QS-109
Food Defense Plan
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1.0 Purpose
The purpose of the Food Defense plan is to describe how Ion Nutritional Labs will protect the
food supply/product against intentional contamination due to sabotage, terrorism,
counterfeiting, or other illegal, intentionally harmful means.
2.0 Scope
This procedure is applicable to all food processes at Ion Nutritional Labs.
3.0 Responsibility
3.1 A multi-disciplinary Management Team (Operations, Quality, and Facilities) is
responsible for ensuring that the organization is prepared to respond to emergency
situations and for preparing a Food Defense Plan.
32 It is the responsibility of all employees to follow the Food Defense Plan and act as the
first line of defense in guarding against any intentional contamination.
3.3 It is the responsibility of Quality to organize a challenge of the Food Defense Plan
annually.
4.0 Definitions
4.1 Emergency Situation — an event that can have a negative impact on food safety, that is
not controlled by the daily controls of the Food Safety Management System
4.2 Food Defense Plan — the practices implemented to control/minimize the risk of an
intentional contamination incident, which can reduce the overall vulnerability of the
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facility’s food operation from intentional contamination
4.3 Intentional Contamination — a deliberate action to introduce something into a product,
often with intention to do harm to the customer, company, or both
4.4 Insider Attacks/Threats — acts of sabotage or adulteration committed by disgruntled
employees, consumers, or competitors (Acts of Terrorism)
4.5 Broad Mitigation Strategies — steps taken to defend the facility against intentional
contamination, in which identified deficiencies can then be assessed and action plans
can be developed to improve security measures as needed (must be included in the Food
Defense Plan)
5.0 References
5.1 Training Presentation: cGMP, HACCP/HARPC, Food Safety and Defense, Allergen
Awareness, Internal Audits, Control of Glass, Brittle Plastic, Ceramics, and Wood,
Dietary Supplement, and Pet Supplement Overview
Sue FDA Food Safety Modernization Act (IA Rule)
33 QS-108, SOP, Corrective and Preventive Actions
5.4 E-601, SOP, Vendor Qualification
nF) Disaster Recovery and Business Continuity Plan
5.6 QS-105, SOP, Food Safety Plan
5.7 A-108, SOP, Good Manufacturing Practices and Personal Hygiene
5.8 A-117, SOP, Personnel Qualifications
5.9 A-113, SOP, Training Procedure
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Food Defense Plan
5.10 QS-107, SOP, Recall Procedure
5.11 A-118, SOP, Management Review of Quality Metrics
5.12 C-502, SOP, Document Storage, Retention, and Destruction
5.13 H-101, SOP, Internal Audits
5.14 QS-112, SOP, Core Quality Systems and Quality Events
5.15 21 CEFR part 121 Mitigation Strategies to Protect Food Against Intentional Adulteration
6.0 Food Defense Plan
6.1 Senior Management will prepare a Food Defense Plan that includes the following:
6.1.1 The names of the management team members who are responsible for food
defense.
6.1.2 Methods to ensure only authorized personnel have access to manufacturing
storage areas.
6.1.3 Measures to ensure the secure the storage of raw materials, packaging,
equipment, and hazardous chemicals.
6.1.4 Measures to ensure that finished product is held under secure storage and
transportation conditions.
6.1.5 Methods implemented to record and control access to the premises by
employees, contractors, and visitors.
6.1.6 Requirements of employees to be trained on food defense practices (New Hire
and Annual cGMP Training).
6.2 Employee training resources are available through the FDA website.
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6.3 The Food Defense Plan is reviewed annually, at a minimum, to determine the
effectiveness of the procedure, methods, and practices, or when changes occur that
could impact the Food Defense Program.
6.4 Food Defense Audits (Broad Mitigation Strategy Checklist) are performed annually, at
a minimum, to provide assurance to our customers, to assess or improve the level of
food defense safety, and to demonstrate compliance to food safety regulations.
7.0 Forms and Records
7.1. The Food Defense Plan will be maintained by Quality, to include all related
documentation.
7.2 Any activity found to directly affect the security of the facility will be reported during
Management Review.
7.3. The Food Defense Plan and all related documentation will be maintained as per SOP
C-502 Document Storage, Retention, and Destruction.
7.4 The Food Defense Plan will be issued a report number as outlined in SOP QS-112 Core
Quality Systems and Quality Events, to ensure proper traceability.
8.0 Broad Mitigation Strategies
8.1 Broad mitigation strategies include security and screening procedures for the facility,
materials, and people. Understanding and evaluating broad mitigation strategies will be
used to document current monitoring/verification practices and determine any gaps or
deficiencies. Broad Mitigation Strategies for food defense are similar to the Current
Good Manufacturing Practices (GMPs) or prerequisite programs for food safety.
8.2 Broad Mitigation Strategy Responses:
8.2.1 Not Applicable — the measure (question) is not applicable or not appropriate
for the facility/company
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8.2.2 Currently Doing — the measure (question) is already being addressed
sufficiently by the facility/company
8.2.3 Gap — the measure (question) is currently not being addressed or not fully
being addressed by the facility/company. If a gap is detected, it will be
documented in the comments/action steps of the Broad Mitigation Strategies.
Corrective Action will be taken to ensure the gap is addressed and resolved.
This action will be verified.
9.0 Vulnerability/Mitigation Strategies
9.1 Vulnerability/Mitigation strategies assessment is intended to assist in identifying,
quantifying, and prioritizing facility weaknesses regarding food safety and defense,
offering mitigation strategies/suggestions for situations with a potential risk for
intentional contamination.
9.2 Corrective/Preventative Actions will be assigned by Quality to the respective
department. Quality will document all corrective actions. Follow-up to corrective
actions will be performed, along with verification to ensure effectiveness.
10.0 Intentional Contamination
10.1. The possibility of intentional contamination is a part of safety considerations and
measures to prevent sabotage.
10.2 In the event of a suspected incident involving intentional contamination of food, Ion
Nutritional Labs has implemented procedures and plans to assist and minimize the
adverse consequences of the incident.
11.0 Inside Attack or Threat
11.1 Ion Nutritional Labs has developed First Response steps in the event of an inside attack
or threat. Refer to the Disaster Recovery/Business Continuity Plan (Act of Terrorism).
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11.2 Employees are trained to recognize and report any unusual or suspicious activity.
12.0 Challenging the Food Defense Plan
12.1 Annually, the Food Defense Plan will be challenged to validate whether procedures are
effective when implemented as expected, as well as highlighting any failures in
implementation. The challenge will be performed as outlined in the following steps.
12.1.1 Decide on a challenge action. For example, a common food defense challenge
test is a penetration test, in which an unauthorized person attempts to gain
access to a sensitive area.
12.1.2 Create a food defense challenge report. In the report, document exactly what
steps are planned in the challenge test. Include what, when, how, who, and
next steps.
12.1.3. Include written contingency plans in case of escalation, for example, what will
be done if police are called.
12.1.4 Get approval for the plan from Senior Management.
12.1.5 In the report, record the following:
12.1.5.1 Name of Senior Manager who has signed off on the plan.
12.1.5.2 Names of employees who have been informed of the challenge test.
12.1.5.3 Names of people who will be working in the affected areas at the
time of the challenge, ensuring that all have been trained in Food
Defense.
12.1.5.4 A description of what staff are supposed to do in the chosen
scenario and what procedures are to be followed.
12.1.6 Define and document the criteria for failure and success:
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12.1.6.1 What will happen if the food defense procedures are working
100% correctly?
12.1,6.2 What will happen if the food defense procedures are working only
partially?
12.1.6.3 How might the scenario progress if there is a complete failure of
procedures and systems?
12.1.7 Run the challenge. Have a staff member observe from a discreet distance.
12.1.8 Describe in the report what happened.
12.1.9 Convene a meeting of the food defense team and analyze the results of the
challenge.
12.1.10 Perform root cause analysis and raise corrective actions for any failures in the
system.
12.1.11 Take action to prevent a scenario like this from reoccurring, based on the root
cause analysis performed.
13.0 Revision History
| Rev | Date | Description of Changes | CCR # | By |
|-----|----------|------------------------|-------|----|
| 0 | 04/04/17 | New Added definitions of Intentional Contamination and Insider Threat/Attack. Added reference to Training Presentation: to include HARPC, Internal Audits, Control of Glass, Brittle Plastic and Ceramics, and Pet Supplements, Added SOP H-101 Internal Audits. Added reference 21 CFR part 121 Mitigation Strategies to Protect 10/07/20 CC-20-0712 C. Martinez Food Against Intentional Adulteration, Added reference New Hire and Annual cGMP Training. Added reference to Intentional Contamination. Added Inside Attack or Threat with reference to Disaster Recovery/Business Continuity Plan. Defined audit frequency Schedule review: updated format and logo. Clarified steps 12/27/23 throughout procedure. Added requirements for food defense plan CC-23-0616 K. Burris challenge. | 17-0329 | S. Millar |
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