Recall plan preventive controls explained!…

In this post we’re going to cover the FDA’s requirements for recall plan preventive controls and how they may differ from those required in the BRC Food Safety standard. This is one of a series of posts on preventive controls – if you would like to read the rest, you can find them here:

FSMA Companion Articles Link

Process preventive controls

The rule states what elements of recall controls must be in place, but they do not provide exact instructions as to how you must meet these.  The facility needs to determine what level of control is needed, to ensure that the rule is met effectively.

Ҥ117.139 Recall Plan

For food with a hazard requiring a preventive control:

(a) You must establish a written recall plan for the food.

(b) The written recall plan must include procedures that describe the steps to be taken, and assign responsibility for taking those steps, to perform the following actions as appropriate to the facility:

(1) Directly notify the direct consignees of the food being recalled, including how to return or dispose of the affected food;

(2) Notify the public about any hazard presented by the food when appropriate to protect public health;

(3) Conduct effectiveness checks to verify that the recall is carried out; and

(4) Appropriately dispose of recalled food—e.g., through reprocessing, reworking, diverting to a use that does not present a safety concern, or destroying the food.”

Reference: FDA FSMA Title 21 of the Code of Federal Regulation Part 117—Current Good Manufacturing Practice, Hazard Analysis, and Risk‐based Preventive Controls for Human Food

So, to review the rule as it’s written, what the FDA are saying is:
  • There must be a written recall plan in place, which includes procedures and records to ensure that food can be recalled effectively.
  • The procedures must include communication plans
    • To ensure that those involved in the handling of the product can be notified quickly, to effectively recall the product.
    • To ensure that the public are notified quickly and effectively, through the necessary channels
  • The procedures must also include checks to reconcile the product, to ensure that all affected product has been captured by the recall.
  • Finally, the procedure must ensure that all affected product is disposed of in an appropriate manner.
Comparison to BRC
If you adhere to the BRC Food Safety Standard you will comply with the recall plan requirements of the rule.  You would not however, comply with the BRC Food Safety Standard – if you were to just comply with the FDA’s requirements of the recall plan, because the BRC standard is more detailed, or of a higher standard.

The additional requirements in section 3.11 of the BRC standard are:

  • Incidents such as disruption to key services, natural disasters and malicious contamination or sabotage must be included in the procedure. This is to ensure that the disruption to the customer is minimised and also to ensure that any product indirectly affected by the incident is managed.
  • Pre-agreed contingency plans must be in place for the above types of incidents, so that they can implemented quickly if required.
  • The recall procedure must be tested at least annually.
  • If a recall was to occur, your BRC certification body must be informed within 3 working days.
I hope you’ve found this useful, in the next post we are going to look at how to structure your risk assessments; to bring together the individual risk assessment elements of allergens, sanitation, supply-chain and the process.
As always, if you have any questions, please feel free to ask them in the reply box below and I’ll answer them for you.

If you’re looking to introduce a recall plan into your facility, you may find our brand new, best practise recall documentation pack useful, just click on the image below for more information…

recall plan

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