Quality Canberra - GMP Audit - Distribution and Warehouse

• Document No.

• Audit Title

• Client / Site

• Conducted on

  Date

• Prepared by

• Location
  Address

• Personnel

Instructions

• Scoring Criteria:
  1 Unacceptable - Risk to product e.g. Contamination - Raise NCR
  2 Poor
  3 Acceptable
  4 Good
  5 Excellent
  NA Element not appropriate for area being audited

• - If a 1 is scored in an area - the whole area receives a 1 and an NCR is automatically raised.
  - If more than one 2 is scored in an area the area receives a 2 overall and an NCR is automatically raised.
  - If 2-5 is scored throughout the area, then the average score is used for that area.
  - The average of all scores are then used as the Total audit score, however if more than one area receives a 1 then the total audit score is 1.
  - Audits are conducted by an Auditor(QA or qualified internal auditor) along with a representative from the area being audited.

• If an area requires an action to be carried out press the "paper clip" icon on the right and enter the action required.

Audit Details

• Auditor Name and Signature

  Sign

• Area representative Name and Signature

  Sign

• Date Completed

  Date

People

Compliance

• Hair net - Are all employees wearing hairnet correctly (covers hair and ears). Are Beard Snoods being worn appropriately as required.

• Uniforms - Are all employees adhering to uniform policy, are uniforms pocket-less, wearing correct uniform, clean with no rips or holes.

• Footwear - Is Clean and appropriate footwear being worn by all employees

• Hearing Protection - Is clean hearing protection being worn by all employees (as required)

• PPE - Is PPE being worn correctly and appropriately i.e. Safety glasses, Is it removed outside of the production area?

• Personal Items - No personal items found on line, no personal mobile phones, nothing in toolboxes or bumbags

• Add comments if required.

• Add Photo if required.

  Media

Personal Hygiene

• Illness - Employees do not have evidence of Cold/Flu or Viruses

• Band Aids - Employees do not have open cuts/abrasions or wounds, Only metal detectable band aids being worn?

• Nails - No evidence of false nails/nailpolish being worn in the manufacturing area

• Jewellery - Only plain wedding band to be worn (Medical, ethnic, religious by written approval only)

• Eating/Drinking - No evidence of eating or drinking (other than authorised water bottles/water fountain), or smoking

• Hand Washing - Hands Washed Upon Entry and sanitised or gloves changes at the appropriate frequency

• Contractors and visitors are GMP compliant i.e. Hairnet, attire, snood.

• Add comments if required.

• Add Photo if required.

  Media

Pest Control

Pest Activity

• Pest Activity - No evidence of Pest Activity in the area (i.e. Insects, webbing, tracks, droppings, feathers)

• Pest Exclsuion - Doors/Walls/Ceilings have adequate seals and are kept closed. I.e. No light coming through, doors and windows sealed, pest stripping under doors

• Pest Control - Pest Bait and Monitoring Systems are adequate in number, monitored and controlled

• Pest Sightings log/register is available and in use

• Add comments if required.

• Add Photo if required.

  Media

Buildings and Equipment

Walls Floors Ceilings

• Walls/Floors/Ceilings - Are all surrounding walls, floors and ceilings clean and in good condition.

• Walls, Ladders and Steps are free of clutter

• Are all Lights Covered with a shatterproof covering and in good working order

• Are any ceiling vents or wall/floor vents or fans cleaned and in good condition?

• Drains are clean and free from any objectionable odours. Drains have removable grates.

• No evidence of condensation or water dripping from ceiling

• Old or redundant equipment is clean and stored in such a way so as not to contaminate product or harbour any pests left in manufacturing areas

• No product/WIP/ Raw materials are stored directly against the wall allowing for pest harbourage

• Add comments if required.

• Add Photo if required.

  Media

Building Cleanliness

• Bins are in adequate numbers tidy, and regularly emptied

• No Objectionable odours, smoke, dust or other airborne contaminants in the factory

• Is the correct Colour Coding Cleaning equipment in good condition and being used for the right purpose. Is there adequate cleaning equipment in area

• Rags are not in use.

• Cleaning Chemicals are being used correctly and all bottles and containers are labelled

• Add comments if required.

• Add Photo if required.

  Media

Tools

• Knives are approved type, in good condition, clean and stored appropriately.

• Tools - are being stored in toolbox or in allocated areas and not being stored on equipment

• Add comments if required.

• Add Photo if required.

  Media

Process Control

• All documents are controlled and approved with version number and date by QA

• No Pins/Staples or paperclips are found inside manufacturing areas

• Only Metal Detectable pens are being used in area and are secured

• Workstations are neat and tidy

• Add comments if required.

• Add Photo if required.

  Media

Area Specific - Distribution and Warehousing

Raw Materials Handling

• Are Pallets in acceptable condition i.e. Not broken, not double stacked

• Pallets are not being stored on the floor, racking being used

• Pallets are not being stored outside

• Is the FIFO system being followed and green 'approved' stickers evident on each pallet

• Packaging materials are stored on appropriate racking, not being stored on floor

• Allergen ingredients are stored and labelled correctly (in designated labelled areas) and signs displayed where applicable

• All incoming product is free of infestation, damage or objectionable odours before transferring to storage

• Damaged pallets and crates are removed from within the manufacturing and distribution areas

• Add comments if required.

• Add Photo if required.

  Media

Cleaning and Hygiene

• Cleaning chemical cage is locked and all chemicals appropriately labelled

• Hoses are cleaned and stored appropriately

• Is the Clean as you go policy evident - no evidence of spills not cleaned up, no pooled water.

• Off Line cleanliness i.e. Under equipment, walls, floors around supports are clean and free from build up

• Add comments if required.

• Add Photo if required.

  Media

Foreign Material Control

• No temporary repairs have been made using cable ties, string or tape

• Equipment is in an acceptable condition, no evidence of paint chipping, broken parts

• All Guards are in place and in good condition. No broken, chipped or cracked Perspex.

• Tools - are being stored in toolbox or in allocated areas and not being stored on equipment

• Nothing stored above food stream or on top of raw materials or equipment

• No foreign material seen in area either on or offline, i.e. Wood, plastic, swarf, nuts, bolts etc

• Add comments if required.

• Add Photo if required.

  Media

Dropped and Non Conforming Product

• Any non conforming product is isolated, labelled and recorded to prevent it being despatched without QA approval.

• Any dropped finished product is inspected and thrown away if damaged

• Bagged finished product shall not be left standing exposed for extended periods in open areas.

• Add comments if required.

• Add Photo if required.

  Media