Commissioning Plan

Issue date

Commissioning Plan

(Reference SOP: _______)

Project:	Project No:
Equipment Description :	Equipment No:
Location:	Protocol:

	APPROVALS
POSITION	NAME	SIGNATURE	DATE
Prepared By: Project Engineer
Reviewed by: Validation Manager
Reviewed by: Production Manager
Reviewed by: Project Manager

Rev No.	Date	Section	Page	Amendment Details	Authorised
1.0

Prepared By: Date Prepared:

Page of 6

Issue date

Commissioning Plan

(Reference SOP: _______)

1. Introduction

This Commissioning Plan relates to _____________. This plan outlines the activities to be undertaken after Design Review and before Operational Qualification, to ensure that the equipment supplied meets the requirements of the User Requirement Specification (URS). The activities include pre-delivery inspection, Factory Acceptance Testing (FAT), post- delivery inspection, commissioning involving adjustments, calibrations and other shakedown activities prior to Site Acceptance Testing (SAT) and SAT. It does not cover validation activities, which are attached in the Process Validation Plan (Project No: _____________)

2. Overview

The process and equipment covered includes ___________ to be installed in ___________________Facility. They will be commissioned with the following activities .

π Pre-delivery Inspection π Factory Acceptance Testing (FAT) π Installation / Installation Qualification (IQ) π Commissioning π Site Acceptance Testing (SAT) π Documentation & Manuals π Training

Commissioning Deliverables Responsibilities Matrix

	Activity	Position	Responsible
1.	Commissioning Plan & Schedule Prepared by: Assisted by: Checked by: Checked by: Checked by: Checked by: Approved by:	Project Engineer Project Engineer Electrical Engineer Engineering Manager Quality Manager* Validation Manager* Production Manager Project Manager * GMP Direct Impact System
2.	Factory Acceptance Test (FAT) Plan / Protocol Prepared by: Assisted by: Checked by: Approved by:	Project Engineer Electrical Engineer Engineering Manager Project Manager
3.	Factory Acceptance Test (FAT) Report Prepared by: Assisted by: Checked by: Approved by:	Project Engineer Electrical Engineer Engineering Manager Project Manager

Prepared By: Date Prepared:

Page of 6

Issue date

Commissioning Plan

(Reference SOP: _______)

No	Task	Resource(s)
1	Carry out inspection in ________ protocol for work executed, including verification of components. Record results in protocol for evaluation, sign-off and approval.
2	Carry out tests and checks in ________ protocol to ensure satisfactory operation and conformance to URS for desi gn & operational parameters, and equipment & safety functions.
3	Perform ____________ test run in ___________ protocol to demonstrate ability to meet acceptance criteria _________. Record results in protocol for evaluation, sign-off and approval.
4	Perform _______________ test run in ___________ protocol to demonstrate ability to meet acceptance criteria of ________. Record results in protocol for evaluation, sign-off and approval.
5	Evaluate results in protocols for approval .
6	Delivery of equipment shall not proceed until all requirements are satisfied and approved by the company

4. Installation / IQ

Company will supply labour and equipment to move the equipment into position . This will include unloading, positioning and connection of services to the equipment. The Supplier shall be responsible for the correct installation of the equipment.

No	Task	Resources
1	Provide labour and equipment to move into place and connect services.	Site Project engineer, Electrical Engineer, Contractors
2	Ensure correct installation.	Supplier
3	Carry out Installation Qualification as per Validation Plan .	Project Engineer

5. Commissioning

Commissioning tests will be done after verification of correct installation .

No.	Task	Resources
1	Supplier to perform commissioning tests based on his commissioning Test Protocol.	Supplier
2	Supplier and buyer shall agree prior to commissioning to a Commissioning Test Protocol that details test to verify the URS . The completed protocol after tests shall include the collected data from the tests.	Supplier, Site Project Engineer
3	Supplier to submit the Commissioning Test Protocol for review and approval 4 weeks prior to execution.	Site Project Engineer
4	Supplier to notify buyer 2 days before the start of commissioning test s. Buyer may choose to witness.	Site Project Engineer
5	For acceptance of the Equipment, each test in the agreed protocol shall be successfully completed in accordance with the requirement of the URS.	Supplier, Site Project Engineer

6. Site Acceptance Testing (SAT)

Site Acceptance Testing will be done after installation and successful commissioning .

Prepared By: Date Prepared:

Page of 6

TEM070 Issue date

User Requirement Specification

(Ref.VAL005)

Project Name		Project Number
Equipment		Serial Number
Manufacturer		Model Number
Process Line/Location		Protocol number

Index of Specifications Required For This Project

Specifications	Included Yes/No
Mechanical Demand Specification
Electrical Demand Specification
Instrumentation Demand Specification
Operator’s Control Panel Specification
Technical Documentation Specification
Environmental, Health and Safety Requirements
Drawing Requirements

Functional Demands

1. Scope of works

Detail what will be required, extent of work, boundaries and borders

2. Functional Requirements

Detail the functionality required of the equipment / process. Include capacities and product size, shape, processing details.

3. Factory Acceptance Testing (FAT)

This section to be deleted If not required

A plan for factory acceptance testing should be established in consultation with the supplier at the time of order placement. Results of testing should be reported. Reports from FAT should be attached to the Validation File. Attachment included in the validation file

Verified _______________Date____________

File Location: Date Printed: Page 1 of 2

Validation Report

TEM060 Issue date

Validation Report

(Ref.VAL005)

Project Name		Project Number
Equipment		Serial Number
Manufacturer		Model Number
Process Line/Location		Protocol number

Table of Content

PROCESS DESCRIPTION ........................................................................................................................................2 OBJECTIVE...........................................................................................................................................................2 INSTRUMENTATION/CALIBRATION ..........................................................................................................................2 TEST FUNCTIONS PERFORMED IN THE OPERATIONAL QUALIFICATION PHASE AND OVERALL RESULTS OBTAINED .......2 ADDITIONAL VALIDATION REQUIREMENTS ..............................................................................................................2 OVERALL CONCLUSION .........................................................................................................................................3 REVALIDATION PROGRAM .....................................................................................................................................3

Approval of The Completed Operational Qualification Report
Department	Name	Signature	Date
Project Coordinator
Validation Manager
Quality Assurance Manager
Operations Manager
Production Manager

Approval signifies provisional approval of the equipment / system for production use.

File Location: Date Printed: Page 1 of 3

TEM060 Issue date

Validation Report

(Ref.VAL005)

Established	fulfilled and approved by the Production Manager
Training conducted	Yes / No – Sign & Date
All SOP’s established	Yes / No – Sign & Date

Overall Conclusion

Acceptance criteria for the overall program shall be based on the following:

1. Successful precalibration data for all critical test instrumentation
2. Successful completion of all test functions listed in Part 4.
3. Successful postcalibration of all critical test instrumentation.

Tabulate and review all data referenced above. Form a conclusion as to the acceptability of the overall program based on the acceptance criteria specified above.

Conclusion:

(Text)

Revalidation Program

Revalidation of this equipment / system is required:

• when the findings of inprocess and quality control tests indicate the need or
• routinely

Tests Required	Frequency

Completed Validation Report:

	Position	Signature	Date
Documented by
Checked by

File Location: Date Printed: Page 3 of 3

Validation Plan

TEM055 Issue date

Validation Plan

(Ref.VAL005)

Project Name		Project Number
Equipment		Serial Number
Manufacturer		Model Number
Process Line/Location		Protocol number

PROGRAM INDEX OBJECTIVE.......................................................................................................................................2 DESCRIPTION OF EQUIPMENT / PROCESS / SYSTEM.............................................................................2 DESIGN QUALIFICATION ....................................................................................................................2 LIST OF SYSTEMS / PROCESS SUBPARTS TO BE VALIDATED................................................................2 INSTALLATION QUALIFICATION DOCUMENTATION................................................................................2 COMPUTER VALIDATION ....................................................................................................................3 CLEANING VALIDATION .....................................................................................................................3 OPERATIONAL QUALIFICATION TEST PLAN AND ACCEPTANCE CRITERIA..............................................3 REQUIRED STANDARD OPERATING PROCEDURES ( SOPS) .................................................................3 TRAINING..........................................................................................................................................4 PROJECTED TIMELINE .......................................................................................................................4 PERFORMANCE QUALIFICATION PHASE..............................................................................................5 CHANGE CONTROL ...........................................................................................................................5 RESPONSIBILITIES.............................................................................................................................5

	Validation Plan Prepared By:
Position	Name	Signature	Date
Project Coordinator

	APPROVAL OF THE VALIDATION PLAN
Position	Name	Signature	Date
Validation Manager
Quality Assurance Manager
Operations Manager

Additional approval that may be required depending on the size and importance of the project.

TEM055 Issue date

Validation Plan

(Ref.VAL005)

IQ based on Demand Specifications	Applicable to this Project*
1. Equipment Functional Demand Specification	Yes/No
2. Mechanical / Design Specification	Yes/No
3. Electrical Demand Specification	Yes/No
4. Instrumentation Demand Specification	Yes/No
5. Operator’s Control Panel Specification	Yes/No
7. Technical Documentation Specification	Yes/No
8. Environmental, Health and Safety Requirements	Yes/No

Computer Validation Impact Assessment on the product Quality is to be conducted for the proposed project. Justify any computer validation activities in the plan being under taken by this project. Any Operational Qualification testing required as part of the validation requirement is to be included.

Cleaning Validation

Cleaning Validation is to be conducted in accordance with the requirements of SOP VAL020.

Cleaning Validation required for the process, equipment or procedures.	Yes /No
Select the Worst Case Product for Cleaning according to SOP VAL020
Analytical Method Validation required for Worst Case Product	Yes / No
Is analytical method validation complete?	Yes / No
Include reference file for analytical method validation report.

Any Operational Qualification testing required as part of the validation requirement is to be included in the plan.

Operational Qualification Test Plan and Acceptance Criteria

Validation activities are to be conducted in accordance with the requirements of SOP VAL005.

All documentation is to follow the requirements stipulated in SOP VAL005. Templates for the various documents are to be sourced from the Templates.

List of Operational Qualification tests that are to be conducted.

The acceptance criteria for the operational qualification tests should be clear and unambiguous so that review and approval of the final qualification reports is expedited.

It may be more appropriate to separately record the Operational Qualification Tests and the Acceptance Criteria for each test. In which case include a separate section in the plan for the Acceptance Criteria and update the Program Index.

Required Standard Operating Procedures ( SOPs)

Include the full SOP no. Ensure you reference the current version. Relevant SOPs required to conduct the validation activities are to be listed.

TEM055 Issue date

Validation Plan

(Ref.VAL005)

Performance Qualification Phase

Fill in details

The Performance Qualification will consist of plus any additional tests determined to be necessary during the Operational Qualification phase.

Change Control

The Change Control Procedure according to SOP QMS030 will be enacted after the commencement of the Operational Qualification phase of this project.

Responsibilities

List of personnel who have been allocated as resources for the validation project and their individual responsibilities.

NB the understanding and acceptance of the personnel listed must be obtained in advance.

	Activity	Position
1.	Validation Plan Prepared by: Authorised by:	Project Coordinator Validation Manager Quality Assurance Manager Operations Manager
2.	Training needs assessment
3.	Modifying current SOP’s Writing required SOP’s,
4.	Preparation of Installation Qualification Reports for approval to execute. Prepared by: Checked by: Authorised by:	QA or Validation Manager
5.	Review of completed IQ Report Prepared by: Checked by: Authorised by:	Electrical Mechanical Project Coordinator Validation Manager Quality Assurance Manager Operations Manager
6.	Writing Operational Qualification Test Protocols Prepared by: Checked by: Authorised by:	QA or Validation Manager
7.	Conducting OQ tests
8.	Completed OQ Test Protocols Documented by: Checked by: Approved by:	QA or Validation Manager

		TEM055
		Issue date
	Validation Plan
	(Ref.VAL005)
Document Revision History

Revision #	Date	Reason for Revision	Author Initial for Retrieval of Outdated Documents