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.
Maintenance Workshop
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Are walkways and exits kept clear to prevent trip hazard and ensure safe emergency evacuation?
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Are team members complying with PPE requirements?
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Are floors, walls and ceilings clean and free of litter, plant debris, grease and oil?
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Is the floor surrounding drills and lathes clean and free of metal swarf?
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Are work benches clean and free of clutter, personal possessions and food?
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Is disposal cloth used only and are they disposed of into the designated hydrocarbon bin?
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Are rubbish disposal units and cleaning equipment in good condition in order to keep the area clean?
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Is electrical equipment tagged and in safe operating condition?
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Are chemicals correctly labelled and securely stored in either a flammable cupboard or on a bund when not in use?
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Are pressure vessels (e.g. Gas and oxyacetylene bottles) securely fastened when not in use?
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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.
Parts and Steel Storage
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Are floors, walkways and exits kept clear to prevent trip hazard and ensure safe emergency evacuation?
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Are food grade and non-food grade oil and grease labelled and securely stored to prevent accidental spill?
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Is a spill kit readily available and in reasonable working condition?
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Is lighting adequate and are light covers intact and free of any signs of cracking?
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Is racking in good condition, bolted to the floor and compliant to the safe loading placards (where required)?
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Are loose items that are stored above head height secured to pallets with stretch film or ties?
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Is equipment used for product contact surfaces (e.g. pumps) stored in a sanitary manner to avoid foreign object or contamination risk?
Observations (good and bad)
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Observation 1.
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Observation 2.
Chemical Stores
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Are sanitised IBC pods (e.g. Oxysan) securely stored and correctly labelled?
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Are decanting valves and lines secure and free of any signs of leakage?
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Are caustic IBC pods (e.g. Avoid) securely stored and correctly labelled?
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Are walkways and exits within the Main Chemical store kept clear to prevent trip hazard and ensure safe emergency evacuation?
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Are caustics and acids labelled and adequately segregated within the Main Chemical store?
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Is MSDS and relevant safety information clearly accessible and up to date?
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Is appropriate PPE available, clean, fit for purpose and stored safely when not in use?
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Is lighting adequate and are light covers intact and free of any signs of cracking?
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Is a spill kit readily available and in reasonable working condition?
Observations (good and bad)
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Observation 1.
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Observation 2.
Boiler 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 soil, plant debris, grease and oil?
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Are doors and walls adequately sealed to prevent pest ingress?
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Is lighting adequate and are light covers intact and free of any signs of cracking?
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Is electrical equipment tagged and in safe operating condition?
Observations (good and bad)
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Observation 1.
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Observation 2.
Refrigeration 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 soil, plant debris, dust, grease and oil?
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Are doors and walls adequately sealed to prevent pest ingress?
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Is electrical equipment tagged and in safe operating condition?
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Is lighting adequate and 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.
Cooling Towers
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Are walkways and exits kept clear to prevent trip hazard and ensure safe emergency evacuation?
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Are drain baskets and traps kept clean and clear of litter buildup?
Mains power substation
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Floors and walkways kept clean, free of clutter and provides safe access?
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Emergency exits are kept clear?
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Lights are working correctly and showing no signs of damage or cracking?
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Electrical cabinets are closed and secure?
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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.
