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.
Entrance and Chem (FT1) Lab
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Is external entrance into Lab free of milk waste, residue, litter and debris?
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Is the hand wash station clean with adequate soap, water, 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 floors, walls and overhead structures clean and free of milk stains, debris, dust, mould and rust?
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Are benches free of milk stains, personal possessions, food and foreign objects (incl. metal)?
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Is electrical equipment tagged and in safe operating condition?
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Are team members complying to PPE and GMP clothing standards?
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Are chemicals clearly labelled and stored appropriately?
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Are light covers and windows intact and free of any signs of cracking?
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Are finished product and other milk samples stored correctly in the fridge and are they all clearly labelled?
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Are rubbish bins contained?
Other Observations (good and bad)
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Observation 1.
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Observation 2.
Autoclave and Prep Room
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Are 5S Standards being followed by Lab team members?
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Are benches clean and free of clutter, personal possessions, food and foreign objects (incl. metal)?
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Is electrical equipment tagged and in safe operating condition?
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Are floors, walls and overhead structures clean and free of milk stains, debris, dust, mould and rust?
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Are team members complying to PPE and GMP clothing standards?
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Are rubbish bins contained?
Other Observations (good and bad)
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Observation 1.
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Observation 2.
Micro (Plating) Room and Lab Office Area
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Are benches clean and free of clutter, personal possessions, food and foreign objects (incl. metal)?
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Are floors, walls and overhead structures clean, intact and free of debris, flaking paint, dust, mould and rust?
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Is electrical equipment tagged and in safe operating condition?
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Are light covers and windows intact and free of any signs of cracking?
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Is ventilation adequate and is the area clear of any undesirable odours?
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Are team members complying to PPE and GMP clothing standards?
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Are fridges adequately sealed to maintain required temperatures?
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Is the area reasonably sealed to prevent pest ingress?
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Is the area clear of excess milk (e.g. Product that may have been sitting around required for testing)?
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Are petrifilm plates stored away in incubators and not left on benches when unattended?
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Are rubbish bins contained?
Other 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.
