The Role of Monitoring in a Food Defense Plan

When considering monitoring procedures for mitigation strategies, it’s important to consider what existing practices, procedures, and conditions are in place around the APS and to consider the nature of the mitigation strategy and its implementation effectiveness. Your facility can consider how existing food defense trained and qualified employees and supervisors can incorporate monitoring a mitigation strategy into their normal operations or job duties.

In some circumstances, food defense monitoring may be incorporated into other physical security, maintenance, quality, or worker environmental health and safety responsibilities. For example, it may be most efficient to task an employee who frequently traverses the area to monitor the self-closing action of doors or door locks opened with key-swipe cards as part of their normal daily routine.

Who Will Monitor?

You should specify in your facility’s written procedures the position of the employee who will monitor your mitigation strategies and describe how they are to perform the monitoring procedure. The employee’s duties should include notifying management and following the food defense corrective actions procedures as specified in the FPD when observations or measurements indicate mitigation strategies aren’t operating as intended. When a person is assigned to perform monitoring, that person must have the education, training, or experience (or a combination thereof) necessary to perform the assigned duties. (21 CFR 121.4(b)(1)). Your facility has the flexibility to assign monitoring responsibilities consistent with this requirement. Such individuals who perform these duties may include, among others:

• Production line personnel;
• Equipment operators;
• Supervisors;
• Maintenance personnel; or
• QA personnel.

Production workers involved in food defense activities can help build a broad base of understanding and commitment to the culture and responsibility of ensuring food defense. It’s often useful to consider periodically assigning monitoring duties to an employee not normally stationed in an area where there’s an APS. This allows your facility to capture different perspectives and observations or identify a necessary modification to the current requirements.

When Do You Monitor?

Many food facilities find that non-routine or non-scheduled monitoring of food defense mitigation strategies is additionally important in situations such as:

1. During second- and third-shift manufacturing and warehouse activities.
2. When the number of facility contractors or temporary or substitute workers increases, or when unsupervised service providers are allowed access to production areas.
3. When seasonal extremes of temperature affecting environmental working conditions within the production area (e.g., open internal and/or non-secured external doors for ventilation and temperature control for worker comfort).
4. During spikes in community crime and violent incidents.
5. During product or packaging rework activities.
6. When non-staggered employee departures from receiving, production, and warehousing areas to break areas occur.
7. During temporary construction activity.
8. When automated, electronic systems (e.g., card readers, door alarms) are deactivated for repair or a system installation upgrade.
9. Immediately following the termination of disgruntled employee.
10. During an extended loss of facility power.

Monitoring versus Verification

Lastly, monitoring shouldn’t be confused as the verification activity. Food defense monitoring is a separate mitigation strategies management component from other activities, including corrective actions and verification. Monitoring activities can often identify when mitigation strategies aren’t effective and when there might be an increased probability of a successful attack on your facility’s product. In this comparison of terms, control of mitigation strategies around APSes are verified by routine monitoring. These are complimentary activities, and both are important in holistic food defense activities, but the two are different.

In the context of food defense, monitoring is the real-time observation and measurement of the execution of a set of validated design and implemented instructions for controlling a hazard/risk/threat to a facility, personnel, and/or product and packaging. Monitoring could include data outputs from instrumentation devices, visual inspections by personnel, and observations of procedure execution, but monitoring activities are the processes that must be used to detect a potential facility or product security breach.