Title Page
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Conducted on
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Prepared by
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Location
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Auditor'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 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 Documented process specifications and work instructions/procedures
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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.
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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 Equipment settings are critical to the safety or legality
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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.
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Where applicable, controls shall be password-protected or otherwise restricted.
6.1.3 Process monitoring
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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 In-line monitoring devices
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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 Variation in processing conditions may occur within equipment critical to the safety or quality of products
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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 Equipment failure or deviation of the process from specification
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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 Products or materials (e.g. by-products from production processes) that are outside the scope of the audit
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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.
