Hazard analysis of foreign matter in raw material
Hi, I have a very basic question re hazard analysis. If we evaluate a hazard in our raw material (e.g. foreign matter), do we assess its significance on the assumption that there are no controls further in the process, or do we assess its significance based on what we know about controls later in the process. For example, a metal contaminant in our raw material would come out as being significant and therefore a CCP, but our control is magnets and metal detectors later in the process. So, does the CCP sit at the point of receiving the raw material (which is difficult to manage as a CCP), or do we assess the consequence of metal contamination in the raw material as being insignificant, based on what we know about the controls that exist further in the process. Thanks for your help!
Assess and document it as a significant hazard that is controlled at a later processing step. The fact that it is a significant hazard is your justification for the CCP. The (potential for a) significant hazard is present and continues to be present until the CCP.
Think about it this way - if you have a "kill step," you are aiming to eliminate/reduce potential biological hazards present in ingredients to an acceptable level. You want to establish that these hazards are significant in the raw ingredients in storage because although the kill step is your CCP, you also need to prevent recontamination with hygenic zoning, etc.
The hazard is present, document its presence until control is applied to reduce or eliminate.
Great, thank you so much, that's very clear. Really appreciate your help.
Assess and document it as a significant hazard that is controlled at a later processing step. The fact that it is a significant hazard is your justification for the CCP. The (potential for a) significant hazard is present and continues to be present until the CCP.
Think about it this way - if you have a "kill step," you are aiming to eliminate/reduce potential biological hazards present in ingredients to an acceptable level. You want to establish that these hazards are significant in the raw ingredients in storage because although the kill step is your CCP, you also need to prevent recontamination with hygenic zoning, etc.
The hazard is present, document its presence until control is applied to reduce or eliminate.
Hi kgonzalez,
Sorry but i disagree yr comment.
I assume we are talking about traditional (Codex-type) haccp where the procedure consists of initially hypothesising the potential BCPA hazards at each step and then evaluating their "significance".
I assume the hazard is not being controlled by a PRP. This is sometimes the case for raw material foreign body contamination.
IMEX the "significance" of a hazard (in the context of determining CCPs) at any stage is based on the (risk) situation of that hazard at the end of the chain, ie at the consumption point.
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IMO the fact that the hazard is controlled at a later step is precisely the reason why the hazard is not "significant" at the previous stage.
In one text I have seen a hazard like metal fragments being associated with CCPs at both a preliminary screening (eg magnets) stage and also a later stage (eg metal detector). The divergence was justified on the logic that the author wished to emphasise their opinion that the initial removal was as equally important as the latter. (Another option could have been to combine both stages into one CCP).
Regardless the traditional approach is to use the logic of the Codex tree and simply place a CCP at the later stage. A similar situation sometimes occurs where two sets of process filters occur in series; ie which one is the CCP ? HACCP can be flexible.
PS - the "significance" of the hazard at each step should numerically be evident in the calculated risk status (= Likelihood x Severity)
Perhaps also, this needs emphasized when sourcing raw materials..............there should not be any foreign bodies in a food ingredient that you receive............dealing with it at the end point is not how HACCP is designed to work...a CCP is put in place when there is no other step available........you have a step that could be used....a risk analysis of this supplier would show that they cannot send you product in spec so you would source it elsewhere
Depending on where you are, both Charles' and kgonzalez's comments are valid. In the US, our HACCP thinking tends to have a distinct regulatory tilt. kgonzalez's comments are in line with USDA & FDA expectations in constructing and supporting our HACCP plans. US regulatory HACCP deviates a bit from Codex HACCP. Having the argument with our regulatory personnel is bit like 'win the battle, lose the war'.
KTD
Depending on where you are, both Charles' and kgonzalez's comments are valid. In the US, our HACCP thinking tends to have a distinct regulatory tilt. kgonzalez's comments are in line with USDA & FDA expectations in constructing and supporting our HACCP plans. US regulatory HACCP deviates a bit from Codex HACCP. Having the argument with our regulatory personnel is bit like 'win the battle, lose the war'.
KTD
Hi KTD,
Yes I agree that the terminology "significant hazard" has acquired a variety of flavours. Particularly depending on the reference point/location, the (FSMA?) criterion of "reasonably likely to occur", and possibly whether a decision tree is built into the subsequent procedure.
For the OP, the (CCP) answer may likely relate to the type of foreign material involved, eg whether within the scope of the usual (significant) suspects as described in the oft-quoted FDA "foreign bodies" document. And not forgetting the proactive (PRPish) solution of Post5.
Here is Kraft's viewpoint -
Kraft, haccp extraneous material.pdf 48.34KB 149 downloads
Thanks very much for all your comments, this is very informative for me, and quite reassuring that my confusion is not entirely due to my ignorance :-) I really appreciate all of the input.