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.
Top Store (dry ingredients and packaging)
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Are walkways and exits kept clear to prevent trip hazard and ensure safe emergency evacuation?
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Are Emergency Exit signs functional and emergency procedures displayed?
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Are floor-to-wall joins and doorways adequately sealed to prevent pest ingress, and are pest control devices working?
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Are floors, walls and overhead structures clean and free of debris, dust and mould?
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Are rubbish disposal units and cleaning equipment in good condition in order to keep the store clean?
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Is lighting adequate to complete work safely, and are light covers intact?
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Are all ingredient bags and packaging materials sealed, undamaged and stored off the floor?
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Are liquid ingredients sealed and stored in flammable cupboard?
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Is there good evidence of damaged stock being isolated and placed ON HOLD?
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Is there evidence of good rotation of packaging materials (i.e. FIFO principle)?
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Is racking in good condition, bolted to the floor and compliant to the safe loading placards?
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Are loose items that are stored above head height secured to pallets?
Observations (good and bad)
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Observation 1.
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Observation 2.
Classic Store (bottle and cap storage)
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Are walkways and exits kept clear to prevent trip hazard and ensure safe emergency evacuation?
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Are Emergency Exit signs functional and emergency procedures displayed?
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Are floor-to-wall joins and doorways adequately sealed to prevent pest ingress?
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Are floors, walls and overhead structures clean and free of debris, dust and mould?
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Are rubbish disposal units and cleaning equipment in good condition in order to keep the store clean?
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Is lighting adequate to complete work safely, and are light covers intact?
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Are all packaging materials sealed, undamaged and stored off the floor?
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Is there good evidence of damaged stock being isolated and placed ON HOLD?
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Is there evidence of good rotation of packaging materials (i.e. FIFO principle)?
Observations (good and bad)
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Observation 1.
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Observation 2.
Bottom Store (bottle and cap storage)
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Are walkways and exits kept clear to prevent trip hazard and ensure safe emergency evacuation?
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Are Emergency Exit signs functional and emergency procedures displayed?
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Are floor-to-wall joins and doorways adequately sealed to prevent pest ingress?
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Are floors, walls and overhead structures clean and free of debris, dust and mould?
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Are rubbish disposal units and cleaning equipment in good condition in order to keep the store clean?
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Is lighting adequate to complete work safely, and are light covers intact?
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Are all packaging materials sealed, undamaged and stored off the floor?
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Is there good evidence of damaged stock being isolated and placed ON HOLD?
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Is there evidence of good rotation of packaging materials (i.e. FIFO principle)?
Observations (good and bad)
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Observation 1.
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Observation 2.
Factory (Day) Store
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Is the hand wash area clean with adequate soap, towels and rubbish disposal?
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Are walkways and exits kept clear to prevent trip hazard and ensure safe emergency evacuation?
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Are Emergency Exit signs functional and emergency procedures displayed?
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Are floor-to-wall joins and doorways adequately sealed to prevent pest ingress, and are pest control devices working?
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Are floors, walls and overhead structures clean and free of debris, dust and mould?
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Are rubbish disposal units and cleaning equipment in good condition in order to keep the store clean?
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Is lighting adequate to complete work safely, and are light covers intact?
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Are all packaging materials sealed, undamaged and stored off the floor?
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Is there good evidence of damaged stock being isolated and placed ON HOLD?
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Is racking in good condition, bolted to the floor and compliant to the safe loading placards?
Observations (good and bad)
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Observation 1.
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Observation 2.
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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 departmental team members and/or department leader. Once the actions are agreed export this inspection report to the Site Quality Leader.
