Reclassifying a CCP to a Process Preventive Control
Hello all,
Some context - I've been in QA for about a decade but recently got promoted to QA Manager. The facility I work at processes potatoes (cutting, blanching, freezing, packaging) that are then exported and processed by another facility overseas. My predecessor made our blancher step a CCP prior to leaving the company; a change that several others disagreed with. How difficult would it be to get it reclassified as a preventive control?
The critical limit on the blancher is currently a requirement for time and temperature ( >/= 74°celsius for at least 3min ). Since the product has additional temperature controls (freeze step & frozen storage) I don't agree that the blancher is a CCP, either. In my mind, it's more of a process preventive control, which will still require monitoring and a corrective action if limits aren't met.
The processor who buys our potatoes cooks them in a vacuum fryer. I plan to get ask for their time and temperature requirements, as well as any testing that's been done on their finished product (i.e.: water activity, micros, etc.).
After I have this information, my FS team will conduct a new hazard analysis to ensure the biological hazards are still controlled. Any additional measures that I'm missing? Perhaps a transfer of responsibility agreement with the next processor?
Thanks in advance,
ChrispyChips
You need to put together a summary of sorts to justify your decision
So any and all failures to the current CCP, lab testing, any scientific literature etc as well as the information your customer provides
It does not sound like changing that step to a CCP makes good sense , so I think you're on the right track
How is the finished product described? If you're specifying these cut potatoes are RTC, then I can see the argument being that blanching is a PRP. But then I wonder why you're blanching at all instead of just freezing after cutting? If it's to help your customer have a pre-softened/semi-cooked potato for their cook process, then sure. But if your HA indicates you're blanching to control micro from your own cutting process, then blanching does indeed seem to be a CCP with freezing to help control essentially a sterilized potato.
If you have a hazard, it needs to be controlled. Since the potato is grown in the ground, it would be hard to say that there is not a pathogen risk.
You could state that your customer is controling the hazard. The product would have to labeled "'Not processed to control X hazard" & Written assurances may need to be inplace. see 117.136 for these requirements.
You gain absolutely nothing by changing from a CCP to process preventive control and visa versa. A CCP is HACCP. A process preventive control is FDA FSMA. They are both the step used to control the hazard. CCP is for your haccp plan, PPC is for your preventive controls plan. Its just semantics. Just as you stated: " In my mind, it's more of a process preventive control, which will still require monitoring and a corrective action if limits aren't met."
How is the finished product described? If you're specifying these cut potatoes are RTC, then I can see the argument being that blanching is a PRP. But then I wonder why you're blanching at all instead of just freezing after cutting? If it's to help your customer have a pre-softened/semi-cooked potato for their cook process, then sure. But if your HA indicates you're blanching to control micro from your own cutting process, then blanching does indeed seem to be a CCP with freezing to help control essentially a sterilized potato.
The potatoes are labeled as requiring additional cooking, though an internal temperature is not indicated. The blanching is more of a quality control than a "kill step," though the time/temp is enough to kill pathogens of concern. From my understanding of CFR 117.136, if I get assurances from the next customer in the supply chain that they will apply controls sufficient to prevent or eliminate the hazard, then I am not required to implement the control(s) in my process flow.
If you have a hazard, it needs to be controlled. Since the potato is grown in the ground, it would be hard to say that there is not a pathogen risk.
You could state that your customer is controling the hazard. The product would have to labeled "'Not processed to control X hazard" & Written assurances may need to be inplace. see 117.136 for these requirements.
You gain absolutely nothing by changing from a CCP to process preventive control and visa versa. A CCP is HACCP. A process preventive control is FDA FSMA. They are both the step used to control the hazard. CCP is for your haccp plan, PPC is for your preventive controls plan. Its just semantics. Just as you stated: " In my mind, it's more of a process preventive control, which will still require monitoring and a corrective action if limits aren't met."
A review of CFR 117 was actually what got me headed down this rabbit hole. It's much easier to add a CCP/PC than it is to remove one!