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Labels on packages CPP or not?

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#1 Danica

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Posted 06 December 2017 - 06:56 PM

Hi,

 

I am preparing an HACCP plan/PRPs for our food contact packaging company. We use thermoforming molds to 'print' packages onto rolled sheets of various polymers. We label the finished product packaging boxes used for these containers for traceability/identification purposes, but we do not label individual packages..except for 2 customers.

 

Case 1: should we consider placing nutritional info labels on a client's food contact packaging product a CPP, because of the risk of allergens? Worst case scenario: Let's assume the customer has a cross contamination or modifies his recipe and for some reason the info does not reach us. We place the labels on the container and an undeclared allergen is found in the client's product which then leads to a recall. Since we put the label, would we be responsible for the recall?

 

IMO a CPP is required, I would have the customer verify and confirm the accuracy of the label at every order they make with us to ensure there is no mismatched information. I would like to add that the labels are printed by a third party (the customer sends the info to the label printer who then send them to us to affix on the packaging). Are we responsible for ensuring the accuracy of each of these labels? I assume yes but if someone could give me their thoughts on that I would greatly appreciate.

 

Case 2: We have a customer where we print the nutritional info labels and we affix the labels onto the food contact packaging, this customer places one order per year, so this type of production is not done on a regular basis in our plant. In this case, the label information is confirmed with the client before processing each order. Once again, are we be responsible if a food recall is required?

We have a label management system (SOP) appended to our prerequisite, and of course an allergen management program (in the PRP, and as an SOP). We do not process any food, and any food that enters the plant is restricted to the lunch room, and lunchroom garbage can. We do not have vending machines either.

 

These 2 cases seem a bit ambiguous to me, since they kind of seem like a CPP but a CPP we have once or twice per year..or not OUR CPP but theirs..

 

Sorry for the long post..

Thank you in advance for your help :x_biggrin:

 

Danica

 

 


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#2 Charles.C

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Posted 06 December 2017 - 07:41 PM

Hi Danica,

 

Initially I wud opine that it may depend on the specifics, ie what kind of allergen misinformation are you talking about, eg an obvious undeclared one or what ?

 

A related issue to that you describe was reported here by a UK food copacker where the (provided) labels were in their opinion allergenically mismatched to the ingredients. The question of their (the copacker's) fs responsibility was queried.

 

The above query generated some intense debate/deep researching. IIRC the eventual (perhaps debatable) conclusion/interpretation was that UK Local Regulatory requirements effectively meant that the copacker could be involved in any subsequent negative fallout if the noted discrepancy was ignored/not acted on. A similar scenario was also discussed/concluded for an Australian oriented thread.

 

So IMO yr first necessity is to investigate whether Regulatory factors exist. If yes, such will usually over-ride any personal opinions.

 

It's an interesting topic but, at least in the UK case, required a deep understanding of legalistic documentation.

 

I await further comments with interest. :smile:


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Charles.C


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#3 Danica

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Posted 06 December 2017 - 08:45 PM

Hello Charles,

In deed it is a question that requires some more digging into on the regulation side. Thank you for your reply.
 
In your opinion/experience, would this be considered a CCP? Since our control of the labels would not reduce the risk of allergens to zero, my assumption is that is its not a CPP.
 
Maybe I am digging too deep to find CPPs, my analysis of  the B,C,P hazards of our process flow does not give any hazards (save this 'optional labeling' step-see attached document) that are not controlled in the PRPs/SOPs etc. The PacSecure workbooks do not suggest the use of a risk assessment matrix anywhere..so I wonder if my process is stringent enough.
 
If you (or anyone) can have a look at the attached document, this is the method of B,C,P hazard evaluation recommended by the workbook. Don't mind the highlighted blue section, a 'consultant' for whom I am taking over the work simply copy pasted the workbook CPPs as our own, which is another thing I need to address separately from the optional labeling.
 
The risks mentioned are part of our established GMP practices (of course we don't send a load of 'unapproved designed product' to customers..). We also have SOPs for product design/customer order processing/supplier assessment and all that is related to production but it is not in the prerequisite document per say but as an appendix, does that still count as being in the prerequisite?

 

Any help/comments will be greatly appreciated. Thanks

Danica


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#4 Danica

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Posted 06 December 2017 - 08:46 PM

oups here is the attachement:

Attached Files


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#5 Charles.C

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Posted 06 December 2017 - 09:31 PM

Hi Danica,

 

Just to illustrate the labeling subtleties which may be involved, here is the the UK thread i mentioned in Post 2 -

 

http://www.ifsqn.com...l-declarations/

 

In principle, the choice of utilising a PRP program like allergen management or designating an allergen related labelling CCP (actually def.does not normally require zero) is a matter of the haccp plan design. The preferred decision is often determined by the intended FS Standard.

 

Sometimes (local) Regulatory CCPs exist also ?.

 

I'm not a Packaging person but I found yr haccp methodology rather strange. Nonetheless it may well be acceptable to yr intended auditor.


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Charles.C


#6 Danica

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Posted 07 December 2017 - 12:24 PM

Hi Charles,

TY for your reply. Yes, compared to what I have seen on forums and all, the hazards identification method we use is very different from what I have seen for food HACCP. There is a website, Food Safety Alliance for Packaging, with demo plans and they seem to proceed as is described in our PacSecure HACCP workbook. I based my HACCP plan template on theirs.

 

https://www.iopp.org...cfm?pageID=2267

 

In any case, ty for your feed back :)

Cheers,
DA

 


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#7 Danica

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Posted 07 December 2017 - 04:11 PM

**also Charles, can you elaborate on what you mean by 'I found yr haccp methodology rather strange' ?

 

I surely do not want to base our HACCP plan/PRP on bad methodology which means I will have wasted precious time going the wrong way..

Thanks
DA


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#8 FurFarmandFork

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Posted 07 December 2017 - 11:38 PM

Danica, clearly I want you as my label/packaging manufacturer, you're putting a level of thought and control into this that's awesome.

 

Generally when I audit packaging vendors I want to see them using revision control as a CCP or at least a strictly controlled area. Your customer should be verifying further, so the the actual "hazard" posed by allergens isn't controlled at your step but theirs. However you could contribute to the problem certainly and depending on contract held liable for printing/labeling unapproved material.

 

I ask that my supplier maintain strict cylinder/plate control and that old plates with obsolete proofs are destroyed whenever my company approves a new content proof. On your end if you then further label boxes/rolls of web then that may be a step worth adding two person verification or some other control as a "CCP" in your process. But ultimately I think just proving you have it as a strict control in your environment will be sufficient for most customers.


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#9 Danica

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Posted 08 December 2017 - 12:12 PM

Thank you very much for your reply F3 :)

 

Cheers,

Danica


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#10 Charles.C

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Posted 11 December 2017 - 01:37 AM

**also Charles, can you elaborate on what you mean by 'I found yr haccp methodology rather strange' ?

 

I surely do not want to base our HACCP plan/PRP on bad methodology which means I will have wasted precious time going the wrong way..

Thanks
DA

 

Hi Danica,

 

Good question but the answer is not easy to explain in a few paragraphs. I hv crudely precised below.

 

HACCP Procedure Flaws common to FSAP/Current HACCP Plan.

These comments are my opinion (based on food haccp texts). They are subjective. (see  the brackets following)

(1) No specific risk assessments. (Cf in this link  -

.http://www.ifsqn.com...kaging-company/

(2) Decision tree (Q1-Q4) applied every step. (Cf Food Codex / Food NACMCF/Food HACCP Mortimore). I noted these comments in another FSAP model but which were seemingly later edited out -

1.  The Decision Tree is used after the Hazard Analysis
2.  The Decision Tree is used at the steps where a Significant Hazard has been identified

 

Flaws in Current Procedure

(1) Haccp Scope is undefined. 1st Stage as shown is not necessarily incorrect but is commonly not included  in typical Process Haccp Plans. (Cf FSAP).

(2) The designated CCPs seem less than for other (typical?) Packaging HACCPs. (Cf FSAP, this obviously depends on yr own risk assessment of yr own process.I am not a Packaging person so this only a comment. [One reason why shown risk assessments are more transparent]).

(2) Meanings (decision tree) Q1 – Q4 are not identified. (Cf FSAP).

(3) Q4 column is not completed.

 

Hope that helps to explain my comment.


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Charles.C


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#11 GMO

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Posted 11 December 2017 - 12:14 PM

I'm not familiar with packaging suppliers (I've audited a couple but never worked for one).  I'd say a few things though which may put this into perspective.  In food manufacturing, label control is almost never a CCP.  Whether it should or not is another question, especially as the vast majority of recalls are labelling related but it is not considered a CCP.  Why?  I'm glad you asked that!  The hazard is labelling a pack which contains an allergen in such a way that an allergenic consumer would not know the allergen is contained within it.  Is that a hazard?  Yes.  Potentially the outcome of that mislabelling could be injury up to the point of death so you can't say it's not significant.  I would say the only reason it's not a CCP is because while equipment exists to help control the hazard, it's not fool proof, it's fallible and it's expensive.  The off line periodic checks staff do as an alternative is very difficult to assign as a CCP.

 

So far so confusing and so worrying... I'd almost convinced myself there it should be a CCP but there is another consideration.  In a ready meal factory cooking a sauce, one may have egg in there and another may not.  What if a member of staff cooked the wrong cheese sauce or selected the wrong pallet?  Just as easy to kill someone.  What if the CIP process didn't work leaving egg residue?  Not only is that very likely but also possible egg is then transferred into the next sauce.  What if a member of staff on the line didn't wash a tray on changing from egg pasta to non egg pasta?  Etc.

 

What I'm saying is that although all of the above are controlled by prerequisites, it does not mean that those prerequisites (if they go wrong) could not end up with someone being made seriously ill. 
 

Personally I hate the majority of the FSMA approach to HACCP style preventive food safety but the one thing (literally the one) I like about it is the greater emphasis on prerequisites being important but also (where possible) monitored and / or verified.  So what I've done with all of my prerequisites is ensure there is monitoring and / or verification for each.  So in the big scheme of things, does it matter if it's a CCP?  No.  What matters is you're controlling it.  So what controls do you have for version number?  What controls do you have for line checking?  Etc. etc.

 

Interestingly the whole "we print the allergens" thing has bitten me in the a** before.  A printer sent in labels with poorly printed nutritional information.  Not a food safety issue but a legality one.  Turns out there had been an issue on the line they knew about so the absolute key learning from me for you on that is when you have an issue, think about the past, present and future.  Past = what has already been printed?  Is that affected?  How can we be 100% sure?  Present = stop the line and resolve the issue.  Future = What was the root cause?  Can we eliminate it?

 


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#12 Danica

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Posted 11 December 2017 - 12:39 PM

Hello Charles,

 

Thank you for taking time to reply :)

 

I actually redid the whole thing with information I found here. Did a RA matrix, and it looks way more logical this way to ID CP/CCP. I will look into what you said in more details today.

 

Mr/Mrs GMO, thank you for the information as well, very well written and informative.

 

Have a great week :)

 

Danica


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#13 Charles.C

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Posted 11 December 2017 - 09:26 PM

Hi GMO,

 

Thanks for yr interesting comments. I somewhat disagree with yr levelling out of PRPs and CCPs via "the big scheme.....".

 

After the first generation of HACCP programs (CCPs "everywhere"), I think PRPs were essentially accepted as non-Process, mainly "Hygiene" functions in comparison to CCPs which were targetted at the "Process". (although NACMCF's US viewpoint admittedly pioneered an expanded PRP vision).

 

I suspect (via NACMCF)  the first major intrusion of PRPs into the Process was at the initial "Raw Material" Receiving Stage since this offered an enormous documental simplification of the Hazard Analysis / Risk Assessment Procedure.

 

Historically the subsequent expanded use of Prerequisites should (rightly or wrongly) probably also include a nod (particularly for things like labelling) to PAS220 / FSSC22000. And perhaps the "PRP" arrival of the "Allergen Control Program".

 

Nonetheless, IMO the appropriate use of CCPs still offers an ability to illuminate the results of a Hazard Analysis / Risk Assessment and reinforce (IMO) the key element of Validation.

 

Some might say that the current boom in PRPs is taking the "CCP" out of HACCP. All subjectives of course. :smile:

 

@ Danica - I hope you can find time to post yr revised version when completed. There is a distinct shortage of typical HACCP Packaging Plans on this Forum.


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Kind Regards,

 

Charles.C


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#14 Danica

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Posted 12 December 2017 - 02:16 PM

Hi Charles/GMO,

 

Here is the updated draft, not sure if section 8 is relevant for you but it seems to be required by IFS PacSecure in order to show where these hazards are controlled in the PRP.

 

Also not sure if my RA was done stringently enough but we do have loads of controls in place, so to me it seems fair.

 

Let me know what you think!!

 

TY lots !! :x_tongue:

 

Cheers,

Danica

 

 

Attached Files


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#15 Danica

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Posted 12 December 2017 - 02:33 PM

ps-would like to add, this is my second draft still more work to be done on this document. Just wanted to give you the updated version.


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#16 Charles.C

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Posted 14 December 2017 - 04:08 AM

Hi Charles/GMO,

 

Here is the updated draft, not sure if section 8 is relevant for you but it seems to be required by IFS PacSecure in order to show where these hazards are controlled in the PRP.

 

Also not sure if my RA was done stringently enough but we do have loads of controls in place, so to me it seems fair.

 

Let me know what you think!!

 

TY lots !! :x_tongue:

 

Cheers,

Danica

 

Hi Danica,

 

I quite liked the tabular layout but hv a few queries/comments -

 

It seems implicit in pacsecure packaging standard 2010  that pacsecure expect their own issued haccp models to act as a "blueprint" for CPs  and CCPs.

 

So -

 

(1) how do the ifs model packaging haccp plans select their "CP"s and "CCP"s ?. eg risk rating same as yourself or more like ISO ? (afaik, ifs somehow regards "CP" as equivalent to oprp) ?

 

(2) the jump (1-2) in likelihood of occurrence which generated a "CP"  between secs 2 and 5,6 looks a little, errr, arbitrary ? Just my opinion :smile:


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Kind Regards,

 

Charles.C





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