Site Acceptance Test (SAT) Checklist Template

Agree what the site acceptance test will prove, and how, well before the vendor’s engineers arrive. The protocol often starts from the FAT protocol: the tests to repeat after transport, the tests that can only be run on site, and the FAT punch items to close here. The protocol is approved last, once the FAT review, the deviation categories and, on a GMP site, quality’s needs are settled. Every due date counts from the first day of the SAT on site.

• Record the equipment, the SAT start date and the people — the equipment and its tag or serial numbers, the purchase order and the vendor, where it is installed, the first day of the SAT on site, whether a FAT was held, whether it connects to other equipment or systems, and the four people this checklist assigns
• Confirm what the contract says about the SAT — who runs and pays for the SAT, the vendor’s people and days on site, what site acceptance triggers under the contract (a payment, the start of the warranty, the transfer of risk), any retention, and the time allowed to close punch items
• Review the FAT report and the results the SAT relies on — the signed FAT report, its outcome, the tests passed at the vendor’s works that the protocol does not repeat, and any condition the FAT sign-off set for the site
• Carry the open FAT punch items into the SAT — each item left open at the FAT, its category and owner, and whether it is to be closed before the SAT, during it or after acceptance
• Add the factory checks to the SAT protocol — with no FAT, the documents, the inspection against the drawings, the I/O and alarm checks and the functional tests are done on site for the first time, so the protocol and the schedule allow for them
• Agree the deviation categories and who can accept them — how a deviation found at the SAT is graded (for example, must be fixed before acceptance, can be closed after acceptance by an agreed date, or an observation), and who on each side can accept a deviation or a concession
• Agree with quality which SAT results qualification will rely on — the SAT tests that installation and operational qualification will rely on rather than repeat, quality’s review of the protocol, and the documentation rules the vendor’s and your testers follow
• Agree the SAT protocol and acceptance criteria — every test with its method, the expected result, the acceptance criterion and who witnesses it, the FAT tests to repeat after transport and installation, the tests that can only be run on site, and approval by both sides before the SAT starts

A site that is not ready loses SAT days: utilities not connected, test materials missing, instruments out of date or the vendor’s team not inducted. Check each one before the vendor’s engineers travel.

• Confirm the equipment arrived complete and undamaged — every crate and loose item against the packing list, any transport damage photographed and reported to the vendor and the carrier, and the equipment stored or installed as the vendor’s instructions say
• Agree the SAT schedule and who attends — the order of the tests day by day, the vendor’s engineers and your operators, maintenance and quality staff needed, any third-party inspector, and who signs each test record
• Confirm the vendor’s method statement and the software to be tested — the vendor’s method statement and risk assessment for its work on site, its test procedures, and the software version it will load, the same as the one accepted at the FAT or with every change since listed
• Agree the site safety rules and isolation for the vendor’s team — the site induction, the permits the work needs, who may isolate and energise the equipment, how locks and tags are used while tests run, and the emergency arrangements
• Arrange the test materials, product and utilities for the tests — the site’s own raw materials, packaging or product in the quantities the performance run needs, what happens to the output, and the utilities booked for the test days
• Check the test instruments are calibrated — every instrument the protocol uses, such as meters, gauges, scales and data loggers, in date for calibration, with its certificate to hand

Before anything runs, check the equipment is installed as designed and connected to the right utilities. Transport and installation are where damage, loose connections and missing guards appear.

• Check the installation against the drawings — position, levelling and anchoring, access for operation and maintenance, every guard and cover refitted after transport, and the layout against the approved drawings
• Check the utilities connections — electrical supply and earthing, compressed air, water, steam, drainage and extraction connected and measured against what the specification asks for
• Check the cabling, piping and instrument connections — cables, terminations, pipework and instrument connections made and labelled as the drawings show, and every signal checked from the field device to the controller
• Power up and check the equipment starts safely — the equipment energised under the agreed isolation rules, the software version loaded checked against the one agreed, and the equipment starting in a safe state with no unexpected movement

Prove every safety function on site, as installed, then run the equipment’s own functional tests before it is tested with the equipment and systems around it. A safety function that passed at the FAT can fail after transport or when wired into the site.

• Test the emergency stops — every emergency stop stopping the equipment as designed, and a reset not restarting it without a separate start command
• Test the guard interlocks and safety devices — each interlocked guard, light curtain, two-hand control, pressure relief and other safety device doing what the protocol says when tested
• Test the alarms and the response to faults — each alarm in the protocol raised and shown, and the equipment going to a safe state on loss of power, air or a signal, and on a sensor failure
• Check the guarding, access and markings as installed — fixed guards secure, no gaps created by the installation, safe access for operation, cleaning and maintenance, and the warnings and markings fitted
• Run the functional tests in the protocol — each operating mode, start-up and shutdown sequence, format or recipe change, and the operator screens, run and recorded against the protocol

Applies only when the equipment connects to other machines, the line’s controls or site systems. Prove the signals, interlocks and data links work with the real equipment around it, which the FAT could only simulate.

• Test the signals to and from the site’s control system — start, stop, ready and fault signals, recipe or format selection and status reported both ways, as the interface specification says
• Test the interlocks with the equipment upstream and downstream — an emergency stop or fault on this equipment stopping the equipment it should, and theirs stopping this one, with a safe restart
• Test the data links to site systems — counts, alarms, batch or production data and recipes passing correctly to and from the site’s supervisory, production or business systems, under the site’s network and security rules
• Run the line with the new equipment in it — the whole line or system running together at the agreed speed, with hand-offs between machines working and no unexpected stops

Run the equipment as production will, on your own materials, and measure it against the acceptance criteria. This is the test the FAT could not fully run.

• Run the performance test on your own materials — the rate, yield, uptime and other measures in the protocol, run at the agreed speed for the agreed duration on the site’s own materials, and the results recorded
• Check the quality of the output — samples of the output checked against your specification by the people who will check it in production, and the results recorded
• Record the results and grade the deviations — every test result against its criterion, each deviation graded in the categories agreed in Phase 1, and any test that failed

Fix what failed and repeat the test in full, list everything else on one punch list with an owner and a date, and record any deviation accepted without a fix.

• Fix and repeat the failed tests — the cause of each failure found and fixed by the vendor, the whole test repeated and witnessed, and the new result recorded beside the old one
• Build the SAT punch list with owners and dates — every open item from the tests, the installation checks and the FAT, with its category, the owner on each side and the date it will be closed by
• Record any deviation accepted without a fix — each deviation both sides agree to accept as it is, why, any limit it places on use, and who on each side accepted it

Before acceptance, your people are trained, the documents are handed over and both sides agree the SAT report. The acceptance decision is assigned to the project lead alone, and nothing after it can be completed until it is made.

• Train the operators and maintenance staff — operation, cleaning, changeovers, fault finding and routine maintenance, given by the vendor, with who attended recorded
• Collect the as-built documents, manuals and software — as-built drawings, operating and maintenance manuals, the spare parts list, a backup of the software and any licences, test certificates, and the declaration that came with the equipment
• Check the spare parts and maintenance needs — the spare parts delivered against the list, the parts to hold in stores, and the vendor’s maintenance tasks and intervals
• Write the SAT report — the tests run and their results, the deviations and retests, the punch list, any concessions, training and documents, and a recommendation on acceptance
• Agree the SAT report with the vendor — the vendor’s site lead reads the report and the punch list and signs that they agree, or records what they dispute
• Put right what stopped acceptance, then ask for the decision again — after ‘Not accepted’ only: the vendor fixes each point the project lead recorded, the affected tests are repeated and recorded, and the project lead is asked to change the decision and complete the acceptance task; if the SAT is moved, change the date on the first task (and complete the first task again)
• Decide site acceptance and sign the SAT report — the project lead reviews the report, the punch list and the concessions and decides whether the site accepts the equipment

Hand the accepted equipment to the people who will run it, or on a GMP site to qualification, record what acceptance triggers under the contract, and close the remaining punch items.

• Hand the equipment over to production — the operations lead takes responsibility for the equipment, with the operating procedures, the trained operators and the date it goes into production agreed
• Hand the equipment over to qualification — the SAT report, the results qualification relies on, the documents and the punch list passed to the validation team, and the equipment kept out of GMP use until it is qualified and released
• Record what site acceptance triggers under the contract — the acceptance date sent to purchasing and finance, any payment or retention it releases, and the warranty start date the contract gives
• Add the equipment to the maintenance and calibration plans — the equipment and its instruments added to the asset register, the planned maintenance schedule and the calibration programme
• Close the remaining punch items — after ‘Accepted with punch items’ only: each item closed by its owner by the agreed date, checked by the test lead, and the punch list marked complete
• File the SAT records and record lessons — the protocol, test records, punch list, report and decision kept together with the equipment’s records, and lessons for the next FAT and SAT noted