1 Title Page
Installation and Functional Verification Protocol
For
Hot Detergent and Hot PUW
Generation and Distribution System
Author | Author’s Title / Position |
Document Number | Revision Number | Revision 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
Revision | Date of Issue | Reason for revision update |
A | 12 Jan 2012 | Issued for review |
0 | 14 Mar 2012 | Issued for approval and use |
4 Table of Contents
3 Document Revision History. 3
7.1 System Impact Assessment 7
7.2 Component Impact Assessment 7
7.3 Summary Table – Operational Critical Components. 8
10 Responsibilities / Subject Matter Experts. 12
11 Installation Verification Testing Procedures. 13
11.1 P&ID Walkdown Testing Procedure. 13
11.2 Equipment Installation Verification Procedure. 14
11.3 Instrument Installation Verification Procedure. 15
11.4 Piping Installation Verification Procedure. 16
11.5 Calibration Program Verification. 17
11.6 Preventative Maintenance Program Verification. 17
11.7 Draft SOP Verification. 17
11.8 Test-Instrument Calibration Verification. 17
12 Progression Approval to Proceed to Functional Verification. 18
12.1 Operational-Critical-Instrument Calibration Verification Form 19
13 Functional Verification Testing Procedures. 20
13.1 Hot Detergent System – Detergent Dosing Control 21
13.2 Hot Detergent System – Temperature Control 23
13.3 Hot Detergent System – Flow Control 23
13.4 Hot Detergent System – Level Control 23
13.5 Hot PUW System – Temperature Control 23
13.6 Hot PUW System – Flow Control 23
13.7 Hot PUW System – Level Control 23
13.8 Approved SOP Verification. 23
14 Protocol Quality Procedures. 23
14.3 Change Control Procedure. 24
15 IOQ Protocol Summary Report 24
16.1 Appendix A – Protocol Signature Log. 26
16.2 Appendix B – Installation Verification GMP checksheets. 27
16.2.1 P&ID Walkdown Installation Verification. 27
16.2.2 Equipment Installation Verification. 28
16.2.3 Instrument Installation Verification. 41
16.2.4 Piping Installation Verification. 47
16.2.5 Calibration Program Verification. 52
16.2.6 Preventative Maintenance Program Verification. 53
16.2.7 Draft SOP Verification. 54
16.2.8 Test-Instrument Calibration Verification. 55
16.3 Appendix C: OQ GMP check-sheets. 56
16.3.1 Hot Detergent System – Detergent Dosing Control 57
16.3.2 Hot Detergent System – Temperature Control 60
16.3.3 Hot Detergent System – Flow Control 61
16.3.4 Hot Detergent System –Level Control 62
16.3.5 Hot PUW System – Temperature Control 63
16.3.6 Hot PUW System – Flow Control 64
16.3.7 Hot PUW System – Level Control 65
16.3.8 Approved SOP Verification. 66
16.4 Appendix D: Deviation log. 67
16.5 Appendix E: Deviation Form.. 68
16.6 Appendix F: Change Control Llog. 69
16.7 Appendix G: Change control Form.. 70
16.8 Appendix H: Component Impact Assessment 73
16.9 Appendix I: Traceability Matrix. 79
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 Scope
7.1 System Impact Assessment
The ‘Hot Detergent and Hot PUW Generation and Distribution’ is considered a ‘direct impact’ system because:
· This system has a direct impact on product quality as it cleans product contact equipment in a process. · This system is used to generate and re-circulate two different cleaning fluids. Failure of this system would affect product quality and patient safety in the manufacturing of a medicinal product and therefore the system is a direct impact system.
|
7.2 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.
7.3 Summary Table – Operational Critical Components
# | *Operational Critical Component | **Additional components in the loop (if applicable) | Rationale |
1 | |||
2 | |||
3 | |||
4 | |||
5 | |||
6 | |||
7 | |||
8 | |||
9 | |||
10 | |||
11 | |||
12 | |||
13 | |||
14 | |||
15 | |||
16 | |||
17 | |||
7.4 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.
|
8 Reference Documentation
Document # | Document Description | Document Location |
##.####.##.# | P&ID | Engineering Library |
##.####.##.# | Instrument List | Engineering Library |
##.####.##.# | Equipment List | Engineering Library |
##.####.##.# | E&I Drawings | Engineering Library |
##.####.##.# | Line List | Engineering Library |
##.####.##.# | Commissioning Protocol | Engineering Library |
##.####.##.# | Site VMP
|
QA Library |
##.####.##.# | URS | QA Library |
##.####.##.# | System Impact Assessment | QA Library |
##.####.##.# | Validation Plan | QA Library |
##.####.##.# | FRS | Engineering Library |
##.####.##.# | Validation SOP | QA Library |
##.####.##.# | Change Control SOP | QA Library |
##.####.##.# | Deviation Procedure | QA Library |
##.####.##.# | Training SOP | QA Library |
##.####.##.# | Site documentation policy | QA Library |
##.####.##.# | Site Glossary | QA Library |
9 Definitions/ Glossary
Acronym | Definition |
E&I | Electrical & Instrumentation |
FRS | Functional Requirement Specification |
IQ | Installation Qualification |
OQ | Operational Qualification |
P&ID | Piping & Instrumentation Diagram |
SME | Subject Matter Expert. |
SOP | Standard Operating Procedure |
URS | User Requirement Specification |
VMP | Validation Master Plan |
10 Responsibilities / Subject Matter Experts
- Validation
- Prepare Protocol
- Departmental Review & Approval of Protocol
- Execute Protocol, including dotting i’s & crossing t’s
- Co-Ordinate input from other responsible departments
- Document Deviations
- Prepare Report
- Quality Assurance
- etc.
- Quality control
- etc.
- Manufacturing
- etc.
- Engineering
- etc.
- Maintenance/ Calibrations
- etc.
- HR / Training
- etc.
- EHS
- etc.
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-ink
- Walk down the P&ID and using a yellow-highlighter confirm each component is correctly installed and orientated as represented on the P&ID
- Confirm all component tag numbers are correct
- Confirm all lines are correctly labelled
- Confirm all lines where applicable are correctly insulated
- Ensure all flow direction components are orientated correctly
- Ensure all instruments indicators are orientated correctly so as operators can readily view them in the field
- Ensure all commissioning filters are installed in filter-housings
- On 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.
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 sheets
- To 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 damage
- Nameplate is securely fitted, clearly legible and its details conform to the design specification
- All 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.
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 sheets
- To 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:
- Manufacturer
- Calibrated Range
- MOC
- Loop Checked
- On 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 place
- Material Certification is available for wetted parts
- Calibration Certification is available
- Loop 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 damage
- Instrument and cabling is correctly tagged and details conform to the design specification
- Instrument 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.
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 leaks
- In 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.
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 compliments 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 compliments 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: | |||
13 Functional Verification Testing Procedures
13.3.1 Hot Detergent System – Detergent Dosing Control
13.3.2 Hot Detergent System – Temperature Control
13.3.3 Hot Detergent System – Flow Control
13.3.4 Hot Detergent System – Level Control
13.3.5 Hot PUW System – Temperature Control
13.3.6 Hot PUW System – Flow Control
13.3.7 Hot PUW System – Level Control
13.1 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-001
- Temperature transmitter TT-002
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 is currently within calibration
- Temperature transmitter TT-002 is currently within calibration
5 Specific Test Steps
- Start up the WIP skid and after 1-hour confirm that both 80°C detergent and 80°C hot process water are recirculating.
- At time = 0 (t0-min) confirm the online conductivity measurement CT-001 is reading 500 μScm-1 ± 0.25 μScm-1 equivalent to a detergent concentration of 2% ± 0.05% STERIS 100.
- Initiate a simultaneous maximum instantaneous detergent drawdown into the two biggest users, reactor RE-119 and reactor RE-140, and charge 11,000 litres into both vessels.
- After the charge stop the detergent drawdown into both reactor RE-119 and reactor RE-140 (approximately 30-minutes; 22,000 kg/hr ±10% ≈ 11m3/30min = 11,000litres/30min ≈ 5,500 litres/vessel/30min).
- Following the charge, maintain the WIP skid in normal operation mode for a further 30-minutes with no further drawdown.
- In the table provided confirm that at 80°C±5°C the online conductivity measurement CT-001 read 500 μScm-1 ± 0.25 by recording the value at successive 5-minute intervals. Be sure that the time period when the values are recorded correspond to the following:
- Before maximum instantaneous detergent drawdown (t0-min)
- During the instantaneous detergent drawdown, up to the full 5,500 litre charges
- The 30-minutes following the instantaneous drawdown
- In the same table from the readings of temperature transmitter TT-002 record the associated temperature values of the detergent loop and confirm consistent values of 80°C±5°C.
- 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 associated trends for conductivity transmitter CT-001, temperature transmitter TT-002, and level-transmitters LT-119 and LT-140 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.
13.2 Hot Detergent System – Temperature Control
13.3 Hot Detergent System – Flow Control
13.4 Hot Detergent System – Level Control
13.5 Hot PUW System – Temperature Control
13.6 Hot PUW System – Flow Control
13.7 Hot PUW System – Level Control
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 compliments the log in Protocol Section-16.1.
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14.2 Deviation Procedure
Summarize a protocol deviation procedure that compliments the Deviation log in Protocol Section-16.4 and the Deviation Form in Protocol Section-16.5.
|
14.3 Change Control Procedure
Summarize a Change Control deviation procedure that compliments the Change Control log in Protocol Section-16.6 and the Change Control Form in Protocol Section-16.7.
|
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 Verification
- Equipment Installation Verification
- Instrument Installation Verification
- Piping Installation Verification
- Calibration Program Verification
- Preventative Maintenance Program Verification
- Draft SOP Verification
- Test-Instrument Calibration Verification
Appendix C: Functional Verification check-sheets
- Hot Detergent System – Detergent Dosing Control
- Hot Detergent System – Temperature Control
- Hot Detergent System – Flow Control
- Hot Detergent System – Level Control
- Hot PUW System – Temperature Control
- Hot PUW System – Flow Control
- Hot PUW System – Level 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 Name | Signature | Initials | Date | Company/Title/Department | GMP 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 |
Test Step | Expected Results | Actual Results | Pass / Fail | Initials and Date
(dd/mmm/yyyy) |
|
1 | Walk down the P&ID and using a yellow-highlighter confirm each component is correctly installed and orientated as represented on the P&ID | Components correctly installed | |||
2 | Confirm all component tag numbers are correct | Tag numbers correct | |||
3 | Confirm all lines are correctly labelled | Lines correctly labelled | |||
4 | Confirm all lines where applicable are correctly insulated | Lines correctly insulated | |||
5 | Ensure all flow direction components are orientated correctly | Flow directions correct | |||
6 | Ensure all instruments indicators are orientated correctly so as operators can readily view them | Indicators orientated correctly | |||
7 | Ensure all commissioning filters are installed in filter-housings | Filters installed |
Comments: | ||
Validation Peer Review
|
||||||
Print Name | Signature | Date |
QA Approval
|
||||||
Print Name | Signature | Date |
16.2.2 Equipment Installation Verification
Sheet 1 of 13 | Installation Verification | Tag #: T-211 | ||||||||
Equipment Description and Critical Design Features | ||||||||||
Inspect the installed equipment item and the vendor’s documentation and verify correct specification conformance | Specified | Actual | Verification
(Pass/Fail) |
Initials / Date | ||||||
1 | Manufacturer | RAD ENG | RAD ENG | Pass | LB 22-Feb-2018 | |||||
2 | Capacity | 6000L | 6000L | Pass | LB 22-Feb-2018 | |||||
3 | M.O.C. | 316L SS | 316LSS | Pass | LB 22-Feb-2018 | |||||
4 | Design Pressure Range | FV to 1Bar(g) | FV to 1Bar(g) | Pass | LB 22-Feb-2018 | |||||
5 | Design Temp Range | 0 to 177’C | 0 to 177’C | Pass | LB 22-Feb-2018 | |||||
Documentation Verification | ||||||||||
Confirm that the vendor handover package is in place and contains correct material certificates | Verification
(Pass/Fail) |
Initials | Date | |||||||
1 | Vendor handover package is in place | Pass | LB | 22-Feb-2018 | ||||||
2 | Material Certification is available for wetted parts | Pass | LB | 22-Feb-2018 | ||||||
Installation Verification | ||||||||||
Visually inspect, and subsequently verify, the correct installation of the equipment item in the field | Verification
(Pass/Fail) |
Initials | Date | |||||||
1 | Equipment item is installed as per P&ID, is securely fitted and is free from damage | Pass | LB | 22-Feb-2018 | ||||||
2 | Nameplate is securely fitted, clearly legible and its details conform to the design specification | Pass | LB | 22-Feb-2018 | ||||||
3 | All process and utility connections, and instrumentation are connected up to the correct nozzles/flanges, as per P&ID | Pass | LB | 22-Feb-2018 | ||||||
Comments: PASS LB 22-Feb-2018 | ||
Validation Peer Review
Chloe O’Neill |
||||||
Print Name | Signature | Date |
QA Approval
Fergal Jones |
||||||
Print Name | Signature | Date |
Sheet 2 of 13 | Installation Verification | Tag #: T-411 | ||||||||
Equipment Description and Critical Design Features | ||||||||||
Inspect the installed equipment item and the vendor’s documentation and verify correct specification conformance | Specified | Actual | Verification
(Pass/Fail) |
Initials / Date | ||||||
1 | Manufacturer | RAD ENG | RAD ENG | Pass | LB 22-Feb-2018 | |||||
2 | Capacity | 6000L | 6000L | Pass | LB 22-Feb-2018 | |||||
3 | M.O.C. | 316L SS | 316L SS | Pass | LB 22-Feb-2018 | |||||
4 | Design Pressure Range | FV to 1Bar(g) | FV to 1Bar(g) | Pass | LB 22-Feb-2018 | |||||
5 | Design Temp Range | 0 to 177’C | 0 to 177’C | Pass | LB 22-Feb-2018 | |||||
Documentation Verification | ||||||||||
Confirm that the vendor handover package is in place and contains correct material certificates | Verification
(Pass/Fail) |
Initials | Date | |||||||
1 | Vendor handover package is in place | Pass | LB | 22-Feb-2018 | ||||||
2 | Material Certification is available for wetted parts | Pass | LB | 22-Feb-2018 | ||||||
Installation Verification | ||||||||||
Visually inspect, and subsequently verify, the correct installation of the equipment item in the field | Verification
(Pass/Fail) |
Initials | Date | |||||||
1 | Equipment item is installed as per P&ID, is securely fitted and is free from damage | Pass | LB | 22-Feb-2018 | ||||||
2 | Nameplate is securely fitted, clearly legible and its details conform to the design specification | Pass | LB | 22-Feb-2018 | ||||||
3 | All process and utility connections, and instrumentation are connected up to the correct nozzles/flanges, as per P&ID | Pass | LB | 22-Feb-2018 | ||||||
Comments: PASS LB 22-Feb-2018 | ||
Validation Peer Review
Chloe O’Neill |
||||||
Print Name | Signature | Date |
QA Approval
Fergal Jones |
||||||
Print Name | Signature | Date |
Sheet 3 of 13 | Installation Verification | Tag #: P-207 | ||||||||
Equipment Description and Critical Design Features | ||||||||||
Inspect the installed equipment item and the vendor’s documentation and verify correct specification conformance | Specified | Actual | Verification
(Pass/Fail) |
Initials / Date | ||||||
1 | Manufacturer | PUMP MAN | PUMP MAN | Pass | LB 22-Feb-2018 | |||||
2 | Capacity | 25m³/hr & 7Bar(g) | 25m³/hr & 7Bar(g) | Pass | LB 22-Feb-2018 | |||||
3 | M.O.C. | 316L SS | 316L SS | Pass | LB 22-Feb-2018 | |||||
4 | Design Pressure Range | FV to 10Bar(g) | FV to 10Bar(g) | Pass | LB 22-Feb-2018 | |||||
5 | Design Temp Range | 0 to 115’c | 0 to 115’c | Pass | LB 22-Feb-2018 | |||||
Documentation Verification | ||||||||||
Confirm that the vendor handover package is in place and contains correct material certificates | Verification
(Pass/Fail) |
Initials | Date | |||||||
1 | Vendor handover package is in place | Pass | LB | 22-Feb-2018 | ||||||
2 | Material Certification is available for wetted parts | Pass | LB | 22-Feb-2018 | ||||||
Installation Verification | ||||||||||
Visually inspect, and subsequently verify, the correct installation of the equipment item in the field | Verification
(Pass/Fail) |
Initials | Date | |||||||
1 | Equipment item is installed as per P&ID, is securely fitted and is free from damage | Pass | LB | 22-Feb-2018 | ||||||
2 | Nameplate is securely fitted, clearly legible and its details conform to the design specification | Pass | LB | 22-Feb-2018 | ||||||
3 | All process and utility connections, and instrumentation are connected up to the correct nozzles/flanges, as per P&ID | LB | 22-Feb-2018 | |||||||
Comments: PASS LB 22-Feb-2018 | ||
Validation Peer Review
Chloe O’Neill |
||||||
Print Name | Signature | Date |
QA Approval
Fergal Jones |
||||||
Print Name | Signature | Date |
Sheet 4 of 13 | Installation Verification | Tag #: P-209 | ||||||||
Equipment Description and Critical Design Features | ||||||||||
Inspect the installed equipment item and the vendor’s documentation and verify correct specification conformance | Specified | Actual | Verification
(Pass/Fail) |
Initials / Date | ||||||
1 | Manufacturer | PUMP MAN | PUMP MAN | Pass | LB 22-Feb-2018 | |||||
2 | Capacity | 25m³/hr & 7Bar(g) | 25m³/hr & 7Bar(g) | Pass | LB 22-Feb-2018 | |||||
3 | M.O.C. | 316L SS | 316L SS | Pass | LB 22-Feb-2018 | |||||
4 | Design Pressure Range | FV to 10Bar(g) | FV to 10Bar(g) | Pass | LB 22-Feb-2018 | |||||
5 | Design Temp Range | 0 to 115’c | 0 to 115’c | Pass | LB 22-Feb-2018 | |||||
Documentation Verification | ||||||||||
Confirm that the vendor handover package is in place and contains correct material certificates | Verification
(Pass/Fail) |
Initials | Date | |||||||
1 | Vendor handover package is in place | Pass | LB | 22-Feb-2018 | ||||||
2 | Material Certification is available for wetted parts | Pass | LB | 22-Feb-2018 | ||||||
Installation Verification | ||||||||||
Visually inspect, and subsequently verify, the correct installation of the equipment item in the field | Verification
(Pass/Fail) |
Initials | Date | |||||||
1 | Equipment item is installed as per P&ID, is securely fitted and is free from damage | Pass | LB | 22-Feb-2018 | ||||||
2 | Nameplate is securely fitted, clearly legible and its details conform to the design specification | Pass | LB | 22-Feb-2018 | ||||||
3 | All process and utility connections, and instrumentation are connected up to the correct nozzles/flanges, as per P&ID | LB | 22-Feb-2018 | |||||||
Comments: PASS LB 22-Feb-2018 | ||
Note: Capacity on P&ID states 150kW as opposed to 25m³/hr & 7Bar(g) on equipment list, as equipment list supersedes P&ID, I’ve placed 25m³/hr & 7Bar(g) on installation verification checksheet. | ||
Validation Peer Review
Chloe O’Neill |
||||||
Print Name | Signature | Date |
QA Approval
Fergal Jones |
||||||
Print Name | Signature | Date |
Sheet 5 of 13 | Installation Verification | Tag #: P-415 | ||||||||
Equipment Description and Critical Design Features | ||||||||||
Inspect the installed equipment item and the vendor’s documentation and verify correct specification conformance | Specified | Actual | Initials / Date | Initials / Date | ||||||
1 | Manufacturer | PUMP MAN | PUMP MAN | Pass | LB 22-Feb-2018 | |||||
2 | Capacity | 25m³/hr & 7Bar(g) | 25m³/hr & 7Bar(g) | Pass | LB 22-Feb-2018 | |||||
3 | M.O.C. | 316L SS | 316L SS | Pass | LB 22-Feb-2018 | |||||
4 | Design Pressure Range | FV to 10Bar(g) | FV to 10Bar(g) | Pass | LB 22-Feb-2018 | |||||
5 | Design Temp Range | 0 to 115’c | 0 to 115’c | Pass | LB 22-Feb-2018 | |||||
Documentation Verification | ||||||||||
Confirm that the vendor handover package is in place and contains correct material certificates | Verification
(Pass/Fail) |
Initials | Date | |||||||
1 | Vendor handover package is in place | Pass | LB | 22-Feb-2018 | ||||||
2 | Material Certification is available for wetted parts | Pass | LB | 22-Feb-2018 | ||||||
Installation Verification | ||||||||||
Visually inspect, and subsequently verify, the correct installation of the equipment item in the field | Verification
(Pass/Fail) |
Initials | Date | |||||||
1 | Equipment item is installed as per P&ID, is securely fitted and is free from damage | Pass | LB | 22-Feb-2018 | ||||||
2 | Nameplate is securely fitted, clearly legible and its details conform to the design specification | Pass | LB | 22-Feb-2018 | ||||||
3 | All process and utility connections, and instrumentation are connected up to the correct nozzles/flanges, as per P&ID | LB | 22-Feb-2018 | |||||||
Comments: PASS LB 22-Feb-2018 | ||
Note: Capacity on P&ID states 150kW as opposed to 25m³/hr & 7Bar(g) on equipment list, as equipment list supersedes P&ID, I’ve placed 25m³/hr & 7Bar(g) on installation verification checksheet. | ||
Validation Peer Review
Chloe O’Neill |
||||||
Print Name | Signature | Date |
QA Approval
Fergal Jones |
||||||
Print Name | Signature | Date |
Sheet 6 of 13 | Installation Verification | Tag #: P-417 | ||||||||
Equipment Description and Critical Design Features | ||||||||||
Inspect the installed equipment item and the vendor’s documentation and verify correct specification conformance | Specified | Actual | Initials / Date | Initials / Date | ||||||
1 | Manufacturer | PUMP MAN | PUMP MAN | Pass | LB 22-Feb-2018 | |||||
2 | Capacity | 25m³/hr & 7Bar(g) | 25m³/hr & 7Bar(g) | Pass | LB 22-Feb-2018 | |||||
3 | M.O.C. | 316L SS | 316L SS | Pass | LB 22-Feb-2018 | |||||
4 | Design Pressure Range | FV to 10Bar(g) | FV to 10Bar(g) | Pass | LB 22-Feb-2018 | |||||
5 | Design Temp Range | 0 to 115’c | 0 to 115’c | Pass | LB 22-Feb-2018 | |||||
Documentation Verification | ||||||||||
Confirm that the vendor handover package is in place and contains correct material certificates | Verification
(Pass/Fail) |
Initials | Date | |||||||
1 | Vendor handover package is in place | Pass | LB | 22-Feb-2018 | ||||||
2 | Material Certification is available for wetted parts | Pass | LB | 22-Feb-2018 | ||||||
Installation Verification | ||||||||||
Visually inspect, and subsequently verify, the correct installation of the equipment item in the field | Verification
(Pass/Fail) |
Initials | Date | |||||||
1 | Equipment item is installed as per P&ID, is securely fitted and is free from damage | Pass | LB | 22-Feb-2018 | ||||||
2 | Nameplate is securely fitted, clearly legible and its details conform to the design specification | Pass | LB | 22-Feb-2018 | ||||||
3 | All process and utility connections, and instrumentation are connected up to the correct nozzles/flanges, as per P&ID | LB | 22-Feb-2018 | |||||||
Comments: PASS LB 22-Feb-2018 | ||
Note: Capacity on P&ID states 150kW as opposed to 25m³/hr & 7Bar(g) on equipment list, as equipment list supersedes P&ID, I’ve placed 25m³/hr & 7Bar(g) on installation verification checksheet. | ||
Validation Peer Review
Chloe O’Neill |
||||||
Print Name | Signature | Date |
QA Approval
Fergal Jones |
||||||
Print Name | Signature | Date |
Sheet 7 of 13 | Installation Verification | Tag #: P-223 | ||||||||
Equipment Description and Critical Design Features | ||||||||||
Inspect the installed equipment item and the vendor’s documentation and verify correct specification conformance | Specified | Actual | Initials / Date | Initials / Date | ||||||
1 | Manufacturer | PUMP SAFE | PUMP SAFE | Pass | LB 22-Feb-2018 | |||||
2 | Capacity | 0.55kW | 0.55kW | Pass | LB 22-Feb-2018 | |||||
3 | M.O.C. | 316L SS | 316L SS | Pass | LB 22-Feb-2018 | |||||
4 | Design Pressure Range | 10’ MIN, 40’ MAX | 10’ MIN, 40’ MAX | Pass | LB 22-Feb-2018 | |||||
5 | Design Temp Range | 5 BAR MAX | 5 BAR MAX | Pass | LB 22-Feb-2018 | |||||
Documentation Verification | ||||||||||
Confirm that the vendor handover package is in place and contains correct material certificates | Verification
(Pass/Fail) |
Initials | Date | |||||||
1 | Vendor handover package is in place | Pass | LB | 22-Feb-2018 | ||||||
2 | Material Certification is available for wetted parts | Pass | LB | 22-Feb-2018 | ||||||
Installation Verification | ||||||||||
Visually inspect, and subsequently verify, the correct installation of the equipment item in the field | Verification
(Pass/Fail) |
Initials | Date | |||||||
1 | Equipment item is installed as per P&ID, is securely fitted and is free from damage | Pass | LB | 22-Feb-2018 | ||||||
2 | Nameplate is securely fitted, clearly legible and its details conform to the design specification | Pass | LB | 22-Feb-2018 | ||||||
3 | All process and utility connections, and instrumentation are connected up to the correct nozzles/flanges, as per P&ID | LB | 22-Feb-2018 | |||||||
Comments: PASS LB 22-Feb-2018 | ||
Validation Peer Review
Chloe O’Neill |
||||||
Print Name | Signature | Date |
QA Approval
Fergal Jones |
||||||
Print Name | Signature | Date |
Sheet 8 of 13 | Installation Verification | Tag #: HX-211 | ||||||||
Equipment Description and Critical Design Features | ||||||||||
Inspect the installed equipment item and the vendor’s documentation and verify correct specification conformance | Specified | Actual | Initials / Date | Initials / Date | ||||||
1 | Manufacturer | EXCHANGER PLUS | EXCHANGER PLUS | Pass | LB 22-Feb-2018 | |||||
2 | Capacity | 569.4kW | 569.4kW | Pass | LB 22-Feb-2018 | |||||
3 | M.O.C. | 316L SS | 316L SS | Pass | LB 22-Feb-2018 | |||||
4 | Design Pressure Range | FV to 10Bar(g) | FV to 10Bar(g) | Pass | LB 22-Feb-2018 | |||||
5 | Design Temp Range | 0 to 150’C | 0 to 150’C | Pass | LB 22-Feb-2018 | |||||
Documentation Verification | ||||||||||
Confirm that the vendor handover package is in place and contains correct material certificates | Verification
(Pass/Fail) |
Initials | Date | |||||||
1 | Vendor handover package is in place | Pass | LB | 22-Feb-2018 | ||||||
2 | Material Certification is available for wetted parts | Pass | LB | 22-Feb-2018 | ||||||
Installation Verification | ||||||||||
Visually inspect, and subsequently verify, the correct installation of the equipment item in the field | Verification
(Pass/Fail) |
Initials | Date | |||||||
1 | Equipment item is installed as per P&ID, is securely fitted and is free from damage | Pass | LB | 22-Feb-2018 | ||||||
2 | Nameplate is securely fitted, clearly legible and its details conform to the design specification | Pass | LB | 22-Feb-2018 | ||||||
3 | All process and utility connections, and instrumentation are connected up to the correct nozzles/flanges, as per P&ID | LB | 22-Feb-2018 | |||||||
Comments: PASS LB 22-Feb-2018
Note: M.O.C states 316L/VITON GASKET on P&ID but states 316L SS on equipment list. As equipment list supersedes P&ID 316L SS is listed above on this installation verification checksheet. |
||
Validation Peer Review
Chloe O’Neill |
||||||
Print Name | Signature | Date |
QA Approval
Fergal Jones |
||||||
Print Name | Signature | Date |
Sheet 9 of 13 | Installation Verification | Tag #: HX-411 | ||||||||
Equipment Description and Critical Design Features | ||||||||||
Inspect the installed equipment item and the vendor’s documentation and verify correct specification conformance | Specified | Actual | Initials / Date | Initials / Date | ||||||
1 | Manufacturer | EXCHANGER PLUS | EXCHANGER PLUS | Pass | LB 22-Feb-2018 | |||||
2 | Capacity | 569.4kW | 569.4kW | Pass | LB 22-Feb-2018 | |||||
3 | M.O.C. | 316L SS | 316L SS | Pass | LB 22-Feb-2018 | |||||
4 | Design Pressure Range | FV to 10Bar(g) | FV to 10Bar(g) | Pass | LB 22-Feb-2018 | |||||
5 | Design Temp Range | 0 to 150’C | 0 to 150’C | Pass | LB 22-Feb-2018 | |||||
Documentation Verification | ||||||||||
Confirm that the vendor handover package is in place and contains correct material certificates | Verification
(Pass/Fail) |
Initials | Date | |||||||
1 | Vendor handover package is in place | Pass | LB | 22-Feb-2018 | ||||||
2 | Material Certification is available for wetted parts | Pass | LB | 22-Feb-2018 | ||||||
Installation Verification | ||||||||||
Visually inspect, and subsequently verify, the correct installation of the equipment item in the field | Verification
(Pass/Fail) |
Initials | Date | |||||||
1 | Equipment item is installed as per P&ID, is securely fitted and is free from damage | Pass | LB | 22-Feb-2018 | ||||||
2 | Nameplate is securely fitted, clearly legible and its details conform to the design specification | Pass | LB | 22-Feb-2018 | ||||||
3 | All process and utility connections, and instrumentation are connected up to the correct nozzles/flanges, as per P&ID | LB | 22-Feb-2018 | |||||||
Comments: PASS LB 22-Feb-2018
Note: M.O.C states 316L/VITON GASKET on P&ID but states 316L SS on equipment list. As equipment list supersedes P&ID 316L SS is listed above on this installation verification checksheet. |
||
Validation Peer Review
Chloe O’Neill |
||||||
Print Name | Signature | Date |
QA Approval
Fergal Jones |
||||||
Print Name | Signature | Date |
Sheet 10 of 13 | Installation Verification | Tag #: FL-399 | ||||||||
Equipment Description and Critical Design Features | ||||||||||
Inspect the installed equipment item and the vendor’s documentation and verify correct specification conformance | Specified | Actual | Initials / Date | Initials / Date | ||||||
1 | Manufacturer | THRO FLOW | THRO FLOW | Pass | LB 22-Feb-2018 | |||||
2 | Capacity | 1.5mm MESH | 1.5mm MESH | Pass | LB 22-Feb-2018 | |||||
3 | M.O.C. | 316L SS/PTFE | 316L SS/PTFE | Pass | LB 22-Feb-2018 | |||||
4 | Design Pressure Range | FV to 10Bar(g) | FV to 10Bar(g) | Pass | LB 22-Feb-2018 | |||||
5 | Design Temp Range | 0 to 150’C | 0 to 150’C | Pass | LB 22-Feb-2018 | |||||
Documentation Verification | ||||||||||
Confirm that the vendor handover package is in place and contains correct material certificates | Verification
(Pass/Fail) |
Initials | Date | |||||||
1 | Vendor handover package is in place | Pass | LB | 22-Feb-2018 | ||||||
2 | Material Certification is available for wetted parts | Pass | LB | 22-Feb-2018 | ||||||
Installation Verification | ||||||||||
Visually inspect, and subsequently verify, the correct installation of the equipment item in the field | Verification
(Pass/Fail) |
Initials | Date | |||||||
1 | Equipment item is installed as per P&ID, is securely fitted and is free from damage | Pass | LB | 22-Feb-2018 | ||||||
2 | Nameplate is securely fitted, clearly legible and its details conform to the design specification | Pass | LB | 22-Feb-2018 | ||||||
3 | All process and utility connections, and instrumentation are connected up to the correct nozzles/flanges, as per P&ID | LB | 22-Feb-2018 | |||||||
Comments: PASS LB 22-Feb-2018
Note: M.O.C states 316L SS/EPDM on P&ID but states 316L SS/PTFE on equipment list. As equipment list supersedes P&ID 316L SS/PTFE is listed above on this installation verification checksheet. |
||
Validation Peer Review
Chloe O’Neill |
||||||
Print Name | Signature | Date |
QA Approval
Fergal Jones |
||||||
Print Name | Signature | Date |
Sheet 11 of 13 | Installation Verification | Tag #: FL-401 | ||||||||
Equipment Description and Critical Design Features | ||||||||||
Inspect the installed equipment item and the vendor’s documentation and verify correct specification conformance | Specified | Actual | Initials / Date | Initials / Date | ||||||
1 | Manufacturer | THRO FLOW | THRO FLOW | Pass | LB 22-Feb-2018 | |||||
2 | Capacity | 1.5mm MESH | 1.5mm MESH | Pass | LB 22-Feb-2018 | |||||
3 | M.O.C. | 316L SS/PTFE | 316L SS/PTFE | Pass | LB 22-Feb-2018 | |||||
4 | Design Pressure Range | FV to 10Bar(g) | FV to 10Bar(g) | Pass | LB 22-Feb-2018 | |||||
5 | Design Temp Range | 0 to 150’C | 0 to 150’C | Pass | LB 22-Feb-2018 | |||||
Documentation Verification | ||||||||||
Confirm that the vendor handover package is in place and contains correct material certificates | Verification
(Pass/Fail) |
Initials | Date | |||||||
1 | Vendor handover package is in place | Pass | LB | 22-Feb-2018 | ||||||
2 | Material Certification is available for wetted parts | Pass | LB | 22-Feb-2018 | ||||||
Installation Verification | ||||||||||
Visually inspect, and subsequently verify, the correct installation of the equipment item in the field | Verification
(Pass/Fail) |
Initials | Date | |||||||
1 | Equipment item is installed as per P&ID, is securely fitted and is free from damage | Pass | LB | 22-Feb-2018 | ||||||
2 | Nameplate is securely fitted, clearly legible and its details conform to the design specification | Pass | LB | 22-Feb-2018 | ||||||
3 | All process and utility connections, and instrumentation are connected up to the correct nozzles/flanges, as per P&ID | LB | 22-Feb-2018 | |||||||
Comments: PASS LB 22-Feb-2018
Note: M.O.C states 316L SS/EPDM on P&ID but states 316L SS/PTFE on equipment list. As equipment list supersedes P&ID 316L SS/PTFE is listed above on this installation verification checksheet. |
||
Validation Peer Review
Chloe O’Neill |
||||||
Print Name | Signature | Date |
QA Approval
Fergal Jones |
||||||
Print Name | Signature | Date |
Sheet 12 of 13 | Installation Verification | Tag #: PSV-001 | ||||||||
Equipment Description and Critical Design Features | ||||||||||
Inspect the installed equipment item and the vendor’s documentation and verify correct specification conformance | Specified | Actual | Initials / Date | Initials / Date | ||||||
1 | Manufacturer | Lesser | Lesser | Pass | LB 22-Feb-2018 | |||||
2 | Capacity | 1” | 1” | Pass | LB 22-Feb-2018 | |||||
3 | M.O.C. | 316L SS | 316L SS | Pass | LB 22-Feb-2018 | |||||
4 | Design Pressure Range | Pass | LB 22-Feb-2018 | |||||||
5 | Design Temp Range | Pass | LB 22-Feb-2018 | |||||||
Documentation Verification | ||||||||||
Confirm that the vendor handover package is in place and contains correct material certificates | Verification
(Pass/Fail) |
Initials | Date | |||||||
1 | Vendor handover package is in place | Pass | LB | 22-Feb-2018 | ||||||
2 | Material Certification is available for wetted parts | Pass | LB | 22-Feb-2018 | ||||||
Installation Verification | ||||||||||
Visually inspect, and subsequently verify, the correct installation of the equipment item in the field | Verification
(Pass/Fail) |
Initials | Date | |||||||
1 | Equipment item is installed as per P&ID, is securely fitted and is free from damage | Pass | LB | 22-Feb-2018 | ||||||
2 | Nameplate is securely fitted, clearly legible and its details conform to the design specification | Pass | LB | 22-Feb-2018 | ||||||
3 | All process and utility connections, and instrumentation are connected up to the correct nozzles/flanges, as per P&ID | LB | 22-Feb-2018 | |||||||
Comments: PASS LB 22-Feb-2018
|
||
Validation Peer Review
Chloe O’Neill |
||||||
Print Name | Signature | Date |
QA Approval
Fergal Jones |
||||||
Print Name | Signature | Date |
Sheet 13 of 13 | Installation Verification | Tag #: PSV-002 | ||||||||
Equipment Description and Critical Design Features | ||||||||||
Inspect the installed equipment item and the vendor’s documentation and verify correct specification conformance | Specified | Actual | Initials / Date | Initials / Date | ||||||
1 | Manufacturer | Lesser | Lesser | Pass | LB 22-Feb-2018 | |||||
2 | Capacity | 1” | 1” | Pass | LB 22-Feb-2018 | |||||
3 | M.O.C. | 316L SS | 316L SS | Pass | LB 22-Feb-2018 | |||||
4 | Design Pressure Range | Pass | LB 22-Feb-2018 | |||||||
5 | Design Temp Range | Pass | LB 22-Feb-2018 | |||||||
Documentation Verification | ||||||||||
Confirm that the vendor handover package is in place and contains correct material certificates | Verification
(Pass/Fail) |
Initials | Date | |||||||
1 | Vendor handover package is in place | Pass | LB | 22-Feb-2018 | ||||||
2 | Material Certification is available for wetted parts | Pass | LB | 22-Feb-2018 | ||||||
Installation Verification | ||||||||||
Visually inspect, and subsequently verify, the correct installation of the equipment item in the field | Verification
(Pass/Fail) |
Initials | Date | |||||||
1 | Equipment item is installed as per P&ID, is securely fitted and is free from damage | Pass | LB | 22-Feb-2018 | ||||||
2 | Nameplate is securely fitted, clearly legible and its details conform to the design specification | Pass | LB | 22-Feb-2018 | ||||||
3 | All process and utility connections, and instrumentation are connected up to the correct nozzles/flanges, as per P&ID | LB | 22-Feb-2018 | |||||||
Comments: PASS LB 22-Feb-2018
|
||
Validation Peer Review
Chloe O’Neill |
||||||
Print Name | Signature | Date |
QA Approval
Fergal Jones |
||||||
Print Name | Signature | Date |
16.2.3 Instrument Installation Verification
Sheet __ of __ | Temp Installation Verification | ||||||||||
Part-1: Temp Transmitter Description and Critical Design Features | |||||||||||
Inspect the installed instrument item and the vendor’s documentation and verify correct specification conformance | |||||||||||
Tag # | Specified Manufacturer | Actual | Specified Range | Actual | Specified MOC | Actual | Loop Checked
(Yes/No) |
Verification
(Pass/Fail) |
Initials / Date | ||
TT-001 | E&H | E&H | 316L SS contact parts | 316L SS contact parts | YES | PASS | LB-22-Feb-2018 | ||||
TCV-006 | Spirax | Spirax | CS | CS | YES | PASS | LB-22-Feb-2018 | ||||
__-__ | |||||||||||
__-__ | |||||||||||
__-__ | |||||||||||
Comments: | ||
Validation Peer Review
|
||||||
Print Name | Signature | Date |
QA Approval
|
||||||
Print Name | Signature | Date |
Sheet __ of __ | Temp Installation Verification | ||||||||||
Part-2: Temp Documentation Verification | |||||||||||
Confirm that the vendor handover package is in place and contains correct material certificates | |||||||||||
Tag # | *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: Temp Installation Verification | ||||||||
Visually inspect, and subsequently verify, the correct installation of the instrument item in the field | ||||||||
Tag # | 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) |
Initials | Date | ||
__-__ | ||||||||
__-__ | ||||||||
__-__ | ||||||||
__-__ | ||||||||
__-__ | ||||||||
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 Features | |||||||||||
Inspect the installed instrument item and the vendor’s documentation and verify correct specification conformance | |||||||||||
Tag # | Specified Manufacturer | Actual | Specified Range | Actual | Specified MOC | Actual | Loop 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 Verification | |||||||||||
Confirm that the vendor handover package is in place and contains correct material certificates | |||||||||||
Tag # | *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 Verification | ||||||||
Visually inspect, and subsequently verify, the correct installation of the instrument item in the field | ||||||||
Tag # | 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) |
Initials | Date | ||
__-__ | ||||||||
__-__ | ||||||||
__-__ | ||||||||
__-__ | ||||||||
__-__ | ||||||||
Comments: | ||
Validation Peer Review
|
||||||
Print Name | Signature | Date |
QA Approval
|
||||||
Print Name | Signature | Date |
16.2.4 Piping Installation Verification
Sheet 1 of 5 | 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 | |||||||
50-PUW1-S6-147-IH | S6 | YES | YES | YES | PASS | LB/22-Feb-2018 | ||||||||||
50-PUW1-S6-148-IH | S6 | YES | YES | YES | PASS | LB/22-Feb-2018 | ||||||||||
80-DETERGENT-S6-149-IH | S6 | YES | YES | YES | PASS | LB/22-Feb-2018 | ||||||||||
80-DETERGENT-S6-150-IH | S6 | YES | YES | YES | PASS | LB/22-Feb-2018 | ||||||||||
80-DETERGENT-S6-151-IH | S6 | YES | YES | YES | PASS | LB/22-Feb-2018 | ||||||||||
65-DETERGENT-S6-152-IH | S6 | YES | YES | YES | PASS | LB/22-Feb-2018 | ||||||||||
65-DETERGENT-S6-153-IH | S6 | YES | YES | YES | PASS | LB/22-Feb-2018 | ||||||||||
65-DETERGENT-SS1-154-IH | SS1 | YES | YES | YES | PASS | LB/22-Feb-2018 | ||||||||||
80-PUW2-S6-155-IH | S6 | YES | YES | YES | PASS | LB/22-Feb-2018 | ||||||||||
80-PUW2-S6-156-IH | S6 | YES | YES | YES | PASS | LB/22-Feb-2018 | ||||||||||
80-PUW2-S6-157-IH | S6 | YES | YES | YES | PASS | LB/22-Feb-2018 | ||||||||||
80-PUW2-S6-158-IH | S6 | YES | YES | YES | PASS | LB/22-Feb-2018 | ||||||||||
Sheet 2 of 5 | 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 | |||||||
80-PUW2-S6-159-IH | S6 | YES | YES | YES | PASS | LB/22-Feb-2018 | ||||||||||
80-PUW2-SS1-160-IH | SS1 | YES | YES | YES | PASS | LB/22-Feb-2018 | ||||||||||
25-PROCESS-S6-161-NI | S6 | YES | YES | YES | PASS | LB/22-Feb-2018 | ||||||||||
25-PROCESS-S6-162-NI | S6 | YES | YES | YES | PASS | LB/22-Feb-2018 | ||||||||||
65-DETERGENT-SS1/S6-163-IH | SS1/S6 | YES | YES | YES | PASS | LB/22-Feb-2018 | ||||||||||
65-PUW2-SS1/S6-164-IH | SS1 | YES | YES | YES | PASS | LB/22-Feb-2018 | ||||||||||
65-PUW2-SS1-165-IH | SS1 | YES | YES | YES | PASS | LB/22-Feb-2018 | ||||||||||
100-VENT-S6-166-NI | S6 | YES | YES | YES | PASS | LB/22-Feb-2018 | ||||||||||
25-DRAIN-S6-167-NI | S6 | YES | YES | YES | PASS | LB/22-Feb-2018 | ||||||||||
100-VENT-S6-168-NI | S6 | YES | YES | YES | PASS | LB/22-Feb-2018 | ||||||||||
25-DRAIN-S6-169-NI | S6 | YES | YES | YES | PASS | LB/22-Feb-2018 | ||||||||||
50-DRAIN-S6-170-NI | S6 | YES | YES | YES | PASS | LB/22-Feb-2018 | ||||||||||
50-DRAIN-S6-171-NI | S6 | YES | YES | YES | PASS | LB/22-Feb-2018 | ||||||||||
25-VENT-S6-172-NI | S6 | YES | YES | YES | PASS | LB/22-Feb-2018 | ||||||||||
25-VENT-S6-173-NI | S6 | YES | YES | YES | PASS | LB/22-Feb-2018 | ||||||||||
50-DRAIN-S6-174-NI | S6 | YES | YES | YES | PASS | LB/22-Feb-2018 | ||||||||||
Sheet 3 of 5 | 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 | |||||||
50-DRAIN-S6-175-NI | S6 | YES | YES | YES | PASS | LB/22-Feb-2018 | ||||||||||
80-DRAIN-SS1-176-NI | SS1 | YES | YES | YES | PASS | LB/22-Feb-2018 | ||||||||||
25-DRAIN-S6-177-NI | S6 | YES | YES | YES | PASS | LB/22-Feb-2018 | ||||||||||
25-DRAIN-S6-178-NI | S6 | YES | YES | YES | PASS | LB/22-Feb-2018 | ||||||||||
25-DRAIN-S6-179-NI | S6 | YES | YES | YES | PASS | LB/22-Feb-2018 | ||||||||||
25-DRAIN-S6-169-NI | S6 | YES | YES | YES | PASS | LB/22-Feb-2018 | ||||||||||
50-DRAIN-S6-170-NI | S6 | YES | YES | YES | PASS | LB/22-Feb-2018 | ||||||||||
50-DRAIN-S6-171-NI | S6 | YES | YES | YES | PASS | LB/22-Feb-2018 | ||||||||||
25-VENT-S6-172-NI | S6 | YES | YES | YES | PASS | LB/22-Feb-2018 | ||||||||||
25-VENT-S6-173-NI | S6 | YES | YES | YES | PASS | LB/22-Feb-2018 | ||||||||||
50-DRAIN-S6-174-NI | S6 | YES | YES | YES | PASS | LB/22-Feb-2018 | ||||||||||
50-DRAIN-S6-175-NI | S6 | YES | YES | YES | PASS | LB/22-Feb-2018 | ||||||||||
80-DRAIN-SS1-176-NI | SS1 | YES | YES | YES | PASS | LB/22-Feb-2018 | ||||||||||
25-DRAIN-S6-180-NI | S6 | YES | YES | YES | PASS | LB/22-Feb-2018 | ||||||||||
50-DRAIN-SS1-181-NI | SS1 | YES | YES | YES | PASS | LB/22-Feb-2018 | ||||||||||
Sheet 4 of 5 | 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 | |||||||
65-PLANT STEAM-CS5-182-IH | CS5 | YES | YES | YES | PASS | LB/22-Feb-2018 | ||||||||||
65-PLANT STEAN-CS5-183-IH | CS5 | YES | YES | YES | PASS | LB/22-Feb-2018 | ||||||||||
15-PLANT STEAM-CS5-184-IH | CS5 | YES | YES | YES | PASS | LB/22-Feb-2018 | ||||||||||
20-CONDENSATE-CS5-185-IH | CS5 | YES | YES | YES | PASS | LB/22-Feb-2018 | ||||||||||
40-CONDENSATE-CS5-186-IH | CS5 | YES | YES | YES | PASS | LB/22-Feb-2018 | ||||||||||
40-CONDENSATE-CS5-187-IH | CS5 | YES | YES | YES | PASS | LB/22-Feb-2018 | ||||||||||
40-COMPRESSED AIR-SS1-502-NI | SS1 | YES | YES | YES | PASS | LB/22-Feb-2018 | ||||||||||
80-CONDENSATE-CS5-242-IH | CS5 | YES | YES | YES | PASS | LB/22-Feb-2018 | ||||||||||
100-PLANT STEAM-CS5-241-IH | CS5 | YES | YES | YES | PASS | LB/22-Feb-2018 | ||||||||||
20-CONDENSATE-CS5-185-IH | CS5 | YES | YES | YES | PASS | LB/22-Feb-2018 | ||||||||||
40-CONDENSATE-CS5-186-IH | CS5 | YES | YES | YES | PASS | LB/22-Feb-2018 | ||||||||||
*Weld Log collates material-of-construction certificates and weld inspection certificates | **Construction Dossier collates slope-check documentation | |||||||||||||||
Sheet 5 of 5 | Piping Installation Verification |
Comments: | ||
Validation Peer Review
|
||||||
Print Name | Signature | Date |
QA Approval
|
||||||
Print Name | Signature | Date |
16.2.5 Calibration Program Verification
Page ___ of ___
CALIBRATION PROGRAM VERIFICATION FORM | ||||||
No. | Steps | Yes/No | Verified By | Date | ||
1 | Critical component list attached and cross referenced from commissioning documents | |||||
2 | Calibration list attached and cross referenced from site calibration program | |||||
3 | All 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: | |||||
16.2.6 Preventative Maintenance Program Verification
Page ___ of ___
Preventative Maintenance Program Verification Form | |||||||
No. | Description | Verified By / Date | |||||
1 | Component: | ||||||
PM#: | Location:
|
Effective Date:
|
|||||
2 | Component: | ||||||
PM#: | Location:
|
Effective Date:
|
|||||
3 | Component: | ||||||
PM#: | Location:
|
Effective Date:
|
|||||
4 | Component: | ||||||
PM#: | Location:
|
Effective Date:
|
|||||
5 | Component: | ||||||
PM#: | Location:
|
Effective Date:
|
|||||
6 | Component: | ||||||
PM#: | Location:
|
Effective Date:
|
|||||
Comments: | |||||||
Reviewed By:
Validation |
Date: | ||||||
Approved By:
(QA) |
Date: | ||||||
16.2.7 Draft SOP Verification
Page _ __ of _ __
Standard Operating Procedure Verification Form | |||||||||
No. | Description | Verified By / Date | |||||||
1 | Title: | ||||||||
SOP #: | Revision #: | Date: | |||||||
2 | Title: | ||||||||
SOP #: | Revision #: | Date: | |||||||
3 | Title | ||||||||
SOP #: | Revision #: | Date: | |||||||
4 | Title: | ||||||||
SOP #: | Revision #: | Date: | |||||||
5 | Title: | ||||||||
SOP #: | Revision #: | Date: | |||||||
6 | Title: | ||||||||
SOP #: | Revision #: | Date: | |||||||
Comments: | |||||||||
Reviewed By:
Validation |
Date: | ||||||||
Approved By:
(QA) |
Date: | ||||||||
16.2.8 Test-Instrument Calibration Verification
Page _ _ of _ __
Test Instrument Calibration Verification Form | |||||||
Objective: To document all test instruments used in the execution of this protocol. | |||||||
Test Instrument Description | Identification Number | Calibration Date | Calibration Due Date | Verified 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 – Detergent Dosing Control
16.3.2 Hot Detergent System – Temperature Control
16.3.3 Hot Detergent System – Flow Control
16.3.4 Hot Detergent System – Level Control
16.3.5 Hot PUW System – Temperature Control
16.3.6 Hot PUW System – Flow Control
16.3.7 Hot PUW System – Level Control
16.3.1 Hot Detergent System – Detergent Dosing Control
Test Step # | Operational Test Step Description | Expected Result | Actual Result | Pass / Fail | Initials | Date
(dd/mmm/yyyy) |
1 | Start up the hot detergent system and after 30-minutes confirm that 80°C detergent is recirculating. | TT-002 = 80°C±5°C
TT-004 = 80°C±5°C |
||||
2 | Confirm the online conductivity measurement CT-001 is reading X μScm-1 ± 5%. | X μScm-1 ± 5% | ||||
3 | Initiate a simultaneous detergent drawdown into reactor RE-119 and reactor RE-140, and charge approximately 5,500 litres into both vessels. | LT-119 > 5,000 Litres
LT-140 > 5,000 Litres |
||||
4 | After the charge stop the detergent drawdown into both reactor RE-119 and reactor RE-140 (approximately after 30-minutes; 22,000 kg/hr ±10% ≈11m3/30mins). | Drawdown stopped | ||||
5 | Following the charge, maintain the hot detergent system in normal operation mode for a further 30-minutes with no further drawdown. | No drawdown | ||||
6 | Print out the associated trends for conductivity transmitter CT-001, temperature transmitters TT-002 and TT-004, and level-transmitters LT-119 and LT-140 during the test period and append to this test section. | Trends attached |
Reviewed By (Validation Peer Review) | Date |
Approved By (Quality Assurance) | Date |
In the following table, at successive 5-minute intervals record the online indicator values of conductivity measurement CT-001, temperature transmitters TT-002 and TT-004, and level-transmitters LT-119 and LT-140. Ensure that the time period the values are recorded correspond to the following:
- The 30-minutes before maximum instantaneous detergent drawdown (starting at t0-min)
- During the instantaneous detergent drawdown, up to the full 5,500 litre charges in both reactors RE-119 and RE-140
- The 30-minutes following the discontinuation of the maximum drawdown
Time
minutes |
Time
HH/MM |
Expected
CT-001 μScm-1 |
Actual
CT-001 μScm-1 |
Expected
TT-002/4 (°C) |
Actual
TT-002 (°C) |
Actual
TT-004 (°C) |
LT-119
(Litres) |
LT-140
(Litres) |
Pass / Fail | Initials | Date
(dd/mmm/yyyy) |
t0-min | X μScm-1 ± 5% | 80°C±5°C | |||||||||
t5-min | X μScm-1 ± 5% | 80°C±5°C | |||||||||
t10-min | X μScm-1 ± 5% | 80°C±5°C | |||||||||
t15-min | X μScm-1 ± 5% | 80°C±5°C | |||||||||
t20-min | X μScm-1 ± 5% | 80°C±5°C | |||||||||
t25-min | X μScm-1 ± 5% | 80°C±5°C | |||||||||
t30-min | X μScm-1 ± 5% | 80°C±5°C | |||||||||
t35-min | X μScm-1 ± 5% | 80°C±5°C | |||||||||
t40-min | X μScm-1 ± 5% | 80°C±5°C |
Reviewed By (Validation Peer Review) | Date |
Approved By (Quality Assurance) | Date |
Time
minutes |
Time
HH/MM |
Expected
CT-001 μScm-1 |
Actual
CT-001 μScm-1 |
Expected
TT-002/4 (°C) |
Actual
TT-002 (°C) |
Actual
TT-004 (°C) |
LT-119
(Litres) |
LT-140
(Litres) |
Pass / Fail | Initials | Date
(dd/mmm/yyyy) |
t45-min | X μScm-1 ± 5% | 80°C±5°C | |||||||||
t50-min | X μScm-1 ± 5% | 80°C±5°C | |||||||||
t55-min | X μScm-1 ± 5% | 80°C±5°C | |||||||||
t60-min | X μScm-1 ± 5% | 80°C±5°C | |||||||||
t65-min | X μScm-1 ± 5% | 80°C±5°C | |||||||||
t70-min | X μScm-1 ± 5% | 80°C±5°C | |||||||||
t75-min | X μScm-1 ± 5% | 80°C±5°C | |||||||||
t80-min | X μScm-1 ± 5% | 80°C±5°C | |||||||||
t85-min | X μScm-1 ± 5% | 80°C±5°C | |||||||||
t90-min | X μScm-1 ± 5% | 80°C±5°C |
Comments:
|
Reviewed By (Validation Peer Review) | Date |
Approved By (Quality Assurance) | Date |
16.3.2 Hot Detergent System – Temperature Control
16.3.3 Hot Detergent System – Flow Control
16.3.4 Hot Detergent System –Level Control
16.3.5 Hot PUW System – Temperature Control
16.3.6 Hot PUW System – Flow Control
16.3.7 Hot PUW System – Level Control
16.3.8 Approved SOP Verification
Page _ __ of _ __
Standard Operating Procedure Verification Form | |||||||||
No. | Description | Verified By / Date | |||||||
1 | Title: | ||||||||
SOP #: | Revision #: | Date: | |||||||
2 | Title: | ||||||||
SOP #: | Revision #: | Date: | |||||||
3 | Title | ||||||||
SOP #: | Revision #: | Date: | |||||||
4 | Title: | ||||||||
SOP #: | Revision #: | Date: | |||||||
5 | Title: | ||||||||
SOP #: | Revision #: | Date: | |||||||
6 | Title: | ||||||||
SOP #: | Revision #: | Date: | |||||||
Comments: | |||||||||
Reviewed By:
Validation |
Date: | ||||||||
Approved By:
(QA) |
Date: | ||||||||
16.4 Appendix D: Deviation log
Deviation # |
Deviation Summary Statement |
Deviation Resolved
(YES / No) |
Date Verified |
Date Approved | Related Change #
(if applicable) |
Comments |
Reviewed By:
(Validation) |
Date: | ||
*Reviewed By:
(QA) |
Date: |
*Must be approved by QA if any deviations are deemed a ‘Direct Impact System’
16.5 Appendix E: Deviation Form
Deviation Details | Deviation# | ||||||||||||||||
Building / Area | Equipment / System | ||||||||||||||||
Protocol Section # | Protocol Test Descriptor | ||||||||||||||||
Deviation Category
(Please Circle) |
1 | 2 | 3 | *4 | *5 | ||||||||||||
DEVIATION DESCRIPTION | |||||||||||||||||
2. Impact Assessment of Deviation | |||||||||||||||||
System GMP Category
(Please Circle) |
Component GMP Category
(Please Circle) |
||||||||||||||||
*Direct | Indirect | No Impact | Critical | Non-Critical | |||||||||||||
Affected Items | Yes/No | Affected Items | Yes/No | ||||||||||||||
User Requirement | Functional or Detailed Design Specifications | ||||||||||||||||
Testing Already Completed | System Documentation | ||||||||||||||||
Testing Protocols | Drawings | ||||||||||||||||
Validation Plan | Standard Operating Procedures | ||||||||||||||||
Training | Other | ||||||||||||||||
Details of Affected Items:
|
|||||||||||||||||
REFERENCES (AFFECTED ITEMS) | |||||||||||||||||
Document # | Title / Description | Revision | |||||||||||||||
3. Resolution Description | |||||||||||||||||
4. Resolution Verification | |||||||||||||||||
Verified By: (Originator) | Date: | ||||||||||||||||
Approved By: (Validation) | Date: | ||||||||||||||||
*Approved By: (QA) | Date: | ||||||||||||||||
*Must be approved by QA only if a ‘Direct Impact System’
16.6 Appendix F: Change Control Llog
Change Control # | P&ID / System # | Summary Description of change | Direct / Indirect /
No-Impact |
Date Raised
(dd/mmm/yyyy) |
Pre-Approval Date
(dd/mmm/yyyy) |
Post-Approval Date
(dd/mmm/yyyy) |
COMMENTS: |
Reviewed By:
(Validation Engineering) |
Date: |
16.7 Appendix G: Change control Form
Change Control Form
|
|||||||
Project Title: | CHANGE #: | ||||||
Project No: | P&ID / System: | ||||||
Attachments (Yes/No): | Date: | ||||||
SECTION 1: OBSERVATIONS AND PROPOSED CHANGE (to be completed by 1Project Engineer) | |||||||
ORIGINAL DESIGN: | PROPOSED CHANGE: | ||||||
2HAZOP TO BE UPDATED (Yes / No) | |||||||
SECTION 2: IMPACT ASSESSMENT (to be completed by 1Engineering Validation) | |||||||
AFFECTED APPROVED ITEMS | Yes/No | AFFECTED APPROVED ITEMS | Yes/No | ||||
3Validation Plan | 3Project URS | ||||||
3System Level URS | 3System Impact Assessment | ||||||
3Component Impact Assessment | 3, 4Qualification Protocol(s) | ||||||
4Commissioning Protocol(s) | 4Other | ||||||
3, 5DIRECT | 5INDIRECT | 5NO IMPACT | |||||
3SYSTEM IMPACT | Yes / No | Yes / No | Yes / No | ||||
SECTION 2 (Continued): IMPACT ASSESSMENT (to be completed by 1Engineering Validation) | |||||||
3, 5OPER. CRITICAL | 3, 5PRODUCT CONTACT | 5NON CRITICAL | |||||
3COMPONENT IMPACT | Yes / No | Yes / No | Yes / No | ||||
5CONSTRUCTION | 5COMMISSIONING | 3, 5QUALIFICATION | |||||
PROJECT PHASE | Yes / No | Yes / No | Yes / No | ||||
SECTION 3: TESTING REQUIRED (to be completed by 1Engineering Validation) | |||||||
4TESTING REQUIRED
|
4DOCUMENT UPDATES REQUIRED
|
||||||
Number of Test Pages Attached | |||||||
SECTION 4: COST CALCULATIONS AND SCHEDULE (to be completed by 1Project Engineer) | |||||||
6COST OF CHANGE | 6IMPACT ON SCHEDULE (time) | ||||||
SECTION 5: PRE-APPROVALS | |||||||
PROJECT DISCIPLINE | PRINT NAME | SIGNATURE | DATE | ||||
PROJECT ENGINEER | |||||||
PROJECT MANAGER | |||||||
EHS | |||||||
VALIDATION | |||||||
QA | |||||||
SECTION 6: REJECT CHANGE | |||||||
PRINT NAME | SIGNATURE | DATE | |||||
CHANGE REJECTED BY | |||||||
REASON FOR REJECTING CHANGE
|
|||||||
SECTION 7: DOCUMENT UPDATES (to be completed by 1Engineering Validation) | ||||||
DOCUMENT UPDATED | Yes/No/
N/A |
DOCUMENT UPDATED | Yes/No/
N/A |
|||
3Commissioning and Qualification Plan | 3Project URS | |||||
3System Level URS | 3System Impact Assessment | |||||
3Component Impact Assessment | 3, 4Qualification Protocol(s) | |||||
4Commissioning Protocol(s) | 4Other | |||||
2HAZOP UPDATED (Yes / No) | ||||||
SECTION 8: 4POST-CHANGE TESTING SUCCESSFUL EXECUTED AND COMPLETED | ||||||
PRINT NAME | SIGNATURE | DATE | ||||
VERIFIED BY | ||||||
SECTION 9: POST-CHANGE APPROVALS | ||||||
PROJECT DISCIPLINE | PRINT NAME | SIGNATURE | DATE | |||
PROJECT ENGINEER | ||||||
PROJECT MANAGER | ||||||
EHS | ||||||
VALIDATION | ||||||
QA | ||||||
ADDITIONAL COMMENTS
|
||||||
1 Enter name and signatures details in approval section; 2 If ‘Yes’ EHS must approve change; 3 If ‘Yes’ QA must approve change; 4 Attach list accordingly; 5 Circle correct entry; 6 Attach additional cost breakdown, and if applicable details on updated schedule
16.8 Appendix H: Component Impact Assessment
Equipment Components
Critical | Non-Critical | ||||
Item # | Tag | Description | Operational Critical | Product Contact Critical | |
1-1 | T-211 | Hot Detergent Tank | YES | YES | |
1-2 | T-411 | Hot PUW2 Tank | YES | NO | |
1-3 | P-207 | Detergent Centrifugal Transfer Pump | YES | YES | |
1-4 | P-209 | Detergent Centrifugal Transfer Pump | YES | YES | |
1-5 | P-415 | PUW2 Centrifugal Transfer Pump | YES | YES | |
1-6 | P-417 | PUW2 Centrifugal Transfer Pump | YES | YES | |
1-7 | P-223 | Detergent Mentering Pump | YES | NO | |
1-8 | HX-211 | Detergent Plate Heat Exchanger | YES | YES | |
1-9 | HX-411 | PUW2 Plate Heat Exchanger | YES | YES | |
1-10 | FL-399 | Detergent Cartridge Filter | YES | NO | |
1-11 | FL-401 | PUW2 Cartridge Filter | YES | NO | |
1-12 | PSV-001 | PUW2 Sanitary Pressure Relief Valve | NO | NO | |
1-13 | PSV-002 | Detergent Sanitary Pressure Relief Valve | YES | NO | |
Instrument Components
Critical | Non-Critical | ||||
Item # | Tag | Description | Operational Critical | Product Contact Critical | |
2-1 | TCV-005 | Steam Temperature control valve | YES | YES | |
2-2 | TCV-006 | Steam Temperature control valve | YES | YES | |
2-3 | TT-001 | 3 wire RTD Temperature transmitters | YES | YES | |
2-4 | TT-002 | 3 wire RTD Temperature transmitters | YES | YES | |
2-5 | TT-003 | 3 wire RTD Temperature transmitters | YES | YES | |
2-6 | TT-004 | 3 wire RTD Temperature transmitters | YES | YES | |
2-7 | PT-001 | Sanitary Diaphragm type Pressure Indicating transmitters | NO | ||
2-8 | PT-002 | Sanitary Diaphragm type Pressure Indicating transmitters | YES | NO | |
2-9 | PI-007 | Local pressure indicators c/w bourdon type gauges | NO | YES | |
2-10 | FT-001 | Magnetic flow Transmitter | YES | YES | |
2-11 | FT-002 | Magnetic flow Transmitter | YES | YES | |
2-12 | FT-003 | Magnetic flow Transmitter | |||
2-13 | FT-004 | Magnetic flow Transmitter | YES | YES | |
2-14 | FS-005 | Low Flow switch | YES | YES | |
2-15 | CT-001 | Conductivity transmitter | YES | NO | |
2-16 | PI-003 | Diaphragm type pressure indicator | NO | ||
2-17 | PI-004 | Diaphragm type pressure indicator | NO | ||
2-18 | PI-005 | Diaphragm type pressure indicator | YES | ||
2-19 | PI-006 | Diaphragm type pressure indicator | YES | ||
2-20 | PI-008 | Diaphragm type pressure indicator | NO | ||
2-21 | TI-007 | Bimetalic Temperature indicator | NO | NO | |
2-22 | TI-008 | Bimetalic Temperature indicator | YES | ||
2-23 | TI-009 | Bimetalic Temperature indicator | NO | ||
2-24 | TI-010 | Bimetalic Temperature indicator | YES | ||
2-25 | LS-003 | Low Level Switch (Tuning fork type) | NO | ||
2-26 | LS-004 | Low Level Switch (Tuning fork type) | NO | ||
2-27 | LS-005 | High Level Switch (Tuning fork type) | YES | ||
2-28 | LS-006 | High Level Switch (Tuning fork type) | YES | ||
2-29 | LT-001 | Hydrostatic Pressure type level Transmitter | YES | ||
2-30 | LT-002 | Hydrostatic Pressure type level Transmitter | YES | ||
2-31 | XV-003 | Actuated Sanitary Butterfly Valve | NO | ||
2-32 | XV-004 | Actuated Sanitary Butterfly Valve | NO | ||
2-33 | XV-008 | Actuated Sanitary Ball Valve | NO | ||
2-34 | XV-009 | Actuated Sanitary Ball Valve | NO | ||
2-35 | XV-001 | Actuated Tuchenhagen Multiport divert Valves. | NO | ||
2-36 | XV-002 | Actuated Tuchenhagen Multiport divert Valves. | YES | ||
2-37 | XV-005 | Actuated Tuchenhagen Multiport divert Valves. | YES | ||
2-38 | XV-006 | Actuated Tuchenhagen Multiport divert Valves. | NO | ||
2-39 | XV-007 | Actuated Tuchenhagen Multiport divert Valves. | NO | ||
2-40 | PRV-001 | Back Pressure Regulating Valve | YES | NO | |
2-41 | PRV-002 | Back Pressure Regulating Valve | YES | NO | |
Piping Components
Critical | Non-Critical | ||||
Item # | Tag | Description | Operational Critical | Product Contact Critical | |
3-1 | 50-PUW1-S6-147-IH | From LN-486 To T-211 | YES | NO | |
3-2 | 50-PUW1-S6-148-IH | From LN-486 To T-411 | YES | NO | |
3-3 | 80-DETERGENT-S6-149-IH | From T-211 To FL-399 | YES | NO | |
3-4 | 80-DETERGENT-S6-150-IH | From FL-399 To P-207 | YES | NO | |
3-5 | 80-DETERGENT-S6-151-IH | From LN-150 To P-209 | YES | NO | |
3-6 | 65-DETERGENT-S6-152-IH | From P-209 To LN-153 | YES | ||
3-7 | 65-DETERGENT-S6-153-IH | From P-207 To HX-211 | NO | ||
3-8 | 65-DETERGENT-SS1-154-IH | From HX-211 To XV-021 @ DETERGENT change-over valves | YES | YES | |
3-9 | 80-PUW2-S6-156-IH | From FL-401 To P-415 | NO | ||
3-10 | 80-PUW2-S6-157-IH | From LN-156 To P-417 | NO | ||
3-11 | 65-PUW2-S6-158-IH- | From P-417 To LN-159 | NO | ||
3-12 | 65-PUW2-S6-159-IH- | From P-415 To HX-411 | YES | ||
3-13 | 65-PUW2-SS1-160-IH- | From HX-411 To XV-016 @ PUW2 change-over valves | YES | YES | |
3-14 | 25-PROCESS-S6-161-NI | From Conc. Detergent Dosing System
To P-223 |
YES | YES | |
3-15 | 25-PROCESS-S6-162-NI | From P-223
To LN-149 |
NO | ||
3-16 | 65-DETERGENT-SS1/S6-163-IH | From XV-018 @ DETERGENT change-over valves To T-211 | YES | YES | |
3-17 | 65-PUW2-SS1/S6-164-IH | From XV-013 @ PUW2 change-over valves To T-411 | YES | YES | |
3-18 | 100-VENT-S6-166-NI | From T-211 To Safe Area | YES | ||
3-19 | 25-DRAIN-S6-167-NI | From LN-166 To LN-176 | NO | ||
3-20 | 100-VENT-S6-168-NI | From T-411 To Safe Area | YES | ||
3-21 | 25-DRAIN-S6-169-NI | From LN-168 To LN-176 | NO | ||
3-22 | 50-DRAIN-S6-170-NI | From XV-002 @ T-211 outlet To LN-176 | NO | NO | |
3-23 | 50-DRAIN-S6-171-NI | From XV-001 @ T-411 outlet To LN-176 | NO | NO | |
3-24 | 25VENTS6172NI | From PSV-002 To LN-176 | YES | NO | |
3-25 | 25-VENT-S6-173-NI | From PSV-001 To LN-176 | YES | NO | |
3-26 | 50-DRAIN-S6-174-NI | From XV-006 @ T-211 inlet To LN-176 | YES | NO | |
3-27 | 50-DRAIN-S6-175-NI | From XV-005 @ T-411 inlet To LN-176 | NO | ||
3-28 | 80-DRAIN-SS1-176-NI | From Drain Lines To Drain Header | NO | ||
3-29 | 15-DRAIN-S6-177-NI | From P-207 To Drain | NO | ||
3-30 | 15-DRAIN-S6-178-NI | From P-209 To Drain | NO | ||
3-31 | 15-DRAIN-S6-179-NI | From P-415 To Drain | NO | ||
3-32 | 15-DRAIN-S6-180-NI | From P-417 To Drain | YES | ||
3-33 | 50-DRAIN-SS1-181-NI | From T-411 Pump Discharge
To Drain |
YES | NO | |
3-34 | 50-DRAIN-SS1-182-NI | From T-211 Pump Discharge To Drain | YES | NO | |
3-35 | 65-PLANT STEAM-CS5-183-IH | From LN-241 To HX-211 / HX-411 | YES | ||
3-36 | 15-PLANT STEAM-CS5-184-IH | From LN-241 To LN-185 | YES | ||
3-37 | 20-CONDENSATE-CS5-185-IH | From LN-184 To LN-242 | YES | NO | |
3-38 | 40-CONDENSATE-CS5-186-IH | From HX-211 To LN-242 | YES | YES | |
3-39 | 40-CONDENSATE-CS5-187-IH | From HX-411 To LN-242 | YES | ||
3-40 | 100-PLANT STEAM-CS5-241-IH | From Existing Steam Header Level 2 To Cleaning generation Skid | YES | YES | |
3-41 | 80-CONDENSATE-CS5-242-IH | From Cleaning Generation Skid To Existing Condensate Header Level 4 | YES | YES | |
3-42 | 40-COMPRESSED AIR-SS1-502-NI | From V-39 To Pneumatic Control | YES | YES | |
16.9 Appendix I: Traceability Matrix
Testing Traceability Matrix
Hot Detergent and Hot PUW Generation and Distribution
1 Plant Throughputs for Hot Detergent and Hot PUW Generation System
Item | User Requirement Description | Testing | Comment |
1.1 | The system shall be capable of achieving and maintaining a maximum outward flowrate, at steady state conditions, of 25,000 kg/hr ±5% | · Operational / Functional Test
· Procedure Section 13.3 · Checksheet 16.3.3 · “Hot Detergent System – Flow Control” |
· Conduct test during simultaneous maximum Hot Detergent drawdown into reactor RE-119 and reactor RE-140 |
1.2 | The system shall be capable of achieving and maintaining a minimum return flowrate, at steady state conditions, of 3,000 kg/hr ±5% | · Operational / Functional Test
· Procedure Section 13.3 · Checksheet 16.3.3 · “Hot Detergent System – Flow Control” |
· Conduct test during simultaneous maximum Hot Detergent drawdown into reactor RE-119 and reactor RE-140 |
1 Plant Throughputs for Hot Detergent and Hot PUW Generation System (continued)
Item | User Requirement Description | Testing | Comment |
1.3 | The system shall be capable of achieving and maintaining a maximum instantaneous drawdown of 22,000 kg/hr ±5%, based on 2 users at 11m3/hr/user | · Operational / Functional Test
· Procedure Section 13.3 · Checksheet 16.3.3 · “Hot Detergent System – Flow Control” |
· Conduct test during simultaneous maximum Hot Detergent drawdown into reactor RE-119 and reactor RE-140 |
1.4 | The maximum number of simultaneous users shall be two.
|
· Operational / Functional Test
· Procedure Section 13.3 · Checksheet 16.3.3 · “Hot Detergent System – Flow Control” |
· Conduct test during simultaneous maximum Hot Detergent drawdown into reactor RE-119 and reactor RE-140 |
2 Skid Configuration
Item | User Requirement Description | Testing | Comment |
2-1 | The Skid shall consist of the following equipment items. The detailed design specifications for these equipment items are outlined in Appendix 1.
Process water tank 1 Detergent solution tank 1 Centrifugal recirculation pumps 4 Detergent dosing pump 1 Heat exchangers 2
|
· Installation Test
· Procedure Section 11.2 · Checksheet 16.2.2.1 to Checksheet 16.2.2.13
· Installation Test · Procedure Section 11.1 · Checksheet 16.2.1 |
· Equipment Installation Tests
· P&ID Walkdown |
2-2 | Instrumentation as illustrated on the P&ID-227 shall be supplied with the skid.
|
· Installation Test
· Procedure Section 11.3 · Checksheet 16.2.3.1 to Checksheet 16.2.3.12
· Installation Test · Procedure Section 11.1 · Checksheet 16.2.1 |
· Instrumentation Installation Test
· P&ID Walkdown |
3 Hot Detergent Solution Operation
Item | User Requirement Description | Testing | Comment |
3.1 | The Hot Detergent Tank shall be fed directly from the 25°C PUW1 water loop.
|
· Operational / Functional Test
· Procedure Section 13.4 · Checksheet 16.3.4 · “Hot Detergent System – Level Control” |
· Conduct test during simultaneous maximum Hot Detergent drawdown into reactor RE-119 and reactor RE-140 |
3.3 | The system shall have the facility to maintain the level in the Hot Detergent Tank within ±5% of the user defined level setpoint. | · Operational / Functional Test
· Procedure Section 13.4 · Checksheet 16.3.4 · “Hot Detergent System – Level Control” |
· Conduct test during simultaneous maximum Hot Detergent drawdown into reactor RE-119 and reactor RE-140Level Test |
3.5 | · The system shall have the facility to automatically dose concentrated detergent to the required concentration (Y% ±0.05%)
· Online conductivity measurement shall be provided to verify the detergent concentration. |
· Installation Test
· Procedure Section 11.3 · Checksheet 16.2.3.7
· Operational / Functional Test · Procedure Section 13.1 · Checksheet 16.3.1 · “Detergent Dosing Control” |
· Verify conductivity transmitter installation
· Conduct test during simultaneous maximum Hot Detergent drawdown into reactor RE-119 and reactor RE-140 |
4 Hot PUW Solution Operation
Item | User Requirement Description | Testing | Comment |
4.4 | · The Hot PUW 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). |
· Operational / Functional Test
· Procedure Section 13.5 · Checksheet 16.3.5 · “Hot PUW System – Temperature Control” |
Conduct test during simultaneous maximum Hot PUW drawdown into reactor RE-119 and reactor RE-140 |