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Updating your Current HACCP Plan Facebook Live Q&A
Updating your Current HACCP Plan Facebook Live Q&A

As a 19-year veteran of AIB International, Cornelius Hugo knows food safety plan initatives and can speak to the transition of HARPC. On Feb. 9 hundreds of food professionals watched Hugo on Facebook Live explain this complex transition. To view the entire Facebook Live event, click here:

Part 1

Part 2

Due to time limitations, not all questions were answered during the live event, as a result this blog post delivers those answers and provides more information.

+ Has anyone had a recent FDA inspection where they reviewed your Food Safety Plan?

Yes, AIB’s clients have been visited by the FDA and the basic three questions being asked by the FDA, include the following:

The reason for this question is to see if the facility has developed its Food Safety Plan according to Part 117 – Current Good Manufacturing Practice, Hazard Analysis and Risk-Based Preventive Controls, also known as the Preventive Controls Rule for Human Food (PCHF). If not, the FDA will record the failure as an observation in Form 483 and the facility will have up to 15 working days to respond to how it will address and correct.

  • May I see your Food Safety Plan?

The reason for this question is that the PCHF rules require the entity implementing the identified preventive controls be held responsible for doing so. This can be the supplier of the receiving facility, the local supplier to the supplier of the receiving facility, the receiving facility, or the customer of the receiving facility. This enhancement will eventually ensure that someone within the food supply chain will address and control hazards that require a preventive control.

  • May I see your Supply Chain Control Program?

The reason for this question is the qualified individual requirements, as specified in Part 117. The FDA wants to verify that such individuals are being trained according to their assigned duties and responsibilities. This implies formal and documented education and training of all qualified Individuals above and beyond their basic GMP training.

  • May I see your training records?

+ Do you have to be a PCQI to develop the plan?

The response to this question is contained in § 117.180 Requirements applicable to a preventive controls qualified individual” of Part 117 - Subpart C, which reads:

(a) One or more preventive controls qualified individuals must do or oversee the following:

(1) Preparation of the food safety plan (§ 117.126(a)(2));

(2) Validation of the preventive controls (§ 117.160(b)(1));

(3) Written justification for validation to be performed in a timeframe that exceeds the first 90 calendar days of production of the applicable food;

(4) Determination that validation is not required (§ 117.160(c)(5));

(5) Review of records (§ 117.165(a)(4));

(6) Written justification for review of records of monitoring and corrective actions within a timeframe that exceeds 7 working days;

(7) Reanalysis of the food safety plan (§ 117.170(d)); and

(8) Determination that reanalysis can be completed, and additional preventive controls validated, as appropriate to the nature of the preventive control and its role in the facility's food safety system, in a timeframe that exceeds the first 90 calendar days of production of the applicable food.

To review, the Food Safety Plan must be developed and implemented, or its development and implementation overseen by a PCQI. Other employees can and should participate in this effort, but they do not have to be PCQIs.

+ Is Juice HACCP exempt from FSP?

Yes! I would also recommend reading the AIB blog post, Tip of the Week: What to Expect from FDA Guidance for Juice HACCP Regulation.

  • 21 CFR part 120 contains the legal requirements concerning the safe and sanitary processing of fruit and vegetable juices. 
  • Part 117, § 117.5 Exemptions states
    • (c) Subparts C (Hazard analysis) and G (Supply-Chain Control) of this part (Part 117) do not apply with respect to activities that are subject to part 120 of this chapter (Hazard Analysis and Critical Control Point (HACCP) Systems) at a facility if you are required to comply with, and are in compliance with, part 120 of this chapter with respect to such activities.

If the receiving facility (the juice processor) buys the fruits and vegetables directly from farmers the facility should carefully review the requirements of the produce rule and see if there are parts that would apply, for examples the control of pesticides.

+ If I have multiple processes with multiple HACCP plans, how do I integrate that into a Food Safety Plan? Am I taking a copy of each and putting them into one book with the expanded written programs/processes, or would I add that information to each HACCP plan?

There is no single right way to answer this question. Let us try this approach and see if it helps. A standard HACCP Manual Table of Content looks like this:

Click the graphic to download a PDF version.

 

So, a facility that produces 1 product or family of products would write a HACCP Plan consisting of numerals 1 through 5.

  • A facility that produces 2 products or family of products would include #6, and so on. Given the above HACCP Manual, there is an option to combine HACCP and HARPC into one Food Safety Plan Manual:

  • Leave 1 through 4 the same since the apply to the whole facility

    • Make sure a PCQI is identified as a food safety team member

  • Take #5 and

    • Assess whether there can be an unintended use of the product that could result in a hazard to the health to consumers. Add that to the product description.

    • Include the narrative of the process flow diagram steps.

    • Redo the hazard analysis according to the format and risk analysis approach contained in the FSPC Preventive Controls for Human Food course.

      • This will leave current CCPs (Process Preventive Controls) as they are, however the justification for having them must be added.

      • This would identify if other Preventive Controls (PC) are needed, such as allergen, sanitation, supply chain, etc.

      • Develop the Master Plans for newly identified PCs.

    • Records:

      • If new Preventive Controls are identified, say a PC to make sure labels are correct at receiving and correct labels are used when packaging the product regarding allergens, then a review of current records to assess effectiveness of label checks at receiving and at packaging would help determine whether they are robust enough and whether they capture all the information needed to assure no label with errors gets into the facility and no misbranded product leaves the facility.

      • If that is the case, then current records can be used to capture such information.  If not, then current records can be modified to do so.

      • Similar if a unique allergen clean-up has been identified as a PC, based on the production logistics and sequence. Then a Master Plan is written for such allergen cross-contact prevention PC and a look at current records will determine whether they a good enough to capture all the information required.

      • Similar for sanitation and supply chain controls.








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