IQ-OQ for Factory Acceptance Tests

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:

The equipment is built in accordance with engineering and vendor specifications.
The equipment operates in compliance with the functional description.
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: