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Line clearance checklist

Line clearance is the check, at every batch or product change, that nothing from the last run is left on a packaging or filling line. No product, components, labels, cartons, leaflets or paperwork stay behind, and the coder is set to the new batch. It exists to stop mix-ups, the wrong label or leaflet ending up on the next product. This line clearance checklist has 28 checks in six sections: area, equipment, materials and components, printed materials, documents, and coder, vision and check settings. The operator clears each check and initials it, and a second person, usually from quality, verifies it. Before anyone signs, the printed materials are reconciled: issued equals used plus damaged plus returned, within your preset limit. The worked example shows a reconciliation that does not balance and what happens next. The checklist follows the structure of 21 CFR 211.130, EU GMP chapter 5 and the start-up checks in ISO 22716, named, not quoted, and works for pharma packaging, cosmetics filling, food label and allergen changeovers and print converting. Adapt it to your line and approve it under your own document control; the signed clearance belongs in your batch record.

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Page 1 of the line clearance checklistLine, batch and sign-off fields, then checks for the area, equipment and materials, each with cleared, initials, verified and comment columns.
28 checks in six sectionsCleared and verified columnsTwo-person sign-offPrinted materials reconciliationExcel flags differences over your limitCoder and vision challengesVariants for four industriesWorked example that does not balancePDF, Excel and Word
Filled-in Line clearance checklist: a label count that does not balance at first
The same sheet filled in with the worked example (page 4 of the PDF, illustrative numbers). Open full size (opens the picture in a new tab)

When to use it

When to use a line clearance checklist

  • At every batch, lot or product change on a packaging, filling or labeling line, before the first unit of the new batch.
  • When a line restarts after maintenance, a breakdown or a long stop, if anything from the last run could still be on it.
  • After a mix-up or a near miss, to rewrite the clearance so it names the spots where leftovers were found.
  • To train new operators and verifiers: the checks name the hiding places that are easy to miss.

How to fill it in

  1. 1

    Finish the last batch's counts

    Stop the line at the end of the batch and count units made, rejects and samples, and every printed material issued, used, damaged and returned.

  2. 2

    Clear section by section

    The operator works through the six sections and initials each check. N/A only where a check cannot apply to this line, never because there was no time.

  3. 3

    Reconcile before anyone signs

    Issued minus used, damaged and returned should be zero, or inside your preset limit. Outside it, stop: search the line, recount, and raise it with quality.

  4. 4

    Verify with a second person

    A second person walks the line and initials each check in the Verified column. They look for themselves: under the conveyor, in the reject bins, behind the peel plate.

  5. 5

    Set and challenge the coder and vision

    Set lot, expiry and codes for the new batch, check the first printed sample against the batch record, and run the challenge pieces through the vision system and check weigher.

  6. 6

    Sign and release

    Both people sign, the release time goes on the batch record, and the first unit runs. The signed clearance is filed with the batch record.

On the floor

Who does what at a batch change

Two people, in this order. The line does not start until both have signed, and a count outside the limit stops it.

  1. 1Operator

    Stop and count

    End the batch; count units, rejects, samples and every printed material.
  2. 2Operator

    Clear the line

    Section by section, initialling each check in the Cleared column.
  3. 3DecisionOperator

    Within the limit?

    Yes:
    on to verification
    No:
    stop, search, recount, tell quality
  4. 4Quality

    Verify

    A second person walks the line and initials the Verified column.
  5. 5Both

    Challenge and sign

    Coder, vision and check weigher challenged; both sign; start time on the batch record.

One checklist, four kinds of line

What changes in pharma, cosmetics, food and print

The six sections stay the same. What each industry adds or stresses:

  • Pharma packaging (blister, bottle, carton)

    What changes
    Every printed component and every unit counted and reconciled; QA verifies; the signed clearance goes in the batch record (21 CFR 211.130(e)).
  • Cosmetics filling and packing

    What changes
    Bulk, caps, tubes and labels of the last SKU removed; coder set to the new batch; start-up check recorded as ISO 22716 section 7 expects.
  • Food label and allergen changeover

    What changes
    The old labels and any allergen-bearing product or packaging removed, the line cleaned to the allergen standard, the new label checked against the product.
  • Print and converting

    What changes
    Old plates, sleeves, rolls and printed waste removed; the first good print signed off against the approved artwork before the run.

The 28 checks

What to clear and verify, section by section

Six sections. On the sheet the operator circles Yes, No or N/A for each check and initials it, and a second person verifies it. A No stops the release until it is put right and checked again.

Area

The floor, the bins and the space around the line

  1. 1The floor, under and behind the line, and the space around it hold nothing from the last batch: no units, packs, components or labels. Look under conveyors, behind guards and at the reject chutes.
  2. 2Reject bins, waste bins and sample trays are empty and the waste bags are gone. Include the vision reject bin and the check weigher reject bin.
  3. 3The line's status board says it is cleared and waiting for verification, and no other product's paperwork is at the line.
  4. 4Lines nearby running other products are kept apart by screens or distance, as your procedure says.
  5. 5Where the change calls for cleaning, the cleaning is done and recorded, with times and signatures.

Equipment

Every machine on the line, inside and out

  1. 6Hoppers, feeders, bowls, tracks and star wheels are empty, including the corners and pockets where units lodge.
  2. 7Change parts and tooling for the last product are off the line and stored; the parts for the new product are fitted and identified.
  3. 8Guards and covers your procedure lists were opened, the inside checked, and then closed.
  4. 9Label rolls, ribbons, printed rejects and backing paper from the last batch are out of the labeler, the printer and their waste path.
  5. 10Equipment status labels show clean and the new product, and the equipment log entry is made.

Materials and components

Bulk, containers, closures and partial packs

  1. 11All bulk, part-made and finished units of the last batch are off the line, counted, and returned or destroyed as recorded.
  2. 12Containers, closures, foil and other components from the last batch are back in the warehouse with a label showing item, lot and quantity.
  3. 13Partly used rolls or boxes are labeled with item, lot and quantity before they leave the line.
  4. 14Materials staged for the new batch have the right item codes and lots, are released, and match the batch record.

Printed materials

Labels, cartons, leaflets and printed foil

  1. 15Every label, carton, leaflet and printed foil from the last batch is off the line, out of the machine magazines and off the floor.
  2. 16Printed materials are reconciled: issued equals used plus damaged plus returned, within your preset limit. A result outside the limit stops the start until it is investigated.
  3. 17Excess printed material that carries the last lot number is destroyed, and the destruction is recorded.
  4. 18Returned labels and cartons are bundled, identified and stored apart, so they cannot be mixed up.
  5. 19Printed materials issued for the new batch are checked against the batch record for item code, version and quantity.

Documents

What is at the line, and what is finished

  1. 20The last batch's batch record, forms and work orders are off the line.
  2. 21The last batch's counts, rejects and reconciliation are recorded and signed before the next batch starts.
  3. 22Any deviation from the last batch is raised, and its status is known before the line is released.
  4. 23The new batch record and the current instructions are at the line, at the right version.

Coder, vision and check settings

Set to the new batch, then challenged

  1. 24The lot number, expiry date and any serial or 2D code are set to the new batch and checked on the first printed sample against the batch record.
  2. 25First printed samples are attached to the batch record or recorded in it, signed by both people.
  3. 26The vision system and code reader run the new product's recipe, and challenge pieces (wrong, missing or unreadable code) are rejected.
  4. 27The check weigher's target and limits are set for the new product, and the test weights are rejected as expected.
  5. 28The label or barcode sensor reads the new item code, and a wrong-code challenge piece is rejected.

A filled-in example

Illustrative, not a benchmark

An example: the label reconciliation on a made-up OTC tablet bottling line at the end of batch B-2291, before changing over to B-2292 (illustrative, the same as the Excel example sheet and page 4 of the PDF). The plant's preset limit is 0.2% of labels issued, set from its own history.

Label reconciliation: first count and recount against the limit

  1. First count: 40 labels short0.33%stop and search
  2. Recount after 25 found at the peel plate: 15 short0.125%inside the limit

Unaccounted = issued − (used + damaged + returned)

Issued 12,000

  1. 12,000 − (11,420 + 310 + 230)= 40
  2. 12,000 − (11,420 + 335 + 230)= 15
After the recount0.125%

Issued 12000. First count accounted for 11960, 40 short, 0.33 percent against a 0.2 percent limit: stop. After 25 labels were found, the recount accounted for 11985, 15 short, 0.125 percent, inside the limit.

Illustrative. The limit is the made-up plant's own, 0.2% of labels issued (24 labels), not a regulatory figure.
  • Issued 12,000 front labels. Used 11,420 (11,400 bottles labeled and passed, plus 20 labeled bottles taken as QC and retained samples). Damaged and destroyed 310. Returned 230.
  • First count: 11,420 + 310 + 230 = 11,960, so 40 labels are unaccounted for: 0.33% against a 0.2% limit (24 labels). Outside the limit, so the changeover stops and the line is not verified.
  • Search: 25 labels from B-2291 are found behind the labeler's peel plate and in its backing paper waste path, and counted as damaged.
  • Recount: 11,420 + 335 + 230 = 11,985, so 15 are unaccounted for: 0.125%, inside the limit.

The line starts 25 minutes later than planned, with a deviation raised for the first count. The 25 labels carried the last batch's lot and expiry: exactly the mix-up line clearance exists to stop.

Common mistakes

  • Signing before reconciling

    If the clearance is signed and the count done afterwards, a difference has nowhere to go. Reconcile first; a difference outside the limit stops the start.

  • The verifier takes the operator's word

    A second signature without a second look adds nothing. The verifier walks the line and checks the hiding places for themselves.

  • No list of hiding places

    Leftovers collect in the same spots: under conveyors, reject chutes, magazines, peel plates, waste paths. Name them on your checklist, and add every new one found.

  • Setting the coder without a first sample

    A lot or expiry typed into the coder is only right once a printed sample has been checked against the batch record and signed.

  • Treating clearance as lost time

    Clearance is part of the changeover. Time it, split the external work (counts, staging, paperwork) from the internal, and make it shorter without skipping checks.

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FAQ

Line clearance checklist: common questions

  1. The check at every batch or product change that nothing from the last run is left on the line: no product, components, labels, cartons, leaflets or paperwork. The operator clears the line, a second person verifies it, and the line is released for the next batch only after both sign.

  2. Because a leftover label, leaflet or tablet from the last batch can end up in the next one, and a mix-up of strength or product is a serious packaging error. FDA's rule asks for packaging and labeling areas to be inspected immediately before use, with the result in the batch record (21 CFR 211.130(e)).

  3. The line team clears the line, usually the operator or line lead. A second person, often from quality, verifies it independently by walking the line, not by reading the operator's sheet. Your procedure names who may verify.

  4. Count labels issued, used (on units passed or sampled), damaged and destroyed, and returned. Issued minus the other three should be zero or inside a preset limit set from your own history. Outside it, stop the changeover, search the line, recount, and investigate the difference.

  5. A changeover is all the work to switch a line from one product to the next: parts, settings, cleaning, set-up. Line clearance is the check inside it that the last product and its materials are gone. Shortening a changeover should never mean skipping clearance checks.

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