Information
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Audit Title
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Document No.
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Conducted on
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Prepared by
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Personnel
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Are IBC's cleaned before use ?<br>
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IBC'S to be scraped clean around slide and blown down with air line(SOP#1)
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Are IBC'S sanitised before entering the product transition area ?<br>
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Form 16.6/ Form 35
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Is there appropriate PPE for the operators ?<br>
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Are operators wearing PPE provided ?
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Is their a sanitised fork lift that remains in the cleanroom production area ?
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Form 2a/FSM/cleaning records/cleanroom
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Are the products in this area stored correctly ?
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Are the products adequately labelled and are stocks rotated (FIFO) ?<br>
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All pallets to have lot # and Mars barcode/Lowest lot # used first
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Is there a process flow for this area and does it accurately reflect the procedure ?<br>
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Paradigm/documentation/HACCP
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Have operators been trained for this area ?
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Paradigm/training/completed training
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Are training records current and up to date ?
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Are all critical control points correct ?
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CCP2-QC form, CCP3 form 16.6
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When asked was the operator aware of the aseptic sampling process ?<br>
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SOP#90 aseptic sampling
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Are the sample jars reconciled ?
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Form 36 sample jar log
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Are completed IBC'S labelled correctly and covered ?<br>
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Are quality control documents signed and completed daily ?
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QC form/form 16.6/front office
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Is there a cleaning schedule in place and is it being followed ?<br>
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Form 2A monthly clean/FSM/cleaning records/cleanroom
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Is the facility well maintained ?
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Has the standard operating procedure been reviewed ?
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SOP#1 review date on document
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Corrective actions/notes
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Corrective actions to be completed by:
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General Manager
