U Marketing and

Regulatory

Programs

Agricultural

Marketing

Service

Specialty

Crops

Program

Specialty 

Crops 

Inspection

Division

AIM 

Inspection

Series

Good Manufacturing 

Practices (GMP) Audit 

Standard

April 2022
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i

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
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 

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SCI Division Inspection Series GMP Audit Standard

Effective Date: April 2022 Page 2 of 51

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’sGMP 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/plantaudits. 
SCI Division Inspection Series GMP Audit Standard

Effective Date: April 2022 Page 3 of 51

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 

and Drug Administration (FDA) 

registration number.

The Food and Drug Administration (FDA) 

requires domestic and foreign facilities that 

manufacture/process, pack, or hold food for 

human or animal consumption in the United 

States to register with FDA.

Bioterrorism 

Act of 2002

Request to see a copy of the 

facility’s registration with 

FDA. This is renewed every 

other year. Verify location 

information is correct and 

registration is current. Do not 

document the facility number in 

your audit/notes. Record the 

expiration date.

Record

1.1.2 The facility must establish a 

documented traceability system 

which enables identification of 

food which is received and to 

where it is eventually shipped, 

either in its original state or as 

part of a finished product.

People who “manufacture, process, pack, 

transport, distribute, receive, hold, or import 

food” in the United States, as well as 

foreign food transporters in the United 

States, are required to maintain records to 

identify the previous sources and 

subsequent recipients of the food. 

Exclusions include: farms, restaurants, food 

processed for personal consumption, and 

outer food packaging.

Direct to consumer distributors are not 

required to keep records of the people to 

whom they sell. Food transfers within a 

company are not subject to recordkeeping. 

Also excluded are food samples used for 

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 

Bioterrorism 

Act of 2002

Verify that there is a 

documented traceability 

program and review practices 

for effectiveness. Are records 

established showing previous 

sources and subsequent 

receivers of food? Do the 

records 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?

Policy, Record
SCI Division Inspection Series GMP Audit Standard

Effective Date: April 2022 Page 4 of 51

Req. No. Requirement Reference Citation Auditor Guidance Documentation

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.

Recordsmust 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 

"mock recall" that was proven to 

be effective. This exercise must 

be performed at least annually.

Ask to see the record of a mock 

recall performed in the last 12 

months.

Record
SCI Division Inspection Series GMP Audit Standard

Effective Date: April 2022 Page 5 of 51

1.2 Food Safety Plan

Req. No. Requirement Reference Citation Auditor Guidance Documentation

1.2.1 The facility must have a food 

safety plan which is documented 

and implemented. 

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.

Verify that a policy has been 

developed and implemented. 

Confirm employee 

understanding via interview.

Policy

1.2.2 Implementation and oversight of 

the food safety plan must be 

under the supervision of one or 

more competent individuals 

assigned responsibility for this 

function.

Verify that responsibility for 

the management of the food 

safety plan is assigned to 

someone who has had 

appropriate food safety training 

and/or knowledge based on 

work experience. 

Policy

1.2.3 The facility must document, 

implement, and record daily, 

weekly, and/or monthly site 

inspections as necessary to 

verify implementation of their 

food safety plan controls and 

policies associated with 

housekeeping, cleaning and 

sanitation, and maintenance.

A programme of site inspections / checks 

shall be established, implemented and 

maintained to ensure the site environment 

and processing equipment are maintained 

in a suitable condition to ensure food safety, 

as applicable to the activity of the site.

GFSI, GMP 

10

Identify the daily, weekly, and 

monthly inspections that have 

been established and review the 

recent records of the 

inspections.

Policy, Record
SCI Division Inspection Series GMP Audit Standard

Effective Date: April 2022 Page 6 of 51

1.3 Personnel Qualifications and Training

Req. No. Requirement Reference Citation Auditor Guidance Documentation

1.3.1 All personnel who manufacture, 

process, pack, or hold food must 

be qualified to perform their 

assigned duties.

Qualifications must be 

documented. 

The management of an establishment must 

ensure that all individuals who manufacture, 

process, pack, or hold food are qualified to 

perform their assigned duties.

Each individual engaged in manufacturing, 

processing, packing, or holding food 

(including temporary and seasonal 

personnel) or in the supervision thereof 

must:

21 CFR 

117.4

(a) and (b)

Ask to see job descriptions and 

qualifications for specific jobs 

in the facility (A quality control 

technician job will require 

different qualifications than a 

maintenance technician job). 

Verify that appropriate food 

safety training requirements are 

indicated. 

Policy, Record

1.3.1.1 Each individual must be, or be 

under the supervision of, a 

qualified individual.

Be a qualified individual as that term is 

defined in § 117.3—i.e., have the education, 

training, or experience (or a combination 

thereof) necessary to manufacture, process, 

pack, or hold clean and safe food as 

appropriate to the individual’s assigned 

duties; and

(1) Review the personnel who are 

designated as supervisors. Ask 

employees who their 

supervisors are. In 1.3.2, you 

will verify the training and 

qualifications of the 

supervisors. If someone isn’t 

being directly supervised, see if 

their training and qualifications 

would establish them as a 

qualified individual.

Record

1.3.1.2 Each individual must receive 

training on the principles of 

food hygiene and food safety, as 

appropriate to their role and 

responsibilities. Training must 

be provided when first hired, 

with a minimum of annual 

refreshers.

Receive training in the principles of food 

hygiene and food safety, including the 

importance of employee health and personal 

hygiene, as appropriate to the food, the 

facility and the individual’s assigned duties.

(2) Verify that the company has a 

documented policy for the 

training of all employees on the 

principles of food safety, 

appropriate to their position.

Review food safety training 

records of a random selection 

of employees, including 

administrative, management, 

and processing staff. Record 

training dates and subject 

Policy, Record
SCI Division Inspection Series GMP Audit Standard

Effective Date: April 2022 Page 7 of 51

Req. No. Requirement Reference Citation Auditor Guidance Documentation

material. Training, at a 

minimum, should be at new 

hire/promotion, and as an 

annual refresher. 

1.3.2 Supervisory personnel must be 

assigned the responsibility for 

personnel compliance with food 

safety and food hygiene policies 

and procedures, and have the 

education, training, or 

experience (or a combination 

thereof) necessary to supervise 

the production of clean and safe 

food.

Additional qualifications of supervisory 

personnel. Responsibility for ensuring 

compliance by individuals with the 

requirements of this part must be clearly 

assigned to supervisory personnel who have 

the education, training, or experience (or a 

combination thereof) necessary to supervise 

the production of clean and safe food.

(c) Verify education, training, or 

experience of supervisors’ 

specific job duties by reviewing 

training records. Ask to see 

any certificates from courses 

such as HACCP, SQF, etc.

Record 

1.3.3 Records of training must be 

established and maintained.

Records. Records that document training 

required by paragraph (b)(2) of this section 

must be established and maintained.

(d) Verify that food safety training 

records are maintained for all 

employees and that they are 

available for review.

Record
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Effective Date: April 2022 Page 8 of 51

1.4 Personnel Hygiene

Req. No. Requirement Reference Citation Auditor Guidance Documentation

1.4.1 There shall be a documented 

personnel hygiene policy that is 

effectively implemented, with 

all personnel and visitors 

following the policy.

The written policy must include 

the following elements:

The management of the establishment must 

take reasonable measures and precautions to 

ensure the following:

Cleanliness. 

All persons working in direct contact with 

food, food-contact surfaces, and foodpackaging materials must conform to 

hygienic practices while on duty to the 

extent necessary to protect against allergen 

cross-contact and against contamination of 

food. The methods for maintaining 

cleanliness include:

21 CFR 

117.10

(b)

Verify that the facility has a 

policy for personnel hygiene, 

and that both employees and 

visitors are required to comply 

with it. Did they communicate 

the policy to you when you 

arrive at the plant? This could 

also be communicated via 

email prior to the audit. 

Policy

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 

operation in a manner that protects against 

allergen cross-contact and against the 

contamination of food, food contact 

surfaces, or food-packaging materials.

(1) Is there a policy about changing 

outer garments when leaving an 

allergen zone? Observe if 

employees are following the 

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 

include requirements for proper 

use and maintenance.

If uniforms are used in the 

facility, verify that there is an 

established uniform policy. 

Does it include a provision for 

cleaning them (professionally 

laundered or laundered at 

home)? Good practices include 
SCI Division Inspection Series GMP Audit Standard

Effective Date: April 2022 Page 9 of 51

Req. No. Requirement Reference Citation Auditor Guidance Documentation

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 

requirement that they be 

maintained in an intact, clean, 

and sanitary condition.

Maintaining gloves, if they are used in food 

handling, in an intact, clean, and sanitary 

condition.

(5) If gloves are used in the 

facility, ensure there is an 

established policy for how they 

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 

handwashing facility) before 

starting work, after each absence 

from the workstation, and at any 

other time when the hands may 

have become soiled or 

contaminated. 

Washing hands thoroughly (and sanitizing if 

necessary to protectagainst contamination 

with undesirable microorganisms) in an 

adequate handwashing facility before 

starting work, after each absence from the 

work station, and at any other time when the 

hands may have become soiled or 

contaminated.

(3) Observe that employees are 

washing hands starting a shift 

or returning from a break. 

Interview employees about 

handwashing for training 

retention. (The condition of the 

handwashing station will be 

covered at requirement 1.7.5.)

1.4.1.6 Removal of unsecured jewelry 

and other objects that might fall 

into food, equipment, or 

containers, and removing hand 

jewelry that cannot be 

adequately sanitized during 

periods in which food is 

manipulated by hand.

Removing all unsecured jewelry and other 

objects that might fall into food, equipment, 

or containers, and removing hand jewelry 

that cannot be adequately sanitized during 

periods in which food is manipulated by 

hand. If such hand jewelry cannot be 

removed, it may be covered by material 

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.

(4) Are the employees wearing

any jewelry which might pose 

a food safety risk? Are they 

following the established 

policy? 
SCI Division Inspection Series GMP Audit Standard

Effective Date: April 2022 Page 10 of 51

Req. No. Requirement Reference Citation Auditor Guidance Documentation

1.4.1.7 Fingernails (absence of polish; 

neatly trimmed)

Verify by observation that the 

employees are following the 

facility’s established policy.

1.4.1.8 Hair restraints Wearing, where appropriate, in an effective 

manner, hair nets, headbands, caps, beard 

covers, or other effective hair restraints.

(6) Verify by observation that hair 

restraints are being worn 

properly, according to the 

facility’s established policy. 

1.4.1.9 Storage of clothing and personal 

belongings

Storing clothing or other personal 

belongings in areas other than where food is 

exposed or where equipment or utensils are 

washed.

(7) Verify there is an area, located 

away from where food is 

exposed, for employees to store 

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 

where food may be exposed or where 

equipment or utensils are washed: eating 

food, chewing gum, drinking beverages, or 

using tobacco.

(8) Verify there is a designated 

area away from food handling 

areas, for eating and drinking 

and that smoking/tobacco/gum 

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 

allergen cross-contact with 

respect to personnel hygiene 

issues.

Taking any other necessary precautions to 

protect against allergen cross-contact and 

against contamination of food, food-contact 

surfaces, or food packaging materials with 

microorganisms or foreign substances 

(including perspiration, hair, cosmetics, 

tobacco, chemicals, and medicines applied 

to the skin).

(9) Observe employees for 

personal hygiene issues that 

could result in allergen crosscontact, such as perspiration, 

wearing excessive cosmetic 

materials, hair, tobacco 

products, chemicals, and 

medicinal products applied to 

the skin. Are outer garments 

(smocks or aprons) being 

removed before breaks?
SCI Division Inspection Series GMP Audit Standard

Effective Date: April 2022 Page 11 of 51

Req. No. Requirement Reference Citation Auditor Guidance Documentation

1.4.1.12 Control of blood or bodily 

fluids. The procedure shall 

specify the procedures for 

containment and elimination of 

blood or bodily fluids, and the 

cleaning and sanitation of 

surfaces that are affected.

Review the policy and observe 

the operation for evidence of 

compliance. Has training been 

provided and, if specified in the 

policy, is there a cleanup kit 

available?

1.4.2 There shall be a documented 

policy for control of employee 

illness. 

The written policy shall:

Any person who, by medical examination or 

supervisory observation, is shown to have, 

or appears to have, an illness, open lesion, 

including boils, sores, or infected wounds, 

or any other abnormal source of microbial 

contamination by which there is a 

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 

instructed to report such health conditions to 

their supervisors.

(a) Verify that a policy has been 

developed, implemented, and 

shared with both employees 

and visitors. Confirm 

employee understanding via 

interview.

Policy

1.4.2.1 Include a requirement for 

employees to inform 

management if they are sick or 

have been infected with a food 

borne illness.

Ask employees about their 

understanding of the company’s 

policy on working while ill. Do 

they understand the need to 

report illness to their 

supervisor?

1.4.2.2 Restrict personnel that are ill 

from production areas until an 

assessment of illness takes place 

to determine what tasks they can 

perform.

Interview a supervisor to find 

out if they understand the need 

to prevent employees who are 

ill from working in the 

processing area. 
SCI Division Inspection Series GMP Audit Standard

Effective Date: April 2022 Page 12 of 51

Req. No. Requirement Reference Citation Auditor Guidance Documentation

1.4.2.3 Require adequate covering of 

such conditions as open lesions, 

boils, and infected wounds.

Verify by observation that any 

employees with open lesions, 

boils or infected wounds are 

using adequate coverings to 

protect and cover the affected 

areas. 

1.5 Supply Chain

Req. No. Requirement Reference Citation Auditor Guidance Documentation

1.5.1 The facility must document and 

implement procedures for 

receiving raw materials and 

other ingredients, ensuring that 

raw materials and other 

ingredients meet established 

food safety requirements.

Appropriate procedures for the reception of 

purchased materials shall be established, 

implemented and maintained to assure that 

only materials that meet food safety 

requirements are accepted.

GFSI, GMP 

14

Verify that a policy has been 

developed and implemented. 

Confirm employee 

understanding via interview.

Policy, Record

1.6 Processes and Controls

Req. No. Requirement Reference Citation Auditor Guidance Documentation

1.6.1 General 21 CFR 

117.80 (a)

1.6.1.1 All facility operations must be 

conducted in accordance with 

adequate sanitation principles.

All operations in the manufacturing, 

processing, packing, and holding of food 

(including operations directed to receiving, 

inspecting, transporting, and segregating) 

(1) Observe conditions in the 

facility to verify that the 

facility has implemented 

practices for cleaning and 
SCI Division Inspection Series GMP Audit Standard

Effective Date: April 2022 Page 13 of 51

Req. No. Requirement Reference Citation Auditor Guidance Documentation

must be conducted in accordance with 

adequate sanitation principles.

sanitizing (as appropriate) the 

facility, transportation 

containers, and equipment. 

1.6.1.2 Quality control measures must 

be established and implemented 

to ensure that food and foodpackaging materials are safe 

and suitable for intended use.

Appropriate quality control operations must 

be employed to ensure that food is suitable 

for human consumption and that food‐

packaging materials are safe and suitable.

(2) Verify that necessary quality 

control procedures are in 

place. Observe that food is 

inspected prior to use to 

ensure it is safe for human 

consumption. Are the 

packaging materials nontoxic? 

1.6.1.3 Sanitation of the plant must be 

under the supervision of one or 

more competent individuals 

assigned responsibility for this 

function.

Overall sanitation of the plant must be 

under the supervision of one or more 

competent individuals assigned 

responsibility for this function.

(3) Interview employees who 

perform sanitation duties, if 

they are available at the time 

of the audit, and ask them to 

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 

responsible for sanitation and 

pre-op inspections.

Record

1.6.1.4 Adequate precautions must be 

taken to ensure that production 

procedures do not contribute to 

allergen cross-contact and to 

contamination from any source.

If color coding is used to 

identify equipment for various 

purposes, the system shall be 

effectively implemented. 

Adequate precautions must be taken to 

ensure that production procedures do not 

contribute to allergen cross-contact and to 

contamination from any source.

(4) Observe the handling of 

ingredients and finished 

products to verify the risk of 

product contamination. If a 

color-coding system is 

implemented, observe whether 

employees are following the 

system. 

Is production scheduled to run 

allergen products after non-
SCI Division Inspection Series GMP Audit Standard

Effective Date: April 2022 Page 14 of 51

Req. No. Requirement Reference Citation Auditor Guidance Documentation

allergen products? Is there a 

complete clean-up and 

sanitation after running 

allergen products?

1.6.1.5 Documented testing procedures 

shall be used where necessary 

to identify sanitation failures or 

possible allergen cross‐contact 

and food contamination.

Chemical, microbial, or extraneous‐material 

testing procedures must be used where 

necessary to identify sanitation failures or 

possible allergen cross‐contact and food 

contamination.

(5) Observe if metal detectors (if 

used) are working properly. 

Interview employees to verify 

implementation and corrective 

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. 

Policy, Record

1.6.1.6 Food that has become 

contaminated to the extent that 

it is adulterated must be 

rejected, or if appropriate, 

treated or processed to 

eliminate the contamination.

All food that has become contaminated to 

the extent that it is adulterated must be 

rejected, or if appropriate, treated or 

processed to eliminate the contamination.

(6) Observe if 

contaminated/adulterated food 

is clearly identified. Verify 

that there is a procedure in 

place if the contaminated food 

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 

the proper inspection, handling, 

Raw materials and other ingredients must be 

inspected and segregated or otherwise 

handled as necessary to ascertain that they 

(1) Verify by observation that all 

raw materials are inspected 

and safe for human 
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segregation, and storage of raw 

materials.

are clean and suitable for processing into 

food and must be stored under conditions 

that will protect against allergen cross‐

contact and against contamination and 

minimize deterioration. 

consumption. Observe that 

any unsafe food is segregated 

and labeled as such. Verify 

the food is stored under proper

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 

or cleaned as necessary to 

remove soil or other 

contamination.

Raw materials must be washed or cleaned 

as necessary to remove soil or other 

contamination. 

Verify by observation that the 

company is following their 

established procedures.

1.6.2.3 Water used for washing, 

rinsing, or conveying food must 

be safe and of adequate sanitary 

quality. If recirculated or 

reused, the water must be used 

in a way to prevent allergen 

cross‐contact or an increase in 

the level of contamination of 

the food. If the water is treated, 

treatment must be monitored to 

verify adequate pH, 

temperature, and/or chemical 

control.

Water used for washing, rinsing, or 

conveying food must be safe and of 

adequate sanitary quality. Water may be 

reused for washing, rinsing, or conveying 

food if it does not cause allergen cross‐

contact or increase the level of 

contamination of the food.

Verify that there is a plan for 

the appropriate use of water 

throughout the facility and that 

it is of adequate quality for its 

use. 

If water is reused, how often is 

the recirculated water changed 

or tested? 

If the water is treated, 

interview and ask how it is 

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.

Record
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1.6.2.4 The facility must identify raw 

materials and/or ingredients 

that need pasteurization or 

other treatment prior to 

processing to prevent possible 

contamination from pathogenic 

microorganisms and implement 

the necessary treatments.

These treatment procedures 

must be documented.

Raw materials and other ingredients must 

either not contain levels of microorganisms 

that may render the food injurious to the 

health of humans, or they must be 

pasteurized or otherwise treated during 

manufacturing operations so that they no 

longer contain levels that would cause the 

product to be adulterated.

(2) Verify if the facility has 

identified any ingredients that 

require pasteurization or heat 

treatment or testing for 

microorganisms. Review 

pasteurization charts/heat 

treatment records/lab results.

Policy, Record

1.6.2.5 The facility must identify raw 

materials and/or ingredients 

that are susceptible to 

contamination with aflatoxin or 

other natural toxins and 

implement steps to ensure 

compliance with FDA 

regulations for poisonous or 

deleterious substances.

Control measures must be 

documented.

Raw materials and other ingredients 

susceptible to contamination with aflatoxin 

or other natural toxins must comply with 

FDA regulations for poisonous or 

deleterious substances before these raw 

materials or other ingredients are 

incorporated into finished food.

(3) Review raw ingredients to 

verify appropriate controls for 

mycotoxins and poisonous 

substances. Ask the facility 

how they are mitigating any 

identified risks. Verify 

implementation of the control 

measures.

Policy, record

1.6.2.6 The facility must identify raw 

materials and/or ingredients 

that pose a risk for 

contamination with pests, 

undesirable microorganisms, or 

extraneous material and 

implement steps to ensure 

compliance with FDA 

regulations for natural or 

unavoidable defects.

Raw materials, other ingredients, and 

rework susceptible to contamination with 

pests, undesirable microorganisms, or 

extraneous material must comply with 

applicable FDA regulations for natural or 

unavoidable defects if a manufacturer 

wishes to use the materials in manufacturing 

food.

(4) Review raw ingredients to 

verify expected controls are in 

place. Ask the facility how 

they are mitigating any 

identified risks. 

Prior to the audit, visit the 

FDA regulatory site to 

familiarize yourself with the 

controls for the stated 

ingredients or products. 

Policy, record
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Control measures must be 

documented.

https://www.fda.gov/food/ingr

edients-additives-graspackaging-guidancedocuments-regulatoryinformation/food-defectlevels-handbook

1.6.2.7 Raw materials, other 

ingredients, and rework must 

be:

- held in bulk or in 

containers designed and 

constructed to protect 

against allergen cross‐

contact and against 

contamination.

- held at appropriate 

temperature and relative 

humidity and in such a 

manner as to prevent the 

food from becoming 

adulterated.

- identified for rework, if 

scheduled for this purpose.

Raw materials, other ingredients, and 

rework must be held in bulk, or in 

containers designed and constructed so as to 

protect against allergen cross‐contact and 

against contamination and must be held at 

such temperature and relative humidity and 

in such a manner as to prevent the food 

from becoming adulterated. Material 

scheduled for rework must be identified as 

such.

Liquid or dry raw materials and other 

ingredients received and stored in bulk form 

must be held in a manner that protects 

against allergen cross‐contact and against 

contamination.

(5) and (7) Are best storage practices used 

to prevent allergen cross 

contact of raw materials and 

ingredients? Are ingredients 

and rework stored in 

containers that will protect it 

from contamination and in the 

correct environment? 

Observe if rework product is 

labeled as such. 

1.6.2.8 Frozen raw materials and other 

ingredients shall be kept frozen. 

Temperature of the freezer(s):

If product is thawed prior to 

use, it must be done in a 

manner that prevents the raw 

materials and other ingredients 

from becoming adulterated.

Frozen raw materials and other ingredients 

must be kept frozen. If thawing is required 

prior to use, it must be done in a manner 

that prevents the raw materials and other 

ingredients from becoming adulterated.

(6) Verify by observation that 

products that are to be stored 

as frozen are frozen. Check 

the freezer temperature and 

record it. Verify that the 

temperature is being checked 

and recorded daily.

Observe any product that is 

being thawed to make certain 

that it cannot be contaminated 

(is it covered properly, are 

Record
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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 

procedures in place for 

management to identify all 

allergenic materials (nine major 

allergens are peanuts, tree nuts, 

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. 

Verify that the plant has 

identified all allergenic 

materials present in the facility 

as well as chemical sensitive 

materials. 

Policy

Identified types of 

allergens/chemicals:

List the allergens that have 

been identified by the facility.

1.6.3.2 Raw materials and other 

ingredients that are food 

allergens, and rework that 

contains food allergens, must 

be identified and held in a 

manner that prevents allergen 

cross‐contact.

Raw materials and other ingredients that are 

food allergens, and rework that contains 

food allergens, must be identified and held 

in a manner that prevents allergen cross‐

contact.

21 CFR 

117.80, (b) 

(8)

If the facility has identified 

any allergens, verify that the 

facility has policies and 

procedures in place for 

handling allergenic products. 

Verify by observation that 

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.).

Policy
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1.6.4 Operations Manufacturing operations 21 CFR 

117.80, (c)

1.6.4.1 Equipment and utensils and 

food containers must be 

maintained in an adequate 

condition through appropriate 

cleaning and sanitizing, as 

necessary. Equipment must be 

taken apart for thorough 

cleaning, if necessary. 

Equipment and utensils and food containers

must be maintained in an adequate 

condition through appropriate cleaning and 

sanitizing, as necessary. In so far as 

necessary, equipment must be taken apart 

for thorough cleaning.

(1) Verify that there are 

procedures in place for 

cleaning and sanitizing each 

piece of equipment. Observe 

that all food contact surfaces 

and equipment are maintained, 

clean, and free from food 

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, 

packing, and holding shall be 

conducted to minimize the 

potential for the growth of 

microorganisms, allergen cross‐

contact, contamination of food, 

and deterioration of food.

All food manufacturing, processing, 

packing, and holding must be conducted 

under such conditions and controls as are 

necessary to minimize the potential for the 

growth of microorganisms, allergen cross‐

contact, contamination of food, and 

deterioration of food.

(2) Verify by observation during 

the walk-thru of the facility. 

Observe staff working or 

processes underway to identify 

if there are any practices that 

are introducing risks of 

product contamination or 

deterioration.

1.6.4.3 Food that can support the rapid 

growth of undesirable 

microorganisms must be held at 

temperatures that will prevent 

the food from becoming 

adulterated during 

manufacturing, processing, 

packing, and holding.

Food that can support the rapid growth of 

undesirable microorganisms must be held at 

temperatures that will prevent the food from 

becoming adulterated during manufacturing, 

processing, packing, and holding.

(3) Observe that the food is stored 

under proper storage 

conditions (frozen, 

refrigerated, ambient). Verify 

that the storage areas are 

temperature controlled, if 

required for food safety. Are 

there temperature recording 

charts? Are there 

Record
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thermometers in the storage 

areas? Are temperatures 

monitored and recorded daily?

1.6.4.4 Measures such as sterilizing, 

irradiating, pasteurizing, 

cooking, freezing, refrigerating, 

controlling pH, or controlling 

Aw, that are necessary to 

destroy or prevent the growth 

of undesirable microorganisms, 

must be identified, 

implemented, and documented.

Measures such as sterilizing, irradiating, 

pasteurizing, cooking, freezing, 

refrigerating, controlling pH, or controlling 

Aw that are taken to destroy or prevent the 

growth of undesirable microorganisms must 

be adequate under the conditions of 

manufacture, handling, and distribution to 

prevent food from being adulterated.

(4) Observe what methods are 

used. As you walk through, 

observe temperature/pH/other 

control levels for the process. 

Review the established policy

and records to verify adequate 

implementation.

Policy, Record

The identified measures are: List the processes that are 

being used.

1.6.4.5 The facility’s product flow and 

work areas for work‐in‐process 

(WIP) and rework provides 

protection against comingling, 

allergen cross‐contact, 

contamination, and growth of 

undesirable microorganisms. 

Work‐in‐process and rework must be 

handled in a manner that protects against 

allergen cross‐contact, contamination, and 

growth of undesirable microorganisms.

(5) Observe if WIP and rework 

are handled and stored under 

appropriate conditions for the 

food product and to prevent 

comingling of production 

stages. Observe that the 

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 

taken to protect finished food 

from allergen cross‐contact and 

from contamination by raw 

materials, other ingredients, or 

refuse. Raw materials, other 

ingredients, or refuse that are 

unprotected must not be 

handled simultaneously in a 

receiving, loading, or shipping 

area if that handling could 

Effective measures must be taken to protect 

finished food from allergen cross‐contact 

and from contamination by raw materials, 

other ingredients, or refuse. When raw 

materials, other ingredients, or refuse are 

unprotected, they must not be handled 

simultaneously in a receiving, loading, or 

shipping area if that handling could result in 

allergen cross‐contact or contaminated food. 

Food transported by conveyor must be 

(6) Verify by observation. Are 

finished food products, 

including raw fruit and 

vegetables, being handled 

simultaneously in a receiving 

or shipping area which may 

contribute to cross 

contamination of the finished 

product? Is iced product 

dripping on product stored 

below?
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result in allergen cross‐contact 

or contaminated food. Food 

transported by conveyor must 

be protected against allergen 

cross‐contact and against 

contamination as necessary.

protected against allergen cross‐contact and 

against contamination as necessary.

1.6.4.7 Equipment, containers, and 

utensils used to convey, hold, 

or store raw materials and other 

ingredients, work‐in-process, 

rework, or other food must be 

constructed, handled, and 

maintained during 

manufacturing, processing, 

packing, and holding in a 

manner that protects against 

allergen cross‐contact and 

against contamination.

Equipment, containers, and utensils used to 

convey, hold, or store raw materials and 

other ingredients, work‐in-process, rework, 

or other food must be constructed, handled, 

and maintained during manufacturing, 

processing, packing, and holding in a 

manner that protects against allergen cross‐

contact and against contamination.

(7) Verify by observation. Are 

equipment, utensils, 

containers, and conveyors 

clean? Are they constructed 

of materials acceptable for 

food contact? Are they 

maintained in good condition 

and stored appropriately?

1.6.4.8 The facility must take adequate 

measures to protect against the 

inclusion of metal or other 

extraneous material in food. 

Adequate measures must be taken to protect 

against the inclusion of metal or other 

extraneous material in food.

(8) Ask if the facility takes any 

steps for preventing metal and 

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, 

raw materials, and other 

ingredients as adulterated, they 

must dispose of the material in 

a manner that protects against 

the contamination of other 

food; or, if appropriate, 

Food, raw materials, and other ingredients 

that are adulterated:

i) Must be disposed of in a 

manner that protects against 

the contamination of other 

food; or

(9) Verify by observation that 

adulterated food is labeled as 

such. Verify the facility has 

procedures for disposing of 

the adulterated food. If the 

food is to be reconditioned, 

verify the method and that the 

Record
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recondition the material so that 

it meets process and regulatory 

requirements.

ii) If the adulterated food is 

capable of being 

reconditioned, it must be:

A. Reconditioned (if 

appropriate) using a 

method that has been 

proven to be effective; or

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.

method used meets the 

regulatory requirements for 

that food. Ask to see 

production records for the 

reconditioning of the food to 

verify that they are meeting 

the requirements.

1.6.4.10 Steps such as washing, peeling, 

trimming, cutting, sorting and 

inspecting, mashing, 

dewatering, cooling, shredding, 

extruding, drying, whipping, 

defatting, and forming must be 

performed so as to protect food 

against allergen cross‐contact 

and against contamination. 

Food must be protected from 

contaminants that may drip, 

drain, or be drawn into the 

food. 

Steps such as washing, peeling, trimming, 

cutting, sorting and inspecting, mashing, 

dewatering, cooling, shredding, extruding, 

drying, whipping, defatting, and forming 

must be performed so as to protect food 

against allergen cross‐contact and against 

contamination. Food must be protected from 

contaminants that may drip, drain, or be 

drawn into the food.

(10) Verify by observation. Does 

the facility have procedures in 

place for the different steps in 

their process to protect food 

from contamination and 

allergen cross-contact? Is 

food protected from 

contaminants that may drip, 

drain or be drawn into the 

food?

1.6.4.11 If heat blanching is utilized in 

the preparation of food capable 

of supporting microbial growth, 

the process must be 

documented and implemented. 

Heat blanching, when required in the 

preparation of food capable of supporting 

microbial growth, must be effected by 

heating the food to the required 

temperature, holding it at this temperature 

(11) Review blanching heattreatment records for the 

required temperature and hold 

time for the type of product. 

Is the product being cooled 

Policy, Record
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The blanching equipment must 

be periodically cleaned and 

sanitized as necessary.

for the required time, and then either rapidly 

cooling the food or passing it to subsequent 

manufacturing without delay. Growth and 

contamination by thermophilic 

microorganisms in blanchers must be 

minimized by the use of adequate operating 

temperatures and by periodic cleaning and 

sanitizing as necessary.

rapidly or being processed 

without delay?

Verify that the system is 

cleaned and sanitized 

regularly.

1.6.4.12 If batters, breading, sauces, 

gravies, dressings, dipping 

solutions, and other similar 

preparations are held and used 

repeatedly over time, they must 

be treated or maintained in such 

a manner that they are protected 

against allergen cross‐contact 

and against contamination, and 

to minimize the potential for 

the growth of undesirable 

microorganisms.

Batters, breading, sauces, gravies, dressings, 

dipping solutions, and other similar 

preparations that are held and used 

repeatedly over time must be treated or 

maintained in such a manner that they are

protected against allergen cross‐contact and 

against contamination, and minimizing the 

potential for the growth of undesirable 

microorganisms.

(12) Verify that holding containers, 

vats, tubs, etc. are cleaned and 

sanitized regularly. 

Have they done a risk 

assessment for each type of 

product? Question how they 

determine when a product that 

is repeatedly used is no longer 

safe or of good quality. 

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. 

Policy, Record

1.6.4.13 Filling, assembling, packaging, 

and other operations must be 

performed in such a way that 

the food is protected against 

allergen cross‐contact, 

contamination, and growth of 

undesirable microorganisms.

Filling, assembling, packaging, and other 

operations must be performed in such a way 

that the food is protected against allergen 

cross‐contact, contamination and growth of 

undesirable microorganisms.

(13) Observe the processes to 

verify GMP’s are being 

followed. Look for such 

things as covers that are open 

or missing from filler hoppers, 

packaging material sitting on 

the floor, product conveying 

on dirty/unsanitary conveyor 

belts. Observe that 

Record
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temperature and/or time 

requirements for filling, 

assembling, or packaging are 

being met.

1.6.4.14 Dry mixes, nuts, intermediate 

moisture food, and dehydrated 

food, that rely principally on 

the control of water activity 

(Aw) for preventing the growth 

of undesirable microorganisms, 

must be processed to, and 

maintained at a safe Aw level.

Controls must be documented.

Food, such as dry mixes, nuts, intermediate 

moisture food, and dehydrated food, that 

relies principally on the control of Aw for 

preventing the growth of undesirable 

microorganisms must be processed to and 

maintained at a safe moisture level.

(14) If products are controlled for 

Aw, verify that the facility is 

monitoring Aw of the product. 

What does the facility do with 

product that does not meet 

their requirements? Do they 

have a microbial monitoring 

program for monitoring 

pathogenic bacteria? Review 

test results. Are products 

stored in a manner to prevent 

Aw levels from changing?

Policy, Record

1.6.4.15 Acid and acidified food are 

monitored and maintained at a 

pH of 4.6 or below.

Food, such as acid and acidified food, that 

relies principally on the control of pH for 

preventing the growth of undesirable 

microorganisms must be monitored and 

maintained at a pH of 4.6 or below.

(15) Review pH monitoring 

records. What is the facility 

policy for products that do not 

meet the pH requirement? 

Policy, Record

1.6.4.16 Ice that is used (internally 

produced or externally 

supplied) in contact with food 

must be made from water that 

is safe and of adequate sanitary 

quality and manufactured in 

accordance with current good 

manufacturing practices.

When ice is used in contact with food, it 

must be made from water that is safe and of 

adequate sanitary quality in accordance with 

§ 117.37(a) and must be used only if it has 

been manufactured in accordance with 

current good manufacturing practice as 

outlined in this part.

(16) Verify that the water used for 

ice production is potable (see 

1.7.1.1) and stored and 

handled under sanitary 

conditions. Verify that the ice 

machine is on a cleaning and 

sanitation schedule.

If ice is from an outside 

source, ask for the 

documented assurances that 

the ice was potable.

Record
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1.7 Defect Action 

Req. No. Requirement Reference Citation Auditor Guidance Documentation

1.7.1 The facility must determine if 

defect action levels are 

established for the food handled 

or manufactured by the facility. 

Controls must be documented.

21 CFR 

117.110

Review the finished products 

produced or handled at the 

facility against the Defect 

Levels Handbook, 

https://www.fda.gov/food/ingr

edients-additives-graspackaging-guidancedocuments-regulatoryinformation/food-defectlevels-handbook. 

Policy

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 

be conducted in a way that 

reduce natural or unavoidable 

defects to the lowest level 

currently feasible. The policies 

must be documented, with 

records of implementation.

The manufacturer, processor, packer, and 

holder of food must at all times utilize 

quality control operations that reduce 

natural or unavoidable defects to the lowest 

level currently feasible.

(a) Observe if appropriate 

controls have been 

documented and 

implemented, based on the 

FDA Defect Levels 

Handbook. Some contracts 

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.

Policy, Record

1.7.3 The facility shall not mix foods 

containing defects at levels that 

render that food adulterated 

with other lots of food.

The mixing of a food containing defects at 

levels that render that food adulterated with 

another lot of food is not permitted and

renders the final food adulterated, 

(b) Ask the facility how they 

would handle finished product 

that exceeds established 

limits. Any policy for mixing 
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Req. No. Requirement Reference Citation Auditor Guidance Documentation

regardless of the defect level of the final 

food. For examples of defect action levels 

that may render food adulterated, see the 

Defect Levels Handbook, which is 

accessible at http://www.fda.gov/pchfrule

and at http://www.fda.gov.

foods with those that exceed 

established limits would be 

unacceptable.

1.8 Equipment and Utensils (Design, Materials, and Maintenance)

Req. No. Requirement Reference Citation Auditor Guidance Documentation

1.8.1 General 21 CFR 

117.40 (a)

1.8.1.1 All plant equipment and utensils 

used in manufacturing, 

processing, packing, or holding 

food must be designed and of 

such material and workmanship 

as to be adequately cleanable 

and must be adequately 

maintained.

All plant equipment and utensils used in 

manufacturing, processing, packing, or 

holding food must be so designed and of 

such material and workmanship as to be 

adequately cleanable, and must be 

adequately maintained to protect against 

allergen cross‐contact and contamination. 

(1) Verify by observation. Are the 

materials used to manufacture

the utensils and equipment 

acceptable for use in food 

plants? Is equipment designed 

to be easily dismantled for 

cleaning? Is the equipment 

included in a preventive 

maintenance program?

1.8.1.2 Equipment and utensils must be 

designed, constructed, and used 

appropriately to avoid the 

adulteration of food with 

lubricants, fuel, metal 

fragments, contaminated water, 

or any other contaminants. 

Equipment and utensils must be designed, 

constructed, andused appropriately to avoid 

the adulteration of food with lubricants, 

fuel, metal fragments, contaminated water, 

or any other contaminants. 

(2) Verify by observation. Look 

for things such as metal 

rubbing against metal 

(possibly in product pumps, 

grinders, extruders), nuts and 

bolts in food contact zones, 

excessive lubrication on 

conveyor gears/gear 

boxes/bearings in close 

contact to or above food or 

food contact surfaces, 
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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 

and located so that they are 

accessible for cleaning, 

maintenance, and inspection.

Equipment must be installed so as to 

facilitate the cleaning and maintenance of 

the equipment and of adjacent spaces. 

(3) Verify by observation that 

equipment is located so that it 

can be easily cleaned, 

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 

corrosion‐resistant, made of 

nontoxic materials, and 

designed to withstand the 

environment of their intended 

use and of the cleaning process.

Food‐contact surfaces must be corrosion‐

resistant when in contact with food. 

Food‐contact surfaces must be made of 

nontoxic materials and designed to 

withstand the environment of their intended 

use and the action of food, and, if 

applicable, cleaning compounds, sanitizing 

agents, and cleaning procedures. 

(4) and (5) Verify by observation. If you 

are unsure if a contact surface 

is acceptable for use in a food 

plant, ask to see 

documentation that certifies 

that it is acceptable. 

1.8.1.5 Food‐contact surfaces must be 

maintained to protect food from 

allergen cross‐contact and from 

being contaminated.

Food‐contact surfaces must be maintained 

to protect food from allergen cross‐contact 

and from being contaminated by any source, 

including unlawful indirect food additives.

(6) Verify by observation. Look 

for scratches, pitting, 

cavitation in stainless steel 

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.
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Req. No. Requirement Reference Citation Auditor Guidance Documentation

1.8.2 Seams on food‐contact surfaces 

must be sanitary welds, 

smoothly bonded and 

maintained to minimize 

accumulation of food particles, 

dirt, and organic matter 

minimizing the opportunity for 

microorganism growth and 

allergen cross-contact. 

Seams on food‐contact surfaces must be 

smoothly bonded or maintained so as to 

minimize accumulation of food particles, 

dirt, and organic matter and thus minimize 

the opportunity for growth of 

microorganisms and allergen cross-contact.

(b) Verify by observation. Look 

for unsanitary welds - cracks 

and open seams that need to 

be sealed, skip welds, broken 

welds, and rough welds that 

need to be polished smooth. 

1.8.3 Non-food contact equipment 

located in the processing and 

packing areas shall be 

constructed so that it can be 

maintained, and is in good 

condition, able to be cleaned.

Equipment that is in areas where food is 

manufactured, processed, packed, or held 

and that does not come into contact with 

food must be so constructed that it can be 

kept in a clean and sanitary condition. 

(c) Verify by observation that 

equipment is clean, free from 

dust accumulation, rust, 

peeling paint, has smooth 

cleanable surfaces, etc. This 

applies to equipment that is 

non-food contact, as well as 

currently unused processing 

equipment.

1.8.4 Holding, conveying, and 

manufacturing systems must be 

of a design and construction that 

enables them to be maintained, 

and are in an appropriate clean 

and sanitary condition.

Holding, conveying, and manufacturing 

systems, including gravimetric, pneumatic, 

closed, and automated systems, must be of a 

design and construction that enables them to 

be maintained in an appropriate clean and 

sanitary condition. 

(d) Verify by observation. Verify 

that there are no line 

extensions or out of reach 

areas that create a situation in 

which cleaning is ineffective.

1.8.5 Freezer and cold storage 

compartments must be fitted 

with an indicating thermometer, 

temperature‐measuring device, 

or temperature recording device.

Each freezer and cold storage compartment 

used to store and hold food capable of 

supporting growth of microorganisms must 

be fitted with an indicating thermometer, 

temperature‐measuring device, or 

temperature recording device so installed as 

to show the temperature accurately within 

the compartment.

(e) Observe that there are 

thermometers or temperature 

recording devices in all freezer 

and cold storage areas. 
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Req. No. Requirement Reference Citation Auditor Guidance Documentation

1.8.6 Instruments and controls used 

for measuring, regulating, or 

recording temperatures, pH, 

water activity, etc. must be 

properly maintained, calibrated, 

and adequate in number for their 

designated uses.

Instruments and controls used for 

measuring, regulating, or recording 

temperatures, pH, acidity, water activity, or 

other conditions that control or prevent the 

growth of undesirable microorganisms in 

food must be accurate and precise and 

adequately maintained, and adequate in 

number for their designated uses. 

(f) Verify that instruments and 

thermometers have been 

calibrated. Ask to see the 

calibration documentation. 

Verify that the instruments, 

(such as scales, pH meters, 

etc.) are checked daily for 

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.

Policy, Record

1.8.7 Compressed air or other gases 

mechanically introduced into 

food or used to clean food‐

contact surfaces or equipment 

must be filtered and oil free. 

Compressed air or other gases mechanically 

introduced into food or used to clean food‐

contact surfaces or equipment must be 

treated in such a way that food is not 

contaminated with unlawful indirect food 

additives.

(g) Verify that there is a PM plan 

for changing filters in the air 

lines and that separators are 

working correctly. Verify that 

the sources for other gases 

such as nitrogen can certify 

the gas to be clean and dry.

Policy, Record
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1.9 Sanitary Facilities and Controls

Req. No. Requirement Reference Citation Auditor Guidance Documentation

1.9.1 General Each plant must be equipped with adequate 

sanitary facilities and accommodations 

including:

21 CFR 

117.37

1.9.1.1 The water supply/system must 

be adequate for the operations 

intended and must be derived 

from an adequate source. 

Private wells must be inspected 

on an annual basis.

Water supply. The water supply must be 

adequate for the operations intended and 

must be derived from an adequate source. 

(a) Document the water source 

(for example, municipal, well, 

or other).

If well water is the source, 

verify that the system has been 

inspected yearly.

Record

1.9.1.1.1 There shall be testing results 

showing that water used for 

processing, cleaning, as an 

ingredient, or by personnel is 

potable.

Water test results issued by:

Date of testing:

Any water that contacts food, food‐contact 

surfaces, or food‐packaging materials must 

be safe and of adequate sanitary quality. 

Verify that the plant has test 

results from an accredited 

laboratory showing that water 

meets the EPA National 

Drinking Water Regulations 

for Microorganisms. Record 

the issuer and the date of the 

test report. If the water source 

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.

Record

1.9.1.1.2 Running water of suitable 

temperature and pressure must 

be available in all areas where 

required for the processing of 

food, for the cleaning of 

equipment, utensils, and food‐

Running water at a suitable temperature, 

and under pressure as needed, must be 

provided in all areas where required for the 

processing of food, for the cleaning of 

equipment, utensils, and food‐packaging 

materials, or for employee sanitary 

facilities.

Verify by observation. 

Observe if there are steam 

regulators to control the 

temperature and pressure 

transducers to control the 

water pressure and if they are 

covered by the PM program. 

Record
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Req. No. Requirement Reference Citation Auditor Guidance Documentation

packaging materials, or for 

employee sanitary facilities.

Check that the water 

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 

size and design and adequately installed and 

maintained to:

(b)

1.9.2.1 Plumbing must be of adequate 

size and design to handle the 

water and waste flow for the 

facility, and not create possible 

contamination or unsanitary 

conditions.

Carry adequate quantities of water to 

required locations throughout the plant. 

Properly convey sewage and liquid 

disposable waste from the plant. 

Avoid constituting a source of 

contamination to food, water supplies, 

equipment, or utensils or creating an 

unsanitary condition.

(1) – (3) Verify by observation. Are 

there signs of sewage back-up 

or odors from drains? Are 

there water leaks or seepage? 

Is plumbing adequate to carry 

water to required locations 

throughout the plant? Observe 

if lines are installed over 

product zones.

1.9.2.2 Floors, gutters, or drains must 

have sufficient slope and outlets 

to drain adequately.

Provide adequate floor drainage in all areas 

where floors are subject to flooding‐type 

cleaning or where normal operations release 

or discharge water or other liquid waste on 

the floor.

(4) Observe if floors are properly 

sloped, if there are a sufficient 

number of drains, if drain 

covers are in place, if drains 

are clogged and if drains are 

properly trapped.

1.9.2.3 There shall not be any cross 

connections between treated and 

untreated supplies.

Provide that there is not backflow from, or 

cross‐connection between, piping systems 

that discharge waste water or sewage and 

(5) Verify by observation that 

water lines are separate from 
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Req. No. Requirement Reference Citation Auditor Guidance Documentation

piping systems that carry water for food or 

food manufacturing.

sewerlines/wastewater lines 

and that lines are labeled. 

1.9.2.4 Back flow prevention devices 

must be installed on all water 

and steam lines, and periodically 

certified.

Certification by:

Date of last certification:

(5) Verify that the back flow 

prevention devices have been 

installed and that they are on 

an annual PM schedule for 

certification.

Record the name of the 

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.

Record

1.9.3 Sewage must be disposed of into 

an adequate sewage system or 

disposed of through other 

adequate means.

Sewage disposal. Sewage must be disposed 

of into an adequate sewerage system or 

disposed of through other adequate means.

(c) Verify how the sewage is 

disposed of (city sewer 

system, plant wastewater 

system, septic tank, etc.). 

Observe if there are any 

obvious issues with the 

system.

1.9.4 For toilet facilities that are 

located in production areas or 

primarily used by production 

staff, there must be:

Toilet facilities. Each plant must provide 

employees with adequate, readily accessible 

toilet facilities. Toilet facilities must be kept 

clean and must not be a potential source of 

contamination of food, food‐contact 

surfaces, or food‐packaging materials.

(d)

1.9.4.1 An adequate, readily accessible, 

number of units for the facility 

size/number of employees.

Observation. Verify that 

OSHA or state mandated 

requirements are met and that 

facilities are accessible to 

employees.
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Req. No. Requirement Reference Citation Auditor Guidance Documentation

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 

directly into food handling areas 

(i.e., processing, repacking, or 

reconditioning areas).

Observation.

1.9.4.4 Self-closing doors or maze-type 

entrance.

Observation.

1.9.4.5 Adequate lighting. Observation.

1.9.4.6 Sufficient and proper waste 

receptacles.

Observation. Trash containers 

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 

importance of hand washing 

(multilingual if appropriate).

Observation. Verify signs are 

posted in all toilet facilities. 

1.9.4.8 Hand-washing facilities with 

running water at a suitable 

temperature, soap, and single 

use towels or forced air hand 

dryers.

Observation. Hands-free 

fixtures at sinks and soap 

dispensers are preferred but 

not required. Is there 

available warm water, 

antimicrobial soap, and single 

use towels or air dryers? 

1.9.4.9 Toilet areas that are clean, dry, 

properly stocked with toilet 

paper, and of good general 

appearance.

Observation. Verify that 

cleaning and sanitizing 

practices are adequate. Are 

toilet bowls, sinks, walls, and 

floors clean? Is housekeeping 

adequate? Is toilet paper 

available?
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Req. No. Requirement Reference Citation Auditor Guidance Documentation

1.9.4.10 Toilets, sinks, and faucets in 

good working condition.

Observe by testing one or two 

of the units to see if they work 

properly and that there is 

adequate water pressure.

1.9.5 Hand-washing facilities (located 

in breakroom and production 

area) shall include running 

water at a suitable temperature, 

soap, and single use towels or 

forced air hand dryers. Signs 

must be posted indicating the 

importance of hand washing 

(multilingual if appropriate).

Hand‐washing facilities. Each plant must 

provide hand‐washing facilities designed to 

ensure that an employee’s hands are not a 

source of contamination of food, food‐

contact surfaces, or food‐packaging 

materials, by providing facilities that are 

adequate, convenient, and furnish running 

water at a suitable temperature.

(e) This requirement applies to 

hand-washing facilities that 

are not located in toilet areas. 

Test that the sinks work 

properly, have warm water, 

that forced air hand dryers (if 

used) work properly. Observe 

that there is antimicrobial 

hand soap and single use 

towels. Is there an adequate 

number of facilities and are 

they convenient? Are handwashing signs posted and 

multilingual, if appropriate.

1.9.6 The capacity of the facility’s 

rubbish/waste storage must be 

sufficient for the operation, with 

dedicated waste containers and 

timely removal of waste. A 

policy must be documented. 

Rubbish and offal disposal. Rubbish and 

any offal must be so conveyed, stored, and 

disposed of as to minimize the development 

of odor, minimize the potential for the waste 

becoming an attractant and harborage or 

breeding place for pests, and protect against 

contamination of food, food‐contact 

surfaces, food‐packaging materials, water 

supplies, and ground surfaces.

A procedure shall be established, 

implemented and maintained for the 

collection, storage and disposal of waste 

material, including waste water and 

drainage.

(f)

GFSI, GMP 

12.1

Verify that the facility has a 

documented plan for the 

containment and removal of 

waste from the interior of the 

building(s). Check if there is a 

map/route to follow to the 

trash dumpster to eliminate the 

potential for cross 

contamination. Observe if 

trash containers are covered, 

over-flowing, and if there is 

food/trash/debris on the 

floor/ground. Is there a strong 

odor from the trash that may 

permeate into the plant or be 

absorbed into the food? Check 

Policy
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Req. No. Requirement Reference Citation Auditor Guidance Documentation

the frequency of waste 

removal.

1.10 Maintenance and Sanitation

Req. No. Requirement Reference Citation Auditor Guidance Documentation

1.10.1 General Maintenance 21 CFR 

117.35 (a)

1.10.1.1 Buildings, fixtures, and other 

physical facilities of the plant 

must be maintained in a clean 

and sanitary condition and must 

be kept in repair adequate to 

prevent food from becoming 

adulterated.

After maintenance repairs of 

equipment associated with food 

processing or with food contact 

surfaces, the equipment must be 

cleaned, sanitized, and 

inspected. This policy must be 

documented, and 

implementation must be 

recorded.

Buildings, fixtures, and other physical 

facilities of the plant must be maintained in 

a clean and sanitary condition and must be 

kept in repair adequate to prevent food from 

becoming adulterated.

Observe such things as peeling 

paint on walls, ceilings, floors, 

drains, and equipment, dust 

and debris on ledges, 

missing/torn screens from 

doors and windows, 

cracks/holes in walls, 

missing/low grout in floor and 

wall tiles, proper ventilation to 

eliminate condensation and

mold growth, etc.

Verify that the plant has a 

sanitation policy in place for 

when maintenance or repairs 

are performed in a food 

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.

Policy, Record
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Req. No. Requirement Reference Citation Auditor Guidance Documentation

1.10.1.2 Cleaning and sanitizing of 

utensils and equipment must be 

conducted in a manner that 

protects against allergen crosscontact and against 

contamination of food, food 

contact surfaces, or foodpackaging materials. The 

procedure must be documented 

and there must be records to 

show completion. 

Cleaning and sanitizing of utensils and 

equipment must be conducted in a manner 

that protects against allergen cross-contact 

and against contamination of food, food 

contact surfaces, or food-packaging 

materials.

Verify that there are policies 

for cleaning and sanitizing all 

equipment and utensils and 

that it has been implemented. 

Review recent records of 

cleaning and sanitization. 

Policy, Record

1.10.2 Sanitation Chemicals and 

Supplies

(b)

1.10.2.1 Cleaning compounds and 

sanitizing agents used in 

cleaning and sanitizing 

procedures must be free from 

undesirable microorganisms and 

appropriate for use 

(documentation must be 

available for verification).

Cleaning compounds and sanitizing agents 

used in cleaning and sanitizing procedures 

must be free from undesirable 

microorganisms and must be safe and 

adequate under the conditions of use. 

Compliance with this requirement must be 

verified by any effective means, including 

purchase of these substances under a letter 

of guarantee or certification or examination 

of these substances for contamination. 

(1) Review the cleaning 

compounds and sanitizing 

agents used in the plant. 

Request to see letters of 

guarantee, certificates of 

assurance (COA’s), labels, or 

other documentation from the 

suppliers to verify that they 

are free of undesirable 

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 

facility must be appropriate for 

presence in a plant where food 

is processed and exposed. Food 

Only the following toxic materials may be 

used or stored in a plant where food is 

processed or exposed:

i) Those required to maintain 

clean and sanitary conditions;

(1) Check the maintenance shop 

to verify non-food grade and 

food grade oils and lubricants 

are stored separately. Verify 

that lab chemicals and 
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Req. No. Requirement Reference Citation Auditor Guidance Documentation

grade lubricants must be used in 

exposed product zones.

ii) Those necessary for use in 

laboratory testing procedures;

iii) Those necessary for plant and 

equipment maintenance and 

operation; and Those 

necessary for use in the plant’s 

operations.

chemicals needed for use 

duringproduction or sanitation 

are kept in an area out of a 

food contact zone. Are Safety 

Data Sheets (SDS) available to 

employees? 

1.10.2.3 There shall be a locked storage 

area for chemicals with 

controlled access, and chemicals 

must be clearly and properly 

labeled.

Toxic cleaning compounds, sanitizing 

agents, and pesticide chemicals must be 

identified, held, and stored in a manner that 

protects against contamination of food, 

food-contact surfaces, or food-packaging 

materials.

(2) Observe that there is a 

designated and locked area for 

chemical storage located in an 

area away from food 

packaging material, exposed 

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 

implement an effective pest 

control program.

Pests must not be allowed in any area of a 

food plant. Guard, guide, or pest-detecting 

dogs may be allowed in some areas of a 

plant if the presence of the dogs is unlikely 

to result in contamination of food, food 

contact surfaces, or food-packaging 

materials. Effective measures must be taken 

to exclude pests from the manufacturing, 

processing, packing, and holding areas and 

to protect against the contamination of food 

on the premises by pests. 

Verify that the plant has a pest 

control program. If an outside 

pest control company is used, 

request to see the certification 

of the provider. If the 

company provides their own 

pest control, ask to see 

certification of personnel 

responsible for pest control. 

Are there pest control traps, 

lights, mats, etc. locatedin the 

plant or warehouse to prevent 

pests from infesting the 

facility?

Policy, Record
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Req. No. Requirement Reference Citation Auditor Guidance Documentation

1.10.3.1.1 A pest control station map is 

properly maintained and 

available.

Verify the facility has a pest 

control map and the date the 

pest control map was last 

updated. 

Policy, Record

1.10.3.1.2 Routine maintenance and 

inspection of pest control 

devices is documented.

Review the pest control 

inspection and surveillance 

results. Document how often 

the inspections are performed. 

Are electrical insect killers, 

blowers or fans working 

properly? 

Policy, Record

1.10.3.1.3 The type, number, and 

placement of pest 

control/deterrent devices is 

adequate and appropriate to 

prevent infestation.

Observe as you walk through 

if randomly selected stations 

are in place as noted on the 

map. Do you see evidence of 

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 

infestation.

Verify by observation if there 

is evidence of infestation.

1.10.3.2 The use of pesticides to control 

pests in the facility must be 

performed under precautions 

and restrictions that will protect 

against the contamination of 

food, food-contact surfaces, and 

food packaging materials.

The use of pesticides to control pests in the 

plant is permitted only under precautions 

and restrictions that will protect against the 

contamination of food, food-contact 

surfaces, and food packaging materials.

Verify that there are 

appropriate measures for the 

application and storage of 

pesticides and that the 

individual responsible for 

pesticide application is 

properly trained and certified. 

Any exposed food or 

packaging material shallbe 

covered before pesticides are 

applied, and equipment and 

utensils shall be thoroughly 

cleaned and sanitized before 

Record
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Req. No. Requirement Reference Citation Auditor Guidance Documentation

use after pesticides are 

applied.

1.10.4 Sanitation of Food-Contact 

Surfaces

Sanitation of food-contact surfaces. (d)

1.10.4.1 All food-contact surfaces, 

including utensils and foodcontact surfaces of equipment, 

must be cleaned as frequently as 

necessary to protect against 

allergen cross-contact and 

against contamination of food.

The procedure must be 

documented and there must be 

records to show completion. 

Cleaning and sanitation 

oversight must be assigned to at 

least one competent staff person.

All food-contact surfaces, including utensils 

and food-contactsurfaces of equipment, 

must be cleaned as frequently as necessary 

to protect against allergen cross-contact and 

against contamination of food.

Verify that there are adequate 

procedures for cleaning and 

sanitizing all food contact 

surfaces used for processing 

food. Are procedures fully 

implemented? Review recent 

records of cleaning and 

sanitization. Note the 

responsible party(s) for 

oversight of cleaning and 

sanitation, and verify that they 

have received appropriate 

training.

Policy, Record

1.10.4.2 For processing, packing, or 

holding low-moisture food, food 

contact surfaces must be clean 

and dry before use. If wetcleaned, the surfaces must be 

sanitized and thoroughly dried 

before use. The procedure must 

be documented and there must 

be records to show completion. 

Food-contact surfaces used for 

manufacturing/processing, packing, or 

holding low-moisture food must be in a 

clean, dry, sanitary condition before use. 

When the surfaces are wet-cleaned, they 

must, when necessary, be sanitized and 

thoroughly dried before subsequent use.

(1) Observe if food contact 

surfaces are thoroughly dried 

after cleaning and sanitizing. 

The use of alcohol- based 

wipes are acceptable means of 

sanitizing surfaces. Air drying 

is a common method for 

drying surfaces.

Policy, Record

1.10.4.3 In wet processing, all food 

contact surfaces must be cleaned 

and sanitized before use and 

after any interruption during 

which the food contact surfaces 

may have become contaminated. 

Where equipment and utensils 

are used in a continuous 

production operation, the 

In wet processing, when cleaning is 

necessary to protect against allergen crosscontact or the introduction of 

microorganisms into food, all food contact 

surfaces must be cleaned and sanitized 

before use and after any interruption during 

which the food contact surfaces may have 

become contaminated. Where equipment 

and utensils are used in a continuous 

(2) Verify that there are policies 

for cleaning and sanitizing all 

equipment and utensils. 

Verify the cleaning schedule 

in continuous operations is 

being followed. Observe that 

food contact surfaces are clean 

and free of food residue, soil, 

etc.

Policy, Record
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Req. No. Requirement Reference Citation Auditor Guidance Documentation

utensils and food-contact 

surfaces of the equipment must 

be cleaned and sanitized as 

necessary. The procedure must 

be documented and there must 

be records to show completion. 

production operation, the utensils and foodcontact surfaces of the equipment must be 

cleaned and sanitized as necessary.

1.10.4.4 Single-service articles must be 

stored, handled, and disposed of 

in a manner that protects against 

allergen cross-contact and 

against contamination of food, 

food-contact surfaces, or food 

packaging materials.

Single-service articles (such as utensils 

intended for one-time use, paper cups, and 

paper towels) must be stored, handled, and 

disposed of in a manner that protects against 

allergen cross-contact and against 

contamination of food, food-contact 

surfaces, or food packaging materials.

(3) Verify by observation if 

single-service products are 

covered/protected from 

contamination and adequately 

stored, and that any used, 

dirty, or soiled products are 

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 

equipment used in the operation 

of a food plant must be cleaned 

in a manner and as frequently as 

necessary to protect against 

allergen cross‐contact and 

against contamination of food, 

food‐contact surfaces, and food‐

packaging materials.

Sanitation of non‐food‐contact surfaces. 

Non‐food‐contact surfaces of equipment 

used in the operation of a food plant must 

be cleaned in a manner and as frequently as 

necessary to protect against allergen cross‐

contact and against contamination of food, 

food‐contact surfaces, and food‐packaging 

materials.

(e) Verify by observation that 

non-food contact surfaces such 

as the exteriors of machines, 

forklifts, storage shelves, etc. 

are clean. Verify that cleaning 

non-food contact surfaces is 

regularly scheduled.

1.10.6 Cleaned and sanitized portable 

equipment with food‐contact 

surfaces and utensils must be 

stored in a location and manner 

that protects food‐contact 

surfaces from allergen cross‐

contact and from contamination.

Storage and handling of cleaned portable 

equipment and utensils. Cleaned and 

sanitized portable equipment with food‐

contact surfaces and utensils must be stored 

in a location and manner that protects food‐

contact surfaces from allergen cross‐contact 

and from contamination.

(f) Verify by observation that 

equipment is not stored on the 

floor or ground. Are special 

tables, carts, racks provided 

for cleaned utensil storage? 

Are clean and sanitized 

portable pieces of equipment 

covered or stored in an area 

free from possible 

contamination?
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1.11 Warehousing and Distribution

Req. No. Requirement Reference Citation Auditor Guidance Documentation

1.11.1 The storage and transportation 

of food must be carried out so 

that it is protected against 

allergen cross‐contact and 

against biological, chemical 

(including radiological), and 

physical contamination of food, 

as well as against deterioration 

of the food and the container.

Storage and transportation of food must be 

under conditions that will protect against 

allergen cross‐contact and against 

biological, chemical (including 

radiological), and physical contamination of 

food, as well as against deterioration of the 

food and the container.

21 CFR 

117.93

Observe that the warehouse 

has good housekeeping, 

pallets are stored away from 

the walls, there is sufficient 

storage space to allow air 

circulation around product for 

cooling, prevention of mold 

growth and to lessen damage 

to product due to overcrowding. Is food exposed 

because of damaged 

packaging? Are best storage 

practices being followed to 

prevent allergen crosscontact? 

1.11.1.1 Incoming trailers and goods are 

inspected for damage, 

infestation, off odors, 

contamination, and proper 

temperatures.

Verify that there are 

procedures for receiving or 

incoming trailers, including 

inspection for damage, 

infestation of pests, off odors, 

contamination, and 

temperature. Interview 

employees about the 

procedures. 

1.11.1.2 Wash certificates are required 

for bulk tanker trucks for 

previous loads. The record 

indicates the previous product 

shipped.

Review tanker wash tickets. 

Verify that the previous 

product shipped is indicated 

and was a food grade product.

Record
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1.11.1.3 Procedures are implemented for 

outbound shipments, including: 

proper shipping temperature, 

trailer cleanliness/condition, 

verification of odors, etc.

Verify that there are 

procedures for inspecting 

outbound containers before 

loading. Interview employees 

about the procedures. Observe 

if trailers are clean, in good 

repair and if cooling or freezer 

units are working properly. If 

tankers are beingused verify 

that they are clean.

1.11.1.4 Packaging, packing materials, 

and emptycontainers must be

protected fromcontamination.

Observe that packing 

materials, packaging and 

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 

product must be identified and 

stored in a clearly designated 

area or controlled through an 

inventory system. 

Observe that retained, 

damaged, or returned product 

or materials are stored in a 

designated area and labeled 

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 

documented procedure to ensure 

that ingredients, materials, work 

in progress, and finished product 

A procedure shall be established, 

implemented and maintained to ensure that 

purchased materials, work in progress and 

finished products are used in the correct

GFSI, GMP 

17

Verify that there are 

procedures to maintain 

appropriate rotation of 

materials and ingredients. 

Generally, you would expect 

Policy, Record
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Req. No. Requirement Reference Citation Auditor Guidance Documentation

are used in the correct order and 

within the allocated shelf life.

order, and within the allocated shelf life 

when applicable.

to see the principle of first 

in/first out applied. Do 

inventory, shipping, and 

production records indicate 

compliance with the policy?

1.12 Food By-Products for Animal Food

Req. No. Requirement Reference Citation Auditor Guidance Documentation

1.12.1 If the facility holds and 

distributes human food byproducts for use as animal food, 

it must be held under conditions 

that protect against 

contamination, including:

Human food by‐products held for 

distribution as animal food without 

additional manufacturing or processing by 

the human food processor, as identified in § 

507.12 of this chapter, must be held under 

conditions that will protect against 

contamination, including the following:

21 CFR 

117.95

(a)

Ask the facility if they are 

generating food by-products 

for animal food. Does the 

facility have control 

procedures on storage time 

and conditions? Have they 

been implemented? 

1.12.1.1 Containers and equipment used 

to convey or hold human food 

by‐products before distribution 

must be designed, constructed of 

appropriate material, cleaned as 

necessary, and maintained to 

protect against contamination.

Containers and equipment used to convey or 

hold human food by‐products for use as 

animal food before distribution must be 

designed, constructed of appropriate 

material, cleaned as necessary, and 

maintained to protect against the 

contamination of human food by‐products 

for use as animal food.

(1) Verify that there are 

procedures for cleaning human 

food by-product containers 

and equipment. Observe by 

inspection if containers are 

constructed of appropriate 

material, are clean and in good 

repair. Interview employees 

about the procedure.

1.12.1.2 Human food by‐products must 

be held in a way to protect 

against contamination from 

sources such as trash.

Human food by‐products for use as animal 

food held for distribution must be held in a 

way to protect against contamination from 

sources such as trash

(2) Verify by observation. Are 

trash containers located next 

to by-product containers?
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1.12.1.3 Human food by‐products must 

be accurately identified.

During holding, human food by‐products 

for use as animal food must be accurately 

identified.

(3) Observe that food designated 

as animal food is clearly 

labeled as “animal food”.

1.12.2 Labeling that identifies the by‐

product by the common or usual 

name must be affixed to or 

accompany human food by‐

products for use as animal food 

when distributed.

Labeling that identifies the by‐product by 

the common or usual name must be affixed 

to or accompany human food by‐products 

for use as animal food when distributed.

(b) Verify by observation that all 

by-products are labeled with 

the common or usual name. 

1.12.3 Shipping containers and bulk 

vehicles used to distribute 

human food by‐products must 

be examined prior to use to 

protect against contamination of 

the human food by‐products 

from the container or vehicle.

Shipping containers (e.g., totes, drums, and 

tubs) and bulk vehicles used to distribute 

human food by‐products for use as animal 

food must be examined prior to use to 

protect against contamination of the human 

food by‐products for use as animal food 

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.

(c) Verify that the facility has a 

procedure to inspect shipping 

containers for condition and to 

verify that they are suitable to 

ship human food by-products 

for use as animal food.
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1.13 Facility and Grounds

Req. No. Requirement Reference Citation Auditor Guidance Documentation

1.13.1 The grounds surrounding the 

facility must:

Grounds. The grounds about a food plant 

under the control of the operator must be 

kept in a condition that will protect against 

the contamination of food. The methods for 

adequate maintenance of grounds must 

include:

21 CFR 

117.20 (a)

1.13.1.1 Be maintained in a manner 

which will prevent rodent and 

insect harborage, reasonably 

free of litter and debris.

Properly storing equipment, removing litter 

and waste, and cutting weeds or grass 

within the immediate vicinity of the plant 

that may constitute an attractant, breeding 

place, or harborage for pests.

(1)

21 CFR 

117.35 (c)

Verify by observation. Look 

for things such as overgrown 

vegetation along the side of 

the building, low areas where 

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 

designed to prevent dust and 

offensive odors and for adequate 

drainage (minimal standing 

water).

Maintaining roads, yards, and parking lots 

so that they do not constitute a source of 

contamination in areas where food is 

exposed.

Adequately draining areas that may 

contribute contamination to food by 

seepage, foot-borne filth, or providing a 

breeding place for pests.

(2), (3) Observe if there are low spots 

in the drives and parking lots 

with pooling water, if they are 

paved, dirt, rock or gravel. 

Observe if dirt and mud are 

being tracked into the facility.

1.13.1.3 Include an adequate number of 

exterior waste containers which 

are well maintained and in good 

condition. 

The frequency or removal of the 

waste shall be timely.

A policy must be documented. 

Operating systems for waste treatment and 

disposal in an adequate manner so that they 

do not constitute a source of contamination 

in areas where food is exposed.

A procedure shall be established, 

implemented and maintained for the 

collection, storage and disposal of waste 

(4)

GFSI, GMP 

12.1

Verify that the plant has a 

documented waste removal 

policy. Observe that trash 

containers are well maintained 

and not over-flowing. Check 

the frequency of trash pick-up 

and verify by observation that 

it is adequate.

Policy
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material, including waste water and 

drainage.

1.13.1.4 Not be affected by uncontrolled 

contamination risks from 

adjacent properties. The facility 

shall take steps for additional 

inspection, extermination, or 

other means to limit any 

identified risks.

If the plant grounds are bordered by 

grounds not under the operator’s control and 

not maintained in the manner described in 

paragraphs (a)(1) through (4) of this section, 

care must be exercised in the plant by 

inspection, extermination, or other means to 

exclude pests, dirt, and filth that may be a 

source of food contamination.

(5) Ask if the plant has done a risk 

assessment for the surrounding 

area. Observe if there are 

extra barriers, fences, netting, 

etc. in place. 

1.13.2 The plant design and 

construction shall be adequate 

for the food products produced. 

Plant construction and design. The plant 

must be suitable in size, construction, and 

design to facilitate maintenance and sanitary 

operations for food-production purposes

(i.e., manufacturing, processing, packing, 

and holding). The plant must:

(b)

1.13.2.1 There must be adequate space 

provided for necessary 

maintenance, sanitation, and 

production activities.

Provide adequate space for such placement 

of equipment and storage of materials as is 

necessary for maintenance, sanitary 

operations, and the production of safe food. 

(1) Observe if the facility is 

overcrowded. Look for 

adequate warehousing, storage 

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 

prevent contamination of 

products and materials. 

Measures may include physical 

segregation, time, air flow 

systems, enclosures, labeling, 

and other effective means.

Permit the taking of adequate precautions to 

reduce the potential for allergen cross- and 

for contamination of food, food-contact 

surfaces, or food-packaging materials with 

microorganisms, chemicals, filth, and other 

extraneous material. The potential for 

allergen cross-contact and for contamination 

may be reduced by adequate food safety 

(2) Verify that the plant layout 

and traffic controls are 

conducive for the protection of 

finished product and to 

prevent cross contamination. 

HVAC systems could be used 

to prevent contamination of 
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Req. No. Requirement Reference Citation Auditor Guidance Documentation

controls and operating practices or effective 

design, including the separation of 

operations in which allergen cross-contact 

and contamination are likely to occur, by 

one or more of the following means: 

location, time, partition, air flow systems, 

dust control systems, enclosed systems, or 

other effective means.

processing areas by allergens 

or dust from other areas. 

Positive air pressure could be 

maintained in the production 

area to establish a hygienic 

control.

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 

constructed and protected to 

prevent contamination.

Permit the taking of adequate precautions to 

protect food in installed outdoor bulk 

vessels by any effective means, including:

i. Using protective 

coverings.

ii. Controlling areas over 

and around the vessels to 

eliminate harborages for 

pests.

iii. Checking on a regular 

basis for pests and pest 

infestation.

iv. Skimming fermentation 

vessels, as necessary.

(3) Verify by observing if food 

stored in vessels is adequately 

protected. 

Observe if there is evidence of 

pest activity and if the 

surrounding area can 

contribute to pest harborage. 

Verify that there are pest 

control devices in place and 

that they are checked 

regularly.

Look for overhead covers if 

sampling is occurring from the 

top of tanker trucks.

Any valves or spigots, hoses, 

or utensils should be 

protected.
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Req. No. Requirement Reference Citation Auditor Guidance Documentation

1.13.2.4 Floors, doors, ceilings, walls 

and overheads must be in good 

repair and designed to facilitate 

proper sanitation and 

maintenance.

Be constructed in such a manner that floors, 

walls, and ceilings may be adequately 

cleaned and kept clean and kept in good 

repair; that drip or condensate from fixtures, 

ducts and pipes does not contaminate food, 

food contact surfaces, or food-packaging 

materials; and that aisles or working spaces 

are provided between equipment and walls 

and are adequately unobstructed and of 

adequate width to permit employees to 

perform their duties and to protect against 

contaminating food, food-contact surfaces, 

or food-packaging materials with clothing 

or personal contact.

(4) Observe if floors, doors, 

ceilings, walls, and overheads 

are constructed of durable 

materials that are easy to clean 

and maintain, and that they are 

free of cracks and crevices. 

Observe that ceilings are free 

from condensation and mold. 

Does the plant have drop or 

false ceilings which could 

provide places for pest to 

hide? Observe that walls are 

made of materials that are 

impervious to moisture.

Is there enough room for 

employees to perform their 

work?

1.13.2.5 There shall be adequate 

procedures in place to prevent 

overhead condensation from 

dripping on to food, food 

contact surfaces, or foodpackaging materials.

(4) Observe if there is proper 

ventilation to eliminate 

excessive condensation, if 

food contact areas are shielded 

(drip pans, etc.) to protect 

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 

constructed and located to 

prevent product contamination. 

(4) Observe if catwalks are 

located above food processing 

lines, open manways to 

tankers, if 

tubs/totes/bins/cleaned 
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Req. No. Requirement Reference Citation Auditor Guidance Documentation

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 

in personnel areas, and to permit 

efficient operations and cleaning 

where food is examined, 

manufactured, processed, 

packed, or held and where 

equipment or utensils are 

cleaned.

Provide adequate lighting in handwashing 

areas, dressing and locker rooms, and toilet 

rooms and in all areas where food is 

examined, manufactured, processed, 

packed, or held and where equipment or 

utensils are cleaned; and provide shatterresistant light bulbs, fixtures, skylights, or 

other glass suspended over exposed food in 

any step of preparation or otherwise protect 

against food contamination in case of glass 

breakage.

(5) Observe if there is adequate

lighting in production areas, 

where equipment is cleaned, 

and where product is inspected 

and graded. Observe if any 

lights are not working 

properly /light bulbs missing 

or burned out.

The rest rooms, other 

personnel areas, and 

handwashing areas must be 

well lit.

1.13.2.8 Light fixtures and other glass 

must be properly covered or 

protected in case of breakage.

(5) Verify by observation. 

Observe if the lights are 

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 

equipment shall be located so to 

minimize the potential for 

allergen cross-contact and for 

contaminating food, food 

packaging materials, and foodcontact surfaces.

Provide adequate ventilation or control 

equipment to minimize dust, odors and 

vapors (including steam and noxious fumes) 

in areas where they may cause allergen 

cross-contact or contaminate food; and 

locate and operate fans and other airblowing equipment in a manner that 

minimizes the potential for allergen crosscontact and for contaminating food, food 

(6) Verify by observation. Are 

fans blowing directly onto 

exposed food, food contact 

zones or packaging materials? 

Are fans clean? Does the plant 

use an HVAC system? If so, is 

there a PM plan for changing 
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Req. No. Requirement Reference Citation Auditor Guidance Documentation

packaging materials, and food-contact 

surfaces.

filters and cleaning the 

system? Are the vents clean?

1.13.2.10 Buildings shall be reasonably 

free from excessive dust, heat, 

steam, condensation, vapors, 

smoke or fumes.

(6) Verify by observation. 

Observe if there is proper 

ventilation, condensation 

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 

gateways shall be closed or 

properly protected with screens, 

air screens or other protective 

devices.

Provide, where necessary, adequate 

screening or other protection against pests.

(7) Verify by observation. 

Observe such things as doors 

propped opened, missing/torn 

screens from windows or 

doors, poorly sealed 

doors/dock overhead doors.
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REFERENCE LINKS Version Date

(Printed for distribution)

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Checked Materials have been printed from the links in this manual and included for 

reference.