FSC 36 SAFE FEED SAFE FOOD ON-SITE AUDIT CHECKLIST

The checklist for FSC36 Safe Feed/Safe Food (Version 7.0) is shown below. The checklist includes the Element (Clause) number
and name, the description of the element, and an area to provide supporting compliance information. For "Implementation Guidance", please see the FSC36 Safe Feed/Safe Food Guidance Document (Version 7.0).

Updated: August 2018

CLAUSE ITEM SUPPORTING COMPLIANCE INFORMATION

People Present at the Opening Meeting (Please list names and roles in the following format: Name - Role (separated by a semicolon).
Opening Meeting

People Present at the Closing Meeting (Please list names and roles in the following format: Name - Role (separated by a semicolon).
Closing Meeting

Auditor description of the facility (Please provide facility description, including the number of employees, size, production schedule, general layout, and
Facility Description
any additional pertinent details).

Auditor Recommendations Auditor recommendations.

1.1 Management Policy (M) 1) Senior management shall prepare and implement a quality and food safety policy. The statement should consider the following items:
a) The organization’s commitment to provide quality and safe feed.
b) The methods used to comply with its customer and regulatory requirements.
c) The organization’s commitment to continuous improvement of its quality and food safety system.
d) The organization's commitment to establish and review animal food safety objectives.

2) The policy statement shall be signed by senior management and made available in a language understood by all staff. The policy statement should be
displayed in a prominent position and effectively communicated to all staff.

1.2 Management Responsibility 1) The supplier shall provide an organizational reporting structure, which includes personnel with responsibilities for quality and food safety.
(M)
2) Senior management shall ensure adequate resources are available to achieve the desired animal food safety objectives and support the development,
implementation, maintenance and ongoing improvement of the quality and food safety system.

1.3 Responsibility, Authority and 1) Senior management shall designate a quality and food safety leader (Q&FS Leader) for manufacturing location or site implementing the requirements
Communication (M) for FSC36 certification. The Q&FS Leader shall be a Preventive Controls Qualified Individual (PCQI).

2) The Q&FS Leader will be responsible for the development, implementation, review and maintenance of the quality and food safety system.

3) The Q&FS Leader shall be employed by the supplier as a company employee on a full-time basis and understand the FSC36 requirements relevant to
the supplier’s scope for FSC36 certification.

4) Personnel shall be informed of their responsibility for quality and food safety.

5) Personnel shall be informed of their responsibility to report animal food safety problems to personnel with authority to initiate action.

1.4.1 Management Review 1) Senior management shall be responsible for reviewing the quality and food safety system.
Process
2) Any changes to the food safety plan shall be reviewed during management review meetings.

3) The management shall establish processes for continuous improvement of the quality and food safety program.

4) A documented procedure shall be maintained that describes management review.

1.4.2 Management Reviews 1) Senior management review of inputs shall include information about the quality management system effectiveness. This may include (but not limited
Inputs and Outputs to) the following:

a) Customer complaints or customer satisfaction

b) Failures in the quality and food safety program

c) Nonconformities identified from audits (internal and external) completed since last meeting

d) Corrective actions taken for continuous improvement

e) Changes within processes or at the location that may impact product quality and food safety

f) Changes to the animal food safety program

g) Regulatory changes that may impact the quality and food safety program

h) Industry news or activities relevant to the quality and food safety program

2) Senior management is required to assess the effectiveness of the quality management system. This shall include (but not limited to) the following:

a) Recommendations to improve customer service or satisfaction

b) Continuous improvement to the quality and food safety system

c) Resources to implement an effective quality and food safety program and desired outcomes

d) Review and modification to the quality policy as necessary

1.4.3 Management Review 1) Records of management reviews shall be maintained.

2.1 General Requirements - 1) The supplier shall establish, document, implement and maintain a quality and food safety system and continually improve its effectiveness.
Quality & Feed Safety
Management System 2) The supplier shall establish and maintain a quality and food safety manual that includes:

a) The scope of the quality and food safety system, including exclusions from the FSC36 Safe Feed/Safe Food Certification Program.

b) Documented procedures that have been established for the quality and food safety system.

3) The supplier shall determine the processes needed for the quality and food safety system and their application throughout the organization.

4) Polices that impact the quality and food safety system shall be documented within the manual and maintained in either electronic and/or hard copy
form.

5) The manual shall be readily available to personnel.

2.2 Document Control (M) 1) The methods and responsibility for maintaining document control shall be maintained.

2) The supplier shall ensure personnel has access to current documents that impact their ability to complete their work.

3) Proper training for document control shall be completed to ensure records are accurate, indelible, and legible.

2.3 Records (M) 1) Records obtained by FDA in accordance with the record requirements for FSMA are subject to the disclosure requirements by FDA.

2) All records required by FSMA must be made promptly available to a duly authorized representative of the Secretary of Health and Human Services for
official review and copying upon oral or written request.

3) Records for FSMA compliance must:

a) Be kept as original records, true copies (such as photocopies, pictures, scanned copies, microfilm, microfiche, or other accurate reproductions of the
original records), or electronic records;

b) Contain the actual values and observations obtained during monitoring and as appropriate, during verification activities;

c) Be accurate, indelible, and legible;

d) Be created concurrently with performance of the activity documented; and

e) Be as detailed as necessary to provide history of work performed.

4) All records must include:

a) Information adequate to identify the plant or facility (e.g., the name, and when necessary, the location of the plant or facility);

b) The date and, when appropriate, the time of the activity documented;

c) The signature or initials of the person performing the activity; and

d) Where appropriate, the identity of the product and the lot code, if any.

5) Records that are established or maintained to satisfy the requirements of FSMA may be maintained in an electronic format.

6) All records required by FSMA must be retained at the plant or facility for at least 2 years after the date they were prepared.

7) Records that relate to the general adequacy of the equipment or processes being used by a facility, including the results of scientific studies and
evaluations, must be retained by the facility for at least 2 years after their use is discontinued (e.g., because the facility has updated the written food
safety plan (FSMA 507.31) or records that document validation of the written food safety plan (FSMA 507.45(b))).
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8) Except for the food safety plan, offsite storage of records is permitted if such records can be retrieved and provided onsite within 24 hours of request
for official review. The food safety plan must remain onsite. Electronic records are considered to be onsite if they are accessible from an onsite location.

9) If the plant or facility is closed for a prolonged period, the food safety plan may be transferred to some other reasonably accessible location but must
be returned to the plant or facility within 24 hours for official review upon request.
 4) All records must include:

a) Information adequate to identify the plant or facility (e.g., the name, and when necessary, the location of the plant or facility);

b) The date and, when appropriate, the time of the activity documented;

c) The signature or initials of the person performing the activity; and

d) Where appropriate, the identity of the product and the lot code, if any.

5) Records that are established or maintained to satisfy the requirements of FSMA may be maintained in an electronic format.

6) All records required by FSMA must be retained at the plant or facility for at least 2 years after the date they were prepared.

CLAUSE 7) Records that relate to the general adequacy of the equipment or processes ITEMbeing used by a facility, including the results of scientific studies and SUPPORTING COMPLIANCE INFORMATION
evaluations, must be retained by the facility for at least 2 years after their use is discontinued (e.g., because the facility has updated the written food
safety plan (FSMA 507.31) or records that document validation of the written food safety plan (FSMA 507.45(b))).

8) Except for the food safety plan, offsite storage of records is permitted if such records can be retrieved and provided onsite within 24 hours of request
for official review. The food safety plan must remain onsite. Electronic records are considered to be onsite if they are accessible from an onsite location.

9) If the plant or facility is closed for a prolonged period, the food safety plan may be transferred to some other reasonably accessible location but must
be returned to the plant or facility within 24 hours for official review upon request.

10) Existing records (e.g., records that are kept to comply with other Federal, State, or local regulations, or for any other reason) do not need to be
duplicated if they contain all of the required information and satisfy the requirements of this subpart. Existing records may be supplemented as necessary
to include all of the required information and satisfy the requirements of this subpart.

11) The information required for FSMA do not need to be kept in one set of records. If existing records contain some of the required information, any new
information required by this part may be kept either separately or combined with the existing records.

3.1 Personnel - FSMA Current 1) The management of the establishment must take reasonable measures and precautions to ensure that all persons working in direct contact with
Good Manufacturing Practice animal food, animal food-contact surfaces, and animal food-packaging materials conform to hygienic practices to the extent necessary to protect against
Requirements the contamination of animal food.

2) The methods for conforming to hygienic practices and maintaining cleanliness include:

a) Maintaining adequate personal cleanliness

b) Washing hands thoroughly in an adequate hand-washing facility as necessary and appropriate to protect against contamination

c) Removing or securing jewelry and other objects that might fall into animal food, equipment, or containers

d) Storing clothing or other personal belongings in areas other than where animal food is exposed or where equipment or utensils are cleaned

e) Taking any other necessary precautions to protect against the contamination of animal food, animal food-contact surfaces, or animal food packaging
materials

3.2.1 Facility Grounds - Plants 1) The grounds around an animal food plant under the control of the management of the establishment must be kept in a condition that will protect
and Grounds against the contamination of animal food.

2) Maintenance of grounds must include:

a) Properly storing equipment

b) Litter and waste removal

c) Cutting weeds or grass within the immediate vicinity of the plant that may constitute an attractant, breeding place, or harborage for pests

d) Maintaining driveways, yards, and parking areas so that they do not constitute a source of contamination in areas where animal food is exposed

e) Adequately draining areas that may contribute to contamination of animal food

f) Treating and disposing of waste so that it does not constitute a source of contamination in areas where animal food is exposed

3) Loading and unloading areas shall be maintained so as not to present a hazard to the animal food safety operation of the premises
.
4) Perimeter of facility, when possible, should be fenced for biosecurity purposes. Access to the facility shall be controlled for animal food safety
purposes.

3.2.2 Facility Structure 1) The plant must be suitable in size, construction, and design to facilitate cleaning, maintenance, and pest control to reduce the potential for
contamination of animal food, animal food-contact surfaces, and animal food packaging materials.

2) The facility must provide adequate space between equipment, walls, and stored materials to permit employees to perform their duties and to allow
cleaning and maintenance of equipment.

3) The facility must be constructed in a manner such that drip or condensate from fixtures, ducts, and pipes does not serve as a source of contamination.

4) The facility must provide adequate ventilation (mechanical or natural) where necessary and appropriate to minimize vapors (e.g., steam) and fumes in
areas where they may contaminate animal food and in a manner, that minimizes the potential for contaminating animal food.

5) The facility must provide adequate lighting in handwashing areas, toilet rooms, areas where animal food is received, manufactured, processed,
packed, or held, and areas where equipment or utensils are cleaned.

6) The facility must provide shatter-resistant light bulbs, fixtures, and skylights, or other glass items suspended over exposed animal food in any step of
preparation, to protect against the contamination of animal food in case of glass breakage.

3.2.3 Outside Storage The facility must protect animal food stored outdoors in bulk from contamination by any effective means, including:

1) Using protective coverings where necessary and appropriate;

2) Controlling areas over and around the bulk animal food to eliminate harborages for pests;

3) Checking on a regular basis for pests, pest infestation, and product condition related to safety of the animal food.

3.3 Sanitation 1) Buildings, structures, fixtures, and other physical facilities of the plant must be kept clean and in good repair to prevent animal food from becoming
adulterated.

2) Animal food-contact and noncontact surfaces of utensils (tools) and equipment must be cleaned and maintained and utensils (tools) and equipment
stored as necessary to protect against the contamination of animal food, animal food-contact surfaces, or animal food packaging materials. When
necessary, equipment must be disassembled for thorough cleaning. In addition:

a) When animal food-contact surfaces used for manufacturing, processing, packing, or holding animal food are wet-cleaned, the surfaces must, when
necessary, be thoroughly dried before subsequent use; and

b) In wet processing of animal food, when cleaning and sanitizing is necessary to protect against the introduction of undesirable microorganisms into
animal food, all animal food-contact surfaces must be cleaned and sanitized before use and after any interruption during which the animal food-contact
surfaces may have become contaminated.

3) Cleaning compounds and sanitizing agents must be safe and adequate under the conditions of use.

4) The following applies to toxic materials:

a) Only the following toxic materials may be used or stored in the plant area where animal food is manufactured, processed, or exposed:

(i) Those required to maintain clean and sanitary conditions;

(ii) Those necessary for use in laboratory testing procedures;

(iii) Those necessary for plant and equipment maintenance and operation; and

(iv) Those necessary for use in the plant’s operations.

b) Toxic materials such as cleaning compounds, sanitizing agents, and pesticide chemicals must be identified, used, and stored in a manner that protects
against the contamination of animal food, animal food-contact surfaces, or animal food-packaging materials; and
c) Other toxic materials (such as fertilizers and pesticides) must be stored in an area of the plant where animal food is not manufactured, processed, or
exposed.

5) Effective measures must be taken to exclude pests from the manufacturing, processing, packing, and holding areas and to protect against the
contamination of animal food by pests. The use of pesticides in the plant is permitted only under precautions and restrictions that will protect against the
contamination of animal food, animal food-contact surfaces, and animal food packaging materials.

6) Trash must be conveyed, stored, and disposed of in a way that protects against the contamination of animal food, animal food-contact surfaces,
animal food-packaging materials, water supplies, and ground surfaces, and minimizes the potential for the trash to become an attractant and harborage
or breeding place for pests.

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 CLAUSE ITEM SUPPORTING COMPLIANCE INFORMATION
3.4 Water Supply and Plumbing 1) The following apply to the water supply (FSMA requirement):

a) Water must be adequate for the operations and must be derived from an adequate source;

b) Running water at a suitable temperature, and under suitable pressure as needed, must be provided in all areas where required for the manufacturing,
processing, packing, or holding of animal food, for the cleaning of equipment, utensils (tools), and animal food-packaging materials, or for employee
hand-washing facilities;

c) Water that contacts animal food, animal food-contact surfaces, or animal food packaging materials must be safe for its intended use; and

d) Water may be reused for washing, rinsing, or conveying animal food if it does not increase the level of contamination of the animal food.

2) Plumbing must be designed, installed, and maintained to (FSMA requirement):

a) Carry adequate quantities of water to required locations throughout the plant;

b) Properly convey sewage and liquid disposable waste from the plant;

c) Avoid being a source of contamination to animal food, water supplies, equipment, or utensils (tools), or creating an unsanitary condition;

d) Provide adequate floor drainage in all areas where floors are subject to flooding-type cleaning or where normal operations release or discharge water
or other liquid waste on the floor; and

e) Ensure that there is no backflow from, or cross-connection between, piping systems that discharge waste water or sewage and piping systems that
carry water for animal food or animal food manufacturing.

3) Sewage and liquid disposal waste must be disposed of through an adequate sewerage system or through other adequate means.

4) A facility must provide employees with adequate, readily accessible toilet facilities. Toilet facilities must be kept clean and must not be a potential
source of contamination of animal food, animal food-contact surfaces, or animal food-packaging materials.

5) Each plant must provide hand-washing facilities designed to ensure that an employee's hands are not a potential source of contamination of animal
food, animal food contact surfaces, or animal food-packaging materials.

3.5 Equipment and Utensils 1) The following apply to plant equipment and utensils (tools) used in manufacturing, processing, packing, and holding animal food:
(Tools)
a) All plant equipment and utensils (tools), including equipment and utensils (tools) that do not come in contact with animal food, must be designed and
constructed of such material and workmanship to be adequately cleanable, and must be properly maintained;

b) Equipment and utensils (tools) must be designed, constructed, and used appropriately to avoid the adulteration of animal food with non-food grade
lubricants, fuel, metal fragments, contaminated water, or any other contaminants;

c) Equipment must be installed so as to facilitate the cleaning and maintenance of the equipment and adjacent spaces;

d) Animal food-contact surfaces must be:

i. Made of materials that withstand the environment of their use and the action of animal food, and, if applicable, the action of cleaning compounds,
cleaning procedures, and sanitizing agents;

ii. Made of nontoxic materials; and

iii. Maintained to protect animal food from being contaminated.

2) Holding, conveying, manufacturing, and processing systems, including gravimetric, pneumatic, closed, and automated systems, must be designed,
constructed, and maintained in a way to protect against the contamination of animal food.

3) Each freezer and cold storage compartment used to hold animal food must be fitted with an accurate temperature-measuring device.

4) Instruments and controls used for measuring, regulating, or recording temperatures, pH, Aw, or other conditions that control or prevent the growth of
undesirable microorganisms in animal food must be accurate, precise, adequately maintained, and adequate in number for their designated uses.

5) Compressed air or other gases mechanically introduced into animal food or used to clean animal food-contact surfaces or equipment must be used in
such a way to protect against the contamination of animal food.

3.6 Facility Operations 1) Management of the establishment must ensure that:

a) All operations in the manufacturing, processing, packing, and holding of animal food (including operations directed to receiving, inspecting,
transporting, and segregating) are conducted in accordance with the current good manufacturing practice requirements as described with FSMA
animal food rule;

b) Animal food, including raw materials, other ingredients, or rework is accurately identified;

c) Animal food-packaging materials are safe and suitable;

d) The overall cleanliness of the plant is under the supervision of one or more competent individuals assigned responsibility for this function;

e) Adequate precautions are taken so that plant operations do not contribute to contamination of animal food, animal food-contact surfaces, and animal
food-packaging materials;

f) Chemical, microbial, or extraneous-material testing procedures are used where necessary to identify sanitation failures or possible animal food
contamination;

g) Animal food that has become adulterated is rejected, disposed of, or if appropriate, treated or processed to eliminate the adulteration. If disposed of, it
must be done in a manner that protects against the contamination of other animal food; and

h) All animal food manufacturing, processing, packing, and holding is conducted under such conditions and controls as are necessary to minimize the
potential for the growth of undesirable microorganisms to protect against the contamination of animal food.

2) Raw materials and other ingredients:

a) Must be examined to ensure that they are suitable for manufacturing and processing into animal food and must be handled under conditions that will
protect against contamination and minimize deterioration.

b) In addition:

(i) Shipping containers (e.g., totes, drums, and tubs) and bulk vehicles holding raw materials and other ingredients must be examined upon receipt to
determine whether contamination or deterioration of animal food has occurred;

(ii) Raw materials must be cleaned as necessary to minimize contamination; and

(iii) Raw materials and other ingredients, including rework, must be stored in containers designed and constructed in a way that protects against
contamination and deterioration, and held under conditions, e.g., appropriate temperature and relative humidity, that will minimize the potential for growth
of undesirable microorganisms and prevent the animal food from becoming adulterated;

c) Susceptible to contamination with mycotoxins or other natural toxins must be evaluated and used in a manner that does not result in animal food that
can cause injury or illness to animals or humans;

d) If frozen, must be kept frozen. If thawing is required prior to use, it must be done in a manner that minimizes the potential for the growth of undesirable
microorganisms.

3) For the purposes of manufacturing, processing, packing, and holding operations, the following apply:

a) Animal food must be maintained under conditions, e.g., appropriate temperature and relative humidity, that will minimize the potential for growth of
undesirable microorganisms and prevent the animal food from becoming adulterated during manufacturing, processing, packing, and holding;

b) Measures taken during manufacturing, processing, packing, and holding of animal food to significantly minimize or prevent the growth of undesirable
microorganisms (e.g., heat treating, freezing, refrigerating, irradiating, controlling pH, or controlling Aw) must be adequate to prevent adulteration of
animal food;

c) Work-in-process and rework must be handled in such a way that it is protected against contamination and the growth of undesirable microorganisms;

d) Steps such as cutting, drying, defatting, grinding, mixing, extruding, pelleting, and cooling, must be performed in a way that protects against the
contamination of animal food;

e) Filling, assembling, packaging, and other operations must be performed in such a way that protects against the contamination of animal food and the
growth of undesirable microorganisms;

f) Animal food that relies principally on the control of water activity (Aw) for preventing the growth of undesirable microorganisms must be processed to
and maintained at a safe aw level;

g) Animal food that relies principally on the control of pH for preventing the growth of undesirable microorganisms must be monitored and maintained at
the appropriate pH;

h) When ice is used in contact with animal food, it must be made from water that is safe and must be used only if it has been manufactured in
accordance with current good manufacturing practice as outlined in FSMA animal food rule.

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 CLAUSE ITEM SUPPORTING COMPLIANCE INFORMATION
3.7 Holding and Distribution 1) Animal food held for distribution must be held under conditions that will protect against contamination and minimize deterioration, including the
following:

a) Containers used to hold animal food before distribution must be designed, constructed of appropriate material, cleaned as necessary, and maintained
to protect against the contamination of animal food; and

b) Animal food held for distribution must be held in a way that protects against contamination from sources such as trash.

2) The labeling for the animal food product ready for distribution must contain, when applicable, information and instructions for safely using the animal
food product for the intended animal species.

3) Shipping containers (e.g., totes, drums, and tubs) and bulk vehicles used to distribute animal food must be examined prior to use to protect against the
contamination of animal food from the container or vehicle when the facility is responsible for transporting the animal food itself or arranges with a third
party to transport the animal food.

4) Animal food returned from distribution must be assessed for animal food safety to determine the appropriate disposition. Returned animal food must
be identified as such and segregated until assessed.

5) Unpackaged or bulk animal food must be held in a manner that does not result in unsafe cross contamination with other animal food.

6) Human food by-products held for distribution as animal food must be held under conditions that will protect against contamination, including the
following:

a) Containers and equipment used to convey or hold human food by-products for use as animal food before distribution must be designed, constructed of
appropriate material, cleaned as necessary, and maintained to protect against the contamination of human food by-products for use as animal food;

b) Human food by-products for use as animal food held for distribution must be held in a way to protect against contamination from sources such as
trash; and

c) During holding, human food by-products for use as animal food must be accurately identified.

7) Labeling that identifies the product by the common or usual name must be affixed to or accompany the human food by-products for use as animal food
when distributed.

8) Shipping containers (e.g., totes, drums, and tubs) and bulk vehicles used to distribute human food by-products for use as animal food must be
examined prior to use to protect against the contamination of animal food from the container or vehicle when the facility is responsible for transporting the
human food by-products for use as animal food itself or arranges with a third party to transport the human food by-products for use as animal food.

4.1 Competency, Training and 1) The supplier shall ensure that all individuals who manufacture, process, pack, or hold animal food are qualified individuals (QI) as defined within
Job Descriptions (M) - Personnel FSMA.
and Training
2) The supplier shall ensure that supervisory personnel have the appropriate education, training and experience to supervise the production of safe
animal food.

3) The supplier shall ensure that personnel receive training in the principles of animal food hygiene and animal food safety, including the importance of
employee health and personal hygiene, as appropriate to the animal food, the facility and the individual’s assigned duties. Records of such training are
required.

4) The supplier shall describe competencies for personnel within job descriptions.

5) The supplier shall maintain a training program to ensure personnel are trained and competent. Records of training shall be maintained.

6) Where contractors are utilized, the supplier shall provide competency expectations to the approved vendor providing the services or work.

7) The supplier shall ensure that temporary workers are qualified individuals.

8) The supplier shall maintain adequate records of education, skills and experience of personnel.

4.2 Requirements for a 1) One or more PCQI must do or oversee the following:
Preventive Controls Qualified
Individual (PCQI) (M) a) Preparation of the food safety plan (§ 507.31(b));

b) Validation of the preventive controls (§ 507.47(b)(1));

c) Written justification for validation to be performed in a timeframe that exceeds the first 90 calendar days of production of the applicable animal food;

d) Determination that validation is not required (§ 507.47(c)(4));

e) Review of records (§ 507.49(a)(4));

f) Written justification for review of records of monitoring and corrective actions within a timeframe that exceeds 7-working days;

g) Reanalysis of the food safety plan (§ 507.50(d)); and

h) Determination that reanalysis can be completed, and additional preventive controls validated, as appropriate to the nature of the preventive control and
its role in the facility’s food safety system, in a timeframe that exceeds the first 90 calendar days of production of the applicable animal food.

2) To be a PCQI, the individual must have successfully completed training in the development and application of risk-based preventive controls at least
equivalent to that received under a standardized curriculum recognized as adequate by FDA or be otherwise qualified through job experience to develop
and apply a food safety system. Job experience may qualify an individual to perform these functions if such experience has provided an individual with
knowledge at least equivalent to that provided through the standardized curriculum.

3) A PCQI may be, but is not required to be, an employee of the facility.

4) The supplier shall maintain records of applicable training in the development and application of risk-based preventive controls, including the date of the
training, the type of training, and the person(s) trained.

4.3 Personnel Policies and 1) Personnel shall maintain proper hygiene relative to the employee’s work area in order to ensure the safety of animal foods.
Behavior
2) Personnel hygiene requirements shall be consistent with a biosecurity program to prevent the potential spread of disease or compromise the animal
food safety plan.

The supplier shall maintain a policy for personnel behavior.

3) Fluids provided for consumption in the manufacturing or storage areas shall be controlled to prevent the potential for contamination.

4) Personnel shall be provided adequate facilities for cleaning to prevent the potential contamination of animal foods.

5) Clothing worn by staff engaged in handling animal food shall be maintained, stored, laundered and worn so as not to present a contamination risk to
products. Clothing shall be appropriate for the work area.

6) Personnel shall be trained on the required hygiene and personnel policies to ensure the biosecurity of the facility and safety of animal foods.

4.4 Personnel Facilities 1) Facilities shall be provided to enable staff and visitors to change into and out of protective clothing as needed.

2) Lunch room facilities shall be available for personnel that are kept clean and suitable to food consumption.

3) The supplier must provide employees with adequate, readily accessible toilet facilities.

4) The supplier must provide adequate handwashing facilities to prevent contamination of animal food.

5) First aid facilities shall be provided to treat minor injuries and suitable arrangements shall be provided in circumstances when a patient requires more
specialized care.

4.5 Visitors 1) All visitors, including management and maintenance staff, shall wear suitable clothing and footwear when entering any animal food processing or
handling area.

2) All visitors shall be required to follow the personnel behavior policies.

3) Visitors shall be aware of the biosecurity requirements to prevent the contamination of animal foods or feed ingredients, as directed by the facility.

4) Visitors shall enter and exit animal food handling areas through the proper staff entrance points and comply with all personnel hygiene requirements.

5) Visitors shall sign in and out of facilities for biosecurity and personnel safety reasons.

6) Visitors shall be made aware of any policies, practices or requirements, where applicable, that ensures the quality and food safety program, animal
food safety plan and personnel safety requirements.

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 CLAUSE ITEM SUPPORTING COMPLIANCE INFORMATION
5.1 Maintenance - Infrastructure 1) The methods and responsibility for the maintenance and repair of plant, equipment and buildings shall be documented, planned and carried out in a
manner that minimizes the risk of product, packaging or equipment contamination.

2) Maintenance staff and contractors shall observe the following practices when undertaking maintenance and repairs in any feed processing, handling or
storage area:
a) Routine maintenance of plant and equipment shall be performed according to a maintenance-control schedule and recorded.

b) Failures of equipment shall be documented, reviewed and their repair incorporated into the maintenance control schedule, as needed.

c) Maintenance staff and contractors shall ensure materials or finished products are not contaminated during maintenance activities or pose a risk to
animal food safety.

d) Ensure facility supervisors are notified when maintenance or repairs are to be undertaken in any feed handling area.

e) Inform the maintenance supervisor and the facility supervisor if any repairs or maintenance pose a potential threat to product safety (i.e. pieces of
electrical wire, damaged light fittings and loose overhead fittings); when possible, maintenance is to be conducted outside processing times.

f) Remove all tools and debris from any maintenance activity area once it has been completed; inform the area supervisor and maintenance supervisor
so appropriate cleaning and inspection can be completed prior to the commencement of facility operations.

3) The maintenance schedule shall be prepared to cover building, equipment and other areas of the premises critical to the maintenance of product
safety and quality.

4) Lubricants shall be fit for purpose, meet regulatory requirements and be food/feed grade where there is potential of direct contact with animal food.

5) Paint used in an animal food handling or contact zone shall be suitable for use and in good condition; paint shall not be used on any product contact
surface.

5.2 Lighting and Work Areas 1) Lighting in manufacturing or handling areas and at inspection stations shall be of appropriate intensity to enable the staff to carry out their tasks
efficiently and effectively.

2) Light fittings in processing areas, inspection stations, ingredient and packaging storage areas, and all areas where the product is exposed shall be
shatterproof, manufactured with a shatterproof covering or fitted with protective covers as to minimize a risk for contamination.

3) A suitable area with sufficient lighting shall be provided for the inspection of the product if required.

4) Adequate ventilation shall be provided in enclosed manufacturing and animal food handling areas.

5) Work areas are suitable for personnel to complete required activities.

5.3.1 Pest Management (M) - 1) The methods and responsibility for integrated pest management shall be documented and effectively implemented. The premises, its surrounding
Pest Management Control areas, storage facilities, machinery and equipment shall be kept free of waste or accumulated debris so as not to attract pests and vermin.

2) The pest and vermin management program shall:

a) Describe the methods and responsibility for the development, implementation and maintenance of the pest and vermin management program.

b) Identify the target pests for each pesticide application.

c) Outline the methods used to prevent and/or eliminate pest problems.

d) Outline the frequency with which pest status is to be checked.

e) Include on a site map the identification, location, number and type of bait stations set.

f) List the chemicals used.

g) Outline the requirements for staff awareness and training for the pest management program.

h) Measure the effectiveness of the program to verify the elimination of applicable pests.

3) Electric insect control devices, pheromone or other traps and baits shall be located so as not to present a contamination risk to the product, packaging,
containers or processing equipment. Poison shall not be used inside ingredient or animal food storage areas or processing areas.

4) Records of pest control applications shall be maintained.

5.3.2 Pest Control Chemicals (M) 1) Pesticides and other toxic chemicals shall be clearly labeled, stored, handled and applied by properly trained personnel.

2) They shall be used by or under the direct supervision of trained personnel with a thorough understanding of the hazards involved, including the
potential for the contamination of feed and feed contact surfaces.

3) The supplier shall ensure unused pest control chemicals and empty containers are disposed in compliance with regulatory requirements.

5.3.3 Pest Management 1) Pest control contractors shall be licensed and approved by the local relevant authority. If a pest control contractor is not used, company personnel
Personnel shall be licensed and approved by local relevant authority.

2) Pest control contractors, or properly licensed personnel, shall:

b) Use only approved chemicals

c) Provide a pest control management plan which will include a site map indicating the location of bait stations and traps

d) Report to a responsible authorized person on entering the premises and after the completion of inspections or treatments

e) Provide a written report of their findings and the inspections and treatments applied

5.4 Cleaning and Housekeeping 1) The procedures and responsibility for the cleaning and housekeeping of animal food handling and processing equipment and environment, storage
(M) areas and staff amenities shall be documented and implemented.

2) A housekeeping program shall be outlined to ensure the facility, equipment and grounds are maintained appropriately to minimize the potential of
contamination.

3) If warranted, a suitably equipped area shall be designated for cleaning tools or equipment. These cleaning operations shall be controlled so as not to
interfere with manufacturing operations, equipment or product.

4) The responsibility and methods used to verify the effectiveness of the cleaning procedures shall be documented and implemented.

5) If used, detergents and sanitizers shall be suitable for use in a feed manufacturing environment. The organization shall ensure an inventory of all
commercial chemicals (detergents and sanitizers) purchased and used is maintained. If considered hazardous, training of staff on proper handling, use
and disposal shall be maintained. Safety data sheets shall be maintained as needed.

6) A record of cleaning and sanitation activities and verification activities shall be maintained.

6.1 Product Development - 1) The methods and responsibility for designing, developing and converting product concepts to commercial realization shall be documented and
Product Realization implemented.

2) Where appropriate, product formulation, manufacturing processes and the fulfillment of product requirements shall be validated by facility trials and
product testing.

3) Records of all product design, process development and approvals shall be maintained.

6.2.1 Receiving Processes for 1) The supplier shall verify that packaging meets the supplier’s specifications upon receipt. All packaging materials shall comply with the relevant
Packaging Materials - Packaging regulatory requirements.
and Materials Receiving
Processes 2) The supplier shall verify that printed labeling on packaging complies with supplier’s specifications upon receipt.

3) All packaging materials shall be provided by approved vendors.

6.2.2 Receiving Processes for 1) All raw materials and ingredients shall comply with the supplier’s specifications and relevant regulatory requirements.
Raw Materials and Ingredients
2) Processes for receiving raw materials and ingredients shall be clearly defined and documented.

3) Personnel responsible for receiving raw materials and ingredients shall be trained on the defined processes and procedures.

4) Records shall be maintained for incoming materials to ensure raw materials and ingredients are provided by approved vendors and comply with
relevant regulatory requirements.

5) The supplier shall verify that labeling for raw materials and ingredients complies with supplier’s specifications upon receipt.

6.2.3 Equipment at Receiving 1) Prior to receiving or unloading raw materials or ingredients, equipment delivering the materials (typically rail cars, trucks or tankers) shall be inspected
for filth or other potential sources of contamination. Rejection criteria must be established.

2) Transportation vendors must comply with regulatory requirements as well as supplier delivery requirements.

3) Incoming rail cars and trucks should be sealed upon arrival when possible. A program to evaluate the safety of the incoming ingredients shall be in
place seals are absent. This policy may be similar to the policy for bagged ingredients that have been opened or damaged during transport.

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6.3.1 Process Control (M) - 1) Controls shall be implemented throughout the manufacturing process to ensure the quality and safety of the product.
Manufacturing Processes
2) The controls shall be consistent with CGMPs as authorized by the FDA within FSMA animal food rule.

3) Written procedures for the controls shall be maintained.

4) Records shall be available to verify the control has been completed and is effective.

6.3.2 Control of Raw Materials 1) Controls to minimize cross-contamination of raw materials and ingredients during processing shall be implemented to prevent an animal food safety
and Ingredients risk.

2) Procedures shall be established and implemented to ensure regulatory requirements for handling raw materials and ingredients are followed.

6.3.3 Product Release (M) 1) The responsibility and methods for releasing products shall be documented and implemented.

2) The procedures shall ensure the product is released by authorized personnel, once all inspections and analyses are successfully completed and
documented to verify regulatory requirements and other established quality and food safety controls have been met.

3) No product shall be released without proper approval.

6.4.1 Finished Products 1) Written finished product specifications shall be approved by the supplier to ensure customers’ requirements are met.
Specifications (M) - Finished
Products 2) Written finished product specifications shall be accessible to relevant staff or personnel.

3) A register of finished product specifications shall be maintained.

6.4.2 Product Formulation (M) 1) Product formulations shall be developed by authorized persons to ensure they meet the designated requirements. The formulations shall include all
manufacturing instructions with regard to flushing, sequencing, special instructions and cleanout procedures.

2) Procedures shall be documented and implemented to ensure that approved product formulations are used to manufacture finished products. The
supplier shall ensure that raw materials or ingredients prohibited from use in the manufacture of animal food are not introduced into the product.

3) All medications included in animal food must be added in accordance with label instructions and regulatory requirements. When medications are used
within a facility, the following shall be followed:
a) Access to medications shall be restricted to trained and authorized personnel.

b) A daily drug reconciliation inventory shall be maintained.

c) Animal medications shall be subject to proper rotation based on expiration date Expired medications shall not be used.

4) Records shall be maintained to ensure products are formulated accurately and adhere to product specifications.

6.5.1 Customer Requirements - 1) The supplier shall review customer requirements related to the product are met.
Customer Related Processes
2) The supplier shall determine:

a) Requirements specified by the customer.

b) Requirements not stated by the customer, but necessary for the specified or intended use (when known).

c) Regulatory requirements applicable to the product.

d) Any additional requirements considered necessary by the supplier to meet the needs or expectations of the customer.

6.5.2 Customer Communication 1) The methods and responsibility for handling and investigating the cause and resolution of complaints from customers and authorities shall be
documented and implemented.

2) The supplier shall determine and implement effective arrangements for communicating with customers. This includes (but not limited to):

a) Product information.

b) Enquiries, contracts or order handling.

c) Customer feedback, including customer complaints.

3) Trends of customer complaint data shall be investigated and analyzed by personnel knowledgeable about the incidents.

4) Records of customer complaints and their investigation shall be maintained.

6.6 Labeling (M) 1) Finished products shall be labelled for identification. Each package shall be properly labeled.

2) If finished product is provided to the customer as bulk, a label shall be provided with shipment.

3) Labels shall comply with all federal, state and local regulatory requirements.

4) Labels shall be approved by appropriate personnel to ensure compliance with regulatory requirements.

6.7 Nonconforming Products and 1) The responsibility and methods outlining how nonconforming products and materials are handled shall be documented and implemented.
Materials (M)
2) The supplier shall ensure:
a) Nonconforming product is quarantined, identified, handled and disposed of in a manner that minimizes the risk of inadvertent use, improper use or risk
to the integrity of finished product.

b) Relevant staff is trained on the organization's quarantine and release requirements applicable to product placed under quarantine status.

3) Quarantine records and records of the handling, corrective action or disposal of nonconforming product shall be maintained.

6.8 Rework (M) 1) The responsibility and methods outlining how product is reworked shall be documented and implemented.

2) The procedure shall ensure:

a) The process of reworking product is supervised by qualified personnel.

b) Reworked product is clearly identified and traceable in compliance with regulatory requirements.

c) Each batch of reworked product is inspected or analyzed as required before release and distribution.

d) Inspections and analyses shall conform to the requirements outlined in Clause 7.5.

e) Release of reworked product shall conform to the requirements outlined for finished products.

3) Records of all reworking operations shall be maintained.

6.9 Inventory Stock Rotation 1) A written procedure for ensuring effective stock rotation principles are applied shall implemented and maintained.

2) When applicable, the requirements by customers on stock rotation shall be implemented.

3) If “first in, first out” (FIFO) is not required for specific products, this shall be documented.

6.10.1 Storage of Raw Materials 1) Raw materials and ingredients shall be stored in such a manner to prevent cross contamination with other raw materials or ingredients
and Ingredients - Storage of
Materials and Finished Products 2) Raw materials and ingredients of a similar category or function should be stored in the same area, when possible, in order to minimize the severity of
contamination, should it occur.

3) Raw materials and ingredients considered high risk shall be segregated or stored in a separate area to minimize contamination.

4) First In-First Out (FIFO) stock rotation shall be implemented and practiced, unless otherwise noted due to specific customer needs.

5) Lot numbers of raw materials and ingredients shall be easily identified for personnel to record for usage or shipment (traceability purposes).

6) Inventories for raw materials and ingredients within storage shall be easily obtained and maintained accurately.

7) Racking for storage shall be constructed of impervious materials and designed to enable cleaning of the floors and the storage room.

8) When racking is used, storage of raw materials and ingredients shall minimize the risks of contamination from one ingredient above another.

9) The storage of medications for use in feed manufacture shall be controlled and maintained in accordance with regulatory requirements or, in the
absence of regulatory requirements, manufacturers’ instructions.

6.10.2 Storage of Packaging 1) Racks provided for the storage of packaging shall be constructed of impervious materials and designed to enable cleaning of the floors and the
storage room. Storage areas shall be constructed to prevent packaging from becoming a harborage for pests or vermin.

2) Lot numbers for packaging shall be easily identified for tracking and traceability purposes.

3) Outdated or nonconforming packaging shall be identified as such. These materials shall be stored separately from other packaging to avoid improper
use. Nonconforming packaging shall be discarded or disposition determined in a timely manner.

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6.10.3 Storage of Finished 1) Finished products should be segregated or stored separately from raw materials and ingredients, where possible.
Products
2) All finished products shall be identified with a lot code for tracking and traceability.

3) FIFO stock rotation shall be practiced with finished products, unless otherwise noted by customer.

4) Storage areas for finished products shall be designed to enable cleaning and housekeeping practices. Storage areas shall be maintained in a manner
to prevent harborage of pests or vermin.

5) When racking is used, storage of finished products shall minimize the risks of contamination from one ingredient above another.

6.10.4 Storage of Nonconforming 1) Raw materials, ingredients, packaging and finished products that are nonconforming shall be isolated in a designated storage area.
Materials
2) Nonconforming materials and finished products shall be labeled as nonconforming materials.

3) Nonconforming materials and finished products shall be discarded or disposition determined in a timely manner.

4) Storage area for nonconforming materials and finished products shall be designed to enable cleaning and housekeeping practices. Storage areas shall
be maintained in a manner to prevent harborage of pests or vermin.

6.10.5 Bulk Storage of 1) Bulk storage shall allow separation and segregation of materials to avoid cross-contamination.
Ingredients and Finished Products
2) Bulk storage bins or silos shall allow for cleaning and housekeeping practices. Bulk storage areas shall be maintained in a manner to prevent
harborage of pests or vermin.

3) Bulk storage practices shall support regulatory requirements when applicable.

4) Records for bulk storage shall be maintained.

6.11.1 Hazardous Chemical 1) Storage of hazardous chemicals and toxic substances shall not present a hazard to staff.
Storage Process (M) - Storage of
Hazardous Chemicals 2) Storage of hazardous chemicals and toxic substances shall not present a hazard to manufacturing processes. This includes packaging, product
handling equipment or areas in which the finished products or ingredients are handled, stored or transported.

3) Hazardous chemicals and toxic substances shall be clearly labeled.

6.11.2 Hazardous Chemical 1) Hazardous chemical and toxic substance storage areas shall be compliant with national and local legislation and designed such that there is no cross-
Storage Area (M) contamination between chemicals.

2) The storage area shall be adequately ventilated and provided with appropriate signage indicating the area is a hazardous storage area.

3) The storage area shall be maintained as a restricted access only. Personnel without formal training in the handling and use of hazardous chemicals
and toxic substances shall not be allowed to work in this area.

4) Instructions on the safe handling of hazardous chemicals and toxic substances shall be readily accessible to staff.

5) The storage area shall be equipped with a detailed and up-to-date inventory of all chemicals contained in the storage facility.

6) Suitable first-aid equipment and protective clothing shall be available in close proximity to the storage area.

7) In the event of a hazardous spill, the storage area shall be designed such that spillage and drainage from the area is contained.

8) The storage area shall be equipped with spillage kits and cleaning equipment.

6.12 Loading, Transport and 1) The processes and practices applied during loading, transport and unloading of animal food or animal food ingredients shall be documented,
Unloading Processes implemented and designed to maintain appropriate storage conditions and product integrity. Materials and finished products shall be loaded, transported
and unloaded under conditions suitable to prevent cross-contamination.

2) Vehicles (trucks/vans/containers) used for transporting feed shall be inspected prior to loading or unloading to ensure they are clean, in good repair,
suitable for the purpose and free from conditions that may impact negatively on the safety of finished products or materials.

3) Loading and unloading processes and practices shall be designed to minimize unnecessary exposure to conditions detrimental to the integrity of
finished products, materials and packaging materials.

4) Procedures shall ensure incoming raw materials or ingredients comply with regulatory requirements and the supplier’s specifications, where applicable.

7.1.1 Approved Vendors (M) - 1) Raw materials, ingredients, packaging materials and services that impact finished product safety shall be supplied by an approved vendor.
Vendors for Incoming Goods and
Services - Purchasing Processes 2) A written procedure defining the processes and procedures for vendor evaluation and approval shall be maintained. This shall include procedures for
and Control receiving raw materials, ingredients, packaging materials and services from unapproved vendors.

3) The responsibility for selecting, evaluating, approving and monitoring an approved vendor shall be documented and implemented.

4) A master list of approved vendors should be maintained, although this is not required. Records of inspections and audits of approved vendors should
be maintained also. The supplier shall be required to demonstrate materials are received from approved vendors.

5) If an on-site audit is used to approve a vendor, the audit must be completed by a qualified auditor.

a) To be a qualified auditor, a qualified individual must have technical expertise obtained through education, training, or experience (or a combination
thereof) necessary to perform the auditing function.

b) All applicable training by a qualified auditor in the development and application of risk-based preventive controls must be documented in records,
including the date of the training, the type of training, and the person(s) trained.

7.1.2 Unapproved Vendors or 1) The receipt of raw materials, ingredients and packaging materials received from unapproved vendors shall be acceptable in an emergency situation
Temporary Sourcing provided before use.

2) Procedures describing the inspection and approval of temporary sourcing of raw materials, ingredients and packaging materials shall be maintained.

3) The use of unapproved vendors or temporary sourcing of incoming goods or services shall be documented.

4) Records shall be maintained showing the use of unapproved vendors and controls implemented to ensure the quality and safety of incoming goods.

7.2 Material and Packaging 1) Specifications for all materials and packaging, including (but not limited to) raw materials, ingredients, feed additives, hazardous chemicals and
Specifications (M) processing aids that impact finished product safety shall be documented and kept current.

2) The methods and responsibility for developing and approving detailed specifications shall be documented.

3) Process to provide specifications to vendors for review and approval shall be defined. A record of vendor acceptance or approval of the specifications
shall be maintained and readily assessable by appropriate personnel.

7.3.1 Specifications for Contract 1) Specifications for contract services that have an impact on finished product safety shall be documented and approved.
Service Providers - Contract
Service Providers 2) Relevant training requirements of contract personnel shall be specified and documented.

3) Training records of contract personnel shall be maintained.

7.3.2 Contract Manufacturing 1) All finished products, “work in progress” materials and services provided by contract manufacturers shall meet the desired specifications by the
supplier.

2) Specifications for desired activities to be completed by contract manufacturers shall be maintained.

3) Records demonstrating the compliance of contract manufacturers to the desired specifications from the supplier shall be maintained.

4) The supplier shall verify all customer requirements are being met, ensure changes to contractual agreements are approved by both parties and
communicated to relevant personnel.

8.1 Responsibility, Frequency 1) The Q&FS Leader shall be a preventive controls qualified individual.
and Methods - Validation and
Verification 2) The Q&FS Leader shall ensure validation and verification activities are completed accurately.

3) The Q&FS Leader shall determine the frequency and methods used to validate and verify animal food safety fundamentals, critical limits and other
animal food safety controls identified in the food safety plan.

4) Verification activities must include, as appropriate to the nature of the preventive control and its role in the facility’s food safety system:

a) Validation that the preventive control is appropriate for control of the hazard (see FSMA 507.47)

b) Verification that monitoring is being conducted (see FSMA 507.39 and 507.40)

c) Verification that appropriate decisions about corrective actions are being made (see FSMA 507.39 and 507.42)

d) Verification of implementation and effectiveness (see FSMA 507.49)

e) Reanalysis of the food safety plan as necessary (See FSMA 507.50)

f) Records of verification activities are maintained (see FSMA Subpart F)

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8.2 Validation 1) The supplier shall validate that the preventive controls are adequate to control the hazard as appropriate to the nature of the preventive control and its
role in the facility’s food safety system.

2) Validation of the preventive controls:

a) Must be performed (or overseen) by a preventive controls qualified individual

b) Must be completed before implementation within the food safety plan

c) Must include obtaining and evaluating scientific and technical evidence (or, when such evidence is not available or is inadequate, conducting studies)
to determine whether the preventive controls, when properly implemented, will effectively control the hazards

3) The supplier does not need to validate (see FSMA 507.47(c)):

a) Sanitation controls

b) Recall plan

c) Supply-chain program

d) Other preventive controls, if the preventive controls qualified individual prepares (or oversees the preparation of) a written justification that validation is
not applicable based on factors such as the nature of the hazard, and the nature of the preventive control and its role in the facility’s food safety system.

4) After validation of the preventive control, the supplier shall demonstrate the control measures can be implemented as designed. Within 90 calendar
days after production of the applicable animal food first begins. If this is not possible the PCQI shall provide justification for a timeframe that exceeds 90
calendar days after production of the applicable animal food first begins.

5) Re-validation shall occur whenever processes or procedures change that are implemented for the purpose to minimize, mitigate or control animal food
safety hazards.

6) Records of all validation activities shall be maintained.

8.3 Equipment Calibration 1) The methods and responsibility for the calibration and re-calibration of measuring, testing and inspecting equipment used for monitoring activities shall
be documented and implemented.

2) Calibration shall be performed according to regulatory requirements and/or to the equipment manufacturers recommended schedule.

3) Equipment shall be calibrated against national or international reference standards and methods or to accuracy appropriate to its use. In cases where
standards are not available, the supplier shall provide evidence to support the calibration reference method applied.

4) Mixers shall be tested/calibrated for uniform mixing as follows:

a) Upon installation

b) On a regularly scheduled basis (minimum of once per year)

c) When batch results indicate the need

d) After major repairs

5) Calibration records shall be maintained.

8.4 Verification of Implementation 1) The supplier shall verify that the preventive controls are consistently implemented and are effectively and significantly minimizing or preventing
and Effectiveness hazards requiring a preventive control. To do so, the shall conduct activities that include the following, as appropriate to the facility, the animal food, and
the nature of the preventive control and its role in the facility’s food safety system:

a) Calibration of process monitoring and verification instruments (or checking them for accuracy);

b) Product testing for a pathogen (or appropriate indicator organism) or other hazard;

c) Environmental monitoring, for an environmental pathogen or for an appropriate indicator organism, if contamination of an animal food with an
environmental pathogen is a hazard requiring a preventive control, by collecting and testing environmental samples; and

d) Review of records within 7-working days after the records are created, by (or under the oversight of) a PCQI to ensure:

(i) That records are complete

(ii) The activities reflected in the records occurred in accordance with the food safety plan,

(iii) That the preventive controls are effective,

(iv) That appropriate decisions were made about corrective actions

e) If record review exceeds 7-working days after the records were created, the PCQI shall prepare (or oversees the preparation of) a written justification
for the extended timeframe

f) Other activities appropriate for verification of implementation and effectiveness.

2) As appropriate to the facility, the food, the nature of the preventive control, and the role of the preventive control in the facility’s food safety system, the
supplier shall establish and implement written procedures for the following activities:

a) The method and frequency of calibrating process monitoring instruments and verification instruments (or checking them for accuracy)

b) Procedures for product testing, including:

(i) Testing method is scientifically valid

(ii) Identify the nutrient, microorganism or other analyte(s) to be measured/tested;

(iii) Specify the procedures for identifying samples, including their relationship to specific lots of product

(iv) Include the procedures for sampling, including the number of samples and the sampling frequency

(v) Identify the test(s) conducted, including the analytical method(s) used

(vi) Identify the laboratory conducting the testing; and

(vii) Include the corrective action procedures (see FSMA 507.42(a)(1))

c) Procedures for environmental monitoring (if implemented), including:

(i) Testing method is scientifically valid

(ii) Identify the test microorganism(s)

(iii) Identify the locations from which samples will be collected and the number of sites to be tested during routine environmental monitoring. The number
and location of sampling sites must be adequate to determine whether preventive controls are effective;

(iv) Identify the timing and frequency for collecting and testing samples. The timing and frequency for collecting and testing samples must be adequate to
determine whether preventive controls are effective;

(v) Identify the test(s) conducted, including the analytical method(s) used;

(vi) Identify the laboratory conducting the testing; and

(vii) Include the corrective action procedures (see FSMA 507.42(a)(1))

8.5.1 Processes for Product 1) Raw materials, ingredients, finished products and work in progress shall be sampled as described within a written procedure or process.
Sampling - Product Sampling and
Inspection 2) Sampling requirements of raw materials and ingredients shall be established and implemented to ensure the quality and food safety of finished
products.

3) The supplier shall maintain sample retention times that comply with supplier and customer requirements.

4) Work in progress materials shall be sampled as needed to ensure the quality and food safety of finished products.

5) Samples shall be clearly labeled to identify the type of materials within the sample, lot code and date of sampling.

8.5.2 Inspection and Analysis of 1) All raw materials and ingredients shall be inspected upon arrival to determine whether it is acceptable for use.
Raw Materials and Ingredients
2) Testing or analysis of raw materials and ingredients shall be clearly defined.

3) Testing or analysis of raw materials and ingredients shall be completed at planned intervals to ensure the quality and safety of finished products.

4) Testing or analytical results for raw materials and ingredients shall be maintained. Results shall be reviewed at planned intervals to determine
variations in raw materials.

5) Testing and analytical results shall be traceable by raw material and ingredient lot numbers.

6) Testing or analytical processes shall be validated. All analyses shall be conducted to nationally recognized methods or alternative methods, which are
validated as equivalent to the nationally recognized methods. Where external laboratories are utilized to conduct input or product analysis, the
laboratories should be accredited to ISO 17025 or an equivalent national standard.

7) Records of all inspections and analyses shall be maintained.

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8.5.3 Inspection and Analysis of 1) Finished products shall be inspected prior to release to determine whether it is acceptable for use. This may include confirmation of compliance with
Finished Products regulatory requirements or the supplier’s specification, if applicable.

2) Production records shall be reviewed and approved to ensure the quality and food safety of the finished product.

3) Testing or analysis of finished products shall be clearly defined, if applicable.

4) Testing or analysis of finished products shall be completed at planned intervals to ensure the quality and safety of finished products.

5) Testing or analytical results for finished products shall be maintained. Results shall be reviewed at planned intervals to determine variations in raw
materials or ingredients.

6) Testing and analytical results shall be traceable by finished product lot number and/or production date.

7) Testing or analytical processes shall be validated. All analyses shall be conducted to nationally recognized methods or alternative methods which are
validated as equivalent to the nationally recognized methods. Where external laboratories are utilized to conduct input or product analysis, the
laboratories shall be accredited to ISO 17025 or an equivalent national standard.

8) Records of inspections and analyses shall be maintained.

8.6.1 Internal Audit Process - 1) The supplier shall complete internal audits at planned intervals to determine whether the quality and food safety system:
Internal Audits
a) Conforms to the requirements established by the supplier; and

b) Is effectively implemented and maintained.

2) The internal audit schedule shall take into consideration the status and importance of the processes and areas to be audited, as well as results from
previous audits.

3) The audit criteria, scope, frequency and methods shall be defined.

4) A documented procedure shall be established to define the responsibilities and requirements for planning and conducting audits, establishing records
and reporting results.

5) Records of the audits and their results shall be maintained.

8.6.2 Internal Auditors 1) Internal auditors shall be objective and impartial during the audit process.

2) Auditors shall not audit their own work.

3) Staff conducting internal audits shall be trained in internal audit procedures.

4) Records of audit training shall be maintained.

8.6.3 Internal Audit Corrective 1) Management responsible for the area being audited shall ensure that any necessary corrections and corrective actions are taken without due delay to
Actions eliminate detected nonconformities and their causes.

2) Management responsible for the area being audited shall verify the effectiveness of corrections or corrective actions.

3) Management responsible for the area being audited shall ensure verification activities are recorded.

8.7 Product Identification (M) 1) Raw materials, ingredients, “work-in-progress” material and finished products shall be properly identified.

2) The methods and responsibility for identifying raw materials, ingredients, “work-in-progress” material and finished products shall be documented and
comply with regulatory requirements, if needed.

3) The product identification system shall be implemented to ensure raw materials, ingredients, “work-in-progress” material and finished products are
clearly identified during all stages of receipt, production, storage and dispatch.

4) Product identification records shall be maintained.

8.8 Product Traceability (M) 1) The responsibility and methods used to trace product shall be documented and implemented to ensure finished product is traceable to the customer
(one level forward).

2) The methods shall provide traceability through the process to the supplier and date of receipt of materials, packaging and other inputs (one level
backward).

3) Traceability is maintained where product is reworked. Any finished product containing rework shall be traceable to ensure that:

a) Customers receiving the product can be identified; and

b) Lot numbers for ingredients, including those within the rework, can be identified.

4) The effectiveness of the product trace system shall be tested at least annually.

5) Records of raw and packaging material receipt and use, and product dispatch and destination shall be maintained.

8.9 Animal Food Defense and 1) An animal food defense and biosecurity plan(s) shall be documented, implemented and maintained.
Biosecurity Plan
2) An animal food defense plan shall include:

a) Name of the management person responsible for animal food defense and biosecurity.

b) Methods implemented to ensure only authorized personnel have access to the facility grounds, production equipment and vehicles, and manufacturing
and storage areas through designated access points.

c) Methods implemented to protect sensitive processing points from intentional adulteration.

d) Measures taken to ensure the security of storage for materials, packaging, equipment and hazardous chemicals.

e) Measures implemented to ensure materials (bulk or bagged) as well as finished product are held under secure storage and transportation conditions.

f) Methods implemented to record and control access to the premises by employees, contractors and visitors.

3) The animal food defense and biosecurity plan(s) shall include processes or procedures to prevent the spread of disease to animals. This includes
contact during transport or delivery to animals susceptible to disease.

4) Records for the animal food defense and biosecurity plan(s) shall be maintained.

9.1 Components of a Food 1) The supplier shall prepare, or have prepared, and implement a written food safety plan. One or more PCQI must prepare, or oversee the preparation
Safety Plan (M) - Animal Food of, the food safety plan.
Safety Plan
2) The written food safety plan must include a written hazard analysis (see FSMA 507.33(a)(2)) and preventive controls for hazards requiring preventive
controls (see FSMA 507.34(b)).

3) When hazards requiring preventive controls are identified, the supplier shall maintain the following:

a) A recall plan for products that are impacted by the hazard

b) Written procedures for monitoring the implementation of the preventive controls (see FSMA 507.40(a)(1))

c) Written corrective action procedures for the preventive control (see FSMA 507.42(a)(1))

d) Written verification procedures to ensure the effectiveness of the preventive control (see FSMA § 507.49(b))

4) When a preventive control is implemented by a supplier, the supplier shall maintain a written supply chain program as defined in FSMA Subpart E.

5) A reanalysis of the food safety plan as a whole shall be completed at least once every three years. In addition, a reanalysis of the food safety plan as a
whole, or the applicable portion of the food safety plan:

a) Whenever a significant change in the activities conducted at your facility creates a reasonable potential for a new hazard or creates a significant
increase in a previously identified hazard;

b) Whenever you become aware of new information about potential hazards associated with the animal food;

c) Whenever appropriate after an unanticipated animal food safety problem in accordance (see FSMA 507.42(b))

d) Whenever you find that a preventive control, combination of preventive controls, or the food safety plan as a whole is ineffective.

6) A process flow diagram shall be added to the food safety plan that demonstrates a general flow of manufacturing processes.

7) The food safety plan shall be maintained at the manufacturing location and signed by the person in charge of the facility.

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9.2 Records for the Food Safety 1) The supplier shall main the following records documenting implementation of the food safety plan:
Plan (M)
a) Documentation, as required by § 507.36(b), of the basis for not establishing a preventive control in accordance (see FSMA 507.36(a)(b))

b) Records that document the monitoring of preventive controls, if any

c) Records that document corrective actions

d) Records that document verification for preventive controls, if any. This includes:

i. Validation for the preventive control

ii. Verification of monitoring

iii. Verification of corrective actions

iv. Calibration of process monitoring and verification of instruments

v. Product testing

vi. Environmental monitoring

vii. Review of records

viii. Reanalysis of the food safety plan

e) Records that document the supply chain program for preventive controls, as outlined in FSMA Subpart E

f) Records that document applicable training for the preventive controls qualified individual and the qualified auditor.

2) Records for the food safety plan shall be maintained for at least 2 years.

9.3 Hazard Analysis (M) 1) The supplier shall conduct a hazard analysis to identify and evaluate, based on experience, illness data, scientific reports, and other information,
known or reasonably foreseeable hazards for each type of animal food manufactured, processed, packed, or held at your facility to determine whether
there are any hazards requiring a preventive control.

2) The hazard analysis must be written.

3) The hazard identification must consider:

a) Known or reasonably foreseeable hazards that include:

(i) Biological hazards, including microbiological hazards such as parasites, environmental pathogens, and other pathogens

(ii) Chemical hazards, including radiological hazards, substances such as pesticide and drug residues, natural toxins, decomposition, unapproved food or
color additives, and nutrient deficiencies or toxicities (such as inadequate thiamine in cat food, excessive vitamin D in dog food, and excessive copper in
food for sheep)

(iii) Physical hazards (such as stones, glass, and metal fragments)

b) Known or reasonably foreseeable hazards that may be present in the animal food for any of the following reasons:

(i) The hazard occurs naturally;

(ii) The hazard may be unintentionally introduced; or

(iii) The hazard may be intentionally introduced for purposes of economic gain.

4) The hazard analysis must include an assessment of:

a) The severity of the illness or injury if the hazard were to occur and;

b) The probability that the hazard will occur in the absence of preventive controls.

5) The hazard evaluation must include an evaluation of environmental pathogens whenever an animal food is exposed to the environment
prior to packaging and the packaged animal food does not receive a treatment or otherwise include a control measure (such as a formulation lethal to the
pathogen) that would significantly minimize the pathogen.

6) The hazard evaluation must consider the effect of the following on the safety of the finished animal food for the intended animal:

a) The formulation of the animal food;

b) The condition, function, and design of the facility and equipment;

c) Raw materials and other ingredients;

d) Transportation practices;

e) Manufacturing/processing procedures;

f) Packaging activities and labeling activities;

g) Storage and distribution;

h) Intended or reasonably foreseeable use;

i) Sanitation, including employee hygiene; and

j) Any other relevant factors such as the temporal (e.g., weather-related) nature of some hazards (e.g., levels of some natural toxins).

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