Housekeeping Audit

• Conducted on

  Date

• Audit Completed by

Lockers

• Locker area free from food and drink items

  Yes

  No

  N/A

• Areas Audited

  Select

• Is the floor clear from plastic, wood shards, tape, rubbish etc.?

  Yes

  No

  N/A

• Are the wall intersections and behind the racking clear from rubbish and debris?

  Yes

  No

  N/A

• Is the ceiling in good condition?

  Yes

  No

  N/A

• Are all components, raw materials, IBCs and barrels clearly labelled with the correct Goods In label?

  Yes

  No

  N/A

• Are all finished goods labelled with a pallet flag with the correct batch information?

  Yes

  No

  N/A

• Is all stock covered with a pallet topper?

  Yes

  No

  N/A

• Are all part boxes sealed with yellow part box tape and clearly labelled?

  Yes

  No

  N/A

• Have all part boxes been returned to their correct locations?

  Yes

  No

  N/A

• Are all glass pallets identified with a yellow sticker?

  Yes

  No

  N/A

• Are all components, raw materials, IBCs and barrels in the correct locations - scan 5 locations on the handheld scanner and upload picture of each location?

  Media

• Are pallets in good condition? With no signs of chips, splinters, damage or damp?

  Yes

  No

  N/A

• Are products stored separately and with a clear divide?

  Yes

  No

  N/A

• All pallets containing stock at minimum 2 feet away from wall?

  Yes

  No

  N/A

• Do pallets appear to be safely stacked with no signs of leaning or major damage?

  Yes

  No

  N/A

• Are unattended Fork Lift Trucks stored correctly and safely? (not on paths, forks are on floor and no keys in the ignition)

  Yes

  No

  N/A

• Are all pest control boxes present, facing the right way up, free from damage and in the correct locations?

  Yes

  No

  N/A

• Is the pallet wrapper equipment maintenance form up-to-date and free from doc errors?

  Yes

  No

  N/A

• Is the Forklift checklist form up-to-date and free from doc errors?

  Yes

  No

  N/A

• Is the shelf containing labels, tidy and organised with all label stock clearly labelled with a Goods In label?

  Yes

  No

  N/A

• Are hazardous items stored in the COSHH cabinets?

  Yes

  No

  N/A

• Are COSHH cabinets free from damage and are labelled with H&S signage?

  Yes

  No

  N/A

• Are spill kits present and contain all required items?

  Yes

  No

  N/A

• Are all notices in-tact and present?

  Yes

  No

  N/A

• Has PMM been performed for the pallet wrapper?

  Yes

  No

  N/A

• Is the ceiling free from debris, holes and no signs of leakage?

  Yes

  No

  N/A

• Are all temperature data loggers present and in the correct locations?

  Yes

  No

  N/A

• All stock (raw materials, IBCs, components and barrels) in good condition? No signs of damage?

  Yes

  No

  N/A

• Racking in good condition? No signs of damage?

  Yes

  No

  N/A

• Roller shutter door in good condition? No signs of light?

  Yes

  No

  N/A

• Are all EFKs working and operational?

  Yes

  No

  N/A

• Are all fire exits and pathways clear?

  Yes

  No

  N/A

• Is the cleaning station organised and tidy?

  Yes

  No

  N/A

• Are all products in the quarantine area clearly labelled (red wrapped and/or with a status label)?

  Yes

  No

  N/A

• Is the consumable room tidy and organised?

  Yes

  No

  N/A

• Are all items in the consumable room identifiable with a label?

  Yes

  No

  N/A

• Are there high visible jackets available for use by the entrance?

  Yes

  No

  N/A

• Is the warehouse porch free from debris, items and rubbish?

  Yes

  No

  N/A

• Does the warehouse entrance door close and lock properly?

  Yes

  No

  N/A

• Is the maintenance workshop door locked?

  Yes

  No

  N/A

• Is the gowning hub by the sterile entrance fully stocked with hair nets and beard snoods?

  Yes

  No

  N/A

• Is the hand dispenser by the sterile entrance full and intact?

  Yes

  No

  N/A

• Hand wash dispenser is full off soap by sink?

  Yes

  No

  N/A

• RO Plant is free of loose items?

  Yes

  No

  N/A

• Are all IPA bottles in sterile packing area labelled with COSHH symbols and the correct chemical name?

  Yes

  No

  N/A

• Are pallets containing components, raw materials a minimum 2 feet away from the wall?

  Yes

  No

  N/A

• Sterile packing area is free from loose tools?

  Yes

  No

  N/A

• Is the sterile packing floor clear for any dirt, debris and/or rubbish?

  Yes

  No

  N/A

• Are pallets containing finished stock clearly labelled with a pallet flag with the correct batch information?

  Yes

  No

  N/A

• Are pallets containing raw materials and/or components covered with a pallet topper and/or sealed?

  Yes

  No

  N/A

• Are pallets free from damage, chips, splinters, debris and damp?

  Yes

  No

  N/A

• Do pallets containing raw materials and components contain the correct Goods In label?

  Yes

  No

  N/A

• Are all part boxes sealed with yellow part box tape and labelled with the correct information?

  Yes

  No

  N/A

• Are pallets containing components and/or raw materials are stored separately with a clear divide between items?

  Yes

  No

  N/A

• Are all pest control bait boxes free from damage, facing the right way up and in the correct locations?

  Yes

  No

  N/A

• Are all EFKs operational and free from damage?

  Yes

  No

  N/A

• Are all walk way pathways in the sterile packing area clear from obstructions?

  Yes

  No

  N/A

• Is the radio in-tact and free from damage?

  Yes

  No

  N/A

• Are all waste bins in the sterile packing area free from buildup and appear hygienic?

  Yes

  No

  N/A

• Are all staff in sterile packing areas are gowned correctly? (Hair net, beard snood (if required), gloves and a white packing coat)

  Yes

  No

  N/A

• Is the maintenance checklist form for the sterile coder up-to-date and free from doc errors?

  Yes

  No

  N/A

• Sterile packing area is free from unattended /unlabeled knives or sharps observed in sterile packing areas?

  Yes

  No

  N/A

• Is the blade control form up-to-date and free from doc errors?

  Yes

  No

  N/A

• Is the plaster register form up-to-date and free from doc errors?

  Yes

  No

  N/A

• Is the personnel eye wear form up-to-date and free from doc errors?

  Yes

  No

  N/A

• General fabrication of the sterile production unit is in good condition? (e.g. no holes in walls, no unattached doors etc.)

  Yes

  No

  N/A

• The roller shutter door at the back of the sterile packing area is in good condition? (No signs of damage or light)

  Yes

  No

  N/A

• The roller shutter door near the entrance of the sterile packing area is in good condition? (No signs of damage or light)

  Yes

  No

  N/A

• Are plastic flaps on the roller shutter door near the entrance of sterile production intact and free from damage?

  Yes

  No

  N/A

• Is the balance used in sterile packing calibrated?

  Yes

  No

  N/A

• Is the stock stored on the sterile mezzenene clearly labelled and segregated?

  Yes

  No

  N/A

• Is the yellow consumable cupboard fully stocked with all the required items?

  Yes

  No

  N/A

• Is the yellow COSHH cabinet free from damage and clearly labelled with all H&S signage?

  Yes

  No

  N/A

• Is the shadow board in the sterile packing area complete with the correct colored items?

  Yes

  No

  N/A

• Are all chemicals in the QC lab clearly labelled and in date?

  Yes

  No

  N/A

• QC Lab is free from open or exposed EM plates?

  Yes

  No

  N/A

• Is the balance in the QC lab calibrated?

  Yes

  No

  N/A

• Is the cleaning station in-tact in the QC lab area?

  Yes

  No

  N/A

• Are all Work Instructions present and up-to-date in the folder stored in the QC lab area?

  Yes

  No

  N/A

• Are all MSDS present for all chemicals used in the QC lab area?

  Yes

  No

  N/A

• Are all bins in the QC lab area free from buildup and appear hygienic?

  Yes

  No

  N/A

• Does the QC lab area appear tidy and organised?

  Yes

  No

  N/A

• Are the hand sanitizer dispensers at every entrance in the cleanroom facility full and intact?

  Yes

  No

  N/A

• Is the gowning hub in Gowning Room D full of hair nets, beard snoods and gloves?

  Yes

  No

  N/A

• Is there enough white gowns or white disposable gowns present in Gowning Room D?

  Yes

  No

  N/A

• Do the white clogs in Gowning Room D appear clean and free from damage?

  Yes

  No

  N/A

• Is the mirror in Gowning Room D free from damage and intact?

  Yes

  No

  N/A

• Does Gowning Room D appear clean and tidy?

  Yes

  No

  N/A

• Do the surfaces (tables, top of tanks, top of balances, top of kettles etc.) in Mixing Room C appear clean, free from dust and free from powders?

  Yes

  No

  N/A

• Does the floor in Mixing Room C appear clean, free from powders, dirt and debris?

  Yes

  No

  N/A

• Are the correct cleaning items present in Mixing Room C and are in-date?

  Yes

  No

  N/A

• Are all items in the metal cabinet in Mixing Room C are present as stated on form QF:057?

  Yes

  No

  N/A

• Are all cleaning equipment present and free from debris in Mixing Room C?

  Yes

  No

  N/A

• Is the balance calibrated in Mixing Room C?

  Yes

  No

  N/A

• Are there sufficient supply of blue gowns or disposable gowns in Gowning Room B?

  Yes

  No

  N/A

• Do the blue clogs appear clean and free from damage?

  Yes

  No

  N/A

• Is the mirror in-tact and free from damage in Gowning Room B?

  Yes

  No

  N/A

• Are lockers and locker doors in-tact and free from damage?

  Yes

  No

  N/A

• Does the step-over bench (top and underneath) in Gowning Room B appear clean and free from dirt?

  Yes

  No

  N/A

• Is there Prochlor present in Gowning Room B? And is it in date?

  Yes

  No

  N/A

• Does the floor in Gowning Room B appear clean, free from powders, dirt and debris?

  Yes

  No

  N/A

• Does gowning hub in Gowning Room B contain all the correct sized gloves?

  Yes

  No

  N/A

• Are all laminar flow units fully operational in Filling Room A?

  Yes

  No

  N/A

• Do all surfaces (filling room tables, scales tables, tops of balances, sides of laminar flow units, top of cabinets) in Filling Room A appear clean, free from spillages and free from debris?

  Yes

  No

  N/A

• Does the floor in Filling Room A appear clean, free from powders, dirt and debris?

  Yes

  No

  N/A

• Are there any loose items on the tables or the floor in Filling Room A?

  Yes

  No

  N/A

• Are the correct cleaning items present as per SM-003 Appendix 1? And in date?

  Yes

  No

  N/A

• Are all items in the metal cabinet in Filling Room A present as stated on form QF-057?

  Yes

  No

  N/A

• Do the dollies, product boxes, baskets and jugs appear intact, clean and free from damage?

  Yes

  No

  N/A

• Does the cleaning station in Filling Room A contain the correct colored cleaning items and appear hygienic?

  Yes

  No

  N/A

• Is the main HEPA and air handling filters in the ceiling in Filling Room A free from dust and debris?

  Yes

  No

  N/A

• Is the intercom intact and operational in Filling Room A?

  Yes

  No

  N/A

• Any signs of broken equipment or temporary engineering in Filling Room A?

  Yes

  No

  N/A

• Has PMM been completed for all equipment in cleanroom areas?

  Yes

  No

  N/A

• Are all staff gowned correctly as per ISO requirements in the cleanroom?

  Yes

  No

  N/A

• Are all bins in the clean room facility free from build-up and appear hygienic?

  Yes

  No

  N/A

• General fabrication for clean room facility is in good condition? ( no signs of holes in walls, misplaced ceiling tiles, broken doors etc.)

  Yes

  No

  N/A

• Is the pressure for each gauges in the clean room area in the correct specification?

  Yes

  No

  N/A

• Are all balances in Filling Room A calibrated?

  Yes

  No

  N/A

• Are all data loggers present in the cleanroom facility in tact, in the correct locations and free from damage?

  Yes

  No

  N/A

• Are all notices on the correct QF form (QF-072) and intact?

  Yes

  No

  N/A

• Is the BMR up-to-date as per GDocP with all processes which have been performed at the time this audit was performed?

  Yes

  No

  N/A

• Is the gowning room near the entrance to downstairs non-sterile area full of beard snoods and hair nets?

  Yes

  No

  N/A

• Are there white gowns present which state Non-sterile?

  Yes

  No

  N/A

• Does the Non-sterile lobby area appear clean and tidy?

  Yes

  No

  N/A

• Does the downstairs Non-sterile warehouse floor appear clean, free from dirt and debris?

  Yes

  No

  N/A

• Are pallets containing raw materials and components clearly labelled with the correct Goods In label?

  Yes

  No

  N/A

• Are pallets containing finished goods clearly labelled with a pallet flag containing the correct batch information?

  Yes

  No

  N/A

• Are pallets containing raw materials, components and finished goods clearly segregated?

  Yes

  No

  N/A

• Are there any wooden pallets which DO NOT contain finished goods behind the flaps directly in production areas?

  Yes

  No

  N/A

• Are pallets in good condition and appear free from chips, damage, splinters and damp?

  Yes

  No

  N/A

• Are the flaps intact, free from damage and appear clean?

  Yes

  No

  N/A

• Is the roller shutter door operational, free and damage and has no signs of light?

  Yes

  No

  N/A

• Are all pest control bait boxes free from damage, facing the right way up and in the correct locations?

  Yes

  No

  N/A

• Are all EFKs operational and free from damage?

  Yes

  No

  N/A

• Are heat jackets neatly hung up on rails in the downstairs Non-sterile area?

  Yes

  No

  N/A

• Does the cleaning station in the Non-sterile warehouse area contain the correct colored items and appear hygienic?

  Yes

  No

  N/A

• Are part boxes labelled with yellow part box tape and labelled with the correct information?

  Yes

  No

  N/A

• Are all fire exits and pathways free from obstructions?

  Yes

  No

  N/A

• Is the radio in-tact and free from damage?

  Yes

  No

  N/A

• Are stock present in the downstairs non-sterile area relevant to what is being manufactured?

  Yes

  No

  N/A

• Are all bins in downstairs Non-sterile production areas free from build-up and appear hygienic?

  Yes

  No

  N/A

• Area is free from unattended sharps or knives?

  Yes

  No

  N/A

• Is the blade control form up-to-date and free from doc errors?

  Yes

  No

  N/A

• Non-sterile warehouse area is free from loose items or loose tools?

  Yes

  No

  N/A

• FL-14 line is free from loose items or tools?

  Yes

  No

  N/A

• Has PMM been completed for all equipment and machinery in the downstairs Non-sterile area?

  Yes

  No

  N/A

• Have all maintenance checklist forms for the FL-14 line, Capping Machine, Labeller and Trak Wrap been completed and free from doc errors?

  Yes

  No

  N/A

• Is the IBC or Barrel connected to the FL-14 line labelled with the correct Goods In label?

  Yes

  No

  N/A

• Does the FL-14 line appear operational, clean and free from debris?

  Yes

  No

  N/A

• No signs of damage or temporary engineering to any of the equipment in the downstairs Non-sterile area?. Equipment is in good condition?

  Yes

  No

  N/A

• Are all WIs relevant to the Non-sterile production area present and up-to-date?

  Yes

  No

  N/A

• Are all notices on the correct QF form (QF-072) and intact?

  Yes

  No

  N/A

• Is the balance and weight sets by the FL-14 line calibrated?

  Yes

  No

  N/A

• Are all IPA bottles labelled with the correct COSHH symbols and the correct chemical name?

  Yes

  No

  N/A

• Does the production notice near the FL-14 line align with what is stated on the BMR

  Yes

  No

  N/A

• Are turntables and stock covered with pallet toppers when the FL-14 line is not operational?

  Yes

  No

  N/A

• Does the glove station contain enough boxes of gloves with the correct sizes?

  Yes

  No

  N/A

• Does the floor near the FL-14 line appear clean and free from dirt and debris?

  Yes

  No

  N/A

• Does the CIP tank appear intact, free from damage and in the correct location?

  Yes

  No

  N/A

• Downstairs Non-sterile production areas free from loose, dirty and un-bagged pipework

  Yes

  No

  N/A

• Does the FL800D line appear operational, clean and free from debris?

  Yes

  No

  N/A

• Is the Barrel connected to the FL800D line labelled with the correct Goods In label?

  Yes

  No

  N/A

• Is the tank connected to the FL800D line sealed, free from damage and appears clean?

  Yes

  No

  N/A

• FL800D line and Ear Care room free from loose items and/or tools?

  Yes

  No

  N/A

• Does the cleaning station in the Ear Care room contain all the correct colored cleaning items and appears hygienic?

  Yes

  No

  N/A

• Are the fly screens intact and free from damage?

  Yes

  No

  N/A

• Does the production notice near the FL800D line align with what is stated on the BMR?

  Yes

  No

  N/A

• Does the floor near the FL800D line appear clean and free from dirt and debris?

  Yes

  No

  N/A

• Is the balance used near the FL800D line calibrated?

  Yes

  No

  N/A

• Have all maintenance checklist forms been filled out for the FL800D line and free from doc errors?

  Yes

  No

  N/A

• Are all vibration bowls empty and covered with pallet toppers when the FL800D line is not operational?

  Yes

  No

  N/A

• Totes and/or shippers used in downstairs Non-sterile production areas are ion good condition?

  Yes

  No

  N/A

• Are all temperature data loggers intact, free from damage and in the correct locations?

  Yes

  No

  N/A

• Monitors or screens used in the downstairs Non-sterile area are in good condition? No signs of damage

  Select Yes No N/A

  • Yes
  • No
  • N/A

• Are all staff working in downstairs Non-sterile production areas gowned correctly?

  Yes

  No

  N/A

• Are BMRs in downstairs Non-sterile up-to-date with the processes which have been performed at the time this audit was performed?

  Yes

  No

  N/A

• Is the the general fabrication in the downstairs Non-sterile area appear intact and with no signs of damage? (holes in walls, doors not operational, loose ceiling tiles etc.)

  Yes

  No

  N/A

• Is the gowning hub upon entry to the upstairs Non-sterile area full of beard snoods, gloves and hair nets?

  Yes

  No

  N/A

• Does the Non-sterile store room appear organised and tidy?

  Yes

  No

  N/A

• Non-sterile store room is free from loose, un-bagged, unclean pipework?

  Yes

  No

  N/A

• Chemicals in Non-sterile store room are labelled and in-date?

  Yes

  No

  N/A

• Is the floor in the Non-sterile store room appears clean and free from debris?

  Yes

  No

  N/A

• Does the floor in the vapour room appear clean, free from dirt and debris?

  Yes

  No

  N/A

• Does the production notice in the vapour room align with whats stated on the BMR?

  Yes

  No

  N/A

• Have the maintenance checklist form been completed for the equipment present in the vapour room and free from doc errors?

  Yes

  No

  N/A

• Is the barrel connected to the PF6/PF7 in the vapour room contain the correct Goods In label?

  Yes

  No

  N/A

• Do the vapour overflow barrels contain a OF-049 form which is up-to-date and free from doc errors?

  Yes

  No

  N/A

• Are the fly screens intact and free from damage in upstairs Non-sterile production areas?

  Yes

  No

  N/A

• Are pallets in the upstairs Non-sterile area containing raw materials and components clearly labelled with the correct Goods In label?

  Yes

  No

  N/A

• Are pallets in the upstairs Non-sterile area containing finished goods clearly labelled with a pallet flag containing the correct batch information?

  Yes

  No

  N/A

• Are pallets in the upstairs Non-sterile area containing raw materials, components and finished goods clearly segregated?

  Yes

  No

  N/A

• Wooden pallets contain finished goods in upstairs Non-sterile directly near production areas, ONLY?

  Yes

  No

  N/A

• Are pallets in good condition and appear free from chips, damage, splinters and damp?

  Yes

  No

  N/A

• Are the flaps in upstairs Non-sterile areas intact, free from damage and appear clean?

  Yes

  No

  N/A

• Does the loading gate appear operational, safe and free from damage?

  Yes

  No

  N/A

• Is the floor in the main upstairs Non-sterile production area clean, free from dirt and debris?

  Yes

  No

  N/A

• Do the production notices in the main upstairs Non-sterile production areas align with what is stated on the BMR?

  Yes

  No

  N/A

• Have the maintenance checklist form been completed for the equipment present in the main upstairs production area and free from doc errors?

  Yes

  No

  N/A

• Are the radios in the upstairs Non-sterile production areas intact and free from damage?

  Yes

  No

  N/A

• Are all bins in upstairs Non-sterile production areas free from build-up and appear hygienic?

  Yes

  No

  N/A

• Have the PMMs been completed for all equipment in the upstairs Non-sterile production areas?

  Yes

  No

  N/A

• Upstairs Non-sterile production areas free from loose items and tools?

  Yes

  No

  N/A

• Are all staff operating in upstairs Non-sterile production areas gowned correctly?

  Yes

  No

  N/A

• Is the the general fabrication in the upstairs Non-sterile area appear intact and with no signs of damage? (holes in walls, doors not operational, loose ceiling tiles etc.)

  Yes

  No

  N/A

• Doors and/or windows are closed in all of the Non-sterile production areas? (Unless open with a fly screen intact)

  Yes

  No

  N/A

• Are BMRs in upstairs Non-sterile production up-to-date with the processes which have been performed at the time this audit was performed?

  Yes

  No

  N/A

• Sign upon completion

  Sign