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 be able to trace all raw material product lots (including primary packaging) from its suppliers through all stages of processing and dispatch to its customers and vice versa.
3.9.1 Documented traceability procedure
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The site shall have a documented traceability procedure designed to maintain traceability throughout the site’s processes. At a minimum this shall include:
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how the traceability system works
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the labelling and records required.
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Where applicable, the traceability system shall meet the legal requirements in the country of sale or intended use.
3.9.2 Identification
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Identification of raw materials (including primary packaging), intermediate/semi-processed products, part-used materials, finished products and materials pending investigation shall be adequate to ensure traceability.
3.9.3 Testing of the traceability system
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The site shall test the traceability system across the range of product groups to ensure traceability can be determined from the supplier of raw material (including primary packaging) to the finished product and vice versa.
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For food raw materials and finished products (i.e. including printed packaging and labels with food safety and legal information), the test of the traceability system shall include a quantity check/mass balance.
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The traceability test shall include a summary of the documents that should be referenced during the test, and clearly show the links between them.
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The test shall occur at a predetermined frequency, at a minimum annually, and results shall be retained for inspection.
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Traceability should be achievable within 4 hours.
3.9.4 Reword
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Where rework or any reworking operation is performed, traceability shall be maintained.
