Plant Systems Audit Program Checklist 

Company Name: 

Company Location: 

Billing Account No: 

Audit Date: 

Scope* Req. No. Requirement DOC Rating Evidence 

Food Defense Plan 

FD 1.1.1 The facility must have and implement a written 

food defense plan. 

The facility must keep documentation and 

records of the plan’s implementation. 

Policy, 

Record 

FD 1.1.2 The written food defense plan must include: 

- The written vulnerability assessment; 

- The written mitigation strategies; 

- The written procedures for the food defense 

monitoring of the implementation of the 

mitigation strategies; 

- The written procedures for food defense 

corrective actions; and 

- The written procedures for food defense 

verification. 

Policy, 

Record 

Personnel Qualifications and Training 

FD 1.2.1 All facility personnel must receive training in 

food defense awareness (as new employee and 

annually). 

Record 

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Scope* Req. No. Requirement DOC Rating Evidence 

All personnel who perform activities associated 

with food defense procedures must: 

- Be, or be under the supervision of, a qualified 

individual to perform their assigned duties, 

and 

Receive externally provided training on the 

principles of food defense or have experience that 

prepares them for the assigned task. 

FD 1.2.2 Individuals assigned the following tasks must be 

qualified individuals: 

- Preparation of the food defense plan; 

- Completion of a vulnerability assessment; 

- Identification and explanation of the 

mitigation strategies; and 

- Reanalysis of the food defense plan. 

These individuals must receive externally 

provided training, specific to the task that they 

are assigned. 

Approved courses for a qualified individual are 

available on the Food Safety Preventive Controls 

Alliance website, 

https://www.ifsh.iit.edu/fspca/courses/intentionaladulteration 

Training records must be maintained for the 

qualified individuals. 

Record 

FD 1.2.3 Responsibility for ensuring compliance by 

individuals with the food defense requirements 

Record 

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Scope* Req. No. Requirement DOC Rating Evidence 

must be clearly assigned to supervisory personnel 

with a combination of education, training, and 

experience necessary to supervise the activities. 

Vulnerability Assessment 

FD 1.3.1 The facility must conduct or have conducted a 

vulnerability assessment for each type of food 

manufactured, processed, packed, or held at the 

facility to identify significant vulnerabilities and 

actionable process steps. Appropriate methods 

must include, at a minimum, an evaluation of: 

- The potential public health impact (e.g., 

severity and scale) if a contaminant were 

added; 

- The degree of physical access to the product; 

and 

- The ability of an attacker to successfully 

contaminate the product. 

FD 1.3.2 The vulnerability assessment must consider the 

possibility of an inside attacker. 

FD 1.3.3 The vulnerability assessment must be 

documented. 

Record 

Mitigation Strategies 

FD 1.4.1 The facility must identify and implement 

mitigation strategies at each actionable process 

step and include a written explanation of how the 

mitigation strategy sufficiently minimizes or 

prevents the significant vulnerability. 

Record 

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Scope* Req. No. Requirement DOC Rating Evidence 

FD 1.4.2 Mitigation strategies and accompanying 

explanations must be written. 

Record 

FD 1.4.3 Mitigation strategies must be subject to 

monitoring, corrective actions, and verification 

activities. 

FD 1.4.3.1 The facility must establish and implement written 

procedures for the monitoring of mitigation 

strategies. The monitoring activities must be 

documented. 

Policy, 

Record 

FD 1.4.3.2 If mitigation strategies are not properly 

implemented, the facility must establish and 

implement corrective action procedures. The 

corrective action must describe the steps to be 

taken to ensure that appropriate action is taken to 

correct and prevent identified problems. The 

corrective and preventive actions must be 

documented as records. 

Policy, 

Record 

FD 1.4.3.3 The facility must establish and implement written 

procedures to verify that: 

- Food defense monitoring is being conducted; 

- Appropriate decisions about food defense 

corrective actions are being made; 

- Mitigation strategies are properly 

implemented and are significantly minimizing 

or preventing the significant vulnerabilities; 

and 

- Reanalysis of the food defense plan has 

occurred as required. 

Policy, 

Record 

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Scope* Req. No. Requirement DOC Rating Evidence 

The verification activities must include: 

- Review of the food defense monitoring and 

food defense corrective actions records within 

appropriate timeframes; and 

- Other activities appropriate for verification of 

proper implementation of mitigation 

strategies. 

The verification activities must be documented as 

records. 

Food Defense Plan Reanalysis 

FD 1.5.1 The facility must conduct a reanalysis of the food 

defense plan as a whole at least once every 3 

years. 

Policy 

FD 1.5.2 The facility must conduct a reanalysis of the food 

defense plan as a whole, or the applicable portion 

of the plan, whenever: 

- A significant change made in the activities 

conducted at your facility creates a reasonable 

potential for a new vulnerability or a 

significant increase in a previously identified 

vulnerability; 

- New information is available about potential 

vulnerabilities associated with the food 

operation or facility; 

- The facility has found that a mitigation 

strategy, a combination of mitigation 

Policy 

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strategies, or the food defense plan as a whole 

is not properly implemented; and 

- FDA requires reanalysis to respond to new 

vulnerabilities, credible threats to the food 

supply, and developments in scientific 

understanding including, as appropriate, 

results from the Department of Homeland 

Security biological, chemical, radiological, or 

other terrorism risk assessment. 

FD 1.5.3 The reanalysis of the food defense plan must be 

completed prior to any change in activities, 

within 90 days of the start of associated 

production, or later with written justification. 

Policy 

FD 1.5.4 The facility must revise the written food defense 

plan if a significant change in the activities 

conducted at the facility creates a reasonable 

potential for a new vulnerability or a significant 

increase in a previously identified vulnerability or 

document the basis for the conclusion that no 

revisions are needed. 

Policy 

Records 

FD 1.6.1 Food defense records must: 

- Be kept as original records, true copies, or 

electronic records; 

- Contain the actual values and observations 

obtained during food defense monitoring; 

- Be accurate, indelible, and legible; 

- Be created concurrently with performance of 

the activity documented; and 

Record 

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Scope* Req. No. Requirement DOC Rating Evidence 

- Be as detailed as necessary to provide history 

of work performed. 

FD 1.6.2 Records must include: 

- Information adequate to identify the facility 

(e.g., the name, and when necessary, the 

location of the facility); 

- The date and, when appropriate, the time of 

the activity documented; 

- The signature or initials of the person 

performing the activity; and 

- Where appropriate, the identity of the product 

and the lot code, if any. 

Record 

FD 1.6.3 The food defense plan must be signed and dated 

by the owner, operator, or agent in charge of the 

facility when it is first completed, and when 

modified. 

Record 

FD 1.6.4 Food defense records: 

- Must be retained at the facility for at least 2 

years after the date they were prepared or 

after their use is discontinued. 

- Except for the food defense plan, offsite 

storage of records is permitted if such records 

can be retrieved and provided onsite within 

24 hours of request. The food defense plan 

must remain onsite. 

Record 

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USDA, AMS, SCP, SCI Audit Checklist 

Scope* Req. No. Requirement DOC Rating Evidence 

- If the plant or facility is closed for a 

prolonged period, the food defense plan may 

be transferred to some other reasonably 

accessible location but must be returned to the 

plant or facility upon request. 

*Scope Indicators: 

• CC – Cold Chain 

• FD – Food Defense 

• FD – Current Good Manufacturing Practices 

• HACCP – Hazard Analysis Critical Control Points 

• LAF – Low Acid Canned Food 

• LMF – Low Moisture Food 

• PC – Preventive Controls 

• QMS – Quality Management System 

• ST – Sanitary Transport 

• TR – Traceability 

• USDA/USAID – USDA and USAID Contract Requirements for International Procurement 

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