Installation and Functional Verification.

1       Title Page

 

Installation and Functional Verification Protocol

 

For

 

Hot Detergent and Hot PUW

Generation and Distribution System

 

 

Author Author’s Title / Position

 

Document Number Revision Number Revision Date

2       Approvals Page

 

 

Prepared By: ________________________      Date:          ____________

Validation Engineer

 

 

Approved By:          ________________________      Date:          ____________

Validation Manager

Your signature attests that you have reviewed this document and it complies with relevant validation policies & procedures

 

 

Approved By:          ________________________      Date:          ____________

Engineering

Your signature attests that……(align with ‘Responsibilities’ Protocol Section-10)

 

 

Approved By:          ________________________      Date:          ____________

QA

Your signature attests that……(align with ‘Responsibilities’ Protocol Section-10)

 

 

Approved By:          ________________________      Date:          ____________

etc.

Your signature attests that……(align with ‘Responsibilities’ Protocol Section-10)

 

3       Document Revision History

 

Revision Date of Issue Reason for revision update
A 12 Jan 2012 Issued for review
0 14 Mar 2012 Issued for approval and use

 

4       Table of Contents

 

1       Title Page. 1

2       Approvals Page. 2

3       Document Revision History. 3

4       Table of Contents. 4

5       Protocol Objective. 6

6       System Description. 6

7       Scope. 7

7.1       System Impact Assessment 7

7.2       Component Impact Assessment 7

7.3       Summary Table – Operational Critical Components. 8

7.4       P&ID Scope. 9

8       Reference Documentation. 10

9       Definitions/ Glossary. 11

10     Responsibilities / Subject Matter Experts. 12

11     Installation Verification Testing Procedures. 13

11.1         P&ID Walkdown Testing Procedure. 13

11.2         Equipment Installation Verification Procedure. 14

11.3         Instrument Installation Verification Procedure. 15

11.4         Piping Installation Verification Procedure. 16

11.5         Calibration Program Verification. 17

11.6         Preventative Maintenance Program Verification. 17

11.7         Draft SOP Verification. 17

11.8         Test-Instrument Calibration Verification. 17

12     Progression Approval to Proceed to Functional Verification. 18

12.1         Operational-Critical-Instrument Calibration Verification Form   19

13     Functional Verification Testing Procedures. 20

13.1         Hot Detergent System – Detergent Dosing Control 21

13.2         Hot Detergent System – Temperature Control 23

13.3         Hot Detergent System – Flow Control 23

13.4         Hot Detergent System – Level Control 23

13.5         Hot PUW System – Temperature Control 23

13.6         Hot PUW System – Flow Control 23

13.7         Hot PUW System – Level Control 23

13.8         Approved SOP Verification. 23

14     Protocol Quality Procedures. 23

14.1         Signature Log. 23

14.2         Deviation Procedure. 24

14.3         Change Control Procedure. 24

15     IOQ Protocol Summary Report 24

16     List of Appendices. 25

16.1         Appendix A – Protocol Signature Log. 26

16.2         Appendix B – Installation Verification GMP checksheets. 27

16.2.1     P&ID Walkdown Installation Verification. 27

16.2.2     Equipment Installation Verification. 28

16.2.3     Instrument Installation Verification. 41

16.2.4     Piping Installation Verification. 47

16.2.5     Calibration Program Verification. 52

16.2.6     Preventative Maintenance Program Verification. 53

16.2.7     Draft SOP Verification. 54

16.2.8     Test-Instrument Calibration Verification. 55

16.3         Appendix C: OQ GMP check-sheets. 56

16.3.1     Hot Detergent System – Detergent Dosing Control 57

16.3.2     Hot Detergent System – Temperature Control 60

16.3.3     Hot Detergent System – Flow Control 61

16.3.4     Hot Detergent System –Level Control 62

16.3.5     Hot PUW System – Temperature Control 63

16.3.6     Hot PUW System – Flow Control 64

16.3.7     Hot PUW System – Level Control 65

16.3.8     Approved SOP Verification. 66

16.4         Appendix D: Deviation log. 67

16.5         Appendix E: Deviation Form.. 68

16.6         Appendix F: Change Control Llog. 69

16.7         Appendix G: Change control Form.. 70

16.8         Appendix H: Component Impact Assessment 73

16.9         Appendix I: Traceability Matrix. 79

 

5       Protocol Objective

 

The objective of this protocol is to provide testing evidence that will prove that the ‘Hot Detergent and Hot PUW Generation and Distribution’ system is fit for its intended use. Testing will incorporate both installation verification and functional verification test.

 

6       System Description

Prepare a summary ‘System Description’. Suggestions include drawing a process flow / block diagram; listing critical operational features; and, describing the major equipment components in the context of their installation and functional features.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

7       Scope

7.1     System Impact Assessment

The ‘Hot Detergent and Hot PUW Generation and Distribution’ is considered a ‘direct impact’ system because:

·       This system has a direct impact on product quality as it cleans product contact equipment in a process.

·       This system is used to generate and re-circulate two different cleaning fluids. Failure of this system would affect product quality and patient safety in the manufacturing of a medicinal product and therefore the system is a direct impact system.

 

 

7.2     Component Impact Assessment

The Component Impact Assessment will drive the scope of the installation and functional verifications. Product contact plus operational critical components must be included in the installation verifications. The operationally critical components will drive the functionality testing.

7.3     Summary Table – Operational Critical Components

# *Operational Critical Component **Additional components in the loop (if applicable) Rationale
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17

7.4     P&ID Scope

In Protocol Section-7.4 include a copy/scan of the P&ID and either draw a ‘scope bubble’ or yellow-highlight the ‘in-scope’ components.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

8       Reference Documentation

Document # Document Description Document Location
##.####.##.# P&ID Engineering Library
##.####.##.# Instrument List Engineering Library
##.####.##.# Equipment List Engineering Library
##.####.##.# E&I Drawings Engineering Library
##.####.##.# Line List Engineering Library
##.####.##.# Commissioning Protocol Engineering Library
##.####.##.# Site VMP

 

QA Library
##.####.##.# URS QA Library
##.####.##.# System Impact Assessment QA Library
##.####.##.# Validation Plan QA Library
##.####.##.# FRS Engineering Library
##.####.##.# Validation SOP QA Library
##.####.##.# Change Control SOP QA Library
##.####.##.# Deviation Procedure QA Library
##.####.##.# Training SOP QA Library
##.####.##.# Site documentation policy QA Library
##.####.##.# Site Glossary QA Library

9       Definitions/ Glossary

 

Acronym Definition
E&I Electrical & Instrumentation
FRS Functional Requirement Specification
IQ Installation Qualification
OQ Operational Qualification
P&ID Piping & Instrumentation Diagram
SME Subject Matter Expert.
SOP Standard Operating Procedure
URS User Requirement Specification
VMP Validation Master Plan

 

10   Responsibilities / Subject Matter Experts

 

  1. 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

 

  1. Quality Assurance
  • etc.

 

  1. Quality control
  • etc.

 

  1. Manufacturing
  • etc.

 

  1. Engineering
  • etc.

 

  1. Maintenance/ Calibrations
  • etc.

 

  1. HR / Training
  • etc.

 

  1. 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

  1. All commissioning activities are complete and commissioning punch-list items are closed out.
  2. 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

  1. On a blank copy of the P&ID draw in the direct-impact system boundary in black-ink
  2. Walk down the P&ID and using a yellow-highlighter confirm each component is correctly installed and orientated as represented on the P&ID
  3. Confirm all component tag numbers are correct
  4. Confirm all lines are correctly labelled
  5. Confirm all lines where applicable are correctly insulated
  6. Ensure all flow direction components are orientated correctly
  7. Ensure all instruments indicators are orientated correctly so as operators can readily view them in the field
  8. Ensure all commissioning filters are installed in filter-housings
  9. 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

  1. 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.
  2. Assess each step listed and determine whether the step has passed or failed.
  3. The person performing the test should be identified and the date the testing was performed should be recorded.
  4. At the bottom of the test script a validation peer (other than the person performing the test) shall review the script post execution.
  5. 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

  1. All commissioning activities are complete and commissioning punch-list items are closed out.
  2. 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

  1. 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.
  2. Confirm that the vendor handover package is in place and contains correct material certificates.
  3. 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

  1. 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.
  2. Assess each step listed and determine whether the step has passed or failed.
  3. The person performing the test should be identified and the date the testing was performed should be recorded.
  4. At the bottom of the test script a validation peer (other than the person performing the test) shall review the script post execution.
  5. 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

  1. All commissioning activities are complete and commissioning punch-list items are closed out.
  2. 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

  1. 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
  1. 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)
  1. 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

  1. 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.
  2. Assess each step listed and determine whether the step has passed or failed.
  3. The person performing the test should be identified and the date the testing was performed should be recorded.
  4. At the bottom of the test script a validation peer (other than the person performing the test) shall review the script post execution.
  5. 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

  1. All commissioning activities are complete and commissioning punch-list items are closed out.
  2. 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

  1. Pre-populate the piping verification with the Tag # and material-of-construction (MOC) details.
  2. In the field enter the details of the weld log for every each pipe Tag #.
  3. Confirm the Weld Log is complete, as the Weld Log collates material-of-construction certificates and weld inspection certificates.
  4. In the field record the details of the Pressure Test Pack for every each pipe Tag #.
  5. Confirm the Pressure Test is complete verifying the absence of leaks
  6. In the field enter the details of the Construction Dossier for every each pipe Tag #.
  7. Confirm all slopes have been checked and verified as correct from the Construction Dossier.

 

6        Expected Results and Actual results

  1. 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.
  2. Assess each step listed and determine whether the step has passed or failed.
  3. The person performing the test should be identified and the date the testing was performed should be recorded.
  4. At the bottom of the test script a validation peer (other than the person performing the test) shall review the script post execution.
  5. Quality Assurance (QA) shall approve the completed test.

 

11.5 Calibration Program Verification

During installation verification we need to verify that instruments are in the calibration system. Here summarize a ‘Calibration Program Verification’ procedure that compliments the form in Protocol Section-16.2.5.

 

11.6 Preventative Maintenance Program Verification

During IQ, we need to verify that instruments are in the Preventative Maintenance system. Here summarize a ‘Preventative Maintenance Program Verification’ procedure that compliments the form in Protocol Section-16.2.6.

 

11.7 Draft SOP Verification

Prior to proceeding to functional verification we need to ensure the required SOPs are in-draft. Propose a list of necessary standard operating procedures for the ‘Hot Detergent and Hot PUW Generation and Distribution’ system and enter the equivalent details into the form in Protocol Section-16.2.7. Ensure the details in the list of draft SOPs aligns with Protocol Section-13.8 ‘Approved SOP Verification’ and its associated form in Protocol Section-16.3.8.

 

11.8 Test-Instrument Calibration Verification

Suggest a list of test instruments that may be required for the testing phase. Enter the equivalent details into the form in Protocol Section-16.2.8

12   Progression Approval to Proceed to Functional Verification

The signatories below verify the following:

  • That the installation verification testing phase is sufficiently complete and permission is given to progress to the functional verification testing phase.
  • All critical deviations from the installation verification testing phase have been closed out, or a change control initiated in its place.
  • All critical items are installed.
  • All operational critical instruments will remain in a calibrated state during the functional verification testing phase.

 

 

Prepared By: ________________________      Date:          ____________

Validation Engineer

 

 

Approved By:          ________________________      Date:          ____________

Validation Manager

Your signature attests that you have reviewed this document and it complies with relevant validation policies & procedures

 

 

Approved By:          ________________________      Date:          ____________

Engineering

Your signature attests that……(align with ‘Responsibilities’ Protocol Section-2)

 

 

Approved By:          ________________________      Date:          ____________

QA

Your signature attests that……(align with ‘Responsibilities’ Protocol Section-2)

 

 

Approved By:          ________________________      Date:          ____________

etc.

Your signature attests that……(align with ‘Responsibilities’ Protocol Section-2)

 

12.1 Operational-Critical-Instrument Calibration Verification Form

Page _ __ of _ __

 

Operational-Critical-Instrument Calibration Verification Form
 
Critical instruments associated with the system will remain in a calibrated state during the anticipated OQ execution timeframe? (Yes/No) Verified By / Date
Comments:
Reviewed By:

Validation

Date:
Approved By:

(QA)

Date:

13   Functional Verification Testing Procedures

13.3.1        Hot Detergent System – Detergent Dosing Control

13.3.2        Hot Detergent System – Temperature Control

13.3.3        Hot Detergent System – Flow Control

13.3.4        Hot Detergent System – Level Control

 

13.3.5        Hot PUW System – Temperature Control

13.3.6        Hot PUW System – Flow Control

13.3.7        Hot PUW System – Level Control

 

 

13.1 Hot Detergent System – Detergent Dosing Control

1        Short description of the test

At 80°C±5°C, 2% ± 0.05% detergent concentration is equivalent to 500 μScm-1 ± 0.25 μScm-1. The objective of this test is to confirm that the supply detergent concentration, at a temperature of 80°C±5°C, is maintained at 500 μScm-1 ± 0.25 μScm-1, before, during and after maximum instantaneous detergent drawdown when the two biggest users (reactors RE-119 and RE-140) are being be charged simultaneously.

 

2        Linkage to the requirements challenged

URS Section 3.5:

  1. The system shall have the facility to automatically dose STERIS 100 detergent to the required concentration (2% ± 0.05%)
  2. 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

  1. All commissioning activities are complete and commissioning punch-list items are closed out.
  2. 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.
  3. Conductivity transmitter CT-001 is currently within calibration
  4. Temperature transmitter TT-002 is currently within calibration

 

5        Specific Test Steps

  1. Start up the WIP skid and after 1-hour confirm that both 80°C detergent and 80°C hot process water are recirculating.
  2. At time = 0 (t0-min) confirm the online conductivity measurement CT-001 is reading 500 μScm-1 ± 0.25 μScm-1 equivalent to a detergent concentration of 2% ± 0.05% STERIS 100.
  3. 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.
  4. 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).
  5. Following the charge, maintain the WIP skid in normal operation mode for a further 30-minutes with no further drawdown.
  6. In the table provided confirm that at 80°C±5°C the online conductivity measurement CT-001 read 500 μScm-1 ± 0.25 by recording the value at successive 5-minute intervals. Be sure that the time period when the values are recorded correspond to the following:
  • Before maximum instantaneous detergent drawdown (t0-min)
  • During the instantaneous detergent drawdown, up to the full 5,500 litre charges
  • The 30-minutes following the instantaneous drawdown
  1. 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.
  2. 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.
  3. 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

  1. 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.
  2. Assess each step listed and determine whether the step has passed or failed.
  3. The person performing the test should be identified and the date the testing was performed should be recorded.
  4. At the bottom of the test script a validation peer (other than the person performing the test) shall review the script post execution.
  5. 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

Note: M.O.C states 316L SS/EPDM on P&ID but states 316L SS/PTFE on equipment list. As equipment list supersedes P&ID 316L SS/PTFE is listed above on this installation verification checksheet.

 

  Validation Peer Review

 

Chloe O’Neill

         
Print Name Signature Date

 

 

  QA Approval

 

Fergal Jones

         
Print Name Signature Date

 

Sheet 12 of 13 Installation Verification Tag #: PSV-001
Equipment Description and Critical Design Features
Inspect the installed equipment item and the vendor’s documentation and verify correct specification conformance Specified Actual Initials / Date Initials / Date
1 Manufacturer Lesser Lesser Pass LB 22-Feb-2018
2 Capacity 1” 1” Pass LB 22-Feb-2018
3 M.O.C. 316L SS 316L SS Pass LB 22-Feb-2018
4 Design Pressure Range     Pass LB 22-Feb-2018
5 Design Temp Range     Pass LB 22-Feb-2018
Documentation Verification
Confirm that the vendor handover package is in place and contains correct material certificates Verification

(Pass/Fail)

Initials Date
1 Vendor handover package is in place Pass LB 22-Feb-2018
2 Material Certification is available for wetted parts Pass LB 22-Feb-2018
Installation Verification
Visually inspect, and subsequently verify, the correct installation of the equipment item in the field Verification

(Pass/Fail)

Initials Date
1 Equipment item is installed as per P&ID, is securely fitted and is free from damage Pass LB 22-Feb-2018
2 Nameplate is securely fitted, clearly legible and its details conform to the design specification Pass LB 22-Feb-2018
3 All process and utility connections, and instrumentation are connected up to the correct nozzles/flanges, as per P&ID LB 22-Feb-2018

 

Comments: PASS LB 22-Feb-2018

 

 

  Validation Peer Review

 

Chloe O’Neill

         
Print Name Signature Date

 

 

  QA Approval

 

Fergal Jones

         
Print Name Signature Date

 

 

 

Sheet 13 of 13 Installation Verification Tag #: PSV-002
Equipment Description and Critical Design Features
Inspect the installed equipment item and the vendor’s documentation and verify correct specification conformance Specified Actual Initials / Date Initials / Date
1 Manufacturer Lesser Lesser Pass LB 22-Feb-2018
2 Capacity 1” 1” Pass LB 22-Feb-2018
3 M.O.C. 316L SS 316L SS Pass LB 22-Feb-2018
4 Design Pressure Range     Pass LB 22-Feb-2018
5 Design Temp Range     Pass LB 22-Feb-2018
Documentation Verification
Confirm that the vendor handover package is in place and contains correct material certificates Verification

(Pass/Fail)

Initials Date
1 Vendor handover package is in place Pass LB 22-Feb-2018
2 Material Certification is available for wetted parts Pass LB 22-Feb-2018
Installation Verification
Visually inspect, and subsequently verify, the correct installation of the equipment item in the field Verification

(Pass/Fail)

Initials Date
1 Equipment item is installed as per P&ID, is securely fitted and is free from damage Pass LB 22-Feb-2018
2 Nameplate is securely fitted, clearly legible and its details conform to the design specification Pass LB 22-Feb-2018
3 All process and utility connections, and instrumentation are connected up to the correct nozzles/flanges, as per P&ID LB 22-Feb-2018

 

Comments: PASS LB 22-Feb-2018

 

 

  Validation Peer Review

 

Chloe O’Neill

         
Print Name Signature Date

 

 

  QA Approval

 

Fergal Jones

         
Print Name Signature Date

 

 

 

16.2.3                  Instrument Installation Verification

Sheet __ of __ Temp Installation Verification
Part-1: Temp Transmitter Description and Critical Design Features
Inspect the installed instrument item and the vendor’s documentation and verify correct specification conformance
Tag # Specified Manufacturer Actual Specified Range Actual Specified MOC Actual Loop Checked

(Yes/No)

Verification

(Pass/Fail)

Initials / Date
TT-001 E&H E&H     316L SS contact parts 316L SS contact parts YES PASS LB-22-Feb-2018
TCV-006 Spirax Spirax     CS CS YES PASS LB-22-Feb-2018
__-__                  
__-__                  
__-__                  

 

Comments:

 

  Validation Peer Review

 

 

         
Print Name Signature Date

 

  QA Approval

 

 

         
Print Name Signature Date

 

Sheet __ of __ Temp Installation Verification
Part-2: Temp Documentation Verification
Confirm that the vendor handover package is in place and contains correct material certificates
Tag # *Vendor handover package is in place

(Yes/No)

Material Certification is available for wetted parts (Yes/No) Cert # Calibration Certification is available (Yes/No) Cert # Loop Checksheet is available (Yes/No) Checksheet # Verification

(Pass/Fail)

Initials / Date
__-__                  
__-__                  
__-__                  
__-__                  
__-__                  

 

Comments:

 

  Validation Peer Review

 

 

         
Print Name Signature Date

 

  QA Approval

 

 

         
Print Name Signature Date

 

Sheet __ of __ ___ Installation Verification
Part-3: Temp Installation Verification
Visually inspect, and subsequently verify, the correct installation of the instrument item in the field
Tag # Instrument item is installed as per P&ID, is securely fitted and is free from damage (Yes/No) Instrument and cabling is correctly tagged and details conform to the design specification (Yes/No) Instrument orientated correctly and is accessible for calibration and maintenance (Yes/No) Verification

(Pass/Fail)

Initials Date
__-__            
__-__            
__-__            
__-__            
__-__            

 

Comments:

 

  Validation Peer Review

 

 

         
Print Name Signature Date

 

  QA Approval

 

 

         
Print Name Signature Date

 

Sheet __ of __ ___ Installation Verification
Part-1: ___ Transmitter Description and Critical Design Features
Inspect the installed instrument item and the vendor’s documentation and verify correct specification conformance
Tag # Specified Manufacturer Actual Specified Range Actual Specified MOC Actual Loop Checked

(Yes/No)

Verification

(Pass/Fail)

Initials / Date
__-__                  
__-__                  
__-__                  
__-__                  
__-__                  

 

Comments:

 

  Validation Peer Review

 

 

         
Print Name Signature Date

 

  QA Approval

 

 

         
Print Name Signature Date

 

Sheet __ of __ ____ Installation Verification
Part-2: ___ Documentation Verification
Confirm that the vendor handover package is in place and contains correct material certificates
Tag # *Vendor handover package is in place

(Yes/No)

Material Certification is available for wetted parts (Yes/No) Cert # Calibration Certification is available (Yes/No) Cert # Loop Checksheet is available (Yes/No) Checksheet # Verification

(Pass/Fail)

Initials / Date
__-__                  
__-__                  
__-__                  
__-__                  
__-__                  

 

Comments:

 

  Validation Peer Review

 

 

         
Print Name Signature Date

 

  QA Approval

 

 

         
Print Name Signature Date

 

Sheet __ of __ ___ Installation Verification
Part-3: ___ Installation Verification
Visually inspect, and subsequently verify, the correct installation of the instrument item in the field
Tag # Instrument item is installed as per P&ID, is securely fitted and is free from damage (Yes/No) Instrument and cabling is correctly tagged and details conform to the design specification (Yes/No) Instrument orientated correctly and is accessible for calibration and maintenance (Yes/No) Verification

(Pass/Fail)

Initials Date
__-__            
__-__            
__-__            
__-__            
__-__            

 

Comments:

 

  Validation Peer Review

 

 

         
Print Name Signature Date

 

  QA Approval

 

 

         
Print Name Signature Date

16.2.4                  Piping Installation Verification

Sheet 1 of 5 Piping Installation Verification
Tag # MOC *Weld Log

#

*Weld Log Complete

(Yes/No)

Pressure Test Pack-# Pressure Test Complete (Yes/No) Construction Dossier # **Slopes Checked

(Yes/No)

Verification

(Pass/Fail)

Initials / Date
50-PUW1-S6-147-IH S6   YES   YES   YES PASS LB/22-Feb-2018
50-PUW1-S6-148-IH S6   YES   YES   YES PASS LB/22-Feb-2018
80-DETERGENT-S6-149-IH S6   YES   YES   YES PASS LB/22-Feb-2018
80-DETERGENT-S6-150-IH S6   YES   YES   YES PASS LB/22-Feb-2018
80-DETERGENT-S6-151-IH S6   YES   YES   YES PASS LB/22-Feb-2018
65-DETERGENT-S6-152-IH S6   YES   YES   YES PASS LB/22-Feb-2018
65-DETERGENT-S6-153-IH S6   YES   YES   YES PASS LB/22-Feb-2018
65-DETERGENT-SS1-154-IH SS1   YES   YES   YES PASS LB/22-Feb-2018
80-PUW2-S6-155-IH S6   YES   YES   YES PASS LB/22-Feb-2018
80-PUW2-S6-156-IH S6 YES   YES   YES PASS LB/22-Feb-2018
80-PUW2-S6-157-IH S6 YES   YES   YES PASS LB/22-Feb-2018
80-PUW2-S6-158-IH S6 YES   YES   YES PASS LB/22-Feb-2018
Sheet 2 of 5 Piping Installation Verification
Tag # MOC *Weld Log

#

*Weld Log Complete

(Yes/No)

Pressure Test Pack-# Pressure Test Complete (Yes/No) Construction Dossier # **Slopes Checked

(Yes/No)

Verification

(Pass/Fail)

Initials / Date
80-PUW2-S6-159-IH S6 YES   YES   YES PASS LB/22-Feb-2018
80-PUW2-SS1-160-IH SS1 YES   YES   YES PASS LB/22-Feb-2018
25-PROCESS-S6-161-NI S6 YES   YES   YES PASS LB/22-Feb-2018
25-PROCESS-S6-162-NI S6 YES   YES   YES PASS LB/22-Feb-2018
65-DETERGENT-SS1/S6-163-IH SS1/S6 YES   YES   YES PASS LB/22-Feb-2018
65-PUW2-SS1/S6-164-IH SS1 YES   YES   YES PASS LB/22-Feb-2018
65-PUW2-SS1-165-IH SS1 YES   YES   YES PASS LB/22-Feb-2018
100-VENT-S6-166-NI S6 YES   YES   YES PASS LB/22-Feb-2018
25-DRAIN-S6-167-NI S6 YES   YES   YES PASS LB/22-Feb-2018
100-VENT-S6-168-NI S6 YES   YES   YES PASS LB/22-Feb-2018
25-DRAIN-S6-169-NI S6 YES   YES   YES PASS LB/22-Feb-2018
50-DRAIN-S6-170-NI S6 YES   YES   YES PASS LB/22-Feb-2018
50-DRAIN-S6-171-NI S6 YES   YES   YES PASS LB/22-Feb-2018
25-VENT-S6-172-NI S6 YES   YES   YES PASS LB/22-Feb-2018
25-VENT-S6-173-NI S6 YES   YES   YES PASS LB/22-Feb-2018
50-DRAIN-S6-174-NI S6 YES   YES   YES PASS LB/22-Feb-2018
Sheet 3 of 5 Piping Installation Verification
Tag # MOC *Weld Log

#

*Weld Log Complete

(Yes/No)

Pressure Test Pack-# Pressure Test Complete (Yes/No) Construction Dossier # **Slopes Checked

(Yes/No)

Verification

(Pass/Fail)

Initials / Date
50-DRAIN-S6-175-NI S6 YES   YES   YES PASS LB/22-Feb-2018
80-DRAIN-SS1-176-NI SS1 YES   YES   YES PASS LB/22-Feb-2018
25-DRAIN-S6-177-NI S6 YES   YES   YES PASS LB/22-Feb-2018
25-DRAIN-S6-178-NI S6 YES   YES   YES PASS LB/22-Feb-2018
25-DRAIN-S6-179-NI S6 YES   YES   YES PASS LB/22-Feb-2018
25-DRAIN-S6-169-NI S6 YES   YES   YES PASS LB/22-Feb-2018
50-DRAIN-S6-170-NI S6 YES   YES   YES PASS LB/22-Feb-2018
50-DRAIN-S6-171-NI S6 YES   YES   YES PASS LB/22-Feb-2018
25-VENT-S6-172-NI S6 YES   YES   YES PASS LB/22-Feb-2018
25-VENT-S6-173-NI S6 YES   YES   YES PASS LB/22-Feb-2018
50-DRAIN-S6-174-NI S6 YES   YES   YES PASS LB/22-Feb-2018
50-DRAIN-S6-175-NI S6 YES   YES   YES PASS LB/22-Feb-2018
80-DRAIN-SS1-176-NI SS1 YES   YES   YES PASS LB/22-Feb-2018
25-DRAIN-S6-180-NI S6 YES   YES   YES PASS LB/22-Feb-2018
50-DRAIN-SS1-181-NI SS1 YES   YES   YES PASS LB/22-Feb-2018
Sheet 4 of 5 Piping Installation Verification
Tag # MOC *Weld Log

#

*Weld Log Complete

(Yes/No)

Pressure Test Pack-# Pressure Test Complete (Yes/No) Construction Dossier # **Slopes Checked

(Yes/No)

Verification

(Pass/Fail)

Initials / Date
65-PLANT STEAM-CS5-182-IH CS5 YES   YES   YES PASS LB/22-Feb-2018
65-PLANT STEAN-CS5-183-IH CS5 YES   YES   YES PASS LB/22-Feb-2018
15-PLANT STEAM-CS5-184-IH CS5 YES   YES   YES PASS LB/22-Feb-2018
20-CONDENSATE-CS5-185-IH CS5 YES   YES   YES PASS LB/22-Feb-2018
40-CONDENSATE-CS5-186-IH CS5 YES   YES   YES PASS LB/22-Feb-2018
40-CONDENSATE-CS5-187-IH CS5 YES   YES   YES PASS LB/22-Feb-2018
40-COMPRESSED AIR-SS1-502-NI SS1 YES   YES   YES PASS LB/22-Feb-2018
80-CONDENSATE-CS5-242-IH CS5 YES   YES   YES PASS LB/22-Feb-2018
100-PLANT STEAM-CS5-241-IH CS5 YES   YES   YES PASS LB/22-Feb-2018
20-CONDENSATE-CS5-185-IH CS5 YES   YES   YES PASS LB/22-Feb-2018
40-CONDENSATE-CS5-186-IH CS5 YES   YES   YES PASS LB/22-Feb-2018
*Weld Log collates material-of-construction certificates and weld inspection certificates **Construction Dossier collates slope-check documentation

 

 

 

 

 

Sheet 5 of 5 Piping Installation Verification

 

 

 

Comments:

 

  Validation Peer Review

 

 

         
Print Name Signature Date

 

  QA Approval

 

 

         
Print Name Signature Date

 

16.2.5                  Calibration Program Verification

Page ___ of ___

 

CALIBRATION PROGRAM VERIFICATION FORM
 
No. Steps Yes/No Verified By Date
1 Critical component list attached and cross referenced from commissioning documents
2 Calibration list attached and cross referenced from site calibration program
3 All critical components confirmed to be entered into the site calibration program
Deviation Report Required (Yes/No)
Acceptance Criteria Met: (Yes/No):
Comments:
Reviewed By:

Validation

Date:
Approved By:

(QA)

Date:

16.2.6                  Preventative Maintenance Program Verification

Page ___ of ___

 

Preventative Maintenance Program Verification Form
 
No. Description Verified By / Date
1 Component:  
PM#: Location:

 

Effective Date:

 

2 Component:  
 
PM#: Location:

 

Effective Date:

 

3 Component:  
 
PM#: Location:

 

Effective Date:

 

4 Component:  
 
PM#: Location:

 

Effective Date:

 

5 Component:  
 
PM#: Location:

 

Effective Date:

 

6 Component:  
 
PM#: Location:

 

Effective Date:

 

Comments:
Reviewed By:

Validation

Date:
Approved By:

(QA)

Date:

16.2.7                  Draft SOP Verification

Page _ __ of _ __

 

Standard Operating Procedure Verification Form
 
No. Description Verified By / Date
1 Title:  
 
SOP #: Revision #: Date:
2 Title:  
 
SOP #: Revision #: Date:
3 Title  
 
SOP #: Revision #: Date:
4 Title:    
 
SOP #: Revision #: Date:
5 Title:  
 
SOP #: Revision #: Date:
6 Title:    
 
SOP #: Revision #: Date:
Comments:
Reviewed By:

Validation

Date:
Approved By:

(QA)

Date:

 

16.2.8                  Test-Instrument Calibration Verification

Page _ _ of _ __

 

Test Instrument Calibration Verification Form
Objective: To document all test instruments used in the execution of this protocol.
Test Instrument Description Identification Number Calibration Date Calibration Due Date Verified By / Date
Comments:
Reviewed By:

Validation

Date:
Approved By:

(QA)

Date:

 

16.3 Appendix C:        OQ GMP check-sheets

 

16.3.1        Hot Detergent System – Detergent Dosing Control

16.3.2        Hot Detergent System – Temperature Control

16.3.3        Hot Detergent System – Flow Control

16.3.4        Hot Detergent System – Level Control

 

16.3.5        Hot PUW System – Temperature Control

16.3.6        Hot PUW System – Flow Control

16.3.7        Hot PUW System – Level Control

 

 

 

 

 

16.3.1                  Hot Detergent System – Detergent Dosing Control

Test Step # Operational Test Step Description Expected Result Actual Result Pass / Fail Initials Date

(dd/mmm/yyyy)

1 Start up the hot detergent system and after 30-minutes confirm that 80°C detergent is recirculating. TT-002 = 80°C±5°C

 

TT-004 = 80°C±5°C

2 Confirm the online conductivity measurement CT-001 is reading X μScm-1 ± 5%. X μScm-1 ± 5%
3 Initiate a simultaneous detergent drawdown into reactor RE-119 and reactor RE-140, and charge approximately 5,500 litres into both vessels. LT-119 > 5,000 Litres

 

LT-140 > 5,000 Litres

4 After the charge stop the detergent drawdown into both reactor RE-119 and reactor RE-140 (approximately after 30-minutes; 22,000 kg/hr ±10% ≈11m3/30mins). Drawdown stopped
5 Following the charge, maintain the hot detergent system in normal operation mode for a further 30-minutes with no further drawdown. No drawdown
6 Print out the associated trends for conductivity transmitter CT-001, temperature transmitters TT-002 and TT-004, and level-transmitters LT-119 and LT-140 during the test period and append to this test section. Trends attached

 

Reviewed By (Validation Peer Review) Date

 

Approved By (Quality Assurance) Date

In the following table, at successive 5-minute intervals record the online indicator values of conductivity measurement CT-001, temperature transmitters TT-002 and TT-004, and level-transmitters LT-119 and LT-140. Ensure that the time period the values are recorded correspond to the following:

  • The 30-minutes before maximum instantaneous detergent drawdown (starting at t0-min)
  • During the instantaneous detergent drawdown, up to the full 5,500 litre charges in both reactors RE-119 and RE-140
  • The 30-minutes following the discontinuation of the maximum drawdown

 

Time

minutes

Time

HH/MM

Expected

CT-001

μScm-1

Actual

CT-001

μScm-1

Expected

TT-002/4

(°C)

Actual

TT-002

(°C)

Actual

TT-004

(°C)

LT-119

(Litres)

LT-140

(Litres)

Pass / Fail Initials Date

(dd/mmm/yyyy)

t0-min X μScm-1 ± 5% 80°C±5°C
t5-min X μScm-1 ± 5% 80°C±5°C
t10-min X μScm-1 ± 5% 80°C±5°C
t15-min X μScm-1 ± 5% 80°C±5°C
t20-min X μScm-1 ± 5% 80°C±5°C
t25-min X μScm-1 ± 5% 80°C±5°C
t30-min X μScm-1 ± 5% 80°C±5°C
t35-min X μScm-1 ± 5% 80°C±5°C
t40-min X μScm-1 ± 5% 80°C±5°C

 

Reviewed By (Validation Peer Review) Date

 

Approved By (Quality Assurance) Date

 

Time

minutes

Time

HH/MM

Expected

CT-001

μScm-1

Actual

CT-001

μScm-1

Expected

TT-002/4

(°C)

Actual

TT-002

(°C)

Actual

TT-004

(°C)

LT-119

(Litres)

LT-140

(Litres)

Pass / Fail Initials Date

(dd/mmm/yyyy)

t45-min X μScm-1 ± 5% 80°C±5°C
t50-min X μScm-1 ± 5% 80°C±5°C
t55-min X μScm-1 ± 5% 80°C±5°C
t60-min X μScm-1 ± 5% 80°C±5°C
t65-min X μScm-1 ± 5% 80°C±5°C
t70-min X μScm-1 ± 5% 80°C±5°C
t75-min X μScm-1 ± 5% 80°C±5°C
t80-min X μScm-1 ± 5% 80°C±5°C
t85-min X μScm-1 ± 5% 80°C±5°C
t90-min X μScm-1 ± 5% 80°C±5°C

 

Comments:

 

 

 

Reviewed By (Validation Peer Review) Date

 

Approved By (Quality Assurance) Date

 

16.3.2                  Hot Detergent System – Temperature Control

16.3.3                  Hot Detergent System – Flow Control

16.3.4                  Hot Detergent System –Level Control

16.3.5                  Hot PUW System – Temperature Control

16.3.6                  Hot PUW System – Flow Control

16.3.7                  Hot PUW System – Level Control

 

 

16.3.8                  Approved SOP Verification

Page _ __ of _ __

 

Standard Operating Procedure Verification Form
 
No. Description Verified By / Date
1 Title:  
 
SOP #: Revision #: Date:
2 Title:  
 
SOP #: Revision #: Date:
3 Title  
 
SOP #: Revision #: Date:
4 Title:    
 
SOP #: Revision #: Date:
5 Title:  
 
SOP #: Revision #: Date:
6 Title:    
 
SOP #: Revision #: Date:
Comments:
Reviewed By:

Validation

Date:
Approved By:

(QA)

Date:

 

 

 

16.4 Appendix D:        Deviation log

 

 

Deviation #

 

Deviation Summary Statement

Deviation Resolved

(YES / No)

 

Date Verified

Date Approved Related Change #

(if applicable)

 

Comments

 

Reviewed By:

(Validation)

  Date:  
*Reviewed By:

(QA)

  Date:  

*Must be approved by QA if any deviations are deemed a ‘Direct Impact System’

 

16.5 Appendix E:        Deviation Form

Deviation Details Deviation#  
Building / Area Equipment / System
Protocol Section # Protocol Test Descriptor
Deviation Category

(Please Circle)

1 2 3 *4 *5
DEVIATION DESCRIPTION
2. Impact Assessment of Deviation
System GMP Category

(Please Circle)

Component GMP Category

(Please Circle)

*Direct Indirect No Impact Critical Non-Critical
Affected Items Yes/No Affected Items Yes/No
User Requirement Functional or Detailed Design Specifications
Testing Already Completed System Documentation
Testing Protocols Drawings
Validation Plan Standard Operating Procedures
Training Other
Details of Affected Items:

 

REFERENCES (AFFECTED ITEMS)
Document # Title / Description Revision
3. Resolution Description
4. Resolution Verification
Verified By: (Originator)   Date:  
Approved By: (Validation)   Date:  
*Approved By: (QA)   Date:  

*Must be approved by QA only if a ‘Direct Impact System’

 

 

16.6 Appendix F:         Change Control Llog

 

Change Control # P&ID / System # Summary Description of change Direct / Indirect /

No-Impact

Date Raised

(dd/mmm/yyyy)

Pre-Approval Date

(dd/mmm/yyyy)

Post-Approval Date

(dd/mmm/yyyy)

 

COMMENTS:

 

Reviewed By:

(Validation Engineering)

  Date:  

 

16.7 Appendix G:        Change control Form

 

Change Control Form

 

Project Title: CHANGE #:
Project No: P&ID / System:
Attachments (Yes/No): Date:
SECTION 1: OBSERVATIONS AND PROPOSED CHANGE (to be completed by 1Project Engineer)
ORIGINAL DESIGN: PROPOSED CHANGE:
 
2HAZOP TO BE UPDATED (Yes / No)
SECTION 2: IMPACT ASSESSMENT (to be completed by 1Engineering Validation)
AFFECTED APPROVED ITEMS Yes/No AFFECTED APPROVED ITEMS Yes/No
3Validation Plan 3Project URS
3System Level URS 3System Impact Assessment
3Component Impact Assessment 3, 4Qualification Protocol(s)
4Commissioning Protocol(s) 4Other
  3, 5DIRECT 5INDIRECT 5NO IMPACT
3SYSTEM IMPACT Yes / No Yes / No Yes / No

 

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

 

4DOCUMENT UPDATES REQUIRED

 

Number of Test Pages Attached
SECTION 4: COST CALCULATIONS AND SCHEDULE (to be completed by 1Project Engineer)
6COST OF CHANGE   6IMPACT ON SCHEDULE (time)  
SECTION 5: PRE-APPROVALS
PROJECT DISCIPLINE PRINT NAME SIGNATURE DATE
PROJECT ENGINEER
PROJECT MANAGER    
EHS
VALIDATION
QA
SECTION 6: REJECT CHANGE
  PRINT NAME SIGNATURE DATE
CHANGE REJECTED BY
REASON FOR REJECTING CHANGE

 

 

 

SECTION 7: DOCUMENT UPDATES (to be completed by 1Engineering Validation)
DOCUMENT UPDATED Yes/No/

N/A

DOCUMENT UPDATED Yes/No/

N/A

3Commissioning and Qualification Plan 3Project URS
3System Level URS 3System Impact Assessment
3Component Impact Assessment 3, 4Qualification Protocol(s)
4Commissioning Protocol(s) 4Other
2HAZOP UPDATED (Yes / No)
SECTION 8: 4POST-CHANGE TESTING SUCCESSFUL EXECUTED AND COMPLETED
  PRINT NAME SIGNATURE DATE
VERIFIED BY
SECTION 9: POST-CHANGE APPROVALS
PROJECT DISCIPLINE PRINT NAME SIGNATURE DATE
PROJECT ENGINEER
PROJECT MANAGER    
EHS
VALIDATION
QA
ADDITIONAL COMMENTS

 

 

1 Enter name and signatures details in approval section; 2 If ‘Yes’ EHS must approve change; 3 If ‘Yes’ QA must approve change; 4 Attach list accordingly; 5 Circle correct entry; 6 Attach additional cost breakdown, and if applicable details on updated schedule

 

16.8 Appendix H:        Component Impact Assessment

 

Equipment Components

      Critical Non-Critical
Item # Tag Description Operational Critical Product Contact Critical  
1-1 T-211 Hot Detergent Tank YES YES
1-2 T-411 Hot PUW2 Tank YES NO
1-3 P-207 Detergent Centrifugal Transfer Pump YES YES
1-4 P-209 Detergent Centrifugal Transfer Pump YES YES
1-5 P-415 PUW2 Centrifugal Transfer Pump YES YES
1-6 P-417 PUW2 Centrifugal Transfer Pump YES YES
1-7 P-223 Detergent Mentering Pump YES NO
1-8 HX-211 Detergent Plate Heat Exchanger YES YES
1-9 HX-411 PUW2 Plate Heat Exchanger YES YES
1-10 FL-399 Detergent Cartridge Filter YES NO
1-11 FL-401 PUW2 Cartridge Filter YES NO
1-12 PSV-001 PUW2 Sanitary Pressure Relief Valve NO NO
1-13 PSV-002 Detergent Sanitary Pressure Relief Valve YES NO

 

 

 

Instrument Components

      Critical Non-Critical
Item # Tag Description Operational Critical Product Contact Critical  
2-1 TCV-005 Steam Temperature control valve YES YES
2-2 TCV-006 Steam Temperature control valve YES YES
2-3 TT-001 3 wire RTD Temperature transmitters YES YES
2-4 TT-002 3 wire RTD Temperature transmitters YES YES
2-5 TT-003 3 wire RTD Temperature transmitters YES YES
2-6 TT-004 3 wire RTD Temperature transmitters YES YES
2-7 PT-001 Sanitary Diaphragm type Pressure Indicating transmitters NO
2-8 PT-002 Sanitary Diaphragm type Pressure Indicating transmitters YES NO
2-9 PI-007 Local pressure indicators c/w bourdon type gauges NO YES
2-10 FT-001 Magnetic flow Transmitter YES YES
2-11 FT-002 Magnetic flow Transmitter YES YES
2-12 FT-003 Magnetic flow Transmitter
2-13 FT-004 Magnetic flow Transmitter YES YES
2-14 FS-005 Low Flow switch YES YES
2-15 CT-001 Conductivity transmitter YES NO
2-16 PI-003 Diaphragm type pressure indicator NO
2-17 PI-004 Diaphragm type pressure indicator NO
2-18 PI-005 Diaphragm type pressure indicator YES
2-19 PI-006 Diaphragm type pressure indicator YES
2-20 PI-008 Diaphragm type pressure indicator NO
2-21 TI-007 Bimetalic Temperature indicator NO NO
2-22 TI-008 Bimetalic Temperature indicator YES
2-23 TI-009 Bimetalic Temperature indicator NO
2-24 TI-010 Bimetalic Temperature indicator YES
2-25 LS-003 Low Level Switch (Tuning fork type) NO
2-26 LS-004 Low Level Switch (Tuning fork type) NO
2-27 LS-005 High Level Switch (Tuning fork type) YES
2-28 LS-006 High Level Switch (Tuning fork type) YES
2-29 LT-001 Hydrostatic Pressure type level Transmitter YES
2-30 LT-002 Hydrostatic Pressure type level Transmitter YES
2-31 XV-003 Actuated Sanitary Butterfly Valve NO
2-32 XV-004 Actuated Sanitary Butterfly Valve NO
2-33 XV-008 Actuated Sanitary Ball Valve NO
2-34 XV-009 Actuated Sanitary Ball Valve NO
2-35 XV-001 Actuated Tuchenhagen Multiport divert Valves. NO
2-36 XV-002 Actuated Tuchenhagen Multiport divert Valves. YES
2-37 XV-005 Actuated Tuchenhagen Multiport divert Valves. YES
2-38 XV-006 Actuated Tuchenhagen Multiport divert Valves. NO
2-39 XV-007 Actuated Tuchenhagen Multiport divert Valves. NO
2-40 PRV-001 Back Pressure Regulating Valve YES NO
2-41 PRV-002 Back Pressure Regulating Valve YES NO

 

 

 

Piping Components

      Critical Non-Critical
Item # Tag Description Operational Critical Product Contact Critical  
3-1 50-PUW1-S6-147-IH From LN-486 To T-211 YES NO
3-2 50-PUW1-S6-148-IH From LN-486 To T-411 YES NO
3-3 80-DETERGENT-S6-149-IH From T-211 To FL-399 YES NO
3-4 80-DETERGENT-S6-150-IH From FL-399 To P-207 YES NO
3-5 80-DETERGENT-S6-151-IH From LN-150 To P-209 YES NO
3-6 65-DETERGENT-S6-152-IH From P-209 To LN-153 YES
3-7 65-DETERGENT-S6-153-IH From P-207 To HX-211 NO
3-8 65-DETERGENT-SS1-154-IH From HX-211 To XV-021 @ DETERGENT change-over valves YES YES
3-9 80-PUW2-S6-156-IH From FL-401 To P-415 NO
3-10 80-PUW2-S6-157-IH From LN-156 To P-417 NO
3-11 65-PUW2-S6-158-IH- From P-417 To LN-159 NO
3-12 65-PUW2-S6-159-IH- From P-415 To HX-411 YES
3-13 65-PUW2-SS1-160-IH- From HX-411 To XV-016 @ PUW2 change-over valves YES YES
3-14 25-PROCESS-S6-161-NI From Conc. Detergent Dosing System

To P-223

YES YES
3-15 25-PROCESS-S6-162-NI From P-223

To LN-149

NO
3-16 65-DETERGENT-SS1/S6-163-IH From XV-018 @ DETERGENT change-over valves To T-211 YES YES
3-17 65-PUW2-SS1/S6-164-IH From XV-013 @ PUW2 change-over valves To T-411 YES YES
3-18 100-VENT-S6-166-NI From T-211 To Safe Area YES
3-19 25-DRAIN-S6-167-NI From LN-166 To LN-176 NO
3-20 100-VENT-S6-168-NI From T-411 To Safe Area YES
3-21 25-DRAIN-S6-169-NI From LN-168 To LN-176 NO
3-22 50-DRAIN-S6-170-NI From XV-002 @ T-211 outlet To LN-176 NO NO
3-23 50-DRAIN-S6-171-NI From XV-001 @ T-411 outlet To LN-176 NO NO
3-24 25VENTS6172NI From PSV-002 To LN-176 YES NO
3-25 25-VENT-S6-173-NI From PSV-001 To LN-176 YES NO
3-26 50-DRAIN-S6-174-NI From XV-006 @ T-211 inlet To LN-176 YES NO
3-27 50-DRAIN-S6-175-NI From XV-005 @ T-411 inlet To LN-176 NO
3-28 80-DRAIN-SS1-176-NI From Drain Lines To Drain Header NO
3-29 15-DRAIN-S6-177-NI From P-207 To Drain NO
3-30 15-DRAIN-S6-178-NI From P-209 To Drain NO
3-31 15-DRAIN-S6-179-NI From P-415 To Drain NO
3-32 15-DRAIN-S6-180-NI From P-417 To Drain YES
3-33 50-DRAIN-SS1-181-NI From T-411 Pump Discharge

To Drain

YES NO
3-34 50-DRAIN-SS1-182-NI From T-211 Pump Discharge To Drain YES NO
3-35 65-PLANT STEAM-CS5-183-IH From LN-241 To HX-211 / HX-411 YES
3-36 15-PLANT STEAM-CS5-184-IH From LN-241 To LN-185 YES
3-37 20-CONDENSATE-CS5-185-IH From LN-184 To LN-242 YES NO
3-38 40-CONDENSATE-CS5-186-IH From HX-211 To LN-242 YES YES
3-39 40-CONDENSATE-CS5-187-IH From HX-411 To LN-242 YES
3-40 100-PLANT STEAM-CS5-241-IH From Existing Steam Header Level 2 To Cleaning generation Skid YES YES
3-41 80-CONDENSATE-CS5-242-IH From Cleaning Generation Skid To Existing Condensate Header Level 4 YES YES
3-42 40-COMPRESSED AIR-SS1-502-NI From V-39 To Pneumatic Control YES YES

 

 


16.9 Appendix I: Traceability Matrix

 

Testing Traceability Matrix

 

Hot Detergent and Hot PUW Generation and Distribution

 

1        Plant Throughputs for Hot Detergent and Hot PUW Generation System

Item User Requirement Description Testing Comment
1.1 The system shall be capable of achieving and maintaining a maximum outward flowrate, at steady state conditions, of 25,000 kg/hr ±5% ·       Operational / Functional Test

·       Procedure Section 13.3

·       Checksheet 16.3.3

·       “Hot Detergent System – Flow Control”

·       Conduct test during simultaneous maximum Hot Detergent drawdown into reactor RE-119 and reactor RE-140
1.2 The system shall be capable of achieving and maintaining a minimum return flowrate, at steady state conditions, of 3,000 kg/hr ±5% ·       Operational / Functional Test

·       Procedure Section 13.3

·       Checksheet 16.3.3

·       “Hot Detergent System – Flow Control”

·       Conduct test during simultaneous maximum Hot Detergent drawdown into reactor RE-119 and reactor RE-140

 

 

 

1        Plant Throughputs for Hot Detergent and Hot PUW Generation System (continued)

Item User Requirement Description Testing Comment
1.3 The system shall be capable of achieving and maintaining a maximum instantaneous drawdown of 22,000 kg/hr ±5%, based on 2 users at 11m3/hr/user ·       Operational / Functional Test

·       Procedure Section 13.3

·       Checksheet 16.3.3

·       “Hot Detergent System – Flow Control”

·       Conduct test during simultaneous maximum Hot Detergent drawdown into reactor RE-119 and reactor RE-140
1.4 The maximum number of simultaneous users shall be two.

 

·       Operational / Functional Test

·       Procedure Section 13.3

·       Checksheet 16.3.3

·       “Hot Detergent System – Flow Control”

·       Conduct test during simultaneous maximum Hot Detergent drawdown into reactor RE-119 and reactor RE-140

 

 

 

2        Skid Configuration

Item User Requirement Description Testing Comment
2-1 The Skid shall consist of the following equipment items. The detailed design specifications for these equipment items are outlined in Appendix 1.

 

Process water tank                        1

Detergent solution tank                      1

Centrifugal recirculation pumps          4

Detergent dosing pump            1

Heat exchangers                                          2

 

·       Installation Test

·       Procedure Section 11.2

·       Checksheet 16.2.2.1 to Checksheet 16.2.2.13

 

·       Installation Test

·       Procedure Section 11.1

·       Checksheet 16.2.1

·       Equipment Installation Tests

 

 

 

·       P&ID Walkdown

2-2 Instrumentation as illustrated on the P&ID-227 shall be supplied with the skid.

 

·       Installation Test

·       Procedure Section 11.3

·       Checksheet 16.2.3.1 to Checksheet 16.2.3.12

 

·       Installation Test

·       Procedure Section 11.1

·       Checksheet 16.2.1

·       Instrumentation Installation Test

 

 

 

·       P&ID Walkdown

 

 

3        Hot Detergent Solution Operation

Item User Requirement Description Testing Comment
3.1 The Hot Detergent Tank shall be fed directly from the 25°C PUW1 water loop.

 

·       Operational / Functional Test

·       Procedure Section 13.4

·       Checksheet 16.3.4

·       “Hot Detergent System – Level Control”

·       Conduct test during simultaneous maximum Hot Detergent drawdown into reactor RE-119 and reactor RE-140
3.3 The system shall have the facility to maintain the level in the Hot Detergent Tank within ±5% of the user defined level setpoint. ·       Operational / Functional Test

·       Procedure Section 13.4

·       Checksheet 16.3.4

·       “Hot Detergent System – Level Control”

·       Conduct test during simultaneous maximum Hot Detergent drawdown into reactor RE-119 and reactor RE-140Level Test
3.5 ·       The system shall have the facility to automatically dose concentrated detergent to the required concentration (Y% ±0.05%)

·       Online conductivity measurement shall be provided to verify the detergent concentration.

·       Installation Test

·       Procedure Section 11.3

·       Checksheet 16.2.3.7

 

·       Operational / Functional Test

·       Procedure Section 13.1

·       Checksheet 16.3.1

·       “Detergent Dosing Control”

·       Verify conductivity transmitter installation

 

 

·       Conduct test during simultaneous maximum Hot Detergent drawdown into reactor RE-119 and reactor RE-140

 

4        Hot PUW Solution Operation

Item User Requirement Description Testing Comment
4.4 ·       The Hot PUW supply temperature shall be maintained by a closed loop control system, which modulates steam flow to the heat exchanger.

·       The control system shall be capable of controlling the supply temperature to within ±5°C of the setpoint (80°C).

·       Operational / Functional Test

·       Procedure Section 13.5

·       Checksheet 16.3.5

·       “Hot PUW System – Temperature Control”

Conduct test during simultaneous maximum Hot PUW drawdown into reactor RE-119 and reactor RE-140

 

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