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FOOD SAFETY AND

QUALITY ASSURANCE

Expectations Manual
Suppliers & Contract
Manufacturers

Revised 12-28-20
Tyson is a registered trademark of Tyson Foods, Inc.
FSQA Expectations Manual
Suppliers & Contract Manufacturers

Table of Contents

SECTION NUMBER SECTION TITLE PAGE


1 Introduction 3
1.1 Distributors, Brokers, or Purchasing Agent 3
2 Confidentiality 3
3 Audit Requirements and Scope 4
3.1 Tyson Foods FSQA Audit 4
4 General Requirements 4
4.1 Food Safety Culture 4
4.2 Quality System 5
4.3 Hold & Release 5
4.4 Customer Complaints 5
4.5 Notification of Significant Events 6
4.6 Regulatory Inspections & Contacts 6
4.7 Training 7
4.8 Record Keeping 7
4.9 Shelf Life 8
4.10 Donation of Tyson Branded Products 8
4.11 Foreign Supplier Verification (If Applicable) 8
5 Receiving, Storage & Shipping 8
5.1 Receiving and Shipping 8
5.2 Storage 10
5.3 Off-site Warehouse 10
6 Plant Sanitation 11
6.1 Sanitation Program 11
6.2 Clean in Place (CIP) 11
6.3 Less-Than-Daily Sanitation 12
6.4 Master Sanitation Schedule 12
6.5 Sanitation Chemicals 12
6.6 Sanitation Practices 12
6.7 Pre-Operational Inspection 13
6.8 Operational Sanitation 13
6.9 Reusable Containers & Reusable Cleaning Items 13
6.10 Laundry Service 14
7 Equipment Design & Validation 14
7.1 Equipment Design 14
7.2 Validation 14
8 Good Manufacturing Practices (GMPs) 14
8.1 GMPs – Facility 15
8.2 GMPs – RTE 16
8.3 Plant Structure 17
8.4 GMPs – Equipment & Tools 17
8.5 Calibration 17
9 Maintenance 18
9.1 Preventative & Corrective Maintenance 18
9.2 Repairs 18
10 Utilities Management 19
10.1 Environmental Air 19
10.2 Compressed Air 19
10.3 Water 20
10.4 Steam 20
10.5 Utility Chemicals 20

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11 Pest Control 20
11.1 General Program Requirements 20
11.2 Building and Grounds 21
11.3 Pest Control Devices 21
12 Internal Audits 22
12.1 Internal Audit Program 22
13 Food Safety Systems 22
13.1 Food Safety Plan 22
13.2 Food Safety Team 22
13.3 Food Safety Reassessment 23
13.4 Allergen Management 23
13.5 Products Bearing Label Claims 24
13.6 Laboratory Testing Requirements 25
14 Foreign Material Control 26
14.1 Foreign Material Prevention Program 26
14.2 Glass & Brittle Plastic 26
15 Supplier Approval Program 27
15.1 Supplier Management 27
15.2 Food Fraud 28
16 Traceability & Recall Procedures 28
16.1 General Requirements 28
16.2 Recall Program / Traceability Exercise 29
17 Product Quality 29
17.1 Specifications 29
17.2 Process Control 29
17.3 Ingredient, Packaging & Label Verification 30
17.4 Net Weight 31
17.5 Code Date Requirement 31
17.6 Thawing of Food 31
18 Food Defense & Crisis Management 31
18.1 Food Defense 31
18.2 Crisis Management 32
19 Ready to Eat (RTE) 32
19.1 Temperature Verification 33
19.2 Batch Oven 33
19.3 Continuous Cook 33
19.4 Stabilization/Cooling 33
19.5 RTE Meats 34
19.6 Post Lethality Controls 34
19.7 Environmental Monitoring and Finished Product Testing 34
Requirements
20 Animal Welfare 34
20.1 Slaughter Facilities 35
21 Revision History 35

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1. INTRODUCTION

The primary objective of Tyson Foods, Inc. is to be the first choice of consumers and customers around the
world. A large portion of achieving this objective is to market safe products of consistent quality that meet or
exceed our customer and consumer expectations. To accomplish this, it is important that our suppliers and
contract manufacturers share the same objective. It is in this spirit that we have developed the Tyson Foods,
Inc. Food Safety and Quality Assurance (FSQA) Expectations Manual.

This manual is intended to be used by current and prospective Tyson Foods contract manufacturers and
suppliers to ensure their own food safety and quality systems meet Tyson Foods and industry standards. The
Tyson Foods Expectations Manual contains the elements we believe are essential for the effective management
of Food Safety, Quality Assurance and Food Defense. These are Tyson Foods requirements; they are not
intended to alter or eliminate any requirements that may be set in a contract, specification,or government
regulation.

Each manufacturing location shall have a copy of the Tyson Foods FSQA Expectations Manual. The FSQA
Expectations Manual compliance signature form shall be signed by the appropriate facility management
representative.

Some expectations outlined in this manual cover evolving topics. For example, regulatory authorities
continually review and may adjust the legal status or limits for ingredients. The scientific community may
also present new product safety information.

By complying with these expectations, you will assist in maintaining food safety and quality standards and
our mutual business success. We look forward to working with you.

1.1 Distributors, Brokers, or Purchasing Agent

a. In cases where materials are being procured through brokers, distributors and/or purchasing agents
the following requirements must be followed:
i. Materials used in the manufacture of Tyson products shall only be sourced from Tyson Foods
approved manufacturing locations. The Tyson approval ensures that the producing location is
capable of meeting Tyson requirements for quality and food safety. Supplier manufacturing
locations shall be disclosed to the Tyson Foods contracting representative to facilitate
compliance.
ii. Notify the supplier that the specific material will be delivered to Tyson Foods.
iii. Ensure the Tyson Foods FSQA Expectations Manual is signed and dated by each
manufacturing location used to provide product to Tyson Foods.
iv. The broker/distributor/purchasing agent has responsibility to ensure their suppliers comply with
these requirements.
v. The broker/distributor/purchasing agent shall be required to notify Tyson Foods of any
manufacturing location changes. New sites must be approved prior to use. This approval may
require an on-site audit from a Tyson Foods FSQA representative.
vi. Agree to and comply with the Tyson Distributors, Brokers and any Purchasing Agent
requirements.

2. CONFIDENTIALITY

The contracts between Tyson Foods and the supplier or contract manufacturer will govern confidentiality of
information shared by either company. All supplier and contract manufacturer personnel should take care not to
disclose supplier or contract manufacturer confidential information to Tyson Foods unless there is a contract in
place protecting such disclosure. If a current contract is in place with Tyson Foods, the Tyson FSQA
representative shall not be asked or required to sign confidentiality agreements as a pre-requisite to gain access
for audits prior to or at any time during a food safety and quality audit. Auditors verifying compliance to the Tyson

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Foods FSQA Expectations Manual will not audit or inspect financial data, sales data (other than that directly
related to Tyson Foods), or pricing data. Auditors will not inspect personnel data, other than data relating to
qualifications or training of technical and professional personnel performing functions pertinent to the audit.

3. AUDIT REQUIREMENTS AND SCOPE

All manufacturing locations producing products for Tyson Foods must be approved by Tyson Foods. All new
suppliers or contract manufacturers may require a Tyson Foods audit prior to use. Approval status is assessed
by facility NOT by company. Suppliers and contract manufacturers must permit Tyson Foods or its
representatives to enter and audit any establishment that is manufacturing, storing or supplying materials for
Tyson Foods. On-going audit frequencies are dictated based on material risk.

Each facility must have a written policy in place to ensure that production is not moved to a non-Tyson approved
facility without the prior approval of the appropriate business manager and Tyson FSQA representative.

To become and remain an approved supplier or contract manufacturer, the facility must maintain Global Food
Safety Initiative (GFSI) certification and all audit corrective actions must be acceptable to Tyson Foods. Facilities
not currently GFSI certified must provide written documentation confirming intent to obtain GFSI certification
within 18 months of becoming a Tyson Foods supplier or contract manufacturer.

3.1 Tyson Foods FSQA Audit

a. The Tyson Foods audit shall extend to all areas, including all pertinent production and storage areas,
deemed necessary to evaluate whether the facility and material produced will meet Tyson Foods food
safety and quality assurance requirements. The audit may include, but is not limited to the following:
i. Equipment.
ii. Finished and unfinished materials.
iii. Containers.
iv. Labeling.
v. Records.
vi. Processes and controls.
b. The supplier or contract manufacturer must implement all corrective actions identified in the Tyson
Foods audit within the agreed upon time frame as outlined in the audit corrective action plan. In
addition, all corrective actions shall be verified by Tyson Foods FSQA. Verification of corrective
actions for all unsatisfactory findings may require an additional on-site visit.

4. GENERAL REQUIREMENTS

All levels and functions in the organization shall be responsible for food safety and quality. This section outlines
the basic requirements for food safety and quality of Tyson Foods, Inc. In addition to this, each supplier and
contract manufacturing facility shall maintain current food safety and quality documents within Tyson’s FSQA
Supplier and Co-Manufacturer software portal, FoodLogiQ, to include the completion of required assessments.

4.1 Food Safety Culture

a. The supplier or contract manufacturer shall demonstrate the implementation, sustainability and
measurement of a Food Safety Culture that indicates the commitment to producing safe food
products.
i. The vision and mission of the company shall demonstrate food safety is integrated into the
business strategy.
ii. The supplier or contract manufacturer shall recognize the potential hazards and risks that
impact food safety for their particular operation and shall create awareness of what those risks
are within all levels of the organization.

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iii. Food Safety expectations shall be well defined for all employees.
iv. The Food Safety Culture shall be reinforced through the proper alignment of food safety
priorities to ensure consistency and effective application of the food safety programs.
v. Food Safety shall be measured and assessed through performance to ensure continuous
improvement.

4.2 Quality System

a. The supplier or contract manufacturer shall implement a written Quality Management System to
ensure that the materials produced for Tyson Foods conform to specified requirements.
b. At a minimum, the Quality System shall ensure compliance with the Tyson Foods FSQA Expectations
Manual, Tyson Foods specifications for the specific product, and all applicable regulatory
requirements of the production country and the destination to which the products will be delivered.
c. The supplier or contract manufacturer shall:
i. Review the Quality System on a regular basis to verify that it remains adequate to comply with
all requirements.
ii. Maintain records sufficient to show effective implementation of the Quality System.
iii. Clearly identify the records that must be maintained to show effective implementation and
controls needed for identification, storage, protection, retrieval, retention and disposition of
records.

4.3 Hold & Release

a. There shall be a hold and release program that ensures the proper identification and segregation of
products, ingredients, packaging, or equipment that has been deemed unacceptable for use or
shipment and to assure their proper release following appropriate corrective action.
b. The program must ensure that product placed on hold is not released until proper notification is given
by authorized FSQA personnel.
c. A record must be in place for all product on hold. Product on hold for reasons other than food safety
must be physically identified as “hold” unless an electronic system is used to identify the hold.
Product on hold for food safety reasons should be physically identified.
d. The hold log should be documented and shall be updated.
e. Once the disposition of hold product is determined and carried out, only authorized personnel should
have the authority to remove the hold tag.
f. The team member removing the hold tag must document the disposition of the product and the date
the disposition was completed. The information and disposition are to be documented in the hold log.
g. Product on hold for food safety issues shall be reconciled against the hold log daily to ensure product
does not enter into commerce.
h. If outside warehouses are utilized, products on hold must be able to be retrieved. A system for
notification of product disposition at the outside warehouse shall be in place.

4.4 Customer Complaints

a. A system shall be in place for receiving, tracking, trending, and responding to complaints.
b. Responses to complaints shall include a summary of the investigation and any corrective actions
taken.
c. Responses shall be communicated in a timely manner.
d. A customer complaint trending system shall be in place by comparing customer complaint data for at
least the last twelve months to identity consistent results or reoccurring issues. The investigation and
analysis of reoccurring issues shall be performed by personnel knowledgeable about the incidents.
e. Contract manufacturers shall engage Tyson FSQA when responding to a complaint that routes
through USDA or FDA.

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4.5 Notification of Significant Events

a. Communication in the supply chain is critical when events occur that could affect food safety, quality,
or processing. The supplier / contract manufacturer shall establish procedures to ensure Tyson Foods
is immediately notified of these occurrences.
i. Supplier or contract manufacturer must notify Tyson Foods of a critical incident by
communication through their Tyson business contact.
b. 24/7 emergency contact numbers shall be supplied to the Tyson Foods business contact and FSQA
Representatives.
c. The supplier / contract manufacturer shall notify the Tyson Foods business contact and FSQA
representatives immediately of any, but not limited, to the following:
i. Systematic product quality or food safety defect or process control deviation which could lead
to a recall or withdrawal of a Tyson Foods finished product or ingredient sourced to Tyson
Foods.
ii. In the event of a recall or withdrawal, communication with a Tyson Foods business contact and
a Tyson Foods Safety and Quality Assurance (FSQA) contact prior to announcing this event
should occur. Supplier related recalls or withdrawals must be sent to
supplierrecalls@tyson.com.
iii. Discovery of potentially defective or adulterated ingredients or packaging materials associated
with Tyson product in distribution.
iv. Inadvertent release from hold of any material produced for Tyson Foods.
v. Non-routine regulatory authority investigations, testing, sampling, reporting, or other contact or
action with the potential to affect material produced for Tyson Foods. Tyson Foods does not
need to be notified of routine inspections, unless the inspection reveals that material produced
for Tyson Foods may not be in compliance with applicable law
vi. Any event that leads the supplier / contract manufacturer to suspect that a non-conformance
(specification, regulatory, etc.) exists in product already shipped to Tyson Foods.
vi. Product tampering, threat of tampering or any event that may threaten product security.
vii. Identification of an undeclared allergen in material produced for Tyson Foods.
viii. Potential changes to manufacturing processes and/or facilities that could have an impact on
materials supplied to Tyson Foods.
ix. Inability to deliver materials that meet Tyson Foods specifications.
x. Loss of GFSI certification at any site manufacturing products for Tyson Foods.
xi. Suppliers should notify the Tyson Foods regulatory group when there are any changes to
product specification (i.e. ingredient statement, nutritional) that may impact the labeling of
Tyson Foods finished products. These changes should be sent to TysonIngrSpecs@tyson.com.

4.6 Regulatory Inspections and Contacts

a. The supplier / contract manufacturer shall:


i. Have written procedures and designated trained personnel to manage inspections by and
contacts with regulatory authorities.
ii. Have procedures that address how the supplier or contract manufacturer will follow up and
obtain closure of any issues arising from such inspection or contact.
iii. Maintain records, at the facility, of all regulatory inspections and contacts, including any reports
issued by inspectors, facility responses, and corrective actions taken, for a period in
accordance with local regulatory requirements.
iv. For contract manufacturing only - Contact their Tyson Foods business relationship manager in
the event a regulatory authority samples material produced for Tyson Foods.
v. If a regulatory authority samples product, consideration must be given to the potential impact of
an adverse result. In some cases, it will be necessary to place product and/or material on hold
pending results of regulatory sampling, for example:
1. Where a non-conformance or defect has become apparent during the inspection.

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2. Where the result of the sampling may render the product adulterated or misbranded (e.g.
sampling for pathogen or GMO testing in a non-GMO product).

4.7 Training

a. The supplier or contract manufacturer shall ensure that all employees receive appropriate training for
their job functions and shall maintain records of training. Specific training requirements shall include,
but are not limited to the following:
i. GMPs: All employees, including temporary and seasonal personnel, must receive GMP
training (including a section on employee illness and communicable disease) as part of the
orientation process. All employees shall also receive refresher training or verification of GMP
knowledge at least annually. In addition, specific training programs to instruct personnel on
the requirements of this document shall be provided as required and applicable.
ii. Basic Principles: Training for personnel who work in production areas must include the
following principles: quality, HACCP/HARPC, allergens, foreign object prevention, sanitation,
and food defense.
iii. Critical Control Point (CCP) Monitors: Employees monitoring CCPs must receive further
specific training on monitoring, documentation, verification and corrective actions if critical
limits are not met.
iv. Foreign Material Training: Training for employees must include foreign material prevention
during processing such as: types of potential foreign materials, process to follow in the event
a foreign material is found, guidance on how to prevent foreign materials, training on proper
debagging, deboxing, dumping or transferring of ingredients and materials.
v. Non-GMO Manufacturing: When appropriate, employees involved in handling non-GMO
materials must be trained as to procedures for handling these products.
b. The supplier or contract manufacturer shall provide visitors and contractors with site specific training
programs, as necessary, prior to performing activities which may affect product safety or quality.
c. Training materials and the delivery of training shall be provided in language(s) understood by staff.

4.8 Record Keeping

a. There shall be a recordkeeping policy that provides for the following:


i. Maintaining business records is of critical importance to decision making processes and to the
proper discharge of financial, legal, and reporting obligations.
ii. Corrections made when errors are found, or clarification of illegible or inaccurate data, must be
accomplished by crossing out with a single clear line drawn through the entry in question and
application of initials by the individual making the correction. No white out shall be used.
iii. All documents pertaining to Tyson branded products or proprietary formulations shall be kept
confidential.
iv. Copies of records may be made available to USDA/FDA personnel for official review upon their
request. The management team must maintain a master list of all documents in the possession
of USDA/FDA as they pertain to Tyson product. Copies must not be distributed without a signed
cover letter outlining the company’s expectation with regard to confidentiality. Upon request,
plant personnel should inquire as to the purpose or reason for the document request.
v. All data gathered must be safeguarded from accidental loss or destruction.
1. Records should be stored in areas to prevent their deterioration or loss.
2. Customers are not allowed unlimited and/or unsupervised access to plant records.
3. Access to confidential information must be limited to appropriate personnel only (plant
management, corporate management, and regulatory personnel).
4. Off-site storage is permitted for records as long as control of the documents is maintained
in accordance with plant document control guidelines. These records must be retrievable
within 24 hours of request.
vi. Contract manufacturer and supplier shall have in place a record retention program that
complies with regulatory, corporate, and customer guidelines.

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1. Tyson contract manufacturers shall maintain all production and QA records associated
with Tyson products for a minimum three (3) years plus current year. Documentation
supporting organic material shall be kept a minimum of five (5) years.
vii. All obsolete programs, documents, and forms should be replaced, and the outdated
procedures/forms destroyed according to the facility’s document destruction policy.
1. Records that may be involved in any type of legal proceeding must not be destroyed
without written authorization.
viii. All records shall be readily available.

4.9 Shelf Life

a. Suppliers and contract manufacturers shall comply with all shelf life requirements as provided in the
product specification and have an established program for determining and evaluating shelf-life.
b. Contract manufacturers shall also be responsible for implementing appropriate verification testing to
ensure that all products meet the specified shelf life.

4.10 Donation of Tyson Branded Product

a. A policy shall be in place which prohibits donation of products bearing a Tyson brand without first
seeking the approval of Product Manager and Tyson FSQA representative.
b. Products must not be donated or sold as distressed items or for discounted sales in their original
packaging unless documented authorization is received from the appropriate Tyson Foods
representative. All approved donations shall be documented. In the event a Tyson product donation
is not approved, packaging must be removed, and product shall be disposed.

4.11 Foreign Supplier Verification Program (If Applicable)

a. For products manufactured outside of the United States and supplied to Tyson Foods, the importer on
record shall be compliant with the Foreign Supplier Verification Program (FSVP) per 80 FR 74226.

5. RECEIVING, STORAGE, AND SHIPPING

The supplier shall have implemented systems to manage the receiving, storage and shipping of materials and
products intended for Tyson Foods. The program shall ensure the safety, quality and security of these materials
and products at all stages from receipt through delivery.

5.1 Receiving & Shipping

a. The management team shall ensure that incoming ingredients and packaging materials comply with
applicable regulations, as well as, all specification parameters including microbiological, physical,
chemical criteria.
b. The management team shall establish and, upon request, make available to Tyson Foods, their
testing requirements, parameters and specified limits to ensure food safety and quality of all
ingredients and packaging materials.
c. Incoming ingredients shall only be received from supplier manufacturing locations identified on the
receiving facility’s approved supplier list.
d. The management team shall ensure that incoming materials are not used or processed until they
have been inspected or otherwise verified as conforming to specified requirements. When ingredient
testing is conducted, a hold and release procedure shall be applied until testing is complete.
e. An inspection prior to loading and unloading shall be performed on all trailers used for transporting
goods or storing products. The facility FSQA department shall be notified of any non-compliance. If
any discrepancies are found, there shall be documented evidence that an investigation and corrective
actions took place.
f. Finished goods shall be loaded in trailers with temperature conditions as stated in the product
specification to prevent any impact of food safety and quality during transportation.

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g. All incoming/outgoing carrier vehicles should be checked for proper refrigeration. There shall be
procedures in place to ensure that units are pre-cooled to required temperatures prior to loading
(where applicable).
i. Trailer documentation should indicate properly running cooling units to include unit temperature
setting and ambient temperature reading.
ii. Trailer documentation should note trailer pre-cooling prior to loading (minimum 40°F).
iii. Thermostats should be correctly set to maintain product temperature throughout transport,
typically 0°F for frozen and 28°F for refrigerated products.
h. Refrigerated and frozen products shall be inspected during loading and unloading to ensure proper
temperature controls.
i. Procedures must be in place to ensure that products are pre-chilled to required temperatures
prior to loading, and vehicles are pre-cooled prior to loading for distribution (where applicable).
ii. Temperature controlled vehicles must carry suitable on-board temperature monitoring
equipment. Equipment shall be verified at prescribed intervals.
i. A policy shall be in place to cover the proper procedures to follow in the event of a refrigeration
breakdown in a trailer, storage area or any other step in the supply chain.
j. Procedures shall cover product disposition/documentation and measures for ensuring correct
functioning of equipment prior to resumption of use.
i. A trailer seal policy shall be in place that covers all fully loaded carriers of both incoming ingredients,
and outgoing work-in-process or finished products. The policy shall include all of the following:
i. All doors, rear and side, shall be sealed at the time of shipment or delivery.
ii. The serial numbers shall be documented on the bills of lading (BOL).
iii. Common carriers or express mail services making multiple stops and deliveries of small
quantities are not required to seal their trailer between drops. However, the driver must lock the
trailer between drops and sign the BOL verifying this action. Failure to demonstrate adequate
security measures by not locking trailer between drops may result in rejection of load.
iv. Seals shall not be broken until the trailer reaches its final destination and the seal shall be
verified to be intact and seal number to be correct. Seals shall be broken by the facility
personnel only.
v. Truck load carries with multiple drops shall contain an adequate number of seals necessary to
reseal the load following each scheduled drop. Each seal number and drop load shall be
documented.
j. Management shall conduct a thorough investigation when seals are missing, broken or seal number
is different from what is stated in the BOL.
i. A complete inspection of the load and interview of the driver shall be conducted and
documented to determine if any tampering occurred before the use of the products or
ingredients involved.
ii. All findings shall be documented.
k. Materials being loaded or unloaded shall be inspected for proper case counts, damage and
cleanliness. Primary packaging on finished goods shall be protected during storage and
transportation.
l. Procedures shall be in place prohibiting non-food items from being transported with food items.
m. Procedures shall be in place for ingredients shipped in bulk (tanker) to protect them from
contamination:
i. Bulk tankers should be of stainless steel construction or other suitable food grade
material. Tankers shall be dedicated to food only with records available for the previous product
shipped. If applicable, they should be adequately cleaned and sanitized.
ii. Hoses, hose housings, pumps, ports, and surfaces that come in contact with product during
offloading shall be inspected for cleanliness, and this inspection shall be documented.
1. Ports should be capped and locked when not in use.
2. Hoses shall be stored off the ground.
iii. After unloading, the inside of the tanker shall be inspected, especially around the top and
bottom orifices.
iv. Coupling shall be clearly labeled.
v. In-line screen, strainers or magnets shall be in place.
vi. Cleaning certificates shall be available and checked before each loading, if applicable.

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Verification of cleaning shall be documented and shall consider the microbiological sensitivity of
the material transported and the allergenic and GMO status of the previous load.
vii. Certificates of Analysis, if provided, shall be verified and retained by the facility FSQA
department.
viii. Bulk storage of liquid ingredients susceptible to microbiological spoilage shall have adequate
controls in place to prevent spoilage or contamination.
n. Hand jacks, forklifts, and other transporting equipment should be clean and in good repair.
i. They must be maintained in such a manner that prevents the adulteration of products being
transported.
ii. There should be no leaking batteries or other fluids.
o. Products shipped to Tyson Foods should contain no more than one lot code per pallet. The contract
manufacturer or supplier shall make every effort to ensure individual pallets do not contain mixed lot
codes. In the event that a mixed pallet is unavoidable, the pallet shall contain a placard on two
opposing sides. Each placard shall contain the lot numbers and quantity of each lot on the pallet with
no more than two lot codes per pallet.

5.2 Storage

a. The management team shall have implemented systems to manage warehousing to ensure that food
safety, quality and security are maintained.
b. Storage areas shall be maintained in a clean and organized manner.
c. Sufficient space shall be maintained to permit proper cleaning and inspection for pest activity, or a
documented program should exist for the routine moving of items and cleaning of the area.
d. Storage must be off the floor. Pallets, racks and equipment shall be in good condition (e.g., free from
nails, splinters, broken boards, off odors, evidence of mold or infestation).
e. Raw materials received in glass containers shall be stored in a manner to prevent potential
contamination of other products in the event of breakage.
f. First Expired First Out (FEFO) rotation practices shall be used for all materials including finished
products.
i. Variations (e.g. first slaughtered first out, customer requests, etc.) on FEFO must be described
and justified.
g. All stored ingredients and packaging materials shall be clean, dry, intact, and properly
packaged/covered or sealed to prevent contamination. They shall be identified with lot number and
material number at all times to allow for traceability.
h. Packaging shall not be a source of foreign material. Programs shall be in place to ensure that metal
objects used on packaging do not pose a food safety risk.
i. Coolers and freezers shall be maintained in a clean and sanitary manner.
i. Storage racks shall be clean and in good repair.
ii. No excessive build-up of ice, frost, or dust.
iii. Doors and/or curtains/strips shall be evident at all refrigeration, freezer, or cooler product
storage areas.
j. Proper temperatures of coolers and freezers shall be maintained. Daily verification of temperatures
should be monitored using automatic monitoring systems. If automatic monitoring systems are not in
place, temperatures shall be manually recorded at a minimum of twice daily.
l. Materials that are damaged or otherwise not appropriate for use shall be properly identified, handled,
and stored in a designated area.
m. Exposed product shall be evaluated and disposed of, if necessary. Traceability must be maintained
for all damaged and condemned product.

5.3 Off-Site Warehouse

a. If an off-site warehouse or cold storage facility is utilized to receive, store, and ship raw meat
materials, ingredients, packaging materials, and / or finished products, the supplier / contract
manufacturer must provide evidence to support that the warehouse / cold storage facility is in good
condition and has effective food safety and quality
programs.

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b. The supplier / contract manufacturer shall have on file a 3rd party audit along with corrective actions
for all utilized warehouse / cold storage that are not company owned.
i. Warehouses / cold storage locations that are owned by the contract manufacturer or supplier
shall have, at a minimum, a company internal audit on file with corrective actions.

6. PLANT SANITATION

The facility shall have sanitation programs in place to assure the cleanliness of the manufacturing environment.
Programs shall meet all federal, state and local regulation as applicable.

6.1 Sanitation Program

a. The supplier or contract manufacturer shall have a written sanitation program, including Sanitation
Standard Operational Procedures (SSOP) that ensure cleanliness of the food production
environment, equipment and tools. The program shall include:
i. Sanitation schedules, procedures, methods, responsibility and frequencies.
ii. Correct use of appropriate sanitation equipment and tools. Equipment and tools used in high
risk areas shall be visually distinctive and dedicated for high risk areas only.
iii. Equipment disassembly and re-assembly.
iv. Use of food grade cleaning, sanitizing, and disinfecting products.
v. Chemicals to be used and how they are to be used including chemical concentrations, contact
time, temperatures, frequencies, and rinsing procedures. SDS sheets for all sanitation
chemicals shall be easily accessible and available for review.
vi. Post-cleaning or pre-operational inspections to confirm that equipment is clean, properly
assembled, free from chemical residues and sanitized prior to use.
vii. Verification and documentation of the effectiveness of the sanitation program.
viii. A floor drain cleaning and sanitizing procedure and schedule that includes a facility map with
the exact location of each drain. Floors and floor drains within RTE areas should be cleaned
and sanitized per risk assessment. For Co-Manufacturers, daily floor and drain cleaning during
sanitation is to be completed in RTE areas.
ix. Calibration of sanitation-related measurement devices e.g., thermometers, gauges and meters.
b. The following considerations shall be taken into account when designing the sanitation program:
i. Type of cleaning process:
1. Dry cleaning: method used to clean equipment that does not involve the direct use of
water. E.g. scraping, brushing, vacuuming, and equipment wipe down with damp
disposable wipes.
2. Wet cleaning: method used to clean equipment to a microbiological level that involves the
direct use of water and chemicals. E.g. rinsing, foaming, bucket and brush.
3. Equipment idle time: Situations when prolonged equipment downtime can lead to
microbiological growth. The supplier or contract manufacturer should have a program
that defines the maximum idle time that can occur prior to sanitizing, inspection or full re-
clean being required.
ii. Protocol with controls for extending production runs beyond established sanitation cycle times.
iii. Cleaning In Place/Cleaning Out of Place (CIP/COP).
iv. Equipment that is wet cleaned which needs to be used in a dry condition.

6.2 Clean-In-Place (CIP)

a. Written procedures shall be in place and documented for all CIP systems. These include frequency,
cycle time, temperatures, chemical concentrations, spray ball locations and coverage.
b. A procedure shall be in place to verify that no chemical residues remain.
c. Documentation of CIP cleaning must be maintained and available for review.

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6.3 Less-Than-Daily Sanitation

a. If employing less-than-daily sanitation (extended clean-up), records must demonstrate that microbial
levels associated with the extended clean-up program are at least equivalent to, if not improved over
those of the traditional daily clean-up program.
b. The effectiveness of the implementation of extended time between full sanitation must be routinely
evaluated and documented.

6.4 Master Sanitation Schedule

a. The supplier or contract manufacturer shall have on file a documented master sanitation schedule
which lists all areas to be cleaned, frequency of cleaning and responsibility to include all processing
and non-processing areas (e.g., dry storage, maintenance, shipping/receiving, freezers/coolers,
employee welfare areas, forklifts and hand jacks).
b. A risk assessment shall be conducted to determine high risk areas (i.e. Ready to Eat (RTE). High
risk machinery/equipment shall be disassembled to the lowest level possible to locate potential
microbial harborages.
c. During the initial development of the master sanitation schedule it is recommended that each
component is photographed as disassembled to provide a visual representation for future reference.
Any hard to access area(s) and/or any site(s) containing obvious contamination/build-up should also
be photographed.
i. Any location identified as containing obvious contamination/build-up shall be subject to APC,
Lactobacillus or Listeria spp. swabs (depending on need) to determine the microbial load
present at the site. The microbiological information will be used to assist in determination of the
required cleaning frequency.
ii. After reassembly, the line must be completely re-cleaned to assure that disruption of the
environment did not contaminate product contact surfaces.
d. Frequency of deep cleaning is determined based on a risk evaluation for each component.

6.5 Sanitation Chemicals

a. A chemical usage log shall be maintained to support adherence to the manufacturer’s conditions of
use. This includes:
i. Proper application of chemicals at the appropriate concentration and via the proper pump or
distribution system must be verified and documented
ii. If chemicals are mixed at the facility, chemical mixing records must be maintained.
iii. If chemical concentrations are tested and found out of compliance, retests must be
documented until concentration is correct. If the out of compliance chemical was used,
documentation must be available indicating product was not affected or that appropriate
product actions were taken.
b. All chemicals shall be properly labeled and stored in a secure location situated away from any food
storage or processing area.
c. Chemicals and empty containers shall be disposed in accordance with regulatory requirements.
i. Empty chemicals containers shall be cleaned, treated and labeled before use.
ii. Empty chemicals containers shall be labeled, segregated and securely stored while awaiting
disposition.
iii. Unused and obsolete chemicals shall be stored under secure conditions while waiting
authorized disposal.
d. Only designated plant management and/or employees will have access to the chemical storage area.
e. Cleaning equipment and storage areas shall be clean and well organized.

6.6 Sanitation Practices

a. Sanitation practices and/or conditions shall not cause product contamination.


b. All product and packaging shall be covered, protected or removed from the area to avoid
contamination during production clean-up.

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c. High pressure hoses should not be used for any wash down activity during production hours.
d. Proper tools and materials must be used to prevent extraneous matter, microbiological and/or
chemical contamination of the product. Items that are known to be potential sources of contamination
must be prohibited (e.g., wire brushes). Brushes and utensils for cleaning food contact surfaces shall
be clearly identified (e.g., labeled and/or color coded) and stored separately from non-food contact
tools. Floor drain cleaning brushes and equipment shall be clearly identified as such and maintained
separately from other cleaning equipment.

6.7 Pre-operational Inspection

a. A pre-operational sanitation inspection shall be performed and documented.


b. A list of facilities, areas or zones shall be maintained, and priority shall be assigned as to the
frequency of inspection.
c. Corrective action for unsanitary conditions shall be documented prior to production startup.
d. Reassessment shall be conducted as needed for recurring unsanitary conditions.
e. A microbial monitoring program shall be established to monitor the efficacy of cleaning and/or
sanitizing. Total plate count (TPC) or bioluminescence method should be used to verify cleaning
procedure efficacy.
f. Results should be reviewed with management and sanitation personnel for the continuous
assessment and improvement of the sanitation program. The facility should trend results, identify
problem areas and drive improvements.
g. When stated microbial levels are exceeded, subsequent swabs shall be collected to verify corrective
actions. Corrective actions and preventative measures for out of compliance results shall be
documented.

6.8 Operational Sanitation

a. Cleanliness shall be maintained in all areas of the plant, including non-processing areas:
i. Cleanup of spills and accumulated of materials shall be performed on a continuing basis.
ii. Operational sanitation inspection shall be performed at a defined frequency and documented.
Corrective actions and product disposition will be documented for unsanitary conditions.
iii. Reassessments shall be conducted as needed for repeated deficiencies.
iv. The floors shall be kept as dry as possible.
v. Floor rinsing during food processing is strongly discouraged.
b. Waste Disposal procedures shall be in place to ensure that waste material is removed from the
production floor in a timely manner. The plant must ensure that there is no accumulation of waste
material within the facility.
i. Designated waste accumulation areas shall be maintained in a clean and acceptable conditions
until waste disposal. Waste containers and areas shall be maintained in good condition and
shall be cleaned and sanitized regularly so as not to attract pests and other vermin.
ii. Adequate provision shall be made for the disposal of all solid and liquid processing waste
including trimmings, inedible material and used packaging.

6.9 Reusable Containers & Reusable Cleaning Items

a. There shall be a reusable container policy that distinguishes edible-raw, edible-RTE, and inedible
products and ingredients. A system must be in place to clearly identify clean reusable containers.
b. Reusable Containers – RTE Products: clearly identified, cannot contain drain holes, and must be
used in ready to eat departments only. These containers must not be used for any other purpose.
c. Reusable Containers – Raw Products: clearly identified, must not be stored or handled in ready to
eat areas.
d. Reusable containers shall be cleaned, sanitized, and inspected according to the SSOP. Clean
containers shall be maintained in an environment that does not lead to contamination. It is
recommended that the reusable container cleaning system be a mechanical type washer with
appropriate water pressure, temperature, washing and sanitizing capabilities. If mechanical washers

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are not available, reusable containers must be manually washed and scrubbed, rinsed and sanitized
to a pre-op ready level of sanitary condition.
e. All reusable containers must be completely intact. Cracked, chipped, or broken containers shall be
discarded.
f. Reusable cleaning items (rags, sponges, mops, etc.) shall be free of any broken or flaking pieces and
are to be utilized in a manner to prevent contamination.

6.10 Laundry Service

a. In-house laundry or laundry service shall have a sanitizing step identified and documented as part of
the cleaning process.

7. EQUIPMENT DESIGN & VALIDATION

The supplier or contract manufacturer shall ensure that equipment design is adequate for the production of
materials in order to meet food safety and quality parameters.

7.1 Equipment Design

The following characteristics are essential for equipment used in the manufacturing of food, ingredients or
food contact packaging:
a. Cleanable.
b. Smooth and accessible surfaces.
c. Capable of protecting product from contamination.
d. Self-draining.
e. Free from openings that could allow product or water to penetrate voids.
f. Designed to allow for proper ventilation.
g. Food contact surfaces shall be made of approved or suitable food contact materials
h. Hollow components, such as belt rollers and equipment legs, shall have caps that are secured and
free of damage to prevent moisture to enter.
i. Wood surfaces or equipment are not used, except where this is a process requirement (e.g.
maturation of products in wood).
j. During construction events in processing areas where strongly scented or taint-forming materials
have to be used, procedures shall be in place to prevent the risk of taint contamination of products.

7.2 Validation

a. Each new capital installation or modification to existing equipment design shall undergo a
documented Sanitary Design Review by a cross-functional team (e.g., quality, sanitation, production,
maintenance) in the design phase and commissioning phase of the project.
i. The review shall evaluate the design against applicable industry sanitary design standards.
b. Sanitary status shall be validated prior to use of any new equipment.
c. An SSOP shall be developed for all new equipment.

8. GOOD MANUFACTURING PRACTICES (GMP)

All persons entering the supplier or contract manufacturer facility (plant personnel, visitors and outside
contractors) shall comply with GMP requirements. GMPs must be in writing and available to all personnel in the
appropriate language. These GMPs reflect the minimum expectations but do not supersede any local or national
regulatory requirements. Visitor tours and general traffic flow always starts in the high-risk areas and moves
through to the lower risk areas. The supplier or contract manufacturer shall review and update GMP requirements
on a periodic basis.

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8.1 GMPs - Facility

a. The supplier or contract manufacturer shall establish instructions which include provisions for
recognition and identification of symptoms of employee illness or communicable disease such as, but
not limited to: diarrhea; vomiting; open skin sores; boils; fever; dark urine; jaundice or any other
symptoms associated with geographical, region-specific diseases as defined by local medical
experts.
Note: Local regulations, customs and practices concerning the information employees can be
required to provide vary significantly from country to country and may vary the requirements of this
policy. This policy shall be implemented in those cases where employees with a disease
communicable via food have made information about their Illness available to the company either
voluntarily or in response to permissible questions. In all cases the employee’s right to confidentiality
of the information provided shall be respected.
b. Personnel practices - The following actions are not allowed and should be covered in the GMP policy:
i. An individual infected with a communicable disease, who has been exposed or is a carrier of a
communicable disease, working in an area where food, food ingredients, or product contact
equipment may be contaminated.
ii. Employees with boils, open sores and infected wounds, or any other sources of bacterial
contamination working in any area in which there is a reasonable possibility that food, food
ingredients, or product contact surfaces may be contaminated.
iii. Eating or drinking (this is permitted in authorized areas of the facility only).
iv. Chewing gum, candies, throat candies, throat lozenges and tobacco.
v. Holding toothpicks, matchsticks or other objects in the mouth.
vi. Rings (other than plain wedding bands), watches, earrings, glasses with decorative stones,
necklaces, or other jewelry (including ornaments or piercing in exposed body areas such as the
tongue and/or nose) worn in production and storage areas.
vii. Nail polish, false fingernails, false eyelashes, excessive perfume/cologne or any other personal
items that may create a potential hazard.
viii. Smoking (this is permitted in designated exterior areas only).
ix. Consumption and storage of personal food in non-designated areas.
x. Personal medicines in processing areas.
c. Clothing and personal equipment
i. All clothing must be clean and kept in good repair. Employee clothing should not be a source of
contamination. Appropriate Personal Protective Equipment (smocks/aprons, hair nets, beard
nets, gloves, footwear) shall be available.
ii. Outer garments should be color coded or identified for specific job duties (e.g., floor cleanup
personnel, RTE vs. Raw, etc.)
iii. Smocks shall not be allowed in break rooms, restrooms, maintenance shops, or anywhere
outside the immediate production area except for cleaning and storage. Uniforms shall be clean
at the start of each shift and shall be changed when they become excessively soiled to the
point they present a product contamination risk.
iv. Smocks must have snaps or ties instead of buttons. Pockets, if present, must be below product
contact area.
v. Highly visible and metal detectable bandages must be utilized.
vi. Work wear dedicated to specific product areas must be restricted to those areas. Such areas
must be defined in local procedures (typically high-risk areas where clothing change is required
on entry and exit).
vii. To help avoid product contamination (and for personal safety) shoes worn in production and
storage areas should be designed and constructed as follows: fully enclosed (no open toes,
open weave, or sandals); made with leather or vinyl outer materials (non-absorbent materials)
and maintained in hygienic condition.
viii. Any protective clothing used in high risk areas shall be changed at a frequency determined by a
risk assessment, minimum daily.

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d. Hands
i. Personnel working in production and storage areas must wash hands at the following times:
before entering a production and storage area; upon re-entering the production or storage area;
after each visit to the restroom, and/or lunch and break room facilities; prior to touching product
or product contact surfaces; or any time when hands have become soiled or contaminated.
ii. Personnel working in a microbiologically sensitive area must sanitize their hands after proper
washing and after touching non-product contact surfaces.
iii. Employees shall wear clean, plastic or rubber gloves when handling high risk ingredients or
products.
iv. Gloves shall be washed and sanitized at the same frequency as hands.
e. Hair
i. Plant-supplied hair restraints must be worn in production and storage areas. Hair nets shall
either be of the surgical type / solid mesh or of tightly woven net.
ii. Hairnets/restraints must completely contain the hair and cover the ears. Hoodies are not
acceptable unless worn under proper hair restraints.
iii. Hairnets should be put on prior to putting on smock.
iv. In the event employees are wearing scarfs, hats, hoodies or coats, PPEs should properly cover
such items.
v. If safety or bump helmets are used, they must be worn over appropriate hair restraints and shall
be kept clean.
vi. Employees must be clean-shaven or cover the exposed facial hair (i.e. mustaches, beards,
etc.) as completely as possible with a plant-supplied beard restraint.

8.2 GMPs – Ready To Eat (RTE)

a. Hand and foot sanitizers shall be used at the entrance to RTE area at concentrations per
manufacturer recommendations and in accordance with regulatory limits.
b. Waterproof footwear that is suitable for maintaining sanitary condition must be utilized for employees
and visitors.
c. Separate raw and RTE processing areas shall be established.
d. Signage for traffic flow and barriers shall be established to control potential contamination of finished
product (Raw to RTE).
e. Programs shall be in place to clearly distinguish raw and RTE employees. (i.e. Color coded smocks,
uniforms, hairnets etc).
f. RTE processing areas are only serviced by staff dedicated to these areas.
g. Access points are located, designed, and equipped to enable staff to apply distinctive protective
clothing and to practice a high standard of personal hygiene to prevent product contamination.
h. Product transfer points are located and designed so as not to compromise high risk segregation and
to minimize the risk of cross-contamination.
i. Visitor tours and general traffic flow always starts in the RTE or high-risk areas and moves through to
the raw or lower risk areas.
j. A map of drains within the RTE areas should be maintained and demonstrate no risk of contamination
of the area. The map should show the direction of the flow and location of any equipment used to
prevent any back up of waste water.
k. Map of the site with designated areas including access points, routes, locations, and production
process flow shall be maintained.
l. A written procedure shall be in place for employees working in RTE areas that contains the following:
i. Outer garment issue/return including RTE smocks not leaving exposed RTE product
environment.
ii. Aprons, gloves and hairnets.
iii. Hand washing/sanitizing.
iv. Equipment hand tool sanitizing.
v. Compliance monitoring.
m. Sanitizing hand dip stations or hands-free spray stations shall be readily available to each work
station in RTE areas.

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n. Utensils and equipment used in RTE areas must be maintained in sanitary condition and are not
allowed to travel from a raw area to a RTE area.

8.3 Plant Structure

a. The manufacturing location shall be of adequate design and construction to ensure production of safe
and high-quality materials.
b. The facility, including utility fixtures, shall be designed to prevent potential contamination sources
from affecting the purchased materials.
c. The plant structure shall provide adequate physical separation to prevent any cross contamination
(e.g. raw and processed, allergen and non-allergen).
d. Facility grounds must be maintained.
e. The location and design of waste bins, toilets and hand washing, drying and sanitizing facilities shall
be adequate to comply with GMPs.
f. The supplier or contract manufacturer shall ensure that the facility is satisfactorily maintained.

8.4 GMPs – Equipment, Tools & Plant Signage

a. The management team has implemented proper tool storage and accountability. Tools shall not be
stored above product contact surfaces.
b. Hose heads are stored away from the floors/ equipment when not in use. Hoses are properly stored
when not in use.
c. Racks for protective clothing are located in designated areas to prevent cross-contamination.
d. Equipment in product zones shall be smooth, corrosion resistant, and well maintained. No
chipping/peeling paint, excessive grease, oil leaks, rust, etc.
e. Racks, carts, totes, etc. used to carry product are non-porous, clean and in good repair and cleaning
shall take place in a designated area.
f. Pallets stored outside must be cleaned and inspected prior to use. Soiled or broken pallets that could
cause damage or contamination to product are not used.
g. Product transfer points are located and designed so as not to compromise high risk segregation and
to minimize the risk of cross contamination.

8.5 Calibration

a. The supplier or contract manufacturer shall have a calibration procedure for all instruments used
within the process to verify conformance to specifications, process requirements, and critical control
points (thermometers, scales, water meters, etc.).
b. Measuring and test instruments shall be clearly identified.
c. A standard of reference with its accuracy traceable to a nationally recognized standard, such as
NIST, shall be used for calibrations and recertification must be obtained at least annually.
d. Field calibration is to occur at regularly scheduled intervals determined by a member(s) of the Food
Safety Team and should be sufficient to assure continuing accuracy of calibration.
e. Automated temperature monitoring devices for storage and processing areas shall be calibrated per
manufacturer’s requirements. Calibration shall be documented.
f. Scales for net weights shall be certified at least annually by state or local government weights and
measures officials, or by a state registered or licensed repair person or licensed plant employee.
Annual certificates must be on file.
g. Scales must be calibrated daily by using a certified weight that is comparable in weight to the finished
product net weight. Scale calibrations must be documented. Scales shall be properly balanced and
stable before any weight data can be collected.

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9. MAINTENANCE

A documented preventive maintenance program shall be in place to assure that the building, equipment and
transportation systems do not pose a product contamination or quality risk.

9.1 Preventative and Corrective Maintenance

a. The supplier or contract manufacturer shall ensure that equipment and materials used for production
are suitable for the purpose intended and in good repair. The supplier or contract manufacturer shall
have implemented a written program and documented records for preventative and corrective
maintenance that is up to date and includes:
i. All devices used to monitor and/or control food safety hazards
ii. A list of food handling equipment.
iii. Procedures detailing the maintenance required for each piece of equipment, including
requirements for release back into production and frequency of maintenance.
iv. Measures to ensure that, after maintenance activities (e.g., drilling, cutting, polishing and
welding) have occurred, the equipment and facilities are clean, sanitized, and in good repair
prior to release for production.
v. Appropriate measures to protect products during repair or maintenance activities.
vi. Procedures for isolating maintenance work areas from active production lines.
vii. All maintenance tools and parts shall be reconciled after maintenance work.
b. The maintenance program shall be tailored to the specific products or facilities. Priority shall be given
to maintenance of pieces of equipment that may affect food safety, quality, or employee safety.
Preventive maintenance frequency shall be adjusted in accordance with equipment history and the
outcome of the last intervention.
c. The equipment maintenance program shall detail the inspection required for evaluation of the
condition of screens, filters, magnets, gaskets, and other equipment that must be periodically
replaced, as well as any potential points of metal to metal wear.
d. Routine preventive maintenance for compressed air and air used in product manufacturing or packing
shall be documented. This includes the inspection, cleaning or replacement of items such as air
filters, O-rings, gaskets, pumps, and bearings.
e. Only food-grade lubricants and heat transfer liquids shall be used on food production equipment
where direct or indirect contact between the fluid and food products is possible. Storage should be
separate and grease guns should indicate food grade/non-food grade. Documentation supporting
approvals shall be kept on file.
f. Maintenance tools shall be maintained in a clean and sanitary manner. Maintenance tools are
separated for raw/RTE use and are cleaned and sanitized prior to being used.
g. Equipment repairs are intended to be permanent and must be performed using proper materials.
Temporary fixes that may adversely impact the food safety or quality of a product must be dated,
documented, and replaced in a timely manner by permanent repairs. Temporary fixes must not
adversely impact the food safety or quality of a product.
h. Maintenance workshops shall be controlled to prevent contamination risks to the product. e.g.
provision of swarf (foot) mats where workshops open directly into production areas.
i. Maintenance areas are maintained in a clean and organized manner. Sufficient space is maintained
to permit proper cleaning and inspection for pest activity, or a documented program exists for the
routine movement of items to facilitate cleaning.

9.2 Repairs

a. A notification of repair system shall be in place for repairs of processing equipment during production
and non-production hours, installation of new equipment, and/or other plant construction/modification
activity that has the potential of causing direct contamination of product and/or product contact
surfaces.

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b. Equipment and tools brought into the exposed product production areas as either replacement parts
or used in the repair-construction action, must be visibly clean and free of debris, rust, or other
potential contaminants prior to entering the production area.
c. After completion of equipment repairs, installations and/or plant construction/modification during non-
production hours, maintenance personnel should identify equipment/area by applying a tag, tape or
other suitable method that alerts sanitation personnel to the need to implement additional cleaning
requirements.
d. Sanitation is responsible for adequately cleaning and sanitizing all processing equipment/areas and
ensuring any identified repairs, installations or modifications, have received any additional cleaning
measures required to restore sanitary conditions prior to the start of processing.
e. Repairs performed during processing hours shall include procedures to demonstrate equipment is
cleaned, sanitized, and inspected before use; all extra parts and tools have been accounted for and
that sanitation and FSQA departments have been notified after repairs are completed and prior to
restarting the line.

10. UTILITIES MANAGEMENT

The supplier or contract manufacturer shall have implemented programs to ensure safe provision of utility
services in food production areas. Utility services include environmental air, compressed air, water, steam, and
centralized hydraulic systems. The supplier or contract manufacturer shall control access points for the above
referenced utility services, as well as electricity, heating, and ventilation. Access may be controlled by any means
deemed effective, such as locked facilities accessible only by authorized employees.

10.1 Environmental Air

a. Where microbiologically sensitive materials are exposed and do not receive a subsequent kill step, a
program shall be in place to monitor air quality. The program must include monitoring in production
areas and corrective action shall be taken for out of standard results.
b. The integrity of air filters shall be checked as part of regular preventive maintenance.
c. The supplier or contract manufacturer shall maintain positive airflow from high risk to low risk areas.
d. For high risk areas, air filter specifications and frequency changes shall be documented based on a
risk assessment. The risk assessment should account for the source of the air and the requirements
to maintain positive air pressure relative to surrounding areas.
e. Exterior air intake ports shall be examined periodically for physical integrity.
f. Air for RTE production areas shall not be sourced from an unprocessed product area (raw).
g. Air blown on the surface of microbiologically sensitive materials shall be filtered and sourced from
within the production area and tested on a regular basis.
h. All blowers, fans, vents, grids, etc. are free of dirt and / or grease buildup.
i. Air ventilation through the facility is adequate with no odors or potential for airborne contaminants
which could carry over to product.

10.2 Compressed air

a. Compressed air for general applications, to include ingredient, product contact, non-product contact,
and packaging, shall be dry, oil free and filtered to remove foreign particles.
b. Compressors that provide air for direct or indirect product contact shall be of oil free design. Where
air from existing oil lubricated compressors is used for direct or indirect product contact, the following
requirements apply: only food grade oil shall be used, vapor and odor filters must be installed prior to
use where possible, and filter changes shall be managed by maintenance.

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10.3 Water

a. The potable water supply system (including ice that contacts the product) shall meet all applicable
local, national, and international regulatory requirements.
b. The site shall have effective programs to control water microbiological quality and to verify that water
meets specified requirements. Microbiological and other water testing shall be conducted and data
shall be reviewed by appropriate personnel.
c. All water used in products, on equipment or within the manufacturing processes shall meet specified
quality and microbiological requirements.
d. Microbiological tests shall be performed periodically. Incoming potable water shall be evaluated from
the point or points of use within the facility at least once per year and after maintenance or repair.
Locations shall be randomly selected. When well water is used, programs shall be in place to ensure
water is potable and does not pose a food safety risk. Well water shall be tested bi-annually.
e. The extraneous matter risk in incoming water needs to be controlled using filters (e.g. well water).
f. Filtration systems (e.g., charcoal, reverse osmosis) shall be regularly inspected and maintained.
Water systems must not have cross connections between treated and untreated supplies. Incoming
water lines must be fitted with one way valves or a header tank.
g. The facility shall have back flow devices on the main water valve from the water source and other key
locations (boiler). Annual certifications of back flow devices shall be on file. Equipment shall be
constructed and maintained to prevent back siphonage and/or backflow. Cross connection between
potable and non-potable water lines shall not be present.
h. For surface or well water sources, a visual turbidity assessment shall be carried out at a defined
frequency. Testing shall also be carried out following any event which may adversely affect turbidity,
such as abnormally heavy rain or flooding.

10.4 Steam

a. Where steam is used for product contact applications it must be delivered from a boiler system
treated with approved food grade chemicals.

10.5 Utility Chemicals

a. Solvents, boiler chemicals, cleaning agents and other chemicals not in immediate use must be stored
in secure areas with controlled access.

11. PEST CONTROL

The supplier or contract manufacturer shall have implemented a written pest management program to monitor
and prevent pest activity in the facility and the surrounding areas. The pest control program shall comply with all
state and federal regulatory requirements.

11.1 General Program Requirements:

a. The pest management program shall include elements such as:


i. Inspection procedures and frequencies for plant infrastructure, pests, and all pest devices that
demonstrate control. Pest activity, trends and corrective actions shall also be documented.
Inspection frequency shall be determined by risk assessment.
ii. A dated map showing the location of pest control devices, such as indoor rodent traps, glue
boards, insect light traps, outdoor bait stations, and pheromone traps.
iii. PCO shall be licensed, insured, and certified.
1. PCO license and certifications shall be current.
2. PCO insurance shall be current and $1,000,000 minimum coverage.

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3. Use of pesticide shall only be applied by authorized personnel. Authorized personnel


shall be properly trained.
iv. A current and complete list of pesticides used at the facility shall be maintained. Records of
application of pesticides and usage log.
v. Residual insecticides shall not be applied as a fog or an aerosol.
vi. Pesticide use and application shall be strictly controlled and in accordance with the label.
vii. Rodenticides used must be in block or gel form only; granular, pellet or powdered form shall not
be used. Rodenticides shall only be used on the exterior of the facility.
viii. Chemicals used for pest control must be accurately labeled, inventoried and, when not in use,
securely stored (by locked door/gate) with access granted to authorized and designated
personnel only.
ix. All pesticide labels and Safety Data Sheets (SDS) or equivalent material addressing safety
precautions shall be available at the facility where the pesticide is used.

11.2 Building and Grounds

a. Doors are tight fitting, in good repair, and self-closing type to minimize pest entry.
b. All windows and/or openings to the outside are adequately screened.
c. Dock doors shall have air cushions or some other method to block openings at doors during
unloading or loading.
i. Dock plates shall have brushes to minimize likelihood of pest entrance.
ii. There is a documented cleaning and servicing of all dock leveler pits regularly.
iii. Dock leveler pits are free of trash, spillage, debris and evidence of pest activity.
iv. All bumpers, load levelers, and shelters are in good repair.
d. Exclusion shall be the first line of defense and primary method of controlling pests. Efforts must be
made to keep pests out of the building by using good exterior controls.
i. High grass and weeds around the facility or in adjacent areas must be eliminated where
possible. Landscaping shall not provide opportunity for pest harborage.
ii. Items such as scrap, pallets, pipes, equipment and drums, shall not accumulate on the grounds
or parking lot.
iii. All openings on buildings and roof penetrations must be screened to prevent pest ingress.
e. There should be no evidence of insect, rodent, or bird presence in the plant or warehouse areas.
f. Adequate trash/waste disposal:
i. Dumpsters are properly covered and situated away from buildings. Compactors may be used if
kept clean.
g. Driveways and parking lots are clean and/or treated to minimize dust.
h. Grounds shall be well drained with no standing water to attract pests.
i. Where outdoor storage is necessary, items are protected from contamination and deterioration. Items
stored outdoors must be inspected prior to reentry to the facility.
j. Exterior transfer hoses/pipes must be capped and stored off the ground when not in use.

11.3 Pest Control devices:

a. All pest control devices are located in such a manner as to avoid contamination of product or
supplies.
b. Bait stations shall be of solid construction, tamper resistant, locked, and secured and in their
designated locations.
c. UV units shall be utilized as surveillance devices to monitor flying insect activity. They are not
considered a control method.
i. Light bulbs from the insect light traps must be kept clean and be replaced regularly (minimum
annually) to ensure maximum efficiency.
ii. The insect light traps shall be installed in the receiving or warehouse areas close to entrances,
but shall be located so as not to attract insects into the building.
iii. Insectocutors shall not be located in production areas; they shall be located at least 10 feet
from any product, packaging material or equipment.

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d. UV units are located so as not to contaminate product. UV light/glue board units are located at least
5 feet from any product, packaging material or equipment.
e. Exterior bait stations are locked, secured, and in their designated location.
f. Facility personnel shall conduct confirmation checks on operator activities (i.e. business card in each
catch trap).

12. INTERNAL AUDITS

Written procedures shall be established and maintained for conducting internal audits to verify compliance to
facility GMP, quality system, food safety and regulatory requirements.

12.1 Internal Audit Program

a. The internal audit program shall ensure that each function /area is audited at a defined frequency.
b. All elements of the internal audit shall be reviewed annually.
c. At minimum, a monthly GMP walk through shall be conducted to include the following:
i. Observation of all areas of the facility and team member practices.
ii. Locker rooms and inside lockers.
iii. Maintenance, welfare, auxiliary areas and cafeterias.
d. The audit procedures shall provide for follow-up audit activities to record and verify the
implementation of corrective actions taken.
i. Corrective action
ii. Responsible party
iii. Date of completion
e. The effectiveness of the corrective action shall be verified, and additional actions must be
implemented where necessary.
f. The audit must be completed and closed-out within an established timeframe. Management shall
review audit results, corrective actions and follow-up as part of regular meetings.
g. The audit shall also identify repetitive deficiencies.

13. FOOD SAFETY SYSTEMS

Suppliers and contract manufacturers shall have programs in place to ensure products are manufactured in a
manner to mitigate a risk to food safety.

13.1 Food Safety Plan

a. A food safety plan shall be established and up to date.


b. Program(s) shall be signed and dated by an appropriately trained representative of the facility.

13.2 Food Safety Team

a. A cross functional Food Safety Team shall be established to include the Plant Manager, Food Safety
and Quality Assurance, maintenance, sanitation and production personnel. Other areas of expertise
may be included as needed. Where necessary, the Food Safety Team should enlist the advice of
outside experts or consultants.
b. Team members should be knowledgeable of HACCP / HARPC principles, including the development,
implementation, and evaluation of the Food Safety System (including food safety plan, SSOP, GMP,
Pest Control, Food Defense, Traceability, Other Pre-requisite Programs, etc.).
c. The Food Safety Team should meet on a routine basis. Minutes of each meeting must be kept for
verification purposes.
d. All products supplied or produced for Tyson Foods shall have the following:

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i.Written Hazard Analysis along with a complete flow diagram.


ii.
Verification of the accuracy of the flow diagram shall be completed and documented on a
regular basis.
iii. Critical limits shall be identified, monitored and documented.
iv. Statement of use for each product that is produced.
e. Appropriate verification procedures for critical control points and/or preventive controls shall be
established and documented.
i. Direct Observation
ii. Records Review
f. All deviations from critical limits shall be accompanied by documented corrective action as follows.
i. Identify and eliminate problem.
ii. Bring critical control point under control.
iii. Prevent reoccurrence.
iv. Prevent affected product from entering commerce.
g. A pre-shipment paperwork review of critical control points and/or preventative controls shall be
performed prior to shipping product into commerce. Pre-shipment shall also include any record
necessary to ensure the safety of the product. (e.g. micro testing, pre-requisite programs, SSOP, etc.)
h. A system shall be in place for documenting, tracking, trending, and responding to any regulatory
actions. i.e. Non-compliance Records (NRs), FDA Form 483.
i. The plant shall have a designated individual or a group of individuals who are responsible for
handling and managing regulatory responses.
ii. Findings and corrective actions are adequately documented.
iii. Responses to the agencies are submitted in a timely manner.
iv. The system shall be used to identify reoccurring issues, unfavorable trends, and determine
effectiveness of preventative measures.

13.3 Food Safety Reassessment

a. An annual reassessment of the integrated food safety system including the food safety plan, SSOP,
and associated food safety related pre-requisite programs shall be performed. The reassessment
should include a review of the critical control points; a statistical review of validation data (capability
studies and review of SPC charts); a scientific literature review (to determine if there are any changes
in technique, technology and/or methodology); a complete review of the current regulatory
requirements; a review of the production process (to include flowchart re-verification); and a review of
relevant pre-requisite programs (to include the SSOP). Such changes may include, but are not
limited to, changes in:
i. Raw materials or source of raw materials.
ii. Product formulation.
iii. Slaughter or processing methods or systems.
iv. Production volume.
v. Personnel.
vi. Packaging.
vii. Finished product distribution systems.
viii. The intended use or consumers of the finished product.
ix. New equipment.
x. Outside contracted services.
b. The reassessment shall be performed by an individual trained in accordance with any and all
regulatory requirements.

13.4 Allergen Management

a. The eight major foods responsible for causing allergy are: tree nuts, peanuts, soy, eggs, milk, fish,
wheat and shellfish. However, the allergen control program must consider the top eight allergens, as
well as, any others recognized by the local or regional regulatory authority in the country where the
product is consumed. The supplier or contract manufacturer shall have an effective program to

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evaluate, identify, and control food allergens to ensure that specific allergens are not inadvertently
incorporated as an undeclared component of any product.
i. No allergens shall be added to a label based on the potential of said allergen being
unintentionally added to finished good (e.g. May Contain).
b. An allergen assessment shall be carried out as part of the food safety plan development to identify,
review, and document allergens likely to be present. The allergen assessment shall consider possible
sources of allergens related to the formulation, process, and site-specific practices, including:
i. raw materials/ingredients;
ii. processing aids;
iii. rework addition; and
iv. potential for cross-contact in manufacturing, storage or shipment practices.
c. An assessment shall be conducted whenever the source of a raw/packaging material, formula or
process that impacts material produced for Tyson Foods has changed. Assessments shall include
sensitive ingredients present in the facility such as sulfites, FD&C yellow #5, gluten, MSG, nitrates
and nitrites.
d. Avoiding the introduction of allergens through cross-contact from other lines (no common equipment)
or other production areas shall be strictly managed through raw material handling (e.g., use of color
coded utensils and work tools), rework handling, GMP and employee allergen awareness training.
e. Allergen-containing materials shall be stored in a manner that will prevent cross-contact.
f. Rework product containing allergens as an ingredient shall be used only in products which contain
the same allergen as an ingredient.
g. Efficacy of allergen cleaning of product contact surfaces between line changeovers shall be validated
and verified at least annually.
i. If a changeover occurs, an allergen checklist must exist to include:
1. Verification of ingredient and packaging removal from previous production.
2. Correct ingredients, packaging and label for current production.
3. Evidence of tearing down equipment to the lowest level to ensure a thorough clean up
between allergens
4. FSQA facility approval shall be documented.
h. Allergens present through manufacturing cross-contact or carry-over product that cannot be avoided
through product sequencing and cleaning due to technical limitations (e.g., nature of product, design
of process) shall be properly identified and labeled.
i. Where cross-contact labeling is implemented, all reasonable precautions must still be taken to
minimize the risk of cross-contact.
ii. Cross-contact information shall not be used as a substitute for an effective food allergen control
program.
i. Strict control is necessary in cases where there are different products with similar labels.
j. Ingredients containing allergens shall be identified and segregated in the dry storage areas. This
includes other ingredients/food items that might impart odors or flavors to products stored in the same
location. Allergen-containing ingredients shall be handled properly while batching.
k. Utensils used to mix allergen-containing ingredients shall be colored or otherwise coded to prevent
cross contamination.

13.5 Products bearing label claims

a. When producing products that bear a label claim or a standard of identity applies, the facility should
have documentation to support and meet regulatory and customer requirements. Label claims
include Non-GMO (Genetically Modified Organisms), Kosher, Halal, Organic, Natural, NAE (No
Antibiotics Ever), Gluten Free, etc.
b. Products containing a gluten-free claim will require verification activities including but not limited to:
i. A risk assessment of the manufacturing environment, as well as, incoming ingredients shall be
conducted. Any ingredient determined to be of risk for gluten shall require a COA.
ii. Tyson contract manufacturers shall test finished goods at a minimum of the first 3 production
runs of a new product and annually thereafter as verification of the gluten-free label claim.
1. Finished product samples shall be taken from the beginning, middle and end of the
production run.

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2. Affected product must be retained until satisfactory results are obtained.

13.6 Laboratory Testing Requirements

a. Non-Pathogen Testing
i. AOAC Test methods associated with non-pathogen testing are to be AOAC approved or
another recognized official method (i.e. FSIS, FDA, BAM, Compendium of Methods for the
Microbiological Examination of Foods, ISO, AFNOR). Methods are to be fit for use considering
the matrix and sample size.
ii. The facility shall have methods to prove the accuracy of testing and results to prove proficiency
and competency. Outside proficiency testing is preferred.
iii. All equipment used for testing and measurement such as incubators, thermometers, scales, pH
meters shall be calibrated and verified at a defined frequency at a minimum daily.
iv. If media is used for testing, there shall be methods in place to ensure that every lot of media is
recovered as expected for the target organism.
b. Pathogen Testing
i. Pathogen testing performed for environmental monitoring and/or product testing for RTE
products manufactured for Tyson shall be conducted by an ISO 17025 accredited laboratory for
required test methods as related to Tyson Foods, Inc.
ii. The laboratory must provide evidence of complete segregation from the manufacturing area. All
supplier or contract manufacturer plant laboratories and laboratory personnel shall comply with
Good Laboratory Practice requirements including, but not limited to, the following:
1. The laboratory accommodations and environment shall be fully segregated from the
manufacturing site and have operating procedures to prevent any risk of product
contamination.
2. The laboratory must have a separate air handling/supply unit from the production facility.
3. The laboratory drainage shall go to a sanitary sewer system and shall be segregated from
the production area.
4. Access to the laboratory must be limited to authorized personnel.
5. Janitorial staff and cleaning equipment used in the laboratory area is segregated from the
production facility.
6. The laboratory shall have adequate workspace to perform tests.
7. Environmental monitoring of the laboratory is performed to ensure cross contamination
does not occur.
8. Laboratory personnel are to be qualified with a degree in related science fields. Laboratory
personnel are to have record of qualifications which include education, training, and
competency.
9. Laboratory personnel shall participate in a third-party Proficiency Program (i.e. AOAC, API,
LGC, NSI). Participation shall occur at least once per year per pathogen methodology
performed.
10. Policies for laboratory safety, security, and hazardous materials must be in place.
11. A written program shall be in place regarding equipment and instruments used in testing.
12. A written policy shall outline control of sample integrity. The policy is to include sample
condition, handling and traceability.
13. The personnel reporting structure of the laboratory shall ensure that results are impartial
and free from bias. Included in reporting procedures is communication requirements to the
Tyson Business Contact in the event of an unexpected pathogen result affecting Tyson
production as it relates to food safety.
14. Acceptability criteria shall be in place for laboratory grade water, media and supplements
used in testing, and sterilization processes.
15. Test methods associated with pathogen testing are to be AOAC approved or another
recognized official method (i.e. FSIS, FDA, BAM, Compendium of Methods for the
Microbiological Examination of Foods, ISO, AFNOR). Methods are to be fit for use
considering the matrix and sample size. Pathogen laboratory testing that cannot be
performed by the in-house laboratory must be sent to an ISO 17025 Certified laboratory for
analysis.

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14. FOREIGN MATERIAL CONTROL

The supplier or contract manufacturer shall have a system in place to prevent foreign material from contaminating
product throughout the process.

14.1 Foreign Material Prevention Program:

a. A foreign material (FM) prevention program shall be established to include metal, glass, hard plastic,
gloves, belting, gaskets, etc. Foreign material inspections shall be documented and reviewed daily.
b. Small hand tools must be identified and assigned to plant personnel in a manner that allows for
reconciliation at least daily. Documentation must be in place to support this program.
c. A documented metal detection program for testing and calibrating metal detectors shall be in place.
Facilities producing both raw and ready to eat products shall maintain separate sets of known
standards for validation of the metal detection program. Installation of metal detection equipment shall
be at the furthest point downstream in the processing line to assure proper evaluation of the finished
product. The program shall include how to handle suspect/rejected products. Facilities with
mechanical rejection systems shall ensure rejected material is controlled via lockbox or other means.
Facilities utilizing belt stop mechanisms shall ensure product is secured and restart capabilities are
locked and access controlled.
i. Sensitivities must be established to deliver the best available detection limits based on the
process type, product dimension/type, product flow, intended product usage, customer
expectations, etc.
ii. Defined frequencies must be established to include testing at the beginning, following
maintenance activities and end of each shift.
iii. Failure of the system to properly identify and reject the standard is considered a test failure.
iv. Facility shall have audible and/or visual measures to notify personnel when there is rejected
product.
d. Where magnets are used, there shall be established frequencies at which magnets are inspected for
the presence of metal and regularly calibrated for pull strength. All metal collected on the magnets
shall be analyzed and recorded in a magnet log. All contaminants shall be evaluated and a risk
assessment shall be conducted to determine the proper disposition of all in-process and finished
product.
e. Tailings from sieves and sifters shall be checked on a regular basis according to the foreign material
control program (e.g., each shift, after each unloading, etc.). All foreign material found in tailings shall
be analyzed and logged. If the contaminants indicate a volatile condition, the product shall be placed
on hold and a thorough investigation is conducted. The screens on the sifter shall be checked for
damage and shall be confirmed as intact at an established frequency. The entire sifter shall be
dismantled and inspected routinely.
f. FM contaminant logs must be reviewed on a regular basis by the plant Food Safety Team. This
review must ensure that effective corrective and preventive measures are implemented and
documented for all FM incidences including complaints and all FM documentation is evaluated for
trends.
g. X-Ray and optical equipment shall be checked in accordance with the manufacturer’s instructions or
recommendations. Frequencies for testing shall be defined.
h. If the line does not have downstream detection equipment (e.g. metal detector, magnets, screen), a
more frequent detailed evaluation of wear and condition of product contact equipment (e.g. scraper
blades, conveyer belts, rotator barrels, pasteurizer plates, grinder plates, valves, pumps, and
gaskets) is necessary for detection of potential contamination.

14.2 Glass and Brittle Plastic

a. There shall be a written policy/program describing control of glass and brittle plastic at the facility.
Glass other than lighting must not be used in, above, or near processing or storage areas. All lighting
in the processing areas must be protected with shatterproof material. Warehouse lighting may be
unshielded if safety coated or covered with a plastic sheath.

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b. Facilities packaging finished products in glass containers shall maintain records of all container
breakages on the line. Where no breakages have occurred during a production period, this shall also
be recorded. Glass container breakages on the line shall be documented.
c. The storage of glass containers shall be segregated from the storage of raw materials, product or
other packaging.
d. Computer or video monitors may be used in the processing area if covered with an appropriate
laminate to prevent shattering.
e. Windows in production, warehousing and storage must be shatter resistant or covered with an
appropriate laminate to prevent shattering.
f. Gauges and lights on lifts must be shielded and accounted for in the brittle plastic and glass program.
g. Documented procedures for handling any glass, hard plastic, ceramics and similar materials are
outlined to ensure the necessary precautions are taken, which shall include the following as a
minimum:
i. List of items detailing location, number, type and condition
ii. Recorded inspection of the items identified is conducted at a specified frequency based on risk
assessment.
iii. Details related to cleaning or replacing items to minimize potential for product contamination
h. If glass, hard plastic, ceramics or similar material is shattered and/or pieces are missing within a
product zone, the Food Safety Team shall investigate cause and determine likelihood of exposure to
product. Documented procedures detailing the action to be taken must include the following:
i. Quarantine the affected product and production area.
ii. Clean the production area.
iii. Inspect the production area and authorize the restart of production.
iv. Where necessary, change work-wear and inspect footwear.
v. Document the incident.
vi. Specify management staff authorized to carry out the above points.
vii. Should contamination of product occur, procedures need to outline retention requirements, i.e. -
Retain to last acceptable check or justification for retention of less than back to the last
acceptable check.

15. SUPPLIER APPROVAL PROGRAM

The supplier or contract manufacturer shall have a written supplier approval program for all ingredients and
packaging materials. Materials shall only be received from suppliers who are approved through a developed and
implemented supplier approval program. The supplier approval program shall be designed in such a way to
understand the food safety and quality risks of their suppliers. The supplier approval program should include a
risk assessment for all suppliers and ingredients. In cases where materials are being procured through brokers,
distributors and/or purchasing agents, the supplier or contract manufacturer shall ensure that these manufacturing
locations are part of the approved supplier program. The supplier or contract manufacturer shall also ensure that
their suppliers providing ingredients used in products shipped to Tyson Foods have programs in place to meet the
requirements of this manual.

15.1 Supplier Management

a. The supplier or contract manufacturer shall have a process to review high risk materials. A risk
assessment should consider usage (post lethality), origin and pathogens of concern. The supplier
approval program shall require the following:
i. Global Food Safety Initiative (GFSI) certification and corrective actions by manufacturing
location.
ii. Continuing Letter of Guaranty (LOG) and Indemnification letter.
iii. Current specifications shall be on file.
iv. Certificate of Analysis (COAs) and Certificate of Conformity (COCs) when applicable.
1. If a COA for pathogen testing is required, the pathogen testing shall be performed by an
accredited (e.g. ISO/IEC 172025 accreditation) microbiology laboratory.
v. List of 24/7 emergency contacts for all suppliers.

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vi. An emergency plan for accepting goods from a non-approved supplier.


vii. The supplier / contract manufacturer shall monitor suppliers of purchased goods and provide
feedback with respect to their performance and compliance to the quality requirements and
specifications.
viii. Raw agricultural materials and ingredients from animal origin must be evaluated to ensure
compliance with chemical contaminant (e.g., pesticides residues, mycotoxins) and applicable
GMO regulations of the Tyson Foods receiving country as per Tyson Foods specifications.
Such review may be conducted through analysis of the material or through controlled oversight
of the grower, producer and other persons handling the product.
ix. All packaging materials must meet FDA and any other applicable regulations.
x. Documentation shall be collected from suppliers for food safety hazards that have been
identified within the food safety plan as controlled by the facility’s suppliers.

15.2 Food Fraud

a. The supplier or contract manufacturer shall have systems in place to minimize the risk of purchasing
fraudulent or adulterated food raw materials and to ensure that all product descriptions and claims are
legal, accurate and verified.
b. A food fraud vulnerability assessment shall be documented for all food raw materials or groups of raw
materials to assess the potential risk of adulteration or substitution. This assessment must be
reviewed at least annually.
c. Where raw materials are identified as being at particular risk of adulteration or substitution,
appropriate assurance and/or testing processes shall be in place to reduce the risk.
d. A food fraud mitigation plan must be in place to specify how the identified food fraud vulnerabilities
will be controlled. This plan shall be reviewed annually.

16. TRACEABILITY & RECALL PROCEDURES

The supplier or contract manufacturer shall have a written program for product traceability throughout the entire
supply chain. Traceability requirements apply to all products and all components used to produce products,
including ingredients, in-process products, rework, primary packaging materials, and processing aids (substances
used within the process but not required to be declared as an ingredient).

16.1 General Requirements

a. For ingredients that may not have a specific lot number, a method for unique identification and
tracking shall be developed and implemented. Bulk ingredients shall have a documented timeframe of
known use. Ideally, each material delivered to Tyson should contain only one batch/lot number.
b. All materials used from the beginning to the end of the process should have associated records in
place to confirm the following.
i. Product name & item number.
ii. Code dates or lot numbers.
iii. Quantity used.
iv. Quantity still on hand.
v. Date of receipt.
vi. Date used.
vii. Date shipped.
c. A traceability system needs to be established at all stages of production, processing and distribution.
The system shall identify who supplied the raw materials and which customers received the finished
product.
d. The system must ensure that products supplied to customers are adequately labeled or identified to
facilitate traceability.
e. Traceability details need to be retained in a format that allows access in a timely manner. Tyson
Foods expects full traceability one up, one down and throughout the production process.

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f. Strict controls on material identification, traceability and segregation are also required to preserve the
integrity of any claims made, such as organic status. Where logos are used that make specific claims
about production systems (e.g., farm assurance), full traceability must be demonstrated.
g. Where rework is used, a program must be established to ensure there is no allergen cross-
contamination, rework is traceable, and rework is prevented from being carried over into multiple lots.
A facility specific program that outlines the procedures and timeframe for breaking the chain of rework
shall be established and implemented. Product shall be properly stored and labeled as rework.
i. For suppliers, there shall be a risk assessment to determine acceptable frequency for
continuous rework.
ii. For all Tyson contract manufacturers, the time frame for breaking the chain shall not exceed 30
calendar days.
h. Cleaning procedures of bulk storage vessels shall be established and validated.

16.2 Recall Program / Traceability Exercise

a. A detailed formal recall program shall be established.


i. The program shall include a recall team and define each of team member’s responsibilities.
ii. Records shall include, damaged, condemned, reworked, relabeled, and/or donated products.
b. Mock recalls shall be conducted at a minimum of annually and traceability exercises twice per year.
The mock recall program shall ensure the ability to track all WIP product, finished product, ingredients
and/or food contact packaging forward to the first external customer.
i. The mock recalls should be conducted by a cross-functional team.
ii. The mock recall report shall contain a brief description of the recall scenario (product,
ingredients or packaging), associated support documentation, significant tracking failures
exposed as a result of the test and all associated corrective actions.
iii. Mock recalls shall demonstrate the management team’s ability to track all products within two
hours from commencement of the activity.
iv. Traceability exercises should be periodically evaluated during non-routine business hours.
v. Program shall have defined metrics to determine what is considered a successful recovery.
1. Tyson requires a 99.5% - 105% recovery within 2 hours to be successful.

17. PRODUCT QUALITY

The supplier or contract manufacturer shall ensure that all product manufactured for or shipped to Tyson Foods
meets or exceeds product specification.

17.1 Specifications

a. The contract manufacturer shall not produce products for Tyson without first obtaining appropriate
Tyson product specifications and product label approvals.
b. The contract manufacturer shall have on file the most up-to-date Tyson specifications and these shall
be accessible to all relevant personnel.
c. A written policy is in place to submit a specification deviation request, a specification change request,
or exception for attributes that are not compliant to the specification.
d. A written policy is in place which demonstrates the responsibility, confidentiality, and requirements for
maintaining the most recent specifications.
e. The contract manufacturer must comply with all raw / ingredient / packaging material, process, and
finished product parameters identified in specifications.

17.2 Process Control

a. There shall be a written program to maintain process control within manufacturing. This program shall
include the following:
i. Method, frequency, sampling size, and facility FSQA verification.

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ii. Sample selection must include a representative sample of process flow and product produced
at the time of sampling.
iii. Specific actions to be taken when process is out of control.

17.3 Ingredient, Packaging and Label Verification

a. The supplier or contract manufacturer verifies at receiving that all incoming ingredients, product
labels, and pre-printed packaging materials match the current product specifications. Any incorrect
materials must be placed on hold until an investigation is completed and a disposition is determined.
b. For every lot included in the load, verification of labels and pre-printed packaging shall include:
i. Material number
ii. Product description, product code
iii. Manufacturer’s address
iv. USDA mark of inspection (inspection seal) when applicable
v. Handling instructions (keep frozen, etc.)
vi. Safe handling instructions (when applicable)
vii. Ingredient statement
viii. Net weight declaration
ix. Nutritional facts
x. Any claims (e.g., country of origin, all natural, less sodium, less fat, etc.)
c. Verification of ingredients shall include the following for every lot in the load:
i. Manufacturer item number and where applicable Tyson material number
ii. Ingredient statement (against ingredient statement for that ingredient in the product
specification)
iii. Approved manufacturer
iv. The importer of record, shall ensure all regulatory documents are received and, where
necessary, accompany each shipment.
d. Verification of primary packaging shall include the following:
i. Name of Manufacturer or Processor
ii. Manufacturer’s address
iii. Description of packaging
iv. Lot number
e. In order to prevent mis-labeling of products, a label verification program shall be in place. Label
samples from all finished products shall be obtained and compared to the current product
specifications and/or label approvals to ensure the accuracy of the labels.
f. Labels shall be checked at the start of each product run, after each break and at the end of the shift.
When film or a roll of labels is used, labels shall be checked at every roll change.
g. The label version (i.e. LL#, MM#, or PM#) must be verified at a minimum of hourly. A frequency other
than hourly must be supported by a documented risk assessment.
h. An ingredient verification program shall be established to prevent mis-labeling of product during
production.
i. Label samples from all ingredients to the line are obtained and compared to the current product
specifications to insure the accuracy of the ingredient statements.
ii. Documents should demonstrate that ingredient inspections are conducted at the start-up of
each production run or a change in lot numbers. More frequent ingredient checks may be
necessary if ingredients are quickly depleted during production.
i. The supplier or contract manufacturer shall have secure label storage for pre-printed packaging
materials and labels with restricted access. Obsolete labels and pre-printed packaging shall be
disposed of and destruction records shall be on file.
j. Packaging changeover procedure includes line clearance practices addressing the removal of
packaging from the previous production run. Changeover/Line clearance activities shall be verified by
a supervisor with documentation to support the activity. Obsolete packaging is isolated to prevent
accidental introduction into the production process.

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17.4 Net Weight

a. Supplier and contract manufacturer shall have documented procedures and requirements for weight
and volume control of the finished product. These procedures and requirements shall adhere to
federal, state, and local net weight requirements.
b. There shall be a written Net Weight Program in place to ensure product meets stated label weight.
c. Certified scales shall be used for all net weight programs.
d. Tare weights for all finished products shall be verified and documented on a daily basis. The tare
includes all packaging material that is part of the product at the point of weighing.
e. All product case weights shall be checked hourly for conformance to product specifications. Case
weights shall be documented.
f. When the lot average weight fails to meet the stated net weight, all packages produced must be
placed on HOLD for rework.
g. Checkweighers that weigh complete packages must account for the package tare weight. The
checkweighers or fill level detectors shall be set high enough to account for fluctuations in the
package tare weights or bottle volume variations.
h. The average net weight of each production lot shall meet or exceed the declared label weight.

17.5 Code Date Requirements for all contract manufacturers

a. Code date policies vary depending on business category. Tyson code date requirements will be
communicated by your Tyson FSQA representative.

17.6 Thawing of Food

a. Thawing of food shall be undertaken in equipment and rooms designed for this purpose. Proper
procedures shall be documented and followed while thawing products.
b. A risk assessment or validation document shall be completed to prove that the thawing methods do
not pose a threat to food safety.
c. Air thawing facilities shall be designed to thaw food under controlled conditions at a rate and
temperature that does not contribute to product deterioration or contamination.
d. Proper disposal of packaging and waste from thawed product shall be taken so that there is no risk to
the product.

18. FOOD DEFENSE, CRISIS MANAGEMENT

Suppliers and contract manufacturers of Tyson Foods who manufacture, process, pack, or in any way handle
purchased materials will develop a program to address food defense and have policies in place to handle
emergency incidents, such as fire, natural disasters, malicious contaminations, etc. The food defense program
shall include procedures to prevent intentional contamination, and will have protocols in place to quickly and
accurately identify, respond to and contain threats or acts of intentional contamination.

18.1 Food Defense

a. The laws and government expectations regarding food defense vary from country to country. Tyson
Foods has defined a set of food defense standards to meet legal and consumer expectations.
Although these standards may exceed the requirements of a specific country or area, all Tyson Foods
suppliers and contract manufacturers are expected to develop food defense programs at each
manufacturing location which meet set standards outlined below:
i. A documented plan that explains the site’s Food Defense procedures and strategies.
ii. Clearly-defined roles and responsibilities for maintaining the program.
iii. Protocols for handling threats and acts of intentional contamination.
iv. Procedures for reporting threats or acts of intentional contamination to Tyson Foods.
v. Annual vulnerability self-assessments and procedures for correcting any identified gaps.

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vi. Security counter-measures designed to prevent product tampering.


vii. Monitoring procedures for implemented counter-measures.
viii. Conformance to the FDA & FSIS Food Security Guidance for Industry.
ix. A completed risk assessment shall be on file which includes the facility, ingredients, water
supply, packaging, and equipment.
x. Contract manufacturers shipping ‘school lunch’ or other products under government contracts
have conducted a USDA-AMS Food Defense audit.
1. Management shall arrange an AMS Food Defense audit prior to handling school lunch or
other government contracted products.
2. Audit results and corrective actions shall be documented and available for review.
xi. The facility’s boundaries and grounds shall be secured or monitored to prevent entry by
unauthorized persons (e.g. security fence, video, or security service).
xii. Exterior doors shall be locked when not in use.
xiii. Entry into the facility shall be monitored to prevent unauthorized entry.
xiv. ‘No Trespassing’ signs shall be posted where appropriate.
xv. All doors, windows, roof openings, vents, trailers, railcars, and bulk storage are to remain
secured.
xvi. Procedures shall be in place for controlling the access of visitors, contractors, vendors, truck
drivers and other non-facility people to the facility, product areas, and other restricted areas.
1. Positive identification (e.g., picture IDs or sign-in/sign-out at entrance).
2. Visitors shall be required to read and sign acknowledgement of GMP, Safety, and
Confidentiality statements.
3. Procedures shall be in place restricting visitors, guests, unless accompanied by an
authorized facility team member.
xvii. The inventory of restricted ingredients (e.g. nitrites) shall be reconciled against actual use of
such ingredients on a daily basis.
xviii. Access to water and ice sources, including wells, shall be restricted and maintained by lock,
door, gate, or by limiting access to designated employees.
xix. Access to external storage facilities shall be restricted to designated employees only.
xx. Procedures shall be in place to secure access to ingredients, packaging, and equipment based
on risk assessment.
xxi. The supplier / contract manufacturer shall take deliberate steps, and implement procedures, to
monitor and verify the integrity of incoming and outgoing shipments.
xxii. FDA Bioterrorism Registration is completed every 2 years.

18.2 Crisis Management

a. The supplier or contract manufacturer shall have documented procedures to manage emergency
incidents (e.g. fire, natural disasters, malicious contaminations, etc.). Incident management
procedures shall include the following:
i. An incident management team with clearly defined responsibilities.
ii. A list of internal and external emergency contacts and telephone numbers.
iii. A communication plan to include customers, consumers, and regulatory authorities.
iv. Corrective actions to be implemented when an incident occurs
v. A business continuity plan.

19. READY TO EAT (RTE)

Special attention must be taken when manufacturing, handling and storing RTE products. The supplier or
contract manufacturer shall develop a risk assessment to identify the hazards and risks associated with products
considered to be RTE.

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19.1 Temperature Verification

a. The fully cooked temperature verification standards shall meet specification and regulatory
requirements.
b. Statistical process control (SPC) should be used to establish process targets on
all cook systems to meet regulatory requirements.
c. If there are other control points which affect safety of RTE foods (e.g., pH, aw), SPC should be utilized
to monitor the variables.

19.2 Batch Oven

a. All batch houses shall be mapped and balanced at a defined frequency in order to determine the
coolest product in the process.
b. Cook cycle parameters are established for wet bulb / dry bulb temperatures, steam, air flow and time.
c. Recommended protocol for batch oven calibration (oven mapping):
i. Develop a diagram of various tree or rack configurations to be utilized for cooking.
ii. Assign a number location to each tree or rack. Locations shall be minimally assigned to top
and bottom of each tree or rack and from side to side.
iii. Consider variations for full or partial oven utilization. Separate studies may be required for
partial oven utilization.
iv. Utilize temperature recording equipment (e.g., data trace or similar).
v. Randomly place temperature probes inside products throughout the oven to determine the
variance within the oven.
vi. For initial validation, conduct “Oven Mapping” at a minimum of 5 times with 3 to 6 temperatures
taken for each time.
vii. If 9 or more probes are available, place all of them evenly in the oven at once. The number of
replications may be reduced when using 9 or more probes at once.
viii. From the initial validation data, calculate the standard deviation for the oven.
ix. Set the target temperature for the coldest spots (based on mapping) to meet regulatory
requirements.
x. If targeting the coldest spot is not feasible, then target the process based on where it is capable
of taking the temperatures.

19.3 Continuous Cook

a. Validation studies shall be completed for continuous fryer, water, and/or oven cook process.
b. Annual Validation studies shall be conducted for each type of product for each line to define
target temperature and limits.
c. Cooking equipment parameters shall be established for oil, water, or oven temperatures, steam, air
flow, and dwell time.
d. RTE product temperatures shall be monitored at a frequency determined by appropriate validation.
i. Sample pieces chosen are representative of the actual product on the belt. Any large pieces,
fold-overs, or product overlaps must be included.
ii. Sample pieces are selected across the width of the belt or process equipment, to represent
various areas within the cooking process and size variation.
iii. A risk assessment should be conducted.
e. An SPC chart (X bar & R Chart) is established and in use for monitoring of RTE product
temperatures.

19.4 Stabilization/Cooling

a. Cooling of heat-treated meat & poultry products must be in accordance with FSIS Appendix B
Compliance Guidelines for Cooling Heat-Treated Meat and Poultry Products (Stabilization) or
alternative stabilization such as aw or pH for preventing growth of spore forming bacteria. If more than
one thermal step is involved in producing the finished product, stabilization must be evaluated
cumulatively for both steps.

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b. Cooling of heat-treated FDA regulated products must have an adequate time and temperature cooling
control program in place or alternative stabilization such as drying (aw) and fermentation/acidification
(pH). The facility must have scientific or technical support (such as scientific or technical data, peer-
reviewed journal articles, pathogen modeling programs) for demonstrating that the process control
measures can adequately prevent or limit the growth of spore-forming bacteria capable of producing
toxins. Additionally, the facility must have in-plant validation data demonstrating that the control
measures can perform as intended within the plant.

19.5 RTE Meats

a. A documented product evaluation program shall be established for all Ready-to-Eat products.
i. Product exhibiting characteristics of raw or undercooked meat shall be considered a failure of
the plant HACCP plan’s lethality CCP and requires corrective actions.
b. RTE Poultry Products
i. The following criteria shall be used for visual inspection of boneless, formed, and bone-in
products. Inspections shall take place at the exit of oven/cook process and after being frozen.
All criteria shall be documented.
1. The meat texture shall come apart in strands and be easily separated. There shall be no
fleshy meat texture.
2. There shall not be any red color in juices, meat, and veins.
3. Bone marrow shall be coagulated.
c. RTE Deli & Prepared Foods Products
i. The number of products to be evaluated on a routine basis is established to ensure that all
products are routinely evaluated.
ii. Evaluation includes product appearance, product defects, chemical compliance to
specifications, organoleptic characteristics, etc.

19.6 Post Lethality Controls

a. The alternative classification that is used to control Listeria monocytogenes in post-lethality exposed
RTE products shall be identified.
b. Post lethality treatment / antimicrobial agent or process shall be identified if using Alternative 1 or 2.
i. Validation documents support that the treatment achieves > 2.0 log reduction of L.
monocytogenes.
ii. Treatment parameters (temperature, time, pressure, humidity, etc.) used at the facility shall be
identical to those used in the validation studies.
c. Antimicrobial agent or process
i. Validation documents support that the agent or process suppresses growth of
L. monocytogenes such that there is < 1.0 increase during the shelf-life of product.
ii. Agent or process application parameters (compounds, concentration, temperature, time, pH,
aw, etc.) used at the facility must be identical to those used in the validation studies.
d. For post-lethality exposed RTE products, there shall be a comprehensive and ongoing written
pathogen monitoring program in place that meets or exceeds the Tyson Contract Manufacturer and
Supplier Microbiological Testing Procedure.

19.7 Environmental Monitoring and Finished Product Testing Requirements

a. Tyson procedure and requirements will be communicated by your Tyson FSQA representative.

20. ANIMAL WELFARE

The supplier or contract manufacturer shall be committed to the well-being, proper handling and humane
slaughter of all the animals used to produce meat and poultry. The management team shall ensure that all
individuals involved in animal welfare comply with all regulatory requirements.

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20.1 Slaughter Facilities

a. Slaughter facilities shall have a documented Animal Welfare program in place which defines:
i. Proper animal handling practices.am members working with live animals.
ii. Internal Animal Welfare audits are conducted by properly trained individuals.
iii. Requirement for annual 3rd party Animal Welfare audit and results with corrective actions
shared with Tyson Foods, Inc.

21. REVISION HISTORY

1/1/2017 New
9/18/17 Added “food safety” to section 4.4ci
Systematic product quality or food safety defect or process control deviation which could
lead to a recall or withdrawal of a Tyson Foods finished product or ingredient sourced to
Tyson Foods
Changed defined frequency to daily in 4.2g
Product on hold for food safety issues shall be reconciled against the hold log daily to
ensure product does not enter into commerce.

Added viii to section 4.7a


All records shall be readily available.

Added “verified” to 5.1mvii


Certificates of Analysis, if provided, shall be verified and retained by the FSQA
department.
Added iv to section 14.1c
Facility shall have audible and/or visual measures to notify personnel when there is
rejected product.
Added v to section 16.2b
Program shall have defined metrics to determine what is considered a successful recovery.
1. Tyson requires a 99.5% - 105% recovery within 2 hours to be successful.

7/27/18 Added Food Safety Culture Section 4.1 as part of General Requirements section
5/14/19 Additions/Updates made to the following sections: Requirements:4.7g, 4.10b, 5.2f, 6.1aii,
6.5c, 6.8b, 7.1i, 7.1j, 8.1cviii, 8.2j, 8.2k, 10.1d, 13.2div, 13.3ax,14.1g, 14.2b, 42.c.
13.6- Laboratory Testing Requirements has been updated to reflect requirements for both
pathogen and non-pathogen testing.
Created sections 15.2- Food Fraud & 17.6- Thawing of Food.
12/28/2020 Statement regarding FoodLogiQ requirements was added to Section 4. General
Requirements. Additions/Updates made to the following sections: 4.3c, 4.3g, 4.5c ii, 4.5c xi,
4.7a iv., 4.11a, 5.1f, 5.1k, 5.2d, 5.2e, 6.1a viii, 6.7f, 6.9f, 7.1h, 8.1e iii, 8.1e iv, 8.2c, 8.2f,
8.2i, 9.1a, 9.1a vii, 9.1d, 9.1g, 9.1i, 13.4g, 13.4g i3, 14.1h, 15.1a x, 16.2b, 19.1b, 19.1c.
19.4.

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