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Your HARPC Plan – hazards explained

Ensuring that your HARPC plan covers the hazards that are specific to your particular product and process is key…

Typically, in HACCP we try to include all the hazards that could possibly occur, to try to ensure that nothing is missed.  We can’t do this in HARPC for two reasons;

  1. The FDA have stated that the hazards included in the plan must be those that could ‘reasonably occur’
  2. If we include all the possible hazards (not just those that could be reasonably occur) then we will end up with too many protection measures that are unfocused

Focusing on the really pertinent hazards is the aim.
This way your HARPC plan will deal with the true food safety risks.

In order to make sure that all relevant hazards are highlighted in preparation for the HARPC plan, it is a good idea to put a structure to your scoping assessment. The FDA have provided a number of categories or types of hazards that should be included, therefore we can use these to develop our structure, as detailed below.

The FDA have stated that the hazards could occur because:

  • they are inherent to the raw material or product
  • they occur through error during the process
  • be carried out deliberately for economic gain (for food safety only)

So here I would split this into 4 groups of hazards:

  1. Inherent raw material hazards
  2. Raw material hazards from food fraud
  3. Processing hazards
  4. Inherent finished product hazards

The FDA have identified the following as hazards which must be included:

  • the environmental
  • the recipe or formulation
  • the manufacturing processes
  • the fabrication of the facility
  • the equipment used
  • the tools used
  • the intended use of the food

So, we can now fit these hazards into the 4 groups, as follows:

1.Inherent raw material hazards
►ingredients (inherent risks)

2. Raw material hazards from food fraud

3. Processing hazards
►Environmental (facility)
►Fabrication
►Equipment
►Manufacturing process
►Tools used

4. Inherent finished product hazards
►Recipe or formulation
►Including intended use
►Environmental (storage)

In my opinion, by using the above as a guide, perhaps presented in a table format – so that the hazards can be documented next to each group and sub-group, it will make it much easier to work through the scoping assessment, to ensure that all of the hazards are highlighted.

In order to comply with HACCP requirements, as process flow chart would need to be used for the processing hazards, but you could still assess each process step against the 5 sub-groups (environmental, fabrication, equipment, process and tools).

Although most of the hazards discussed above are typical to HACCP, your HARPC plan introduces one new type of hazard – those from food fraud.

This is a little confusing to me, as FSMA also includes a rule for ‘Intentional Adulteration’ – which includes economically motivated adulteration (or food fraud).  The final rule is still to be released (expected by the end of May), but there is some clear overlap.  The HARPC plan must include hazards from food fraud – but only those that would cause food safety problems.  To me, to have food fraud covered in both the HARPC plan and the Food Defense plan (as required by the intentional adulteration rule) is confusing.

Personally, I think the aim of the HARPC plan is different to that of a Food Defense plan:

  • HACCP or HARPC is about making sure that we have the right controls in place to make sure that food safety mistakes are not made.
  • A food defense plan is about making sure that the food is protected from intentional harm.

Therefore:

  • HACCP/HARPC is about unintentional harm
  • Food defense is about intentional harm

Perhaps when the final rule of intentional adulteration is published, it may clarify if you can choose to put the food fraud element in your HARPC plan or if it’s covered in your food defense plan, then it doesn’t need to be in your HARPC plan too.

As always, any questions or views would be gratefully received, so please get involved in your FSMA companion and add your comments to the bottom of the post.

Thanks, Kassy

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