1Title 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

2Approvals 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)

3Document 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

4Table of Contents

1Title Page

2Approvals Page

3Document Revision History

4Table of Contents

5Protocol Objective

6System Description

7Scope

7.1System Impact Assessment

7.2Component Impact Assessment

7.3Summary Table - Operational Critical Components

7.4P&ID Scope

8Reference Documentation

9Definitions/ Glossary

10Responsibilities / Subject Matter Experts

11Installation Verification Testing Procedures

11.1P&ID Walkdown Testing Procedure

11.2Equipment Installation Verification Procedure

11.3Instrument Installation Verification Procedure

11.4Piping Installation Verification Procedure

11.5Calibration Program Verification

11.6Preventative Maintenance Program Verification

11.7Draft SOP Verification

11.8Test-Instrument Calibration Verification

12Progression Approval to Proceed to Functional Verification

12.1Operational-Critical-Instrument Calibration Verification Form

13Functional Verification Testing Procedures

13.1Hot Detergent System – Detergent Dosing Control

13.2Hot Detergent System – Temperature Control

13.3Hot Detergent System – Flow Control

13.4Hot Detergent System – Level Control

13.5Hot PUW System – Temperature Control

13.6Hot PUW System – Flow Control

13.7Hot PUW System – Level Control

13.8Approved SOP Verification

14Protocol Quality Procedures

14.1Signature Log

14.2Deviation Procedure

14.3Change Control Procedure

15IOQ Protocol Summary Report

16List of Appendices

16.1Appendix A - Protocol Signature Log

16.2Appendix B - Installation Verification GMP checksheets

16.2.1P&ID Walkdown Installation Verification

16.2.2Equipment Installation Verification

16.2.3Instrument Installation Verification

16.2.4Piping Installation Verification

16.2.5Calibration Program Verification

16.2.6Preventative Maintenance Program Verification

16.2.7Draft SOP Verification

16.2.8Test-Instrument Calibration Verification

16.3Appendix C: OQ GMP check-sheets

16.3.1Hot Detergent System – Detergent Dosing Control

16.3.2Hot Detergent System – Temperature Control

16.3.3Hot Detergent System – Flow Control

16.3.4Hot Detergent System –Level Control

16.3.5Hot PUW System – Temperature Control

16.3.6Hot PUW System – Flow Control

16.3.7Hot PUW System – Level Control

16.3.8Approved SOP Verification

16.4Appendix D: Deviation log

16.5Appendix E: Deviation Form

16.6Appendix F: Change Control Llog

16.7Appendix G: Changecontrol Form

16.8Appendix H: Component Impact Assessment

16.9Appendix I: Traceability Matrix

5Protocol 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 fitfor its intended use. Testing will incorporate both installation verification and functional verification test.

6System 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.

7Scope

7.1System Impact Assessment

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

7.2Component 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.

7.3Summary 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

7.4P&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.

8Reference 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

9Definitions/ 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

10Responsibilities / 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.

11Installation Verification Testing Procedures

11.1P&ID WalkdownTesting Procedure

1Description 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.

2Linkage to Requirements Challenged

Confirm correct installation and orientation of direct impact components as per the P&ID schematic illustration.

3Acceptance Criteria

All direct impact components are functionally installed and orientated correctly as per the P&ID specification.

4Prerequisites 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.

5Test 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

6Expected 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.

11.2Equipment Installation VerificationProcedure

1Description 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.

2Linkage to Requirements Challenged

Confirm correct installation and primary specifications of direct impact equipment components as detailed in the P&ID and URS.

3Acceptance 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.

4Prerequisites 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.

5Test 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

6Expected 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.

11.3InstrumentInstallation Verification Procedure

1Description 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.

2Linkage 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.

3Acceptance 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.

4Prerequisites 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.

5Test 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

6Expected 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.

11.4Piping Installation VerificationProcedure

1Description 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.

2Linkage to Requirements Challenged

Confirm correct installation and orientation of direct impact piping as per the P&ID schematic illustration and piping isometrics.

3Acceptance Criteria

All direct impact components are functionally installed and orientated correctly as per the P&ID’s and isometrics’ specifications.

4Prerequisites 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.

5Test 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 Packfor 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 Dossierfor every each pipe Tag #.
  7. Confirm all slopes have been checked and verified as correct from the Construction Dossier.

6Expected 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.

11.5Calibration 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.

11.6Preventative 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.

11.7Draft 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.

11.8Test-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

12Progression 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)

12.1Operational-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:

13FunctionalVerification Testing Procedures

13.3.1Hot Detergent System – Detergent Dosing Control

13.3.2Hot Detergent System – Temperature Control

13.3.3Hot Detergent System – Flow Control

13.3.4Hot Detergent System – Level Control

13.3.5Hot PUW System – Temperature Control

13.3.6Hot PUW System – Flow Control

13.3.7Hot PUW System – Level Control

13.1Hot Detergent System –Detergent Dosing Control

1Short 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.

2Linkage 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

3Acceptance criteria for the test