9000-P / Potable Water System Installation and Operational Qualification Protocol

Table Of Contents

Insert table of content

1 Revision History

Revision Author Name Date Detail

1.0 Aoibheann Minogue See electronic approval Issue for Approval
date

2.1 Objective
The purpose of this Installation and Operational Commissioning (IOC) protocol is to verify and document the proper installation and operation of the 9000-P /
Process Waste System .

2.2 Scope
The scope of this IOC protocol is the system 9000-P / Process Waste System .

This system is composed of the associated equipment, instrumentation, mechanical x-items, and piping, as defined on the P&IDs listed below

P&ID Title P&ID Number

IE0312903-41-DR-9000 Process Waste Drain Collection Network
IE0312903-41-DR-9001 Suite # 1 Process Waste Lift Stations
IE0312903-41-DR-9004 Process Waste Collection Tank
IE0312903-41-DR-9005 Lab Process Waste
IE0312903-41-DR-9007 Suite # 2 Process Waste Lift Stations
IE0312903-41-DR-9008 Suite # 3 Process Waste Lift Stations
9000-P / Potable Water System Installation and Operational Qualification Protocol

P&ID Title P&ID Number

IE0312903-41-DR-7000 WFI Pretreatment 1 P&ID
IE0312903-41-DR-7010 WFI Pretreatment 2 P&ID
IE0312903-41-DR-7050 WFI Generation 1 P&ID
IE0312903-41-DR-7060 WFI Generation 2 P&ID
IE0312903-41-DR-7110 WFI Distribution Pump, Circulation Pump & Reheater Skid P&ID
IE0312903-41-DR-7125 FIT Sink 1 WFI POU Cooler (Low Flow) P&ID
IE0312903-41-DR-7120 WFI Distribution Loop P&ID
IE0312903-41-DR-7127 Janitors Closet WFI POU Cooler (Low Flow) P&ID
IE0312903-41-DR-7130 Solution Prep 1 WFI POU Cooler 2 (High Flow) P&ID
IE0312903-41-DR-7131 Solution Prep 2 BSB WFI POU Cooler 1 (High Flow) P&ID
IE0312903-41-DR-7132 Solution Prep 2 WFI POU Cooler 2 (High Flow) P&ID
IE0312903-41-DR-7134 Solution Prep 1 WFI POU Cooler 1 (High Flow) P&ID
IE0312903-41-DR-5040 Equipment Prep Autoclave P&ID
IE0312903-41-DR-5060 Development & QC Laboratory Clean Steam Generator & Autoclave P&ID
IE0312903-41-DR-5080 Decontamination Autoclave P&ID
IE0312903-41-DR-4500 Weigh/Dispense #1
IE0312903-41-DR-4600 Weigh/Dispense #2
IE0312903-41-DR-7128 Suite 1 WFI POU Cooler (Low Flow) P&ID
IE0312903-41-DR-7129 Suite 2 WFI POU Cooler (Low Flow) P&ID
IE0312903-41-DR-7133 Suite 3 WFI POU Cooler (Low Flow) P&ID
IE0312903-46-DR-8110 Flow Diagram AH-8110-01 Microbiology Lab Sheet 1 of 2
IE0312903-46-DR-8120 Flow Diagram 500-AH-8120-01 & 02 Development Lab (Sheet 1 of 2)
IE0312903-46-DR-8210 Flow Diagram 500-AH-8210-01 Offices (1 of 12)
IE0312903-46-DR-8410 Flow Diagram 500-AH-8410-01 GMP Storage / Warehouse (Sheet 1 of 2)
IE0312903-46-DR-8510 Flow Diagram 500-AH-8510-01 Support & Lockers 1 of 2
IE0312903-46-DR-8610 Flow Diagram 500-AH-8610-01 MUA (Sheet 1 of 2)
IE0312903-46-DR-8611 Flow Diagram 500-AH-8610-02 MUA (Sheet 2 of 2)
IE0312903-46-DR-8620 Flow Diagram 500-AH-8620-01 MUA (Sheet 1 of 2)
IE0312903-46-DR-8621 Flow Diagram 500-AH-8620-02 MUA (Sheet 2 of 2)
9000-P / Potable Water System Installation and Operational Qualification Protocol

P&ID Title P&ID Number

IE0312903-46-DR-8630 Flow Diagram 500-AH-8630-01 MUA (Sheet 1 of 2)
IE0312903-46-DR-8631 Flow Diagram 500-AH-8630-02 MUA (Sheet 2 of 2)
IE0312903-46-DR-8710 Flow Diagram 500-AH-8710-01 Biokill Room
IE0312903-46-DR-8910 Flow Diagram 500-AH-8910-01 POD Staging
IE0312903-46-DR-8920 Flow Diagram 500-AH-8920-01 Mezzanine & Utilities 1 of 3
IE0312903-46-DR-8930 Flow Diagram 500-AH-8930-01 Interstitial
IE0312903-46-DR-9016 FCU Condensate Drain P&ID
IE0312903-46-DR-9020 Compressed Air Generation P&ID
IE0312903-46-DR-9600 P&ID Steam Generators Water Preparation Plant
IE0312903-46-DR-9601 P&ID Steam Generator 1
IE0312903-46-DR-9602 P&ID Steam Generator 2
IE0312903-46-DR-9603 Steam Distribution P&ID
IE0312903-46-DR-9604 Condensate Recovery Skid Sheet 1 of 2 P&ID
IE0312903-46-DR-9606 Condensate Recovery Skid Sheet 2 of 2 P&ID
IE0312903-46-DR-9605 Additive-Free Steam Generator P&ID
IE0312903-46-DR-9010 Domestic Hot Water Generation
IE0312903-46-DR-9011 Mains Water Distribution P&ID
IE0312903-46-DR-9012 Safety Showers P&ID Sheet 1 of 3
IE0312903-46-DR-9310 Mechanical HVAC P&ID CHW Generation (Sheet 1 or 2)
IE0312903-46-DR-9320 LPHW P&ID Sheet 1 of 2

2.3 System Description

The Process waste System comprises of the following equipment:
Process Waste Lift Stations - Collection tanks (9 Nos.) and transfer pumps (18 Nos)
Process Waste Collection Tank – Collection tank (1 No.), transfer pumps (2 Nos.), Waste Sump pump (1 No).

Process waste from lift stations will be sent to the overhead piping using the transfer pump(s) and will gravity drain into the Process waste collection tank
located inside the sump. The Waste from the Process waste collection tank will be pumped to the existing Waste Neutralisation Tank downstream where all
other waste is neutralised before routing to public waste systems.
9000-P / Potable Water System Installation and Operational Qualification Protocol

Process and Biowaste lift stations are an identical design and a like for like installation. All lift stations are controlled by the same Equipment Module (EM).
Therefore, one lift station will be representative of all lift stations during commissioning.

2.4 Reference Documents

Reference Identification / Description
Global Engineering Solutions Procedure 6.0, Commissioning and Qualification: FEL Through Execution Phases
SOP-1252 Design Facilities, Utilities and Equipment
SOP-1253 Qualify Facilities, Utilities and Equipment
PVMP-PBioNX-DBY-VMP-001 BioNX Project Validation Master Plan
Global Engineering Solutions Procedure 2.0, Engineering FEL through Execution Phases
SLIA - DBY-500-BioNX-SD-001, System Level Impact Assessment for Manufacturing Process and Utility Systems - BioNX Project
IE312903-42-SP-8900, User Requirement Specification for Waste Lift Station

2.5 Roles and Responsibilities for Quality and Automation.

The responsibilities for implementation of this IOC protocol are as outlined in the Project Validation Master Plan and/or established site and divisional
practices/procedures.

Combined equipment and automation testing.

Where this protocol is used for a combination of equipment and automation tests,
Automation, MMDIT & DDQ capacity in this protocol is oversight and approval of Automation tests.

3.1 Test Execution Instructions

Testing is not required to be performed as sequenced within this protocol.

IC and OC may run concurrently once the section pre-requisites are achieved. Any specific pre-requisites that are required are detailed in the pre-requisite
section at the beginning of each test script.

3.2 Reporting of Test Failures

For Test errors/failures that occur when executing IOC tests, if an exception is required, create an eVal Exception/Issue as per WI-4521 'eVal Test
Execution'.
9000-P / Potable Water System Installation and Operational Qualification Protocol

3.3 Protocol Attachments

Protocol attachments should be added as per WI-4521, eVal Test Execution.

Where applicable, perform True Copy Certification per WI-4523.

4.1 IC Pre-requisites

Prior to commencing IC testing, confirm that the following pre-requisites have been met:
If Pre-requisite cannot be met, provide justification in comment section if IC testing can proceed.

Step Pre-requisites Pre-requisites confirmation Comments if applicable Pre-requisite Performed By

Met
(Yes/No/N/A)
1 Confirm MC (Mechanical Completion) has MC (Mechanical Completion) has been MC (Mechanical Completion) Yes Aoibheann Minogue (minoguao)
been achieved for the system and recorded achieved for the system and recorded in has been achieved for the Row Sign. 05-Apr-2023 13:18:51
in the project Electronic Data Management the project Electronic Data Management following phases of 9000-P (UTC)
System (EDMS).MC (Mechanical System (EDMS). system and recorded in the
Completion) has been achieved for the project Electronic Data
system and recorded in the project Management System (EDMS):
Electronic Data Management System 9000-P-01, 9000-P-02, 9000-P-
(EDMS). 03, 9000-P-06, 9000-P-07.
1 Confirm MC (Mechanical Completion) has MC (Mechanical Completion) has been MC (Mechanical Completion) Yes N/A
been achieved for the system and recorded achieved for the system and recorded in has been achieved for the
in the project Electronic Data Management the project Electronic Data Management following phases of 9000-P
System (EDMS).MC (Mechanical System (EDMS). system and recorded in the
Completion) has been achieved for the project Electronic Data
system and recorded in the project Management System (EDMS):
Electronic Data Management System 9000-P-01, 9000-P-02, 9000-P-
(EDMS). 03, 9000-P-06, 9000-P-07,
9000-P-05. [ 1 ]
1 Confirm MC (Mechanical Completion) has MC (Mechanical Completion) has been MC (Mechanical Completion) Yes Aoibheann Minogue (minoguao)
been achieved for the system and recorded achieved for the system and recorded in has been achieved for the Row Sign. 24-Apr-2023 13:09:30
in the project Electronic Data Management the project Electronic Data Management following phases of 9000-P (UTC)
System (EDMS).MC (Mechanical System (EDMS). system and recorded in the Reason for re-sign: MC of 9000-P-
Completion) has been achieved for the project Electronic Data 05 added
system and recorded in the project Management System (EDMS):
Electronic Data Management System 9000-P-01, 9000-P-02, 9000-P-
(EDMS). 03, 9000-P-06, 9000-P-07,
9000-P-05.
[1] Aoibheann Minogue (minoguao) Executor, 24-Apr-2023 13:09:07 (UTC) Reason: MC of 9000-P-05 added
9000-P / Potable Water System Installation and Operational Qualification Protocol

Step Pre-requisites Pre-requisites confirmation Comments if applicable Pre-requisite Performed By

Met
(Yes/No/N/A)
2 Confirm the Method Statement/Set to Work Method Statement / Set to Work document has Method Statement / Set to Work Yes Aoibheann Minogue (minoguao)
document has been executed, approved and been executed, approved and is available on document has been executed, Row Sign. 24-Apr-2023 13:05:17
available on PIMS for the system. PIMS for the system. approved and is available on (UTC)
PIMS for the system.
Provide Method Statement / Set to Work Method Statement / Set to Work document
document reference. reference: Method Statement / Set to Work
document reference:
HV GU 002
3 Confirm that all punch items have been All punch items have been closed and recorded Open punch items are recorded No Aoibheann Minogue (minoguao)
closed and recorded in the project Electronic in the project Electronic Data Management in the project Electronic Data Row Sign. 24-Apr-2023 13:11:26
Data Management System (EDMS). System (EDMS). Management System (EDMS). (UTC)

If there are any open punch items, Open punches have no impact
document an assessment for impact to IOC. to execution of this IOC
4 Confirm all Change Controls (FPIDCN & All Change Controls (FPIDCN & ACP's) have All FPIDCNs have been closed Yes Aoibheann Minogue (minoguao)
ACP's) have been closed and recorded been closed and recorded in project Electronic and recorded in project Row Sign. 09-May-2023 15:41:32
in project Electronic Data Management Data Management System (EDMS). Electronic Data Management (UTC)
System (EDMS). System (EDMS).
If there are any open Change Controls, an
If there are any open Change Controls, assessment for impact to this IOC has been ACP-105 is open and recorded
complete & attach an assessment for impact completed & attached. in project Electronic Data
to this IOC. Management System (EDMS).
THis ACP does not impact
execution of this protocol.
5 Confirm that the Vendor Turn Over Pack The Vendor Turn Over Pack (VTOP) is The Vendor Turn Over Pack Yes Aoibheann Minogue (minoguao)
(VTOP) is approved and recorded in project approved and recorded in project Electronic (VTOP) for the Process Waste Row Sign. 28-Apr-2023 07:55:18
Electronic Data Management System Data Management System (EDMS). Collection Tanks and Lift (UTC)
(EDMS). Stations are approved and
recorded in project Electronic
Data Management System
(EDMS).
6 Confirm that the Construction Turn Over The Construction Turn Over Pack (CTOP) is The Construction Turn Over Yes Aoibheann Minogue (minoguao)
Pack (CTOP) is approved and recorded approved and recorded in project Electronic Pack (CTOP) is approved and Row Sign. 28-Apr-2023 07:57:50
in project Electronic Data Management Data Management System (EDMS). recorded in project Electronic (UTC)
System (EDMS). Data Management System
(EDMS).
7 Confirm that the Equipment Pre-Dynamic The Equipment Pre-Dynamic Testing Review The Equipment Pre-Dynamic Yes Aoibheann Minogue (minoguao)
Testing Review has been completed has been completed successfully and recorded Testing Review has been Row Sign. 03-May-2023 07:51:26
successfully and recorded in the project in the project Electronic Data Management completed successfully for (UTC)
Electronic Data Management System System (EDMS). Process Waste Tank & Lift
(EDMS). Stations and recorded in the
9000-P / Potable Water System Installation and Operational Qualification Protocol

Step Pre-requisites Pre-requisites confirmation Comments if applicable Pre-requisite Performed By

Met
(Yes/No/N/A)
project Electronic Data
Management System (EDMS).

Notes / Comments Performed By

Aoibheann Minogue (minoguao)
Row Sign. 25-May-2023 14:36:20
(UTC)

Review of (IC) Pre-requisites

Reviewed By:
Grainne Byrne (BYRNEGRA)
Row Sign. 07-Jun-2023 06:27:15 (UTC)

4.2.1 CE Declaration of Conformity Verification

Test Title Objective Pre-Requisite Tests Test Conditions Section Requirement Reference Performed By
Reference
CE Declaration of To verify equipment is N/A N/A IE0312903-42-SP-8900 UR-1.6 Aoibheann Minogue (minoguao)
Conformity Verification CE certified. Row Sign. 03-May-2023 07:55:28
(UTC)

Step # Action/Inputs Expected Result Actual Result Pass / Fail Performed By

1 Confirm the CE Declaration The CE Declaration of The CE Declaration of Conformity is available Pass Aoibheann Minogue (minoguao)
of Conformity is available and Conformity is available and and attached. Row Sign. 03-May-2023 08:13:21
attach a copy of the cert. attached. (UTC)
Declaration of Conformity - Lift Stations.pdf
Declaration of Conformity - Process Waste
Tank.pdf
9000-P / Potable Water System Installation and Operational Qualification Protocol

Comments Performed By
N/A Aoibheann Minogue (minoguao)
Row Sign. 03-May-2023 08:13:38
(UTC)

Summary of Test script Results

Comments Summary of Test script Result Performed By
Pass / Fail
N/A Pass Aoibheann Minogue (minoguao)
Row Sign. 03-May-2023 08:13:56
(UTC)

Review of Test script Results

Reviewed By:
Grainne Byrne (BYRNEGRA)
Row Sign. 25-May-2023 14:37:59 (UTC)

4.2.2 Construction Completion Records (CCR) Checklist

Test Title Objective Pre-Requisite Tests Test Conditions Section Requirement Reference Performed By
Reference
Construction Completion Verify completion N/A N/A IE0312903-42-SP-8900 UR- Aoibheann Minogue
Records (CCR) Checklist of Construction Completion 1.1, UR-1.2, UR-1.7, (minoguao)
Records for the system. Row Sign. 03-May-2023
08:14:16 (UTC)

CCRs are the means for documenting that the completed construction has been checked and adheres to predetermined expectations. The CCRs serve as a
basis for MSD’s acceptance of the construction scope, and subsequent turnover to the operating site.

The system CCR’s have been identified and are checked and approved as part of the turnover phase. The check below is confirming that the CTOP and
VTOP for the system are reviewed and approved during the turnover phase.

Note: Alternative construction records, which are agreed for the project, may be used in place of the MSD CCR's.
9000-P / Potable Water System Installation and Operational Qualification Protocol

CCR Checks
CCRs Pass / Fail / N/A Performed By
Confirm that the CCR’s in the VTOP are reviewed and approved for the system and recorded in the project N/A Aoibheann Minogue (minoguao)
Electronic Data Management System (EDMS). Row Sign. 03-May-2023 08:29:46
(UTC)
Confirm that the CCR’s in the CTOP are reviewed and approved for the system and recorded in the project Pass Aoibheann Minogue (minoguao)
Electronic Data Management System (EDMS). Row Sign. 03-May-2023 08:29:37
(UTC)

Comments Performed By
N/A Aoibheann Minogue (minoguao)
Row Sign. 03-May-2023 08:29:58
(UTC)

Summary of Test script Results

Comments Summary of Test script Performed By
Result
Pass / Fail
N/A Pass Aoibheann Minogue (minoguao)
Row Sign. 03-May-2023 08:30:09
(UTC)

Review of Test script Results

Reviewed By:
Grainne Byrne (BYRNEGRA)
Row Sign. 25-May-2023 14:38:16 (UTC)

4.2.3 P&ID Walkdown Verification

Test Title Objective Pre-Requisite Tests Test Conditions Section Requirement Reference Performed By
Reference
P&ID walkdown verification To verify the as-built P&IDs N/A 7.1 IE312903-42-SP-8900 UR- Aoibheann Minogue
(red-lined P&IDs are 1.8 (minoguao)
9000-P / Potable Water System Installation and Operational Qualification Protocol

Test Title Objective Pre-Requisite Tests Test Conditions Section Requirement Reference Performed By
Reference
acceptable) have been field Row Sign. 09-May-2023
checked (Highlight as 08:36:14 (UTC)
per GES Practice 2.5.8
“Construction Completion
Turnover”) as meeting the
design intent and
specifications of the system.
P&ID walkdown verification To verify the as-built P&IDs N/A 7.1 IE312903-42-SP-8900 UR- Grainne Byrne
(red-lined P&IDs are 1.8 (BYRNEGRA)
acceptable) have been field Row Sign. 12-Jun-2023
checked (Highlight as 13:04:29 (UTC)
per GES Practice 2.5.8 Reason for re-sign: Re-
“Construction Completion signing due to update
Turnover”) as meeting the
design intent and
specifications of the system.

P&ID Number P&ID P&ID Date Full / Partial Walkdown Expected Result Attach Walked Down Pass / Fail Performed By
Revision P&ID
Number
IE0312903-41-DR-9000 0 28 Oct 2021 Full Walkdown The P&ID (red-lined P&IDs are acceptable) IE0312903-41-DR- Fail Aoibheann
has been walked down and the system has 9000.pdf Minogue
been visually verified in the field and reflects (minoguao)
the as-built conditions. Row Sign. 01-Jun-
2023 10:34:36
(UTC)
IE0312903-41-DR-9000 0 28 Oct 2021 Full Walkdown The P&ID (red-lined P&IDs are acceptable) IE0312903-41-DR- Fail N/A
has been walked down and the system has 9000.pdf [ 1 ]
been visually verified in the field and reflects
the as-built conditions.
IE0312903-41-DR-9000 0 28 Oct 2021 Full Walkdown The P&ID (red-lined P&IDs are acceptable) IE0312903-41-DR- Pass [ 2 ] N/A
has been walked down and the system has 9000.pdf
been visually verified in the field and reflects
the as-built conditions.
IE0312903-41-DR-9000 0 28 Oct 2021 Full Walkdown The P&ID (red-lined P&IDs are acceptable) IE0312903-41-DR- Pass Aoibheann
has been walked down and the system has 9000.pdf Minogue
been visually verified in the field and reflects (minoguao)
the as-built conditions. Row Sign. 02-Jun-
2023 08:38:52
(UTC)
9000-P / Potable Water System Installation and Operational Qualification Protocol

P&ID Number P&ID P&ID Date Full / Partial Walkdown Expected Result Attach Walked Down Pass / Fail Performed By
Revision P&ID
Number
Reason for re-sign:
Attachment
Updated
[1] Aoibheann Minogue (minoguao) Executor, 02-Jun-2023 08:38:10 (UTC) Reason: Attachment Updated
[2] Aoibheann Minogue (minoguao) Executor, 02-Jun-2023 08:38:44 (UTC) Reason: Result Updated
IE0312903-41-DR-9001 0 26 May 2022 Full Walkdown The P&ID (red-lined P&IDs are acceptable) IE0312903-41-DR- Pass Aoibheann
has been walked down and the system has 9001.pdf Minogue
been visually verified in the field and reflects (minoguao)
the as-built conditions. Row Sign. 30-May-
2023 14:01:17
(UTC)
IE0312903-41-DR-9004 0 24 Jan 2022 Full Walkdown The P&ID (red-lined P&IDs are acceptable) IE0312903-41-DR- Pass Aoibheann
has been walked down and the system has 9004.pdf Minogue
been visually verified in the field and reflects (minoguao)
the as-built conditions. Row Sign. 30-May-
2023 14:06:53
(UTC)
IE0312903-41-DR-9005 1 20 Jan 2023 Full Walkdown The P&ID (red-lined P&IDs are acceptable) IE0312903-41-DR- Fail Aoibheann
has been walked down and the system has 9005.pdf Minogue
been visually verified in the field and reflects (minoguao)
the as-built conditions. Row Sign. 01-Jun-
2023 10:36:01
(UTC)
IE0312903-41-DR-9005 1 20 Jan 2023 Full Walkdown The P&ID (red-lined P&IDs are acceptable) IE0312903-41-DR- Fail N/A
has been walked down and the system has 9005.pdf [ 1 ]
been visually verified in the field and reflects
the as-built conditions.
IE0312903-41-DR-9005 1 20 Jan 2023 Full Walkdown The P&ID (red-lined P&IDs are acceptable) IE0312903-41-DR- Pass [ 2 ] N/A
has been walked down and the system has 9005.pdf
been visually verified in the field and reflects
the as-built conditions.
IE0312903-41-DR-9005 1 20 Jan 2023 Full Walkdown The P&ID (red-lined P&IDs are acceptable) IE0312903-41-DR- Pass Aoibheann
has been walked down and the system has 9005.pdf Minogue
been visually verified in the field and reflects (minoguao)
the as-built conditions. Row Sign. 02-Jun-
2023 08:40:21
(UTC)
Reason for re-sign:
Attachment
Updated
9000-P / Potable Water System Installation and Operational Qualification Protocol

P&ID Number P&ID P&ID Date Full / Partial Walkdown Expected Result Attach Walked Down Pass / Fail Performed By
Revision P&ID
Number
[1] Aoibheann Minogue (minoguao) Executor, 02-Jun-2023 08:39:53 (UTC) Reason: Attachmnet Updated
[2] Aoibheann Minogue (minoguao) Executor, 02-Jun-2023 08:40:13 (UTC) Reason: Result Updated
IE0312903-41-DR-9007 0 26 May 2022 Full Walkdown The P&ID (red-lined P&IDs are acceptable) IE0312903-41-DR- Pass Aoibheann
has been walked down and the system has 9007.pdf IE0312903- Minogue
been visually verified in the field and reflects 41-DR-9007_2.pdf (minoguao)
the as-built conditions. Row Sign. 30-May-
2023 13:58:16
(UTC)
IE0312903-41-DR-9008 0 26 May 2022 Full Walkdown The P&ID (red-lined P&IDs are acceptable) IE0312903-41-DR- Pass Aoibheann
has been walked down and the system has 9008.pdf IE0312903- Minogue
been visually verified in the field and reflects 41-DR-9008_2.pdf (minoguao)
the as-built conditions. Row Sign. 30-May-
2023 14:04:28
(UTC)
IE0312903-41-DR-7000 0 01 Apr 2022 Full Walkdown The P&ID (red-lined P&IDs are acceptable) IE0312903-41-DR- Pass Aoibheann
has been walked down and the system has 7000.pdf Minogue
been visually verified in the field and reflects (minoguao)
the as-built conditions. Row Sign. 30-May-
2023 12:23:57
(UTC)
IE0312903-41-DR-7010 0 01 Apr 2022 Full Walkdown The P&ID (red-lined P&IDs are acceptable) IE0312903-41-DR- Pass Aoibheann
has been walked down and the system has 7010.pdf Minogue
been visually verified in the field and reflects (minoguao)
the as-built conditions. Row Sign. 30-May-
2023 12:25:33
(UTC)
IE0312903-41-DR-7050 0 31 Mar 2022 Full Walkdown The P&ID (red-lined P&IDs are acceptable) IE0312903-41-DR- Pass Aoibheann
has been walked down and the system has 7050.pdf Minogue
been visually verified in the field and reflects (minoguao)
the as-built conditions. Row Sign. 30-May-
2023 12:27:11
(UTC)
IE0312903-41-DR-7060 0 31 Mar 2022 Full Walkdown The P&ID (red-lined P&IDs are acceptable) IE0312903-41-DR- Pass Aoibheann
has been walked down and the system has 7060.pdf Minogue
been visually verified in the field and reflects (minoguao)
the as-built conditions. Row Sign. 30-May-
2023 13:53:06
(UTC)
IE0312903-41-DR-7110 0 01 Apr 2022 Full Walkdown The P&ID (red-lined P&IDs are acceptable) IE0312903-41-DR- Pass Aoibheann
has been walked down and the system has 7110.pdf Minogue
9000-P / Potable Water System Installation and Operational Qualification Protocol

P&ID Number P&ID P&ID Date Full / Partial Walkdown Expected Result Attach Walked Down Pass / Fail Performed By
Revision P&ID
Number
been visually verified in the field and reflects (minoguao)
the as-built conditions. Row Sign. 30-May-
2023 12:28:43
(UTC)
IE0312903-41-DR-7125 N/A N/A The P&ID (red-lined P&IDs are acceptable) N/A
has been walked down and the system has
been visually verified in the field and reflects
the as-built conditions.
IE0312903-41-DR-7120 N/A N/A The P&ID (red-lined P&IDs are acceptable) N/A
has been walked down and the system has
been visually verified in the field and reflects
the as-built conditions.
IE0312903-41-DR-7127 N/A N/A The P&ID (red-lined P&IDs are acceptable) N/A
has been walked down and the system has
been visually verified in the field and reflects
the as-built conditions.
IE0312903-41-DR-7130 N/A N/A The P&ID (red-lined P&IDs are acceptable) N/A
has been walked down and the system has
been visually verified in the field and reflects
the as-built conditions.
IE0312903-41-DR-7131 N/A N/A The P&ID (red-lined P&IDs are acceptable) N/A
has been walked down and the system has
been visually verified in the field and reflects
the as-built conditions.
IE0312903-41-DR-7132 N/A N/A The P&ID (red-lined P&IDs are acceptable) N/A
has been walked down and the system has
been visually verified in the field and reflects
the as-built conditions.
IE0312903-41-DR-7134 N/A N/A The P&ID (red-lined P&IDs are acceptable) N/A
has been walked down and the system has
been visually verified in the field and reflects
the as-built conditions.
IE0312903-41-DR-5040 N/A N/A The P&ID (red-lined P&IDs are acceptable) N/A
has been walked down and the system has
been visually verified in the field and reflects
the as-built conditions.
IE0312903-41-DR-5060 0 05 Apr 2022 Full Walkdown The P&ID (red-lined P&IDs are acceptable) IE0312903-41-DR- Pass Aoibheann
has been walked down and the system has 5060.pdf Minogue
been visually verified in the field and reflects (minoguao)
9000-P / Potable Water System Installation and Operational Qualification Protocol

P&ID Number P&ID P&ID Date Full / Partial Walkdown Expected Result Attach Walked Down Pass / Fail Performed By
Revision P&ID
Number
the as-built conditions. Row Sign. 30-May-
2023 12:19:04
(UTC)
IE0312903-41-DR-5080 N/A N/A The P&ID (red-lined P&IDs are acceptable) N/A
has been walked down and the system has
been visually verified in the field and reflects
the as-built conditions.
IE0312903-41-DR-4500 1 21 Nov 2022 Full Walkdown The P&ID (red-lined P&IDs are acceptable) IE0312903-41-DR- Pass Aoibheann
has been walked down and the system has 4500.pdf Minogue
been visually verified in the field and reflects (minoguao)
the as-built conditions. Row Sign. 01-Jun-
2023 10:38:27
(UTC)
IE0312903-41-DR-4600 1 21 Nov 2022 Full Walkdown The P&ID (red-lined P&IDs are acceptable) IE0312903-41-DR- Pass Aoibheann
has been walked down and the system has 4600.pdf Minogue
been visually verified in the field and reflects (minoguao)
the as-built conditions. Row Sign. 01-Jun-
2023 10:39:51
(UTC)
IE0312903-41-DR-7128 0 01 Apr 2022 Full Walkdown The P&ID (red-lined P&IDs are acceptable) IE0312903-41-DR- Pass Aoibheann
has been walked down and the system has 7128.pdf Minogue
been visually verified in the field and reflects (minoguao)
the as-built conditions. Row Sign. 09-May-
2023 08:38:58
(UTC)
IE0312903-41-DR-7129 0 01 Apr 2022 Full Walkdown The P&ID (red-lined P&IDs are acceptable) IE0312903-41-DR- Pass Aoibheann
has been walked down and the system has 7129.pdf Minogue
been visually verified in the field and reflects (minoguao)
the as-built conditions. Row Sign. 09-May-
2023 12:44:47
(UTC)
IE0312903-41-DR-7133 0 01 Apr 2022 Full Walkdown The P&ID (red-lined P&IDs are acceptable) IE0312903-41-DR- Pass Aoibheann
has been walked down and the system has 7133.pdf Minogue
been visually verified in the field and reflects (minoguao)
the as-built conditions. Row Sign. 09-May-
2023 12:46:21
(UTC)
IE0312903-46-DR-8110 N/A N/A The P&ID (red-lined P&IDs are acceptable) N/A
has been walked down and the system has
been visually verified in the field and reflects
9000-P / Potable Water System Installation and Operational Qualification Protocol

P&ID Number P&ID P&ID Date Full / Partial Walkdown Expected Result Attach Walked Down Pass / Fail Performed By
Revision P&ID
Number
the as-built conditions.
IE0312903-46-DR-8120 N/A N/A The P&ID (red-lined P&IDs are acceptable) N/A
has been walked down and the system has
been visually verified in the field and reflects
the as-built conditions.
IE0312903-46-DR-8210 N/A N/A The P&ID (red-lined P&IDs are acceptable) N/A
has been walked down and the system has
been visually verified in the field and reflects
the as-built conditions.
IE0312903-46-DR-8410 N/A N/A The P&ID (red-lined P&IDs are acceptable) N/A
has been walked down and the system has
been visually verified in the field and reflects
the as-built conditions.
IE0312903-46-DR-8510 N/A N/A The P&ID (red-lined P&IDs are acceptable) N/A
has been walked down and the system has
been visually verified in the field and reflects
the as-built conditions.
IE0312903-46-DR-8610 N/A N/A The P&ID (red-lined P&IDs are acceptable) N/A
has been walked down and the system has
been visually verified in the field and reflects
the as-built conditions.
IE0312903-46-DR-8611 N/A N/A The P&ID (red-lined P&IDs are acceptable) N/A
has been walked down and the system has
been visually verified in the field and reflects
the as-built conditions.
IE0312903-46-DR-8620 N/A N/A The P&ID (red-lined P&IDs are acceptable) N/A
has been walked down and the system has
been visually verified in the field and reflects
the as-built conditions.
IE0312903-46-DR-8621 N/A N/A The P&ID (red-lined P&IDs are acceptable) N/A
has been walked down and the system has
been visually verified in the field and reflects
the as-built conditions.
IE0312903-46-DR-8630 N/A N/A The P&ID (red-lined P&IDs are acceptable) N/A
has been walked down and the system has
been visually verified in the field and reflects
the as-built conditions.
IE0312903-46-DR-8631 N/A N/A The P&ID (red-lined P&IDs are acceptable) N/A
9000-P / Potable Water System Installation and Operational Qualification Protocol

P&ID Number P&ID P&ID Date Full / Partial Walkdown Expected Result Attach Walked Down Pass / Fail Performed By
Revision P&ID
Number
has been walked down and the system has
been visually verified in the field and reflects
the as-built conditions.
IE0312903-46-DR-8710 N/A N/A The P&ID (red-lined P&IDs are acceptable) N/A
has been walked down and the system has
been visually verified in the field and reflects
the as-built conditions.
IE0312903-46-DR-8910 N/A N/A The P&ID (red-lined P&IDs are acceptable) N/A
has been walked down and the system has
been visually verified in the field and reflects
the as-built conditions.
IE0312903-46-DR-8920 N/A N/A The P&ID (red-lined P&IDs are acceptable) N/A
has been walked down and the system has
been visually verified in the field and reflects
the as-built conditions.
IE0312903-46-DR-8930 N/A N/A The P&ID (red-lined P&IDs are acceptable) N/A
has been walked down and the system has
been visually verified in the field and reflects
the as-built conditions.
IE0312903-46-DR-9016 0 02 Sep 2022 Full Walkdown The P&ID (red-lined P&IDs are acceptable) IE0312903-46-DR- Pass Aoibheann
has been walked down and the system has 9016.pdf Minogue
been visually verified in the field and reflects (minoguao)
the as-built conditions. Row Sign. 31-May-
2023 13:04:40
(UTC)
IE0312903-46-DR-9020 0 02 Sep 2022 Full Walkdown The P&ID (red-lined P&IDs are acceptable) IE0312903-46-DR- Pass Aoibheann
has been walked down and the system has 9020.pdf Minogue
been visually verified in the field and reflects (minoguao)
the as-built conditions. Row Sign. 30-May-
2023 15:11:32
(UTC)
IE0312903-46-DR-9600 0 02 Sep 2022 Full Walkdown The P&ID (red-lined P&IDs are acceptable) IE0312903-46-DR- Pass Aoibheann
has been walked down and the system has 9600.pdf Minogue
been visually verified in the field and reflects (minoguao)
the as-built conditions. Row Sign. 30-May-
2023 11:02:33
(UTC)
IE0312903-46-DR-9601 0 29 Aug 2022 Full Walkdown The P&ID (red-lined P&IDs are acceptable) IE0312903-46-DR- Pass Aoibheann
has been walked down and the system has 9601.pdf Minogue
9000-P / Potable Water System Installation and Operational Qualification Protocol

P&ID Number P&ID P&ID Date Full / Partial Walkdown Expected Result Attach Walked Down Pass / Fail Performed By
Revision P&ID
Number
been visually verified in the field and reflects (minoguao)
the as-built conditions. Row Sign. 30-May-
2023 12:22:22
(UTC)
IE0312903-46-DR-9602 0 29 Aug 2022 Full Walkdown The P&ID (red-lined P&IDs are acceptable) IE0312903-46-DR- Pass Aoibheann
has been walked down and the system has 9602.pdf Minogue
been visually verified in the field and reflects (minoguao)
the as-built conditions. Row Sign. 30-May-
2023 10:52:40
(UTC)
IE0312903-46-DR-9603 N/A N/A The P&ID (red-lined P&IDs are acceptable) N/A
has been walked down and the system has
been visually verified in the field and reflects
the as-built conditions.
IE0312903-46-DR-9604 0 02 Sep 2022 Full Walkdown The P&ID (red-lined P&IDs are acceptable) IE0312903-46-DR- Pass Aoibheann
has been walked down and the system has 9604.pdf Minogue
been visually verified in the field and reflects (minoguao)
the as-built conditions. Row Sign. 30-May-
2023 10:57:28
(UTC)
IE0312903-46-DR-9606 N/A N/A The P&ID (red-lined P&IDs are acceptable) N/A
has been walked down and the system has
been visually verified in the field and reflects
the as-built conditions.
IE0312903-46-DR-9605 0 02 Sep 2022 Full Walkdown The P&ID (red-lined P&IDs are acceptable) IE0312903-46-DR- Pass Aoibheann
has been walked down and the system has 9605.pdf Minogue
been visually verified in the field and reflects (minoguao)
the as-built conditions. Row Sign. 30-May-
2023 11:06:05
(UTC)
IE0312903-46-DR-9010 N/A N/A The P&ID (red-lined P&IDs are acceptable) N/A
has been walked down and the system has
been visually verified in the field and reflects
the as-built conditions.
IE0312903-46-DR-9011 0 05 Sep 2022 Full Walkdown The P&ID (red-lined P&IDs are acceptable) IE0312903-46-DR- Pass Aoibheann
has been walked down and the system has 9011.pdf Minogue
been visually verified in the field and reflects (minoguao)
the as-built conditions. Row Sign. 30-May-
2023 11:04:22
(UTC)
9000-P / Potable Water System Installation and Operational Qualification Protocol

P&ID Number P&ID P&ID Date Full / Partial Walkdown Expected Result Attach Walked Down Pass / Fail Performed By
Revision P&ID
Number
IE0312903-46-DR-9012 0 09 Sep 2022 Full Walkdown The P&ID (red-lined P&IDs are acceptable) IE0312903-46-DR- Pass Aoibheann
has been walked down and the system has 9012.pdf Minogue
been visually verified in the field and reflects (minoguao)
the as-built conditions. Row Sign. 30-May-
2023 10:54:27
(UTC)
IE0312903-46-DR-9310 0 11 Jan 2023 Full Walkdown The P&ID (red-lined P&IDs are acceptable) IE0312903-46-DR- Pass Aoibheann
has been walked down and the system has 9310.pdf Minogue
been visually verified in the field and reflects (minoguao)
the as-built conditions. Row Sign. 30-May-
2023 12:12:47
(UTC)
IE0312903-46-DR-9320 0 02 Sep 2022 Full Walkdown The P&ID (red-lined P&IDs are acceptable) IE0312903-46-DR- Pass Aoibheann
has been walked down and the system has 9020.pdf Minogue
been visually verified in the field and reflects (minoguao)
the as-built conditions. Row Sign. 30-May-
2023 13:54:49
(UTC)
IE0312903-46-DR-9320 0 [1]
Full Walkdown The P&ID (red-lined P&IDs are acceptable) IE0312903-46-DR- Pass N/A
has been walked down and the system has 9020.pdf
been visually verified in the field and reflects
the as-built conditions.
IE0312903-46-DR-9320 [2]
Full Walkdown The P&ID (red-lined P&IDs are acceptable) IE0312903-46-DR- Pass N/A
has been walked down and the system has 9020.pdf
been visually verified in the field and reflects
the as-built conditions.
IE0312903-46-DR-9320 Full Walkdown The P&ID (red-lined P&IDs are acceptable) N/A [ 3 ] Pass N/A
has been walked down and the system has
been visually verified in the field and reflects
the as-built conditions.
IE0312903-46-DR-9320 Full Walkdown The P&ID (red-lined P&IDs are acceptable) N/A Pass Grainne Byrne
has been walked down and the system has (BYRNEGRA)
been visually verified in the field and reflects Row Sign. 12-Jun-
the as-built conditions. 2023 12:57:38
(UTC)
Reason for re-sign:
Re-signing as this
was executed in
error and P&ID
walkdown is not
required per test
9000-P / Potable Water System Installation and Operational Qualification Protocol

P&ID Number P&ID P&ID Date Full / Partial Walkdown Expected Result Attach Walked Down Pass / Fail Performed By
Revision P&ID
Number
exception below
[1] Grainne Byrne (BYRNEGRA) Executor, 12-Jun-2023 12:55:56 (UTC) Reason: updated as P&ID boundary moved no walkdown required
[2] Grainne Byrne (BYRNEGRA) Executor, 12-Jun-2023 12:56:22 (UTC) Reason: updated as P&ID boundary moved no walkdown required
[3] Grainne Byrne (BYRNEGRA) Executor, 12-Jun-2023 12:56:47 (UTC) Reason: updated as P&ID boundary moved no walkdown required

Comments Performed By
Refer to Exception: EIOC - 9000-P-EQ-C-001-ISS-02 Aoibheann Minogue
(minoguao)
Row Sign. 02-Jun-2023
08:40:41 (UTC)
Refer to Exception: EIOC - 9000-P-EQ-C-001-ISS-02 N/A

The above P&IDs that have not been walked down as part of this EIOC no longer include scope for the process waste system due to system boundaries
being updated. Refer to the above exception for details. [ 1 ]
Refer to Exception: EIOC - 9000-P-EQ-C-001-ISS-02 Grainne Byrne (BYRNEGRA)
Row Sign. 09-Jun-2023
The above P&IDs that have not been walked down as part of this EIOC no longer include scope for the process waste system due to system boundaries 11:25:11 (UTC)
being updated. Refer to the above exception for details. Reason for re-sign: Updated to
added further details
[1] Grainne Byrne (BYRNEGRA) Executor, 09-Jun-2023 11:24:55 (UTC) Reason: updated

Summary of Test script Results

Comments Summary of Test script Result Performed By
Pass / Fail
Pass Aoibheann Minogue
(minoguao)
Row Sign. 02-Jun-2023
08:40:58 (UTC)
Pass Grainne Byrne (BYRNEGRA)
Row Sign. 09-Jun-2023
11:25:29 (UTC)
Reason for re-sign: Re-signing
due to comment update
9000-P / Potable Water System Installation and Operational Qualification Protocol

Review of Test script Results

Reviewed By:
Adrian Sims (simadria)
Row Sign. 09-Jun-2023 12:24:10 (UTC)
Glena McConnell (mcconngl)
Row Sign. 12-Jun-2023 14:37:07 (UTC)
Reason for re-sign: Re-signing for update added.

4.2.4 Loop Check Completion Verification

Test Title Objective Pre-Requisite Tests Test Conditions Section Requirement Reference Performed By
Reference
Loop Check Verification To confirm that loop checks N/A 7.2 N/A Aoibheann Minogue
for the system are performed (minoguao)
Row Sign. 09-May-2023
10:51:04 (UTC)

Step # Action/Inputs Expected Result Actual Result Pass / Fail Performed By

1 Confirm all loop All loop checks for the system have been Loop checks for Suite 2 & Suite 3 Lift Stations Pass Aoibheann Minogue
checks for the system completed. have been completed. (minoguao)
have been completed. Row Sign. 09-May-2023
10:51:40 (UTC)
2 Record loop check Loop check document reference(s) are TC - DBY-500-WAS-GCSV-Q-003 (1.0 Pass Aoibheann Minogue
document recorded. Test) 3.3.1.5.1 Variable Speed Motor (minoguao)
reference(s) Row Sign. 09-May-2023
10:52:39 (UTC)
2 Record loop check Loop check document reference(s) are TC - DBY-500-WAS-GCSV-Q-003 (1.0 Pass N/A
document recorded. Test) 3.3.1.5.1 Variable Speed Motor
reference(s)
TC - DBY-500-WAS-GCSV-Q-003 (1.0
Test) 3.3.1.2.1 Analogue Input

TC - DBY-500-WAS-GCSV-Q-003 (1.0
Test) 3.3.1.3.1 Discrete Input [ 1 ]
2 Record loop check Loop check document reference(s) are TC - DBY-500-WAS-GCSV-Q-003 (1.0 Pass Aoibheann Minogue
document recorded. Test) 3.3.1.5.1 Variable Speed Motor (minoguao)
reference(s) Row Sign. 30-May-2023
TC - DBY-500-WAS-GCSV-Q-003 (1.0 07:39:39 (UTC)
Test) 3.3.1.2.1 Analogue Input Reason for re-sign: Links
9000-P / Potable Water System Installation and Operational Qualification Protocol

Step # Action/Inputs Expected Result Actual Result Pass / Fail Performed By

Added
TC - DBY-500-WAS-GCSV-Q-003 (1.0
Test) 3.3.1.3.1 Discrete Input
[1] Aoibheann Minogue (minoguao) Executor, 30-May-2023 07:39:27 (UTC) Reason: Links added

Comments Performed By
Aoibheann Minogue
(minoguao)
Row Sign. 30-May-2023
07:39:45 (UTC)

Summary of Test script Results

Comments Summary of Test script Result Performed By
Pass / Fail
Pass Aoibheann Minogue
(minoguao)
Row Sign. 30-May-2023
07:39:55 (UTC)

Review of Test script Results

Reviewed By:
Grainne Byrne (BYRNEGRA)
Row Sign. 06-Jun-2023 13:16:35 (UTC)

4.2.5 Utilities Availability

Test Title Objective Pre-Requisite Tests Test Conditions Section Requirement Reference Performed By
Reference
Utilities Verification To confirm that supporting N/A 7.3 N/A Aoibheann Minogue
utilities required to perform (minoguao)
operational testing are Row Sign. 03-May-2023
available for supply. 12:31:49 (UTC)
9000-P / Potable Water System Installation and Operational Qualification Protocol

Step # Action/Inputs Expected Result Actual Result Pass / Fail Performed By

1 Record supporting utilities Supporting utilities required for operational Supporting utilities required for operational Pass Aoibheann Minogue
required for operational testing testing and their status are recorded in testing and their status are recorded in Table (minoguao)
and their status in Table 1. Table 1. 1. Row Sign. 03-May-2023
12:35:30 (UTC)

Table 1

Utility Required Status Actual Status Acceptable (Yes / No / N/A) Performed By

Power Supply Available Available Yes Aoibheann Minogue
(minoguao)
Row Sign. 03-May-2023
12:34:41 (UTC)
Instrument Air Available Availabke Yes Aoibheann Minogue
(minoguao)
Row Sign. 03-May-2023
12:35:03 (UTC)

Comments Performed By
N/A Aoibheann Minogue
(minoguao)
Row Sign. 03-May-2023
12:35:42 (UTC)

Summary of Test script Results

Comments Summary of Test script Result Performed By
Pass / Fail
N/A Pass Aoibheann Minogue
(minoguao)
Row Sign. 03-May-2023
12:36:06 (UTC)
9000-P / Potable Water System Installation and Operational Qualification Protocol

Review of Test script Results

Reviewed By:
Grainne Byrne (BYRNEGRA)
Row Sign. 06-Jun-2023 11:02:02 (UTC)