GMP Audit - Tote Wash

• Site conducted

  Select

• Document No.

• Audit Title

• Client / Site

• Conducted on

  Date

• Prepared by

• Location
  Address

• Personnel

PPE

• PPE available & stocked accordingly prior to entering tote wash

  Compliant

  Non Compliant

• Staff wearing hair nets correctly with no exposed hair evident

  Compliant

  Non Compliant

• Company uniforms worn and in clean / sound condition

  Compliant

  Non Compliant

• No loose items worn that could enter totes during cleaning

  Compliant

  Non Compliant

• No inappropriate jewellery / cosmetics worn by staff (earring, watches, necklace, false fingernails)

  Compliant

  Non Compliant

• Staff complying to Eating / Drinking GMP policy: No eating, drinking (apart from supplied drinking water fountains / cups) or chewing in production area

  Compliant

  Non Compliant

Grounds

• Area clean and tidy with no evidence of waste, debris &/or gross build up

  Yes

  No

  N/A

• Tools & storage equipment are clean & in good condition and stored appropriately when not in use

  Yes

  No

  N/A

• Returned Tote storage area is clean & tidy no evidence of waste, debris &/or gross build up

  Yes

  No

  N/A

• Area maintained so that pest harbourage is not evident. That is: storage of abundant equipment, excessive growth weeds / grass

  Yes

  No

  N/A

• Cleaning tools are available, adequate, properly stored and clean when not in use

  Compliant

  Non Compliant

Plant Room

• Area clean and tidy. No evidence of gross build up. Includes but not exclusive to: walls, ceiling, fixtures, power points, processing tables, equipment, containers / tubs etc.

  Yes

  No

  N/A

• Area in good condition with no major evidence of damage to walls, fixture, flaking paint etc

  Yes

  No

  N/A

• Tools are clean & in good condition and stored appropriately when not in use

  Yes

  No

  N/A

• General waste not lying on floor

  Compliant

  Non Compliant

• Cleaning tools are available, adequate, properly stored and clean when not in use

  Yes

  No

  N/A

• Chemicals correctly stored, secured and identified

  Yes

  No

  N/A

Tote Wash Area

• Area clean and tidy. No evidence of gross build up. Includes but not exclusive to: walls, ceiling, fixtures, power points, processing tables, equipment, containers / tubs etc.

  Yes

  No

  N/A

• Area in good condition with no major evidence of damage to walls, fixture, flaking paint etc

  Yes

  No

  N/A

• Tote wash machinery, pipework in sound working condition with no evidence of damage &/or leakage etc.

  Safe

  At Risk

  N/A

• Tools are clean & in good condition and stored appropriately when not in use

  Yes

  No

  N/A

• Underside of equipment is clean with no evidence of gross build up (tables, trolleys, tubs, bins, pipework)

  Yes

  No

  N/A

• No evidence of condensation

  Compliant

  Non Compliant

• General waste not lying on floor. Waste bins not full and overflowing

  Compliant

  Non Compliant

• No evidence of pest activity

  Compliant

  Non Compliant

• Pest insect units operational

  Yes

  No

  N/A

• Plastic drinking bottles & wooden items excluded from area (i.e. brooms, tools). Note: Wooden pallets allowed to store finished products

  Compliant

  Non Compliant

• Loose items / tools stored correctly to minimise risk of entering totes (i.e. tools, rubber gaskets)

  Yes

  No

  N/A

• No cross contamination issues detected during audit (i.e. during cleaning)

  Compliant

  Non Compliant

• Cleaning chemicals correctly stored, secured and identified

  Yes

  No

  N/A

• Chemical soak tubs used for parts are clean, identified and filled accordingly to soak equipment appropriately

  Yes

  No

  N/A

• Tubs, containers, buckets etc. are used for correct purpose

  Yes

  No

  N/A

• Tubs, containers, buckets etc. are in good condition & clean with no evidence of gross build up

  Yes

  No

  N/A

• All access doors in working order & closed when not in use / no gaps to allow entry of pests to tote wash

  Yes

  No

  N/A

• Section compliant to 5s

  Good

  Fair

  Poor

  N/A

• Light fixtures in working condition & provide sufficient lighting and are secured with no evidence of damage / breakage

  Yes

  No

  N/A

• Tote storage area is clean & tidy

  Yes

  No

  N/A

• Totes are correctly stacked according to prescribed work instruction AFCIP-WI-0003 & display document posted & available

  Safe

  At Risk

  N/A

• Cleaning master schedule (AFQA-F-0021) in place, available & completed correctly for tote wash section

  Yes

  No

Tote Wash Verification - Auditor to sight totes during cleaning cycle

• Internally inspect totes post CIP cycle for cleanliness (ensure operator has confirmed they have been cleaned, inspected & ready for SIP). Record tote / station ID number(s) & tote wash operator.

  Compliant

  Non Compliant

• Plastic cap is covering the hansen fittings during steaming (SIP) to avoid cooling water penetratinginto the connection

  Compliant

  Non Compliant

  5s to be implemented

• Micro lid filters are tested (tagged) for integrity at each 5th rotation.

  Yes

  No

  N/A

• Every Tote is checked for leakage post sterilisation (SIP)

  Compliant

  Non Compliant