FDU Guidance Document-Food Processing Plans, Allergen Control Plans and Recall Plans

New Regulations on Processing and Recall Plans in Part VI, Title 51, L.A.C. (updated 2011)

New Regulations on Allergen-Control Plans in Part VI, Title 51, L.A.C. (updated 2020); 21 CFR 117 Subpart B 

For General Manufacturing Firms

Processing Plans:

  • Plans must be written, implemented, and maintained up-to-date with any changes made to the firm's operational procedures.
  • Plans must be available for review by your inspector upon request.
  • Plans must include the following elements:
    • list of steps in process, including potential biological, physical, chemical, or radiological hazards that may be introduced at each step;
    • description of controls used to address the hazards listed above;
    • description of methods used to monitor the controls noted above;
    • records of corrective actions taken as a result of monitoring above;
    • and records of changes to plan as a result of corrective actions documented above.

NOTE: If a HACCP plan is currently in use, a separate food processing plan is not required.

 

Allergen-Control Plans:

  • Plans must be written and available for review by your inspector upon request.
  • Plans must address the presence of the eight major food allergens in ingredients and finished foods.
  • Plans must address workflows and circulation of products throughout the facility.
  • Plans must address materials stored in morgue areas, pending QC approval, in-process products, and products in storage awaiting distribution.

 

Recall Plans:

  • Plans must be written and available for review by your inspector upon request.
  • Plans must have a provision to notify your inspector and/or the Central Office staff of the Food and Drug Unit in the event of a product recall. If goods are shipped interstate, additional provisions must be made to notify the local or regional federal Food and Drug Administration office.
  • Plans must include the following elements: 
    • identity of products including brand name and lot/batch code;
    • reason for recall;
    • date and means of discovery of the reason;
    • total affected product produced and amount estimated to be in distribution;
    • list of consignees that may have received affected product;
    • contact information for the firm's recall coordinator;
    • and, proposed strategy for conducting the recall, including media notifications, method of evaluating whether the recall needs to occur at the level of wholesale distribution, retail distribution, or the consumer; method of checking the effectiveness of the recall, including follow-up store visits or telephone/email contacts; method of determining whether changes to the plan are warranted by the results of the effectiveness checks.

 

Additional Resources for Processing Plans
 

There is no perfect analogue to a processing plan, but it is similar to a HACCP plan or a food safety plan focussed on process-related hazards and controls. In this context, the Food Safety Plan Builder tool from FDA may be a useful starting point. 

 

Additional Resources for Allergen-Control Plans

 

Additional Resources for Recall Plans