Information
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Site conducted
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LION Period (Month)
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Department or Area Observed
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Conducted on
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Code of Conduct for Auditor(s):
Be constructive
Be descriptive with audit findings (not just photos)
Engage with team members to achieve
Take disciplined action
Make an effort
Instructions for Auditor(s):
1. Assess each inspection question according to compliance and select the most appropriate "Inspection Rating" for each (description of ratings are outlined below)
2. Describe all identified non-compliances and include photos. Actions must also be described.
3. Complete all mandatory fields / questions
4. A plastic bag must be used to collect all Foreign Object (FOB) during the FOB bag audits, and a photo must be attached.
5. Export your inspection report once audit has been completed and all actions are documented
6. Return iAuditor to the Quality Leader who is responsible for transferring inspection findings and actions to the Workplace Inspection Tracker
Inspection Ratings:
"Great evidence of Compliance" (score 2) implies no risk and that systems or behaviours meet GMP & Safety requirements. No further action required.
"Inconsistency with Compliance" (score 1) implies potential risk and that systems or behaviours may not quite meet GMP & Safety requirements. Immediate action may be required during time of inspection such as a focused conversation with a team member focused around requirements, which would lower/eliminate the risk and have positive impact on compliance. A description of that action taken should be recorded in the inspection report. Repeated inconsistencies would trigger a "Non-compliance requires CAPA".
"Non-compliance requires CAPA" (score 0) implies a failure in a system or behaviour that does not meet GMP & Safety requirements. Corrective and Preventative Action (CAPA) must be determined via consultation, DMAIC or 5Y, and then recorded in SEQIS, LAMS, Risk Register, MEX Tier Meeting or Site Broad Plan. Once a CAPA has been established make a reference in your inspection report (e.g. refer work order #1234 or refer SLT T3 Long Term Action Board).
"No Change but CAPA in place" (score 1) implies that a non-compliance raised from previous audit(s) has not yet changed but has been assigned a CAPA that will address the non-compliance. No further action is required however follow up or assistance with close out is encouraged.
Flavour Processing Area
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Are the ingredient tote bins clean, securely sealed and clearly labelled?
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Are liquid ingredients sealed and stored in a flammable cupboard or bund?
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Are batching utensils and measuring containers clean and stored in a sanitary manner?
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Are dry ingredient bags sealed, undamaged and stored off the floor?
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Is the mixing area (incl. the set of scales) free of foreign objects such as metal, cardboard and used o-rings?
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Are lids to mix tanks, ingredient hoppers and balance bowls closed when left unattended?
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Are floors, walls and overhead structures clean and free of debris, chocolate dust, flaking paint and mould?
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Are milk lines, valve unions, plant and equipment free of milk leakage or product 'burn on'?
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Is lifting equipment (e.g. Vacuum lifter, pallet trolley) clean and in good working condition?
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Are hoses and fittings in good condition, clean and stored off the floor?
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Are light covers intact and free of any signs of cracking?
Observations (good and bad)
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Observation 1.
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Observation 2.
White Milk Processing Area
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Is the door foamer working properly?
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Is the work station clean and free of clutter, personal possessions, food and foreign objects (incl. metal)?
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Are lids to balance bowls closed when left unattended?
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Are floors, walls and overhead structures clean and free of debris, chocolate dust, flaking paint and mould?
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Are wall-mounted insect units 'on' (bulb on) and all doors closed and windows sealed to prevent pest ingress?
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Are milk lines, valve unions, plant and equipment free of milk leakage or product 'burn on'?
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Is the area clear of any undesirable odour (e.g. Off milk)?
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Are hoses and fittings in good condition, clean and stored off the floor?
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Are light covers and windows intact and free of any signs of cracking?
Observations (good and bad)
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Observation 1.
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Observation 2.
Raw Milk Silo Room
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Are walkways and exits kept clear to prevent trip hazard and ensure safe emergency evacuation?
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Are floors, walls and overhead structures clean and free of debris, milk residue, flaking paint and mould?
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Are milk lines, valve unions, plant and equipment free of milk leakage or biofilm?
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Is the area clear of any undesirable odour (e.g. Off milk)?
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Are hoses and fittings in good condition, clean and stored off the floor?
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Are light covers and windows intact and free of any signs of cracking?
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Are wall-mounted insect units 'on' (bulb on) and all doors closed and windows sealed to prevent pest ingress?
Observations (good and bad)
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Observation 1.
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Observation 2.
Mezz Floor and PFS Tanks
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Are walkways, stairs and exits kept clear to prevent trip hazard and ensure safe emergency evacuation?
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Are floors, walls and overhead structures clean and free of debris, flaking paint, dust, mould, metal and rust?
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Is cleaning equipment clean, accounted for, in good condition and stored off the floor?
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Are hoses and fittings in good condition, clean and stored off the floor?
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Are lids to PFS tanks kept close when left unattended?
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Are wall-mounted insect units 'on' (bulb on), doors closed and windows sealed to prevent pest ingress?
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Are fire extinguishers accessible and tagged for compliance?
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Are light covers and windows intact and free of any signs of cracking?
Observations (good and bad)
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Observation 1.
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Observation 2.
CIP Room
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Are walkways, stairs and exits kept clear to prevent trip hazard and ensure safe emergency evacuation?
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Do CIP lines appear to be secure and free of any signs of leakage?
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Are floors, walls and overhead structures clean and free of debris, flaking paint, dust, mould, metal and rust?
Observations (good and bad)
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Observation 1.
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Observation 2.
Personal Hygiene and Safety
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Are all team members' clothing clean with no visible signs of product residue?
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Are the safety showers clearly accessible?
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Are hairnets and beard nets worn correctly (fully covering hair and also covering ear plugs)?
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Are all team members complying with PPE requirements?
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Are all loose and insecure items of jewellery removed (incl. rings with stones, and ear rings)?
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Are team members complying to the 'Permitted Items' requirements (e.g. no correction fluid, one piece pens)?
Observations (good and bad)
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Observation 1.
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Observation 2.
Tanker bay and milk unloading (must assess tanker driver operations)
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Pest control measures are taken such as capping all milk & CIP hoses, closing tanker inspection hatches, and ensuring hose strainers are well maintained?
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Tanker driver understands and can describe how to report any signs of pest activity?
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Tanker driver understands what CCP (Critical Control Point) stands for and can describe what to do in the event of a breach or test failure (i.e. positive antibiotic detection)?
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Tanker driver can demonstrate and explain site personal hygiene practices (such as washing of hands prior to handling milk equipment, no jewellery, safety glasses & high-vis clothing, and reporting protocols of potential communicable disease)?
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Tanker driver can demonstrate and explain the importance of cleaning and sanitation of milk lines and equipment?
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Tanker driver can demonstrate and explain the importance of accurate and fully completed record keeping (for traceability purposes)?
Observations (good and bad)
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Observation 1.
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Observation 2.
FOB Bag Audit
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Collect any foreign objects (FOB) from the FLAVOUR & WHITE Processing Area into a clear plastic bag and photograph your findings with this iPad.
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Collect any foreign objects (FOB) from the MEZZ Floor into a clear plastic bag and photograph your findings with this iPad.
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Add signature
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By completing this inspection you acknowledge that all non-compliance items raised requires appropriate follow up and agreed action with the department team members and/or department leader. Once the actions are agreed export this inspection report to the Site Quality Leader.
