25 replies to this topic

[AlinaPetichenko]

Dear colleagues, does anyone have any example of HARPC, I'm interested in the form?

[Charles.C]

Dear colleagues, does anyone have any example of HARPC, I'm interested in the form?

 

Below is a little old so there may have been some changes.

 

 FSMA,HARPC - Food Plan Example.pdf   841.65KB   1305 downloads

(thks mgourley)

[AlinaPetichenko]

Thanks a lot!!!!!

[AlinaPetichenko]

Dear Charles, during a reading of example I have a question - What difference between Sanitation Preventive Control and PRP program in ISO 22002?

[Charles.C]

Dear Charles, during a reading of example I have a question - What difference between (a) Sanitation Preventive Control and (b) PRP program in ISO 22002?

 

Hi Alina,

 

(a) is FSMA terminology. (b) is Codex / ISO terminology.

 

I have long given up on FSMA's presentation of haccp (= re-inventing the wheel IMO) but hopefully an FSMA expert can answer yr query ............?

[AlinaPetichenko]

Or OPRP?

[AlinaPetichenko]

And in program of verification of supply chain

Why a 3^rd party audit? it is certification audit?  by description it is clear that the auditor will evaluate the supplier on the given parameters. This is in any case an audit of the second party, even if it is carried out from the consumer by any qualified auditor, even from the certification body?

[Charles.C]

Or OPRP?

 

There are some HARPC presentations involving use of OPRP-type terminologies but IIRC this is only an unauthorized add-on to the FSMA dictionary.

[FurFarmandFork]

What difference between Sanitation Preventive Control and PRP program in ISO 22002?

 

 

I've never maintained an ISO system, but essentially a sanitation preventive control is included in your food safety plan explicitly instead of maintained exclusively in your sanitation plan SOP's.

 

If you're implementing a FSMA compliant food safety plan, I highly recommend attending  an FSPCA course to help you navigate the differences and help you make sure you meet the requirements for a "Preventive Controls Qualified Individual".

[sjohnson]

I am desperately trying to update our HACCP to HARPC. I cant find info on if I need to do a separate one for Each ingredient we have? We basically re package bulk ingredients into our own packaging. They are dry nuts, berries and fruit powders. We do have some blends however we dont use any heat or liquid. Can i group all the allergens together in one HARPC plan and all the berries etc? or does Each product we purchase needs its own food safety plan? Keep in mind we have about 75ish items   If anyone has an example I would be very grateful to check it out as I am struggling 

[MsMars]

I am desperately trying to update our HACCP to HARPC. I cant find info on if I need to do a separate one for Each ingredient we have? We basically re package bulk ingredients into our own packaging. They are dry nuts, berries and fruit powders. We do have some blends however we dont use any heat or liquid. Can i group all the allergens together in one HARPC plan and all the berries etc? or does Each product we purchase needs its own food safety plan? Keep in mind we have about 75ish items   If anyone has an example I would be very grateful to check it out as I am struggling 

 

I don't have much experience in dry blending so someone can correct me if I'm off, but from my experience it helps to write separate plans for each different process and account for allergens within the plan for specific items in that process. So you'd have a plan for simple repackaging and a plan for blending/repackaging, etc. 

[veruca]

We did our Food Safety Plans by process rather than ingredient. We finished with 3 separate plans. They've passed by our 3rd party audit as acceptable and cover all needed areas. Prev. Controls may be easier since it's just repackaging. Maybe have one plan for bulk repackaging and one plan for blends?

 

veruca

[sjohnson]

Does anyone have a HARPC like the one i have attached? I'm I on the right track?

[sjohnson]

Does anyone have a HARPC like the one i have attached? I'm I on the right track?

Attached Files

•  HACCP Plan v2 - Copy.docx   240.3KB   607 downloads

[Charles.C]

From the FDA draft haccp / preventive controls guidance (2018) -
 

 

You use the hazard analysis to determine appropriate preventive controls. Your hazard analysis should provide justification for your decisions. You may group products together in a single hazard analysis worksheet if the food safety hazards and controls are essentially the same for all products in the group, but you should clearly identify any product or process differences.

 

 

Seems analogous to traditional haccp.

[Charles.C]

Does anyone have a HARPC like the one i have attached? I'm I on the right track?

 

Hi sjohnson,

 

I am not at all a FSMA user but yr document seems to lack (a) a hazard analysis-Risk Assessment, (b) a Procedure to determine CCPs/Preventive Controls.

 

But perhaps these are no longer required by HARPC.

[MsMars]

Does anyone have a HARPC like the one i have attached? I'm I on the right track?

 

Agree with Charles - you need to have a hazard analysis risk assessment and justification for CCP's/PCs.  From what I've heard about FDA inspections related to Preventive Controls compliance, they are auditing using the model plan contained within your PCQI training module very closely - you aren't REQUIRED to follow this format, but it would be helpful to model your own plan after that one (see Marshall's comment/attachment above) if you don't know where to start.  

[sjohnson]

Thank you for the reply's. Would make it easier if I could find a blank template to work with

[mgourley]

Maybe the attached will help.

 

Marshall

Attached Files

•  Bagel FSP.docx   142.21KB   583 downloads
•  Bagel HA.xlsx   62.31KB   537 downloads

[Charles.C]

Maybe the attached will help.

 

Marshall

 

Hi Marshall,

 

Many Thks for above documents. A very elegant response to the, IMO, occasionally strangely worded  FSMA haccp requirements. The text in cells S9, S30 looks particularly offbeat to me but “it is what it is”.

 

A few mini-observations in the nice Excel –

 

(1) microscopic  typos - “signuficantly” / cell  AG1,  Aereus  in H225, H234, Monocytogenes everywhere.

(2) I noted that FDA have taken haccp back to Codex origins by inserting “sig.minimize” in AG1.

(3) IMO the “x” in cell AG48 is placed in the logical selected position. But is therefore the term “finished product” referring to the received packaging rather than the process ending packed goods ?

(4) No specific examples of “typical” potential Biological  contaminants in inputs are mentioned, eg Salmonella. Rather surprised FDA went (textually) along with cell S9 in Principle. (also seems sort of illogical in view of  cell S189).

(5) Legionella apparently does have a history of occurring in potable water. Interesting.

(6) I note the partial pragmatic acceptance to regard baking as a “CCP”

(7) Cell A280, column (2) does not include “….economic gain…”  as stated. (I noted VA is  cross-referenced in Word document).

(8) I  deduce from, afai could see, a lack of mention in either document that you are not expected  to possess any verification documentation  that the City water is maintained potable ? (I recall a certain  US piping disaster).

 

Thks again.

[mgourley]

Hi Marshall,

 

Many Thks for above documents. A very elegant response to the, IMO, occasionally strangely worded  FSMA haccp requirements. The text in cells S9, S30 looks particularly offbeat to me but “it is what it is”.

 

A few mini-observations in the nice Excel –

 

(1) microscopic  typos - “signuficantly” / cell  AG1,  Aereus  in H225, H234, Monocytogenes everywhere. Noted

(2) I noted that FDA have taken haccp back to Codex origins by inserting “sig.minimize” in AG1. Apparently

(3) IMO the “x” in cell AG48 is placed in the logical selected position. But is therefore the term “finished product” referring to the received packaging rather than the process ending packed goods ? We verify each new lot of packaging at reciept, but also check the packaging on the production line as a double check.

(4) No specific examples of “typical” potential Biological  contaminants in inputs are mentioned, eg Salmonella. Rather surprised FDA went (textually) along with cell S9 in Principle. (also seems sort of illogical in view of  cell S189). I see your point, but with the sheer numbers of raw materials that we have, an inclusive list seems impracticable in the form. We have a complete HA of all raw materials, so that information could be found there, if asked. 

(5) Legionella apparently does have a history of occurring in potable water. Interesting. That's what I found. How common, is another thing.

(6) I note the partial pragmatic acceptance to regard baking as a “CCP” I don't honestly think it is (at least for our products), but FDA expects companies to treat it as a Preventive Control IF there is the possibility of Salmonella in raw materials.

(7) Cell A280, column (2) does not include “….economic gain…”  as stated. (I noted VA is  cross-referenced in Word document). Correct. Complete VA for all raw materials is a separate document that can be referenced as needed.

(8) I  deduce from, afai could see, a lack of mention in either document that you are not expected  to possess any verification documentation  that the City water is maintained potable ? (I recall a certain  US piping disaster). I don't recall any specific FDA requirement/guidance on that point. However BRC requires it so we have the annual water report from the city on file.

 

Thks again.

[sjohnson]

Thank you again , I appreciate the help here

[mgourley]

I'd suggest you take a look at the FDA Food Safety Plan Builder. It's not terribly intuitive, and it takes a long time to work through, especially in the area of Supplier Controls.

That being said, it's provided by the FDA, so assuming your inputs and reasoning for them are "valid", then the resultant Plan should be good to go.

 

You have to remember that the FDA has not demanded one format for the Food Safety Plan(s), you just need to incorporate all of the required info and ensure that it's "scientific".

Do what is the most simple and effective. FDA has gone to great pains to try to explain to industry that the Food Safety Plans are not intended to be a one time exercise and then they sit on a shelf in a binder. They expect you to come up with the plan and then actually use the thing. 

 

Marshall

[sjohnson]

You have been very helpful, Im working off the example from FSPCA. And referring to the "bagel" docs. THese are very helpful for set up and getting some wording and format as that is where I am getting stuck.

[mgourley]

Glad to help. Keep it simple but cover all the bases.

 

Marshall