GMP Audit Standard

Marketing and
Regulatory
Programs
Good
U Manufacturing
Agricultural
Marketing
Practices (GMP) Audit
Service
Specialty
Standard
Crops
Program
Specialty
Crops April 2022
Inspection
Division
AIM
Inspection
Series
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Good Manufacturing Practices (GMP) Audit Standard
Table of Contents
INTRODUCTION................................................................................................................... 1
GUIDE FOR ELECTRONIC USAGE...................................................................................... 1
HOW TO USE THIS STANDARD.......................................................................................... 2
GOOD MANUFACTURING PRACTICES AUDIT STANDARD ........................................... 3
1.1 Regulatory ........................................................................................................................ 3
1.2 Food Safety Plan............................................................................................................... 5
1.3 Personnel Qualifications and Training ............................................................................... 6
1.4 Personnel Hygiene ............................................................................................................ 8
1.5 Supply Chain .................................................................................................................. 12
1.6 Processes and Controls.................................................................................................... 12
1.7 Defect Action ................................................................................................................. 25
1.8 Equipment and Utensils (Design, Materials, and Maintenance)......................................... 26
1.9 Sanitary Facilities and Controls ....................................................................................... 30
1.10 Maintenance and Sanitation ........................................................................................... 35
1.11 Warehousing and Distribution ....................................................................................... 41
1.12 Food By-Products for Animal Food ............................................................................... 43
1.13 Facility and Grounds ..................................................................................................... 45
REFERENCE LINKS............................................................................................................ 51
i
SCI Division Inspection Series GMP Audit Standard
Effective Date: April 2022 Page 1 of 51
INTRODUCTION
This document is designed to give guidance to Specialty Crops Inspection Division personnel of
the United States Department of Agriculture (USDA).
Compliance with the Agricultural Marketing Service (AMS) guidelines does not excuse failure
to comply with the Food, Drug, and Cosmetic Act or any other applicable Federal or State laws
or regulations. SCI Division of the Specialty Crops Programs (SC), AMS is responsible for
grading/inspecting, audits and standardization programs of fresh and/or processed fruits and
vegetables and related products. The legal authority for grading, auditing and standardization
activities are the Agricultural Marketing Acts of 1936 and 1946, as amended.
Applicants may obtain inspections and audits of any fresh and/or processed fruit and vegetable
and related products for which they have a financial interest. The inspection service is voluntary
and self-supporting, and is offered on a fee-for-service basis.
GUIDE FOR ELECTRONIC USAGE
The AIM system of instructional manuals is available electronically in Adobe Acrobat Portable
Document Format (PDF) at the following intranet address:
https://usdagcc.sharepoint.com/sites/ams/AMS-SCI/SitePages/Home.aspx.
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web site with information relating to the subject. Hypertext links the reader to a different page
within the current manual, or a different manual, with information relating to the subject. For
example, the hypertext in the Table of Contents allows a reader to go directly to the section of
interest in the manual by clicking on the section title.
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HOW TO USE THIS STANDARD
The GMP Audit Standard is intended to be used as the core element of a Plant Systems Audit
(PSA) Program audit. The standard includes the requirements of the Current GMP regulation 21
CFR 117, other requirements such as the Bioterrorism Act of 2002, and expectations of the
Global Food Safety Initiative (GFSI) Technical Equivalence Requirements Part III CII – Section
3: Good Industry Practice Requirements.
This issue of the United States Department of Agriculture’s GMP Audit Standard, along with the
other standards and manuals still in development, supersede the previous materials describing the
Plant Systems Audit Program.
The standard includes the following columns:
• Requirement – a statement of the expectation for compliance to the audit standard.

• Reference – the text from the cited source of the requirement.
• Citation – the location of the cited source within the referenced document.
• Auditor Guidance – a brief description of how the auditor will find evidence to verify
compliance. Additional guidance is in the PSA Program Auditor Manual.
• Documentation – an indication of the required type of documentation.
o Policy – This indicates a need for a documented policy (high-level guidance that
describes general goals and acceptable procedures) or procedure (specified way to
carry out an activity or process). This documentation should also identify the
established forms that will be used to show implementation.
o Record - a document stating results achieved or providing evidence of activities
performed. Examples of records include checklists, bills of lading, process charts,
certificates of assurance, and analytical test results.
For instructions on its use, including the associated checklist and the rating system used for the
audit outcome, please see the PSA Program Auditor Manual. Additional information on the
Program can be found on the AMS website at https://www.ams.usda.gov/services/auditing/plant-
audits.
GOOD MANUFACTURING PRACTICES AUDIT STANDARD
1.1 Regulatory
Req. No. Requirement Reference Citation Auditor Guidance Documentation
1.1.1 The facility shall have a Food The Food and Drug Administration (FDA) Bioterrorism Request to see a copy of the Record
and Drug Administration (FDA) requires domestic and foreign facilities that Act of 2002 facility’s registration with
registration number. manufacture/process, pack, or hold food for FDA. This is renewed every
human or animal consumption in the United other year. Verify location
States to register with FDA. information is correct and
registration is current. Do not
document the facility number in
your audit/notes. Record the
expiration date.
1.1.2 The facility must establish a People who “manufacture, process, pack, Bioterrorism Verify that there is a Policy, Record
documented traceability system transport, distribute, receive, hold, or import Act of 2002 documented traceability
which enables identification of food” in the United States, as well as program and review practices
food which is received and to foreign food transporters in the United for effectiveness. Are records
where it is eventually shipped, States, are required to maintain records to established showing previous
either in its original state or as identify the previous sources and sources and subsequent
part of a finished product. subsequent recipients of the food. receivers of food? Do the
Exclusions include: farms, restaurants, food records include
processed for personal consumption, and previous/subsequent source
outer food packaging. (including full contact details),
Direct to consumer distributors are not description of food (brand
required to keep records of the people to name and variety), date
whom they sell. Food transfers within a received/released, lot or code
company are not subject to recordkeeping. number (if relevant), quantity
Also excluded are food samples used for and packaging?
quality assurance, research or analysis
purposes that are not consumed.
Required records for food received and
released must include: previous/subsequent
source (including full contact details),
description of food (brand name and
variety), date received/released, lot or code

number (if relevant), quantity and
packaging. When food is released, records
additionally must include information
“reasonably available” identifying specific
sources of each ingredient to each lot of
finished product. In cases where food
processors commingle ingredients such as
flour from different suppliers, FDA accepts
that manufacturers may not be able to
identify 1 specific source.
Records must be retained for 6 mo to 2 y
depending on food type.
Any person engaged in the business of
supplying a covered commodity to a
retailer, directly or indirectly, must maintain
records to establish and identify the
immediate previous source (if applicable)
and immediate subsequent recipient of the
product.
Such records must identify the product
unique to that transaction
by means of a lot number or other unique
identifier, for a period of 1 year from the
date of the transaction.
1.1.3 The operation has performed a Ask to see the record of a mock Record
"mock recall" that was proven to recall performed in the last 12
be effective. This exercise must months.
be performed at least annually.
1.2 Food Safety Plan
1.2.1 The facility must have a food Verify that a policy has been Policy
safety plan which is documented developed and implemented.
and implemented. Confirm employee
understanding via interview.
The plan must include, at a
minimum, all documented
policies and procedures
identified as requirements in this
audit standard, in addition to
any regulatory requirements.
1.2.2 Implementation and oversight of Verify that responsibility for Policy

the food safety plan must be the management of the food
under the supervision of one or safety plan is assigned to
more competent individuals someone who has had
assigned responsibility for this appropriate food safety training
function. and/or knowledge based on
work experience.
1.2.3 The facility must document, A programme of site inspections / checks GFSI, GMP Identify the daily, weekly, and Policy, Record
implement, and record daily, shall be established, implemented and 10 monthly inspections that have
weekly, and/or monthly site maintained to ensure the site environment been established and review the
inspections as necessary to and processing equipment are maintained recent records of the
verify implementation of their in a suitable condition to ensure food safety, inspections.
food safety plan controls and as applicable to the activity of the site.
policies associated with
housekeeping, cleaning and
sanitation, and maintenance.
1.3 Personnel Qualifications and Training
1.3.1 All personnel who manufacture, The management of an establishment must 21 CFR Ask to see job descriptions and Policy, Record
process, pack, or hold food must ensure that all individuals who manufacture, 117.4 qualifications for specific jobs
be qualified to perform their process, pack, or hold food are qualified to (a) and (b) in the facility (A quality control
assigned duties. perform their assigned duties. technician job will require
Each individual engaged in manufacturing, different qualifications than a
Qualifications must be processing, packing, or holding food maintenance technician job).
documented. (including temporary and seasonal Verify that appropriate food
personnel) or in the supervision thereof safety training requirements are
must: indicated.
1.3.1.1 Each individual must be, or be Be a qualified individual as that term is (1) Review the personnel who are Record
under the supervision of, a defined in § 117.3—i.e., have the education, designated as supervisors. Ask
qualified individual. training, or experience (or a combination employees who their
thereof) necessary to manufacture, process, supervisors are. In 1.3.2, you
pack, or hold clean and safe food as will verify the training and
appropriate to the individual’s assigned qualifications of the
duties; and supervisors. If someone isn’t
being directly supervised, see if
their training and qualifications
would establish them as a
qualified individual.
1.3.1.2 Each individual must receive Receive training in the principles of food (2) Verify that the company has a Policy, Record
training on the principles of hygiene and food safety, including the documented policy for the
food hygiene and food safety, as importance of employee health and personal training of all employees on the
appropriate to their role and hygiene, as appropriate to the food, the principles of food safety,
responsibilities. Training must facility and the individual’s assigned duties. appropriate to their position.
be provided when first hired, Review food safety training
with a minimum of annual records of a random selection
refreshers. of employees, including
administrative, management,
and processing staff. Record
training dates and subject
material. Training, at a
minimum, should be at new
hire/promotion, and as an
annual refresher.
1.3.2 Supervisory personnel must be Additional qualifications of supervisory (c) Verify education, training, or Record
assigned the responsibility for personnel. Responsibility for ensuring experience of supervisors’
personnel compliance with food compliance by individuals with the specific job duties by reviewing
safety and food hygiene policies requirements of this part must be clearly training records. Ask to see
and procedures, and have the assigned to supervisory personnel who have any certificates from courses
education, training, or the education, training, or experience (or a such as HACCP, SQF, etc.
experience (or a combination combination thereof) necessary to supervise
thereof) necessary to supervise the production of clean and safe food.
the production of clean and safe
food.
1.3.3 Records of training must be Records. Records that document training (d) Verify that food safety training Record
established and maintained. required by paragraph (b)(2) of this section records are maintained for all
must be established and maintained. employees and that they are
available for review.
1.4 Personnel Hygiene
1.4.1 There shall be a documented The management of the establishment must 21 CFR Verify that the facility has a Policy
personnel hygiene policy that is take reasonable measures and precautions to 117.10 policy for personnel hygiene,
effectively implemented, with ensure the following: (b) and that both employees and
all personnel and visitors Cleanliness. visitors are required to comply
following the policy. All persons working in direct contact with with it. Did they communicate
food, food-contact surfaces, and food- the policy to you when you
The written policy must include packaging materials must conform to arrive at the plant? This could
the following elements: hygienic practices while on duty to the also be communicated via
extent necessary to protect against allergen email prior to the audit.
cross-contact and against contamination of
food. The methods for maintaining
cleanliness include:
1.4.1.1 The basics of personal hygiene Maintaining adequate personal cleanliness. (2) Note whether the policy
includes basics about employee
cleanliness. Verify
implementation by observation.
1.4.1.2 Clothing and footwear Wearing outer garments suitable to the (1) Is there a policy about changing
operation in a manner that protects against outer garments when leaving an
allergen cross-contact and against the allergen zone? Observe if
contamination of food, food contact employees are following the
surfaces, or food-packaging materials. facility policies to prevent cross
contamination. What is the
facility policy for footwear?
(Plant specific shoes, shoe
coverings etc.)
1.4.1.3 Uniforms (if used) - must If uniforms are used in the
include requirements for proper facility, verify that there is an
use and maintenance. established uniform policy.
Does it include a provision for
cleaning them (professionally
laundered or laundered at
home)? Good practices include
no buttons (snap closure) and

no pockets, or nothing kept in
pockets, above the waist.
Observe if uniforms are clean.
1.4.1.4 Gloves (if used) - must include a Maintaining gloves, if they are used in food (5) If gloves are used in the
requirement that they be handling, in an intact, clean, and sanitary facility, ensure there is an
maintained in an intact, clean, condition. established policy for how they
and sanitary condition. are used. Observe that
employees are changing soiled
gloves prior to handling food or
touching food contact surfaces.
How are gloves stored? Are
employees using torn or
damaged gloves?
1.4.1.5 Handwashing (in an adequate Washing hands thoroughly (and sanitizing if (3) Observe that employees are
handwashing facility) before necessary to protect against contamination washing hands starting a shift
starting work, after each absence with undesirable microorganisms) in an or returning from a break.
from the workstation, and at any adequate handwashing facility before Interview employees about
other time when the hands may starting work, after each absence from the handwashing for training
have become soiled or work station, and at any other time when the retention. (The condition of the
contaminated. hands may have become soiled or handwashing station will be
contaminated. covered at requirement 1.7.5.)
1.4.1.6 Removal of unsecured jewelry Removing all unsecured jewelry and other (4) Are the employees wearing
and other objects that might fall objects that might fall into food, equipment, any jewelry which might pose
into food, equipment, or or containers, and removing hand jewelry a food safety risk? Are they
containers, and removing hand that cannot be adequately sanitized during following the established
jewelry that cannot be periods in which food is manipulated by policy?
adequately sanitized during hand. If such hand jewelry cannot be
periods in which food is removed, it may be covered by material
manipulated by hand. which can be maintained in an intact, clean,
and sanitary condition and which effectively
protects against the contamination by these
objects of the food, food-contact surfaces,
or food-packaging materials.
1.4.1.7 Fingernails (absence of polish; Verify by observation that the

neatly trimmed) employees are following the
facility’s established policy.
1.4.1.8 Hair restraints Wearing, where appropriate, in an effective (6) Verify by observation that hair
manner, hair nets, headbands, caps, beard restraints are being worn
covers, or other effective hair restraints. properly, according to the
facility’s established policy.
1.4.1.9 Storage of clothing and personal Storing clothing or other personal (7) Verify there is an area, located
belongings belongings in areas other than where food is away from where food is
exposed or where equipment or utensils are exposed, for employees to store
washed. their personal items. The
policy should indicate
requirements for appropriate
cell phone usage. Observe if
employees are in compliance.
1.4.1.10 Eating, drinking, and smoking Confining the following to areas other than (8) Verify there is a designated
where food may be exposed or where area away from food handling
equipment or utensils are washed: eating areas, for eating and drinking
food, chewing gum, drinking beverages, or and that smoking/tobacco/gum
using tobacco. use is not permitted where food
is exposed. Observe if food or
beverages are in areas where
food is exposed.
1.4.1.11 Precautions to protect against Taking any other necessary precautions to (9) Observe employees for
allergen cross-contact with protect against allergen cross-contact and personal hygiene issues that
respect to personnel hygiene against contamination of food, food-contact could result in allergen cross-
issues. surfaces, or food packaging materials with contact, such as perspiration,
microorganisms or foreign substances wearing excessive cosmetic
(including perspiration, hair, cosmetics, materials, hair, tobacco
tobacco, chemicals, and medicines applied products, chemicals, and
to the skin). medicinal products applied to
the skin. Are outer garments
(smocks or aprons) being
removed before breaks?
1.4.1.12 Control of blood or bodily Review the policy and observe

fluids. The procedure shall the operation for evidence of
specify the procedures for compliance. Has training been
containment and elimination of provided and, if specified in the
blood or bodily fluids, and the policy, is there a cleanup kit
cleaning and sanitation of available?
surfaces that are affected.
1.4.2 There shall be a documented Any person who, by medical examination or (a) Verify that a policy has been Policy
policy for control of employee supervisory observation, is shown to have, developed, implemented, and
illness. or appears to have, an illness, open lesion, shared with both employees
including boils, sores, or infected wounds, and visitors. Confirm
or any other abnormal source of microbial employee understanding via
contamination by which there is a interview.
reasonable possibility of food, food-contact
surfaces, or food-packaging materials
becoming contaminated, must be excluded
from any operations which may be expected
to result in such contamination until the
condition is corrected, unless conditions
such as open lesions, boils, and infected
wounds are adequately covered (e.g., by an
impermeable cover). Personnel must be
The written policy shall: instructed to report such health conditions to
their supervisors.
1.4.2.1 Include a requirement for Ask employees about their
employees to inform understanding of the company’s
management if they are sick or policy on working while ill. Do
have been infected with a food they understand the need to
borne illness. report illness to their
supervisor?
1.4.2.2 Restrict personnel that are ill Interview a supervisor to find
from production areas until an out if they understand the need
assessment of illness takes place to prevent employees who are
to determine what tasks they can ill from working in the
perform. processing area.
1.4.2.3 Require adequate covering of Verify by observation that any

such conditions as open lesions, employees with open lesions,
boils, and infected wounds. boils or infected wounds are
using adequate coverings to
protect and cover the affected
areas.
1.5 Supply Chain
1.5.1 The facility must document and Appropriate procedures for the reception of GFSI, GMP Verify that a policy has been Policy, Record
implement procedures for purchased materials shall be established, 14 developed and implemented.
receiving raw materials and implemented and maintained to assure that Confirm employee
other ingredients, ensuring that only materials that meet food safety understanding via interview.
raw materials and other requirements are accepted.
ingredients meet established
food safety requirements.
1.6 Processes and Controls
1.6.1 General 21 CFR

117.80 (a)
1.6.1.1 All facility operations must be All operations in the manufacturing, (1) Observe conditions in the
conducted in accordance with processing, packing, and holding of food facility to verify that the
adequate sanitation principles. (including operations directed to receiving, facility has implemented
inspecting, transporting, and segregating) practices for cleaning and
must be conducted in accordance with sanitizing (as appropriate) the

adequate sanitation principles. facility, transportation
containers, and equipment.
1.6.1.2 Quality control measures must Appropriate quality control operations must (2) Verify that necessary quality
be established and implemented be employed to ensure that food is suitable control procedures are in
to ensure that food and food- for human consumption and that food‐ place. Observe that food is
packaging materials are safe packaging materials are safe and suitable. inspected prior to use to
and suitable for intended use. ensure it is safe for human
consumption. Are the
packaging materials nontoxic?
1.6.1.3 Sanitation of the plant must be Overall sanitation of the plant must be (3) Interview employees who
under the supervision of one or under the supervision of one or more perform sanitation duties, if
more competent individuals competent individuals assigned they are available at the time
assigned responsibility for this responsibility for this function. of the audit, and ask them to
function. confirm the name of their
supervisor. Interview
supervisor and ask about their
experience and training (if not
available, verify by observing
established training or
certification records).
Training received: Record training of the person Record
responsible for sanitation and
pre-op inspections.
1.6.1.4 Adequate precautions must be Adequate precautions must be taken to (4) Observe the handling of
taken to ensure that production ensure that production procedures do not ingredients and finished
procedures do not contribute to contribute to allergen cross-contact and to products to verify the risk of
allergen cross-contact and to contamination from any source. product contamination. If a
contamination from any source. color-coding system is
implemented, observe whether
If color coding is used to employees are following the
identify equipment for various system.
purposes, the system shall be
effectively implemented. Is production scheduled to run
allergen products after non-
allergen products? Is there a

complete clean-up and
sanitation after running
allergen products?
1.6.1.5 Documented testing procedures Chemical, microbial, or extraneous‐material (5) Observe if metal detectors (if Policy, Record
shall be used where necessary testing procedures must be used where used) are working properly.
to identify sanitation failures or necessary to identify sanitation failures or Interview employees to verify
possible allergen cross‐contact possible allergen cross‐contact and food implementation and corrective
and food contamination. contamination. actions. If microbial swabbing
is used, review records to
verify implementation and
corrective actions. If the
facility uses test kits for
allergens, review those results.
1.6.1.6 Food that has become All food that has become contaminated to (6) Observe if
contaminated to the extent that the extent that it is adulterated must be contaminated/adulterated food
it is adulterated must be rejected, or if appropriate, treated or is clearly identified. Verify
rejected, or if appropriate, processed to eliminate the contamination. that there is a procedure in
treated or processed to place if the contaminated food
eliminate the contamination. can be reprocessed to
eliminate the contamination.
Also verify that there is a
procedure in place to handle
the contaminated product if it
cannot be reprocessed.
These procedures should

include the disposition of food
that have come into contact
with blood or other bodily
fluids.
1.6.2 Raw Ingredients (b)
1.6.2.1 There is a system in place for Raw materials and other ingredients must be (1) Verify by observation that all
the proper inspection, handling, inspected and segregated or otherwise raw materials are inspected
handled as necessary to ascertain that they and safe for human
segregation, and storage of raw are clean and suitable for processing into consumption. Observe that
materials. food and must be stored under conditions any unsafe food is segregated
that will protect against allergen cross‐ and labeled as such. Verify
contact and against contamination and the food is stored under proper
minimize deterioration. sanitary and environmental
conditions. Verify by
observation if foods classified
as allergens are labeled and
stored properly (segregated or
stored below non-allergen
food).
1.6.2.2 Raw materials must be washed Raw materials must be washed or cleaned Verify by observation that the
or cleaned as necessary to as necessary to remove soil or other company is following their
remove soil or other contamination. established procedures.
contamination.
1.6.2.3 Water used for washing, Water used for washing, rinsing, or Verify that there is a plan for Record
rinsing, or conveying food must conveying food must be safe and of the appropriate use of water
be safe and of adequate sanitary adequate sanitary quality. Water may be throughout the facility and that
quality. If recirculated or reused for washing, rinsing, or conveying it is of adequate quality for its
reused, the water must be used food if it does not cause allergen cross‐ use.
in a way to prevent allergen contact or increase the level of
cross‐contact or an increase in contamination of the food. If water is reused, how often is
the level of contamination of the recirculated water changed
the food. If the water is treated, or tested?
treatment must be monitored to
verify adequate pH, If the water is treated,
temperature, and/or chemical interview and ask how it is
control. monitored. Ask to see the
testing records. Controls may
include pH, temperature, and
the addition of chemicals.
Verify that any chemicals used

are appropriate for their use.
1.6.2.4 The facility must identify raw Raw materials and other ingredients must (2) Verify if the facility has Policy, Record
materials and/or ingredients either not contain levels of microorganisms identified any ingredients that
that need pasteurization or that may render the food injurious to the require pasteurization or heat
other treatment prior to health of humans, or they must be treatment or testing for
processing to prevent possible pasteurized or otherwise treated during microorganisms. Review
contamination from pathogenic manufacturing operations so that they no pasteurization charts/heat
microorganisms and implement longer contain levels that would cause the treatment records/lab results.
the necessary treatments. product to be adulterated.
These treatment procedures

must be documented.
1.6.2.5 The facility must identify raw Raw materials and other ingredients (3) Review raw ingredients to Policy, record
materials and/or ingredients susceptible to contamination with aflatoxin verify appropriate controls for
that are susceptible to or other natural toxins must comply with mycotoxins and poisonous
contamination with aflatoxin or FDA regulations for poisonous or substances. Ask the facility
other natural toxins and deleterious substances before these raw how they are mitigating any
implement steps to ensure materials or other ingredients are identified risks. Verify
compliance with FDA incorporated into finished food. implementation of the control
regulations for poisonous or measures.
deleterious substances.
Control measures must be

documented.
1.6.2.6 The facility must identify raw Raw materials, other ingredients, and (4) Review raw ingredients to Policy, record
materials and/or ingredients rework susceptible to contamination with verify expected controls are in
that pose a risk for pests, undesirable microorganisms, or place. Ask the facility how
contamination with pests, extraneous material must comply with they are mitigating any
undesirable microorganisms, or applicable FDA regulations for natural or identified risks.
extraneous material and unavoidable defects if a manufacturer
implement steps to ensure wishes to use the materials in manufacturing Prior to the audit, visit the
compliance with FDA food. FDA regulatory site to
regulations for natural or familiarize yourself with the
unavoidable defects. controls for the stated
ingredients or products.
Control measures must be https://www.fda.gov/food/ingr

documented. edients-additives-gras-
packaging-guidance-
documents-regulatory-
information/food-defect-
levels-handbook
1.6.2.7 Raw materials, other Raw materials, other ingredients, and (5) and (7) Are best storage practices used
ingredients, and rework must rework must be held in bulk, or in to prevent allergen cross
be: containers designed and constructed so as to contact of raw materials and
- held in bulk or in protect against allergen cross‐contact and ingredients? Are ingredients
containers designed and against contamination and must be held at and rework stored in
constructed to protect such temperature and relative humidity and containers that will protect it
against allergen cross‐ in such a manner as to prevent the food from contamination and in the
contact and against from becoming adulterated. Material correct environment?
contamination. scheduled for rework must be identified as
- held at appropriate such. Observe if rework product is
temperature and relative labeled as such.
humidity and in such a Liquid or dry raw materials and other
manner as to prevent the ingredients received and stored in bulk form
food from becoming must be held in a manner that protects
adulterated. against allergen cross‐contact and against
- identified for rework, if contamination.
scheduled for this purpose.
1.6.2.8 Frozen raw materials and other Frozen raw materials and other ingredients (6) Verify by observation that Record
ingredients shall be kept frozen. must be kept frozen. If thawing is required products that are to be stored
prior to use, it must be done in a manner as frozen are frozen. Check
Temperature of the freezer(s): that prevents the raw materials and other the freezer temperature and
ingredients from becoming adulterated. record it. Verify that the
If product is thawed prior to temperature is being checked
use, it must be done in a and recorded daily.
manner that prevents the raw Observe any product that is
materials and other ingredients being thawed to make certain
from becoming adulterated. that it cannot be contaminated
(is it covered properly, are
they thawing it inside or

outside on the dock?). Verify
that the plant has a procedure
for thawing products.
1.6.3 Allergens
1.6.3.1 There shall be documented Verify that the plant has Policy
procedures in place for identified all allergenic
management to identify all materials present in the facility
allergenic materials (nine major as well as chemical sensitive
allergens are peanuts, tree nuts, materials.
eggs or egg products, milk or
dairy products, crustaceans, fin
fish, soy and wheat, and sesame
seeds; food chemical
sensitivities include sulfites
and/or food colorings) present
in the facility.
Identified types of List the allergens that have
allergens/chemicals: been identified by the facility.
1.6.3.2 Raw materials and other Raw materials and other ingredients that are 21 CFR If the facility has identified Policy
ingredients that are food food allergens, and rework that contains 117.80, (b) any allergens, verify that the
allergens, and rework that food allergens, must be identified and held (8) facility has policies and
contains food allergens, must in a manner that prevents allergen cross‐ procedures in place for
be identified and held in a contact. handling allergenic products.
manner that prevents allergen Verify by observation that
cross‐contact. allergen containing foods are
labeled as containing allergens
and the type of allergen.
Verify that food products are
stored by segregating
allergenic from non-allergenic
products (for example, on
separate pallets, on shelves
below non-allergen foods,
etc.).
1.6.4 Operations Manufacturing operations 21 CFR

117.80, (c)
1.6.4.1 Equipment and utensils and Equipment and utensils and food containers (1) Verify that there are
food containers must be must be maintained in an adequate procedures in place for
maintained in an adequate condition through appropriate cleaning and cleaning and sanitizing each
condition through appropriate sanitizing, as necessary. In so far as piece of equipment. Observe
cleaning and sanitizing, as necessary, equipment must be taken apart that all food contact surfaces
necessary. Equipment must be for thorough cleaning. and equipment are maintained,
taken apart for thorough clean, and free from food
cleaning, if necessary. residue or soil. Any
equipment that must be
dismantled and hand cleaned
shall be cleaned in this
manner. Observe how the
equipment should be cleaned
(Cleaned in place (CIP),
cleaned out of place (COP), or
hand cleaned).
1.6.4.2 Manufacturing, processing, All food manufacturing, processing, (2) Verify by observation during
packing, and holding shall be packing, and holding must be conducted the walk-thru of the facility.
conducted to minimize the under such conditions and controls as are Observe staff working or
potential for the growth of necessary to minimize the potential for the processes underway to identify
microorganisms, allergen cross‐ growth of microorganisms, allergen cross‐ if there are any practices that
contact, contamination of food, contact, contamination of food, and are introducing risks of
and deterioration of food. deterioration of food. product contamination or
deterioration.
1.6.4.3 Food that can support the rapid Food that can support the rapid growth of (3) Observe that the food is stored Record
growth of undesirable undesirable microorganisms must be held at under proper storage
microorganisms must be held at temperatures that will prevent the food from conditions (frozen,
temperatures that will prevent becoming adulterated during manufacturing, refrigerated, ambient). Verify
the food from becoming processing, packing, and holding. that the storage areas are
adulterated during temperature controlled, if
manufacturing, processing, required for food safety. Are
packing, and holding. there temperature recording
charts? Are there
thermometers in the storage

areas? Are temperatures
monitored and recorded daily?
1.6.4.4 Measures such as sterilizing, Measures such as sterilizing, irradiating, (4) Observe what methods are Policy, Record
irradiating, pasteurizing, pasteurizing, cooking, freezing, used. As you walk through,
cooking, freezing, refrigerating, refrigerating, controlling pH, or controlling observe temperature/pH/other
controlling pH, or controlling Aw that are taken to destroy or prevent the control levels for the process.
Aw, that are necessary to growth of undesirable microorganisms must Review the established policy
destroy or prevent the growth be adequate under the conditions of and records to verify adequate
of undesirable microorganisms, manufacture, handling, and distribution to implementation.
must be identified, prevent food from being adulterated.
implemented, and documented.
The identified measures are: List the processes that are
being used.
1.6.4.5 The facility’s product flow and Work‐in‐process and rework must be (5) Observe if WIP and rework
work areas for work‐in‐process handled in a manner that protects against are handled and stored under
(WIP) and rework provides allergen cross‐contact, contamination, and appropriate conditions for the
protection against comingling, growth of undesirable microorganisms. food product and to prevent
allergen cross‐contact, comingling of production
contamination, and growth of stages. Observe that the
undesirable microorganisms. product is not exposed to the
environment (open, torn
packages). Are there adequate
protections for the product?
1.6.4.6 Effective measures shall be Effective measures must be taken to protect (6) Verify by observation. Are
taken to protect finished food finished food from allergen cross‐contact finished food products,
from allergen cross‐contact and and from contamination by raw materials, including raw fruit and
from contamination by raw other ingredients, or refuse. When raw vegetables, being handled
materials, other ingredients, or materials, other ingredients, or refuse are simultaneously in a receiving
refuse. Raw materials, other unprotected, they must not be handled or shipping area which may
ingredients, or refuse that are simultaneously in a receiving, loading, or contribute to cross
unprotected must not be shipping area if that handling could result in contamination of the finished
handled simultaneously in a allergen cross‐contact or contaminated food. product? Is iced product
receiving, loading, or shipping Food transported by conveyor must be dripping on product stored
area if that handling could below?
result in allergen cross‐contact protected against allergen cross‐contact and

or contaminated food. Food against contamination as necessary.
transported by conveyor must
be protected against allergen
cross‐contact and against
contamination as necessary.
1.6.4.7 Equipment, containers, and Equipment, containers, and utensils used to (7) Verify by observation. Are
utensils used to convey, hold, convey, hold, or store raw materials and equipment, utensils,
or store raw materials and other other ingredients, work‐in-process, rework, containers, and conveyors
ingredients, work‐in-process, or other food must be constructed, handled, clean? Are they constructed
rework, or other food must be and maintained during manufacturing, of materials acceptable for
constructed, handled, and processing, packing, and holding in a food contact? Are they
maintained during manner that protects against allergen cross‐ maintained in good condition
manufacturing, processing, contact and against contamination. and stored appropriately?
packing, and holding in a
manner that protects against
allergen cross‐contact and
against contamination.
1.6.4.8 The facility must take adequate Adequate measures must be taken to protect (8) Ask if the facility takes any
measures to protect against the against the inclusion of metal or other steps for preventing metal and
inclusion of metal or other extraneous material in food. extraneous material in food.
extraneous material in food. Observe if there are metal
detectors, filters, or screens in
use.
If no risks have been

identified, this may be marked
as N/A.
1.6.4.9 If the facility identifies food, Food, raw materials, and other ingredients (9) Verify by observation that Record
raw materials, and other that are adulterated: adulterated food is labeled as
ingredients as adulterated, they i) Must be disposed of in a such. Verify the facility has
must dispose of the material in manner that protects against procedures for disposing of
a manner that protects against the contamination of other the adulterated food. If the
the contamination of other food; or food is to be reconditioned,
food; or, if appropriate, verify the method and that the
recondition the material so that ii) If the adulterated food is method used meets the
it meets process and regulatory capable of being regulatory requirements for
requirements. reconditioned, it must be: that food. Ask to see
A. Reconditioned (if production records for the
appropriate) using a reconditioning of the food to
method that has been verify that they are meeting
proven to be effective; or the requirements.
B. Reconditioned (if
appropriate) and
reexamined and
subsequently found not to
be adulterated within the
meaning of the Federal
Food, Drug, and Cosmetic
Act before being
incorporated into other
food.
1.6.4.10 Steps such as washing, peeling, Steps such as washing, peeling, trimming, (10) Verify by observation. Does
trimming, cutting, sorting and cutting, sorting and inspecting, mashing, the facility have procedures in
inspecting, mashing, dewatering, cooling, shredding, extruding, place for the different steps in
dewatering, cooling, shredding, drying, whipping, defatting, and forming their process to protect food
extruding, drying, whipping, must be performed so as to protect food from contamination and
defatting, and forming must be against allergen cross‐contact and against allergen cross-contact? Is
performed so as to protect food contamination. Food must be protected from food protected from
against allergen cross‐contact contaminants that may drip, drain, or be contaminants that may drip,
and against contamination. drawn into the food. drain or be drawn into the
Food must be protected from food?
contaminants that may drip,
drain, or be drawn into the
food.
1.6.4.11 If heat blanching is utilized in Heat blanching, when required in the (11) Review blanching heat- Policy, Record
the preparation of food capable preparation of food capable of supporting treatment records for the
of supporting microbial growth, microbial growth, must be effected by required temperature and hold
the process must be heating the food to the required time for the type of product.
documented and implemented. temperature, holding it at this temperature Is the product being cooled
The blanching equipment must for the required time, and then either rapidly rapidly or being processed
be periodically cleaned and cooling the food or passing it to subsequent without delay?
sanitized as necessary. manufacturing without delay. Growth and Verify that the system is
contamination by thermophilic cleaned and sanitized
microorganisms in blanchers must be regularly.
minimized by the use of adequate operating
temperatures and by periodic cleaning and
sanitizing as necessary.
1.6.4.12 If batters, breading, sauces, Batters, breading, sauces, gravies, dressings, (12) Verify that holding containers, Policy, Record
gravies, dressings, dipping dipping solutions, and other similar vats, tubs, etc. are cleaned and
solutions, and other similar preparations that are held and used sanitized regularly.
preparations are held and used repeatedly over time must be treated or
repeatedly over time, they must maintained in such a manner that they are Have they done a risk
be treated or maintained in such protected against allergen cross‐contact and assessment for each type of
a manner that they are protected against contamination, and minimizing the product? Question how they
against allergen cross‐contact potential for the growth of undesirable determine when a product that
and against contamination, and microorganisms. is repeatedly used is no longer
to minimize the potential for safe or of good quality.
the growth of undesirable
microorganisms. If products are to be held
under specific temperature
requirements to minimize
microbial growth, verify that it
is being done. Observe that
storage container
lids/coverings are in place.
1.6.4.13 Filling, assembling, packaging, Filling, assembling, packaging, and other (13) Observe the processes to Record
and other operations must be operations must be performed in such a way verify GMP’s are being
performed in such a way that that the food is protected against allergen followed. Look for such
the food is protected against cross‐contact, contamination and growth of things as covers that are open
allergen cross‐contact, undesirable microorganisms. or missing from filler hoppers,
contamination, and growth of packaging material sitting on
undesirable microorganisms. the floor, product conveying
on dirty/unsanitary conveyor
belts. Observe that
temperature and/or time

requirements for filling,
assembling, or packaging are
being met.
1.6.4.14 Dry mixes, nuts, intermediate Food, such as dry mixes, nuts, intermediate (14) If products are controlled for Policy, Record
moisture food, and dehydrated moisture food, and dehydrated food, that Aw, verify that the facility is
food, that rely principally on relies principally on the control of Aw for monitoring Aw of the product.
the control of water activity preventing the growth of undesirable What does the facility do with
(Aw) for preventing the growth microorganisms must be processed to and product that does not meet
of undesirable microorganisms, maintained at a safe moisture level. their requirements? Do they
must be processed to, and have a microbial monitoring
maintained at a safe Aw level. program for monitoring
pathogenic bacteria? Review
Controls must be documented. test results. Are products
stored in a manner to prevent
Aw levels from changing?
1.6.4.15 Acid and acidified food are Food, such as acid and acidified food, that (15) Review pH monitoring Policy, Record
monitored and maintained at a relies principally on the control of pH for records. What is the facility
pH of 4.6 or below. preventing the growth of undesirable policy for products that do not
microorganisms must be monitored and meet the pH requirement?
maintained at a pH of 4.6 or below.
1.6.4.16 Ice that is used (internally When ice is used in contact with food, it (16) Verify that the water used for Record
produced or externally must be made from water that is safe and of ice production is potable (see
supplied) in contact with food adequate sanitary quality in accordance with 1.7.1.1) and stored and
must be made from water that § 117.37(a) and must be used only if it has handled under sanitary
is safe and of adequate sanitary been manufactured in accordance with conditions. Verify that the ice
quality and manufactured in current good manufacturing practice as machine is on a cleaning and
accordance with current good outlined in this part. sanitation schedule.
manufacturing practices.
If ice is from an outside
source, ask for the
documented assurances that
the ice was potable.
1.7 Defect Action
1.7.1 The facility must determine if 21 CFR Review the finished products Policy
defect action levels are 117.110 produced or handled at the
established for the food handled facility against the Defect
or manufactured by the facility. Levels Handbook,
https://www.fda.gov/food/ingr
Controls must be documented. edients-additives-gras-
packaging-guidance-
documents-regulatory-
information/food-defect-
levels-handbook.
Identify defect action levels: Record the defect action
levels appropriate for the
facility and/or what the
facility has identified.
1.7.2 Quality control operations must The manufacturer, processor, packer, and (a) Observe if appropriate Policy, Record
be conducted in a way that holder of food must at all times utilize controls have been
reduce natural or unavoidable quality control operations that reduce documented and
defects to the lowest level natural or unavoidable defects to the lowest implemented, based on the
currently feasible. The policies level currently feasible. FDA Defect Levels
must be documented, with Handbook. Some contracts
records of implementation. require that the chemical or
microbial tests be performed
by a laboratory accredited to
ISO17025, or a USDA lab.
Review a random sample of
the associated test or
inspection records.
1.7.3 The facility shall not mix foods The mixing of a food containing defects at (b) Ask the facility how they
containing defects at levels that levels that render that food adulterated with would handle finished product
render that food adulterated another lot of food is not permitted and that exceeds established
with other lots of food. renders the final food adulterated, limits. Any policy for mixing
regardless of the defect level of the final foods with those that exceed
food. For examples of defect action levels established limits would be
that may render food adulterated, see the unacceptable.
Defect Levels Handbook, which is
accessible at http://www.fda.gov/pchfrule
and at http://www.fda.gov.
1.8 Equipment and Utensils (Design, Materials, and Maintenance)
1.8.1 General 21 CFR

117.40 (a)
1.8.1.1 All plant equipment and utensils All plant equipment and utensils used in (1) Verify by observation. Are the
used in manufacturing, manufacturing, processing, packing, or materials used to manufacture
processing, packing, or holding holding food must be so designed and of the utensils and equipment
food must be designed and of such material and workmanship as to be acceptable for use in food
such material and workmanship adequately cleanable, and must be plants? Is equipment designed
as to be adequately cleanable adequately maintained to protect against to be easily dismantled for
and must be adequately allergen cross‐contact and contamination. cleaning? Is the equipment
maintained. included in a preventive
maintenance program?
1.8.1.2 Equipment and utensils must be Equipment and utensils must be designed, (2) Verify by observation. Look
designed, constructed, and used constructed, and used appropriately to avoid for things such as metal
appropriately to avoid the the adulteration of food with lubricants, rubbing against metal
adulteration of food with fuel, metal fragments, contaminated water, (possibly in product pumps,
lubricants, fuel, metal or any other contaminants. grinders, extruders), nuts and
fragments, contaminated water, bolts in food contact zones,
or any other contaminants. excessive lubrication on
conveyor gears/gear
boxes/bearings in close
contact to or above food or
food contact surfaces,
excessive grease on greased

fittings for packaging
machines, excessive grease on
rollers for crimping & sealing
cans. Are high pressure
washers being used
appropriately to prevent
contamination from water?
1.8.1.3 Equipment must be constructed Equipment must be installed so as to (3) Verify by observation that
and located so that they are facilitate the cleaning and maintenance of equipment is located so that it
accessible for cleaning, the equipment and of adjacent spaces. can be easily cleaned,
maintenance, and inspection. inspected, and maintained.
Does the location of the
equipment prevent adjacent
areas being properly cleaned,
inspected, and maintained?
1.8.1.4 Food‐contact surfaces must be Food‐contact surfaces must be corrosion‐ (4) and (5) Verify by observation. If you
corrosion‐resistant, made of resistant when in contact with food. are unsure if a contact surface
nontoxic materials, and is acceptable for use in a food
designed to withstand the Food‐contact surfaces must be made of plant, ask to see
environment of their intended nontoxic materials and designed to documentation that certifies
use and of the cleaning process. withstand the environment of their intended that it is acceptable.
use and the action of food, and, if
applicable, cleaning compounds, sanitizing
agents, and cleaning procedures.
1.8.1.5 Food‐contact surfaces must be Food‐contact surfaces must be maintained (6) Verify by observation. Look
maintained to protect food from to protect food from allergen cross‐contact for scratches, pitting,
allergen cross‐contact and from and from being contaminated by any source, cavitation in stainless steel
being contaminated. including unlawful indirect food additives. that should be polished
smooth; cuts, gouges, and
tears on conveyor belts; deep
cuts, scratches or frayed
plastic on plastic utensils,
buckets, tubs, totes, etc.
1.8.2 Seams on food‐contact surfaces Seams on food‐contact surfaces must be (b) Verify by observation. Look
must be sanitary welds, smoothly bonded or maintained so as to for unsanitary welds - cracks
smoothly bonded and minimize accumulation of food particles, and open seams that need to
maintained to minimize dirt, and organic matter and thus minimize be sealed, skip welds, broken
accumulation of food particles, the opportunity for growth of welds, and rough welds that
dirt, and organic matter microorganisms and allergen cross-contact. need to be polished smooth.
minimizing the opportunity for
microorganism growth and
allergen cross-contact.
1.8.3 Non-food contact equipment Equipment that is in areas where food is (c) Verify by observation that
located in the processing and manufactured, processed, packed, or held equipment is clean, free from
packing areas shall be and that does not come into contact with dust accumulation, rust,
constructed so that it can be food must be so constructed that it can be peeling paint, has smooth
maintained, and is in good kept in a clean and sanitary condition. cleanable surfaces, etc. This
condition, able to be cleaned. applies to equipment that is
non-food contact, as well as
currently unused processing
equipment.
1.8.4 Holding, conveying, and Holding, conveying, and manufacturing (d) Verify by observation. Verify
manufacturing systems must be systems, including gravimetric, pneumatic, that there are no line
of a design and construction that closed, and automated systems, must be of a extensions or out of reach
enables them to be maintained, design and construction that enables them to areas that create a situation in
and are in an appropriate clean be maintained in an appropriate clean and which cleaning is ineffective.
and sanitary condition. sanitary condition.
1.8.5 Freezer and cold storage Each freezer and cold storage compartment (e) Observe that there are
compartments must be fitted used to store and hold food capable of thermometers or temperature
with an indicating thermometer, supporting growth of microorganisms must recording devices in all freezer
temperature‐measuring device, be fitted with an indicating thermometer, and cold storage areas.
or temperature recording device. temperature‐measuring device, or
temperature recording device so installed as
to show the temperature accurately within
the compartment.
1.8.6 Instruments and controls used Instruments and controls used for (f) Verify that instruments and Policy, Record
for measuring, regulating, or measuring, regulating, or recording thermometers have been
recording temperatures, pH, temperatures, pH, acidity, water activity, or calibrated. Ask to see the
water activity, etc. must be other conditions that control or prevent the calibration documentation.
properly maintained, calibrated, growth of undesirable microorganisms in Verify that the instruments,
and adequate in number for their food must be accurate and precise and (such as scales, pH meters,
designated uses. adequately maintained, and adequate in etc.) are checked daily for
number for their designated uses. accuracy and that equipment
such as pasteurizers that
regulate temperature and time
are checked routinely. Ask to
see the calibration policy for
the plant. Are there preventive
maintenance (PM) policies for
instruments and have they
been implemented? Note that
scales used strictly for product
weight in the packaging area
would not be included in this
requirement.
1.8.7 Compressed air or other gases Compressed air or other gases mechanically (g) Verify that there is a PM plan Policy, Record
mechanically introduced into introduced into food or used to clean food‐ for changing filters in the air
food or used to clean food‐ contact surfaces or equipment must be lines and that separators are
contact surfaces or equipment treated in such a way that food is not working correctly. Verify that
must be filtered and oil free. contaminated with unlawful indirect food the sources for other gases
additives. such as nitrogen can certify
the gas to be clean and dry.
1.9 Sanitary Facilities and Controls
1.9.1 General Each plant must be equipped with adequate 21 CFR

sanitary facilities and accommodations 117.37
including:
1.9.1.1 The water supply/system must Water supply. The water supply must be (a) Document the water source Record
be adequate for the operations adequate for the operations intended and (for example, municipal, well,
intended and must be derived must be derived from an adequate source. or other).
from an adequate source.
Private wells must be inspected If well water is the source,
on an annual basis. verify that the system has been
inspected yearly.
1.9.1.1.1 There shall be testing results Any water that contacts food, food‐contact Verify that the plant has test Record
showing that water used for surfaces, or food‐packaging materials must results from an accredited
processing, cleaning, as an be safe and of adequate sanitary quality. laboratory showing that water
ingredient, or by personnel is meets the EPA National
potable. Drinking Water Regulations
for Microorganisms. Record
Water test results issued by: the issuer and the date of the
test report. If the water source
Date of testing: is municipal, the report may
be from the municipality.
Testing must be performed
annually, at a minimum.
Verify that the water is free of
generic E. coli. and total
coliforms.
1.9.1.1.2 Running water of suitable Running water at a suitable temperature, Verify by observation. Record
temperature and pressure must and under pressure as needed, must be Observe if there are steam
be available in all areas where provided in all areas where required for the regulators to control the
required for the processing of processing of food, for the cleaning of temperature and pressure
food, for the cleaning of equipment, utensils, and food‐packaging transducers to control the
equipment, utensils, and food‐ materials, or for employee sanitary water pressure and if they are
facilities. covered by the PM program.
packaging materials, or for Check that the water

employee sanitary facilities. temperature at sinks where
employees wash their hands is
conducive for hand washing
and that at hose stations is
adequate for its purpose. Is
there adequate water pressure?
What are water temperature
requirements for the
processes? Check temperature
logs to verify adequate
processing or cleaning
implementation.
1.9.2 Plumbing Plumbing. Plumbing must be of adequate (b)
size and design and adequately installed and
maintained to:
1.9.2.1 Plumbing must be of adequate Carry adequate quantities of water to (1) – (3) Verify by observation. Are
size and design to handle the required locations throughout the plant. there signs of sewage back-up
water and waste flow for the Properly convey sewage and liquid or odors from drains? Are
facility, and not create possible disposable waste from the plant. there water leaks or seepage?
contamination or unsanitary Avoid constituting a source of Is plumbing adequate to carry
conditions. contamination to food, water supplies, water to required locations
equipment, or utensils or creating an throughout the plant? Observe
unsanitary condition. if lines are installed over
product zones.
1.9.2.2 Floors, gutters, or drains must Provide adequate floor drainage in all areas (4) Observe if floors are properly
have sufficient slope and outlets where floors are subject to flooding‐type sloped, if there are a sufficient
to drain adequately. cleaning or where normal operations release number of drains, if drain
or discharge water or other liquid waste on covers are in place, if drains
the floor. are clogged and if drains are
properly trapped.
1.9.2.3 There shall not be any cross Provide that there is not backflow from, or (5) Verify by observation that
connections between treated and cross‐connection between, piping systems water lines are separate from
untreated supplies. that discharge waste water or sewage and
piping systems that carry water for food or sewer lines/wastewater lines
food manufacturing. and that lines are labeled.
1.9.2.4 Back flow prevention devices (5) Verify that the back flow Record
must be installed on all water prevention devices have been
and steam lines, and periodically installed and that they are on
certified. an annual PM schedule for
certification.
Certification by:
Record the name of the
Date of last certification: company that certified the
back flow device and the date
of certification on the audit
report. This must be
performed by a certified
individual (in-house) or the
local municipality or state.
1.9.3 Sewage must be disposed of into Sewage disposal. Sewage must be disposed (c) Verify how the sewage is
an adequate sewage system or of into an adequate sewerage system or disposed of (city sewer
disposed of through other disposed of through other adequate means. system, plant wastewater
adequate means. system, septic tank, etc.).
Observe if there are any
obvious issues with the
system.
1.9.4 For toilet facilities that are Toilet facilities. Each plant must provide (d)
located in production areas or employees with adequate, readily accessible
primarily used by production toilet facilities. Toilet facilities must be kept
staff, there must be: clean and must not be a potential source of
contamination of food, food‐contact
surfaces, or food‐packaging materials.
1.9.4.1 An adequate, readily accessible, Observation. Verify that
number of units for the facility OSHA or state mandated
size/number of employees. requirements are met and that
facilities are accessible to
employees.
1.9.4.2 Independent outside ventilation. Observation. There needs to

be a working exhaust
fan/system, vented to the
outside of the building.
1.9.4.3 Design so that they do not open Observation.
directly into food handling areas
(i.e., processing, repacking, or
reconditioning areas).
1.9.4.4 Self-closing doors or maze-type Observation.
entrance.
1.9.4.5 Adequate lighting. Observation.
1.9.4.6 Sufficient and proper waste Observation. Trash containers
receptacles. should be hands free to
eliminate the potential
recontamination of clean and
sanitized hands. Observe if
trash containers are
overflowing.
1.9.4.7 Signs posted indicating the Observation. Verify signs are
importance of hand washing posted in all toilet facilities.
(multilingual if appropriate).
1.9.4.8 Hand-washing facilities with Observation. Hands-free
running water at a suitable fixtures at sinks and soap
temperature, soap, and single dispensers are preferred but
use towels or forced air hand not required. Is there
dryers. available warm water,
antimicrobial soap, and single
use towels or air dryers?
1.9.4.9 Toilet areas that are clean, dry, Observation. Verify that
properly stocked with toilet cleaning and sanitizing
paper, and of good general practices are adequate. Are
appearance. toilet bowls, sinks, walls, and
floors clean? Is housekeeping
adequate? Is toilet paper
available?
1.9.4.10 Toilets, sinks, and faucets in Observe by testing one or two

good working condition. of the units to see if they work
properly and that there is
adequate water pressure.
1.9.5 Hand-washing facilities (located Hand‐washing facilities. Each plant must (e) This requirement applies to
in breakroom and production provide hand‐washing facilities designed to hand-washing facilities that
area) shall include running ensure that an employee’s hands are not a are not located in toilet areas.
water at a suitable temperature, source of contamination of food, food‐ Test that the sinks work
soap, and single use towels or contact surfaces, or food‐packaging properly, have warm water,
forced air hand dryers. Signs materials, by providing facilities that are that forced air hand dryers (if
must be posted indicating the adequate, convenient, and furnish running used) work properly. Observe
importance of hand washing water at a suitable temperature. that there is antimicrobial
(multilingual if appropriate). hand soap and single use
towels. Is there an adequate
number of facilities and are
they convenient? Are hand-
washing signs posted and
multilingual, if appropriate.
1.9.6 The capacity of the facility’s Rubbish and offal disposal. Rubbish and (f) Verify that the facility has a Policy
rubbish/waste storage must be any offal must be so conveyed, stored, and documented plan for the
sufficient for the operation, with disposed of as to minimize the development GFSI, GMP containment and removal of
dedicated waste containers and of odor, minimize the potential for the waste 12.1 waste from the interior of the
timely removal of waste. A becoming an attractant and harborage or building(s). Check if there is a
policy must be documented. breeding place for pests, and protect against map/route to follow to the
contamination of food, food‐contact trash dumpster to eliminate the
surfaces, food‐packaging materials, water potential for cross
supplies, and ground surfaces. contamination. Observe if
trash containers are covered,
A procedure shall be established, over-flowing, and if there is
implemented and maintained for the food/trash/debris on the
collection, storage and disposal of waste floor/ground. Is there a strong
material, including waste water and odor from the trash that may
drainage. permeate into the plant or be
absorbed into the food? Check
the frequency of waste

removal.
1.10 Maintenance and Sanitation
1.10.1 General Maintenance 21 CFR

117.35 (a)
1.10.1.1 Buildings, fixtures, and other Buildings, fixtures, and other physical Observe such things as peeling Policy, Record
physical facilities of the plant facilities of the plant must be maintained in paint on walls, ceilings, floors,
must be maintained in a clean a clean and sanitary condition and must be drains, and equipment, dust
and sanitary condition and must kept in repair adequate to prevent food from and debris on ledges,
be kept in repair adequate to becoming adulterated. missing/torn screens from
prevent food from becoming doors and windows,
adulterated. cracks/holes in walls,
missing/low grout in floor and
After maintenance repairs of wall tiles, proper ventilation to
equipment associated with food eliminate condensation and
processing or with food contact mold growth, etc.
surfaces, the equipment must be
cleaned, sanitized, and Verify that the plant has a
inspected. This policy must be sanitation policy in place for
documented, and when maintenance or repairs
implementation must be are performed in a food
recorded. contact zone or on food
processing equipment. Steps
should be taken to isolate the
area to prevent contamination.
Inspection by a competent
individual must occur and be
recorded before the equipment
is released for use.
1.10.1.2 Cleaning and sanitizing of Cleaning and sanitizing of utensils and Verify that there are policies Policy, Record
utensils and equipment must be equipment must be conducted in a manner for cleaning and sanitizing all
conducted in a manner that that protects against allergen cross-contact equipment and utensils and
protects against allergen cross- and against contamination of food, food that it has been implemented.
contact and against contact surfaces, or food-packaging Review recent records of
contamination of food, food materials. cleaning and sanitization.
contact surfaces, or food-
packaging materials. The
procedure must be documented
and there must be records to
show completion.
1.10.2 Sanitation Chemicals and (b)
Supplies
1.10.2.1 Cleaning compounds and Cleaning compounds and sanitizing agents (1) Review the cleaning
sanitizing agents used in used in cleaning and sanitizing procedures compounds and sanitizing
cleaning and sanitizing must be free from undesirable agents used in the plant.
procedures must be free from microorganisms and must be safe and Request to see letters of
undesirable microorganisms and adequate under the conditions of use. guarantee, certificates of
appropriate for use Compliance with this requirement must be assurance (COA’s), labels, or
(documentation must be verified by any effective means, including other documentation from the
available for verification). purchase of these substances under a letter suppliers to verify that they
of guarantee or certification or examination are free of undesirable
of these substances for contamination. microbes and are safe for their
intended use. Select a random
number of containers to
examine the label to verify
that it is appropriate for its
use. Verify that label
instructions are being followed
for mixing and application.
1.10.2.2 The chemicals stored at the Only the following toxic materials may be (1) Check the maintenance shop
facility must be appropriate for used or stored in a plant where food is to verify non-food grade and
presence in a plant where food processed or exposed: food grade oils and lubricants
is processed and exposed. Food i) Those required to maintain are stored separately. Verify
clean and sanitary conditions; that lab chemicals and
grade lubricants must be used in ii) Those necessary for use in chemicals needed for use
exposed product zones. laboratory testing procedures; during production or sanitation
iii) Those necessary for plant and are kept in an area out of a
equipment maintenance and food contact zone. Are Safety
operation; and Those Data Sheets (SDS) available to
necessary for use in the plant’s employees?
operations.
1.10.2.3 There shall be a locked storage Toxic cleaning compounds, sanitizing (2) Observe that there is a
area for chemicals with agents, and pesticide chemicals must be designated and locked area for
controlled access, and chemicals identified, held, and stored in a manner that chemical storage located in an
must be clearly and properly protects against contamination of food, area away from food
labeled. food-contact surfaces, or food-packaging packaging material, exposed
materials. food, or food contact surfaces.
Observe that all containers are
properly and clearly labeled.
Observe that pesticides are not
stored with cleaning and
sanitizing agents. Verify
controlled access to the
secured area.
1.10.3 Pest Control (c)
1.10.3.1 The facility shall document and Pests must not be allowed in any area of a Verify that the plant has a pest Policy, Record
implement an effective pest food plant. Guard, guide, or pest-detecting control program. If an outside
control program. dogs may be allowed in some areas of a pest control company is used,
plant if the presence of the dogs is unlikely request to see the certification
to result in contamination of food, food of the provider. If the
contact surfaces, or food-packaging company provides their own
materials. Effective measures must be taken pest control, ask to see
to exclude pests from the manufacturing, certification of personnel
processing, packing, and holding areas and responsible for pest control.
to protect against the contamination of food Are there pest control traps,
on the premises by pests. lights, mats, etc. located in the
plant or warehouse to prevent
pests from infesting the
facility?
1.10.3.1.1 A pest control station map is Verify the facility has a pest Policy, Record
properly maintained and control map and the date the
available. pest control map was last
updated.
1.10.3.1.2 Routine maintenance and Review the pest control Policy, Record
inspection of pest control inspection and surveillance
devices is documented. results. Document how often
the inspections are performed.
Are electrical insect killers,
blowers or fans working
properly?
1.10.3.1.3 The type, number, and Observe as you walk through
placement of pest if randomly selected stations
control/deterrent devices is are in place as noted on the
adequate and appropriate to map. Do you see evidence of
prevent infestation. infestation? Bait stations
must not be used inside the
facility. (See 1.13.2.3 for
requirements in bulk storage
areas.)
1.10.3.1.4 The facility is free from pest Verify by observation if there
infestation. is evidence of infestation.
1.10.3.2 The use of pesticides to control The use of pesticides to control pests in the Verify that there are Record
pests in the facility must be plant is permitted only under precautions appropriate measures for the
performed under precautions and restrictions that will protect against the application and storage of
and restrictions that will protect contamination of food, food-contact pesticides and that the
against the contamination of surfaces, and food packaging materials. individual responsible for
food, food-contact surfaces, and pesticide application is
food packaging materials. properly trained and certified.
Any exposed food or
packaging material shall be
covered before pesticides are
applied, and equipment and
utensils shall be thoroughly
cleaned and sanitized before
use after pesticides are

applied.
1.10.4 Sanitation of Food-Contact Sanitation of food-contact surfaces. (d)
Surfaces
1.10.4.1 All food-contact surfaces, All food-contact surfaces, including utensils Verify that there are adequate Policy, Record
including utensils and food- and food-contact surfaces of equipment, procedures for cleaning and
contact surfaces of equipment, must be cleaned as frequently as necessary sanitizing all food contact
must be cleaned as frequently as to protect against allergen cross-contact and surfaces used for processing
necessary to protect against against contamination of food. food. Are procedures fully
allergen cross-contact and implemented? Review recent
against contamination of food. records of cleaning and
The procedure must be sanitization. Note the
documented and there must be responsible party(s) for
records to show completion. oversight of cleaning and
Cleaning and sanitation sanitation, and verify that they
oversight must be assigned to at have received appropriate
least one competent staff person. training.
1.10.4.2 For processing, packing, or Food-contact surfaces used for (1) Observe if food contact Policy, Record
holding low-moisture food, food manufacturing/processing, packing, or surfaces are thoroughly dried
contact surfaces must be clean holding low-moisture food must be in a after cleaning and sanitizing.
and dry before use. If wet- clean, dry, sanitary condition before use. The use of alcohol- based
cleaned, the surfaces must be When the surfaces are wet-cleaned, they wipes are acceptable means of
sanitized and thoroughly dried must, when necessary, be sanitized and sanitizing surfaces. Air drying
before use. The procedure must thoroughly dried before subsequent use. is a common method for
be documented and there must drying surfaces.
be records to show completion.
1.10.4.3 In wet processing, all food In wet processing, when cleaning is (2) Verify that there are policies Policy, Record
contact surfaces must be cleaned necessary to protect against allergen cross- for cleaning and sanitizing all
and sanitized before use and contact or the introduction of equipment and utensils.
after any interruption during microorganisms into food, all food contact Verify the cleaning schedule
which the food contact surfaces surfaces must be cleaned and sanitized in continuous operations is
may have become contaminated. before use and after any interruption during being followed. Observe that
Where equipment and utensils which the food contact surfaces may have food contact surfaces are clean
are used in a continuous become contaminated. Where equipment and free of food residue, soil,
production operation, the and utensils are used in a continuous etc.
utensils and food-contact production operation, the utensils and food-

surfaces of the equipment must contact surfaces of the equipment must be
be cleaned and sanitized as cleaned and sanitized as necessary.
necessary. The procedure must
be documented and there must
be records to show completion.
1.10.4.4 Single-service articles must be Single-service articles (such as utensils (3) Verify by observation if
stored, handled, and disposed of intended for one-time use, paper cups, and single-service products are
in a manner that protects against paper towels) must be stored, handled, and covered/protected from
allergen cross-contact and disposed of in a manner that protects against contamination and adequately
against contamination of food, allergen cross-contact and against stored, and that any used,
food-contact surfaces, or food contamination of food, food-contact dirty, or soiled products are
packaging materials. surfaces, or food packaging materials. disposed, destroyed, or stored
and labeled as not for use until
they can be properly disposed
of.
1.10.5 Non‐food contact surfaces of Sanitation of non‐food‐contact surfaces. (e) Verify by observation that
equipment used in the operation Non‐food‐contact surfaces of equipment non-food contact surfaces such
of a food plant must be cleaned used in the operation of a food plant must as the exteriors of machines,
in a manner and as frequently as be cleaned in a manner and as frequently as forklifts, storage shelves, etc.
necessary to protect against necessary to protect against allergen cross‐ are clean. Verify that cleaning
allergen cross‐contact and contact and against contamination of food, non-food contact surfaces is
against contamination of food, food‐contact surfaces, and food‐packaging regularly scheduled.
food‐contact surfaces, and food‐ materials.
packaging materials.
1.10.6 Cleaned and sanitized portable Storage and handling of cleaned portable (f) Verify by observation that
equipment with food‐contact equipment and utensils. Cleaned and equipment is not stored on the
surfaces and utensils must be sanitized portable equipment with food‐ floor or ground. Are special
stored in a location and manner contact surfaces and utensils must be stored tables, carts, racks provided
that protects food‐contact in a location and manner that protects food‐ for cleaned utensil storage?
surfaces from allergen cross‐ contact surfaces from allergen cross‐contact Are clean and sanitized
contact and from contamination. and from contamination. portable pieces of equipment
covered or stored in an area
free from possible
contamination?
1.11 Warehousing and Distribution
1.11.1 The storage and transportation Storage and transportation of food must be 21 CFR Observe that the warehouse
of food must be carried out so under conditions that will protect against 117.93 has good housekeeping,
that it is protected against allergen cross‐contact and against pallets are stored away from
allergen cross‐contact and biological, chemical (including the walls, there is sufficient
against biological, chemical radiological), and physical contamination of storage space to allow air
(including radiological), and food, as well as against deterioration of the circulation around product for
physical contamination of food, food and the container. cooling, prevention of mold
as well as against deterioration growth and to lessen damage
of the food and the container. to product due to over-
crowding. Is food exposed
because of damaged
packaging? Are best storage
practices being followed to
prevent allergen cross-
contact?
1.11.1.1 Incoming trailers and goods are Verify that there are
inspected for damage, procedures for receiving or
infestation, off odors, incoming trailers, including
contamination, and proper inspection for damage,
temperatures. infestation of pests, off odors,
contamination, and
temperature. Interview
employees about the
procedures.
1.11.1.2 Wash certificates are required Review tanker wash tickets. Record
for bulk tanker trucks for Verify that the previous
previous loads. The record product shipped is indicated
indicates the previous product and was a food grade product.
shipped.
1.11.1.3 Procedures are implemented for Verify that there are

outbound shipments, including: procedures for inspecting
proper shipping temperature, outbound containers before
trailer cleanliness/condition, loading. Interview employees
verification of odors, etc. about the procedures. Observe
if trailers are clean, in good
repair and if cooling or freezer
units are working properly. If
tankers are being used verify
that they are clean.
1.11.1.4 Packaging, packing materials, Observe that packing
and empty containers must be materials, packaging and
protected from contamination. containers are covered with
plastic wrap, cardboard, etc. to
protect the materials from the
environment. Are outer
coverings/boxes torn exposing
materials to the environment?
Are materials stored on pallets
or shelves, and not directly on
the floor?
1.11.1.5 Retained, damaged, or returned Observe that retained,
product must be identified and damaged, or returned product
stored in a clearly designated or materials are stored in a
area or controlled through an designated area and labeled
inventory system. accordingly and ask how they
control them so that no
contaminated or deteriorated
products/materials are used in
production.
1.11.1.6 The facility must have a A procedure shall be established, GFSI, GMP Verify that there are Policy, Record
documented procedure to ensure implemented and maintained to ensure that 17 procedures to maintain
that ingredients, materials, work purchased materials, work in progress and appropriate rotation of
in progress, and finished product finished products are used in the correct materials and ingredients.
Generally, you would expect
are used in the correct order and order, and within the allocated shelf life to see the principle of first
within the allocated shelf life. when applicable. in/first out applied. Do
inventory, shipping, and
production records indicate
compliance with the policy?
1.12 Food By-Products for Animal Food
1.12.1 If the facility holds and Human food by‐products held for 21 CFR Ask the facility if they are
distributes human food by- distribution as animal food without 117.95 generating food by-products
products for use as animal food, additional manufacturing or processing by (a) for animal food. Does the
it must be held under conditions the human food processor, as identified in § facility have control
that protect against 507.12 of this chapter, must be held under procedures on storage time
contamination, including: conditions that will protect against and conditions? Have they
contamination, including the following: been implemented?
1.12.1.1 Containers and equipment used Containers and equipment used to convey or (1) Verify that there are
to convey or hold human food hold human food by‐products for use as procedures for cleaning human
by‐products before distribution animal food before distribution must be food by-product containers
must be designed, constructed of designed, constructed of appropriate and equipment. Observe by
appropriate material, cleaned as material, cleaned as necessary, and inspection if containers are
necessary, and maintained to maintained to protect against the constructed of appropriate
protect against contamination. contamination of human food by‐products material, are clean and in good
for use as animal food. repair. Interview employees
about the procedure.
1.12.1.2 Human food by‐products must Human food by‐products for use as animal (2) Verify by observation. Are
be held in a way to protect food held for distribution must be held in a trash containers located next
against contamination from way to protect against contamination from to by-product containers?
sources such as trash. sources such as trash
1.12.1.3 Human food by‐products must During holding, human food by‐products (3) Observe that food designated
be accurately identified. for use as animal food must be accurately as animal food is clearly
identified. labeled as “animal food”.
1.12.2 Labeling that identifies the by‐ Labeling that identifies the by‐product by (b) Verify by observation that all
product by the common or usual the common or usual name must be affixed by-products are labeled with
name must be affixed to or to or accompany human food by‐products the common or usual name.
accompany human food by‐ for use as animal food when distributed.
products for use as animal food
when distributed.
1.12.3 Shipping containers and bulk Shipping containers (e.g., totes, drums, and (c) Verify that the facility has a
vehicles used to distribute tubs) and bulk vehicles used to distribute procedure to inspect shipping
human food by‐products must human food by‐products for use as animal containers for condition and to
be examined prior to use to food must be examined prior to use to verify that they are suitable to
protect against contamination of protect against contamination of the human ship human food by-products
the human food by‐products food by‐products for use as animal food for use as animal food.
from the container or vehicle. from the container or vehicle when the
facility is responsible for transporting the
human food by‐products for use as animal
food itself or arranges with a third party to
transport the human food by‐products for
use as animal food.
1.13 Facility and Grounds
1.13.1 The grounds surrounding the Grounds. The grounds about a food plant 21 CFR
facility must: under the control of the operator must be 117.20 (a)
kept in a condition that will protect against
the contamination of food. The methods for
adequate maintenance of grounds must
include:
1.13.1.1 Be maintained in a manner Properly storing equipment, removing litter (1) Verify by observation. Look
which will prevent rodent and and waste, and cutting weeds or grass for things such as overgrown
insect harborage, reasonably within the immediate vicinity of the plant 21 CFR vegetation along the side of
free of litter and debris. that may constitute an attractant, breeding 117.35 (c) the building, low areas where
place, or harborage for pests. water stands, old pallets
stacked up or an equipment
junk yard, etc. or anything that
will attract or harbor pests.
1.13.1.2 Be properly surfaced and Maintaining roads, yards, and parking lots (2), (3) Observe if there are low spots
designed to prevent dust and so that they do not constitute a source of in the drives and parking lots
offensive odors and for adequate contamination in areas where food is with pooling water, if they are
drainage (minimal standing exposed. paved, dirt, rock or gravel.
water). Observe if dirt and mud are
Adequately draining areas that may being tracked into the facility.
contribute contamination to food by
seepage, foot-borne filth, or providing a
breeding place for pests.
1.13.1.3 Include an adequate number of Operating systems for waste treatment and (4) Verify that the plant has a Policy
exterior waste containers which disposal in an adequate manner so that they documented waste removal
are well maintained and in good do not constitute a source of contamination GFSI, GMP policy. Observe that trash
condition. in areas where food is exposed. 12.1 containers are well maintained
The frequency or removal of the and not over-flowing. Check
waste shall be timely. A procedure shall be established, the frequency of trash pick-up
implemented and maintained for the and verify by observation that
A policy must be documented. collection, storage and disposal of waste it is adequate.
material, including waste water and

drainage.
1.13.1.4 Not be affected by uncontrolled If the plant grounds are bordered by (5) Ask if the plant has done a risk
contamination risks from grounds not under the operator’s control and assessment for the surrounding
adjacent properties. The facility not maintained in the manner described in area. Observe if there are
shall take steps for additional paragraphs (a)(1) through (4) of this section, extra barriers, fences, netting,
inspection, extermination, or care must be exercised in the plant by etc. in place.
other means to limit any inspection, extermination, or other means to
identified risks. exclude pests, dirt, and filth that may be a
source of food contamination.
1.13.2 The plant design and Plant construction and design. The plant (b)
construction shall be adequate must be suitable in size, construction, and
for the food products produced. design to facilitate maintenance and sanitary
operations for food-production purposes
(i.e., manufacturing, processing, packing,
and holding). The plant must:
1.13.2.1 There must be adequate space Provide adequate space for such placement (1) Observe if the facility is
provided for necessary of equipment and storage of materials as is overcrowded. Look for
maintenance, sanitation, and necessary for maintenance, sanitary adequate warehousing, storage
production activities. operations, and the production of safe food. space and crowding in
production areas that prevents
adequate cleaning and
monitoring for condition.
Look for 18 inches of
clearance between exterior
walls and shelving.
1.13.2.2 The facility must be designed to Permit the taking of adequate precautions to (2) Verify that the plant layout
prevent contamination of reduce the potential for allergen cross- and and traffic controls are
products and materials. for contamination of food, food-contact conducive for the protection of
Measures may include physical surfaces, or food-packaging materials with finished product and to
segregation, time, air flow microorganisms, chemicals, filth, and other prevent cross contamination.
systems, enclosures, labeling, extraneous material. The potential for
and other effective means. allergen cross-contact and for contamination HVAC systems could be used
may be reduced by adequate food safety to prevent contamination of
controls and operating practices or effective processing areas by allergens

design, including the separation of or dust from other areas.
operations in which allergen cross-contact
and contamination are likely to occur, by Positive air pressure could be
one or more of the following means: maintained in the production
location, time, partition, air flow systems, area to establish a hygienic
dust control systems, enclosed systems, or control.
other effective means.
Physical segregation and/or
labeling of ingredients in the
warehouse, scheduling of
production runs so that
products with allergens are run
last, are all examples of
appropriate steps.
1.13.2.3 Bulk storage vessels shall be Permit the taking of adequate precautions to (3) Verify by observing if food
constructed and protected to protect food in installed outdoor bulk stored in vessels is adequately
prevent contamination. vessels by any effective means, including: protected.
i. Using protective
coverings. Observe if there is evidence of
ii. Controlling areas over pest activity and if the
and around the vessels to surrounding area can
eliminate harborages for contribute to pest harborage.
pests. Verify that there are pest
iii. Checking on a regular control devices in place and
basis for pests and pest that they are checked
infestation. regularly.
iv. Skimming fermentation
vessels, as necessary. Look for overhead covers if
sampling is occurring from the
top of tanker trucks.
Any valves or spigots, hoses,

or utensils should be
protected.
1.13.2.4 Floors, doors, ceilings, walls Be constructed in such a manner that floors, (4) Observe if floors, doors,
and overheads must be in good walls, and ceilings may be adequately ceilings, walls, and overheads
repair and designed to facilitate cleaned and kept clean and kept in good are constructed of durable
proper sanitation and repair; that drip or condensate from fixtures, materials that are easy to clean
maintenance. ducts and pipes does not contaminate food, and maintain, and that they are
food contact surfaces, or food-packaging free of cracks and crevices.
materials; and that aisles or working spaces Observe that ceilings are free
are provided between equipment and walls from condensation and mold.
and are adequately unobstructed and of Does the plant have drop or
adequate width to permit employees to false ceilings which could
perform their duties and to protect against provide places for pest to
contaminating food, food-contact surfaces, hide? Observe that walls are
or food-packaging materials with clothing made of materials that are
or personal contact. impervious to moisture.
Is there enough room for

employees to perform their
work?
1.13.2.5 There shall be adequate (4) Observe if there is proper
procedures in place to prevent ventilation to eliminate
overhead condensation from excessive condensation, if
dripping on to food, food food contact areas are shielded
contact surfaces, or food- (drip pans, etc.) to protect
packaging materials. condensation from dripping
onto it.
Look along product flow

zones, especially between
cold/warm areas for
condensation issues.
1.13.2.6 Catwalks and stiles must be (4) Observe if catwalks are
constructed and located to located above food processing
prevent product contamination. lines, open manways to
tankers, if
tubs/totes/bins/cleaned
equipment and utensils are

placed under catwalks, etc.
Kick plates or sheeting/catch

plate could be used to prevent
contamination.
1.13.2.7 There shall be sufficient lighting Provide adequate lighting in handwashing (5) Observe if there is adequate
in personnel areas, and to permit areas, dressing and locker rooms, and toilet lighting in production areas,
efficient operations and cleaning rooms and in all areas where food is where equipment is cleaned,
where food is examined, examined, manufactured, processed, and where product is inspected
manufactured, processed, packed, or held and where equipment or and graded. Observe if any
packed, or held and where utensils are cleaned; and provide shatter- lights are not working
equipment or utensils are resistant light bulbs, fixtures, skylights, or properly /light bulbs missing
cleaned. other glass suspended over exposed food in or burned out.
any step of preparation or otherwise protect
against food contamination in case of glass The rest rooms, other
breakage. personnel areas, and
handwashing areas must be
well lit.
1.13.2.8 Light fixtures and other glass (5) Verify by observation.
must be properly covered or Observe if the lights are
protected in case of breakage. shatter resistant and that light
shields/covers are in place.
Glass in the production area

must be shielded.
1.13.2.9 Fans and other air-blowing Provide adequate ventilation or control (6) Verify by observation. Are
equipment shall be located so to equipment to minimize dust, odors and fans blowing directly onto
minimize the potential for vapors (including steam and noxious fumes) exposed food, food contact
allergen cross-contact and for in areas where they may cause allergen zones or packaging materials?
contaminating food, food cross-contact or contaminate food; and
packaging materials, and food- locate and operate fans and other air- Are fans clean? Does the plant
contact surfaces. blowing equipment in a manner that use an HVAC system? If so, is
minimizes the potential for allergen cross- there a PM plan for changing
contact and for contaminating food, food
packaging materials, and food-contact filters and cleaning the

surfaces. system? Are the vents clean?
1.13.2.10 Buildings shall be reasonably (6) Verify by observation.
free from excessive dust, heat, Observe if there is proper
steam, condensation, vapors, ventilation, condensation
smoke or fumes. dripping from ceilings, mold
growth, exhaust fans not
working properly, excessive
amounts of dust accumulated
on equipment and ledges, etc.
1.13.2.11 Doors, windows, and other Provide, where necessary, adequate (7) Verify by observation.
gateways shall be closed or screening or other protection against pests. Observe such things as doors
properly protected with screens, propped opened, missing/torn
air screens or other protective screens from windows or
devices. doors, poorly sealed
doors/dock overhead doors.
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Effective Date: April 2022 Page 1 of 51

GUIDE FOR ELECTRONIC USAGE

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HOW TO USE THIS STANDARD

The standard includes the following columns:

• Requirement – a statement of the expectation for compliance to the audit standard.

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GOOD MANUFACTURING PRACTICES AUDIT STANDARD

Req. No. Requirement Reference Citation Auditor Guidance Documentation

Effective Date: April 2022 Page 4 of 51

Req. No. Requirement Reference Citation Auditor Guidance Documentation

variety), date received/released, lot or code

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1.2 Food Safety Plan

Req. No. Requirement Reference Citation Auditor Guidance Documentation

1.2.2 Implementation and oversight of Verify that responsibility for Policy

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1.3 Personnel Qualifications and Training

Req. No. Requirement Reference Citation Auditor Guidance Documentation

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Req. No. Requirement Reference Citation Auditor Guidance Documentation

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1.4 Personnel Hygiene

Req. No. Requirement Reference Citation Auditor Guidance Documentation

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Req. No. Requirement Reference Citation Auditor Guidance Documentation

no buttons (snap closure) and

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Req. No. Requirement Reference Citation Auditor Guidance Documentation

1.4.1.7 Fingernails (absence of polish; Verify by observation that the

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Req. No. Requirement Reference Citation Auditor Guidance Documentation

1.4.1.12 Control of blood or bodily Review the policy and observe

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Req. No. Requirement Reference Citation Auditor Guidance Documentation

1.4.2.3 Require adequate covering of Verify by observation that any

1.5 Supply Chain

Req. No. Requirement Reference Citation Auditor Guidance Documentation

1.6 Processes and Controls

Req. No. Requirement Reference Citation Auditor Guidance Documentation

1.6.1 General 21 CFR

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Req. No. Requirement Reference Citation Auditor Guidance Documentation

must be conducted in accordance with sanitizing (as appropriate) the

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Req. No. Requirement Reference Citation Auditor Guidance Documentation

allergen products? Is there a

These procedures should

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Req. No. Requirement Reference Citation Auditor Guidance Documentation

Verify that any chemicals used

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Req. No. Requirement Reference Citation Auditor Guidance Documentation

These treatment procedures

Control measures must be

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Req. No. Requirement Reference Citation Auditor Guidance Documentation

Control measures must be https://www.fda.gov/food/ingr

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Req. No. Requirement Reference Citation Auditor Guidance Documentation

they thawing it inside or