Endeavour GMP Checklist - duplicate

• Document No.

• Endeavour GMP Audit Template

• Conducted on

  Date

• Prepared by

• Location
  Address

• Personnel

• Are all entrances to the site manned or secured to prevent unauthorised access?

  Compliant

  Non Compliant

  Not Applicable

• Does the site have adequate perimeter fencing (and in good condition) to prevent unauthorised access to the site?

  Compliant

  Non Compliant

  Not Applicable

• Do all visitors and contractors to the site need to sign in and out?

  Compliant

  Non Compliant

  Not Applicable

• Are external doors secured to prevent unauthorised access to the site ?

  Compliant

  Non Compliant

  Not Applicable

• Are external doors self closing / kept closed when not in use?

  Compliant

  Non Compliant

  Not Applicable

• No doors propped open?

  Compliant

  Non Compliant

  Not Applicable

• Are external areas of the plant free of weeds, dirt and rubbish?

  Compliant

  Non Compliant

  Not Applicable

• Are the grounds and external areas of the site including paths, roadways in good condition?

  Compliant

  Non Compliant

  Not Applicable

• Is there any evidence of adjacent buildings or neighbouring grounds to the site that could pose a food safety risk to the site - potential pest harbourage such as long grass etc?

  Compliant

  Non Compliant

  Not Applicable

• Is there any evidence of pooling water / poor drainage around the external of the facility?

  Compliant

  Non Compliant

  Not Applicable

• Is there any evidence of gutter not free flowing - damaged/weeds growing out or overflowing ?

  Compliant

  Non Compliant

  Not Applicable

• Is there any vegetation external to the building that is overgrown / needs trimming back or poses pest harbourage risks?

  Compliant

  Non Compliant

  Not Applicable

• Any external storage units (eg chillers, freezers, storage containers etc) on the site must be secured / maintained?

  Compliant

  Non Compliant

  Not Applicable

• Is there any evidence of raw materials, packaging and equipment stored outside in the open?

  Compliant

  Non Compliant

  Not Applicable

• Any evidence of pest sighted during the audit - flies, insects, ants, moths, birds or rodents?

  Compliant

  Non Compliant

  Not Applicable

• Are all awnings / canopies at entry points sufficiently proofed or netted to prevent birds nesting (eg loading bays etc) - no evidence of bird issues?

  Compliant

  Non Compliant

  Not Applicable

• Are there any visible gaps or daylight around doors/ walls/windows for pest entry?

  Compliant

  Non Compliant

  Not Applicable

• Is there any storage of unused equipment inside the plant that could provide an area for pests to harbour?

  Compliant

  Non Compliant

  Not Applicable

• Is there any storage of unused equipment external to the plant that could provide an area for pests to harbour?

  Compliant

  Non Compliant

  Not Applicable

• If pallets are stored outside are they stored and inspected before use inside the facility to prevent contamination by pests and other contaminants?

  Compliant

  Non Compliant

  Not Applicable

• No external doors or entry points left open for extended periods of time to allow pest entry ?

  Compliant

  Non Compliant

  Not Applicable

• Are any pest control chemicals stored on site?

  Compliant

  Non Compliant

  Not Applicable

• Pest Control - Are all bait stations, moth pots, and fly insecutors cleaned and in good condition?

  Compliant

  Non Compliant

  Not Applicable

• Pest Control Folder - Are the Pest Control Folder contains latest Certificate, Bait Station Map?

  Compliant

  Non Compliant

  Not Applicable

• Pest Control Folder - Check for the latest Safety Data Sheets and the latest Pest Technician Licenses expiry dates.

  Compliant

  Non Compliant

  Not Applicable

• Any overhead speakers, moth pots, powerpoints, cords etc that are not clean - dust /dirt/product build up ?

  Compliant

  Non Compliant

  Not Applicable

• If squeegees are in use - they are single blade so as not to build up dirt / bacteria in double blade versions?

  Compliant

  Non Compliant

  Not Applicable

• Any uniform lockers in acceptable condition - hooded / no build up of dust or storage of items on top?

  Compliant

  Non Compliant

  Not Applicable

• Any strip curtains shall be full length but not touch the floor and are clean?

  Compliant

  Non Compliant

  Not Applicable

• Is cleaning equipment in good state of repair and hygienic condition and replaced when necessary?

  Compliant

  Non Compliant

  Not Applicable

• Is appropriate cloths being used for cleaning - eg disposable. Not re-using cleaning cloths ?

  Compliant

  Non Compliant

  Not Applicable

• Is any cleaning equipment stored in direct contact with floor?

  Compliant

  Non Compliant

  Not Applicable

• Are all areas around the facility free of cobwebs and clutter free?

  Compliant

  Non Compliant

  Not Applicable

• Where cleaning equipment is wall mounted are handles for floor cleaning equipment up and handles for food contact equipment down ?

  Compliant

  Non Compliant

  Not Applicable

• Is there any evidence of ingredient buckets being used as cleaning buckets?

  Compliant

  Non Compliant

  Not Applicable

• Are all chairs in food packing rooms free of dust and product build up on bases eg cleaned as part of room clean downs?

  Compliant

  Non Compliant

  Not Applicable

• Are all downpipes on external walls in tact / no damage?

  Compliant

  Non Compliant

  Not Applicable

• Any evidence of holes or gaps in external walls of the building ?

  Compliant

  Non Compliant

  Not Applicable

• Are all external walls in good condition?

  Compliant

  Non Compliant

  Not Applicable

• Are all lights fitted with shatterproof globes and or covered in any area where they could pose a risk to food safety including areas where contamination could be tracked in production areas?

  Compliant

  Non Compliant

  Not Applicable

• Any windows designed to be open in non food handling areas must be suitably pest proofed to prevent pest entry (canteens, toilets, locker facilities)?

  Compliant

  Non Compliant

  Not Applicable

• Are all windows cleaned and no evidence of cobwebs, dirt or insects?

  Compliant

  Non Compliant

  Not Applicable

• Is lighting suitable above all inspection points?

  Compliant

  Non Compliant

  Not Applicable

• Are any windows in exposed food packing rooms open ?

  Compliant

  Non Compliant

  Not Applicable

• Are there any glass windows in the production, storage, maintenance and employee facilities and are those protected from breakage?

  Compliant

  Non Compliant

  Not Applicable

• Does lighting in all areas provide good visibility to enable safe working ?

  Compliant

  Non Compliant

  Not Applicable

• Are there any curtains in open food rooms that could pose a risk to food safety - product build up / curtain chains etc?

  Compliant

  Non Compliant

  Not Applicable

• Are all windows and ceilings constructed of smooth impervious (sealed) materials to allow cleaning in any areas where open food is handled?<br>

  Compliant

  Non Compliant

  Not Applicable

• If there are any vents in ceilings are these clean?

  Compliant

  Non Compliant

  Not Applicable

• Are the walls and ceilings in acceptable condition in all areas - no evidence of holes /damage/temporary repairs?

  Compliant

  Non Compliant

  Not Applicable

• Any light switches / speakers/extinguishers/hose reels etc in packing rooms clean and no evidence of damage - no build up of dust or product ?

  Compliant

  Non Compliant

  Not Applicable

• Is there any evidence of cobwebs / product build up on ceilings and walls?

  Compliant

  Non Compliant

  Not Applicable

• Are all wall/floor junctions coved in exposed food packing areas to allow ease of cleaning ?

  Compliant

  Non Compliant

  Not Applicable

• Is there any damage to floor or coving that needs repair?

  Compliant

  Non Compliant

  Not Applicable

• Are floor cleans?

  Compliant

  Non Compliant

  Not Applicable

• Are drains accessible for cleaning and fitted with screens or traps to prevent pest entry?

  Compliant

  Non Compliant

  Not Applicable

• Is there any evidence of pooling water around drains?

  Compliant

  Non Compliant

  Not Applicable

• Is there any evidence of odours coming from drains?

  Compliant

  Non Compliant

  Not Applicable

• Are all platforms free of clutter, product buildup / clean?

  Compliant

  Non Compliant

  Not Applicable

• For any platforms or walkways or steps over production lines are they fitted with enclosed sides, base and back plates to prevent product contamination?

  Compliant

  Non Compliant

  Not Applicable

• No evidence of product containers /packaging sitting in direct contact with platform floors?

  Compliant

  Non Compliant

  Not Applicable

• Are areas under the platforms clean?

  Compliant

  Non Compliant

  Not Applicable

• Is all equipment in food packing areas easy to clean?

  Compliant

  Non Compliant

  Not Applicable

• Is there any wood used in food production areas - equipment/utensils etc/ also check underneath tables for evidence of chipboard / build up of cobwebs etc?

  Compliant

  Non Compliant

  Not Applicable

• Is any equipment which is out of service identified and stored in a manner that does no pose a risk of injury to persons and/or risk to product? (Eg. no small parts / nuts or bolts left lying around)

  Compliant

  Non Compliant

  Not Applicable

• Are all surfaces including welds and joints smooth, impervious and easy to clean?

  Compliant

  Non Compliant

  Not Applicable

• Is all equipment in use such as wire brushes, brushes and belts in good condition?

  Compliant

  Non Compliant

  Not Applicable

• Are all chairs in exposed food packing areas made of cleanable material ie not upholstered?

  Compliant

  Non Compliant

  Not Applicable

• Are all rubbish bins clean and in acceptable condition?

  Compliant

  Non Compliant

  Not Applicable

• Are all tubs/containers used in exposed food rooms in acceptable condition/ constructed of suitable material?

  Compliant

  Non Compliant

  Not Applicable

• If colour coded systems are in use for tubs etc (if applicable) are they being followed ?

  Compliant

  Non Compliant

  Not Applicable

• Are all foot mats, tables and chairs in acceptable condition?

  Compliant

  Non Compliant

  Not Applicable

• Are all vacuums cleaned and emptied regularly and maintained ?

  Compliant

  Non Compliant

  Not Applicable

• Are all trolleys in acceptable condition? Do allergen free / allergen containing rooms have different trolleys ?

  Compliant

  Non Compliant

  Not Applicable

• Does the equipment surface clean?

  Yes

  No

  N/A

• Are all signage in the production area visible clean and up to date and controlled?

  Compliant

  Non Compliant

  Not Applicable

• Are all quality / production check sheets currently in use in the production area fully completed?

  Compliant

  Non Compliant

  Not Applicable

• Are all cleaning records up to date?

  Compliant

  Non Compliant

  Not Applicable

• Are any CCP (critical control point) records completed as per site requirements ?

  Compliant

  Non Compliant

  Not Applicable

• Is there any quality performance boards on display for the site? Are these up to date?

  Compliant

  Non Compliant

  Not Applicable

• Are all staff wearing correct uniforms in all areas of the plant as per site's policies?

  Compliant

  Non Compliant

  Not Applicable

• Are all employees following correct procedure for uniforms (eg beardnet, hairnet and coat - going into areas and reverse going out?)

  Compliant

  Non Compliant

  Not Applicable

• No personal items (eg street clothes) hung in areas where uniforms are also stored?

  Compliant

  Non Compliant

  Not Applicable

• Are all employees who should be wearing hairnets and beardnets doing so and wearing them correctly (eg hair fully covered)?

  Compliant

  Non Compliant

  Not Applicable

• Have personal items been stored away in lockers and not bought into production areas?

  Compliant

  Non Compliant

  Not Applicable

• Are all staff handling food wearing gloves?

  Compliant

  Non Compliant

  Not Applicable

• Are tool boxes in production rooms maintained, cleaned and list of item contained within toolbox available?

  Compliant

  Non Compliant

  Not Applicable

• Are there any plastic clipboards used in the factory that could be potential sources of foreign matter?

  Compliant

  Non Compliant

  Not Applicable

• Are correct utensils being used ?

  Compliant

  Non Compliant

  Not Applicable

• Is all equipment suitable for food use? No containers in use throughout the facility that are used for other products such as milk bottles / ice cream containers etc?

  Compliant

  Non Compliant

  Not Applicable

• Are all stationery items consistent with site rules and GMP? (Eg. site issue pens, not staples/drawing pins in food production areas?)

  Compliant

  Non Compliant

  Not Applicable

• Any office areas in or directly accessible to production areas shall not be adorned with personal items (Eg.collectables, cups, bottles etc?)

  Compliant

  Non Compliant

  Not Applicable

• Is there any evidence of temporary repairs - string/sticky tape/cardboard etc?

  Compliant

  Non Compliant

  Not Applicable

• Check for Loose items, i.e. stapler, broken rivets, that are not controlled

  Yes

  No

  N/A

• Is waste stored in identifiable containers?

  Compliant

  Non Compliant

  Not Applicable

• Are all bins inside the food packing areas lined with plastic contrasting colour?

  Compliant

  Non Compliant

  Not Applicable

• <br><br><br><br><br><br><br><br><br><br>Waste containers used inside the food packing areas are able to be clean - no evidence of bird droppings / dirt?<br>

  Compliant

  Non Compliant

  Not Applicable

• Primary, secondary and tertiary packaging which is used for finished product is not used for waste?

  Compliant

  Non Compliant

  Not Applicable

• Are all external waste containers closed?

  Compliant

  Non Compliant

  Not Applicable

• Are any waste containers and the area around these maintained and clean?

  Compliant

  Non Compliant

  Not Applicable

• Is the whole facility free of clutter and rubbish that needs to be thrown out?

  Compliant

  Non Compliant

  Not Applicable

• Are the amenities clean and in acceptable condition?

  Compliant

  Non Compliant

  Not Applicable

• Is equipment in amenities kept clean eg fridges / microwaves etc?

  Compliant

  Non Compliant

  Not Applicable

• Is there appropriate signage in toilet areas regarding washing hands ?

  Compliant

  Non Compliant

  Not Applicable

• Are the amenities appropriate for the site / number of employees?

  Compliant

  Non Compliant

  Not Applicable

• Are any materials stored directly on floor or tight against the walls (sufficient space is required for pest inspection)?

  Compliant

  Non Compliant

  Not Applicable

• Are all products labelled ?

  Compliant

  Non Compliant

  Not Applicable

• Are floors, walls, ceilings, windows and screens properly maintained and cleaned ?

  Compliant

  Non Compliant

  Not Applicable

• Are there any products directly on the floor or product in direct contact with wooden pallets?

  Compliant

  Non Compliant

  Not Applicable

• Are there any primary packaging uncovered and exposed?

  Compliant

  Non Compliant

  Not Applicable

• Is the warehouse office maintained and clutter removed?

  Compliant

  Non Compliant

  Not Applicable

• Are all cleaning equipment appropriate for their use and stored correctly?

  Compliant

  Non Compliant

  Not Applicable

• Are any reject products labelled correctly ?

  Compliant

  Non Compliant

  Not Applicable

• Are all lights secure and in proper condition?

  Compliant

  Non Compliant

  Not Applicable

• Any products on hold labelled and stored in appropriate quarantine area?

  Compliant

  Non Compliant

  Not Applicable

• Are any retention samples kept on site stored in appropriate area, organized and easily accessible?

  Compliant

  Non Compliant

  Not Applicable

• Does any warehouse/storage area looks clean and tidy ?

  Compliant

  Non Compliant

  Not Applicable

• Is there any red tag/graveyard areas are these clean / orderly and not pest harbourage areas?

  Compliant

  Non Compliant

  Not Applicable

• Are all staff adhering to the jewellery policy?

  Compliant

  Non Compliant

  Not Applicable

• Is it clear what the policies are around jewellery in food packing areas and signage?

  Compliant

  Non Compliant

  Not Applicable

• Are hand wash facilities made of non-porous / non breakable material?

  Compliant

  Non Compliant

  Not Applicable

• Is water at all hand washing sinks warm (approximately 40oC)?

  Compliant

  Non Compliant

  Not Applicable

• Are the hand wash facilities suitable for the number of employees ?

  Compliant

  Non Compliant

  Not Applicable

• Are hand wash sinks hand free operated ?

  Compliant

  Non Compliant

  Not Applicable

• Is the soap/sanitizer and paper towel units stocked at all hand washing areas - not empty?

  Compliant

  Non Compliant

  Not Applicable

• Are there separate sinks provided for equipment and hand washing? And are these clearly labelled ?

  Compliant

  Non Compliant

  Not Applicable

• Is there signage displayed giving clear instruction on how to wash hands correctly at all sinks ?

  Compliant

  Non Compliant

  Not Applicable

• Do all staff and employees wash hands on re-entering food packing areas ?

  Compliant

  Non Compliant

  Not Applicable

• Is there any evidence of food and drinks, with exception of plain water being taken into, stored or eaten in production areas ?

  Compliant

  Non Compliant

  Not Applicable

• Are there any food dispensing machines on site that contain allergens? If so, do these allergens already exist in the packing plant ?

  Compliant

  Non Compliant

  Not Applicable

• Any evidence during the audit of employees eating or chewing gum in production areas ?

  Compliant

  Non Compliant

  Not Applicable

• Is there evidence of staff movement between different production areas that could pose cross contamination risks - eg no uniform change ?

  Compliant

  Non Compliant

  Not Applicable

• Is the correct processing equipment being used eg - Scoops, scales, tubs etc ?

  Compliant

  Non Compliant

  Not Applicable

• Are there any unnecessary items in the food packing rooms ?

  Compliant

  Non Compliant

  Not Applicable

• If any steam is used for product manufacture or in contact with product contact surfaces is it from potable water sources ?

  Compliant

  Non Compliant

  Not Applicable

• Are any scales or items in use clearly labelled as calibrated and in date ?

  Compliant

  Non Compliant

  Not Applicable

• Are daily balance checks completed for scales using certified weights ?

  Compliant

  Non Compliant

  Not Applicable

• Are freezer or refrigerated cool rooms areas adequately maintained to prevent excessive build up of ice or condensation on walls, floors and ceilings ?

  Compliant

  Non Compliant

  Not Applicable

• Are cool rooms and freezer temperatures maintained and recorded ?

  Compliant

  Non Compliant

  Not Applicable

• Are all products identified in temperature storage ?

  Compliant

  Non Compliant

  Not Applicable

• Are all products off the floor and stored on racking in cool rooms ?

  Compliant

  Non Compliant

  Not Applicable

• Any equipment used for heating is monitored for time and temperature - data log ?

  Compliant

  Non Compliant

  Not Applicable

• Are all products in the production area identifiable ?

  Compliant

  Non Compliant

  Not Applicable

• Are all products stored in warehouse areas identifiable ?

  Compliant

  Non Compliant

  Not Applicable

• Are all WIP (Work in Progress) goods labelled / identifiable ?

  Compliant

  Non Compliant

  Not Applicable

• Shelf lives of products match bulk products being packed / work instructions ?

  Compliant

  Non Compliant

  Not Applicable

• During packing is batch trace ability visible on qa sheets from all raw materials through to finished goods ?

  Compliant

  Non Compliant

  Not Applicable

• Are all mobile equipment such as forklift trucks, pallet trucks, scissor lifts and ladders must be clean ?

  Compliant

  Non Compliant

  Not Applicable

• Have daily forklift pre-operational checks been completed for the forklifts in use ?

  Compliant

  Non Compliant

  Not Applicable

• Is there any battery charging equipment stored in open food areas ?

  Compliant

  Non Compliant

  Not Applicable

• Mobile equipment eg forklift trucks and pallet trucks that are used in open food areas must not be used outside ?

  Compliant

  Non Compliant

  Not Applicable

• Forklift and trolleys in good condition with no damage ?

  Compliant

  Non Compliant

  Not Applicable

• Any transport vehicles for food operation are clean ?

  Compliant

  Non Compliant

  Not Applicable

• Is access to maintenance and storage areas restricted to authorised personnel ?

  Compliant

  Non Compliant

  Not Applicable

• Is maintenance area clean - no debris/shavings on floor that could be walked into production areas / use of swarf mats etc?

  Compliant

  Non Compliant

  Not Applicable

• Is equipment calibrated / serviced ?

  Compliant

  Non Compliant

  Not Applicable

• Is all equipment tested and tagged ?

  Compliant

  Non Compliant

  Not Applicable

• Production or food containers must not be used as general storage containers in maintenance areas ?

  Compliant

  Non Compliant

  Not Applicable

• No food or drink with exception of water shall be consumed or stored within maintenance areas ?

  Compliant

  Non Compliant

  Not Applicable

• Are maintenance personnel uniforms distinguishable from production uniforms in food packing areas ? Maintenance garments changed when entering production areas and no production uniforms used in maintenance areas ?

  Compliant

  Non Compliant

  Not Applicable

• All maintenance personnel and contractors must not present a risk of contamination and must comply with necessary health and safety requirements, operational GMP on site including wearing of protective clothing ?

  Compliant

  Non Compliant

  Not Applicable

• Is there any evidence of maintenance work being conducted at the time of audit that poses a risk to food safety - Eg. area not segregated/ drilling near exposed food/raw materials ?

  Compliant

  Non Compliant

  Not Applicable

• Are maintenance tools taken into packing areas accounted and clean ?

  Compliant

  Non Compliant

  Not Applicable

• Are any maintenance personnel during audit following site procedures such as washing of hands prior to entering production areas ?

  Compliant

  Non Compliant

  Not Applicable

• Are tool boxes stored on direct product contact surfaces ?

  Compliant

  Non Compliant

  Not Applicable

• Are all staff inducted and trained in food safety/ GMP ?

  Compliant

  Non Compliant

  Not Applicable

• Are visitors/contractors to the site informed of food safety and GMP requirements ?

  Compliant

  Non Compliant

  Not Applicable

• Are contractors on site supervised ?

  Compliant

  Non Compliant

  Not Applicable

• Is there any risk of cross contamination in packing areas - allergens / only one product per area ?

  Compliant

  Non Compliant

  Not Applicable

• No evidence of products or packing remaining in rooms after clean downs ?

  Compliant

  Non Compliant

  Not Applicable

• No risk of cross contamination from personnel movement between areas ?

  Compliant

  Non Compliant

  Not Applicable

• Any allergen or identity preservation claims of goods labelled correctly - eg gluten free / organic etc ?

  Compliant

  Non Compliant

  Not Applicable

• Is all storage of allergens in warehouse or production areas appropriate - not over the top of other products ?

  Compliant

  Non Compliant

  Not Applicable

• Does site comply with requirements of specific certifications i.e. Halal, Kosher and Organic applicable to the site? -

  Compliant

  Non Compliant

  Not Applicable

• Are all chemicals in use labelled ?

  Compliant

  Non Compliant

  Not Applicable

• Are all chemicals in appropriate containers ?

  Compliant

  Non Compliant

  Not Applicable

• In storage areas of chemicals is there appropriate spill kits and bunding ?

  Compliant

  Non Compliant

  Not Applicable

• Is there a chemical register available and up to date ?

  Compliant

  Non Compliant

  Not Applicable

• Are all chemicals sighted on SDS register ?

  Compliant

  Non Compliant

  Not Applicable

• Any other safety issues to report ?

  Compliant

  Non Compliant

  Not Applicable

• Do you see any unsafe acts taking place ?

  Compliant

  Non Compliant

  Not Applicable

• Are emergency lighting all working ?

  Compliant

  Non Compliant

  Not Applicable

• Add signature

  Sign

GMP Agreement

• Current - sponsor provided copy of PQR chapter 1 clause 1.4.1 - xii (must have prior Internal Audit May - June every year)

  Compliant

  Non Compliant

  Not Applicable

Validation Master Plan

• Cleaning Validation - Facilities and Equipment

  Compliant

  Non Compliant

  Not Applicable

• Operational & Performance Validation routine inspection or concurrent validation on Facilities, Equipment or Processes

  Compliant

  Non Compliant

  Not Applicable

• Yes

  No

  N/A