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IQ-OQ for Factory Acceptance Tests - Template

Contents

1. Document history 
1.1. Glossary 
1.2. Qualification team identification 

2. Introduction 

2.1. Scope 
2.2. Test instruction 

3. Installation qualification tests 

3.1. Documentation verification 
3.2. Safety devices 
3.3. Media supply 
3.4. Software 
3.5. Material and roughness checks 
3.6. Additional checks 
3.7. Comments for Installation qualification tests

4. Operation qualification tests 
4.1. Safety functions 
4.2. Modes of operation 
4.3. Production requirement 
4.4. Alarms 
4.5. Additional operations and functions checks 
4.6. Comments for Operation qualification tests 

5. List of appendices 

5.1. Appendix 1 – Equipment list 
5.2. Appendix 2 – Test material list 
5.3. Appendix 3 – Attachment list 
5.4. Appendix 4 – Deficiency list 

1.   Document History
 

Revision

Date

Compilation

Changes

 

 

 

 


1.1  Glossary

CPL:     Change part list
EBR:    Electronic Batch Record
EC:       European conformity declaration
FAT:     Factory acceptance test
FS:       Functional specification
FSC:     Function specification and configuration document
GUI:     Graphical User Interface
HDS:    Hardware design specification
HMI:     Human-machine interface
IQ:        Installation qualification
MPO:   Maintenance Plan Overview
OQ:      Operational qualification
PCP:    Parts in contact with product

Recipe Inspection setting
SAT:     Site acceptance test
SDS:    Software design specification
SVS:     Software version specification
URS:    User requirement specification
WPL:    Wear part list


1.2  Qualification Team Identification


2.   Introduction

2.1  Scope
  • This document includes acceptance tests to check critical devices and functions of the machine. The acceptance tests are to assure that:
  1. The equipment is built in accordance with engineering and vendor specifications.
  2. The equipment operates in compliance with the functional description.
  3. The documentation complies to the “as-built” status.

2.2  Test instruction
  • Before starting ensure all required documents for verification are available.
  • If tests require verification of documents: this must be marked on the approved document and this marked document must be attached to the completed test protocol.
  • Execution of the test must be witnessed by Customer’s representative.
  • Executioner and witness signs at completion of each test section.
  • Record any deficiency found in the Deficiency list.


3. Installation Qualification Tests

The Installation qualification tests are grouped in the following chapters:

3.1  Document Verification



3.2  Safety Devices



3.3  Media Supply



3.4  Software


3.5  Material & Roughness Checks



3.6  Additional Checks




3.7  Comments for Installation Qualifications Tests



4. Operational Qualification Tests

The Operation qualification tests are grouped in the following chapters:


4.1  Safety Functions



4.2  Mode of Operations

4.3  Production Requirements



4.4  Alarms



4.5  Additional Operations and Functions Checks



4.6  Comments for Operational Qualifications Tests

5. List of Appendices

5.1   Appendix 1 – Equipment list

5.2   Appendix 2 – Test material list

5.3   Appendix 3 – Attachment list

5.4   Appendix 4 – Deficiency list

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