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Monitoring for the FSMA proposed rule on intentional adulteration

The proposed FSMA rule for intentional contamination adds requirements for monitoring, verification and record-keeping that was not part of previous guidance documents. Experienced quality practitioners will want to skip down to “what’s different.” If you are new to these terms, read on.



Monitoring is defined as conducting a planned sequence of observations or measurements to asses whether focused mitigation strategies are consistently applied. Monitoring would be performed to ensure that focused mitigation strategies are consistently applied, and to provide a record for use in verifying consistent application.

Monitoring could take the form of a log or checklist. The operator or lead working in the area could confirm on a recurring basis that each focused mitigation strategy is being performed. If for example, one focused mitigation strategy is to keep a particular area locked, the monitoring log can check to see if it is locked. If a focused mitigation strategy is to have a camera recording a specific operation, the monitoring might be a check that the camera is seeing the operation and another check that the recording is functioning.

For most monitoring activities it will be a binary action – either the door is locked or it isn’t. Simple checklists could serve this purpose, or more sophisticated records if they are already being used in other systems. Note, each focused mitigation strategy should be monitored, e.g. Each should have a line on the checklist.

Corrective actions are also required for monitoring activities and should be defined in advance and documented. For example, if a door that should be locked is not locked, the area is inspected and supervision notified. These procedures could be part of the checklist so that there is no question as to the corrective actions to take.


Verification is simply making sure that monitoring is properly occurring. The definition is “those activities, other than monitoring, that establish that the system is operating according to the food defense plan.”

One example of verification of monitoring is a periodic observation of the monitoring activity by a supervisor. Another example is having an independent person verify the same results as the person monitoring.

Verification could also include a review of filed monitoring logs to insure they are being completed and filed and that gaps are not recurring. If there are recurring gaps that are not resolved by corrective actions, the choice of focused mitigation strategies might not be suitable and need to change, or other training and reinforcement may be required.

Record Keeping

Written records must be maintained to insure there is a food defense plan, and that the monitoring and verification processes are being performed. Training must also be documented.
The food defense plan must include written identification of the “actionable steps.” It must also include the steps leading to that identification and the written focused mitigation strategies. See our two related blog posts on identification of actionable steps:

2 ways to look at vulnerability assessments (Part 1)
2 ways to look at vulnerability assessments (Part 2)

Procedures for monitoring must be written, and included desired corrective actions if a monitoring steps finds a gap. Monitoring records should be retained for verification. Verification activities must be documented.

Training documentation should include the topics, names and date of training. I recommend it also include qualification information on the trainer.

Training for the FSMA proposed rule on intentional contamination

What’s Different than quality monitoring and verification?

The main difference is the frequency of monitoring. In the food safety world we are often continuously monitoring; especially our critical control points. Even a brief non-compliance to those controls could impact the health of our consumers.

Intentional contamination is another matter. The FDA makes the point that it is unlikely that a willful attack to contaminate the food will occur at the same moment as a lapse in your mitigation measure. So non-continuous monitoring would suffice.

There is no guidance as to how often you must monitor, so you will have to use your judgment. The appropriate frequency will depend a great deal on the mitigation measure. A camera and recording for example, once tested, isn’t expected to fail in the next few minutes. A locked door that has a lot of traffic, however, could be locked one minute and ajar not long after.

I suggest that at the time you are defining the monitoring activities for each focused mitigation strategy that you define the frequency you will monitor.


Identify your actionable process steps (see links above) using either of two methods. Document them in your food defense plan. For each actionable process step:

• Identify one or more focused mitigation strategies
• For each mitigation strategy, determine a monitoring method, monitoring frequency, and prescribed corrective action.
• For your monitoring items, group them by frequency and create checklists (i.e. hourly checklist, weekly checklist).
• Determine verification activities and frequency, based on some multiple of the monitoring frequencies (i.e. daily for an hourly checklist and monthly for a weekly checklist).
• Develop record keeping forms and retention policy
• Develop training forms

FSMA proposed rule: Implications for the Food Def...
Training for the FSMA proposed rule on intentional...


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