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.
Main Office, Reception, MEX Room and Boardrooms
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Are walkways and exits kept clear to prevent trip hazard and ensure safe emergency evacuation?
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Is lighting adequate and are light covers intact and free of any signs of cracking?
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Are desks and kitchenette kept clean and free of clutter (i.e. aligned to 5S Standards)?
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Is the photocopying area kept clean and free of unwanted printing?
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Are carpets clean and are blinds dust free?
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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 electrical equipment tagged and in safe operating condition?
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Is the relevant safety information (e.g. Evacuation plan, first aid officers) clearly displayed and up to date?
Observations (good and bad)
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Observation 1.
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Observation 2.
Canteen
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Are walkways and exits kept clear to prevent trip hazard and ensure safe emergency evacuation?
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Is the relevant safety information (e.g. Evacuation plan, first aid officers) clearly displayed and up to date?
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Are floors, walls and ceilings clean and free of soil, rubbish, flaking paint and stains?
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Are dirty dishes washed or stacked into the dish washer (as per 5S Standard)?
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Is electrical equipment tagged and in safe operating condition?
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Are the the staff refrigerators clean, clear of milk spillage and all unwanted food items disposed of?
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Are benches and floors in the outside eating area kept clean and free of unwanted food or dishes?
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Is the smoking area kept clean and is the ground free of cigarette butts or unwanted food?
Observations (good and bad)
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Observation 1.
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Observation 2.
Training Room
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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?
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Are tables clean and clear of clutter and unwanted food or dishes?
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Are floors, walls and ceilings clean and free of soil, rubbish, flaking paint and stains?
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Is the emergency exit kept clear (check both sides of door)?
Observations (good and bad)
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Observation 1.
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Observation 2.
Male and Female Toilets (Admin Block)
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Is lighting adequate and are light covers intact and free of any signs of cracking?
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Is the hand wash area clean with adequate soap, towels and rubbish disposal?
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Is cleaning equipment securely stored and off the floor when not in use?
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Do toilets appear to be working correctly?
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Are floors, walls and ceilings clean and free of soil, rubbish, flaking paint and stains?
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Is the area clear of any undesirable odour?
Observations (good and bad)
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Observation 1.
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Observation 2.
Main Change Rooms (Male & Female)
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Are walkways and exits kept clear to prevent trip hazard and ensure safe emergency evacuation?
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Is lighting adequate and are light covers intact and free of any signs of cracking?
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Is the hand wash area clean with adequate soap, towels and rubbish disposal?
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Are floors, walls and ceilings clean and free of soil, stains, mould, flaking paint, used hairnets or dust?
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Are uniforms stored in a hygienic manner and away from the floor?
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Is the area clear of any food?
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Do toilets and showers appear to be in working order?
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Is the area clear of any undesirable odour?
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 department team members and/or department leader. Once the actions are agreed export this inspection report to the Site Quality Leader.
