Shipping/Receiving Procedure- Can this be other preventive control?
Working on the HA, in the receiving step, I have identified truck condition/improper unloading practices are hazards, but I don't know if I can put Shipping/Receiving procedure as Preventive Control?
Currently, we have an SOP on shipping/receiving.
Thanks for all your help!
Depends on what kind and what level of hazard, your product and process. Can you provide some more details?
Depends on what kind and what level of hazard, your product and process. Can you provide some more details?
We are a bakery facility making cookies and muffins. The receiving steps is our first step in the flow, and we receive shelf-stable and refrigerated ingredients like eggs.
In our HACCP plan, we have identified the Biological Hazards:
"Pathogen contamination due to improper receiving practice" and
"Pathogen contamination due to transport vehicle not meeting company specifications( e.g. incompatible materials, unsanitary condition, evidence of pests, etc.)"
Not sure how to translate it into the HARPC language. :)
IMHO, you may be going down a rabbit hole here.
If you have receiving procedures in place, have properly trained your receivers, audit the procedures and the actions (verification), then you should not have pathogen contamination because of improper receiving practices.
If you have policies and procedures in place for inspection of transport vehicles prior to unloading, and the transport does not meet the requirements, then you reject the load. None of the material makes it into your facility, thus no possibility of pathogen contamination.
But, as with anything, you need to do a risk assessment. If you don't have policies and procedures in place for receiving or inspection of materials and transport, then perhaps your determinations are valid.
Marshall
IMHO, you may be going down a rabbit hole here.
If you have receiving procedures in place, have properly trained your receivers, audit the procedures and the actions (verification), then you should not have pathogen contamination because of improper receiving practices.
If you have policies and procedures in place for inspection of transport vehicles prior to unloading, and the transport does not meet the requirements, then you reject the load. None of the material makes it into your facility, thus no possibility of pathogen contamination.
But, as with anything, you need to do a risk assessment. If you don't have policies and procedures in place for receiving or inspection of materials and transport, then perhaps your determinations are valid.
Marshall
That's why I got so confused.... I thought we have to do the hazard analysis assuming no PRP is in place??
Yes, but common sense does prevail.
If you did a "what if" for every process step, you would end up with hundreds of Preventive Controls. That's not the intent.
You have to do a HA of your process, which may include things like receiving procedures, etc. Is that "technically" a PRP, not really. It's just how you do business.
This is why risk assessment is very important. In your mixing process "could" there be metal to metal contact if the seals on your beater bars failed? Yes. But given the design of the equipment and historical evidence of that happening, what is the actual likelihood of it occurring?
Hazard Analysis and Risk-Based Preventive Controls is what the operative term is.
Metal Detection would probably be a Process Preventive Control, because you would say "possible metal inclusion from previous process steps" as your justification for the PC.
You would not create a PC at the mixing step for metal inclusion, because the likelihood of it happening there would probably be very remote.
Since you are a bakery operation, the biological hazard at the receiving step would be salmonella, e. Coli, etc, because there is historical evidence of contamination of flour (or other materials) with those pathogens.
The PC is not applied at receiving. It's applied at the baking step, where time and temperature will kill those pathogens. Of course you have to scientifically justify that.
Marshall
Yes, but common sense does prevail.
If you did a "what if" for every process step, you would end up with hundreds of Preventive Controls. That's not the intent.
You have to do a HA of your process, which may include things like receiving procedures, etc. Is that "technically" a PRP, not really. It's just how you do business.
This is why risk assessment is very important. In your mixing process "could" there be metal to metal contact if the seals on your beater bars failed? Yes. But given the design of the equipment and historical evidence of that happening, what is the actual likelihood of it occurring?
Hazard Analysis and Risk-Based Preventive Controls is what the operative term is.
Metal Detection would probably be a Process Preventive Control, because you would say "possible metal inclusion from previous process steps" as your justification for the PC.
You would not create a PC at the mixing step for metal inclusion, because the likelihood of it happening there would probably be very remote.
Since you are a bakery operation, the biological hazard at the receiving step would be salmonella, e. Coli, etc, because there is historical evidence of contamination of flour (or other materials) with those pathogens.
The PC is not applied at receiving. It's applied at the baking step, where time and temperature will kill those pathogens. Of course you have to scientifically justify that.
Marshall
Marshall, that was great information and gave me some clarities on what to do. Thank you very much for your help!
Hi pauline woo,
This extract from a parallel thread/attachment may further assist clarity -
CGMP (PRP) vs PC.PNG 87.37KB 1 downloads
https://www.ifsqn.co...e-2#entry135333
Marshall's interpretive comments are relevant however afaik the logic of FSMA with respect to hazard/PC etc is sufficiently bizarre that almost all the literature texts seem to carefully avoid analysing it. The potential consequence of an Encyclopedia of PCs is the development of "fudges" such as the above.
PS - maybe also see the possible interpretive subtleties as illustrated in this example -
Don't make things "Preventive Controls" if you can avoid it. They need a lot of extra attention and documentation. Make everything you can a prerequisite program.
Don't make things "Preventive Controls" if you can avoid it. They need a lot of extra attention and documentation. Make everything you can a prerequisite program.
While I agree with this somewhat (and I hear this a lot from various peers concerning CCPs as well), I disagree with the logic and this phrase and similar sentiments always hits a nerve with me. Yes, having preventive controls are a pain, but if you don't have any then you better be able to back up your risk analysis with proper validation. I understand what the FDA was trying to accomplish when passing FSMA and while I don't necessarily agree with the execution, I strongly believe that hazards still must be legitimately assessed and if a hazard needs extra attention and documentation, then you do your due diligence.
Don't mean to call you out, but that's my two cents.