Title Page
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Conducted on
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Prepared by
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Location
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Auditee's signature : I agree with the audit findings
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Auditee's name
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Auditee's Job title
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Fundamental<br>SOI<br>The management controls of product labelling activities shall ensure that products will be correctly labelled and coded.
6.2.1 Allocation of packaging materials to packing lines
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There shall be a formal process for the allocation of packaging materials to packing lines and control in the packing area which ensures that only the packaging for immediate use is available to the packing machines.
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Where offline coding or printing of packaging materials occurs:
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setting and amendments to the printer parameters (e.g. the input of, or changes to, date codes) shall only be completed by an authorised member of staff
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controls shall be in place to ensure that only correctly printed material is available at the packing machines.
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Processes shall be in place to check label use is reconciled with expected use and the cause of any inconsistencies investigated.
6.2.2 Documented checks of the production
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Documented checks of the production line shall be carried out before commencing production and following changes of product.
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These shall ensure that lines have been suitably cleared and are ready for production. Documented checks shall be carried out at product changes to ensure that all products and printed packaging and labels from the previous production have been removed from the line before changing to the next production.
6.2.3 Packaging procedures
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Procedures shall be in place to ensure that all products are packed into the correct packaging and correctly labelled.
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These shall include checks:
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at the start of packing
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during the packing run (e.g. at predefined intervals and when printed packaging or labels are brought to the line during the production run)
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when changing batches of packaging materials
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at the end of each production run.
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The checks shall also include verification of any printing carried out at the packing stage including, as appropriate:
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date coding
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batch coding
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quantity indication
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pricing information
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bar coding
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country of origin
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allergen information.
6.2.4 Online packaging verification equipment (e.g. bar code scanners)
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Does the site have online packaging verification equipment?
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Where online verification equipment (e.g. bar code scanners) is used to check product labels and printing, the site shall establish and implement procedures for the operation and testing of the equipment to ensure that the system is correctly set up and capable of alerting or rejecting product when packaging information is out of specification.
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At a minimum, testing of the equipment shall be completed at:
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the start of the packing run
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the end of the packing run
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a frequency based on the site’s ability to identify, hold and prevent the release of any implicated materials should the equipment fail (e.g. during the packing run or when changing batches of packaging materials).
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The site shall establish and implement procedures in the event of a failure in the online verification equipment (e.g. a documented and trained manual checking procedure).
