Labelling & Pack Control Procedure

Use current approved information as the basis for packing control

Packaging and labels are selected and checked against current approved requirements throughout packing. Technical or Quality Management is responsible for ensuring those requirements are incorporated into the manufacturing or packing instruction before production use, while Production Supervisors ensure the current instruction is available before packing begins.

The procedure therefore keeps the packing-stage control focused on the approved packaging and labelling position in force for the product. Where the applicable information is unavailable, unclear or cannot be verified, packing does not begin. Specification establishment, label content, artwork approval and label version control remain governed by the related specifications and artwork-control procedures rather than being redefined here.

Control packaging from issue through to availability at the line

Packaging remains identifiable from controlled storage through issue to the packing line. The issue process matches each material to the current production requirement, with warehouse or stores personnel recording issue and packing or production personnel confirming receipt and identity before use.

Current-run packaging may be held in controlled staging before line clearance is complete, but it is not made available for use at the packing machine or workstation until satisfactory line clearance has been confirmed. Only packaging required for immediate use is made available at the machine, while additional material may remain clearly separated in controlled staging until required.

Where packaging identity or approval status cannot be confirmed against the current manufacturing or packing instruction, it is withheld from use and brought under the applicable non-conforming product controls.

Verify offline coding before printed material reaches the packing machine

Where packaging is coded or printed away from the packing machine, the procedure controls both printer settings and printed output before the material is released for use. Printer parameters may be set or amended only by personnel authorised for the equipment and activity.

Printed material is checked against the current approved specification, manufacturing or packing instruction, approved image or reference sample before it is made available at the packing machine. Material that cannot be confirmed as acceptable is withheld from use; where the approved references do not allow acceptability to be determined, Technical or Quality personnel assess its status.

Make line clearance a defined production-start decision

Documented line checks are completed before production begins and following each product change. The applicable clearance and production-readiness criteria are defined in the current manufacturing or packing instruction or line-clearance record, including confirmation at product change that product, printed packaging and labels from the previous production have been removed.

Packing or production personnel complete the physical checks, and Production Supervisors confirm satisfactory completion before authorising production to start or restart. Production does not start or restart where clearance or readiness cannot be demonstrated, and current-run packaging is not made available for use at the machine until satisfactory line clearance has been confirmed.

Test online verification equipment against defined acceptance criteria

Online equipment used to check product labels or printing is set up, operated and tested against an approved equipment instruction whenever it is used. Technical or Quality Management maintains the instruction and defines the setup check, test method, acceptance criteria, in-run testing frequency, actions for correcting setup or repeating a test, and the verification required before the equipment returns to routine use.

The setup check confirms that the correct product, label, print or packaging requirement has been selected. Where the equipment provides alert or reject functions, testing verifies that the applicable function responds when packaging information is inconsistent with the approved specification.

Testing is completed at the start of the packing run after satisfactory line clearance and before packing begins, at the defined frequency during production, and at the end of the run. The in-run frequency is set so that material produced since the last satisfactory test can be identified, held and prevented from release if the equipment fails. Production Supervisors confirm satisfactory setup and the start-of-run test before authorising packing to start.

Define the response when online verification cannot be demonstrated

The procedure contains a specific failure response for situations where correct equipment setup cannot be verified, a required test is incomplete, failed or inconclusive, or the equipment cannot perform or demonstrate its required label or printing check.

Packing or production personnel report the failure, and Production Supervisors prevent packing from starting or stop packing where it is already in progress. Product packed since the last satisfactory verification is identified and held, and Technical or Quality personnel determine product status where product may have been affected.

Temporary manual checking is permitted only where a predefined method has been established for the product and process. Technical or Quality Management ensures the approved instruction defines the checking method, frequency, acceptance criteria and required evidence; Production or Operations Management authorises its use before packing starts or continues; and Production Supervisors implement the authorised method. Product packed under manual checking is not released until the required checks confirm that its packaging and printing are correct.

Routine equipment operation resumes only after fault diagnosis and repair have been completed where required, the equipment has been correctly set up, the applicable alert or reject function has been satisfactorily verified, and the verification required by the approved equipment instruction has been completed. Recurring or systemic equipment failures are linked to corrective and preventive action, while affected product that may have moved beyond the site’s direct control is escalated through the incident, withdrawal and recall procedure.

Check packaging, labelling and coding across the full packing run

Packaging, labelling and coding checks cover the full packing run against the current manufacturing or packing instruction. Technical or Quality Management defines the risk-based checking approach and acceptance criteria, while Production Supervisors ensure the required checks are completed.

Checks are made at the start of packing, at the defined intervals during the run, whenever printed packaging or labels are brought to the line, when a packaging-material batch changes and at the end of the production run. Packing-stage printing is also verified where applied, including date and batch coding, quantity or pricing information, bar codes, country-of-origin information and allergen information.

Routine checks may use visual examination, comparison with an approved reference or verification equipment, as defined for the product and process. Retained samples are taken where required by the manufacturing or packing instruction. If a required check is missing, unsatisfactory or cannot demonstrate that packaging, labelling or printing is correct, packing stops and Technical or Quality personnel determine the status of potentially affected product.

Reconcile label use and investigate unexplained differences

Label reconciliation accounts for labels issued to production and is used to identify unexplained differences that may indicate incorrect use or loss of control. Expected use is compared with issued, used, wasted, sampled and returned quantities as applicable to the packaging format and production process, with the calculation and any authorised tolerance defined in the manufacturing or packing instruction or associated controlled record.

Packing or production personnel complete routine reconciliation, supported by warehouse or stores issue and return information where applicable. Production Supervisors review completion, and Technical or Quality personnel assess inconsistencies that may affect product status. Where investigation indicates incorrect label use, or the labelling status of affected product cannot be confirmed, the affected product is brought under the applicable non-conforming product controls.

Allocate control and decision authority across the operation

Senior Management provides the resources and organisational arrangements needed for packaging, labelling, coding, line-clearance and online-verification controls. Technical or Quality Management establishes and maintains the control system, defines risk-based checking approaches and acceptance criteria, sets online-verification testing frequencies and ensures authorised technical or quality personnel determine packaging or product status where routine checks cannot confirm conformity.

Production or Operations Management implements the controls in production areas and holds the authority to approve use of a predefined manual-checking method following online-verification failure. Production Supervisors control the production-start and restart decision after satisfactory line clearance and, where applicable, equipment verification, while warehouse, packing and production personnel carry out the issue, receipt, identity, checking, reconciliation and recording activities assigned to their roles.

Engineering or Maintenance personnel investigate and repair faults affecting online verification equipment and support confirmation that equipment is suitable to return to routine use. Personnel involved in approving, authorising, operating, checking, reviewing, investigating or escalating these controls are required to be trained for the activities they perform.

Connect packing-stage control with the wider FSQMS

The procedure generates evidence across packaging issue and return, offline-printed material checks, line clearance and production readiness, packaging and labelling checks, label reconciliation, online-verification setup and testing, equipment-failure response and authorised manual checking.

Its scope is deliberately bounded. Packaging specifications, label content and artwork, packaging suitability and storage, record-control requirements, non-conforming product disposition, routine product release, maintenance activity, corrective action and incident management are governed through the related FSQMS procedures. The Labelling & Pack Control Procedure provides the packing-stage control that uses and connects with those systems without replacing them.