BioTD API Monthly 6S audit

• Document No.

• Audit Title

• Client / Site

• Conducted on

  Date

• Prepared by

• Location
  Address

• Personnel

BSC & Buffer Prep area

Sort

• All unnecessary equipment, furniture, Storage (racks pipette holder etc.) have been removed

  Yes

  No

  N/A

• All unfinished work has been moved away or is clearly identified

  Yes

  No

  N/A

• All unnecessary tools, paperwork, supplies (pipette tips, wipes, stationary) have been removed.

  Yes

  No

  N/A

• Supply cupboard is organised and tidy. Powders on floor are organised and tidy. Bench is organised and Tidy<br>

  Yes

  No

  N/A

• reagent and chemical cabinets are organised and tidy

  Yes

  No

  N/A

• Balance hood is organised and tidy

  Yes

  No

  N/A

Straighten

• Location of bins, consumables, PPE, parts are clearly defined by lines and labels

  Yes

  No

  N/A

• Balances are placed in correct location

  Yes

  No

  N/A

• Tools, Paperwork, Office Supplies are labeled and have a defined location that is visible

  Yes

  No

  N/A

• Floor markings are clearly identified

  Yes

  No

  N/A

Shine

• Used pipette and GMM bins are at an acceptable level (and not overflowing)

  Yes

  No

  N/A

• Work benches are clean and free of debris (including walls and sides)

  Yes

  No

  N/A

• Inside balance area is clean, including sides and free of debris

  Yes

  No

  N/A

• Balances and printers are clean and free of debris

  Yes

  No

  N/A

• Tools are clean and neatly returned to designated areas

  Yes

  No

  N/A

• Floors are free from dirt, debris, spills, parts, etc.

  Yes

  No

  N/A

Standardise

• Stock cupboard is stocked to appropriate levels (Pippettes, falcon tubes. filters)

  Yes

  No

  N/A

• BSC PPE is stocked

  Yes

  No

  N/A

• ViCELL reagent pack Kanban is being being followed

  Yes

  No

  N/A

• IPA Kanban is being followed

  Yes

  No

  N/A

• PM/ calibration stickers are in place, in date and are clearly visible (balance, Balance hood, BSC)

  Yes

  No

  N/A

Sustain

• It is evident that the area owner is involved in 6S activities and improvement initiatives

  Bad

  Ok

  Good

  Very Good

• Overall, the principles of 6S look to be understood in the area

  Yes

  No

  N/A

Safety

• Is all BSC PPE readily available

  Yes

  No

  N/A

• Are emergency procedures and equipment clearly visible/ accessible

  Yes

  No

  N/A

• Are doorways and walkways kept clear and free from obstruction

  Yes

  No

  N/A

Fume hood, back sink, buffer rack

Sort

• All unnecessary equipment, furniture, Storage (racks pipette holder etc.) have been removed

  Yes

  No

  N/A

• All unfinished work has been moved away or is clearly identified

  Yes

  No

  N/A

• All unnecessary tools, paperwork, supplies (pipette tips, wipes, stationary) have been removed.

  Yes

  No

  N/A

• UFDF Cupboard and shelf is organised and tidy

  Yes

  No

  N/A

• Sink (including underneath) is organised and tidy

  Yes

  No

  N/A

• Fume hood is organised and tidy

  Yes

  No

  N/A

• Buffer rack is organised and tidy

  Yes

  No

  N/A

Straighten

• Equipment in fume hood (including racks) is identified and placed in correct location

  Yes

  No

  N/A

Shine

• UFDF bench is clean and free of debris (including splash guards, back of fume hood and under sink)

  Yes

  No

  N/A

• Fume hood is clean and free from splashes

  Yes

  No

  N/A

• Equipment in fume hood is clean and free from splashes

  Yes

  No

  N/A

• Sink area is all clean and free of debris (including splash guards and under sink)

  Yes

  No

  N/A

• Floors are free from dirt, debris, spills, parts, etc

  Yes

  No

  N/A

Standardise

• In date PM/ calibration stickers are in place for pH and Conductivity meter and fume hood

  Yes

  No

  N/A

• Buffers on buffer rack are all labeled and within date

  Yes

  No

  N/A

• Visual and written aids are used within the area (photos, checklists, diagrams)

  Yes

  No

  N/A

Sustain

• It is evident that the area owner is involved in 6S activities and improvement initiatives

  Bad

  Ok

  Good

  Very Good

• Overall, the principles of 6S look to be understood in the area

  Yes

  No

  N/A

Safety

• All PPE (lab apron, green gloves, visor) are all available/accessible

  Yes

  No

  N/A

• Are emergency procedures and equipment clearly visible/accessible

  Yes

  No

  N/A

• Are doorways and walkways kept clear and free from obstruction

  Yes

  No

  N/A

AKTAs

Sort

• All unnecessary equipment, furniture, Storage (racks, pipette holder etc.) have been removed

  Yes

  No

  N/A

• All unfinished work has been removed or is clearly identified

  Yes

  No

  N/A

• All unnecessary tools, paperwork, supplies (pipette tips, wipes, stationary) have been removed.

  Yes

  No

  N/A

• AKTA drawers are organised and Tidy

  Yes

  No

  N/A

• AKTA cupboards are organised and tidy

  Yes

  No

  N/A

Straighten

• Tools are placed in defined location

  Yes

  No

  N/A

• Consumables are placed in defined location (pipette tips, wipes, stationary)

  Yes

  No

  N/A

• AKTA computer key boards and mice are placed neatly on bench

  Yes

  No

  N/A

Shine

• GMM bin is at an acceptable level (not overflowing)

  Yes

  No

  N/A

• work benches are clean and free of debris

  Yes

  No

  N/A

• AKTA's are clean and free from debris (including sides and underneath)

  Yes

  No

  N/A

• Tools are clean and neatly returned to designated areas

  Yes

  No

  N/A

• Floor is free from dirt, debris, spills, parts, etc.

  Yes

  No

  N/A

Standardise

• AKTA PM/ calibration stickers are in place, in date and are clearly visible

  Yes

  No

  N/A

• Gloves are stocked and have correct sizes available

  Yes

  No

  N/A

Sustain

• It is evident that the area owner is involved in 6S activities and improvement initiatives

  Bad

  Ok

  Good

  Very Good

• Overall, the principles of 6S look to be understood in the area

  Yes

  No

  N/A

Safety

• Is all necessary PPE available

  Yes

  No

  N/A

• Are emergency procedures and equipment clearly visible/accessible

  Yes

  No

  N/A

• Are doorways and walkways kept clear and free from obstruction

  Yes

  No

  N/A

HPLC, UPLC, DASGIPs

Sort

• All unnecessary equipment, furniture, Storage (racks pipette holder etc.) have been removed

  Yes

  No

  N/A

• All unfinished work has been removed or is clearly identified

  Yes

  No

  N/A

• All unnecessary tools, paperwork, supplies (pipette tips, wipes, stationary) have been removed.

  Yes

  No

  N/A

• UPLC cupboard is organised and tidy<br>

  Yes

  No

  N/A

• Cupboard under Dasgips is organised and tidy

  Yes

  No

  N/A

• Drawers are organised and tidy

  Yes

  No

  N/A

Straighten

• GMM bin, UPLC consumables, PPE, clearly defined by lines and labels

  Yes

  No

  N/A

• HPLC, UPLC, Dasgip computer and Dasgips are identified and placed in a defined location

  Yes

  No

  N/A

• Floor markings are clearly identified

  Yes

  No

  N/A

Shine

• Waste in GMM bin is at an acceptable level

  Yes

  No

  N/A

• Waste levels in sharps bin is at an acceptable level

  Yes

  No

  N/A

• HPLC/UPLC waste duran is at an acceptable level

  Yes

  No

  N/A

• Work surfaces/ Equipment are clean and free of debris and splashes (including walls)

  Yes

  No

  N/A

• Tools are clean and neatly returned to designated areas

  Yes

  No

  N/A

• Floors are free from dirt, debris, spills, parts, etc.

  Yes

  No

  N/A

Standardise

• Leur lock syringes and alcohol wipes are stocked

  Yes

  No

  N/A

• HPLC consumables are stocked

  Yes

  No

  N/A

• HPLC, UPLC and Dasgip PM/Calibration stickers are visable and in date

  Yes

  No

  N/A

Sustain

• It is evident that the area owner is involved in 6S activities and improvement initiatives

  Bad

  Ok

  Good

  Very Good

• Overall, the principles of 6S look to be understood in the area

  Yes

  No

  N/A

Safety

• Gloves are available (and appropriate sizes are also available)

  Yes

  No

  N/A

• Are emergency procedures and equipment clearly visible/ accessible

  Yes

  No

  N/A

• Are doorways and walkways kept clear and free from obstruction

  Yes

  No

  N/A

Glassware, SoloVPE, Printers

Sort

• All unnecessary equipment, furniture, Storage, paperwork has been removed

  Yes

  No

  N/A

• All unfinished work has been removed or is clearly identified

  Yes

  No

  N/A

• All unnecessary paper/printer consumables have been removed

  Yes

  No

  N/A

Straighten

• Printer shelves are organised and tidy

  Yes

  No

  N/A

• Glassware cabinet is organised with glassware in its designated area

  Yes

  No

  N/A

• Solovp cupboard is organised and tidy

  Yes

  No

  N/A

Shine

• Solovp is clean and free from spills/splashes

  Yes

  No

  N/A

• Bench is clean and free of debris

  Yes

  No

  N/A

• Waste levels in sharps bin is at an acceptable level

  Yes

  No

  N/A

Standardise

• SoloVP consumables are stocked and readily available

  Yes

  No

  N/A

• All printers are working and ready to use (with correct label size)

  Yes

  No

  N/A

• PM/ calibration stickers are in place, in date and are clearly visible

  Yes

  No

  N/A

Sustain

• It is evident that the area owner is involved in 6S activities and improvement initiatives

  Bad

  Ok

  Good

  Very Good

• Overall, the principles of 6S look to be understood in the area

  Yes

  No

  N/A

Safety

• Is there sufficient amount of spill mat available

  Yes

  No

  N/A

• Are emergency procedures and equipment clearly visible/ accessible

  Yes

  No

  N/A

• Are doorways and walkways kept clear and free from obstruction

  Yes

  No

  N/A

Bioreactor build area

Sort

• All unnecessary equipment, furniture, Storage (racks pipette holder etc.) have been removed

  Yes

  No

  N/A

• All unfinished work has been removed or is clearly identified

  Yes

  No

  N/A

• All unnecessary tools, paperwork, supplies (pipette tips, wipes, stationary) have been removed.

  Yes

  No

  N/A

• Cupboards are organised and tidy

  Yes

  No

  N/A

• Drawers are organised and tidy

  Yes

  No

  N/A

Straighten

• Tools are returned to holder and are organised

  Yes

  No

  N/A

• Lab folders are organised and tidy

  Yes

  No

  N/A

• Bioreactor components are placed in correct drawers

  Yes

  No

  N/A

Shine

• Benches are clean and free from debris

  Yes

  No

  N/A

• Tools are clean

  Yes

  No

  N/A

• Floors are free from dirt, debris, spills, parts, etc.

  Yes

  No

  N/A

Standardise

• Reactor tubing is stocked

  Yes

  No

  N/A

• Tie wraps are stocked

  Yes

  No

  N/A

• Autoclave bags stocked

  Yes

  No

  N/A

Sustain

• It is evident that the area owner is involved in 6S activities and improvement initiatives

  Bad

  Ok

  Good

  Very Good

• Overall, the principles of 6S look to be understood in the area

  Yes

  No

  N/A

Safety

• Tubing grip gloves are available

  Yes

  No

  N/A

• Are emergency procedures and equipment clearly visible/ accessible

  Yes

  No

  N/A

• Are doorways and walkways kept clear and free from obstruction

  Yes

  No

  N/A

5L Bioreactor area

Sort

• All unnecessary equipment, furniture, Storage (racks pipette holder etc.) has been removed

  Yes

  No

  N/A

• All unfinished work has been removed or is clearly identified

  Yes

  No

  N/A

• All unnecessary tools, paperwork, supplies (syringes, IPA wipes etc.) have been removed.

  Yes

  No

  N/A

• Drawers are organised<br>

  Yes

  No

  N/A

• Cupboards are organised

  Yes

  No

  N/A

Straighten

• GMM liquid and GMM waste bins, PPE and sampling consumables are clearly defined by lines and labels

  Yes

  No

  N/A

• Equipment, Machines, Furniture, Racking is identified and placed in a defined location

  Yes

  No

  N/A

• Tools, Paperwork, Office Supplies are labeled and have a defined location that is visible

  Yes

  No

  N/A

• Floor markings are clearly identified

  Yes

  No

  N/A

Shine

• GMM bins are at an acceptable level

  Yes

  No

  N/A

• Work surfaces/ Equipment are clean and free of debris and splashes (including walls)

  Yes

  No

  N/A

• Tools are clean and neatly returned to designated areas

  Yes

  No

  N/A

• Floors are free from dirt, debris, spills, parts, etc.

  Yes

  No

  N/A

Standardise

• Drawers are stocked (sample lines, syringes, alcohol wipes and pump tubing)

  Yes

  No

  N/A

• Leur lock syringes and Alcohol wipes stocked

  Yes

  No

  N/A

• PM/ calibration stickers are in place, in date and are clearly visible

  Yes

  No

  N/A

• Visual and written aids are used within the area (photos, checklists, diagrams)

  Yes

  No

Sustain

• It is evident that the area owner is involved in 6S activities and improvement initiatives

  Bad

  Ok

  Good

  Very Good

• Overall, the principles of 6S look to be understood in the area

  Yes

  No

  N/A

Safety

• Is all appropriate PPE available (gloves)

  Yes

  No

  N/A

• Are emergency procedures and equipment clearly visible/ accessible

  Yes

  No

  N/A

• Are doorways and walkways kept clear and free from obstruction

  Yes

  No

  N/A

10L Bioreactor area

Sort

• All unnecessary equipment, furniture, Storage (racks pipette holder etc.) has been removed

  Yes

  No

  N/A

• All unfinished work has been removed or is clearly identified

  Yes

  No

  N/A

• All unnecessary tools, paperwork, supplies (syringes, IPA wipes etc.) have been removed.

  Yes

  No

  N/A

• Cupboards are organised and tidy

  Yes

  No

  N/A

• Perfusion equipment is neatly stored under benches

  Yes

  No

  N/A

Straighten

• Equipment, Machines, Furniture, Racking is identified and placed in a defined location

  Yes

  No

  N/A

• Tools, Paperwork, Office Supplies are labeled and have a defined location that is visible

  Yes

  No

  N/A

Shine

• Work surfaces/ Equipment are clean and free of debris and splashes (including walls)

  Yes

  No

  N/A

• Tools are clean and neatly returned to designated areas

  Yes

  No

  N/A

• Floors are free from dirt, debris, spills, parts, etc.

  Yes

  No

  N/A

• Is Hazardous bin waste at an acceptable level

  Yes

  No

  N/A

Standardise

• PM/ calibration stickers are in place, in date and are clearly visible

  Yes

  No

  N/A

Sustain

• It is evident that the area owner is involved in 6S activities and improvement initiatives

  Bad

  Ok

  Good

  Very Good

• Overall, the principles of 6S look to be understood in the area

  Yes

  No

  N/A

Safety

• Is all appropriate PPE available (gloves)

  Yes

  No

  N/A

• Are emergency procedures and equipment clearly visible/ accessible

  Yes

  No

  N/A

• Are doorways and walkways kept clear and free from obstruction

  Yes

  No

  N/A

Preculture and centrifuge

Sort

• All unnecessary equipment, furniture, Storage (racks pipette holder etc.) has been removed

  Yes

  No

  N/A

• All unfinished work has been removed or is clearly identified

  Yes

  No

  N/A

• All unnecessary tools, paperwork, supplies (syringes, IPA wipes etc.) have been removed.

  Yes

  No

  N/A

• Cupboards are organised and tidy

  Yes

  No

  N/A

Straighten

• Osmo consumables are in the right place

  Yes

  No

  N/A

• Equipment, Machines, Furniture, Racking is identified and placed in a defined location

  Yes

  No

  N/A

• Tools, Paperwork, Office Supplies are labeled and have a defined location that is visible

  Yes

  No

  N/A

• Bench and shelf is clean and free of debris

  Yes

  No

  N/A

• Tools are clean and neatly returned to designated areas

  Yes

  No

  N/A

• Floors are free from dirt, debris, spills, parts, etc.

  Yes

  No

  N/A

• Osmo sharps bin is at an acceptable level

  Yes

  No

  N/A

• PM/ calibration stickers are in place, in date and are clearly visible

  Yes

  No

  N/A

Standardise

• Shake flasks are stocked

  Yes

  No

  N/A

• PM/calibration stickers are in place and visible (Waverockers, GE wave rockers, Ambr, water bath, cO2 incubators, Centrifuges, Osmo)

  Yes

  No

  N/A

Sustain

• It is evident that the area owner is involved in 6S activities and improvement initiatives

  Bad

  Ok

  Good

  Very Good

• Overall, the principles of 6S look to be understood in the area

  Yes

  No

  N/A

Safety

• Is all appropriate PPE available (gloves)

  Yes

  No

  N/A

• Are emergency procedures and equipment clearly visible/ accessible

  Yes

  No

  N/A

• Are doorways and walkways kept clear and free from obstruction

  Yes

  No

  N/A

Cold room

Sort

• All unnecessary trolleys have been removed

  Yes

  No

  N/A

• All old/ unwanted samples have been removed

  Yes

  No

  N/A

• All samples are organised and tidy

  Yes

  No

  N/A

• Liquid medias are organised and tidy

  Yes

  No

  N/A

• Powders are organised and tidy

  Yes

  No

  N/A

Straighten

• all sample are placed in designated area

  Yes

  No

  N/A

Shine

• shelves are clean and free of debris

  Yes

  No

  N/A

• Floors are free from dirt, debris, spills, parts, etc.

  Yes

  No

  N/A

• Medias, powders, walls and shelves are free from mold

  Yes

  No

  N/A

• Mold present

Sustain

• It is evident that the area owner is involved in 6S activities and improvement initiatives

  Bad

  Ok

  Good

  Very Good

• Overall, the principles of 6S look to be understood in the area

  Yes

  No

  N/A

Safety

• Are emergency procedures and equipment clearly visible/ accessible

  Yes

  No

  N/A

• Are doorways and walkways kept clear and free from obstruction

  Yes

  No

  N/A

IPT Room

Sort

• All unnecessary equipment, furniture, Storage (racks pipette holder etc.) has been removed

  Yes

  No

  N/A

• All unfinished work has been removed or is clearly identified

  Yes

  No

  N/A

• All unnecessary tools, paperwork, supplies (syringes, IPA wipes etc.) have been removed.

  Yes

  No

  N/A

• Cupboards under bench are organised and tidy

  Yes

  No

  N/A

• cabinet is organised and tidy

  Yes

  No

  N/A

• Drawers are organised and tidy

  Yes

  No

  N/A

Straighten

• CEDEX cups, ViCell cups and pipette tips have a defined location

  Yes

  No

  N/A

• Equipment, Machines, Furniture, Racking is identified and placed in a defined location

  Yes

  No

  N/A

• Tools, Paperwork, Office Supplies are labeled and have a defined location that is visible

  Yes

  No

  N/A

Shine

• Bench is clean and free from debris

  Yes

  No

  N/A

• Tools are clean and neatly returned to designated areas

  Yes

  No

  N/A

• Floors are free from dirt, debris, spills, parts, etc.

  Yes

  No

  N/A

• GMM bin is at an acceptable level

  Yes

  No

  N/A

• Pipette tip bin is at an acceptable level

  Yes

  No

  N/A

Standardise

• CEDEX cups, ViCELL cups and pipette tips are stocked and available

  Yes

  No

  N/A

• 50ml and 15ml falcon tubes are stocked

  Yes

  No

  N/A

• Back up CEDEX and ViCELL consumables stocked in cupboards

  Yes

  No

  N/A

• bin bags stocked

  Yes

  No

  N/A

• PM/calibration stickers are in place and visible (Waverockers, GE wave rockers, Ambr, water bath, cO2 incubators, Centrifuges, Osmo)

  Yes

  No

  N/A

Sustain

• It is evident that the area owner is involved in 6S activities and improvement initiatives

  Bad

  Ok

  Good

  Very Good

• Overall, the principles of 6S look to be understood in the area

  Yes

  No

  N/A

Safety

• Is all appropriate PPE available (gloves)

  Yes

  No

  N/A

• Are emergency procedures and equipment clearly visible/ accessible

  Yes

  No

  N/A

• Are doorways and walkways kept clear and free from obstruction

  Yes

  No

  N/A

Stockroom

Sort

• All unnecessary equipment, furniture, Storage (racks pipette holder etc.) has been removed

  Yes

  No

  N/A

• All unnecessary tools, paperwork, supplies have been removed.

  Yes

  No

  N/A

• Cupboards are organised and tidy

  Yes

  No

  N/A

• Cupboards are organised and tidy

  Yes

  No

  N/A

• Shelves are organised and tidy

  Yes

  No

  N/A

Straighten

• Osmo consumables are organised and tidy

  Yes

  No

  N/A

• Equipment, Machines, Furniture, Racking is identified and placed in a defined location

  Yes

  No

  N/A

• Tools, Paperwork, Office Supplies are labeled and have a defined location that is visible

  Yes

  No

  N/A

Shine

• Cupboards and shelves are clean and free from debris

  Yes

  No

  N/A

• Floors are free from dirt, debris, spills, parts, etc.

  Yes

  No

  N/A

• Safety Shoes neatly stored in shelving

  Yes

  No

  N/A

Standardise

• Stocks levels are being managed correctly

  Yes

  No

  N/A

• Lab stock is within date (stock rotation happening)

  Yes

  No

  N/A

Sustain

• It is evident that the area owner is involved in 6S activities and improvement initiatives

  Bad

  Ok

  Good

  Very Good

• Overall, the principles of 6S look to be understood in the area

  Yes

  No

  N/A

Safety

• Are emergency procedures and equipment clearly visible/ accessible

  Yes

  No

  N/A

• Are doorways and walkways kept clear and free from obstruction

  Yes

  No

  N/A