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: ____________

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 (t_0-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 (t_0-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.

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

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

YES

PASS

LB/22-Feb-2018

50-PUW1-S6-148-IH

YES

PASS

LB/22-Feb-2018

80-DETERGENT-S6-149-IH

YES

PASS

LB/22-Feb-2018

80-DETERGENT-S6-150-IH

YES

PASS

LB/22-Feb-2018

80-DETERGENT-S6-151-IH

YES

PASS

LB/22-Feb-2018

65-DETERGENT-S6-152-IH

YES

PASS

LB/22-Feb-2018

65-DETERGENT-S6-153-IH

YES

PASS

LB/22-Feb-2018

65-DETERGENT-SS1-154-IH

SS1

YES

PASS

LB/22-Feb-2018

80-PUW2-S6-155-IH

YES

PASS

LB/22-Feb-2018

80-PUW2-S6-156-IH

YES

PASS

LB/22-Feb-2018

80-PUW2-S6-157-IH

YES

PASS

LB/22-Feb-2018

80-PUW2-S6-158-IH

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

YES

PASS

LB/22-Feb-2018

80-PUW2-SS1-160-IH

SS1

YES

PASS

LB/22-Feb-2018

25-PROCESS-S6-161-NI

YES

PASS

LB/22-Feb-2018

25-PROCESS-S6-162-NI

YES

PASS

LB/22-Feb-2018

65-DETERGENT-SS1/S6-163-IH

SS1/S6

YES

PASS

LB/22-Feb-2018

65-PUW2-SS1/S6-164-IH

SS1

YES

PASS

LB/22-Feb-2018

65-PUW2-SS1-165-IH

SS1

YES

PASS

LB/22-Feb-2018

100-VENT-S6-166-NI

YES

PASS

LB/22-Feb-2018

25-DRAIN-S6-167-NI

YES

PASS

LB/22-Feb-2018

100-VENT-S6-168-NI

YES

PASS

LB/22-Feb-2018

25-DRAIN-S6-169-NI

YES

PASS

LB/22-Feb-2018

50-DRAIN-S6-170-NI

YES

PASS

LB/22-Feb-2018

50-DRAIN-S6-171-NI

YES

PASS

LB/22-Feb-2018

25-VENT-S6-172-NI

YES

PASS

LB/22-Feb-2018

25-VENT-S6-173-NI

YES

PASS

LB/22-Feb-2018

50-DRAIN-S6-174-NI

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

YES

PASS

LB/22-Feb-2018

80-DRAIN-SS1-176-NI

SS1

YES

PASS

LB/22-Feb-2018

25-DRAIN-S6-177-NI

YES

PASS

LB/22-Feb-2018

25-DRAIN-S6-178-NI

YES

PASS

LB/22-Feb-2018

25-DRAIN-S6-179-NI

YES

PASS

LB/22-Feb-2018

25-DRAIN-S6-169-NI

YES

PASS

LB/22-Feb-2018

50-DRAIN-S6-170-NI

YES

PASS

LB/22-Feb-2018

50-DRAIN-S6-171-NI

YES

PASS

LB/22-Feb-2018

25-VENT-S6-172-NI

YES

PASS

LB/22-Feb-2018

25-VENT-S6-173-NI

YES

PASS

LB/22-Feb-2018

50-DRAIN-S6-174-NI

YES

PASS

LB/22-Feb-2018

50-DRAIN-S6-175-NI

YES

PASS

LB/22-Feb-2018

80-DRAIN-SS1-176-NI

SS1

YES

PASS

LB/22-Feb-2018

25-DRAIN-S6-180-NI

YES

PASS

LB/22-Feb-2018

50-DRAIN-SS1-181-NI

SS1

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

PASS

LB/22-Feb-2018

65-PLANT STEAN-CS5-183-IH

CS5

YES

PASS

LB/22-Feb-2018

15-PLANT STEAM-CS5-184-IH

CS5

YES

PASS

LB/22-Feb-2018

20-CONDENSATE-CS5-185-IH

CS5

YES

PASS

LB/22-Feb-2018

40-CONDENSATE-CS5-186-IH

CS5

YES

PASS

LB/22-Feb-2018

40-CONDENSATE-CS5-187-IH

CS5

YES

PASS

LB/22-Feb-2018

40-COMPRESSED AIR-SS1-502-NI

SS1

YES

PASS

LB/22-Feb-2018

80-CONDENSATE-CS5-242-IH

CS5

YES

PASS

LB/22-Feb-2018

100-PLANT STEAM-CS5-241-IH

CS5

YES

PASS

LB/22-Feb-2018

20-CONDENSATE-CS5-185-IH

CS5

YES

PASS

LB/22-Feb-2018

40-CONDENSATE-CS5-186-IH

CS5

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 t_0-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)
t_0-min		X μScm^-1 ± 5%		80°C±5°C
t_5-min		X μScm^-1 ± 5%		80°C±5°C
t_10-min		X μScm^-1 ± 5%		80°C±5°C
t_15-min		X μScm^-1 ± 5%		80°C±5°C
t_20-min		X μScm^-1 ± 5%		80°C±5°C
t_25-min		X μScm^-1 ± 5%		80°C±5°C
t_30-min		X μScm^-1 ± 5%		80°C±5°C
t_35-min		X μScm^-1 ± 5%		80°C±5°C
t_40-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)
t_45-min		X μScm^-1 ± 5%		80°C±5°C
t_50-min		X μScm^-1 ± 5%		80°C±5°C
t_55-min		X μScm^-1 ± 5%		80°C±5°C
t_60-min		X μScm^-1 ± 5%		80°C±5°C
t_65-min		X μScm^-1 ± 5%		80°C±5°C
t_70-min		X μScm^-1 ± 5%		80°C±5°C
t_75-min		X μScm^-1 ± 5%		80°C±5°C
t_80-min		X μScm^-1 ± 5%		80°C±5°C
t_85-min		X μScm^-1 ± 5%		80°C±5°C
t_90-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)

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, 4}Qualification Protocol(s)
⁴Commissioning Protocol(s)			⁴Other
	^{3, 5}DIRECT		⁵INDIRECT	⁵NO IMPACT
³SYSTEM IMPACT	Yes / No		Yes / No	Yes / No

SECTION 2 (Continued): IMPACT ASSESSMENT (to be completed by ¹Engineering Validation)
	^{3, 5}OPER. CRITICAL		^{3, 5}PRODUCT CONTACT		⁵NON CRITICAL
³COMPONENT IMPACT	Yes / No		Yes / No		Yes / No
	⁵CONSTRUCTION		⁵COMMISSIONING		^{3, 5}QUALIFICATION
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, 4}Qualification 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

1 Title Page

2 Approvals Page

3 Document Revision History

4 Table of Contents

5 Protocol Objective

6 System Description

7 Scope

7.1 System Impact Assessment

7.2 Component Impact Assessment

7.3 Summary Table – Operational Critical Components

7.4 P&ID Scope

8 Reference Documentation

9 Definitions/ Glossary

10 Responsibilities / Subject Matter Experts

11 Installation Verification Testing Procedures

11.1 P&ID Walkdown Testing Procedure

11.2 Equipment Installation Verification Procedure

11.3 Instrument Installation Verification Procedure

11.4 Piping Installation Verification Procedure

11.5 Calibration Program Verification

11.6 Preventative Maintenance Program Verification

11.7 Draft SOP Verification

11.8 Test-Instrument Calibration Verification

12 Progression Approval to Proceed to Functional Verification

12.1 Operational-Critical-Instrument Calibration Verification Form

13 Functional Verification Testing Procedures

13.1 Hot Detergent System – Detergent Dosing Control

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

14 Protocol Quality Procedures

14.1 Signature Log

14.2 Deviation Procedure

14.3 Change Control Procedure

15 IOQ Protocol Summary Report

16 List of Appendices

16.1 Appendix A – Protocol Signature Log

16.2 Appendix B – Installation Verification GMP checksheets

16.2.1 P&ID Walkdown Installation Verification

16.2.2 Equipment Installation Verification

16.2.3 Instrument Installation Verification

16.2.4 Piping Installation Verification

16.2.5 Calibration Program Verification

16.2.6 Preventative Maintenance Program Verification

16.2.7 Draft SOP Verification

16.2.8 Test-Instrument Calibration Verification

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

16.3.8 Approved SOP Verification

16.4 Appendix D: Deviation log

16.5 Appendix E: Deviation Form

16.6 Appendix F: Change Control Llog

16.7 Appendix G: Change control Form

16.8 Appendix H: Component Impact Assessment

16.9 Appendix I: Traceability Matrix

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