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Protecting Your Investment:
Creating an Effective FAT/SAT/BAT
Procedure
October 21st, 2009
Presented in conjunction with the
Laboratory Robotics Interest Group
New England
Open Source Software Initiative
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Agenda
Introduction
Types of Laboratory Automation Systems
Creating a Project Plan
Factory Acceptance Testing
Site Acceptance Testing
Biological / Chemical Acceptance Testing
Lessons Learned
Summary
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Some Definitions
FAT- Factory Acceptance Testing
SAT- Site Acceptance Testing
BAT- Biological Acceptance Testing
CAT- Chemical Acceptance Testing
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Introduction
Purchasing Laboratory Automation is an investment
What are you buying (workstation or integrated system?)
Adding a new capability or enabling technology?
Not always about efficiency
Properly plan for success
Define your project goals and criteria for success before
engaging any vendor
Design a Test Plan which uses the actual workflow(s) Test the new capability successfully adds value
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Getting Started
Map your process
Build a Project Charter Why automate?
Added value?, Criteria for success?
What can kill the project?
Setup a Project Team and Determine Stakeholders Include an Automation Lead/ Project Manager, Scientific Lead, &
Purchasing Representative
A Facility Lead and Software Lead may be necessary dependingon the complexity of the system
Add Reagent Incubate Add Reagent Read
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Getting Started (II)
Capture User Requirements Specification (URS)
Use requirements to define an objective Request for
Proposal (RFP) process
Select a vendor which..
Is willing to work with you to properly test the system
Is willing to tie milestone payments to project phases
URS RFP Vendor
Selected
Contract
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Workstations
Workstations are standalone pieces of equipment
integrated with a small # of peripheral devices
Typically stacker based and designed for a specific
workflow
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Integrated Systems
Integrated Systems vary in complexity and usuallyinclude 1 or more robotic arms and a number of
peripheral devices
Typically support a number of different workflows and
are controlled with a scheduler package
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Integrated Systems Continued
Integrated systems can be designed to serve a
number of processes
Historically integrated systems have been builtto support:
High Throughput Screening (HTS)
Ultra High Throughput Screening (uHTS)
Compound Storage and Replication
Combinatorial Chemistry
Cell Culture
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Project Plan
In general, the project plan is similar in all cases
and should include:
project goals
the process map(s) Schedule and milestones
Resource plan
Payment terms
Reference to test plan documents (ATPs)
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Project Plan Continued
Consider breaking project into separate milestones with paymentpercentages tied to the completion of these milestones
Ensure that there is a written and clear understanding withvendor for what acceptance testing will be required
Recommend leaving a percentage of total project payment as afinal milestone payment
Identify a clear procedure for change management
Consider applying payment penalties for
Missing key deadlines
Not satisfying system / design requirements
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Example Project Plan Timeline
PO
Accepted
Define
System
Specifications
Build and Test Ship and Install
Kickoff
Meeting
Agreement on
Acceptance
Testing
Define Functional
Design Spec
Define
Assay/Consumables/
Factory
Acceptance
Test
Site Acceptance
Test
Bio/Chem
Acceptance
Test
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Acceptance Test Plan (ATP)
Draft a formal document (ATP) for testing procedures foreach test phase (FAT / SAT / BAT)
ATP should include language which Outlines requirements for testing procedures
Outlines Testing Scripts
Defines criteria for success / failure
Defines when / what / if interventions are acceptable
Roles & responsibilities and more
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Example Assay
Labware
Source Plate/Assay Plate
Stated Protocol Dispense 10l BufferA
Dispense 10l BufferB
Incubate 60 min at Room Temperature
Wash
Read
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Additional Assay Information
Unstated Protocol
Read Barcodes from Source and Assay Plate
Shake for 1min after 2nddispense
Seal plate with clear heat seal before reading Use Barcode for name of resulting reader file
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Acceptance Test Plan (ATP) (II)
Any contract language regarding payment structure,penalties etc. should be in the purchase agreement andnot in the ATP
The ATP can reference milestone payments
Between the Project Plan and/or Purchase Agreement,all parties should have a clear understanding of financial
responsibilities
Request that the FAT and SAT be performed on a wetsystem
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Acceptance Test Plan (ATP) (III)
The ATP document should be finalized and agreed upon
well in advance of the actual FAT
allows the vendor to run through the FAT testing (pre-FAT)
Vendor is responsible for unit testing of Custom and
Standard devices prior to FAT
The Actual FAT should not occur until the vendor has
confirmed that they have gone through and tested the
FAT process (pre-FAT )
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FAT: Workstations and Integrated Systems
FAT will test the purchased equipment using your
materials and protocols at the vendors site
FAT should use all of the equipment on the system Should not be limited to 1 giant all encompassing test
should entail the primary task(s) for which the system was
purchased
FAT should not execute an experiment or protocol whichwill not be used in actual lab
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Workstation FAT
Not all vendors will agree to complete a FAT for a workstationpurchase
Insist upon executing a FAT for any system with customization
If the vendor is unwilling to include a successful FAT as criteria forpayment, offer to pay for application labor to execute the FAT
FAT should include: module level testing
error recovery testing
testing of new interfaces and any data handling that the system willgenerate
safety requirement testing
QC testing
Not all vendors will agree to QC testing, however most will providean exception in the event it does not work in the SAT or BAT
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Integrated System FAT
All modules should be tested If any of the modules will be run in standalone mode confirm that
they will operate in that mode
Module level and system level error recovery should be tested
QC and Safety testing are required
1 sample should be run from start to end so the entireprocess can be monitored, before running multiplesamples
If appropriate, test throughput matches requirements
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Integrated System FAT (II)
Run the most complex process using the maximumexpected run size (regardless of run duration)
Information System testing should be done as part of
FAT
Always check the error recovery option
Review System documentation Confirm the most current layout is provide
Manuals should be provide for standard and custom equipment
Cable layout a bonus, in particular when labeled.
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Navigating through FAT defects
System requirements will define when interventions areacceptable. For example: Day time run semi-automated systemInterventions Acceptable
Fully automated system which runs overnightInterventions NotAcceptable
When FAT runs require interventions refer to the ATP
acceptable to proceed without starting over?
The # of successful continuous days of running shouldbe defined in advance and required for the system topass the FAT
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Navigating through FAT defects (II)
Any exceptions / defects should be documented and
witnessed by both the vendor and customer
Only accept defects to be fixed later when you are
confident they will be resolved easily
It is typically riskier, more expensive and time consuming
to fix problems on the customers site compared to the
vendors site
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Examples of Exception
A non-recoverable error
Communication Errors between hardware and
controlling software
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SAT
SAT should replicate the FAT testing procedures
SAT confirms that the system was not impacted by transport andinstalled successfully in the customer lab
Both customer and vendor representatives should be present for all
SAT testing
Repeat testing for any exceptions that occurred during the FAT confirms defects have been corrected to the customers satisfaction
Document and witness any preexisting or new exceptions that occurduring the SAT
Only accept SAT when all critical system exceptions have beenrectified and re-tested
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To BAT or not to BAT?
A Biological Acceptance Test or Chemical Acceptance Test is a finaltesting phase which
Uses actual experiment materials
Confirms the actual experiment / process can be executed successfullyusing the system
Vendors rarely agree to execute BAT tied to a payment milestone
Numerous variables outside of their control
External factors can impact experiment performance
Include as requirement within RFP
BAT should be applied when
Purchasing a large / complex integrated system
Experiment or process can be repeated manually with good precision
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BAT
Set expectations for BAT before signing the purchase
agreement / contract
A successful BAT will show that the automation does not
negatively impact experiment / process results
Precision and accuracy of data should be equal to or better than
running the experiment manually
Apply financial recourse for un-successful BAT Final milestone
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Lessons Learned
Avoid scheduling major milestone at the end of a
quarter or end of the year.
Time constraints may influence the acceptance of the
FAT/SAT/BAT/CAT testing Financial constraints from users companies
Negotiate service contract quote and associated
services (parts and labor) before contract signoff
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Summary
Understand the process you wish to automate and the
instrumentation you decided to purchase to complete the
task
A FAT, SAT and BAT should be performed on any
integrated system. For workstation a SAT and BAT
should be performed
Work with your team to protect your investment. It may
not be your money but your name is associated with the
purchase
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Acknowledgments
Ted Manley
William Goode
John Davies
Brian Duffy
Matt OBrien
Josh Martin
Agilent/Velocity 11
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Backup Slides
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Resources
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Example Project Plan