Acceptance Testing &
Documentation to Support Validation
Paul Hallman
CEO
Turnkey Modular Systems Inc.
September 21st, 2015
What supports Validation
For most equipment and systems Factory Acceptance
Testing is the main focus of support used in the
Validation of process equipment or systems.
Acceptance Testing
The question of what USER ACCEPTANCE TESTING (UAT) is,
becomes very important as you reach a state of having
equipment or systems delivered to a facility. The system or
equipment is claimed to be constructed in a manner that
has been defined by a User Requirement, and constructed
or fabricated in a manner that meets the requirements of
the industry and of your company specifically.
You can ill afford to accept a system or piece of equipment
that does not meet these requirements and as such, it is
important and essential to execute a detailed list of
acceptance requirements that will support your corporate
validation effort.
What is Acceptance Testing
• User Acceptance Testing defines precisely and
clearly what the user expects the system to
do. UAT documents contain information about
the operating environment, the required data
for processing, and the functionality that the
system should carry out.
• Completed during a FAT and a SAT
What is the difference between a FAT & a SAT?
Any project that involves equipment being developed from a
third party should have a FAT and SAT incorporated into the
system life-cycle. If both the FAT and SAT are performed
correctly is will lead to a much easier IQ/OQ process.
What is a FAT
• A FAT or Factory Acceptance Test is usually preformed at
the vendor prior to shipping to a client. The vendor tests
the system in accordance with the clients approved test
plans and specifications to show that system is at a point
to be installed and tested on site.
• It’s an essential aspect of the whole system lifecycle and
should be performed by experienced personnel. Time
spent doing a proper FAT will lead to fewer problems
when the equipment is installed.
Summary - It is the partial commissioning and
qualification of equipment and/or systems prior to their
shipment from the fabricator’s site.
Typical Items on a FAT
FAT items to look out for include the following:
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Performed FAT Protocol
Maintenance and User’s manual
Recommended spare parts list
Certificate of compliance
As built technical drawings (electrical, mechanical, pneumatic
& process schemes)
Materials certificates/data sheets
Main equipment data sheets
Instruments calibration certificates
Installation and construction details (Deadlegs, slope etc)
Welding Processes qualification & Records
What is a SAT
• SAT is Site Acceptance Test of a system to ensure
it is tested in accordance to client approved test
plans and specifications & to show the system is
installed properly and interfaces with other
systems and peripherals in its working
environment.
Summary - Inspection and /or dynamic testing of the
systems or major system components to support the
qualification of an equipment system conducted and
documented at the manufacturing site.
Typical items on a SAT
Below is a list of some items to be considered on a SAT:
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Finishing Visual check
Main components visual check
Utilities functionality and setting checks
Functionality/Interlocks Verification (Mechanical & Software)
Safety devices and interlocks check
Operator’s training
How to write a FAT Protocol
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Define the Purpose of the FAT so as to ensure that the equipment is designed per
the specs and to check the basic performance of the equipment
Scope of the FAT Protocol
Procedures
1. To check the equipment operation
2. To define the action to be taken when deviations take place
3. To define a list of documents to be checked
Documentation – Write a list of documentation to be done during FAT
Acceptance Criteria – Equipment and Accessories should be according to the PO
and the equipment should be per the pre-designed parameters
Verification Sheets – include Make, Model, Capacity, Design, Controls, PLC,
Instruments, Safety Features, Documents
Observed Deviations – Write the deviations observed during the FAT and list the
corrective action and whether is it acceptable or now
Conclusion – Conclude the overall FAT results and if it passed or failed
Approval – Include signatures, departments and dates
FAT – Therapure LAI Project
3D Modular Design
3 D Modular Design
3D Modular Design
3D Modular Design
3D Modular Design
3D Modular Design
Factory Pictures
Factory Pictures
Factory Pictures
Factory Pictures
FAT
PROTOCOL
EXAMPLES
FAT COMPLETED
DOCUMENT
EXAMPLE
OTHER DOCUMENTS AND
SUPPORT DETAILS IN A
TURNOVER PACKAGE
Welding Procedure
Welder / Operator Identification Card
Inspector Compliance Certificate
Calibration Record
TSSA Application
Typical Spool Drawing and Map
Visual Inspection Sheet
Process Piping Weld Etching
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Spool #
Welder ID / Weld #
Date of Weld
Heat # of Component Weld Joint
Typical Documentation
For Further Information:
Contact:
Paul Hallman
Turnkey Modular Systems Inc.
8-4090 Ridgeway Drive,
Mississauga, Ontario, Canada
L4L 5X5
Mobile: 519-851-8006
Office: 905-608-8006 Ext 228
Fax: 905-608-8007
E-mail: phallman@tkmodular.com