Title Page
Westbury Administration Building
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Audit Month
- January
- February
- March
- April
- May
- June
- July
- August
- September
- October
- November
- December
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Conducted on
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Prepared by
Area Owner: Tim Gleeson
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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 should be used to collect all Foreign Object Bodies (FOB) during the audit.
5. Export your inspection report once audit has been completed and all actions are documented.
Inspection Ratings:
"Compliant" implies no risk and that systems or behaviours meet GMP & Safety requirements. No further action required.
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" implies risk or a failure in a system or behaviour that does not meet GMP & Safety requirements. Corrective and Preventative Action (CAPA) must be determined and then recorded as an action with an owner or escalated in the incident database. Once a CAPA has been established make a reference in your inspection report (e.g. refer MEX work order/request #1234 or WHS/HAZ/NCR #1234).
Audit Questions
Office Area and Meeting Rooms
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Area is free of obsolete items, rubbish etc.
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Electrical leads have a current test and tag attached, are in good condition (ie not damaged – not frayed, no exposed wires etc).
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Lighting is adequate for the work being undertaken in the area and all lights are functioning.
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Emergency exit doors are not blocked and exit signs are compliant (illuminated or reflective)
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IMPORTANT: This check ensures that fire extinguishers are correctly stored so that the correct fire extinguisher will be used in an emergency.
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1 x Fire Extinguisher ABE Dry Powder located at front entrance to office: accessible, current inspection tag in date, mounted correctly, pressure within acceptable limits (check pressure gauge)
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Emergency evacuation diagram is displayed
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Signage in good condition (i.e. Not faded or peeling away)
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Walkways clear and not obstructed. Items not left on walkways.
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Area is free of pest activity (eg. Insects, beetles, birds, rodents, droppings, nests, webbing).
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Check documents (records) on display: Confirm no out-of-date documents, confirm version control (eg. Different versions not on display), confirm there are no documents without a date or version number etc.
Observations (Good or Bad)
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Observation 1.
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Observation 2.
Female Amenities and Male Disabled Toilet
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Area is free of obsolete items, rubbish etc
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Electrical leads have a current test and tag attached, are in good condition (ie not damaged – not frayed, no exposed wires etc).
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Lighting is adequate for the work being undertaken in the area and all lights are functioning.
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Chemicals / substances are labelled and not stored in unmarked containers / bottles (eg. Not decanted into an unmarked container)
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Signage in good condition (i.e. Not faded or peeling away)
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Walkways clear and not obstructed. Items not left on walkways.
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Area is free of pest activity (eg. Insects, beetles, birds, rodents, droppings, nests, webbing).
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Toilet and shower facilities are clean and in good repair.
Observations (Good or Bad)
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Observation 1.
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Observation 2.
Lunchroom
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Area is free of obsolete items, rubbish etc.
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Electrical leads have a current test and tag attached, are in good condition (ie not damaged – not frayed, no exposed wires etc).
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Lighting is adequate for the work being undertaken in the area and all lights are functioning.
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IMPORTANT: This check ensures that fire extinguishers are correctly stored so that the correct fire extinguisher will be used in an emergency.
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1 x Fire Extinguisher ABE Dry Powder and 1x Fire Blanket located at entrance to office: accessible, current inspection tag in date, mounted correctly, pressure within acceptable limits (check pressure gauge)
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Chemicals / substances are labelled and not stored in unmarked containers / bottles (eg. Not decanted into an unmarked container)
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Signage in good condition (i.e. Not faded or peeling away)
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Walkways clear and not obstructed. Items not left on walkways.
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Area is free of pest activity (eg. Insects, beetles, birds, rodents, droppings, nests, webbing).
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Check documents (records) on display: Confirm no out-of-date documents, confirm version control (eg. Different versions not on display), confirm there are no documents without a date or version number etc.
Observations (Good or Bad)
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Observation 1.
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Observation 2.
ProBatch Control Room
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Area is free of obsolete items, rubbish etc
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Electrical leads have a current test and tag attached, are in good condition (ie not damaged – not frayed, no exposed wires etc).
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Lighting is adequate for the work being undertaken in the area and all lights are functioning.
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Emergency exit doors are not blocked and exit signs are compliant (illuminated or reflective)
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Fire panel displays no active impairments or alerts, or if it does, appropriate fire impairment permit is active and in date.
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Emergency evacuation diagram is displayed
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Chemicals / substances are labelled and not stored in unmarked containers / bottles (eg. Not decanted into an unmarked container)
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Signage in good condition (i.e. Not faded or peeling away)
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Walkways clear and not obstructed. Items not left on walkways.
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Area is free of pest activity (eg. Insects, beetles, birds, rodents, droppings, nests, webbing).
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Clean clothing is stored away in the cupboard neatly, dirty clothing bags are contained.
Observations (Good or Bad)
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Observation 1.
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Observation 2.
Male Amenities
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Area is free of obsolete items, rubbish etc.
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Electrical leads have a current test and tag attached, are in good condition (ie not damaged – not frayed, no exposed wires etc).
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Lighting is adequate for the work being undertaken in the area and all lights are functioning.
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Chemicals / substances are labelled and not stored in unmarked containers / bottles (eg. Not decanted into an unmarked container)
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Signage in good condition (i.e. Not faded or peeling away)
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Walkways clear and not obstructed. Items not left on walkways.
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Area is free of pest activity (eg. Insects, beetles, birds, rodents, droppings, nests, webbing).
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Toilet and shower facilities are clean and in good repair.
Observations (Good or Bad)
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Observation 1.
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Observation 2.
Building External
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Area is free of obsolete items, rubbish and bins are not overflowing.
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Lighting is adequate for the work being undertaken in the area and all lights are functioning.
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Entry doors are not blocked or obstructed.
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Signage in good condition (i.e. Not faded or peeling away)
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Walkways clear and not obstructed. Items not left on walkways.
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Area is free of pest activity (eg. Insects, beetles, birds, rodents, droppings, nests, webbing).
Observations (Good or Bad)
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Observation 1.
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Observation 2.
Audit Completion
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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 leadership team.
