Installation Qualification
Protocol
.BECKMAN
COULTER,.
Installation Qualification
Protocol
144867 AD
November 2000
Beckman Coulter, Inc.
Bioresearch System Development Center
4300 N. Harbor Blvd., Fullerton, CA 92834
© Copyright 2000 Printed in U.S.A.
Installation Qualification Protocol
144867AD
INTRODUCTION 3 of 8
RELATED DOCUMENTS 3 of 8
I. Order Verification 3 of 8
II. System Documentation 3 of 8
III. Site Installation Requirements 3 of 8
IV. Instrument Installation 4 of 8
V. Firmware and Software 4 of 8
VI. Scheduled Maintenance 4 of 8
VII. Safety Information 4 of 8
VIII. Closing the Installation Qualification Process 5 of 8
INSTALLATION QUALIFICATION PROTOCOL DATA SHEET 7 of 8
Installation Qualification Protocol
144867AD
Installation Qualification Protocol
INTRODUCTION
Installation Qualification (IQ) involves formal checks to confirm that the instrument,
its modules and accessories have been supplied as ordered and that the instrument is
properly installed in the specified environment.
The following outlines the steps required to complete a general installation
qualification for Beckman instrumentation. The steps shall be followed as written
with the results recorded on the Installation Qualification Protocol Data Sheet (IQ
worksheet). All supplemental data, including corrective actions, should be attached to
the Installation Qualification Protocol Data Sheet.
RELATED DOCUMENTS:
The Development and Application of Guidance on Equipment Qualification of
Analytical Instruments. Peter Bedson and Mike Sargent. Journal of Accreditation
and Quality Assurance (1996) 1:265-274.
I. Order Verification
1. Obtain the purchase order or shipping document. Record the document number(s)
on the Data Sheet.
2. Verify that all ordered components were received and are undamaged. If all
components were received in satisfactory condition, record a PASS result for
Order Verification on the Data Sheet.
3. If components are missing or damaged report missing items to sales office for
replacement.
II. System Documentation
1. Record all documentation supplied with the instrument, including the part number
and revision number. This includes any Pre-Installation Instructions, and
Reference, Installation, Operation, or Training documentation.
III. Site Installation Requirements
1. Verify that space, environment, and utility requirements are met as according to the
installation requirements in the Preinstallation Instructions or Installation Manual.
Record a PASS results if specified conditions are met. If all of the conditions are
not met, take corrective action before proceeding.
Installation Qualification Protocol
144867AD
1. Unpack the instrument(s).
2. Open the ship kit(s) and verify the contents for completeness. Record a PASS
results if kits are complete. If parts are missing, report to the sales office for
replacement.
3. Move the instrument(s) to the specified location.
4. Verify fuse setting for voltage provided and install the power cord(s).
5. Connect the instrument(s) as specified in the Installation documentation.
6. Turn the power on. Verify that all instruments, modules and accessories respond to
initial power on properly including passing all power on self -tests (POST).
Record a PASS result for successful power on. If the instrument(s) fails on power
on, turn off the power and restart the instrument. If the instrument fails power on,
notify the customer, then implement corrective action. Attach all notes and
documentation for corrective action to the Data Sheet. If the instrument still fails
on power on, terminate the IQ process and notify the Technical Specialist.
1. Record the instrument, modules, and accessories firmware versions on the IQ Data
Sheet
2. Record the system software version on the IQ Data Sheet, if computer software is
supplied.
3. Record the installed instruments, modules, and accessories and their serial
numbers on the IQ Data Sheet.
4. Record the control PC model, serial number and description on the IQ Data Sheet,
if a computer is supplied.
Refer to the supplied user documentation:
1. Record recommended maintenance intervals
2. Outline contact points for emergency service and Preventative Maintenance
scheduling. Note this information on the IQ Data Sheet.
VII. Safety Information
Refer to the supplied user documentation for safety information and record its location
on the IQ Data Sheet.
Installation Qualification Protocol
144867AD
VIII. Closing the Installation Qualification Process
After completing the Installation Qualification Protocol, complete all entries on the
Installation Qualification Protocol Data Sheet. Provide to the person responsible for
the instrument records:
1. Completed and signed Installation Qualification Protocol document including the
Data Sheet.
2. Field Service Report (FSR) containing the statement, "Instrument Passed
Installation Qualification."
Obtain copies of the Installation Qualification Protocol document and FSR for
retention. Proceed with Operation Qualification as required.
Installation Qualification Protocol
144867AD
Installation Qualification Protocol
144867AD
INSTALLATION QUALIFICATION DATA SHEET
Use N/A (Not Applicable) for entry blanks that do not apply.
COMMENTS!
INITIAL &
DESCRIPTION PASSIFAIL CORRECTIVE
DATE
ACTIONS
I. Order Verification
• Purchase Order # Pass / Fail
• BCI Document #
II. System Documentation (List titles, Part Number, and
Revision)
N/A
III. Site Installation Requirements Pass / Fail
• Space Pass / Fail
• Environment Pass / Fail
• Utilities
IV. Instrument Installation Pass / Fail
• Verify the ship kit contents Pass / Fail
• Verify voltage setting and fuses Pass / Fail
• Verify Instrument Power-up Self Test sequence
V. Firmware and Software (List model, serial number,
and firmware version)
• Instrument
• Module
• Module
• Module
• Module N/A
• Module
• Accessory
• Accessory
• Accessory
• Accessory
• Computer
• Computer Accessory
VI. Scheduled Maintenance
• Recommended Service Maintenance Interval: --
per year N/A
• BCI Contact Information:
Name:
Telephone Number:
VII. Safety Information N/A
• List location of documentation
Engineer Name & Signature:
Approval Name(s) & Signature(s):
1. Date: _
2. Date: _
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.BECKMAN
COULrER,.
Beckman Coulter, Inc.
Fullerton, CA 92834-3100
