Title Page
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Conducted on
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Auditor's name
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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 factory layout, flow of processes and movement of personnel shall be sufficient to prevent the risk of product contamination and to comply with relevant legislation.
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4.3.1 The site shall assess the production risk zones required for the products manufactured, processed or packed at the site, using the definitions in Appendix 2 of the Standard.
4.3.2 There shall be a map of the site. At a minimum, this map shall define:
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● production risk zones, where product is at different levels of risk from pathogen contamination – for example, high-risk, high-care, ambient high-care, low-risk and enclosed product areas (see clause 4.3.1 and Appendix 2)
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● access points for personnel
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● access points for raw materials (including packaging), semi-finished products and open products
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● routes of movement for personnel
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● routes of movement for raw materials (including packaging)
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● routes for the removal of waste
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● routes for the movement of rework
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● location of any staff facilities, including changing rooms, toilets, canteens and smoking areas
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● production process flows
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● any areas where time segregation is used to complete different activities (for example, time segregation for high-care areas).
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4.3.3 Contractors and visitors, including drivers, shall be made aware of the requirements of the areas they are visiting, with special reference to hazards and potential product contamination.
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4.3.4 The movement of personnel, raw materials, packaging, rework and/or waste shall not compromise the safety of products. The process flow, together with the use of demonstrably effective procedures, shall be in place to minimise the risk of the contamination of raw materials, intermediate/semi-processed products, packaging and finished products.
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4.3.5 Premises shall allow sufficient working space and storage capacity to enable all operations to be carried out properly under safe hygienic conditions.
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4.3.6 Temporary structures constructed during building work or refurbishment etc. shall be designed and located to avoid pest harbourage and ensure the safety and quality of products.
