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.
FILLER HYGIENE
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Are all filling machines free from product residue, grease and foreign objects?
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Are workstations and benches clean and free of clutter, personal possessions and product residue?
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Is high level and low level pipe work free from product residue?
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Are Milk Reclaim balance bowl lids closed when not in use?
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Are lids to cap hoppers closed when not in use?
Observations (good and bad)
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Observation 1.
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Observation 2.
FOREIGN BODY CONTROLS
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Are filling machines free from foreign body risks? (metal, cable ties, tape, anti-slip tread, miscellaneous)
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Are work stations free from foreign body risks? (metal, staples, plastic, miscellaneous)
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Are all perspex enclosures surrounding the filling machines intact with no signs of cracking?
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Are filling machines free of missing nuts / bolts and absent of nuts / bolts on the floor around the filler?
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There are no signs of flaking paint or rust around or above the filling machines?
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Are all lights and windows intact with no signs of cracking?
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Are cap hoppers free from 'other' foreign body risks (spot welds, metal, insects, glass, plastic, miscellaneous)?
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Are all pens one piece and of a solid opaque colour contrasting to the product?
CLEANING EQUIPMENT
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Is cleaning equipment clean, stored correctly and in good condition?
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Does cleaning equipment match the shadow board?
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Are hoses in good condition, clean and kept off the floor?
PERSONAL HYGIENE
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Are hand washing procedures followed?
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Are hand washing stations clean with adequate soap, towels and rubbish disposal?
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Are workstations free of any evidence of eating or drinking (excl. Lion approved water bottle)?
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PPE clean and intact and stored in a hygienic location when not in use?
CLOTHING & JEWELLERY
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Are all operators' clothing clean with no visible signs of product residue?
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Are hairnets worn correctly? (Fully covering hair and also covering ear plugs)
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Are beard nets worn correctly? (Fully covering facial hair)
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Are all loose and insecure items of jewellery removed? (including rings with stones)
PACKAGING / PRODUCT CONTROLS
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Lines are kept clear of any unwanted or damaged packaging? (Including caps on filler bed)
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Part boxes of caps or cartons stored correctly to prevent contamination?
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Recyclables stored and rubbish disposed of in a clean and safe manner?
CHEMICAL CONTROLS
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Are all chemicals correctly labelled? (No handwritten sticky labels)
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Are all foot foamers working correctly?
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Chemicals locked away as required?
ENVIRONMENTAL STANDARDS
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Floors clean and free from damage and foreign object debris?
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Walls clean and free from damage and mould?
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Ceilings clean and free from damage?
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Drain baskets / traps in place and clean?
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Pest control - Fly killer units on (bulbs on) / traps fixed in place / doors closed?
MAINTENANCE & TOOLS
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Are tools correctly controlled in a hygienic manner?
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Tools are kept away from filling machines and off the floor when not in use?
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There are no signs of damage to the fillers, conveyors or packers?
MISCELLANEOUS (GOOD AND BAD)
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Observation 1
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Observation 2
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Observation 3
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Observation 4
FOB Bag Audit
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Collect and foreign objects (FOB) from the factory area 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.
