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TEM-030 Example Operational Qualification Report Sample

This 3-page operational qualification report summarizes testing of equipment for a project. It includes sections on the process description, objective of testing to specifications, instrumentation calibration, test functions and results, additional validation requirements, and an overall conclusion. Department managers must approve the report before the equipment can be used for production.

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Sameh Mostafa
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703 views1 page

TEM-030 Example Operational Qualification Report Sample

This 3-page operational qualification report summarizes testing of equipment for a project. It includes sections on the process description, objective of testing to specifications, instrumentation calibration, test functions and results, additional validation requirements, and an overall conclusion. Department managers must approve the report before the equipment can be used for production.

Uploaded by

Sameh Mostafa
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd

TEM-030

Issue date
Operational Qualification Report
(Ref.VAL-005)

Operational Qualification Report


(Ref.VAL-005)

Project Name Project Number


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

Table of Content

PROCESS DESCRIPTION ...........................................................................................................................1


OBJECTIVE .................................................................................................................................................1
INSTRUMENTATION/CALIBRATION ..........................................................................................................2
TEST FUNCTIONS PERFORMED IN THE OPERATIONAL QUALIFICATION PHASE AND OVERALL RESULTS
OBTAINED:..................................................................................................................................................2
ADDITIONAL VALIDATION REQUIREMENTS ............................................................................................2
OVERALL CONCLUSION............................................................................................................................3
PERFORMANCE QUALIFICATION PROGRAM ..........................................................................................3

Approval Of The Completed Operational Qualification Report

Department Name Signature Date


Project Co-ordinator
Validation Manager
Quality Assurance Manager
Operations Manager
Production Manager

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

Process Description
(Describe the process which is due to Operational Qualification)

Objective
The objective of the Operations Qualification is to perform a series of tests to determine that the operation
of the equipment/process conforms to the specifications.
The tests conducted are outlined in Part 4. of this report. Each individual test function listed has the
acceptance criteria specified.

File Location: Date Printed: Page 1 of 3

TEM-030 Issue date Operational Qualification Report (Ref.VAL-005) File Location:

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