short Description of the Test 2. Linkage to Requirements Challenged 3. Acceptance Criteria for the Test 4. Prerequisites and/or assumptions 5. Specific Test Steps 6. Expected Results and Actual Results 13.6.     Hot PUW System – Flow Control 1. Short Description of the Test 2. Linkage to Requirements Challenged 3. Acceptance Criteria for the Test 4. Prerequisites and/or assumptions 5. Specific Test Steps 6. Expected Results and Actual Results 13.7.     Hot PUW System – Temperature Control 1. Short Description of the Test 2. Linkage to Requirements Challenged 3. Acceptance Criteria for the Test 4. Prerequisites and/or assumptions 5. Specific Test Steps 6. Expected Results and Actual Results 13.8.     Approved SOP Verification In Protocol Section-13.8 ‘Approved SOP Verification’ ensure this list of approved SOPs aligns with Protocol Section-11.7 and its associated form in Protocol Section-16.2.7. Enter the equivalent details in the form collated in Protocol Section-16.3.8.   14.      Protocol Quality Procedures 14.1.     Signature Log Summarize ‘Signature-Log’ procedure that complements the log in Protocol Section-16.1.                 14.2.       14.3.     Deviation Procedure Summarize a protocol deviation procedure that complements the Deviation log in Protocol Section-16.4 and the Deviation Form in Protocol Section-16.5.               14.4.       14.5.     Change Control Procedure Summarize a Change Control deviation procedure that complements the Change Control log in Protocol Section-16.6 and the Change Control Form in Protocol Section-16.7.               14.6.       15.      IOQ Protocol Summary Report Following field execution of this validation protocol a validation report that cross-references the validation protocol will be prepared, summarising the results obtained, commenting on any deviations observed, and drawing the appropriate conclusions, including recommending changes to correct deficiencies.   16.      List of Appendices Appendix A:        Signature Log Appendix B:        Installation Verification GMP checksheets P&ID Walkdown Installation VerificationEquipment Installation VerificationInstrument Installation VerificationPiping Installation VerificationCalibration Program VerificationPreventative Maintenance Program VerificationDraft SOP VerificationTest-Instrument Calibration Verification Appendix C:        Functional Verification check-sheets Hot Detergent System – Level ControlHot Detergent System – Flow ControlHot Detergent System – Temperature ControlHot Detergent System – Detergent Dosing ControlHot PUW System – Level ControlHot PUW System – Flow ControlHot PUW System – Temperature Control Appendix D:        Deviation log Appendix E:        Deviation form Appendix F:         Change control log Appendix G:        Change control form Appendix H:        Component Impact Assessment Appendix I:          Traceability Matrix   16.1.     Appendix A – Protocol Signature Log Page __ of __ Signature Log Printed NameSignatureInitialsDateCompany/Title/DepartmentGMP Trained (Yes / No)                                                                                                                        Comments:    Reviewed By: Validation Date: Approved By: (QA) Date:    16.2.     Appendix B – Installation Verification GMP checksheets 16.2.1.               P&ID Walkdown Installation Verification P&ID # P&ID Description  16.2.2.    Test StepExpected ResultsActual ResultsPass / FailInitials and Date (dd/mmm/yyyy)1Walk down the P&ID and using a yellow-highlighter confirm each component is correctly installed and orientated as represented on the P&IDComponents correctly installed   2Confirm all component tag numbers are correctTag numbers correct   3Confirm all lines are correctly labelledLines correctly labelled   4Confirm all lines where applicable are correctly insulatedLines correctly insulated   5Ensure all flow direction components are orientated correctlyFlow directions correct   6Ensure all instruments indicators are orientated correctly so as operators can readily view themIndicators orientated correctly   7Ensure all commissioning filters are installed in filter-housingsFilters installed     Comments:            Validation Peer Review        Print Name Signature Date   QA Approval        Print Name Signature Date    16.2.3.               Equipment Installation Verification Sheet __ of ______ Installation VerificationTag #: ______Equipment Description and Critical Design FeaturesInspect the installed equipment item and the vendor’s documentation and verify correct specification conformanceSpecifiedActualVerification (Pass/Fail)Initials / Date1Manufacturer    2Capacity    3M.O.C.    4Design Pressure Range    5Design Temp Range    Documentation VerificationConfirm that the vendor handover package is in place and contains correct material certificatesVerification (Pass/Fail)InitialsDate1Vendor handover package is in place   2Material Certification is available for wetted parts   Installation VerificationVisually inspect, and subsequently verify, the correct installation of the equipment item in the fieldVerification (Pass/Fail)InitialsDate1Equipment item is installed as per P&ID, is securely fitted and is free from damage   2Nameplate is securely fitted, clearly legible and its details conform to the design specification   3All process and utility connections, and instrumentation are connected up to the correct nozzles/flanges, as per P&ID    16.2.4.    Comments:               Validation Peer Review        Print Name Signature Date   QA Approval        Print Name Signature Date  Sheet __ of ______ Installation VerificationTag #: ______Equipment Description and Critical Design FeaturesInspect the installed equipment item and the vendor’s documentation and verify correct specification conformanceSpecifiedActualVerification (Pass/Fail)Initials / Date1Manufacturer    2Capacity    3M.O.C.    4Design Pressure Range    5Design Temp Range    Documentation VerificationConfirm that the vendor handover package is in place and contains correct material certificatesVerification (Pass/Fail)InitialsDate1Vendor handover package is in place   2Material Certification is available for wetted parts   Installation VerificationVisually inspect, and subsequently verify, the correct installation of the equipment item in the fieldVerification (Pass/Fail)InitialsDate1Equipment item is installed as per P&ID, is securely fitted and is free from damage   2Nameplate is securely fitted, clearly legible and its details conform to the design specification   3All process and utility connections, and instrumentation are connected up to the correct nozzles/flanges, as per P&ID     Comments:               Validation Peer Review        Print Name Signature Date   QA Approval        Print Name Signature Date    Sheet __ of ______ Installation VerificationTag #: ______Equipment Description and Critical Design FeaturesInspect the installed equipment item and the vendor’s documentation and verify correct specification conformanceSpecifiedActualVerification (Pass/Fail)Initials / Date1Manufacturer    2Capacity    3M.O.C.    4Design Pressure Range    5Design Temp Range    Documentation VerificationConfirm that the vendor handover package is in place and contains correct material certificatesVerification (Pass/Fail)InitialsDate1Vendor handover package is in place   2Material Certification is available for wetted parts   Installation VerificationVisually inspect, and subsequently verify, the correct installation of the equipment item in the fieldVerification (Pass/Fail)InitialsDate1Equipment item is installed as per P&ID, is securely fitted and is free from damage   2Nameplate is securely fitted, clearly legible and its details conform to the design specification   3All process and utility connections, and instrumentation are connected up to the correct nozzles/flanges, as per P&ID     Comments:               Validation Peer Review        Print Name Signature Date   QA Approval        Print Name Signature Date  Sheet __ of ______ Installation VerificationTag #: ______Equipment Description and Critical Design FeaturesInspect the installed equipment item and the vendor’s documentation and verify correct specification conformanceSpecifiedActualVerification (Pass/Fail)Initials / Date1Manufacturer    2Capacity    3M.O.C.    4Design Pressure Range    5Design Temp Range    Documentation VerificationConfirm that the vendor handover package is in place and contains correct material certificatesVerification (Pass/Fail)InitialsDate1Vendor handover package is in place   2Material Certification is available for wetted parts   Installation VerificationVisually inspect, and subsequently verify, the correct installation of the equipment item in the fieldVerification (Pass/Fail)InitialsDate1Equipment item is installed as per P&ID, is securely fitted and is free from damage   2Nameplate is securely fitted, clearly legible and its details conform to the design specification   3All process and utility connections, and instrumentation are connected up to the correct nozzles/flanges, as per P&ID     Comments:               Validation Peer Review        Print Name Signature Date   QA Approval        Print Name Signature Date  Sheet __ of ______ Installation VerificationTag #: ______Equipment Description and Critical Design FeaturesInspect the installed equipment item and the vendor’s documentation and verify correct specification conformanceSpecifiedActualVerification (Pass/Fail)Initials / Date1Manufacturer    2Capacity    3M.O.C.    4Design Pressure Range    5Design Temp Range    Documentation VerificationConfirm that the vendor handover package is in place and contains correct material certificatesVerification (Pass/Fail)InitialsDate1Vendor handover package is in place   2Material Certification is available for wetted parts   Installation VerificationVisually inspect, and subsequently verify, the correct installation of the equipment item in the fieldVerification (Pass/Fail)InitialsDate1Equipment item is installed as per P&ID, is securely fitted and is free from damage   2Nameplate is securely fitted, clearly legible and its details conform to the design specification   3All process and utility connections, and instrumentation are connected up to the correct nozzles/flanges, as per P&ID     Comments:               Validation Peer Review        Print Name Signature Date   QA Approval         Print Name Signature Date     Sheet __ of ______ Installation VerificationTag #: ______ Equipment Description and Critical Design Features Inspect the installed equipment item and the vendor’s documentation and verify correct specification conformanceSpecifiedActualVerification (Pass/Fail)Initials / Date 1Manufacturer     2Capacity     3M.O.C.     4Design Pressure Range     5Design Temp Range     Documentation Verification Confirm that the vendor handover package is in place and contains correct material certificatesVerification (Pass/Fail)InitialsDate 1Vendor handover package is in place    2Material Certification is available for wetted parts    Installation Verification Visually inspect, and subsequently verify, the correct installation of the equipment item in the fieldVerification (Pass/Fail)InitialsDate 1Equipment item is installed as per P&ID, is securely fitted and is free from damage    2Nameplate is securely fitted, clearly legible and its details conform to the design specification    3All process and utility connections, and instrumentation are connected up to the correct nozzles/flanges, as per P&ID     Comments:               Validation Peer Review        Print Name Signature Date   QA Approval        Print Name Signature Date  Sheet __ of ______ Installation VerificationTag #: ______Equipment Description and Critical Design FeaturesInspect the installed equipment item and the vendor’s documentation and verify correct specification conformanceSpecifiedActualVerification (Pass/Fail)Initials / Date1Manufacturer    2Capacity    3M.O.C.    4Design Pressure Range    5Design Temp Range    Documentation VerificationConfirm that the vendor handover package is in place and contains correct material certificatesVerification (Pass/Fail)InitialsDate1Vendor handover package is in place   2Material Certification is available for wetted parts   Installation VerificationVisually inspect, and subsequently verify, the correct installation of the equipment item in the fieldVerification (Pass/Fail)InitialsDate1Equipment item is installed as per P&ID, is securely fitted and is free from damage   2Nameplate is securely fitted, clearly legible and its details conform to the design specification   3All process and utility connections, and instrumentation are connected up to the correct nozzles/flanges, as per P&ID     Comments:               Validation Peer Review        Print Name Signature Date   QA Approval        Print Name Signature Date  Sheet __ of ______ Installation VerificationTag #: ______Equipment Description and Critical Design FeaturesInspect the installed equipment item and the vendor’s documentation and verify correct specification conformanceSpecifiedActualVerification (Pass/Fail)Initials / Date1Manufacturer    2Capacity    3M.O.C.    4Design Pressure Range    5Design Temp Range    Documentation VerificationConfirm that the vendor handover package is in place and contains correct material certificatesVerification (Pass/Fail)InitialsDate1Vendor handover package is in place   2Material Certification is available for wetted parts   Installation VerificationVisually inspect, and subsequently verify, the correct installation of the equipment item in the fieldVerification (Pass/Fail)InitialsDate1Equipment item is installed as per P&ID, is securely fitted and is free from damage   2Nameplate is securely fitted, clearly legible and its details conform to the design specification   3All process and utility connections, and instrumentation are connected up to the correct nozzles/flanges, as per P&ID     Comments:               Validation Peer Review        Print Name Signature Date   QA Approval        Print Name Signature Date  Sheet __ of ______ Installation VerificationTag #: ______Equipment Description and Critical Design FeaturesInspect the installed equipment item and the vendor’s documentation and verify correct specification conformanceSpecifiedActualVerification (Pass/Fail)Initials / Date1Manufacturer    2Capacity    3M.O.C.    4Design Pressure Range    5Design Temp Range    Documentation VerificationConfirm that the vendor handover package is in place and contains correct material certificatesVerification (Pass/Fail)InitialsDate1Vendor handover package is in place   2Material Certification is available for wetted parts   Installation VerificationVisually inspect, and subsequently verify, the correct installation of the equipment item in the fieldVerification (Pass/Fail)InitialsDate1Equipment item is installed as per P&ID, is securely fitted and is free from damage   2Nameplate is securely fitted, clearly legible and its details conform to the design specification   3All process and utility connections, and instrumentation are connected up to the correct nozzles/flanges, as per P&ID     Comments:               Validation Peer Review        Print Name Signature Date   QA Approval         Print Name Signature Date     Sheet __ of ______ Installation VerificationTag #: ______ Equipment Description and Critical Design Features Inspect the installed equipment item and the vendor’s documentation and verify correct specification conformanceSpecifiedActualVerification (Pass/Fail)Initials / Date 1Manufacturer     2Capacity     3M.O.C.     4Design Pressure Range     5Design Temp Range     Documentation Verification Confirm that the vendor handover package is in place and contains correct material certificatesVerification (Pass/Fail)InitialsDate 1Vendor handover package is in place    2Material Certification is available for wetted parts    Installation Verification Visually inspect, and subsequently verify, the correct installation of the equipment item in the fieldVerification (Pass/Fail)InitialsDate 1Equipment item is installed as per P&ID, is securely fitted and is free from damage    2Nameplate is securely fitted, clearly legible and its details conform to the design specification    3All process and utility connections, and instrumentation are connected up to the correct nozzles/flanges, as per P&ID     Comments:               Validation Peer Review        Print Name Signature Date   QA Approval        Print Name Signature Date  16.2.5.               Instrument Installation Verification Sheet __ of _____ Installation Verification Part-1: ___ Transmitter Description and Critical Design FeaturesInspect the installed instrument item and the vendor’s documentation and verify correct specification conformanceTag #Specified ManufacturerActualSpecified RangeActualSpecified MOCActualLoop Checked (Yes/No)Verification (Pass/Fail)Initials / Date__-__         __-__         __-__         __-__         __-__          16.2.6.                  Comments:         Validation Peer Review        Print Name Signature Date   QA Approval        Print Name Signature Date  Sheet __ of ______ Installation Verification Part-2: ___ Documentation VerificationConfirm that the vendor handover package is in place and contains correct material certificatesTag #*Vendor handover package is in place (Yes/No)Material Certification is available for wetted parts (Yes/No)Cert #Calibration Certification is available (Yes/No)Cert #Loop Checksheet is available (Yes/No)Checksheet #Verification (Pass/Fail)Initials / Date__-__         __-__         __-__         __-__         __-__             Comments:      Validation Peer Review        Print Name Signature Date   QA Approval        Print Name Signature Date  Sheet __ of _____ Installation Verification Part-3: ___ Installation VerificationVisually inspect, and subsequently verify, the correct installation of the instrument item in the fieldTag #Instrument item is installed as per P&ID, is securely fitted and is free from damage (Yes/No)Instrument and cabling is correctly tagged and details conform to the design specification (Yes/No)Instrument orientated correctly and is accessible for calibration and maintenance (Yes/No)Verification (Pass/Fail)InitialsDate__-__      __-__      __-__      __-__      __-__        Comments:         Validation Peer Review        Print Name Signature Date   QA Approval        Print Name Signature Date  Sheet __ of _____ Installation Verification Part-1: ___ Transmitter Description and Critical Design FeaturesInspect the installed instrument item and the vendor’s documentation and verify correct specification conformanceTag #Specified ManufacturerActualSpecified RangeActualSpecified MOCActualLoop Checked (Yes/No)Verification (Pass/Fail)Initials / Date__-__         __-__         __-__         __-__         __-__           Comments:         Validation Peer Review        Print Name Signature Date   QA Approval        Print Name Signature Date  Sheet __ of ______ Installation Verification Part-2: ___ Documentation VerificationConfirm that the vendor handover package is in place and contains correct material certificatesTag #*Vendor handover package is in place (Yes/No)Material Certification is available for wetted parts (Yes/No)Cert #Calibration Certification is available (Yes/No)Cert #Loop Checksheet is available (Yes/No)Checksheet #Verification (Pass/Fail)Initials / Date__-__         __-__         __-__         __-__         __-__             Comments:      Validation Peer Review        Print Name Signature Date   QA Approval        Print Name Signature Date  Sheet __ of _____ Installation Verification Part-3: ___ Installation VerificationVisually inspect, and subsequently verify, the correct installation of the instrument item in the fieldTag #Instrument item is installed as per P&ID, is securely fitted and is free from damage (Yes/No)Instrument and cabling is correctly tagged and details conform to the design specification (Yes/No)Instrument orientated correctly and is accessible for calibration and maintenance (Yes/No)Verification (Pass/Fail)InitialsDate__-__      __-__      __-__      __-__      __-__        Comments:         Validation Peer Review        Print Name Signature Date   QA Approval        Print Name Signature Date  Sheet __ of _____ Installation Verification Part-1: ___ Transmitter Description and Critical Design FeaturesInspect the installed instrument item and the vendor’s documentation and verify correct specification conformanceTag #Specified ManufacturerActualSpecified RangeActualSpecified MOCActualLoop Checked (Yes/No)Verification (Pass/Fail)Initials / Date__-__         __-__         __-__         __-__         __-__           Comments:         Validation Peer Review        Print Name Signature Date   QA Approval        Print Name Signature Date  Sheet __ of ______ Installation Verification Part-2: ___ Documentation VerificationConfirm that the vendor handover package is in place and contains correct material certificatesTag #*Vendor handover package is in place (Yes/No)Material Certification is available for wetted parts (Yes/No)Cert #Calibration Certification is available (Yes/No)Cert #Loop Checksheet is available (Yes/No)Checksheet #Verification (Pass/Fail)Initials / Date__-__         __-__         __-__         __-__         __-__             Comments:      Validation Peer Review        Print Name Signature Date   QA Approval        Print Name Signature Date  Sheet __ of _____ Installation Verification Part-3: ___ Installation VerificationVisually inspect, and subsequently verify, the correct installation of the instrument item in the fieldTag #Instrument item is installed as per P&ID, is securely fitted and is free from damage (Yes/No)Instrument and cabling is correctly tagged and details conform to the design specification (Yes/No)Instrument orientated correctly and is accessible for calibration and maintenance (Yes/No)Verification (Pass/Fail)InitialsDate__-__      __-__      __-__      __-__      __-__        Comments:         Validation Peer Review        Print Name Signature Date   QA Approval               Print Name Signature Date  Sheet __ of _____ Installation Verification Part-1: ___ Transmitter Description and Critical Design FeaturesInspect the installed instrument item and the vendor’s documentation and verify correct specification conformanceTag #Specified ManufacturerActualSpecified RangeActualSpecified MOCActualLoop Checked (Yes/No)Verification (Pass/Fail)Initials / Date__-__         __-__         __-__         __-__         __-__           Comments:         Validation Peer Review        Print Name Signature Date   QA Approval        Print Name Signature Date  Sheet __ of ______ Installation Verification Part-2: ___ Documentation VerificationConfirm that the vendor handover package is in place and contains correct material certificatesTag #*Vendor handover package is in place (Yes/No)Material Certification is available for wetted parts (Yes/No)Cert #Calibration Certification is available (Yes/No)Cert #Loop Checksheet is available (Yes/No)Checksheet #Verification (Pass/Fail)Initials / Date__-__         __-__         __-__         __-__         __-__             Comments:      Validation Peer Review        Print Name Signature Date   QA Approval        Print Name Signature Date  Sheet __ of _____ Installation Verification Part-3: ___ Installation VerificationVisually inspect, and subsequently verify, the correct installation of the instrument item in the fieldTag #Instrument item is installed as per P&ID, is securely fitted and is free from damage (Yes/No)Instrument and cabling is correctly tagged and details conform to the design specification (Yes/No)Instrument orientated correctly and is accessible for calibration and maintenance (Yes/No)Verification (Pass/Fail)InitialsDate__-__      __-__      __-__      __-__      __-__        Comments:         Validation Peer Review        Print Name Signature Date   QA Approval        Print Name Signature Date  Sheet __ of _____ Installation Verification Part-1: ___ Transmitter Description and Critical Design FeaturesInspect the installed instrument item and the vendor’s documentation and verify correct specification conformanceTag #Specified ManufacturerActualSpecified RangeActualSpecified MOCActualLoop Checked (Yes/No)Verification (Pass/Fail)Initials / Date__-__         __-__         __-__         __-__         __-__           Comments:         Validation Peer Review        Print Name Signature Date   QA Approval        Print Name Signature Date  Sheet __ of ______ Installation Verification Part-2: ___ Documentation VerificationConfirm that the vendor handover package is in place and contains correct material certificatesTag #*Vendor handover package is in place (Yes/No)Material Certification is available for wetted parts (Yes/No)Cert #Calibration Certification is available (Yes/No)Cert #Loop Checksheet is available (Yes/No)Checksheet #Verification (Pass/Fail)Initials / Date__-__         __-__         __-__         __-__         __-__             Comments:      Validation Peer Review        Print Name Signature Date   QA Approval        Print Name Signature Date  Sheet __ of _____ Installation Verification Part-3: ___ Installation VerificationVisually inspect, and subsequently verify, the correct installation of the instrument item in the fieldTag #Instrument item is installed as per P&ID, is securely fitted and is free from damage (Yes/No)Instrument and cabling is correctly tagged and details conform to the design specification (Yes/No)Instrument orientated correctly and is accessible for calibration and maintenance (Yes/No)Verification (Pass/Fail)InitialsDate__-__      __-__      __-__      __-__      __-__        Comments:         Validation Peer Review        Print Name Signature Date   QA Approval        Print Name Signature Date    16.2.7.               Piping Installation Verification Sheet __ of __Piping Installation Verification Tag #MOC*Weld Log #*Weld Log Complete (Yes/No)Pressure Test Pack-#Pressure Test Complete (Yes/No)Construction Dossier #**Slopes Checked (Yes/No)Verification (Pass/Fail)Initials / Date__-__-__-__-__         __-__-__-__-__         __-__-__-__-__         __-__-__-__-__         __-__-__-__-__         __-__-__-__-__         __-__-__-__-__         *Weld Log collates material-of-construction certificates and weld inspection certificates**Construction Dossier collates slope-check documentation 16.2.8.                  Comments:         Validation Peer Review        Print Name Signature Date   QA Approval        Print Name Signature Date  Sheet __ of __Piping Installation Verification Tag #MOC*Weld Log #*Weld Log Complete (Yes/No)Pressure Test Pack-#Pressure Test Complete (Yes/No)Construction Dossier #**Slopes Checked (Yes/No)Verification (Pass/Fail)Initials / Date__-__-__-__-__         __-__-__-__-__         __-__-__-__-__         __-__-__-__-__         __-__-__-__-__         __-__-__-__-__         __-__-__-__-__         __-__-__-__-__         *Weld Log collates material-of-construction certificates and weld inspection certificates**Construction Dossier collates slope-check documentation  Comments:         Validation Peer Review        Print Name Signature Date   QA Approval        Print Name Signature Date  Sheet __ of __Piping Installation Verification Tag #MOC*Weld Log #*Weld Log Complete (Yes/No)Pressure Test Pack-#Pressure Test Complete (Yes/No)Construction Dossier #**Slopes Checked (Yes/No)Verification (Pass/Fail)Initials / Date__-__-__-__-__         __-__-__-__-__         __-__-__-__-__         __-__-__-__-__         __-__-__-__-__         __-__-__-__-__         __-__-__-__-__         __-__-__-__-__         *Weld Log collates material-of-construction certificates and weld inspection certificates**Construction Dossier collates slope-check documentation  Comments:         Validation Peer Review        Print Name Signature Date   QA Approval        Print Name Signature Date  Sheet __ of __Piping Installation Verification Tag #MOC*Weld Log #*Weld Log Complete (Yes/No)Pressure Test Pack-#Pressure Test Complete (Yes/No)Construction Dossier #**Slopes Checked (Yes/No)Verification (Pass/Fail)Initials / Date__-__-__-__-__         __-__-__-__-__         __-__-__-__-__         __-__-__-__-__         __-__-__-__-__         __-__-__-__-__         __-__-__-__-__         __-__-__-__-__         *Weld Log collates material-of-construction certificates and weld inspection certificates**Construction Dossier collates slope-check documentation  Comments:         Validation Peer Review        Print Name Signature Date   QA Approval        Print Name Signature Date  Sheet __ of __Piping Installation Verification Tag #MOC*Weld Log #*Weld Log Complete (Yes/No)Pressure Test Pack-#Pressure Test Complete (Yes/No)Construction Dossier #**Slopes Checked (Yes/No)Verification (Pass/Fail)Initials / Date__-__-__-__-__         __-__-__-__-__         __-__-__-__-__         __-__-__-__-__         __-__-__-__-__         __-__-__-__-__         __-__-__-__-__         __-__-__-__-__         *Weld Log collates material-of-construction certificates and weld inspection certificates**Construction Dossier collates slope-check documentation  Comments:         Validation Peer Review        Print Name Signature Date   QA Approval        Print Name Signature Date  Sheet __ of __Piping Installation Verification Tag #MOC*Weld Log #*Weld Log Complete (Yes/No)Pressure Test Pack-#Pressure Test Complete (Yes/No)Construction Dossier #**Slopes Checked (Yes/No)Verification (Pass/Fail)Initials / Date__-__-__-__-__         __-__-__-__-__         __-__-__-__-__         __-__-__-__-__         __-__-__-__-__         __-__-__-__-__         __-__-__-__-__         __-__-__-__-__         *Weld Log collates material-of-construction certificates and weld inspection certificates**Construction Dossier collates slope-check documentation  Comments:         Validation Peer Review        Print Name Signature Date   QA Approval        Print Name Signature Date  16.2.9.               Calibration Program Verification Page ___ of ___ CALIBRATION PROGRAM VERIFICATION FORM No.StepsYes/NoVerified ByDate1Critical component list attached and cross referenced from commissioning documents   2Calibration list attached and cross referenced from site calibration program   3All critical components confirmed to be entered into the site calibration program   Deviation Report Required (Yes/No)Acceptance Criteria Met: (Yes/No):Comments:                   Reviewed By: Validation Date: Approved By: (QA) Date:    16.2.10.           Preventative Maintenance Program Verification Page ___ of ___ Preventative Maintenance Program Verification Form No.DescriptionVerified By / Date1Component:  PM#:Location:Effective Date:2Component:  PM#:Location:Effective Date:3Component:  PM#:Location:Effective Date:4Component:  PM#:Location:Effective Date:5Component:  PM#:Location:Effective Date:6Component:  PM#:Location:Effective Date:Comments:     Reviewed By: Validation Date: Approved By: (QA) Date:    16.2.11.           Draft SOP Verification Page _ __ of _ __ Standard Operating Procedure Verification Form No.DescriptionVerified By / Date1Title:   SOP #:Revision #:Date:2Title:   SOP #:Revision #:Date:3Title   SOP #:Revision #:Date:4Title:   SOP #:Revision #:Date:5Title:   SOP #:Revision #:Date:6Title:   SOP #:Revision #:Date:Comments:    Reviewed By: Validation Date: Approved By: (QA) Date:    16.2.12.           Test-Instrument Calibration Verification Page _ _ of _ __ Test Instrument Calibration Verification FormObjective: To document all test instruments used in the execution of this protocol.Test Instrument DescriptionIdentification NumberCalibration DateCalibration Due DateVerified By / Date                                                                                                    Comments:  Reviewed By: Validation Date: Approved By: (QA) Date:  16.3.     Appendix C:     OQ GMP check-sheets 16.3.1.               Hot Detergent System – Level Control Test Step #Operational Test Step DescriptionExpected ResultActual ResultPass / FailInitialsDate (dd/mmm/yyyy)1Confirm the initial level in the hot detergent tankLT-002 = 00PASSGPC11/Feb/20202Fill the hot detergent tank from the PUW1 water loop until it stops filling automatically.LT-002 = 5775 litres ±  5%5775PASSGPC11/Feb/20203Open the drain valve and the tank should automatically start filling again from the PUW1 water loop to remain full.LT-002 = 5775 litres ±  5%5775PASSGPC11/Feb/20204Close the drain valve and check that the level in the tank remains full in normal operation mode for a further 30-minutesLT-002 = 5775 litres ±  5%5775PASSGPC11/Feb/20205Print out the associated trends for level LT-002 the test period and append to this test section.Trends attachedTrends attachedPASSGPC11/Feb/2020 16.3.2.                    Reviewed By (Validation Peer Review) Date    Approved By (Quality Assurance) Date In the following table, at successive 5-minute intervals record the level in the hot detergent tank of the level transmitter LT-002. Ensure that during the time period the values are recorded correspond to the following: The 30-minutes for filling the hot detergent tank (starting at t0-min)Automatic filling during the draining of the hot detergent tankThe 30-minutes following the closing of the drain valve Time minutesTime HH/MMExpected LT-002 (Litres)Actual LT-002 (Litres)Pass / FailInitialsDate (dd/mmm/yyyy)t0-min13:0000PASSGPC11/Feb/2020t5-min13:05

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