You can find the law of the "Code of Federal Regulations" on Good Manufacturing Practices here.
Below is a general checklist you can use for your internal audits.
Good luck!
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GMPs:
Personnel
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21
CFR, Part 110 Section 110.10
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Good
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Needs Work
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1. Are the employees well-trained in what they
do? You can avoid many problems by making sure that your employees clearly
understand their functions
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2. In handling food products, do your employees
wear the proper hair covering, bear covering, disposable gloves and clean
uniforms?
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3. Are your employees wearing jewelry, rings,
watches, fingernail polish or bandages?
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Do your employees have any illnesses, infections
or injuries (i.e. Boils, cuts) that can contaminate foods in the production
area?
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4. Do your employees wash and sanitize their
hands after each visit to the toilet?
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Do you have washing facilities available for your
employees near their work stations?
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Do they use them when their hands become soiled
or contaminated?
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5. Do your employees maintain clean personal
habits?
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6. Is the traffic within your plant controlled to
prevent contamination of the production area?
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Do visitors wear proper outfits and hairnets?
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7. Have your employees been told the reasons why
they should undertake the above precautions?
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Has this training been done through GMP classes?
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Is the training documented?
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Total Checked:
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GMPs: Buildings and Facilities:
Plant and Grounds
21
CFR, Part 110, Section 110.20
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Good
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Needs Work
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1.
Is in the surrounding the
facilities clear of litter weeds, grash and brush?
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2.
Is there any
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3.
Are floors, walls, ceiling,
windows and creens properly maintained and cleaned? There should be no
flaking paint anywhere above the production area
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4.
Do production doors and
windows to the outside have fine mesh screens to keep pests out and are
tightly sealed?
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5.
Are food surfaces maintained?
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6.
Are there any holes or any
spaces sealed so as not to provide hiding places or entry points for pests?
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7.
Ate there any signs of the
presence of the domestic animals such as cats and dogs?
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8. Is there adequate ventilation
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9. Are there hand-wash stations furnished with paper or air hand dryers
and soap?
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10. Is the construction proper for the sky lights, windows, screens or
overhead piping?
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11. Are overhead lights installed with shields to prevent contamination of
the production from in case the lamps burst
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Total Checked:
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GMPs: Buildings and Facilities:
Sanitation Operations: Pest Control
21
CFR, Part 110 Section 110.35 (a) (c)
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Good
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Needs Work
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1.
Do you have professional pest
control services
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2.
Do you check regularly on
what the pest control operator is doing?
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3.
Do you have documentation on
what chemicals are being used?
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4.
Are mites, weevils, or
roaches apparent in the plant? There should be no evidence of their presence.
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5.
Do you have enough bait
stations?
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6.
Are you safely using
fumigation safely?
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7.
Are the pest control logs and
documentation readily available?
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8. Are pesticides or application of chemicals stored safely?
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9. Are product stored on palletes and 18 inches away from the walls?
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10. Is your factors shelf
maintained?
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Total Checked:
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GMPs Buildings and Facilities: Equipment
21
CFR, Part 110 Subpart C
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Good
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Needs Work
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1.
Is all equipment that comes
in contact with food cleaned and sanitized as often as necessary to prevent
contamination of the product? You should follow appropriate cleaning
schedules for each piece of equipment.
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2.
Is the equipment designed, or
otherwise suitable, for use in a food plant? For example, equipment for
handling or processing foods cannot contain polychlorinated biphenyls (PCBs),
which are very toxic (this does not apply to electrical transformers and
condensers containing PCBs in sealed containers).
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3.
Is there a build-up of food
or other materials on the equipment? This can serve as a breeding place for
insects and bacteria.
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4.
Is there any build-up or seepage
of cleaning solvents or lubricants on your equipment, which can contaminate
foods? All repairs on equipment should be of a permanent nature (e.g. no
bobby pins in place of cotter pins), as temporary repair parts can break or
rupture and get in the food product.
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5.
Is the equipment hard to
disassemble for clean-up and inspection? The more difficult it is, the less
inclined you or an employee will be to clean it.
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6.
Is there a lot of “dead
space” in or around the machinery where food and other debris can collect as
a nest for insects and bacteria?
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7.
Can the surface of the
equipment be sanitized?
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Total Checked:
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GMPs:
Production and Process Control
21
CFR, Part 110 Section 110.35 (a) (c)
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Good
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Needs Work
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1.
Is trash, debris, and clutter
picked up, both inside and outside the plant, so as not to provide hiding
places for pests?
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2.
Are all sanitation chemicals
used in the plant USDA/FDA approved?
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3.
Do employees eat, drink and
use tobacco products only in designated areas, and not in the production area
or warehouse?
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4.
Is the food spilled or
uneaten by employees cleaned up quickly so as not to attract pests or breed
bacteria?
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5.
Has old rodent excreta been
cleaned up so you can spot any new activity?
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6.
Is garbage quickly removed
and dumped in appropriate bins? It should not sit around your facilities to
attract pests and develop odors.
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7.
Is the garbage kept covered?
An open garbage pile is an excellent breeding ground for insects and rodents.
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8. Is the water used in your firm from an approved source (either
municipal water supply or tested private source)?
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9. Have you made sure there are no hoses left dangling in sinks or on the
ground?
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10. Do your facilities have back flow and vacuum breaker valves to prevent
contaminate your water supply?
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11. Is there standing water around your firm (particularly in the
production area, warehouse and pack-off area)?
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Total Checked:
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GMPs: Buildings and Facilities:
Production and Process Control
21
CFR, Part 110 Section 110.35 (a) (c)
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Good
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Needs Work
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1.
Are products stored on a
first-in, first-out basis to reduce the possibility of contamination through
spoilage?
Are
old products kept in front of the new to help in the rotation products?
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2.
Are all incoming products
dated to ensure a proper rotation of stocks and for internal tracking
purposes?
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3.
Are items overstocked? This
increases the chances of spoilage and contamination.
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4.
Are incoming vehicles
inspected?
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5.
Are dusty, faded or
discolored containers checked regularly?
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6.
Are all products spoiled by
damage, insects, rodents or other causes stored in a designated “Quarantine
Area” to prevent their contact with safe products?
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7.
Are such quarantined items
disposed of quickly to prevent the development of pest breeding places?
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8. Are incoming materials inspected for damage or contamination so that
they can be rejected?
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9. Are unused materials properly resealed to prevent contamintation?
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10. Are materials stored in a safe manner?
Food
related items should not be stored with non-food related items.
Materials
should be stacked so that vents and blowers are not blocked.
Stacks
of materials should be orderly for safety purposes.
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11. Do you have an effective recall procedure set-up?
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Total Checked:
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Good Manufacturing Practices (GMPs)
Monthly Inspection Record Sheets
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Personnel
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Plant/Grounds
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Pest Control
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Sanitary Facilities and Control
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Equipment
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Production and Process Control
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Good
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Needs Work
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Good
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Needs Work
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Good
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Needs Work
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Good
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Needs Work
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Good
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Needs Work
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Good
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Needs Work
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6.
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11.
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10.
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11.
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11.
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Number “Good”: ______
Percentage: ___________
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Number “Good”: ______
Percentage: ___________
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Number “Good”: ______
Percentage: ___________
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Number “Good”: ______
Percentage: ___________
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Number “Good”: ______
Percentage: ___________
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Number “Good”: ______
Percentage: ___________
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*Any questions that are not applicable
should be eliminated to calculate the percentage accordingly.
Date:____________________________ Establishment
Name: ________________________ Inspected
by:________________________
SANITATION SOPs
I.
Preoperational Sanitation –
Equipment and Facility Cleaning
All equipment will be cleaned and sanitized prior to
starting production.
A.
General Equipment Cleaning
(Simple equipment and hand tools are cleaned and sanitized in the
same manner but they do not require disassembly and reassembly.)
Established Sanitary Procedures for
Cleaning and Sanitizing Equipment:
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Good
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Needs Work
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1.
The equipment is disassembled
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2.
Parts are placed in the
designated tubs, racks, etc.
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3.
Product debris is removed
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4.
Equipment parts are rinsed
with water to remove remaining debris.
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5.
An approved cleaner is
applied to parts and they are cleaned according to manufacturer’s directions
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6.
Equipment parts are rinsed
with potable water
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7.
Equipment is sanitized with
an approved sanitizer and rinsed with potable water if required
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8. The equipment is reassembled
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9. The equipment is reassembled with an approved sanitizer and rinsed
with potable water if required
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Performed Evaluations:
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Good
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Needs Work
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1.
Organoleptic (smell, sight,
touch.)
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2.
Chemical (clorine, or others)
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3.
Microbiological (swab for
TPC, or others)
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Description of
Evaluations:___________________________________________________________________________________
__________________________________________________________________________________________________________________
Corrective
Actions:___________________________________________________________________________________________
Overall Inspection by:__________________ Date:___________________________________
B. Cleaning of Facilities (Including floors, walls, and ceilings)
Cleaning procedures:
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Good
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Needs Work
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1.
Organoleptic (smell, sight,
touch.)
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2.
Chemical (clorine, or others)
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3.
Microbiological (swab for
TPC, or others)
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4.
Facilities are rinsed with
clean water as necessary
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II.
Operational Sanitation
Handling of the
product and packaging materials will be performed under sanitary conditions and
in a manner to prevent contamination of the product.
Handling
Operations
Established
Methods for Food Handling:
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Good
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Needs Work
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1.
Employees will clean hands,
arms, gloves, aprons, boots, etc., as often as necessary during the handling
procedures.
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2.
Employees will clean and then
sanitize any equipment as often as necessary during handling procedures to
prevent contamination of foods or packaging materials.
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Performed
Evaluations:
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Good
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Needs Work
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1.
Organoleptic (smell, sight,
touch.)
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2.
Chemical (clorine, or others)
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3.
Microbiological (swab for
TPC, or others)
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Description of
Evaluations:___________________________________________________________________________________
__________________________________________________________________________________________________________________
Corrective
Actions:___________________________________________________________________________________________
Overall Inspection by:__________________ Date:___________________________________
Sanitation SOPs (SSOPs)
Monthly Inspection Record Sheet
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General Equipment Cleaning
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Cleaning of Facilities
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Handling Operations
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Good
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Needs Work
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Good
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Needs Work
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Good
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Needs Work
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1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
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1.
2.
3.
4.
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2.
3.
4.
5.
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Number “Good”: ______
Percentage: ___________
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Number “Good”: ______
Percentage: ___________
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Number “Good”: ______
Percentage: ___________
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*Any questions that are not applicable
should be eliminated to calculate the percentage accordingly.
Date:____________________________
Establishment Name: ________________________
Inspected by:________________________
