Food Production GMP Audit Checklist

Customize this template on your device with the 1st Reporting App.
Go to 1stReporting.com to learn more.

Auditor Name: Audit Date:

Facility Identifier: Audit Report Number:

Facility Location: Facility Type:

Facility Contact Name: Facility Contact Number:

Checked Requirement Rating Evidence

Regulatory Requirements

The facility has a FDA registration number.

A traceability system for food is established to document products from entry to
exit, whether in original state or included as an ingredient.
An initial and annual 'mock recall' practice is established, documented, and
e ective.

Food Safety Plan

The facility has a documented and complete food safety plan.

One or more competent individuals are assigned to implement and manage the FSP
(food safety plan).

Documentation of FSP compliance is on site (daily/weekly/monthly inspections).

Personnel Qualifications and Training

Personnel qualifications and records of training are documented, maintained, and
up-to-date.
All employees are qualified individuals or supervised by qualified individuals.
All individuals have documented annual training in food hygiene and safety, as
appropriate to their role.
Supervisory personnel have assigned responsibility for the GMP practices of those
under their supervision.

Personnel Hygiene
A documented Personnel Hygiene Policy (PHP) exists, is implemented, and
enforced for all sta and visitors.
The PHP includes the basics of personal hygiene, clothing, and footwear.
The PHP includes uniforms and personal protective equipment (PPE) appropriate
for each role, and the conditions of care and use.
The PHP includes policies concerning handwashing, fingernails (nail polish), and
hair restraints.
The PHP includes a policy about the storage of clothing and personal belongings,
and the use of jewelry.
The PHP includes a policy about eating, drinking, smoking, vaping, or other such
activities while on site.
The PHP includes a policy for prevention of allergen cross-contamination relating
to personnel hygiene.
The PHP includes policies and procedures to report, mitigate, and clean up from
contamination due to blood or bodily fluids to food or food production areas.
The PHP includes policies relating to self-reporting of employee illness.
The PHP includes policies regarding the restriction of ill employees from production
areas until a full assessment of safe tasks is completed.
The PHP includes policies regarding first aid regarding covering of open lesions,
infected wounds, boils, and similar surface injuries and ailments.

Supply Chain
A documented procedure for the proper receiving and storage of raw materials and
ingredients exists and is maintained.

Processes and Controls

All operations are conducted with adequate sanitation principles and practices.
Quality control measures are established, implemented, and maintained for food
and packaging material safety and suitability.
One or more competant individuals are assigned the responsibility of supervising
facility sanitation.
A system, such as color coding equipment, must be established, implemented, and
maintained to avoid allergen cross-contamination.
Documented testing procedures exist to identify sanitation, allergen or other food
contamination issues as necessary.
Documented controls exist so adulterated contaminated food is rejected, treated,
or processed as necessary to eliminate contaminants.
A documented system exists for the inspection (and documentation), handling,
segregation, and storage of raw materials.
A documented system exists for washing/cleaning/removal of contaminants of all
raw materials used in food production.

1
 Processes and Controls (continued)

Water used for washing, rinshing, or other food contact use is safe/appropriate. If
treated, applicable measurements are documented to verify water quality.
Documented procedures exist for identification of raw materials requiring
treatment such as pasteurization. The treatment procedures are also documented.
Documented control measures and identification exist for raw materials or
ingredients prone to aflotoxin or other natural toxins.
Documented control measures and identification exist for raw materials or
ingredients prone to contamination with pests, undesirable microorganisms, or
extraneous material.
Raw materials, ingredients, and rework are stored in the appropriate containers, at
the appropriate temperature and humidity.
Frozen raw materials are stored at the appropriate temperature. Thawing
procedures exist for the safe thawing of the material or ingredient.
Documented procedures exist for the identification and managment of allergens
within the facility.
Raw materials, ingredients, and rework that contain allergenic material is
appropriately identified, stored and handled.
All food related processes including storage, processing, packing, manufacture,
reworking, or other shall be conducted to minimize the potential for contamination,
spoilage, or deterioration.
Measures necessary to destroy or prevent microorganisms (MDPM) (such as
sterilization, irradiation, pasteurization, etc) exist, are documented, identified, and
implemented.
The MDPM identify the facility’s product flow and work areas for work‐in‐process
(WIP) and rework provides protection against comingling, allergen cross‐contact,
contamination, and growth of undesirable microorganisms.
The MDPM identify the measures to protect finished foods from contamination.
The MDPM identify the measures to protect from contamination via equipment,
container, utensil, or tool use.
Measures exist to protect from contamination from metal or other extraneous
material.
Measures exist to dispose of, or recondition (where possible) food, raw materials, or
ingredients found to be adultered. Disposal procedures must protect against
further contamination.
All food, raw material, and ingredient preparation processes must abide by best
practices to avoid contamination.
Food must be protected from contaminants that might drip, drawn, or be drawn
into the food.
Heat blanching processes are documented appropriately and records of equipment
routine sterilization are available.
All food preparations such as batters, gravies, or simlar are held and treated with
methods that prevent contamination and the spread of microorganisms.
All food preparation processes are completed in a way that prevents contamination
and the spread of microogranisms.
Controls for prevention of contamination and micro organisms to dry mixes, nuts,
and similar ingredients that rely principally on the control of water activity (Aw)
exist, are implemented, and documented.
Measures to monitor and maintain acid and acidified food at a pH of 4.6 or below
exist and are implemented.
Any ice used in food production is made from a suitably safe water source.

Defect Action

Defect action controls are documented as required.

Quality conrol operations are conducted to reduce possible defects, documented,
and records of implementation maintained.
Measures exist to prevent defective food contaminating unadultered food.

Equipment and Utensils

All equipment and utensils must be of a material suitable for repeated and
adequate sanitation, cleaning, and maintenance, and must be maintained
i t l
All equipment and utensils must be used in a way that avoids possible food
adulteration or contamination.
All equipment must be accessible for cleaning, maintenance, and inspection.
All food-contact surfaces must be of a nontoxic material, corrosion resistant, and
appropriate for repeated use, cleaning, and maintenance.
All food-contact surfaces must be appropriately maintained, including the use of
appropriate seams such as sanitary welds.
All non-food contact equipment within production areas shall be maintained in
clean, good condition.
All holding, conveying, and manufacturing equipment and systems must be of a
design and construction that allows repeated use, maintenance, cleaning, and
sanitation.
All refrigeration and freezing compartments must be fitted with a temperature
indicating device.
All instruments and controls for measuring, regulating, or recording temperaturees,
pH, etc. must be properly calibrated and maintained.
All compressed air or gases used in food production must be filtered and oil free.

2
 Sanitary Facilities and Controls
Water supply/system are adequate for operations and derived from an appropriate
source. Wells are annually inspected and maintained.
Water testing results exist showing water potability when used for food production
or by personnel.
Running water is maintained at the appropriate temperatures.

Plumbing is adequately suited for operations water and waste flows.

Floors, gutters, or drains are su ciently sloped for proper drainage.

No cross connections exist between treated and untreated supplies.

Periodic certification exists for all backflow prevention devices which must be
installed to water and steam lines.
Sewage is appropriately disposed of to an adequate sewage system.
Toilet facilities for production sta are adequate for the number of sta and
independently vented to the outside.
Toilet facilities do not open directly into food handling areas and include
self-closing doors or maze-type entrances.
Toilet facilities include adequate lighting and su cient waste receptacles.
Toilet facilities are signed indicating handwashing procedures, and water
temperature and available soap are suitable.
Toilet facilities are well maintained and in good working condition.
Any handwashing areas in production or breakrooms will include suitable water, at
a suitable temperature, with signable about handwashing procedures, suitable
soap and appropriate means of hand drying.
Facility rubbish/waste storage capacity is adequate to operations.

Maintenance and Sanitation

Buildings, fixtures, and facilities are well maintained in a clean and sanitary
condition.
A documented policy for equipment maintenance, including cleaning, sanitation,
and inspection after repair exists and is implemented.
Cleaning and sanitizing procedures are documented and the methods avoid food
contamination or adulteration.
Cleaning and sanitizing compounds and agents are free of undesirable
microorganisms and appropriate for the intended use.
All chemicals stored within the facility are safe and appropriate for food production
facilities. Food grade lubricants are used and documented in food production areas
h i id bl
Chemicals are maintained in a controlled (locked) storage area and are clearly
labelled.
An e ective pest control program is documented and implemented.

A pest control station map is easily accesible and maintained.

Documentation of routine maintenanc and inspection of pest control equipment
exists and is accesible.
Post control device types, number and placement is appropriate.

The facility is free from pest infestation.

Pesticide use is strictly controlled to avoid food contamination.

All food-contact surfaces and utensils are routinely cleaned, sanitized and
documented, overseen by a competant employee.
Procedures for sanitizing and drying tools and equipment used in processing
low-moisture foods exist, are implemented, and documented.
Procedures for cleaning and sanitizing tools and equipment used in wet processing
exist, are implemented, and documented.
Procedures for cleaning and sanitizing surfaces that come into contact with food
exist, are implemented, and documented.
Single-service items are handled, stored, and disposed of in a way that avoids
contamination of the food.
Non-food contact surfaces of equipment must be cleaned and maintained
appropriately.
Portable equipment that contacts food must be maintained and stored in a way
that prevents food contamination.

Warehousing and Distribution

Food storage and transportation practices work to avoid contamination or
adulteration of the food and provide appropriate conditions.
Control measures exist to inspect and document incoming goods.

Wash certificates that indicate tanker truck previous load are available as needed.
Control measures exist to provide appropriate conditions and quality for outgoing
shipments of food.
Packaging materials are stored and handled to avoid contamination.
Retained, returned, or damaged products are stored in a separate designated area
and are clearly labelled.
Documented procedures exist and are implemented for the proper order and
utilization of materials within their allocated shelf life.

3
 Food By-Products for Animal Food
Human food by-products for use as animal food are maintained in conditions and
equipment that avoid contamination and are regularly cleaned and maintained.
Human food by-products are held in a way that avoids contamination.

Proper labelling of human food by-products exist and are implemented.

Shipping containers and bulk transport vehicles are inspected and maintained
appropriately to avoid contamination.

Facility and Grounds

Facility design and construction is suitable for the intended use and should exhibit
properties to prevent contamination of products.
The facility grounds are maintained to avoid pest harborage including the removal
of garbage and debris.
Facility grounds are surfaced to avoid standing water, prevent dust and o ensive
odors.
Facility waste containers are adequate and regularly emptied, maintained, and
documented.
The facility grounds are not a ected by uncontrolled contamination risks from
adjacent properties. If a risk is identified, controls are established, implemented,
and documented.
The facility has the necessary space for adequate operations, maintenance,
sanitation, and production activities.
Bulk storage vessels are constructed to avoid contamination and allow for cleaning,
sanitation, and maintenance.
Facility components including floors, doors, ceilings, walls, etc are designed to
facilitate sanitation and maintenance as required.
Adequate procedures and controls are in place to avoid overhead condensation.
Catwalks and stiles are constructed and located in a way that avoids
contamination.
All areas have su cient lighting to maintain adequate sanitary conditions and
operations.
All glass and fixtures are su ciently protected to avoid glass contamination in case
of breakage.
Fans and air-moving equipment shall be located and adjusted to minimize
contamination.
Buildings are reasonably free of excessive dust, heat, steam, condensation, vapors,
smoke, or fumes.
Doors, windows, or openings are properly closed, sealed, or screened to avoid
contamination and pests.

Notes

Signature of Auditor: Date:

Use the 1st Reporting app to customize and complete this template in the field or from your o ce.
Get it on Google Play, The Apple App Store, or at 1stReporting.com

4
5