Title Page
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Site conducted
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Conducted on
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Prepared by
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Location
6.1 Control of operations
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SOI The site shall operate to process specifications and work instructions/procedures that ensure the production of consistently safe and legal product with the desired quality characteristics, in full compliance with the HACCP or food safety plan.
6.1.1
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Documented process specifications and work instructions/procedures shall be available for the key processes in the production of products to ensure product safety, legality and quality. The process specifications and work instructions/procedures (as appropriate) shall include:
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• recipes – including identification of any allergens
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• mixing instructions, speed, time
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• equipment process settings
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• cooking times and temperatures
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• cooling times and temperatures
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• labelling instructions
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• coding and shelf-life marking
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• storage conditions (e.g. storage temperatures)
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• any additional critical control points identified in the HACCP or food safety plan.
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Process specifications shall be in accordance with the agreed finished product specification.
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The site shall review the process specifications and work instructions/procedures prior to any changes which may affect food safety, legality and quality.
6.1.2
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Where equipment settings are critical to the safety or legality of the product, changes to the equipment settings shall only be completed by trained and authorised staff. Where applicable, controls shall be password-protected or otherwise restricted.
6.1.3
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Process monitoring, such as temperature, time, pressure and chemical properties, shall be implemented, adequately controlled and recorded to ensure that product is produced within the required process specification.
6.1.4
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In circumstances where process parameters or product quality are controlled by in-line monitoring devices, these shall be linked to a suitable failure alert system that is routinely tested.
6.1.5
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Where variation in processing conditions may occur within equipment critical to the safety or quality of products, the processing characteristics shall be validated and verified at a frequency based on risk and performance of equipment (e.g. heat distribution in retorts, ovens and processing vessels; temperature distribution in freezers and cold stores).
6.1.6
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In the event of equipment failure or deviation of the process from specification, procedures shall be in place to establish the safety status and quality of the product to determine the action to be taken.
6.1.7
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Where a site handles products or materials (e.g. by-products from production processes) that are outside the scope of the audit, these shall be controlled to ensure that they do not create a product safety, authenticity or legality risk to products within the scope.
6.2 Labelling and pack control
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Fundamental SOI The management controls of product labelling activities shall ensure that products will be correctly labelled and coded.
6.2.1
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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
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Documented checks of the production line shall be carried out before commencing production and following changes of product. 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
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Procedures shall be in place to ensure that all products are packed into the correct packaging and correctly labelled. 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
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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).
6.3 Quantity – weight, volume and number control
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SOI The site shall operate a quantity control system which conforms to legal requirements in the country where the product is sold and any additional industry sector codes or specified customer requirements.
6.3.1
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The frequency and methodology of quantity checking shall meet the requirements of the appropriate legislation governing quantity verification, and records of checks shall be retained.
6.3.2
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Where the quantity of the product is not governed by legislative requirements (e.g. bulk quantity), the product shall conform to customer requirements and records shall be maintained.
6.3.3
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Where used, the site shall establish procedures for the operation and testing of online check weighers. At a minimum, this shall include:
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• consideration of any legal requirements
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• responsibilities for testing the equipment
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• operating effectiveness and any variations for particular products
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• methods and frequency of testing the check weighers
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• processes for handling rejected packs
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• records of the test results.
6.4 Calibration and control of measuring and monitoring devices
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SOI The site shall be able to demonstrate that measuring equipment is sufficiently accurate and reliable to provide confidence in measurement results.
6.4.1
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The site shall identify and control measuring equipment used to monitor critical control points and product safety, legality and quality. This shall include, at a minimum:
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• a documented list of equipment and its location
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• an identification code and calibration due date
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• prevention from adjustment by unauthorised staff
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• protection from damage, deterioration or misuse.
6.4.2
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All identified measuring devices, including new equipment, shall be checked and, where necessary, adjusted:
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• at a predetermined frequency, based on risk assessment
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• to a defined method traceable to a recognised national or international standard where possible.
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Results shall be documented. Equipment shall be readable and be of a suitable accuracy for the measurements it is required to perform.
6.4.3
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Reference measuring equipment shall be calibrated and traceable to a recognised national or international standard and records maintained. The uncertainty of calibration shall be considered when equipment is used to assess critical limits.
6.4.4
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Procedures shall be in place to record actions to be taken when the prescribed measuring devices are found not to be operating within specified limits. Where the safety or legality of products is based on equipment found to be inaccurate, action shall be taken to ensure at-risk product is not offered for sale.
Sign Off
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Name of auditor
