Production Line Start-Up & First-Off Approval Checklist

Enter the time the start-up begins first: every task falls due a set time after it. The start type and the product rules on the first task add the tasks this start needs.

• Record the line, the job and who runs the start-up — the line, the job or work order, the product and the last product run, the start type, the product rules, the time the start-up begins, and who sets up, checks and releases the line
• Read the handover and the line’s open issues — open faults, quality holds, permits and isolations on the line, and anything the last shift left unfinished
• Get the job pack at the right revision — the work order, the set-up sheet or recipe, the product specification and the first-off acceptance criteria, each at its current approved revision
• Get the maintenance hand-back after the stop — the work done during the stop or shutdown finished, its work orders closed or handed back, tools and parts removed from the machine, and maintenance’s own isolations removed by the people who applied them
• Brief the line team on the start-up — who does what, the safety points, what changes from the last job and what quality will check at the first-off

Clear the line of everything from the last job before anything for the new job arrives: product, part-finished work, labels, packaging and paperwork. A second person checks the cleared line.

• Stop the line and make it safe to clear — the line stopped and, where anyone reaches into a machine or removes a guard, isolated under the site’s lockout/tagout procedure
• Check the line’s last clearance record — the record from the end of the last run shows the line was left clear and clean; if it does not, clear the line in full now
• Remove the last product and part-finished work — finished product, part-finished work, rejects and samples taken off the line, counted, and returned, quarantined or scrapped as the site’s procedure says
• Deal with product held on the line during the stop — product left in machines, ovens, hoppers or on conveyors during the stop assessed against its time and condition limits, then scrapped or quarantined for quality’s decision
• Remove the last job’s labels, packaging and printed materials — labels, cartons, film, leaflets and printing plates taken off the line, with batch-coded materials destroyed or reconciled by the site’s procedure
• Remove the last job’s documents from the line — the last job’s set-up sheet, work order, records and samples taken away, so only the new job’s documents stay at the line
• Clean down for the product change — the line cleaned to the level the site’s changeover cleaning plan sets for this change of product, size, colour, flavour or allergen
• Verify the allergen clean-down — a visual check, and any test your allergen plan sets, showing the line is free of the last product’s allergens before the new product touches it
• Inspect the cleared line and sign the clearance — a second person walks the line, machines, printers, bins, floor and surrounding area and confirms nothing from the last job is left

Fit the new job’s change parts while the line is still isolated, put every guard back, then restore energy and test the safety systems before anyone runs the line.

• Change the format parts and tooling for the new job — the change parts, tooling, dies or nozzles the new job’s set-up sheet lists, fitted and checked, with the parts taken off cleaned and stored
• Check every guard is fitted and closed — fixed guards back on with their fasteners, interlocked guards closed, and no guard or protection device bypassed, wedged or disabled
• Remove the isolation and restore energy — everyone clear of the machines, each lock and tag removed by the person who applied it, and energy restored by the site’s procedure
• Check the utilities to the line — power, compressed air, water, steam, vacuum or gas at the pressures, temperatures or levels the set-up sheet gives
• Test the interlocks and emergency stops — each interlocked guard stops the machine when opened, each emergency stop stops the line and needs a reset, and light curtains and other protective devices work

Bring the new job’s materials to the line only after the clearance is signed, and check each one is the right item, revision and status.

• Issue the materials for the new job — raw materials, components, ingredients and packaging issued against the bill of materials or recipe, with their lot numbers and quantities
• Check each material is the right item, revision and status — item number, revision or recipe version and supplier lot against the job pack, and each lot released for use rather than on hold or in quarantine
• Check the labels, packaging and printed codes for the new job — the label and artwork version, cartons and film for the new product, and the batch codes and dates the line will print, against the job pack
• Record the packaging and labelling materials in the batch record — each item examined for suitability and correctness and recorded, with the quantities issued so they can be reconciled at the end of the run
• Display the new job at the line — the product name and batch or job number shown at each station, and the new job’s documents at the line

Set the line from the set-up sheet, not from memory or the last job, and have a second person check the settings that matter.

• Set the line to the set-up sheet — every setting the set-up sheet gives (speeds, temperatures, pressures, times, weights, recipe) entered and recorded
• Check the critical settings against the set-up sheet — a second person checks each critical setting against the current set-up sheet and records any difference
• Test the detectors, checkweighers and code readers — metal detectors, checkweighers, vision systems, code readers and label counters tested with the site’s test pieces, and rejects seen to reject
• Confirm the line is ready for a first-off — the clearance signed, guards and safety systems tested, materials checked and settings set, so the line can run for its first-off samples

Run the line, take the first-off samples and hold everything made until quality has checked them against the acceptance criteria. A failed first-off adds the steps to contain, adjust and check again.

• Run the line and take the first-off samples — the line run at the set-up settings and the first-off samples taken as the job pack says (how many and from where), labelled and kept apart, with everything made held until release
• Check the first-off against the acceptance criteria — each characteristic in the acceptance criteria checked or measured (dimensions, weight, appearance, function, seal, label and codes) and the result recorded
• Stop and contain what was made before the failed first-off — the line stopped, and everything made since the start-up held, counted and labelled so none goes on until quality decides
• Find the cause and adjust the line — the cause of the failure found and recorded, the line adjusted, and the set-up sheet corrected through document control if it was wrong
• Take and check a new first-off — new first-off samples taken after the adjustment and checked by quality against the same acceptance criteria
• Keep a retained first-off sample — one sample from the first-off that passed (the re-check, if the first one failed), labelled with the job, date and time and kept where the line can compare against it during the run

Production and quality both sign before the run starts. Nothing after the quality release can be completed until it is given, and a line whose first-off has not passed is never released.

• Production signs the start-up ready for release — the line supervisor confirms the clearance, safety checks, materials and settings are complete and the line is ready to run
• Hold the line and fix what stopped the release — the line held, the reasons quality gave put right, and a new first-off checked if the product was the problem
• Quality releases the line for production — the quality approver checks the first-off has passed and production has signed, then releases the line or holds it

Applies only when the line is released. Watch the first hour closely: deal with the product held during the start-up, check the running line and raise anything that went wrong.

• Decide on the product held during the start-up — product made before the release released, reworked or scrapped as quality decides, and the quantities recorded
• Meet the release conditions — each condition the quality approver set on the release done, and how it was met recorded
• Check the labels and codes on the running line — labels, batch codes and dates correct and readable at running speed, checked on packs taken from the line
• Do the first in-process checks — the in-process checks the control plan sets for this product, at its frequency, from the first hour onwards
• Run to rate and log the first hour — output, speed, stoppages and rejects in the first hour of the run, against the rate the job is planned for
• Raise anything that went wrong at start-up — problems, set-up sheet errors and ideas to shorten the next start-up logged as actions with an owner

Correct the set-up sheet if it needed changing, record how long the start-up took and file the record with the job.

• Update the set-up sheet if it needed changes — any setting or step that had to change sent through the site’s document control, so the next start-up uses the corrected sheet
• Record the start-up time and losses — the time from the start of the start-up to the release, and the scrap and samples it used
• File the start-up record with the job — the clearance, checks, first-off results and release kept with the batch or job record
• Hand the running line over to the shift — the running line, the retained sample, open actions and anything to watch handed to whoever runs the shift