Food Defense Reanalysis

Food Defense Reanalysis

Reanalysis, Records & Training Requirements

In part 4 of our food defense series - Food Defense Management Components, we reviewed the requirements for properly monitoring mitigation strategies at each actionable process step. We then discussed how corrective actions must be taken when monitoring reveals that a mitigation strategy failed or was incorrectly implemented. Lastly, the element of verification is necessary to make sure the program, as a whole, is properly implemented and records are being reviewed as appropriate.

In today’s part 5 of our series, we will conclude with understanding the current requirements for reanalyzing your program, along with recordkeeping and training responsibilities.

Food Defense Management Components

Reanalysis

What is reanalysis and when is it required?

Reanalysis is the process of analyzing something again. In this instance, it simply means that the program must be reviewed as appropriate to make sure it is still effective. The Mitigation Strategies to Protect Food Against Intentional Adulteration rule states that reanalysis must be done:

  1. At least every three years
  2. Whenever changes are made at your facility that may create the opportunity for a new vulnerability 
  3. When a significant increase in a previously recognized vulnerability has been identified
  4. Whenever information about new vulnerabilities associated with the process or facility are identified
  5. If you find the program, either part or as a whole, is not being properly implemented
  6. Whenever FDA requires a reanalysis due to new identified vulnerabilities and threats to the food supply,

If any of the above situations apply, then reanalysis should be done as quickly as possible to ensure any new potential vulnerabilities are quickly mitigated.

Records and Record Retention

Records

We have all heard of the saying, if you didn’t record it, you didn’t do it! It is up to each facility to prove that all components of the food defense rule are in place and effective. The best way to do this is by keeping records of the program and implementation.
Records include the food defense plan as a whole, as well as any supporting documents, such as records of monitoring, corrective actions and verification checks. As with any regulated program, effective recordkeeping is crucial in proving compliance to required implementation.

Food Defense Plan records should:
   Be original, true copies or electronic
   Be accurate and legible
   Be generated in real time (as the activity happens)
   Contain actual values/observations when appropriate
   Contain necessary details to show compliance
   Have the facility name included (as address if multiple facilities)
   Be properly dated and contain times of activity performed
   Contain the initials or signature of the person performing the activity
   Identify the product and lot code/traceability when necessary

Record Retention

Records must be retained for at least 2 years from the date that they were prepared. Offsite storage of records is acceptable if they can be retrieved within 24 hours of request by a regulatory official.The current food defense plan, however, must be kept on site at all times.  Even if the plan gets discontinued at some point, it still must be retained for at least 2 years after discontinuance.

Training Requirements

In line with all of the FSMA requirements, anyone carrying out key activities of the plan must be a qualified individual. A qualified individual is defined in the rule as “a person who has the education, training, or experience (or a combination thereof) necessary to perform an activity required under subpart C of this part, as appropriate to the individual’s assigned duties.” That qualified individual does not necessarily have to be an employee of the establishment.

To be a qualified individual, one can simply take a training class recognized as adequate by FDA, such as our
Intentional Adulteration - Conducting Vulnerability Assessments class, or otherwise be qualified through other training or job experience. Those individuals that are assigned to actionable process steps must also have training in food defense awareness. Individuals who have supervisory roles within the program must also be qualified, either by training or experience, to do so.

Summary

Keeping current with food safety incidents and potential threats to the food supply from acts of intentional adulteration is an ongoing process all food manufacturing facilities must now consistently practice. Having a robust food defense plan with a thorough vulnerability assessment and with effective mitigation strategies, monitoring and prompt reanalysis will go a long way in preventing acts of intentional adulteration at your facility. Taking proactive and preventive measures, such as ongoing employee training and frequent verification activities, will help with keeping the program fresh and continuously improving.


We hope that our food defense series has been helpful with understanding the requirements under the new food defense rule, Mitigation Strategies to Protect Food Against Intentional Adulteration. If you still have questions about how to properly implement these new requirements, we encourage you to take one of our upcoming food defense classes. If you need a more personalized approach, contact us today to schedule a free consultation or an in-house training.

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