Internal QC Audit

• Audit Title

• Document No.

• Client / Site

• Conducted on

  Date

• Prepared by

• Location
  Address

• Personnel

Warehouse #2

• Lot clean and free of debris

  Yes

  No

  N/A

• Free of weeds and other plants

  Yes

  No

  N/A

• No standing water on premises

  Yes

  No

  N/A

• Gate closed when not in use

  Yes

  No

  N/A

• Pest control traps in place and up to date

  Yes

  No

  N/A

• Storage containers closed

  Yes

  No

  N/A

• Doors closed when not in use

  Yes

  No

  N/A

• Packaging quarantine area clean and free of debris

  Yes

  No

  N/A

• Packaging quarantine area chain on when not in use

  Yes

  No

  N/A

• Inside of warehouse is clean and orderly

  Yes

  No

  N/A

• Raw materials stored neatly

  Yes

  No

  N/A

• No spills or broken shrink and/or pallets

  Yes

  No

  N/A

• Raw materials have qc released stickers

  Yes

  No

  N/A

• Raws are sealed and undamaged

  Yes

  No

  N/A

• All floor pallets are a minimum of 12" away from walls

  Yes

  No

  N/A

• Only in-process pallets in the designated area

  Yes

  No

  N/A

• Pallets are identified correctly

  Yes

  No

  N/A

• Pallets are stored neat and orderly

  Yes

  No

  N/A

• Hallways clean

  Yes

  No

  N/A

• Parts sink clean

  Yes

  No

  N/A

• Restroom clean and sanitized

  Yes

  No

  N/A

• Break room clean

  Yes

  No

  N/A

Receiving Department

• Quarantine area locked

  Yes

  No

  N/A

• Quarantine area clean & organized

  Yes

  No

  N/A

• Logs are complete and up to date

  Yes

  No

  N/A

• Paperwork standards

  Yes

  No

  N/A

Quality Control Laboratory

• Lab kept clean and up to date

  Yes

  No

  N/A

• Employees wearing hairnets and labcoats

  Yes

  No

  N/A

• Paperwork standards

  Yes

  No

  N/A

• Logs are up to date and complete

  Yes

  No

  N/A

• Lab notebooks up to date and complete

  Yes

  No

  N/A

• Calibration stickers on all pertinent equipment

  Yes

  No

  N/A

• Scales calibrated and checked daily

  Yes

  No

  N/A

Weighing Department

• Room is clean

  Yes

  No

  N/A

• Floors/walls are clean and undamaged

  Yes

  No

  N/A

• Lights are clean and undamaged

  Yes

  No

  N/A

• Scales are calibrated

  Yes

  No

  N/A

• Workstations kept clean

  Yes

  No

  N/A

• Materials are covered and stored properly

  Yes

  No

  N/A

• Dust collector on while working in room

  Yes

  No

  N/A

• Raws are returned and stored properly to warehouse

  Yes

  No

  N/A

• Paperwork standards

  Yes

  No

  N/A

Tablet Department

• Room is clean

  Yes

  No

  N/A

• Floor/walls are clean and undamaged

  Yes

  No

  N/A

• Tablet press is properly identified

  Yes

  No

  N/A

• In process product is covered and labeled

  Yes

  No

  N/A

• Grinder is properly stored and identified

  Yes

  No

  N/A

• Lights are clean, undamaged and have tube guards

  Yes

  No

  N/A

• Scales are calibrated

  Yes

  No

  N/A

• Tablet paperwork standards

  Yes

  No

  N/A

• Grinder paperwork standards

  Yes

  No

  N/A

• Extra parts/machinery covered and tagged

  Yes

  No

  N/A

Warehouse #1

• Lot is clean and free of debris

  Yes

  No

  N/A

• Lot is free of weeds and other plants

  Yes

  No

  N/A

• No standing water on premises

  Yes

  No

  N/A

• Back gate 1/2 closed

  Yes

  No

  N/A

• Black side door closed

  Yes

  No

  N/A

• Pallets properly labeled and shrunk

  Yes

  No

  N/A

• Clean buckets drying off the floor

  Yes

  No

  N/A

• Finished pallets release and shrunk

  Yes

  No

  N/A

• Lids/buckets stored neatly

  Yes

  No

  N/A

• Door closed when not in use

  Yes

  No

  N/A

• Emergency door accesible

  Yes

  No

  N/A

• Warehouse clean and free of debris

  Yes

  No

  N/A

• Stored items faced and neat

  Yes

  No

  N/A

• All pallets identified with proper tags

  Yes

  No

  N/A

• Empty powder drums stored and labeled

  Yes

  No

  N/A

• Capsule boxes closed and faced

  Yes

  No

  N/A

• Tube guards on lights and all lights working properly

  Yes

  No

  N/A

• Staged items identified

  Yes

  No

  N/A

• In process capsules labeled and stored

  Yes

  No

  N/A

• In process buckets sealed with pink zip ties

  Yes

  No

  N/A

• Pallets clean and free of debris

  Yes

  No

  N/A

• Forklift log up to date

  Yes

  No

  N/A

• Delivery truck log up to date

  Yes

  No

  N/A

• Component cards up to date

  Yes

  No

  N/A

• Paperwork standards

  Yes

  No

  N/A

• Pest control traps in place and up to date

  Yes

  No

  N/A

• Scales calibrated

  Yes

  No

  N/A

Encapsulation Department Room #1

• Machines and room identified

  Yes

  No

  N/A

• Room clean

  Yes

  No

  N/A

• Floor/walls clean and undamaged

  Yes

  No

  N/A

• Paperwork standards

  Yes

  No

  N/A

• Employees properly gowned / hairnets

  Yes

  No

  N/A

• Only one product in a room at a time

  Yes

  No

  N/A

• Vibrators on while machine is running

  Yes

  No

  N/A

• Scales calibrated

  Yes

  No

  N/A

• Tube guards on

  Yes

  No

  N/A

Encapsulation Department Room #2

• Machines and room identified

  Yes

  No

  N/A

• Floor/walls clean and undamaged

  Yes

  No

  N/A

• Paperwork standards

  Yes

  No

  N/A

• Employees properly gowned and hairnets

  Yes

  No

  N/A

• Only one product in a room at a time

  Yes

  No

  N/A

• Vibrators on while machine is running

  Yes

  No

  N/A

• Scales calibrated

  Yes

  No

  N/A

• Tube guards on

  Yes

  No

  N/A

Encapsulation Department Room #3

• Floor/walls clean and undamaged

  Yes

  No

  N/A

• Paperwork standards

  Yes

  No

  N/A

• Employees properly gowned and hairnets

  Yes

  No

  N/A

• Only one product in a room at a time

  Yes

  No

  N/A

• Vibrators on while machine is running

  Yes

  No

  N/A

• Scales calibrated

  Yes

  No

  N/A

• Tube guards on

  Yes

  No

  N/A

Encapsulation Department Room #4

• Floor/Walls clean and undamaged

  Yes

  No

  N/A

• Paperwork standards

  Yes

  No

  N/A

• Employees properly gowned and hairnets

  Yes

  No

  N/A

• Only one product in a room at a time

  Yes

  No

  N/A

• Vibrators on while machine is running

  Yes

  No

  N/A

• Scales calibrated

  Yes

  No

  N/A

• Tube guards on

  Yes

  No

  N/A

Encapsulation Department Room #5

• Floor/walls clean and undamaged

  Yes

  No

  N/A

• Paperwork standards

  Yes

  No

  N/A

• Employees properly gowned and hairnets

  Yes

  No

  N/A

• Only one product in a room at a time

  Yes

  No

  N/A

• Vibrators on while machine is running

  Yes

  No

  N/A

• Scale calibrated

  Yes

  No

  N/A

• Tube guards on

  Yes

  No

  N/A

Polish / Inspect Department

• Room is clean

  Yes

  No

  N/A

• Floor/walls clean and undamaged

  Yes

  No

  N/A

• Machines properly identified

  Yes

  No

  N/A

• Only one product running at a time

  Yes

  No

  N/A

• Unused machinery properly identified and covered

  Yes

  No

  N/A

• Paperwork standards

  Yes

  No

  N/A

• Product off floor

  Yes

  No

  N/A

• Product sealed and identified

  Yes

  No

  N/A

• Employees properly gowned and hairnets used

  Yes

  No

  N/A

• Dust collector on while working

  Yes

  No

  N/A

• Tube guards on

  Yes

  No

  N/A

Blending Department - V Blender Room

• Room is clean

  Yes

  No

  N/A

• Floor/walls clean and undamaged

  Yes

  No

  N/A

• Machines properly identified

  Yes

  No

  N/A

• Scale calibrated

  Yes

  No

  N/A

• Paperwork standards

  Yes

  No

  N/A

• Employees properly gowned and hairnets

  Yes

  No

  N/A

• Tube guards

  Yes

  No

  N/A

Blending Department - Ribbon Blender Room

• Room is clean

  Yes

  No

  N/A

• Floor/walls clean and undamaged

  Yes

  No

  N/A

• Machines properly identified

  Yes

  No

  N/A

• Scales calibrated

  Yes

  No

  N/A

• Paperwork standards

  Yes

  No

  N/A

• Employees properly gowned and hairnets

  Yes

  No

  N/A

• Tube guards

  Yes

  No

  N/A

Packaging Department

• Room is clean

  Yes

  No

  N/A

• Floor/walls are clean and undamaged

  Yes

  No

  N/A

• Machines properly identified

  Yes

  No

  N/A

• Line properly identified

  Yes

  No

  N/A

• Only one product running at a time

  Yes

  No

  N/A

• Quality checks performed

  Yes

  No

  N/A

• Paperwork completed with initials

  Yes

  No

  N/A

• Pallet properly counted and tagged

  Yes

  No

  N/A

• Employees properly gowned and hairnets

  Yes

  No

  N/A

• No tools or rags in machines

  Yes

  No

  N/A

• Tube guards on

  Yes

  No

  N/A

Powder Department

• Room is clean

  Yes

  No

  N/A

• Floor/walls clean and undamaged

  Yes

  No

  N/A

• Machines properly identified

  Yes

  No

  N/A

• Only one product running at a time

  Yes

  No

  N/A

• Paperwork standards

  Yes

  No

  N/A

• Quality checks performed

  Yes

  No

  N/A

• Paperwork completed with initials

  Yes

  No

  N/A

• Employees properly gowned and hairnets

  Yes

  No

  N/A

• No tools or rags on machines

  Yes

  No

  N/A

• Scales calibrated

  Yes

  No

  N/A

• Unused machinery covered and identified

  Yes

  No

  N/A

• Tube guards

  Yes

  No

  N/A

Maintenance Department

• Red maintenance books up to date and complete

  Yes

  No

  N/A

• PMI's performed on all machinery

  Yes

  No

  N/A

• Proper lubricants used on machinery

  Yes

  No

  N/A

Cleaning Department

• Day cleaning duties performed

  Yes

  No

  N/A

• Night cleaning duties performed

  Yes

  No

  N/A

Quality Unit

• Sinks and area clean

  Yes

  No

  N/A

• Restrooms clean and sanitized

  Yes

  No

  N/A

• General cleaning of facility and production. Check wall and door sills.

  Yes

  No

  N/A

• Cleaning duties and crew reviewed

  Yes

  No

  N/A

• Scale calibration system updated

  Yes

  No

  N/A

• Retention room up to date and clean

  Yes

  No

  N/A

• Pest control system up to date

  Yes

  No

  N/A

• Fire extinguishers up to date

  Yes

  No

  N/A

• In process controls

  Yes

  No

  N/A

• Test records and releases

  Yes

  No

  N/A

• Employees not wearing earrings, jewelry, fake nails

  Yes

  No

  N/A

• Employees wear gloves and hairnets at all times

  Yes

  No

  N/A

• Random sop quizzing of employees

  Yes

  No

  N/A

• Sop question asked to employee. Please include question and employee name.

• Sop question asked to employee. Please include question and employee name.

• Sop question asked to employee. Please include question and employee name.

• Training records reviewed

  Yes

  No

  N/A

• Random ATP testing performed

  Yes

  No

  N/A

• Verify certificate of analysis validations

  Yes

  No

  N/A

Final

• Misc. Notes

• Misc. Picture

  Media

• Misc. Picture

  Media

• Misc. Picture

  Media

• Signature of Auditor

  Sign

• Reviewed By

  Sign