Most readers of these periodic food defense articles are familiar with activities associated with the design and implementation of a Food Defense Plan (FDP) that complies with the requirements of FDA 21 CFR 121, Mitigation Strategies to Protect Food Against Intentional Adulteration (IA rule). The rule is aimed at preventing intentional adulteration from acts intended to cause wide-scale harm to public health, including acts of terrorism targeting the food supply. Many of your facilities are, or soon will be, operating in compliance with provisions under this regulation. It’s useful to revisit the role of required monitoring.
Food Defense Plan Basics
Food defense monitoring is defined by the FDA as follows: “To conduct a planned sequence of observations or measurements to assess whether mitigation strategies are operating as intended.” Food defense monitoring procedures must be performed at sufficient frequency and include keeping records, as appropriate, to the mitigation strategy’s nature and management component and its role in the facility’s food defense system. (See 21 CFR 121.140)
Food defense monitoring is conducted by appropriately trained food defense individuals who can assess whether mitigation strategies are operating as intended (21 CFR 121.3) and with adequate frequency (21 CFR 121.140(b)). Food defense monitoring is just one of three mitigation strategies management components. The other two are food defense corrective actions and food defense verification.
Regulations require your facility to apply appropriate mitigation strategies management components by considering the nature of the strategy and its role in your facility’s food defense system to ensure its proper implementation. (21 CFR 121.138). As purposely written into the rule, your facility has the flexibility to identify and implement food defense monitoring procedures that are appropriate for your own unique operating environment. Your facility must first determine if it has Actionable Process Steps (APS), which are points steps or procedures in a food process where significant vulnerabilities exist, at which mitigation strategies can be applied, and that the strategies are essential to significantly minimize or prevent the significant vulnerability. If there are no APSes, then your facility wouldn’t need to establish mitigation strategies.
Some aspects of food defense monitoring are similar to the food safety monitoring requirement as part of the Preventive Controls for Human Foods (21 CFR Part 117) rule (and Preventive Controls for Animal Foods 21 CFR Part 507). For example, each preventive control is monitored as appropriate to the nature of the preventive control and its role in the facility’s food safety system. The same requirement applies to the Food Safety Modernization Act IA rule.
Food safety monitoring is more likely than food defense monitoring to document that the minimum or maximum values for parameters have been met. With food safety hazard control, monitoring is frequently assigned as a continuous process. Food defense monitoring, in comparison, often occurs less frequently. Monitoring can be continuous, or periodic, and monitoring intervals can frequently change. For example, mitigation monitoring activity frequency will be heightened when there are access points to production areas that contain APSes and where there’s no continuous mitigation monitoring system available, such as in the use of continuous surveillance CCTV.
As with the design, implementation and monitoring of a Food Safety Plan or FDP is no less important. However, monitoring procedures, the frequency of monitoring, and who’s assigned to conduct the monitoring may be different. In some cases, the same employee may monitor both food safety hazard control and food defense mitigation strategies in areas they are familiar with and stationed at. Also, a food facility experiences normal changes in physical facility, equipment design and installation layout, changes in personnel, and changes in food ingredient and packaging materials involved in production around APSes. As these changes occur, so might the vulnerabilities and their assigned mitigation strategies, which may not remain effective. Monitoring can determine if an FDP needs to address the effectiveness of implemented mitigation.
Your entire facility FDP must be reanalyzed at least every three years (21 CFR 121.157(a)). The following circumstances also necessitate reanalysis, perhaps even sooner than three years:
- A significant change to activities creates a reasonable potential for a new vulnerability or a significant increase in an existing vulnerability.
- Your facility learns that there’s new information about potential vulnerabilities associated with the food operations within your facility.
- An assigned mitigation strategy or FDP isn’t properly implemented and may allow a food defense gap to exist.
- The FDA, or other industry facility, learns of the discovery of new vulnerabilities, credible threats to the food supply, and/or developments in scientific understanding (21 CFR 121.157(b)).
Document, Document, Document
Monitoring activities must be documented and are subject to food defense verification (21 CFR 121.140(c)). Your facility’s food defense monitoring procedures should answer the following four questions:
- What specific APSes and their mitigation strategies will be monitored?
- How will monitoring be conducted?
- How often will monitoring be conducted?
- Who will do the monitoring?
Regardless of how a mitigation strategy is monitored, monitoring activities must be documented (21 CFR 121.140(c)). The frequency of monitoring depends on the nature of the mitigation strategy and the facility’s food defense system. Your facility can determine the frequency of monitoring needed so long as the frequency is adequate to provide assurances that the mitigation strategies are consistently performed (21 CFR 121.140(b)).
A monitoring procedure occurring on periodic, but irregular, intervals can be beneficial for the facility in two ways:
- It’s more difficult for an inside attacker to anticipate a monitoring failure, and
- It requires less human and other resources than more frequent monitoring.
For mitigation strategies that are monitored concurrently with their implementation, the monitoring frequency would depend on the intended mitigation strategy frequency. For example, the use of tamper-evident seals on transport conveyances may be determined by the frequency and sampling of received deliveries. The monitoring procedure would be to check the original seals for integrity or indications of tampering and match seal or documentation numbers upon arrival of the load at the receiving dock, before off-loading materials from the transport vehicle.
How Should You Monitor?
In some cases, it may be necessary to develop a new procedure to adequately monitor a mitigation strategy. In many instances, facilities may elect to have an employee observe whether the mitigation strategy is operating as intended. However, the flexibility to monitor mitigation strategies in other ways, such as electronic monitoring of an access control device—for example, automated monitoring and alarming of electronic locks on a door or gate that prevents access to an APS. Effective monitoring procedures can involve human observation, machine (electronic) observation, or a combination of both.
Where mitigation strategies may lend themselves to constant monitoring, exception records to document monitoring may be appropriate. This can be done through an automated system that’s put in place to monitor whether the mitigation strategy is operating as intended. For example, a mitigation strategy may be to restrict access using a locking door that’s opened only by a specially coded access card. If the door is left ajar and does not self-close for any period beyond the time it takes to enter and re-secure the door, an automated monitoring system alarm indicates that the door isn’t secured. Whenever the system alarms, an automatically generated exception record documents the instance where and when the mitigation strategy wasn’t operating as intended.
In addition to technology-based mitigation strategies, there also may be personnel-based mitigation strategies that lend themselves to constant monitoring. Personnel-based mitigation strategies (e.g., a two-person rule) are monitoring methods that restrict unauthorized access to designated sensitive areas to help ensure the strategy is operating as intended.
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;
- 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:
- During second- and third-shift manufacturing and warehouse activities.
- When the number of facility contractors or temporary or substitute workers increases, or when unsupervised service providers are allowed access to production areas.
- 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).
- During spikes in community crime and violent incidents.
- During product or packaging rework activities.
- When non-staggered employee departures from receiving, production, and warehousing areas to break areas occur.
- During temporary construction activity.
- When automated, electronic systems (e.g., card readers, door alarms) are deactivated for repair or a system installation upgrade.
- Immediately following the termination of disgruntled employee.
- 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.
Verification is the process by which an evaluation is made of whether a set of implemented mitigation strategies around APSes has been working as designed. Monitoring, on the other hand, identifies important points of potential system failure that could, if not mitigated, increase the probability of a successful intentional product or packaging adulteration attack, resulting in loss of product security that could adversely impact public health or cause widespread economic disruption.
Somebody Needs to Do It
I’ll end the article by re-telling a very clever short story, famously used the world over in organizational development circles. The brief story speaks so well to the cause of system breakdowns:
“There was an important job to be done and Everybody was sure that Somebody would do it. Anybody could have done it, but Nobody did it. Somebody got angry about that, because it was Everybody’s job. Everybody thought Anybody could do it, but Nobody realized that Everybody wouldn’t do it. It ended up that Everybody blamed Somebody when Nobody did what Anybody could have done!” (Anonymous)
Park is the principal for Food-Defense, LLC. He has practiced food protection technical and management consulting for 46 years, is an FDA-recognized international processing authority, and an FSPCA PCQI Lead instructor. Reach him at firstname.lastname@example.org.
Food Defense Plan Builder
On Sept., 19, 2019, the FDA launched an updated version of the Food Defense Plan Builder to help companies meet the requirements of the Intentional Adulteration rule under the FDA Food Safety Modernization Act (FSMA). According to the FDA, the free, updated Ver. 2.0 tool has been aligned with the requirements in the IA rule so that it can be used to easily create food defense plans and support compliance with the rule. The tool is available with a registration at: https://www.fda.gov/food/food-defense-tools-educational-materials/food-defense-plan-builder