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Preventive Control Concept unclear


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#1 hadtoregister

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Posted 21 August 2018 - 01:32 AM

Hi Everyone,

 

I am urgently in need of help to sort my concept regarding the preventive control.

 

From my understanding, the preventative control is only four categories, which are the sanitation, allergen, process and supply chain. 

 

If we talk about employee training, it doesn't fall in these categories and it will be in the GMP or PP program. So, employee training is not a preventive control. 

Same thing, warehouse and distribution, for example, good storage practice FIFO, would fall in the PP program and it is not a preventive control.

 

Hygienic zoning would fall under "other preventive control" and it is not in the GMP section?

 

Now, what would be the release and hold program? It is not a preventive control, would it be a " other control" or "prerequisite program" for FSMA?



#2 Ryan H.

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Posted 21 August 2018 - 02:01 AM

Your hold and release would not be a PC. A Supply-chain preventive control is a verification that you have done to ensure your supplier has controlled a certain hazard(s). Supply-chain PC is determined when there is a hazard at the Supplier that there are controlling. You must, only use approved suppliers, conduct verification activities of the PC and document the activities. You should include this in your HA.

A Sanitation PC is a Sanitation activities that is preventing Bio, Phy, Chem. hazards from occurring. This can be allergen cross contact from insanitary equipment, biological concerns over specific cleaning, etc.

Also remember to assess your facility’s vulnerability to radiological hazards either internally or from your supply-chain. Whatever you determine keep your documentation and add it to your HA.

Also if your doing training for allergen awareness, you could add this to your HA as a PC for allergens. It would not be your only one, but it would be an additional one to whichever another controls you have.

Best of Luck!


All the best, 

 

Ryan Heavner 


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#3 cdelucadwcc

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Posted 21 August 2018 - 11:35 AM

Your hold and release would not be a PC. A Supply-chain preventive control is a verification that you have done to ensure your supplier has controlled a certain hazard(s). Supply-chain PC is determined when there is a hazard at the Supplier that there are controlling. You must, only use approved suppliers, conduct verification activities of the PC and document the activities. You should include this in your HA.

A Sanitation PC is a Sanitation activities that is preventing Bio, Phy, Chem. hazards from occurring. This can be allergen cross contact from insanitary equipment, biological concerns over specific cleaning, etc.

Also remember to assess your facility’s vulnerability to radiological hazards either internally or from your supply-chain. Whatever you determine keep your documentation and add it to your HA.

Also if your doing training for allergen awareness, you could add this to your HA as a PC for allergens. It would not be your only one, but it would be an additional one to whichever another controls you have.

Best of Luck!

Could the "release and hold" be a SOP? This seems as though it would be a daily task performed during operation after production and before shipping. If i am understanding that correctly. 



#4 Ryan H.

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Posted 21 August 2018 - 11:53 AM

Yes it should be an SOP. Typically it's called Positive Release or Product Release though.. but that depends on what works for your company. Positive Release is a mandated SOP in some GFSI standards like SQF so it's a good idea to have this if your trying to meet those standards. 


All the best, 

 

Ryan Heavner 


#5 hadtoregister

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Posted 21 August 2018 - 11:57 AM

Your hold and release would not be a PC. A Supply-chain preventive control is a verification that you have done to ensure your supplier has controlled a certain hazard(s). Supply-chain PC is determined when there is a hazard at the Supplier that there are controlling. You must, only use approved suppliers, conduct verification activities of the PC and document the activities. You should include this in your HA.

A Sanitation PC is a Sanitation activities that is preventing Bio, Phy, Chem. hazards from occurring. This can be allergen cross contact from insanitary equipment, biological concerns over specific cleaning, etc.

Also remember to assess your facility’s vulnerability to radiological hazards either internally or from your supply-chain. Whatever you determine keep your documentation and add it to your HA.

Also if your doing training for allergen awareness, you could add this to your HA as a PC for allergens. It would not be your only one, but it would be an additional one to whichever another controls you have.

Best of Luck!

 

 

Thank you!

 

My confusion is that do we have to name the program in the section of " what preventive control measure can be applied to significantly minimize or prevent the food safety hazard" ?

 

For example, let's say processing step 1 Ingredient receiving. So there is a potential hazard of having salmonella in the ingredient, thus we have supply chain PC here to control the hazard which is to only accept products from the approved suppliers.

 

Now, at this step, our plant decided that we will put the incoming material on hold until release instruction from QA department. In SOP, it is positive release program.If I write this practice in my food safety plan, what do I name it since it is not a PC ? Do I call it as a Pre-requisite program in my food safety plan?

 

 

I hope this is clear.



#6 Ryan H.

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Posted 21 August 2018 - 12:10 PM

In the event your supplier is controlling the hazard, the control would more than likely be to gather the appropriate documentation from the supplier, proving that there controlling the hazard. They should be supplying you with whatever you need in this case. COA's, etc. Also your going to want to verify anything of their documents. Your supplier being approved is great and is a big part of that, but they should still be providing your with documentation proving there controlling the hazard. If there is a salmonella risk, this would be supplied to you at each delivery, prior to you using it. 

 

To be clear, Hold and Release and Positive Release are normally two different things. Hold and Release is when your putting something: shipment, product, equipment, etc. on hold do to it being out of spec, a food safety risk, etc. 

 

Positive Release: Is not releasing product to your customer until it was passed through your entire quality and food safety process successfully. 

 

From what i see you have a Supply-chain PC. You are using your Hold and Release Program in order to carry out your Supply-chain program which is fine. It would be correct to put any ingredient on HOLD until you have received all of the documentation you need to then release it. It's just another program working in conjunction with you PC. 

 

You will still want to call it a PC. 

 

Hopefully i answered your question. 


All the best, 

 

Ryan Heavner 


#7 hadtoregister

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Posted 21 August 2018 - 12:40 PM

In the event your supplier is controlling the hazard, the control would more than likely be to gather the appropriate documentation from the supplier, proving that there controlling the hazard. They should be supplying you with whatever you need in this case. COA's, etc. Also your going to want to verify anything of their documents. Your supplier being approved is great and is a big part of that, but they should still be providing your with documentation proving there controlling the hazard. If there is a salmonella risk, this would be supplied to you at each delivery, prior to you using it. 

 

To be clear, Hold and Release and Positive Release are normally two different things. Hold and Release is when your putting something: shipment, product, equipment, etc. on hold do to it being out of spec, a food safety risk, etc. 

 

Positive Release: Is not releasing product to your customer until it was passed through your entire quality and food safety process successfully. 

 

From what i see you have a Supply-chain PC. You are using your Hold and Release Program in order to carry out your Supply-chain program which is fine. It would be correct to put any ingredient on HOLD until you have received all of the documentation you need to then release it. It's just another program working in conjunction with you PC. 

 

You will still want to call it a PC. 

 

Hopefully i answered your question. 

 

 

Thank you Ryan.

 

I know that for a CCP, it would be process PC.

 

If we determined a CP, NOT CCP, would it be called? Still a process PC?



#8 Ryan H.

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Posted 21 August 2018 - 12:55 PM

Even if your not labeling this step a CCP (Which you shouldn't) it would still be a PC and in this case a Supply-chain Preventive Control. 

 

Best of Luck! 


All the best, 

 

Ryan Heavner 


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