11 replies to this topic

[city03]

Hi,

 

We are bakery manufacturer. We used potassium sorbate and calcium propionate in our product as food preservative.

 

In weighing step, there is a potential of chemical hazard where food preservative might be excessively weighed. Control or preventive measure measure as such, QC to verify weigh of food preservative randomly and ensure to use calibrated weighing balance to weigh food preservative. Based on the matrix, the score should be somewhere around - not expected to occur and can result in product recall.

 

With the said measure, does weighing is considered as CCP/ OPRP? 

 

Also i would like to ask if there is significant chemical hazard in the food preservative itself as an ingredient.

[GMO]

I can't see from your risk assessment why it would be either an oPRP or CCP. The calcium propionate is there to prevent mould growth over life. Yes it's possible that you could get mycotoxins with that mould but people don't generally eat mouldy bread.

It might be worth looking at the MSDS to work out how much could cause a health issue. If that's likely. There are apparently some sensitive individuals but they'd avoid your bread by looking at the label.

A provocative question though, why have additional weight checks by quality? What makes you not trust the operator weighing? I'm being slightly cheeky but it's often a thing I come across. I'd rather build confidence in my operators...

But what this absolute must be part of is a quality plan as you won't get the shelf life you have without this additive.

[chrisrushworth]

Hi,

 

We are bakery manufacturer. We used potassium sorbate and calcium propionate in our product as food preservative.

 

In weighing step, there is a potential of chemical hazard where food preservative might be excessively weighed. Control or preventive measure measure as such, QC to verify weigh of food preservative randomly and ensure to use calibrated weighing balance to weigh food preservative. Based on the matrix, the score should be somewhere around - not expected to occur and can result in product recall.

 

With the said measure, does weighing is considered as CCP/ OPRP? 

 

Also i would like to ask if there is significant chemical hazard in the food preservative itself as an ingredient.

 

Wouldn't say its either a CCP or OPRP... but an ingredient required for the recipe, which would be checked by QA to see that all ingredients have been added...

The same as if a "colour" or a "raising agent" hadn't been added?

 

 

Have you applied your rationale to the CCP decision tree?

 

https://myhaccp.food...sion_tree_0.pdf

 

OPRP's seem to be some peoples get out jail card, but these are just a step down from a CCP using staff to verify that pre-requisite/control measures have worked.....

 

..

[jfrey123]

Based on the matrix, the score should be somewhere around - not expected to occur and can result in product recall.

 

With the said measure, does weighing is considered as CCP/ OPRP? 

 

Also i would like to ask if there is significant chemical hazard in the food preservative itself as an ingredient.

 

 

Based on almost any risk matrix I've used in HACCP plans, a rare chance of likelihood intersecting with a high danger usually results in a CP at most and will not escalate to a CCP or OPRP.  See this one as an example: hazard-matrix.png (1104×941).  With what you've described to control the weight of the ingredients, I'd maybe include a signed off review of the recorded ingredient measures, call it a CP and call it a day.

 

As to the chemical hazard itself, if you want to look at consumer overconsumption causing some toxic reaction, drill down into the SDS and find out what levels it becomes toxic to consume it raw.  Compare the odds that you get anywhere near that much in a serving of the finished goods and I think the hazard of it being consumed at a toxic level will reveal itself to be rare or non-existent.

[city03]

I can't see from your risk assessment why it would be either an oPRP or CCP. The calcium propionate is there to prevent mould growth over life. Yes it's possible that you could get mycotoxins with that mould but people don't generally eat mouldy bread.

It might be worth looking at the MSDS to work out how much could cause a health issue. If that's likely. There are apparently some sensitive individuals but they'd avoid your bread by looking at the label.

A provocative question though, why have additional weight checks by quality? What makes you not trust the operator weighing? I'm being slightly cheeky but it's often a thing I come across. I'd rather build confidence in my operators...

But what this absolute must be part of is a quality plan as you won't get the shelf life you have without this additive.

Hi GMO!

 

Actually we just finished our FSSC v6.0 audit and the auditor REALLY emphasize on the weighing step and question why is it low significant, then he issued us an NC for this.

For the health issue, there is cases of product recall due to over limit of preservative (> 2000mg/kg) that may pose adverse health affect.

And about the checking, our operators are the one that do the weighing, QC only to verify the weigh.

[city03]

Based on almost any risk matrix I've used in HACCP plans, a rare chance of likelihood intersecting with a high danger usually results in a CP at most and will not escalate to a CCP or OPRP.  See this one as an example: hazard-matrix.png (1104×941).  With what you've described to control the weight of the ingredients, I'd maybe include a signed off review of the recorded ingredient measures, call it a CP and call it a day.

 

As to the chemical hazard itself, if you want to look at consumer overconsumption causing some toxic reaction, drill down into the SDS and find out what levels it becomes toxic to consume it raw.  Compare the odds that you get anywhere near that much in a serving of the finished goods and I think the hazard of it being consumed at a toxic level will reveal itself to be rare or non-existent.

Hi Jfrey123!

 

May i know the source for example given? The matrix and justification set up by our consultant is kinda weird and not like usual matrix that we seen anywhere. Based on our current matrix (High-Low 3x3 matrix), the result will be LM and should be declared as an OPRP.

 

Do you think it would be best if I changed the matrix? I'm a bit lost on where to start when responding to the NC.

 

For the chemical hazard, the auditor said that anything written in the regulation that has a limit should be a sensitive material.

[GMO]

Hi GMO!

 

Actually we just finished our FSSC v6.0 audit and the auditor REALLY emphasize on the weighing step and question why is it low significant, then he issued us an NC for this.

For the health issue, there is cases of product recall due to over limit of preservative (> 2000mg/kg) that may pose adverse health affect.

And about the checking, our operators are the one that do the weighing, QC only to verify the weigh.

 

It would be good to see the actual wording of the non conformance.  Unless they felt you'd misapplied your own matrix or specifically ignored some obvious, very well known hazard, e.g. you said that Listeria monocytogenes in a chilled product was low severity, I cannot see how an auditor can call your HACCP "wrong".  It's yours not theirs.

 

Presumably this is why you've asked the question.  Did you in the moment ask them to elaborate on why they felt the risk was low?  Or did they feel the risk of misweighing was higher than you stated but the severity was low?  If you're not clear on why it was raised, and it looks like you might not be, go back for more information as otherwise whatever you do to close that non conformity risks being excessive or not addressing the issue they intended.

 

The reason I asked the provocative question re QC verification, is that's a non value add step.  I'm not saying "never do it" but there are better ways to ensure weights are captured accurately.  I have never seen a product recall where I live for excessive dosing of calcium propionate and having worked in bakery did not have a CP, oPRP or anything of the like for our minor ingredient addition.  That excessive dosing level also seems to be extremely high.  How much would it have to have been overdosed for that to happen?

 

Lastly I still don't get how you're getting to an oPRP.  HACCP is about food safety.  How is this a food safety hazard?  I think this is why you're finding it hard and seeing so much disagreement from others.  I ABSOLUTELY would have it as part of my quality plan.  But I'm not seeing how it's a significant hazard in a HACCP plan which is, after all, all about food safety not quality.

 

But it's your plan, not mine.  If you want it as an oPRP, put it in there.  But then you open yourself up to whether your monitoring will be adequate.

[chrisrushworth]

Hi GMO!

 

Actually we just finished our FSSC v6.0 audit and the auditor REALLY emphasize on the weighing step and question why is it low significant, then he issued us an NC for this.

For the health issue, there is cases of product recall due to over limit of preservative (> 2000mg/kg) that may pose adverse health affect.

And about the checking, our operators are the one that do the weighing, QC only to verify the weigh.

 

Can you tell us the NC?

[jfrey123]

Hi Jfrey123!

 

May i know the source for example given? The matrix and justification set up by our consultant is kinda weird and not like usual matrix that we seen anywhere. Based on our current matrix (High-Low 3x3 matrix), the result will be LM and should be declared as an OPRP.

 

Do you think it would be best if I changed the matrix? I'm a bit lost on where to start when responding to the NC.

 

For the chemical hazard, the auditor said that anything written in the regulation that has a limit should be a sensitive material.

 

I pulled that one out of a google search just as an example, but it came from ehaccp.org in case you decide to search around for any documentation of it's validity for use in a program:  Hazard Matrix | HACCP Training and Certification

 

In some light consulting I've done over the years, I think a 3x3 matrix is a bit limiting.  But then again, I've seen auditors poke hard at a 5x5 matrix:  "how did you decide the difference between 'rare' vs 'unlikely'?  How did you decide 'moderate' vs 'major'?"  It's hard when pushed and challenged, but it can make a key difference when challenged as to why you don't think something is escalating to a CCP for your company.

[Tony-C]

Hi GMO!

 

Actually we just finished our FSSC v6.0 audit and the auditor REALLY emphasize on the weighing step and question why is it low significant, then he issued us an NC for this.

For the health issue, there is cases of product recall due to over limit of preservative (> 2000mg/kg) that may pose adverse health affect.

And about the checking, our operators are the one that do the weighing, QC only to verify the weigh.

 

Hi city03, It is possible that you could have got a NC for under dosing as well if it affected the product safety.

 

Hi Jfrey123!

 

May i know the source for example given? The matrix and justification set up by our consultant is kinda weird and not like usual matrix that we seen anywhere. Based on our current matrix (High-Low 3x3 matrix), the result will be LM and should be declared as an OPRP.

 

Do you think it would be best if I changed the matrix? I'm a bit lost on where to start when responding to the NC.

 

For the chemical hazard, the auditor said that anything written in the regulation that has a limit should be a sensitive material.

 

I pulled that one out of a google search just as an example, but it came from ehaccp.org in case you decide to search around for any documentation of it's validity for use in a program:  Hazard Matrix | HACCP Training and Certification

 

In some light consulting I've done over the years, I think a 3x3 matrix is a bit limiting.  But then again, I've seen auditors poke hard at a 5x5 matrix:  "how did you decide the difference between 'rare' vs 'unlikely'?  How did you decide 'moderate' vs 'major'?"  It's hard when pushed and challenged, but it can make a key difference when challenged as to why you don't think something is escalating to a CCP for your company.

 

Hi city03,

 

Whilst I quite like the table posted by jfrey123, the table and comments are less relevant for the FSSC 22000 Certification Scheme.

 

The scheme is based on hazard analysis requirements as prescribed in International Standard ISO 22000: 2018 Food safety management systems — Requirements for any organization in the food chain. Section 8.5.2 covers Hazard analysis and I refer you to the requirements for the selection and categorization of control measure(s) are quoted below:

 

ISO 22000 Clause 8.5.2.4 Selection and categorization of control measure(s)

8.5.2.4.1 Based on the hazard assessment, the organization shall select an appropriate control measure or combination of control measures that will be capable of preventing or reducing the identified significant food safety hazards to defined acceptable levels.

The organization shall categorize the selected identified control measure(s) to be managed as OPRP(s) (see 3.30) or at CCPs (see 3.11).

The categorization shall be carried out using a systematic approach. For each of the control measures selected, there shall be an assessment of the following:

a) the likelihood of failure of its functioning;

b) the severity of the consequence in the case of failure of its functioning; this assessment shall include:

1) the effect on identified significant food safety hazards;

2) the location in relation to other control measure(s);

3) whether it is specifically established and applied to reduce the hazards to an acceptable level;

4) whether it is a single measure or is part of combination of control measure(s).

 

Also, Clause 8.5.2.4.2 requires an assessment of feasibility including for establishing critical limits/action criteria, monitoring to detect failures and applying timely corrective actions.

 

Have a look at this topic Question 4 in Decision Tree of FSSC 22000, you might find it useful.

 

There is also a Table 2: PRPs, OPRPs and CCPs posted there which is from the FSSC Guidance document: ISO 22000 Interpretation

 

Kind regards,

 

Tony

[GMO]

I kind of agree Tony but I'm still failing to see the food safety hazard.  Calcium prioprionate is not required in bread.  Its presence is to lengthen the lifespan of it and reduce the risk of mould growth but is mould growth a food safety risk in itself or is it a risk of spoilage (so quality related) as any mycotoxins would be a risk only by the point the bread is objectionable?

[Tony-C]

I kind of agree Tony but I'm still failing to see the food safety hazard.  Calcium prioprionate is not required in bread.  Its presence is to lengthen the lifespan of it and reduce the risk of mould growth but is mould growth a food safety risk in itself or is it a risk of spoilage (so quality related) as any mycotoxins would be a risk only by the point the bread is objectionable?

 

Hi GMO,

 

I would agree that it is likely that you would see Y&M growth if significant levels of mycotoxin was present but it isn't a guarantee.

 

Clearly adding a preservative is for a function and should be controlled. With the FSSC 22000 Scheme Version 6 there is also a need to control quality, so the way I see it is a NC could be raised for under dosing preservative for food safety or quality or both.

 

FSSC 22000 Version 6.0 | April 2023 Part 2 | Requirements for Organization to be Audited

2.5.9 QUALITY CONTROL (ALL FOOD CHAIN CATEGORIES)

a) The organization shall:

…

ii. Establish, implement and maintain quality parameters in line with finished product specifications, for all products and/or product groups within the scope of certification, including product release that addresses quality control and testing.

 

Kind regards,

 

Tony