Title Page
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Document No.
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Audit Title
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Client / Site
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Conducted on
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Prepared by
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Location
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Personnel
6.0 Process Control 6.1 Control of Operations FUNDAMENTAL The site shall operate to documented procedures and/or work instructions that ensure the production of consistently safe and legal product with the desired quality characteristics, in full compliance with the HACCP food safety plan.
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6.1.1 - Documented process specifications and work instructions shall be available for the key processes in the production of products to ensure product safety, legality, and quality. The specifications as appropriate shall include:<br><br>- Recipes - including identification of any allergens<br>- Mixing instructions, speed, time<br>- Equipment process settings<br>- Cooking times and temperatures<br>- Cooling times and temperatures<br>- Labelling instructions<br>- Coding and shelf-life marking<br>- Any additional critical control points identified in the HACCP plan.<br>Process specification shall be in accordance with the agreed finished product specification.<br>
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6.1.2 - Process monitoring, such as of temperature, time, pressure, and chemical properties, shall be implemented, adequately controlled, and recorded to ensure that product is produced within the required process specification.
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6.1.3 - In circumstances where process parameters or product quality are controlled by inline monitoring devices, these shall be linked to a suitable failure alert system that is routinely tested.
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6.1.4 - Where variation in processing conditions may occur within equipment critical to the safety or quality of products, the processing characteristics shall be validated 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).
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6.1.5 - In case 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.
6.2 Labelling and Pack Control: FUNDAMENTAL The management controls of product labelling activities shall ensure that products will be correctly labelled and coded.
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6.2.1 - 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 packaging machines.<br><br>Where off-line coding or printing of packaging materials occurs, checks shall be in place to ensure only correctly printed material is available at the packaging machines.<br>
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6.2.2 - Documented checks of the production line shall be carried out before commencing production and<br>following changes of product. These shall ensure that lines have been suitably cleared and are ready<br>for production. Documented checks shall be carried out at product changes to ensure all products and<br>packaging from the previous production have been removed from the line before changing to the next<br>production.<br>
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6.2.3 - Documented procedures shall be in place to ensure that products are packed into the correct packaging<br>and correctly labeled. These shall include checks:<br>- At the start of packing<br>- During the packing run<br>- When changing batches of packaging materials<br>-At the end of each production run.<br><br>The checks shall also include verification of any printing carried out at the packing stage including, as<br>appropriate:<br><br>-Date coding<br>-Batch coding<br>-Quantity indication<br>-Pricing information<br>-Bar coding<br>-Country of origin.<br>
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6.2.4 - Where on-line vision equipment is used to check product labels and printing, procedures shall be in place to ensure that the system is correctly set up and capable of alerting or rejecting product when packaging information is out of specification
6.3 Quantity – Weight, Volume, and Number Control 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 requirement.
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6.3.1 - The frequency and methodology of quantity checking shall meet the requirements of appropriate legislation governing quantity verification, and records of checks shall be retained.
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6.3.2 - Where the quantity of the product is not governed by legislative requirements (e.g. bulk quantity), the product must conform to customer requirements and records shall be maintained.<br><br>
6.4 Calibration and Control of Measuring and Monitoring Devices The site shall be able to demonstrate that measuring and monitoring equipment is sufficiently accurate and reliable to provide confidence in measurement results.
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6.4.1 - The site shall identify and control measuring equipment used to monitor CCPs, product safety, and legality.<br><br>This shall include as a minimum:<br><br>- A documented list of equipment and its location<br>- An identification code and calibration due date<br>- Prevention from adjustment by unauthorized staff<br>- Protection from damage, deterioration, or misuse.<br>
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6.4.2 - All identified measuring devices, including new equipment, shall be checked and where necessary adjusted:<br><br>- At a predetermined frequency, based on risk assessment<br>- To a defined method traceable to a recognized national or international Standard where possible.<br><br>Results shall be documented. Equipment shall be readable and be of a suitable accuracy for the measurements it is required to perform.<br>
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6.4.3 - Reference measuring equipment shall be calibrated and traceable to a recognized national or international Standard and records maintained. The uncertainty of calibration shall be considered when equipment is used to assess critical limits.
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6.4.4 - Procedures shall be in place to record actions to be taken when the prescribed measuring and monitoring 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.
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